Source: https://www.docketalarm.com/cases/PTAB/IPR2018-00421/Inter_Partes_Review_of_U.S._Pat._9693978/
Timestamp: 2018-03-23 01:12:46
Document Index: 392721984

Matched Legal Cases: ['§ 42', '§ 42', '§ 42', 'Application No. 15', '§ 42', 'Application No.06737018', '§314', 'Application No. 14977808']

Inter Partes Review of U.S. Pat. 9,693,978, IPR2018-00421 (P.T.A.B.) via Docket Alarm
") .end() .append($overlay) .find("#docket_report").hide().end() .css('min-height', Math.max($('.counsel_overlay').height(), $('#sidebar').height())) .find(".counsel_overlay .close, #sidebar .close").click(function () { $.bbq.removeState("show_party"); return false; }).end(); $(window).scroll(0); add_counsel_copy(); } function get_visible_text(content) { // Not so easy to get the visible text var saved = $(content).clone(); // Remove the hidden parts $(content).find(':hidden').remove(); // Get the remaining text var visible_text = $(content).text(); // Now revert back to our saved version $(content).replaceWith(saved); return visible_text; } function initialize_show_more_less(){ $(".show_more").click(function () { $.bbq.pushState({show_more : true}); return false; });	$(".show_less").click(function () { $.bbq.removeState('show_more'); return false; }); } function handle_docket_page_keydown(event) { if (event.keyCode === 27) { // ESCAPE: close the counsel window if open. var state = $.bbq.getState(); var caught = false; if(state.show_more) { $.bbq.removeState('show_more'); event.preventDefault(); } if(state.show_party) { $.bbq.removeState('show_party'); event.preventDefault(); } } else if (event.keyCode === 38 || event.keyCode === 40) { // UP/DOWN ARROW: Cycle through parties. var state = $.bbq.getState(); if(state.show_party) { var party_idx = parseInt(state.show_party.split("-")[0]); if (!isNaN(party_idx)) { var $cur = $("#dockets_bd .pname[data-index=" + party_idx + "]"); var $to_click = event.keyCode === 38 ? $($cur.prevAll(".pname")[0]): $($cur.nextAll(".pname")[0]); event.preventDefault(); $to_click.click(); } } } else if(event.keyCode == 70 && (event.ctrlKey || event.metaKey)) { // Ctrl+F: filter the docket page. var state = $.bbq.getState(); if (state.show_party) { // Use normal CTRL+F when viewing a party. return; } $("#FilterBlock input, .FilterBlock input").focus().select(); if(!$("#FilterBlock input, .FilterBlock input").is(":visible") || parseInt($("#actionbar").css("margin-top")) < 0) { $('html,body').animate({ scrollTop: 0}, 150); } event.preventDefault(); } } function handle_party_click() { var key_val = $(this).attr('href').slice(1).split("="); var new_state = {}; new_state[key_val[0]] = key_val[1]; $.bbq.pushState(new_state); return false; } /** * Does all sorts of initialization for the docket report */ function initialize_docket_report() { /////////// // Handle Parties and Counsel Overlay. $(".pname").click(handle_party_click); initialize_show_more_less(); // Remove the listener so it doesn't double up. window.removeEventListener('keydown', handle_docket_page_keydown); window.addEventListener('keydown', handle_docket_page_keydown); /////////// // Handle emailing the docket report $("#email_docket").button({ icons: { primary: "ui-icon-mail-closed" } }).click(function () { $(".update_docket.button").button( "option", "disabled", true); $("#email_docket").button( "option", "disabled", true); progress_loader(true, 3, "email"); $.post("/email_docket_report.ajax", {id:5350415818686464}, function(result) { progress_loader(false, null, "email"); if(result.success) { show_success_usermsg("Email Sent");	// Reload the page to reflect the updated docket if(result.updated) location.reload(); } else { show_error_usermsg(result.error); } $(".update_docket.button").button( "option", "disabled", false); $("#email_docket").button( "option", "disabled", false); }, "json"); return false; }); /////////// // Handle updates to the docket $("#update_docket.button").button({ icons: { primary: "ui-icon-refresh" } }); $(".update_docket").click(function () { update_docket_report(); return false; }); // Make sure the messages span across the entire width of the table var th_len = $("#docket_report th:visible").length; if(th_len) { $("#docket_report .message td").attr("colspan", th_len); } /////////// // Copy Docket to clipboard function get_party_info_text() { function fixup_txt(txt) { return get_visible_text(txt) // Remove all "big" whitespace .replace(/\r?\n|\r|\t/g, " ") .replace(/[\s\b]+/g, " ") // A bit hackish, but remove links .replace(/\(?\s*view\s+docket\s*\)?/g, "") .replace(/\(?\s*view\s+document\s*\)?/g, "") .replace(/\(\s*view\s*\)/g, "") .strip(); } function get_fixedspace(cols, col_widths, num_spaces) { var has_text=false, out=""; do { has_text = false; for(i=0; i<= col_widths[i] ? cols[i].length: last_space > 0 ? last_space: col_widths[i]; if(width > 0) { has_text = true; out += cols[i].substr(0, width); } // Now add column spacers for(j=0; j < num_spaces + col_widths[i]-width; j++) out += " "; cols[i] = cols[i].substr(width); } out = out.strip() + "\n"; } while(has_text); return out; } // Figure out how much data is in each column var max_widths = [], tot_widths = []; $("table#docket_report tr:visible").each(function() { var cols = $(this).find("td:visible:not(.nocopy), th:visible:not(.nocopy)"); for(i=0; i max_widths[i]) max_widths[i] = txt_len; if(!tot_widths[i]) tot_widths[i] = txt_len; else tot_widths[i] += txt_len; } }); // Calculate the amount of space between columns var num_spaces = max_widths.length < 4 ? 4 : max_widths.length < 5 ? 2: 1; // Certain columns may have fixed widths. Give first column, // the date column, a fixed witdth. var fixed_width = {0:10}; // Now calculate the rest of the column widths var tot_max_width=0, tot_tot_width=0, tot_fixed_width=0; for(i=0; i< min_var_width ? max_widths[i] + 1 : min_var_width; for(k=i+1; kmin_width) { char_widths[i]++; char_widths[k]--; } } } var out = ""; $("table#docket_report tr:visible").each(function() { var cols = $(this).find("td:visible:not(.nocopy), th:visible:not(.nocopy)") .map(function (i, e) { return fixup_txt(e) } ); out += get_fixedspace(cols, char_widths, num_spaces) + "\n"; }); return out; } copy_to_clipboard("#clipboard_docket", function _get_text($this) { // Get the citation name and remove extra spaces return get_party_info_text() + "\nDocket Alarm\n" + window.location.toString(); }, "Docket copied"); /////////// // The docket sidebar. var $sidebar = $("#sidebar"); setup_common_sidebar($sidebar[0], $("#footer")[0], ".panel > h3, .panel > p, .pname, .jump_to"); // On window resize, reset sidebar state b/c size affects whether // sidebar gets shown by default. var win_width = $(window).width(); $(window).resize(function () { // Correct the x-location of the sidebar if the height changes. if(win_width != $(window).width()) { $sidebar.css('left', ''); win_width = $(window).width(); } }); /////////// // Handle the docket tracking link if(user_logged_in) { // If logged in, show the tracking link $(".docket_add:not(.signup)") .click(function () { analytics_track("docket", "track"); var dockadd$ = $(this); dockadd$.addClass("clicked"); var data = get_docket_info_from_object($("#HiddenCaseInfoBlock")); add_docket(data, function () { dockadd$.removeClass("clicked"); $(".search_result_loader").hide(); $("#DocketSearchOverlay").dialog("close"); }, function (result) { dockadd$.removeClass("clicked"); edit_docket(result.alert_id); } ); }); } else { // If no user is logged in, then tracking becomes signup. $(".docket_add").addClass("signup").attr("href", "#") // Unbind any other click handlers that may bring up other windows. .unbind('click') .click(function () { show_signup_dialog(false, false, true); return false; }).show(); } // Handle the docket tracking edit link. $(".docket_edit") .click(function() { // Edit the user's alert id if we have one, otherwise the anonymous edit_docket(user_alert_id || 5350415818686464 ); }); on_docket_changed_calback = function(alert_id) { if(alert_id == "null" || !user_alert_id) document.location.reload(true); } $(".docket_export").click(function() { if(show_signup_dialog(false, false, false, true)) { return; } var $t = $(this).addClass('disabled'); var $case_info = $("#HiddenCaseInfoBlock"); export_docket_report({ data : { title: $case_info.find(".title").text(), docket: $case_info.find(".docket").text(), court: $case_info.find(".court").text(), court_id: $case_info.find(".court_id").text(), link: $case_info.find(".link").text(), sig: $case_info.find(".sig").text(), }, success : function (url) { window.location = url; // It takes a moment to download, don't enable yet. setTimeout(function () { $t.removeClass('disabled'); }, 1000); }, error : function (e) { $t.removeClass('disabled'); show_error_usermsg(e); }, }) return false; }); /////////// // Handle filtering the docket. var last_update = null; function enqueue_filter_update() { // Wait a half second until the user finishes typing, then update if(last_update) clearTimeout(last_update) last_update = setTimeout(function () { last_update = null; var filter = $("#filter_txt").val(); $.bbq.pushState({q:filter}); $("#filter_txt").dequeue(); }, 10); } $("#FilterBlock") .find("#filter_txt").keydown(function (e) { if (e.which == 13) { // Enter. if($("#filter_txt").val() == $.bbq.getState().q) { // Nothing has changed. Advance to the next/prev result. highlight_next_prev(!event.shiftKey); } else { // The filter has changed. enqueue_filter_update(); } } else if (event.keyCode === 27) { // Escape, clear the filter. $("#filter_txt").val(""); $.bbq.removeState('q'); enqueue_filter_update(); // If the filter box has focus, clear it. $("#FilterBlock input, .FilterBlock input").blur(); } else { // We cant update on each letter, if we use bbq state. ; // enqueue_filter_update() } $(".filter_error").fadeOut("slow"); }) // Add a blur handler for mobile which doesn't really have "return" .blur(enqueue_filter_update).end() .find(".do_search").click(enqueue_filter_update).end(); $(".filter_show_all").click(function (e) { $("#filter_txt").val(""); enqueue_filter_update(); return false; }); /////////// // Handle the little scroll-bar indicator at the right. var $date_scroller = $("
").hide(); $("body").append($date_scroller); $.expr[':'].inviewport = function(obj, index, meta, stack) { var r = obj.getBoundingClientRect(); return r.bottom > 0 && r.top < document.documentElement.clientHeight; } var $doc_report = $("#docket_report"); var fadeTimeout = null; $(window).scroll(function() { var date = null; // Only find the relevant date if we've scrolled into the docket report. if($doc_report[0].getBoundingClientRect().top <= 0) { // Get all of the var first = $doc_report.find(".docket_row:inviewport").first(); if(first && first.length) { date = first.find(".filing_date_col").attr("datetime"); } } // Stop any animations that we may be doing. if(fadeTimeout) { clearTimeout(fadeTimeout); } if(date && date.length) { // No need to show the day. Month and year are good. date = date.replace(/\/\d+\//g, '/'); $date_scroller.text(date).show().css("opacity", 1); // Make it slowly fade out. fadeTimeout = setTimeout(function () { $date_scroller.fadeOut("slow"); }, 1300); } else { // No date. Immediately close it. $("#date_scroller").hide(); } }); //////////// // The analytics button and the analytics pane underneath the actionbar. var $anabar = $("#analyticsbar"); var analytics_opts = null; function get_analytics_opts(callback) { // Grab all of the analytics options for this docket from the server. if(analytics_opts) { callback(); return; } var param = $.param({ court:"Patent Trial and Appeal Board", docket:"IPR2018-00421" }); // Show a loader if it's going to take a while (it shouldn't). var loadershow = setTimeout(function() { $("#top_loader").show(); }, 100); $.getJSON("/analytics/options.ajax?" + param, function(resp) { if(resp.success) { delete resp.success; // Remove the mesage from the payload. clearTimeout(loadershow); // Don't let the loader be shown. $("#top_loader").hide(); // Close it if it already was shown. analytics_opts = resp; // Save the analytics options. callback(); } else { show_error_usermsg(resp.error); } }); } $(".do_analytics").click(function () { var ANALYTICS_HEIGHT = 108; if($anabar.is(":visible") && $anabar.height()) { // Hide it. $anabar.animate({height:0}, 200, function() { $anabar.hide(); }); } else { // Show it. analytics_track("docket", "analytics"); get_analytics_opts(function() { $anabar.find(".type").addClass("disabled"); for(k in analytics_opts) { if(analytics_opts[k].length) { // Find the corresponding type field. var $atype = $anabar.find(".type[data-type=" + k + "]"); // Enable it. $atype.removeClass("disabled"); if(!$atype.length) { console.log("Unknown analytics type"); } } } // Show the analytics pane $anabar.css('display', 'block') .animate({height: ANALYTICS_HEIGHT}, 200); }); } }); $anabar.find(".select_type .type").click(function () { if($(this).hasClass("disabled")) { return false; } var type = $(this).data("type"); var vals = []; $anabar .find(".select_subtype select").html(analytics_opts[type].map( function(v) { return "" + v.val + ""; }).join("")).change().end() .find(".select_type").hide().end() .find(".select_subtype") .find(".select div").text("Select " + capitalize(type)).end() .find(".type").html($(this).html()).end() .data("type", type) .show(); }).end().find(".select_subtype .back").click(function () { $anabar .find(".select_type").show().end() .find(".select_subtype").hide(); }).end().find(".select_subtype .select select").change(function () { $anabar.find(".select_subtype a.view").attr('href', $(this).val()); }); /////////////////// // Handle the actionbar during resizing. $(window).resize(function () { adjust_actionbar_items($("#actionbar"), $("#docket_report")); }); adjust_actionbar_items($("#actionbar"), $("#docket_report")); } function update_docket_page_from_state() { var state = $.bbq.getState(); if(state.q && state.q != $("#filter_txt").val()) { $("#filter_txt").val(state.q); } else if (!state.q) { $("#filter_txt").val(""); } filter_docket_report(state.q); if(state.show_more) { $("#parties_block, #sidebar .panel").addClass("more_shown"); } else { $("#parties_block, #sidebar .panel").removeClass("more_shown"); } show_party_detail(state.show_party); } $(document).ready(function() { download_docket_report(function () { var party_html = create_party_rows(parties_by_type.special_names_by_type, parties_by_type.other, function (html) { $(".parties .pnames").html(html); initialize_show_more_less(); $(".pname").click(handle_party_click); create_docket_rows(); update_from_state(); }); }); // Creates the first twenty docket rows create_docket_rows(); // Update Menus update_from_state(); // Make the party buttons work, among other things. initialize_docket_report(); $(window).bind('hashchange', function(e) { update_docket_page_from_state(); }); // Update now update_docket_page_from_state(); // And also when the docket report is done being rendered. onEvent('docket_report_render_complete', update_docket_page_from_state); }); /** * Presents a dialog box to the user offering to batch download filings in the * docket report. */ function download_docket_filings() { if(docket_report_needs_download) { // The docket is not yet fully downloaded. show_error_usermsg("This docket is still downloading, please try again " + "in a few seconds.") return; } function remove_checks() { // Remove the checkboxes, if there are thousands, this may also take time. $("#docket_report tr .dl_check, #docket_report tr .dl_check_all").remove(); $("#docket_report tr .noDownload").removeClass("noDownload"); // Take us out of the mode. $("body").removeClass("download_mode"); } if($("body").hasClass("download_mode")) { // If we're already in download mode, get out of it. remove_checks(); var dialog = $(".ui-dialog.download_dialog #warning_msg"); if(dialog && dialog.length) { $(".ui-dialog.download_dialog #warning_msg").dialog("destroy").remove(); } return; } analytics_track("docket", "download"); var $case_info = $("#HiddenCaseInfoBlock"); var doc_data = { title: $case_info.find(".title").text(), docket: $case_info.find(".docket").text(), court: $case_info.find(".court").text(), court_id: $case_info.find(".court_id").text(), }; function get_file_list($dialog, callback) { // A function which generates the list of all documents. var file_list = []; var docket_i = 0; var docket_rows = $("#docket_report tr"); // We can grab data on multiple documents at once. var num_at_once = 5; function update_progress_and_do_next(incr) { // Increment the filing counter. docket_i += (incr || 1); // Set the progress bar var perc = 100 * docket_i / docket_rows.length; $dialog .find(".status").text("Preparing " + file_list.length + " documents for download.").end() .find(".perc").text(perc.toFixed(0) + "%").end() .find(".progress .bar").width(perc + "%"); // Go on to the next document. if(docket_i % 5 == 0) { // Don't let the callstack get too high. setTimeout(get_next_docket_entry, 0); } else { get_next_docket_entry(); } } function get_next_docket_entry() { if($dialog.data("canceled") === true) { // User canceled and closed the dialog box. Abort. remove_checks(); return; } if (docket_i >= docket_rows.length) { // completion callback remove_checks(); // Removing checks changes the DOM, recenter the dialog. $dialog.dialog("option", "position", {my: "center", at: "center", of: window}); if(file_list.length == 0) { // No files selected. show_error_usermsg("No files selected.", "nofiles"); } // Make the callback, even if there are no files. callback(file_list); return; } var filings = []; for(var n_i = 0; n_i <= num_at_once; n_i ++) { if (docket_i >= docket_rows.length) { break; } var $row = $(docket_rows[docket_i + n_i]); // Make sure this one is checked. if($row.find("input").is(":checked") !== true || // Ignore the select all row. $row.find("th .dl_check_all").length > 0) { // Go to the next one. continue; } // Now get the index in the docket report. var docket_report_i = $row.data("i"); if(docket_report_i === undefined) { // This shouldn't happen, but try to fail gracefully. console.log("No docket report in row"); update_progress_and_do_next(n_i + 1); return; } filings.push(docket_report[docket_report_i].number); } if(!filings.length) { update_progress_and_do_next(num_at_once); return; } var getdata = $.param(doc_data) + "&" + filings.map(function (f) { return "filing=" + encodeURIComponent(f); }).join("&"); $.get("/get_attachment_list.ajax", getdata, function(result) { if(result.success) { var results = result.all; if(!results) { results = {}; results[filings[0]] = result; } var status = ''; var num_more = 0; for (filing_num in results) { var r = results[filing_num]; // Set the status. status += "
"); } update_progress_and_do_next(num_at_once); }, 'json'); } $dialog // Recenter as we may have scrolled during file selection. .dialog("option", "position", {my: "center", at: "center", of: window}) // Set the status. .find(".status").text("Determining filings to download."); get_next_docket_entry();	} if(show_signup_dialog(false, true, false)) { return; } // First figure out which documents to download. This is fast. var indices_to_download = {}; for(var i = 0; i < docket_report.length; i++) { var d = docket_report[i]; if(d.link) { indices_to_download[i] = true; } else if (d.exhibits && d.exhibits.length) { for(var j = 0; j < d.exhibits.length; j++ ){ if(d.exhibits[j].link) { indices_to_download[i] = true; break; } } } } // Put us into download mode. $("body").addClass("download_mode"); // Add checkboxes to each filing. This can be slow so we do it asynchronously. var canceled = false; // Add one checkbox to one docket row synchronously. function add_checkbox_if_necessary($self, idx) { if(canceled) { return false; } var found_in_report = false; // Get the docket report index var i = $self.data("i"); if(i !== undefined) { found_in_report = indices_to_download[i]; } else { // This may be an organized report var indices = $self.data("i") || []; for (i in indices) { if (indices_to_download[i] == true) { found_in_report = true; break; } } } if(found_in_report) { // Adding with innerHTML is faster than append. It's still slow though. $self.find("td:first")[0].innerHTML += " " + " Select "; } else { $self.addClass("noDownload"); } return found_in_report; }; var $rows = $("#docket_report tr.docket_row"); // Counters to determine how many items have been added and if we're done. var added_checkboxes = 0; var last_idx = 0; var finished_checkboxes = false; // Add a set of checkboxes, calling the function above, and setting vars. function add_checkbox_range(start_idx, end_idx) { if(canceled) { finished_checkboxes = true; return; } var max_idx = end_idx > $rows.length ? $rows.length : end_idx; for(var i = start_idx; i < max_idx; i++) { if(add_checkbox_if_necessary($($rows[i]), i)) { added_checkboxes += 1; } last_idx = i; } if(i >= $rows.length - 1) { finished_checkboxes = true; } } // Add checkboxes to each downloadable item. This is slow, so do it async. var SYNC_CHECKBOXES = 200; // How many checkboxes to add at once. var ASYNC_TIME = 50; // How often we add them. var MIN_PROGRESS_BAR = 100; // The minimum we need to even use a progress bar. // Make one synchronous call. add_checkbox_range(0, SYNC_CHECKBOXES); // Setup the asynchronous calls. function get_async_calls(start) { if(start === undefined) { start = SYNC_CHECKBOXES; } return function () { add_checkbox_range(start, start + SYNC_CHECKBOXES); if(!finished_checkboxes) { setTimeout(function () { get_async_calls(start + SYNC_CHECKBOXES)(); }, ASYNC_TIME); } }; } // After we've checked a few docket entries, check some corner cases. if(added_checkboxes == 0) { show_error_usermsg("No documents to download.", "nofiles"); $("body").removeClass("download_mode"); return; } else if(added_checkboxes == 1) { // If there is only one, set it checked by default. $("#docket_report tr .dl_check input").prop('checked', true); } else if(added_checkboxes > 1) { // Add a select all checkbox if there are multiple. $("#docket_report tr th:first").append(" " + " Select All " ).find("input").change(function() { var check_all = $(this).is(":checked"); $("#docket_report tr .dl_check input").prop('checked', check_all); });	} // Setup the floating dialog. var msg = "Select the documents to download. " if (!last_billing_info.is_user_flat_rate) { msg += "Under the pay-as-you-go plan, you may " + "be charged for each downloaded document. " } var diag_pos = { my:"right bottom", at:"right top", of:$("#docket_report")}; var $picker_dialog = show_confirm_usermsg({ title : "Batch Download", subtitle : msg, okay : function() { if(!finished_checkboxes) { // Don't close the dialog. return false; } // Proceed download_files(get_file_list, "Inter Partes Review of U.S. Pat. 9,693,978.zip"); }, cancel : function() { canceled = true; remove_checks(); }, dialog_options : { dialogClass : "download_dialog", closeOnEscape : false, modal : false, // Put the dialog at the right edge of the docket report. position : diag_pos, }}) .find(".okay").text("Download").end(); function check_finished_checkboxes() { if(finished_checkboxes) { $picker_dialog .find(".warning").text(msg).end() .find(".okay").removeClass("disabled").end() .dialog('option', 'position', diag_pos); } else if(!canceled) { var perc = ((last_idx / $rows.length) * 100).toFixed(1); $picker_dialog .find(".warning").text("Preparing, " + perc + "% complete.").end() .find(".okay").addClass("disabled").end(); // Run this function again to setTimeout(check_finished_checkboxes, ASYNC_TIME); return; } } if($rows.length >= MIN_PROGRESS_BAR) { check_finished_checkboxes(); } // Asynchronously dequeue, so that we get a chance to reflow/refresh. setTimeout(function () { get_async_calls()();}, ASYNC_TIME); return false; } $(document).ready(function () { $(".download_docket_filings").click(download_docket_filings); }); /************************************************** * Create Docket Rows **************************************************/ var docket_report = JSON.parse('[\u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Board Notice of Filing Date Accorded to Petition None: Notice of Accord Filing Date (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00222/22/2018\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002202\u002D22\u002D2018\u002DBoard\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Notice_of_Filing_Date_Accorded_to_Petition\u002D5\u002DNotice_of_Accord_Filing_Date\u0022, \u000A \u0022number\u0022: \u002202\u002D22\u002D2018\u002DBoard\u0022, \u000A \u0022filing_party\u0022: \u0022Board\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: null, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYTY4NGMwNTMtOTE1Yy00ODg1LTk3MWItODZiMmQyNDUxNWIyOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/02\u002D22\u002D2018\u002DBoard/Notice_of_Filing_Date_Accorded_to_Petition\u002D5\u002DNotice_of_Accord_Filing_Date/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYTY4NGMwNTMtOTE1Yy00ODg1LTk3MWItODZiMmQyNDUxNWIyOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00222/22/2018\u0022, \u000A \u0022date_added\u0022: \u00222/22/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 5040, \u000A \u0022pages\u0022: 5, \u000A \u0022e2e_number\u0022: \u00225\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Notice of Accord Filing Date\u0022, \u000A \u0022filename\u0022: \u0022IPR2018\u002D00421 Caption.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 5040, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022parties_from_title\u0022: [\u000A [\u000A \u0022CATALENT PHARMA SOLUTIONS, INC.\u0022\u000A ], \u000A [\u000A \u0022PATHEON SOFTGELS INC.\u0022\u000A ]\u000A ], \u000A \u0022num_pages\u0022: 6, \u000A \u0022parties\u0022: {\u000A \u0022petitioner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Gregory L. Porter, Esq.\u0022, \u000A \u0022email\u0022: \u0022GregPorter@andrewskurth.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022David Bradin, Esq.\u0022, \u000A \u0022email\u0022: \u0022DavidBradin@andrewskurth.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Andrews Kurth LLP\u0022\u000A }\u000A ], \u000A \u0022patent owner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Eldora L. Ellison\u0022, \u000A \u0022email\u0022: \u0022eellison\u002DPTAB@skgf.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022David H. Holman\u0022, \u000A \u0022email\u0022: \u0022dholman\u002DPTAB@skgf.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022David W. Roadcap\u0022, \u000A \u0022email\u0022: \u0022droadcap\u002DPTAB@skgf.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Sterne, Kessler, Goldstein \u0026 Fox P.L.L.C.\u0022\u000A }\u000A ]\u000A }, \u000A \u0022patents\u0022: [\u000A \u00229693978\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022For more information, please consult the Office Patent Trial Practice Guide, 77 Fed. Reg. 48756 (Aug. 14, 2012), which is available on the Board Web site at http://www.uspto.gov/PTAB.\u0022, \u000A \u0022Patent Owner is advised of the requirement to submit mandatory notice information under 37 C.F.R. § 42.8(a)(2) within 21 days of service of the petition.\u0022, \u000A \u0022The parties are advised that under 37 C.F.R. § 42.10(c), recognition of counsel pro hac vice requires a showing of good cause.\u0022, \u000A \u0022Many non\u002Dprofit organizations, both inside and outside the intellectual property field, offer alternative dispute resolution services.\u0022, \u000A \u0022If the parties actually engage in alternative dispute resolution, the PTAB would be interested to learn what mechanism (e.g., arbitration, Case IPR2018\u002D00421 Patent No. 9,693,978 mediation, etc.) was used and the general result.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Notice of Filing Date Accorded to Petition\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Patent Owner Power of Attorney None: Patent Owner Power of Attorney (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPatent Owner Mandatory Notice None: Patent Owner Mandatory Notice (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00222/14/2018\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002202\u002D14\u002D2018\u002DPatent_Owner\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Power_of_Attorney\u002D4\u002DPatent_Owner_Power_of_Attorney\u0022, \u000A \u0022number\u0022: \u002202\u002D14\u002D2018\u002DPatent_Owner\u0022, \u000A \u0022filing_party\u0022: \u0022Patent Owner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: null, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMjE3Mjg0YzAtMzc0OC00NTRmLTk1YWMtNGNmMzg2OGM2MjY4OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/02\u002D14\u002D2018\u002DPatent_Owner/Power_of_Attorney\u002D4\u002DPatent_Owner_Power_of_Attorney/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMjE3Mjg0YzAtMzc0OC00NTRmLTk1YWMtNGNmMzg2OGM2MjY4OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00222/14/2018\u0022, \u000A \u0022date_added\u0022: \u00222/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 16308, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u00224\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Patent Owner Power of Attorney\u0022, \u000A \u0022filename\u0022: \u0022IPR2018\u002D00421 Patent Owner Power of Attorney.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 16308, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 4, \u000A \u0022patents\u0022: [\u000A \u00229693978\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Mail Stop \u005C\u0022PATENT BOARD\u005C\u0022 Patent Trial and Appeal Board U.S. Patent and Trademark Office P.O.\u0022, \u000A \u0022Patent No. 9,693,978 Pursuant to 37 CPR.\u0022, \u000A \u0022§ 42.10(b), Patent Owner Patheon Softgels Inc., having a principal place of business at 4815 Emperor Blvd, Durham, NC 27703, hereby appoints the following practitioners as its attorneys to transact all business in the United States Patent \u0026 Trademark Office associated with an inter partes review of US.\u0022, \u000A \u0022The undersigned hereby certifies that the above\u002Dcaptioned Patheon Softgels Inc.’s Power of Attorney was served in its entirety on February 14, 2018, upon the following parties via email: Gregory L. Porter, Esq.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Power of Attorney\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Mandatory_Notice\u002D3\u002DPatent_Owner_Mandatory_Notice\u0022, \u000A \u0022number\u0022: \u002202\u002D14\u002D2018\u002DPatent_Owner\u0022, \u000A \u0022filing_party\u0022: \u0022Patent Owner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: null, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZDBhYjc2OTYtZTlhMC00NzlmLTg2ZjktMTk2ZjNjYzhmODM0OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/02\u002D14\u002D2018\u002DPatent_Owner/Mandatory_Notice\u002D3\u002DPatent_Owner_Mandatory_Notice/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZDBhYjc2OTYtZTlhMC00NzlmLTg2ZjktMTk2ZjNjYzhmODM0OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00222/14/2018\u0022, \u000A \u0022date_added\u0022: \u00222/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 16308, \u000A \u0022pages\u0022: 5, \u000A \u0022e2e_number\u0022: \u00223\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Patent Owner Mandatory Notice\u0022, \u000A \u0022filename\u0022: \u0022IPR2018\u002D00421 Patent Owner Mandatory Notice.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 16308, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 6, \u000A \u0022patents\u0022: [\u000A \u00229038884\u0022, \u000A \u00229693978\u0022, \u000A \u00229693979\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Patent Owner, Patheon Softgels Inc., hereby files mandatory notices pursuant\u0022, \u000A \u0022Application No. 15/817,471 filed November 20, 2017 (pending).\u0022, \u000A \u0022The following judicial matters may be affected by a decision in this proceeding:\u0022, \u000A \u0022Please direct all correspondence regarding this proceeding to the lead and back\u002Dup counsel at the addresses listed above.\u0022, \u000A \u0022The Patent Trial and Appeal Board is hereby authorized to charge any fees associated with this proceeding to Deposit Account 19\u002D0036 (Customer ID No. 45324).\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Mandatory Notice\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Petitioner Power of Attorney None: Petitioner\u0027s Power of Attorney (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Petition None: Petition for Inter Partes Review of U.S. Patent No. 9,693,978 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1001: Declaration of Peter Draper (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1002: Curriculum Vitae of Peter Draper (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1003: U.S. Patent No. 9,693,978 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1004: Prosecution History of U.S. 9,693,978 (60/659,679) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1005: Prosecution History of U.S. 9,693,978 (11/367,238) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1006: Prosecution History of U.S. Patent No. 9,693,978 (App. No. 14/977,808) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1007: Prosecution History of EP 1863458 (Counterpart of U.S. Patent No. 9,693,978) (Part A) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1007: Prosecution History of EP 1863458 (Counterpart of U.S. Patent No. 9,693,978) (Part B) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1008: Prosecution History of U.S. Patent No. 9,693,979 (App. No. 15/159,972) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1009: U.S. Patent No. 6,383,471 (¿¿¿Chen¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1010: U.S. Publication No. 20040157928 (¿¿¿Kim¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1011: U.S. Publication No. 20040224020 (¿¿¿Schoenhard¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1012: U.S. Patent No. 5,141,961 (¿¿¿Coapman¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1013: U.S. Patent No. 5,641,512 (¿¿¿Cimileuca¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1014: U.S. Patent No. 5,360,615 (¿¿¿Yu¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1015: U.S. Patent No. 6,383,515 (¿¿¿Sawyer¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1016: U.S. Publication No. 20060099246 (¿¿¿Tanner¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1017: Wikipedia, Conjugate acid (July 8, 2016) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1018: U.S. Publication No. 20050158377 (¿¿¿Popp¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1019: U.S. Patent No. 6,066,339 (¿¿¿Stark¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1020: U.S. Patent No. 6,251,426 (¿¿¿Gullapalli¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1021: Banner Pharmacaps, Inc. Citizen Petition to the Food and Drug Administration (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1022: Wikipedia, Robert Pauli Scherer, https://en.wikipedia.org/wiki/Robert_Pauli_Scherer (January 8, 2018) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1023: R.M.C. Dawson et al., Data for Biochemical Research (Oxford: Clarendon Press 1959) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1024: Jarkko Rautio et al., ¿¿¿In Vitro Evaluation of Acyloxyalkyl Esters as Dermal Prodrugs of Ketoprofen and Naproxen,¿¿¿ Journal of Pharmaceutical Sciences, Vol. 87, No. 12, 1622\u002D1628 (December 1998) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1025: Letter from Sharon Hertz, Department Of Health \u0026 Human Services, to Roche Palo Alto LLC regarding NDA 18\u002D965 (November 10, 2004) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1026: U.S. Patent No. 3,035,973 (¿¿¿Klotz¿¿¿) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1027: H. Sevelius et al., ¿¿¿Bioavailability of Naproxen Sodium and Its Relationship to Clinical Analgesic Effects,¿¿¿ 10 Br. J. Clin. Pharmac. 259\u002D263 (1980) (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1028: Banner Pharmacaps Inc. NDA 21\u002D920, Naproxen Sodium Capsules (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1029: Robert Thornton Morrison \u0026 Robert Neilson Boyd, Organic Chemistry (4th ed., Allyn and Bacon, Inc. 1983) (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Power_of_Attorney\u002D1\u002DPetitioners_Power_of_Attorney\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: null, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZTY2ZWU5NzMtOGY5MC00MDAyLTlhOWQtZWExMjUzNGI3ZmU2OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Power_of_Attorney\u002D1\u002DPetitioners_Power_of_Attorney/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZTY2ZWU5NzMtOGY5MC00MDAyLTlhOWQtZWExMjUzNGI3ZmU2OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u00221\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Petitioner\u0027s Power of Attorney\u0022, \u000A \u0022filename\u0022: \u0022POA_978.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 4, \u000A \u0022patents\u0022: [\u000A \u00229693978\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Mail Stop PATENT BOARD Patent Trial and Appeal Board US.\u0022, \u000A \u0022Pursuant to 37 C.F.R. § 42.10 (b), Catalent Pharma Solutions, Inc. hereby appoints the Practitioners associated with Customer No. 23444, as its attorneys to prosecute the aforementioned proceeding, and to transact all business in the United States Patent and Trademark Office connected therewith, including the appointment of lead and back\u002Dup counsel.\u0022, \u000A \u0022Please recognize the correspondence addresses (including any electronic mail addresses) for the above identified Inter Partes Review proceeding number to be the addresses associated with the appointed lead and back\u002Dup counsel.\u0022, \u000A \u0022The undersigned is authorized to sign this Power of Attorney on behalf of Catalent Pharma Solutions, Inc.\u0022, \u000A \u0022Dated: January 3\u003B, 2018 Catalent Pharma Solutions, Inc.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Power of Attorney\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Petition\u002D2\u002DPetition_for_Inter_Partes_Review_of_US_Patent_No_9,693,978\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: null, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvN2EyNWY5NGYtYjE4OS00YmE0LTg5ODYtMzYyMDk5MGY2ZGM2OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Petition\u002D2\u002DPetition_for_Inter_Partes_Review_of_US_Patent_No_9%2C693%2C978/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvN2EyNWY5NGYtYjE4OS00YmE0LTg5ODYtMzYyMDk5MGY2ZGM2OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 69, \u000A \u0022e2e_number\u0022: \u00222\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Petition for Inter Partes Review of U.S. Patent No. 9,693,978\u0022, \u000A \u0022filename\u0022: \u0022Petition_978.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [\u000A {\u000A \u0022type\u0022: \u0022Petition\u0022\u000A }\u000A ], \u000A \u0022parties_from_title\u0022: [\u000A [\u000A \u0022CATALENT PHARMA SOLUTIONS, INC.\u0022\u000A ], \u000A [\u000A \u0022PATHEON SOFTGELS INC.\u0022\u000A ]\u000A ], \u000A \u0022num_pages\u0022: 70, \u000A \u0022parties\u0022: {\u000A \u0022petitioner\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Andrews Kurth\u0022\u000A }\u000A ], \u000A \u0022patent owner\u0022: []\u000A }, \u000A \u0022patents\u0022: [\u000A \u00225681584\u0022, \u000A \u00225641512\u0022, \u000A \u00226383471\u0022, \u000A \u00226482516\u0022, \u000A \u00225141961\u0022, \u000A \u00225595758\u0022, \u000A \u00225146730\u0022, \u000A \u00226383515\u0022, \u000A \u00226251426\u0022, \u000A \u00229693978\u0022, \u000A \u00229693979\u0022, \u000A \u00226066339\u0022, \u000A \u00225360615\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Accordingly, the soft gelatin capsule solvent systems and partial ionization techniques of the type used in the ’978 Patent were well known for use in naproxen salt and other softgel formulations well before March 8, 2005.\u0022, \u000A \u0022Appropriate calculations to convert mole equivalents to weight percent show that the broadest reasonable interpretation of “about 5%” to a POSA Petition for Inter Partes Review Patent No. 9,693,978\u0022, \u000A \u00222 The Patentee’s purported other goals of increasing naproxen sodium bioavailability by partially neutralizing it with lactic acid, and suppressing PEG Petition for Inter Partes Review Patent No. 9,693,978\u0022, \u000A \u0022The carrier includes an “ionizing agent capable of ionizing the functional group,” a surfactant, and optionally solubilizers, triglycerides, and neutralizing Petition for Inter Partes Review Patent No. 9,693,978\u0022, \u000A \u0022The working examples ([0080]\u002D[0092]) used either naproxen (230 g/mole) or the close structural analog Dexibuprofen (206 g/mole) (i.e., both compounds are aromatic\u002Dsubstituted propanoic acids, with similar molecular weights, pKa values, aqueous\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Petition\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1001\u002DDeclaration_of_Peter_Draper\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 1, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTc4ZmUzMTQtMGU2Mi00NmMwLThhZDUtNWE3MTAyNjkxZDIxOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1001\u002DDeclaration_of_Peter_Draper/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTc4ZmUzMTQtMGU2Mi00NmMwLThhZDUtNWE3MTAyNjkxZDIxOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 107, \u000A \u0022e2e_number\u0022: \u00221001\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221001\u0022, \u000A \u0022title\u0022: \u0022Declaration of Peter Draper\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1001_978 2018\u002D01\u002D14 Final Expert Declaration.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 108, \u000A \u0022patents\u0022: [\u000A \u00225641512\u0022, \u000A \u00226383471\u0022, \u000A \u00226482516\u0022, \u000A \u00225681584\u0022, \u000A \u00225146730\u0022, \u000A \u00225141961\u0022, \u000A \u00225595758\u0022, \u000A \u00226251426\u0022, \u000A \u00229693978\u0022, \u000A \u00226383515\u0022, \u000A \u00226066339\u0022, \u000A \u00225360615\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022I gained in‐depth experience of soft gelatin capsule dosage form design, development and manufacture, particularly complex formulations for the optimum delivery of active pharmaceutical ingredients.\u0022, \u000A \u0022invention, and that, during inter partes review, claims are to be given their broadest reasonable interpretation consistent with the specification, prosecution history, and Declaration of Peter Draper Patent No. 9,693,978 knowledge of a person of ordinary skill in the art.\u0022, \u000A \u0022I understand that the claimed subject matter would have been obvious to a person of ordinary skill in the art if, for example, it resulted from the combination of known elements according to known methods to yield IPR2018\u002D00421 \u002D\u002D Ex. 1001 Catalent Pharma Solutions, Inc., Petitioner\u0022, \u000A \u0022In addition, I understand that the obviousness inquiry should not be performed with the benefit of hindsight, but should be considered through the eyes of a person of ordinary skill in the relevant art at the time of the claimed invention, and that is what I have done in my analysis.\u0022, \u000A \u0022In a July 12, 2016 Office Action, the Examiner rejected certain claims as lacking novelty over Yu which discloses a softgel formulation of ibuprofen and 0.4 mole equivalents of its sodium salt, along with 52% PEG 600 and 1\u002D10% polyvinyl pyrrolidone.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1002\u002D2\u002DCurriculum_Vitae_of_Peter_Draper\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 2, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNjdhNGVjOWItNTAwYS00MjllLWI1MTYtZTVkODMyOThhZTY4OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1002\u002D2\u002DCurriculum_Vitae_of_Peter_Draper/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNjdhNGVjOWItNTAwYS00MjllLWI1MTYtZTVkODMyOThhZTY4OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u00221002\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221002\u0022, \u000A \u0022title\u0022: \u0022Curriculum Vitae of Peter Draper\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1002_DraperCV.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 4, \u000A \u0022summary\u0022: [\u000A \u0022A successful career was progressed in a number of positions, providing in\u002Ddepth experience of pharmaceutical dosage form design and development and the associated regulatory processes.\u0022, \u000A \u0022Gained an in\u002Ddepth experience of soft gel capsule dosage form design, development and manufacture, particularly complex formulations for the optimum delivery of active pharmaceutical ingredients.\u0022, \u000A \u0022Major projects included: • Establishment and management of a specialist suite for the development and manufacture of soft gel capsules containing cytotoxic active ingredients.\u0022, \u000A \u0022Gel\u002DCell Capsules 2005 to 2006 • General Manager of the Gel\u002DCell Company concerned with the development and contract manufacture of consumer pharmaceutical and nutritional Soft Gel products In Canada\u0022, \u000A \u0022Catalent Pharma Solutions • Vice President Product Innovation (R\u0026D) 2017 – Technical support as necessary for the progression of a portfolio of patent applications initiated by Accucaps Industries Ltd., and Member of the Catalent Intellectual Property Review Board concerned with soft gel capsules.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1003\u002D3\u002DUS_Patent_No_9,693,978\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 3, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNzE4YjJmNGUtNWM1Yi00MzZiLWFkYWQtODNmYmZmMmVkNzA4OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1003\u002D3\u002DUS_Patent_No_9%2C693%2C978/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNzE4YjJmNGUtNWM1Yi00MzZiLWFkYWQtODNmYmZmMmVkNzA4OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 7, \u000A \u0022e2e_number\u0022: \u00221003\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221003\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 9,693,978\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1003_US9693978.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 8, \u000A \u0022patents\u0022: [\u000A \u00226287594\u0022, \u000A \u00226689382\u0022, \u000A \u00225648358\u0022, \u000A \u00227101572\u0022, \u000A \u00225541210\u0022, \u000A \u00226365180\u0022, \u000A \u00225071643\u0022, \u000A \u00225885608\u0022, \u000A \u00225505961\u0022, \u000A \u00226387400\u0022, \u000A \u00225360615\u0022, \u000A \u00229531979\u0022, \u000A \u00226383515\u0022, \u000A \u00225484606\u0022, \u000A \u00229693978\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Inventors: Nachiappan Chidambaram, Salt Lake City, UT (US)\u003B Aqeel Fatmi, Greensboro, NC (US) (73) Assignee: Banner Life Sciences LLC, High Point, NC (US) ( *) Notice: Subject to any disclaimer, the term of this patent is extended or adjusted under 35 U.S.C. 154(b) by 0 days.\u0022, \u000A \u0022discloses pharmaceutically acceptable solutions containing a medicament suitable for filling softgel capsules comprising a polymer such as polyethylene glycol and an acid salt of a compound having three or more carbon atoms, such as sodium propionate.\u0022, \u000A \u0022The method comprises solubilizing acetaminophen in a mixture of propylene gly col, polyethylene glycol, water, polyvinylpyrrolidone and Filled one\u002Dpiece soft gelatin capsules (\u005C\u0022softgels\u005C\u0022) have sodium or potassium acetate.\u0022, \u000A \u0022In cases where the free pharmaceutical agent is acidic, are quite different from two\u002Dpiece hardshell capsules, soft the resulting anion can react with the polyethylene glycol in gels are more capable of retaining a liquid fill material.\u0022, \u000A \u0022propylene glycol, glycerin, low molecular weight alcohols, Therefore it is an object of the invention to provide a ketones, acids, amines, and esters all tend to degrade or 35 stable solvent system for pharmaceutical agents, which is dissolve the gelatin shell to some extent.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1004\u002D4\u002DProsecution_History_of_US_9,693,978_60659,679\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 4, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTdhY2Q2YTItN2RiYi00OTM3LWEyNGUtZGViMjM5ZDc0MjJjOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1004\u002D4\u002DProsecution_History_of_US_9%2C693%2C978_60659%2C679/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTdhY2Q2YTItN2RiYi00OTM3LWEyNGUtZGViMjM5ZDc0MjJjOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 34, \u000A \u0022e2e_number\u0022: \u00221004\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221004\u0022, \u000A \u0022title\u0022: \u0022Prosecution History of U.S. 9,693,978 (60/659,679)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1004_FileHist_60659679.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 35, \u000A \u0022patents\u0022: [\u000A \u00226689382\u0022, \u000A \u00225360615\u0022, \u000A \u00225505961\u0022, \u000A \u00226383515\u0022, \u000A \u00226065967\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Other solvents such as propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, amines, and esters all tend to degrade or dissolve the gelatin shell to some extent.\u0022, \u000A \u0022U.S. Patent No. 5,505,961 to Shelley et al. describes a method for increasing the solubility of acetaminophen alone or in combination with other pharmaceutically active agents to form a clear solution for encapsulation into a softgel capsule.\u0022, \u000A \u0022Therefore it is an object of the invention to provide a stable solvent system for pharmaceutical agents, which is suitable for encapsulation in a softgel capsule, wherein the formation of PEG esters is minimized.\u0022, \u000A \u0022Suitable preservatives include alkyl esters of p\u002Dhydroxy benzoic acid such as methyl, ethyl, propyl, butyl and heptyl (collectively known as \u005C\u0022parabens\u005C\u0022) or combinations thereof.\u0022, \u000A \u0022From: USB AG, Stamford Branch To: Banner Life Sciences LLC The document was recorded in the United States Patent and Trademark Office at Reel 036239 , Frame 0188 , or for which a copy thereof is attached.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1005\u002D5\u002DProsecution_History_of_US_9,693,978_11367,238\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 5, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTY4MjEzYjgtMjI5Yi00YTE0LWE3YzUtNGJlZTFkZmE5NzA3OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1005\u002D5\u002DProsecution_History_of_US_9%2C693%2C978_11367%2C238/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTY4MjEzYjgtMjI5Yi00YTE0LWE3YzUtNGJlZTFkZmE5NzA3OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 445, \u000A \u0022e2e_number\u0022: \u00221005\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221005\u0022, \u000A \u0022title\u0022: \u0022Prosecution History of U.S. 9,693,978 (11/367,238)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1005_FileHist_11367238.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 446, \u000A \u0022patents\u0022: [\u000A \u00226112492\u0022, \u000A \u00229210996\u0022, \u000A \u00229408031\u0022, \u000A \u00229408030\u0022, \u000A \u00225509332\u0022, \u000A \u00229067891\u0022, \u000A \u00229407488\u0022, \u000A \u00225059626\u0022, \u000A \u00229406270\u0022, \u000A \u00226110000\u0022, \u000A \u00226442122\u0022, \u000A \u00225110606\u0022, \u000A \u00227541549\u0022, \u000A \u00225263899\u0022, \u000A \u00225505961\u0022, \u000A \u00226689382\u0022, \u000A \u00226503340\u0022, \u000A \u00229114120\u0022, \u000A \u00226383515\u0022, \u000A \u00226022448\u0022, \u000A \u00226701217\u0022, \u000A \u00225648358\u0022, \u000A \u00228836848\u0022, \u000A \u00225541210\u0022, \u000A \u00227602111\u0022, \u000A \u00227771725\u0022, \u000A \u00225484606\u0022, \u000A \u00227855090\u0022, \u000A \u00229513197\u0022, \u000A \u00228157387\u0022, \u000A \u00229054191\u0022, \u000A \u00225011852\u0022, \u000A \u00228684407\u0022, \u000A \u00229125120\u0022, \u000A \u00225071643\u0022, \u000A \u00225885608\u0022, \u000A \u00228802625\u0022, \u000A \u00225360615\u0022, \u000A \u00229208445\u0022, \u000A \u00225912011\u0022, \u000A \u00226910689\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Other solvents such as propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, arnines, and esters all tend to degrade or dissolve the gelatin shell to some extent.\u0022, \u000A \u0022U.S. Patent No. 5,505,961 to Shelley et al. describes a method for increasing the solubility of acetaminophen alone or in combination with other pharmaceutically active agents to form a clear solution for encapsulation into a softgel capsule.\u0022, \u000A \u0022Therefore it is an object of the invention to provide a stable solvent system for pharmaceutical agents, which is suitable for encapsulation in a softgel capsule, wherein the formation of PEG esters is minimized.\u0022, \u000A \u0022Suitable preservatives include alkyl esters of p\u002Dhydroxy benzoic acid such as methyl, ethyl, propyl, butyl and heptyl (collectively known as \u005C\u0022parabens\u005C\u0022) or combinations thereof.\u0022, \u000A \u002223579 N\u003B\u003Bme Registration Number as mylour al.torney(s) or ilgent(s) to prosec:ule I he iJpplicalion itlen!ifiecl above, and to transact all business In tile United Stales Patent \u003Bmd Ti·\u003C~tiernark Office connected llrElrSivith.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1006\u002D6\u002DProsecution_History_of_US_Patent_No_9,693,978_App_No_14977,808\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 6, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWQyM2FlNjAtZTFhOC00MjEwLWEyNWEtMDFmYTlmMTFmOWFkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1006\u002D6\u002DProsecution_History_of_US_Patent_No_9%2C693%2C978_App_No_14977%2C808/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWQyM2FlNjAtZTFhOC00MjEwLWEyNWEtMDFmYTlmMTFmOWFkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 257, \u000A \u0022e2e_number\u0022: \u00221006\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221006\u0022, \u000A \u0022title\u0022: \u0022Prosecution History of U.S. Patent No. 9,693,978 (App. No. 14/977,808)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1006_FileHist_14977808.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 258, \u000A \u0022patents\u0022: [\u000A \u00225306615\u0022, \u000A \u00228231925\u0022, \u000A \u00229531979\u0022, \u000A \u00225211541\u0022, \u000A \u00225151234\u0022, \u000A \u00225505961\u0022, \u000A \u00226689382\u0022, \u000A \u00225603755\u0022, \u000A \u00226383515\u0022, \u000A \u00225484606\u0022, \u000A \u00227141201\u0022, \u000A \u00225648358\u0022, \u000A \u00225541210\u0022, \u000A \u00229216403\u0022, \u000A \u00229342987\u0022, \u000A \u00225540230\u0022, \u000A \u00225885608\u0022, \u000A \u00226065967\u0022, \u000A \u00225360615\u0022, \u000A \u00225912011\u0022, \u000A \u00229693978\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Acid\u002Dbase chemistry teaches that the Ka of a weak acid and the Kb of its conjugate base are related according to the equation: where Kw is the ionic constant of water and has a value of approximately LOx 10\u005C\u00221 \u002Dl at room temperature.\u0022, \u000A \u0022Other solvents such as propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, amines, and esters all tend to degrade or dissolve the gelatin shell to some extent.\u0022, \u000A \u0022discloses pharrriaceutically acceptable solutions containing a medicament suitable for filling softgel capsules comprising a polymer such as polyethylene glycol and an acid salt of a compound having three or more carbon atoms, such as sodium propionate.\u0022, \u000A \u0022Therefore it is an object of the invention to provide a stable solvent system for pharmaceutical agents, which is suitable for encapsulation in a softgel capsule, wherein the formation of PEG esters is minimized.\u0022, \u000A \u0022Suitable preservatives include alkyl esters of p\u002Dhydroxy benzoic acid such as methyl, ethyl, propyl, butyl and heptyl (collectively known as \u005C\u0022parabens\u005C\u0022) or combinations thereof.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1007\u002D7\u002DProsecution_History_of_EP_1863458_Counterpart_of_US_Patent_No_9,693,978_Part_A\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 7, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZjVmMTlhNzMtZjY1ZS00MmU5LWJmNGUtNWE2NWYzOWQ2ZDBhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1007\u002D7\u002DProsecution_History_of_EP_1863458_Counterpart_of_US_Patent_No_9%2C693%2C978_Part_A/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZjVmMTlhNzMtZjY1ZS00MmU5LWJmNGUtNWE2NWYzOWQ2ZDBhOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 801, \u000A \u0022e2e_number\u0022: \u00221007\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221007\u0022, \u000A \u0022title\u0022: \u0022Prosecution History of EP 1863458 (Counterpart of U.S. Patent No. 9,693,978) (Part A)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1007a_FileHist_EP1863458.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 802, \u000A \u0022patents\u0022: [\u000A \u00226910689\u0022, \u000A \u00229210996\u0022, \u000A \u00229408031\u0022, \u000A \u00229408030\u0022, \u000A \u00229209854\u0022, \u000A \u00225509332\u0022, \u000A \u00229531979\u0022, \u000A \u00229067891\u0022, \u000A \u00228293270\u0022, \u000A \u00229407488\u0022, \u000A \u00225059626\u0022, \u000A \u00229406270\u0022, \u000A \u00229510618\u0022, \u000A \u00229310618\u0022, \u000A \u00225110606\u0022, \u000A \u00228524280\u0022, \u000A \u00225627854\u0022, \u000A \u00228851521\u0022, \u000A \u00225505961\u0022, \u000A \u00226689382\u0022, \u000A \u00228060103\u0022, \u000A \u00226503340\u0022, \u000A \u00225360015\u0022, \u000A \u00226383515\u0022, \u000A \u00225484606\u0022, \u000A \u00228309107\u0022, \u000A \u00229519792\u0022, \u000A \u00229552211\u0022, \u000A \u00225310566\u0022, \u000A \u00229311753\u0022, \u000A \u00228333989\u0022, \u000A \u00229513197\u0022, \u000A \u00229552201\u0022, \u000A \u00225059526\u0022, \u000A \u00228157387\u0022, \u000A \u00229054191\u0022, \u000A \u00225011852\u0022, \u000A \u00225406529\u0022, \u000A \u00225071643\u0022, \u000A \u00226922203\u0022, \u000A \u00225406530\u0022, \u000A \u00228802625\u0022, \u000A \u00225360615\u0022, \u000A \u00229208445\u0022, \u000A \u00225912011\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Other solvents such as propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, amines, and esters all tend to degrade or dissolve the gelatin shell to some extent.\u0022, \u000A \u0022Excipients Formulations may be prepared using a pharmaceutically acceptable carrier composed of materials that are considered safe and effective and may be administered to an individual without causing undesirable biological side Petitioner \u002D Catalent Pharma Solutions Ex. 1007a, Pg.\u0022, \u000A \u0022Other solvents such as propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, amines, and esters all tend to degrade or dissolve the gelatin shell to some extent.\u0022, \u000A \u0022Excipients Formulations may be prepared using a pharmaceutically acceptable carrier composed of materials that are considered safe and effective and may be administered to an individual without causing undesirable biological side Petitioner \u002D Catalent Pharma Solutions Ex. 1007a, Pg.\u0022, \u000A \u0022Other solvents such as propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, amines, and esters all tend to degrade or dissolve the gelatin shell to some extent.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1007\u002D8\u002DProsecution_History_of_EP_1863458_Counterpart_of_US_Patent_No_9,693,978_Part_B\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 8, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNzVhOGUzNmUtNGFiMi00Njc2LTg4ODMtMmYzZjlkYmEwMWNkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1007\u002D8\u002DProsecution_History_of_EP_1863458_Counterpart_of_US_Patent_No_9%2C693%2C978_Part_B/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNzVhOGUzNmUtNGFiMi00Njc2LTg4ODMtMmYzZjlkYmEwMWNkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 241, \u000A \u0022e2e_number\u0022: \u00221007\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221007\u0022, \u000A \u0022title\u0022: \u0022Prosecution History of EP 1863458 (Counterpart of U.S. Patent No. 9,693,978) (Part B)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1007b_OppProc_EP1863458.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 242, \u000A \u0022patents\u0022: [\u000A \u00229209854\u0022, \u000A \u00229780121\u0022, \u000A \u00229531979\u0022, \u000A \u00229212134\u0022, \u000A \u00227841729\u0022, \u000A \u00226031935\u0022, \u000A \u00225505961\u0022, \u000A \u00226689382\u0022, \u000A \u00228507386\u0022, \u000A \u00228685445\u0022, \u000A \u00229780444\u0022, \u000A \u00226383515\u0022, \u000A \u00225484606\u0022, \u000A \u00225231096\u0022, \u000A \u00225478858\u0022, \u000A \u00225180721\u0022, \u000A \u00229780240\u0022, \u000A \u00225541210\u0022, \u000A \u00229519792\u0022, \u000A \u00229552211\u0022, \u000A \u00225310566\u0022, \u000A \u00229311753\u0022, \u000A \u00229353932\u0022, \u000A \u00225021416\u0022, \u000A \u00229552101\u0022, \u000A \u00229552201\u0022, \u000A \u00225729087\u0022, \u000A \u00226033152\u0022, \u000A \u00225071643\u0022, \u000A \u00225091528\u0022, \u000A \u00226922203\u0022, \u000A \u00225360615\u0022, \u000A \u00229551101\u0022, \u000A \u00226034648\u0022, \u000A \u00225912011\u0022, \u000A \u00225281591\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Non\u002Dpatent literature internet original file name: 07\u002D solubility of PEG600.pdf attached as: Other\u002Devidence\u002D3.pdf Beyer, Walter, \u005C\u0022Lehrbuch der organischen Chmie\u005C\u0022 Stuttgart: Hirzel, 1988, Ed.21 particular relevance: page 280 original file name: 08 \u002D Beyer Walter, Lehrbuch der organischen Chemie.pdf attached as: Published\u002DEvidence\u002D5.pdf Wikipedia , \u005C\u0022Excerpt from the German Wikipedia weppage on Milchsaure (lactic acid)\u005C\u0022 , [cited 13.06.2017] Available from: [https://de.wikipedia.org/w/index.php?title\u003DMilchsaure\u0026old id\u003D 165775114] original file name: 09\u002D excerpt from the Wikipedia on Milchsaure (lactic acid).pdf attached as: Published\u002DEvidence\u002D6.pdf EPO Form 2300E\u002D B0.01.17.EIN Page 4 of 6 Petitioner \u002D Catalent Pharma Solutions Ex. 1007b, Pg.\u0022, \u000A \u0022Samples were analyzed by HPLC: Agilent 1100 Series HPLC System Column: DeactiSil ODS\u002D3 5u 100A, 25cm X 4.6mm (ES Industries) Column Oven Temperature: ambient Flow Rate: 1.5 mUmin Injection Volume: 25 uL UV Detector at 272 nm Run Time: 60 minutes Mobile Phase A: Phosphate Buffer:Acetonitrile (3:2 ratio) Mobile Phase B: Phosphate Buffer:Acetonitrile (1 :3 ratio) Limit of quantitation was approximated to be 0.00011 mg/mL Page 4 of 8 March 2012 Petitioner \u002D Catalent Pharma Solutions Ex. 1007b, Pg.\u0022, \u000A \u0022European Patent Application No.06737018.9 Banner Pharmacaps, Inc PC Ref: PABCX/P38814EP In general, the amount of PEG ester in the formulations prepared in accordance with the teaching of 01 when subjected to stressed conditions varied from 0.0093 to 0.014.\u0022, \u000A \u0022The compositions prepared by the method of the present invention exhibited lower levels of PEG esters at room temperature and after the stress study.\u0022, \u000A \u0022Density, g/cm 3 @ 20oc Melting or Freezing Range, C Solubility in Water at 20°C, % by wt Viscosity at 1 00°C, eSt Average Number of Repeating Oxyethylene Units Avg.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1008\u002D9\u002DProsecution_History_of_US_Patent_No_9,693,979_App_No_15159,972\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 9, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMzVkZDk5YTAtMDMzOS00MGVjLTljMTYtYTQwM2FjMDg2MGIyOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1008\u002D9\u002DProsecution_History_of_US_Patent_No_9%2C693%2C979_App_No_15159%2C972/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMzVkZDk5YTAtMDMzOS00MGVjLTljMTYtYTQwM2FjMDg2MGIyOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 236, \u000A \u0022e2e_number\u0022: \u00221008\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221008\u0022, \u000A \u0022title\u0022: \u0022Prosecution History of U.S. Patent No. 9,693,979 (App. No. 15/159,972)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1008_FileHist_15159972.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 237, \u000A \u0022patents\u0022: [\u000A \u00225159972\u0022, \u000A \u00227002018\u0022, \u000A \u00227001000\u0022, \u000A \u00225912345\u0022, \u000A \u00225540230\u0022, \u000A \u00226146369\u0022, \u000A \u00226488219\u0022, \u000A \u00227587381\u0022, \u000A \u00227004015\u0022, \u000A \u00225505961\u0022, \u000A \u00226065967\u0022, \u000A \u00226689382\u0022, \u000A \u00225360615\u0022, \u000A \u00225700321\u0022, \u000A \u00226383515\u0022, \u000A \u00228061706\u0022, \u000A \u00229693979\u0022, \u000A \u00227141201\u0022, \u000A \u00225120120\u0022, \u000A \u00225231925\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022It is respectfully requested that the Examiner initial and return copies of the enclosed PTO/SB/08 Forms and to indicate in the official file wrapper of the above\u002Didentified patent application that each item of the cited information has been considered.\u0022, \u000A \u0022Other solvents such as propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, amines, and esters all tend to degrade or dissolve the gelatin shell to some extent.\u0022, \u000A \u0022U.S. Patent No. 5,505,961 to Shelley et al. describes a method for increasing the solubility of acetaminophen alone or in combination with other pharmaceutically active agents to form a clear solution for encapsulation into a softgel capsule.\u0022, \u000A \u0022Therefore, it is an object of the invention to provide a stable solvent system for pharmaceutical agents, which is suitable for encapsulation in a softgel capsule, wherein the formation of PEG esters is minimized.\u0022, \u000A \u0022Suitable preservatives include alkyl esters of p\u002Dhydroxy benzoic acid such as methyl, ethyl, propyl, butyl and heptyl (collectively known as \u005C\u0022parabens\u005C\u0022) or combinations thereof Flavorings can be used to mask unpleasant odors and tastes of fill formulations.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1009\u002D10\u002DUS_Patent_No_6,383,471_Chen\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 10, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOGEwZThkYzMtZmQxZC00ZTMzLTllNzQtNTlkMTgzNjExMDgwOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1009\u002D10\u002DUS_Patent_No_6%2C383%2C471_Chen/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOGEwZThkYzMtZmQxZC00ZTMzLTllNzQtNTlkMTgzNjExMDgwOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 30, \u000A \u0022e2e_number\u0022: \u00221009\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221009\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 6,383,471 (¿¿¿Chen¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1009_US6383471.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 31, \u000A \u0022patents\u0022: [\u000A \u00225741822\u0022, \u000A \u00225766629\u0022, \u000A \u00225614491\u0022, \u000A \u00225731355\u0022, \u000A \u00225858401\u0022, \u000A \u00225145684\u0022, \u000A \u00225300529\u0022, \u000A \u00225726181\u0022, \u000A \u00225652212\u0022, \u000A \u00225244925\u0022, \u000A \u00225071643\u0022, \u000A \u00225342625\u0022, \u000A \u00225645856\u0022, \u000A \u00225616330\u0022, \u000A \u00225360615\u0022, \u000A \u00225589455\u0022, \u000A \u00225639724\u0022, \u000A \u00225773029\u0022, \u000A \u00225639474\u0022, \u000A \u00225532002\u0022, \u000A \u00225376688\u0022, \u000A \u00226383471\u0022, \u000A \u00225747066\u0022, \u000A \u00225468502\u0022, \u000A \u00225653987\u0022, \u000A \u00225364632\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The present invention overcomes the problems described above characteristic of conventional formulations, by pro viding pharmaceutical compositions including an ionizable hydrophobic therapeutic agent and a carrier.\u0022, \u000A \u0022Among the above\u002Dlisted hydrophobic therapeutic agents having at least one acidic functional group, preferred hydro phobic therapeutic agents are: acetohexamide, acrivastine, alatrofioxacin, albuterol, alclofenac, amodiaquine, 60 amphotericin, aspirin, atorvastatin, atovaquone, baclofen, benazepril, bezafibrate, bromfenac, butobarbital, candesartan, capsaicin, captopril, celecoxib, cerivastatin, cetrizine, chlorambucil, chlorpropamide, chlorthalidone, clinofibrate, cinoxacin, ciprofioxacin, clinofibrate, 65 cloxacillin, cromoglicate, cromolyn, dantrolene, diclofenac, dicumarol, divalproex, docusate, dronabinol, enalapril, enoxacin, eposartan, etodolac, etoposide, fenbufen, Petitioner \u002D Catalent Pharma Solutions Ex. 1009, Pg.\u0022, \u000A \u0022Likewise, for certain polypropylene oxide containing block copoly mers (poloxamers, available commercially as PLURONIC® surfactants, BASF Corp.), the HLB values may not accu rately reflect the true physical chemical nature of the com pounds.\u0022, \u000A \u0022Keeping these inherent difficulties in mind, and using HLB values as a guide, one skilled in the art can readily identify surfactants having suitable hydrophilic ity or hydrophobicity for use in the present invention, as described herein.\u0022, \u000A \u0022Alcohol\u002DOil Transesterification Products A large number of surfactants of different degrees of hydrophobicity or hydrophilicity can be prepared by reac tion of alcohols or polyalcohols with a variety of natural 60 and/or hydrogenated oils.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1010\u002D11\u002DUS_Publication_No_20040157928_Kim\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 11, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMzcwMWM2ZDYtOGYyMC00MmQ1LTliMjEtYzc0MjhiYjQ3NTI3OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1010\u002D11\u002DUS_Publication_No_20040157928_Kim/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMzcwMWM2ZDYtOGYyMC00MmQ1LTliMjEtYzc0MjhiYjQ3NTI3OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 17, \u000A \u0022e2e_number\u0022: \u00221010\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221010\u0022, \u000A \u0022title\u0022: \u0022U.S. Publication No. 20040157928 (¿¿¿Kim¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1010_USPub_20040157928.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 18, \u000A \u0022patents\u0022: [\u000A \u00225071643\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The solvent system of the invention has advantages in that it can enhance bioavailability by improving the disintegration degree and dissolution ratio of a hardly soluble drug and also provide a capsule with a sufficiently small volume to permit easy swallowing.\u0022, \u000A \u0022[0032] The conventional approaches to improve the avail ability of hardly soluble drugs have widely been carried out depending on the selection of a surfactant type vehicle and in some cases, unexpectedly, significant results were observed even when well known components were applied.\u0022, \u000A \u0022[0034] Therefore, the present invention employs a solvent system which is definitely distinguishable from the prior arts, which is accomplished by compositely considering various factors, including optimal conditions for enhancing bioavailability of the hardly soluble acidic drugs, that is, the relation between hardly soluble acidic drugs and each of accompanied components, ionization degree of the solvent system, use of an appropriate cationic acceptance, water content and selection of the optimal mixing ratio of the constituting components, and therefore any of prior arts does not teach the present invention in this point of view.\u0022, \u000A \u0022[0036] Moreover, by establishing the above\u002Ddescribed conditions, the present invention has advantages in that it can provide further benefits in addition to the improvement of the disintegration rate and the dissolution rate of a highly concentrated solution\u003B that is, surfactants with various advantageous properties can be used alone or in combina tion, a capsule shell can be produced without glycerin, and the products made by encapsulating a drug in a highly concentrated solution by using the solvent system of the present invention has a relatively small volume allowing easy swallowing, as compared to products made by encap sulating a drug according to the conventional dissolution method.\u0022, \u000A \u0022The comparative formulation (control) was Naxen tablet (produced by ChongKunDang, Lot No. DA005), which is one of the commercially available according to the provision of the therapeutic equivalence in the Korea phar macopoeia and the results of the test of the dissolution rate in water are shown in FIG. 2.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1011\u002D12\u002DUS_Publication_No_20040224020_Schoenhard\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 12, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZTE3ZTY5YjQtZjgxMi00ZTg1LTk4OTEtMTFjZTA3MWUxZTlhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1011\u002D12\u002DUS_Publication_No_20040224020_Schoenhard/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZTE3ZTY5YjQtZjgxMi00ZTg1LTk4OTEtMTFjZTA3MWUxZTlhOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 38, \u000A \u0022e2e_number\u0022: \u00221011\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221011\u0022, \u000A \u0022title\u0022: \u0022U.S. Publication No. 20040224020 (¿¿¿Schoenhard¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1011_USPub_20040224020.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 39, \u000A \u0022patents\u0022: [\u000A \u00225324351\u0022, \u000A \u00226413536\u0022, \u000A \u00225968554\u0022, \u000A \u00225514680\u0022, \u000A \u00225817323\u0022, \u000A \u00225556838\u0022, \u000A \u00225735105\u0022, \u000A \u00225747058\u0022, \u000A \u00225422160\u0022, \u000A \u00226475494\u0022, \u000A \u00225968542\u0022, \u000A \u00225459983\u0022, \u000A \u00225624681\u0022, \u000A \u00225569466\u0022, \u000A \u00225130311\u0022, \u000A \u00226193999\u0022, \u000A \u00225616601\u0022, \u000A \u00225380534\u0022, \u000A \u00226066339\u0022, \u000A \u00225321012\u0022, \u000A \u00225472712\u0022, \u000A \u00226285380\u0022, \u000A \u00225550142\u0022, \u000A \u00225505961\u0022, \u000A \u00225624036\u0022, \u000A \u00226120806\u0022, \u000A \u00225604260\u0022, \u000A \u00225409944\u0022, \u000A \u00226183845\u0022, \u000A \u00225200191\u0022, \u000A \u00226288894\u0022, \u000A \u00225510368\u0022, \u000A \u00225436265\u0022, \u000A \u00225681584\u0022, \u000A \u00225604253\u0022, \u000A \u00225356467\u0022, \u000A \u00226482516\u0022, \u000A \u00226077540\u0022, \u000A \u00226214376\u0022, \u000A \u00225891470\u0022, \u000A \u00225593994\u0022, \u000A \u00225552422\u0022, \u000A \u00226096338\u0022, \u000A \u00226258380\u0022, \u000A \u00225536752\u0022, \u000A \u00225286493\u0022, \u000A \u00225502058\u0022, \u000A \u00226194000\u0022, \u000A \u00225569461\u0022, \u000A \u00225521213\u0022, \u000A \u00226375957\u0022, \u000A \u00225484598\u0022, \u000A \u00225750145\u0022, \u000A \u00225985321\u0022, \u000A \u00225827535\u0022, \u000A \u00226004582\u0022, \u000A \u00225595758\u0022, \u000A \u00226251426\u0022, \u000A \u00226288398\u0022, \u000A \u00226387400\u0022, \u000A \u00226387404\u0022, \u000A \u00225475995\u0022, \u000A \u00225682733\u0022, \u000A \u00226139999\u0022, \u000A \u00225273760\u0022, \u000A \u00225146730\u0022, \u000A \u00225639780\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Representative opioid agonists include at least one of the following: alfentanil, allylprodine, alphaprodine, anileridine, apomorphine, apo codeine, benzylmorphine, bezitramide, buprenorphine, butorphanol, clonitazene, codeine, cyclazocine, cyclorphen, cyprenorphine, desomorphine, dextromoramide, dezocine, diampromide, dihydrocodeine, dihydromorphine, dimenoxadol, dimepheptanol, dimethylthiambutene, dioxyaphetyl butyrate, dipipanone, eptazocine, ethohep tazine, ethylmethylthiambutene, ethylmorphine, etonita zene, fentanyl, heroin, hydrocodone, hydroxymethylmor phinan, hydromorphone, hydroxypethidine, isomethadone, ketobemidone, levallorphan, levorphanol, levophenacyl morphan, lofentanil, meperidine, meptazinol, metazocine, methadone, methylmorphine, metopon, morphine, myro phine, nalbuphine, narceine, nicomorphine, norlevorphanol, normethadone, nalorphine, normorphine, norpipanone, ohmefentanyl, opium, oxycodone, oxymorphone, papavere tum, pentazocine, phenadoxone, phenomorphan, phenazo cine, phenoperidine, pholcodine, piminodine, piritramide, propheptazine, promedol, profadol, properidine, propiram, propoxyphene, remifentanyl, sufentanyl, tramadol, tilidine, salts thereof, mixtures of any of the foregoing, mixed mu \u002Dagonists/antagonists, mu \u002Dantagonist combinations, or others known in the art.\u0022, \u000A \u0022[0046] Representative opioid antagonists include at least one of the following: naltrexone (marketed in 50 mg dosage forms from Du Pont Pharma as Re Via® or Trexan®), naloxone (marketed as Narcane®, NALOXONE/PENTA ZOCINE® from Pharma Pac), nalmefene, methylnaltrex one, naloxone methiodide, nalorphine, naloxonazine, nalide, nalmexone, nalbuphine, nalorphine dinicotinate, naltrindole (NTI), naltrindole isothiocyanate, (NTII), naltriben (NTB), nor\u002Dbinaltorphimine (nor\u002DBNI), b\u002Dfunaltrexamine (b\u002DFNA), BNTX, cyprodime, ICI\u002D174,864, LY117413, MR2266, or an opioid antagonist having the same pentacyclic nucleus as nalmefene, naltrexone, buprenorphine, levorphanol, meptazinol, pentazocine, dezocine, or their pharmacologi cally effective esters or salts.\u0022, \u000A \u0022[0047] According to the invention, the therapeutically active agent of the immediate release gelatin capsule coating can be an opioid agonist or metabolite, as well as conjugate thereof, such as morphine, tramadol, oxycodone, hydroc odone, oxymorphone, or hydromorphone.\u0022, \u000A \u0022A hot melt of a polymer, plasticizer (dibutyl sebacate), and stabi lizer (oleic acid) is prepared as a homogeneous mixture, which is then diluted with an alkaline solution to obtain an aqueous dispersion, which can be directly applied.\u0022, \u000A \u0022Techniques and compositions for making tablets (compressed and molded), capsules (hard and soft gelatin) and pills are also described in Remington\u0027s Pharmaceutical Sciences, (Arthur Osol, editor), 1553\u002D1593 (1980), incorpo rated by reference herein.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1012\u002D13\u002DUS_Patent_No_5,141,961_Coapman\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 13, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZGI5MDM4OTYtOWQwYi00NWZkLWFlYWYtZjNmZTk5ZjFlZmIyOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1012\u002D13\u002DUS_Patent_No_5%2C141%2C961_Coapman/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZGI5MDM4OTYtOWQwYi00NWZkLWFlYWYtZjNmZTk5ZjFlZmIyOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 9, \u000A \u0022e2e_number\u0022: \u00221012\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221012\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 5,141,961 (¿¿¿Coapman¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1012_US5141961.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 10, \u000A \u0022patents\u0022: [\u000A \u00225141772\u0022, \u000A \u00225141718\u0022, \u000A \u00225141961\u0022, \u000A \u00228404409\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022In general, these actives have a solubility less than or equal to about 1 percent by 15 weight in water at 25\u005C\u0022 C. Useful classes of pharmaceuti cally\u002Dactive compounds which can be incorporated into the present compositions include analgesics\u003B anti\u002Din flammatory agents, anti\u002Dpyretics, calcium channel blockers, beta\u002Dblockers, antibacterials, antidepressants, antidiabetics, anti\u002Demetics, antihistamines, cerebral stim ulants, sedatives, anti\u002Dparasitics, expectorants, diuretics, decongestants, antitussives, muscle relaxants, anit\u002DPar kinsonian agents, bronchodilators, cardiotonics, antibi\u002D otics, antivirals, nutritional supplements (such as vita mins, minerals, fatty acids, amino acids, and the like), and mixtures thereof.\u0022, \u000A \u0022Examples of preferred difficulty soluble pharmaceuti cal actives useful in the present invention include, but are not limited to, acetaminophen, acetylsalicylic acid, ibuprofen, fenbuprofen, fenoprofen, flurbiprofen, indo methacin, ketoprofen, naproxen, their pharmaceutical ly\u002Dacceptable salts, and mixtures thereof.\u0022, \u000A \u0022A process according to claim 6 wherein said diffi culty soluble pharmaceutical active is selected from the group consisting of acetaminophen, acetylsalicylic acid, 20 ibuprofen, fenbuprofen, fenoprofen, flubiprofen, indo\u002D methacin, naproxen, and mixtures thereof.\u0022, \u000A \u0022A process according to claim 15 wherein said difficulty soluble pharmaceutical active is selected from the group consisting of acetaminophen, acetylsalicylic 5 acid, ibuprofen, fenbuprofen, fenoprofen, flurbiprofen, indomethacin, naproxen, and mixtures thereof.\u0022, \u000A \u0022A process according to claim 16 which further comprises combining in step (a) from about 0.5% to about 20% of a second pharmaceutical active selected from the group consisting of dextromethorphan hydro bromide, doxylamine succinate, pseudoephedrine hy drochloride, chlorpheniramine maleate, guaifenesin, triprolidine hydrochloride, diphenhydramine hydro\u002D 15 chloride, and mixtures thereof.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1013\u002D14\u002DUS_Patent_No_5,641,512_Cimileuca\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 14, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYWMzYzE0MDgtYjczZi00NDhlLWFlOGYtYTg2NGFjZjhmNWFiOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1013\u002D14\u002DUS_Patent_No_5%2C641%2C512_Cimileuca/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYWMzYzE0MDgtYjczZi00NDhlLWFlOGYtYTg2NGFjZjhmNWFiOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 6, \u000A \u0022e2e_number\u0022: \u00221013\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221013\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 5,641,512 (¿¿¿Cimileuca¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1013_US5641512.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 7, \u000A \u0022patents\u0022: [\u000A \u00225071643\u0022, \u000A \u00225370864\u0022, \u000A \u00225173304\u0022, \u000A \u00225458879\u0022, \u000A \u00225405616\u0022, \u000A \u00225641512\u0022, \u000A \u00225360615\u0022, \u000A \u00225141961\u0022, \u000A \u00225300305\u0022, \u000A \u00225431916\u0022, \u000A \u00225407665\u0022, \u000A \u00225484606\u0022, \u000A \u00225376688\u0022, \u000A \u00229504527\u0022, \u000A \u00228404409\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Additionally, soft gelatin capsules are aestheti cally appealing (especially when filled with a transparent 25 liquid) and can be manufactured in a wide variety of sizes, shapes, and colors.\u0022, \u000A \u0022The present inventor has found incorporating a specific component in the outer gela\u002D tin shell, i.e., a xanthine derivative overcomes incompat\u002D ability problems with an analgesic active.\u0022, \u000A \u0022Without being limited by theory, the water is believed to aid in the rapid dissolution or rupture of the soft gelatin shell upon contact with the gastrointestinal fluids encountered in the body.\u0022, \u000A \u0022In a preferred mauner of execution, the analgesic pharmaceutical active, polyethylene glycol, polyvinylpyrrolidone, and sol vent are combined and mixed until dissolved to form a homogeneous solution.\u0022, \u000A \u002247\u002D49 (August 1989)\u003B R. F. Jimerson, \u005C\u0022Softgel (Soft Gelatin Capsule) Update\u005C\u0022, Drug Development and Industrial Phar macy (Interphex \u002786 Conference), vol.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1014\u002D15\u002DUS_Patent_No_5,360,615_Yu\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 15, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOWFjNDY4ZWEtYWNjZC00NTMyLWI3NGItMzc4YjU1YWM5ZjA2OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1014\u002D15\u002DUS_Patent_No_5%2C360%2C615_Yu/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOWFjNDY4ZWEtYWNjZC00NTMyLWI3NGItMzc4YjU1YWM5ZjA2OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 10, \u000A \u0022e2e_number\u0022: \u00221014\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221014\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 5,360,615 (¿¿¿Yu¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1014_US5360615.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 11, \u000A \u0022patents\u0022: [\u000A \u00225071643\u0022, \u000A \u00225360615\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Field of the Invention This invention relates to a novel solvent system for 15 enhancing the solubility of pharmaceutical agents by partial ionization to produce highly concentrated pri marily non\u002Daqueous water miscible solutions of those agents\u003B which as liquids are suitable for encapsulation in both softgels (previously known as soft elastic gelatin 20 capsules) and in two piece hard gelatin shells, which can be sealed to retain liquid\u003B which as semi\u002Dsolids are suit able for encapsulation in two\u002Dpiece hardshell capsules\u003B and which as solid solutions are suitable for conversion into tablets.\u0022, \u000A \u0022Gardella et al, U.S. Pat. No. 4,002,718, teaches at column 3, line 47, the use of small amounts of polyvinyl pyrrolidone or glycerin to hasten dissolution of micron\u002D 65 ized digoxin in a liquid vehicle, polyethylene glycol, to form a solution suitable for softgels.\u0022, \u000A \u0022For example, Table 1 lists solubilities of the acidic pharmaceutical agents, ibu profen, naproxen, indomethacin and acetaminophen in polyethylene glycol and the corresponding minimum softgel capsule size required to encapsulate a unit dose as a clear solution.\u0022, \u000A \u0022The present invention also relates to unit dose forms of ibuprofen, naproxen, indomethacin, and acetamino\u002D 50 phen comprising either a softgel or two piece capsule or a tablet containing within a therapeutically effective amount of the appropriate highly concentrated solution of said pharmaceutical agent as disclosed above.\u0022, \u000A \u002223% 61% 67% The addition of sodium hydroxide and water to ibu profen (Table 3), or to naproxen, indomethacin, or acet aminophen in polyethylene glycol (PEG) increases the 55 solubility of that pharmaceutical agent up to a certain point.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1015\u002D16\u002DUS_Patent_No_6,383,515_Sawyer\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 16, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOWVjZmEzMTAtMzQyNi00MzM4LThlOWMtYzE0NTg3ZDFiOWRmOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1015\u002D16\u002DUS_Patent_No_6%2C383%2C515_Sawyer/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOWVjZmEzMTAtMzQyNi00MzM4LThlOWMtYzE0NTg3ZDFiOWRmOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 9, \u000A \u0022e2e_number\u0022: \u00221015\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221015\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 6,383,515 (¿¿¿Sawyer¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1015_US6383515.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 10, \u000A \u0022patents\u0022: [\u000A \u00225360615\u0022, \u000A \u00225071643\u0022, \u000A \u00225505961\u0022, \u000A \u00226383515\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022More particularly, the invention relates to pharmaceutically acceptable solvent systems capable of producing a highly concentrated solution 10 of a medicament, such as acetaminophen or naproxen, for use in a soft gelatin capsule.\u0022, \u000A \u0022Propylene glycol, glycerin, low molecular weight alcohols, ketones, acids, amines, and esters all tend to degrade or dissolve the softgellayer gelatin to some extent.\u0022, \u000A \u0022Formulation of Example 1 Ingredient Amount Weight Percent (%) Polyethylene glycol 600 Dimethyl isosorbide Water Soybean oil 25 g 15 g 5 g 16 g 25% 15% 5% 16% Petitioner \u002D Catalent Pharma Solutions Ex. 1015, Pg.\u0022, \u000A \u0022TABLE 1\u002Dcontinued Formulation of Example 1 Ingredient Amount Weight Percent(%) Sodium propionate Acetaminophen Chlorpheniramine Pseudoephedrine Dextromethorphan Doxylamine succinate Propylene glycol 5.5 g 33 g 0 g 0 g 0 g 0 g 0 g 5.5% 33% 0% 0% 0% 0% 0% was prepared by mixing at room temperature until dissolved.\u0022, \u000A \u0022A 1:1 by weight sodium propi\u002D onate solution (in water) was added to the mix dropwise at about 4 to 5 drops per minute while the slurry was main tained under nitrogen and while stirring continued at about 200 rpm.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1016\u002D17\u002DUS_Publication_No_20060099246_Tanner\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 17, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZTQ4NDRkNmItMWRkMC00OTAzLTgwNmUtNDdkZWRjZmZmZTM1OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1016\u002D17\u002DUS_Publication_No_20060099246_Tanner/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZTQ4NDRkNmItMWRkMC00OTAzLTgwNmUtNDdkZWRjZmZmZTM1OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 11, \u000A \u0022e2e_number\u0022: \u00221016\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221016\u0022, \u000A \u0022title\u0022: \u0022U.S. Publication No. 20060099246 (¿¿¿Tanner¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1016_USPub_20060099246.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 12, \u000A \u0022patents\u0022: [\u000A \u00225376688\u0022, \u000A \u00225360615\u0022, \u000A \u00225071643\u0022, \u000A \u00225505961\u0022, \u000A \u00226582727\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022For reasons of economy, gela tin can be most practically be derived from collagen sources which would normally require refining before consumption or which would otherwise make up protein\u002Dcontaining waste material destined for animal feeds, agricultural fertilizers, or for other industries.\u0022, \u000A \u0022Such unifor mity is more difficult to achieve via a tableting process wherein solids must be uniformly mixed and compressed, or via incorporation of the total dose of active ingredient into a bulk liquid carrier which must be measured out prior to each oral administration.\u0022, \u000A \u0022[0046] This experiment suggested the possibility that cer tain drug formulations, particularly those with alkaline prop erties, which had long been thought to be difficult or impossible to encapsulate, might, in a properly designed system, be amenable to stable and commercial production in a soft capsule.\u0022, \u000A \u0022[0049] Experimentation was undertaken to assess the effect of salt concentration, that is, to determine the relative susceptibility of gelatin and non\u002Dgelatin capsules to 100% neutralized potassium ibuprofen in polyethylene glycol 600 (PEG 600) at varying drug loading solutions, in an accel erated stability test protocol (40° C.\u002D75% RH).\u0022, \u000A \u0022The system according to claim 1, wherein the active ingredient is selected from the group consisting of pseu doephedrine hydrochloride, dextromethorphan hydrobro mide, doxylamine succinate, guafenesin, diphenhydramine, aspirin, caffeine, ranitidine, cimetidine, celecoxib, ritonavir, and fexofenadine and combinations thereof.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1017\u002D18\u002DWikipedia,_Conjugate_acid_July_8,_2016\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 18, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNDdmOTFjOTctMWJlOS00OTQyLWExMTQtMjJmNTY0MTdiZjRkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1017\u002D18\u002DWikipedia%2C_Conjugate_acid_July_8%2C_2016/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNDdmOTFjOTctMWJlOS00OTQyLWExMTQtMjJmNTY0MTdiZjRkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 6, \u000A \u0022e2e_number\u0022: \u00221017\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221017\u0022, \u000A \u0022title\u0022: \u0022Wikipedia, Conjugate acid (July 8, 2016)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1017_Conjugate acids_Wikipedia.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 7, \u000A \u0022patents\u0022: [\u000A \u00227203658\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Hence, a conjugate base is a species formed by the removal of a proton from an acidY1 In summary, this can be represented as the following chemical reaction: Jobannes Nicolaus Bmnsted (left) and Martin Lowry (right).\u0022, \u000A \u0022This shift to the right in the chemical equilibrium of the reaction means that ammonium does not dissociate easily in water (weak acid), and its conjugate base is stronger than the hydroxide ion.\u0022, \u000A \u0022The water molecule acts as a base because it receives the Hydrogen Proton and its conjugate acid is the hydronium ion (H30 \u005C\u005C \u003B.·, .~·,.,._.,..,.,..,...~ .\u0022, \u000A \u0022Lactic acid has the formula C3H60 6 and its conjugate base is used in intravenous fluids that consist of sodium and potassium cations along with lactate and chloride anions in solution with distilled water.\u0022, \u000A \u0022Conjugate acid\u002D Wikipedia, the free encyclopedia Page 6 of6 • Buffer solution • Deprotonation • Protonation • Salt (chemistry) References 1.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1018\u002D19\u002DUS_Publication_No_20050158377_Popp\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 19, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTU4NTUwYjYtNjFhNS00MWYxLTkyMGItYjhhYzQ2YTU0MzRhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1018\u002D19\u002DUS_Publication_No_20050158377_Popp/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTU4NTUwYjYtNjFhNS00MWYxLTkyMGItYjhhYzQ2YTU0MzRhOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 14, \u000A \u0022e2e_number\u0022: \u00221018\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221018\u0022, \u000A \u0022title\u0022: \u0022U.S. Publication No. 20050158377 (¿¿¿Popp¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1018_USPub_20050158377.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 15, \u000A \u0022patents\u0022: [\u000A \u00225200191\u0022, \u000A \u00226251426\u0022, \u000A \u00225587149\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022[0072] These differences allow the present soft gel cap sules to maintain a high purity level and a low concentration of degradation products of the dermatological active ingre dient both during formation of the pharmaceutical dosage form and during an extended storage period.\u0022, \u000A \u0022In preferred embodiments, the internal liquid phase of the present soft gel capsules com prises a solution, suspension, or paste of a pharmacologi cally active agent and one or more fatty acids or derivatives thereof.\u0022, \u000A \u0022Preferred, non limiting examples of penicillins useful in this regard include those selected from the group consisting of amidinocillin, amdinocillin, pivoxil, amoxicillin, ampicillan, apalcillin, Petitioner \u002D Catalent Pharma Solutions Ex. 1018, Pg.\u0022, \u000A \u0022Preferred, non\u002Dlimiting examples of dis orders of hair follicles and sebaceous glands treatable according to the present methods include those selected from the group consisting of acne, rosacea, perioral derma titis, hypertrichosis, alopecia, pseudofolliculitis barbae, keratinous cysts, and combinations thereof.\u0022, \u000A \u0022Preferred, non\u002Dlimiting examples of scaling popular diseases treatable according to the present methods include those selected from the group consisting of psoriasis, pityri asis rosea, lichen planus, pityriasis rubra pilaris, and com binations thereof.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1019\u002D20\u002DUS_Patent_No_6,066,339_Stark\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 20, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvY2QyNTYwMDgtMDljYS00NGQ5LWJiMTYtY2RlMWNiYzg2MTU0OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1019\u002D20\u002DUS_Patent_No_6%2C066%2C339_Stark/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvY2QyNTYwMDgtMDljYS00NGQ5LWJiMTYtY2RlMWNiYzg2MTU0OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 16, \u000A \u0022e2e_number\u0022: \u00221019\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221019\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 6,066,339 (¿¿¿Stark¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1019_US6066339.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 17, \u000A \u0022patents\u0022: [\u000A \u00225616345\u0022, \u000A \u00225656291\u0022, \u000A \u00225478577\u0022, \u000A \u00225378474\u0022, \u000A \u00225411745\u0022, \u000A \u00225002776\u0022, \u000A \u00225364620\u0022, \u000A \u00225520931\u0022, \u000A \u00225667805\u0022, \u000A \u00225229131\u0022, \u000A \u00225336504\u0022, \u000A \u00225219621\u0022, \u000A \u00225178868\u0022, \u000A \u00225286493\u0022, \u000A \u00225593694\u0022, \u000A \u00225593695\u0022, \u000A \u00225273760\u0022, \u000A \u00225202128\u0022, \u000A \u00225741524\u0022, \u000A \u00225330766\u0022, \u000A \u00226066339\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022It has been suggested that the use of modified release morphine formulations, apart from their convenience and their ability to provide continuous analgesia, may also result in a lower incidence and severity of morphine\u002Drelated side effects (Gourlay, G. K. et al., Pain (1997) 69, 295\u002D302.\u0022, \u000A \u0022U.S. Pat. No. 5,478,577, describes and claims a method for providing effective pain management in humans for a time period of about 24 hours using an opioid analgesic such 10 as morphine in a solid, controlled\u002Drelease oral dosage form.\u0022, \u000A \u0022In order to minimise morphine\u002Drelated side effects, which are a distinct disadvantage and which add to the suffering of those experiencing long\u002Dterm pain such as cancer patients, what is required is a formulation which exhibits minimal peak to trough fluctuations, namely a substantially fiat plasma profile over the dosage period.\u0022, \u000A \u0022The osmotic agent according to the invention refers to a pharmaceutically acceptable material that enhances the pas sage of the water soluble morphine through the rate controlling polymer coat or through the tissue in the gas trointestinal tract (GIT).\u0022, \u000A \u0022Thus, we have found that it is 60 benefi~ial to prevent the loss of water of hydration during the drying process involved in manufacturing the multiparticu late formulation according to the invention when morphine sulphate pentahydrate is used.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1020\u002D21\u002DUS_Patent_No_6,251,426_Gullapalli\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 21, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvN2U2NjE0OTgtNzkxNC00YzgyLTk2YzgtODAyZmU3NGMxMGRkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1020\u002D21\u002DUS_Patent_No_6%2C251%2C426_Gullapalli/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvN2U2NjE0OTgtNzkxNC00YzgyLTk2YzgtODAyZmU3NGMxMGRkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 5, \u000A \u0022e2e_number\u0022: \u00221020\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221020\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 6,251,426 (¿¿¿Gullapalli¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1020_US6251426.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 6, \u000A \u0022patents\u0022: [\u000A \u00225484606\u0022, \u000A \u00225006595\u0022, \u000A \u00225376688\u0022, \u000A \u00225360615\u0022, \u000A \u00225071643\u0022, \u000A \u00225141961\u0022, \u000A \u00225431916\u0022, \u000A \u00225827852\u0022, \u000A \u00225641512\u0022, \u000A \u00225510385\u0022, \u000A \u00225538737\u0022, \u000A \u00226251426\u0022, \u000A \u00225660859\u0022, \u000A \u00225468502\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022An especially preferred surfac tant is d\u002Dalpha tocopheryl polyethylene glycol 1000 succi nate sold by Eastman Chemical Company under the trade mark Vitamin E TPGS.\u0022, \u000A \u0022Taste modifiers include non reducing sugars, such as xylitol, maltitol, or Lycasin® manufactured by Raquette America, Inc. of Keokuk, Iowa and normally will comprise up to about 5% by weight of the sheath composition.\u0022, \u000A \u0022The overall volume of the fill is also made possible by the fact that only polyethylene glycol and polyvinylpyrrolidone are required for dissolution, with a surfactant preferably being included to enhance bioavailability of the ibuprofen when 35 ingested.\u0022, \u000A \u0022Gelatin, lime bone Glycerin Maltitol, 75% Water, purified Certain modifications and improvements will occur to those skilled in the art upon a reading of the foregoing description.\u0022, \u000A \u0022The softgel capsule of claim 18, wherein said surfac\u002D 20 tant is selected from esters of d\u002Dalpha tocopheryl, polyoxy ethylene castor oil derivatives, and polyglycolyzed glycer ides.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1021\u002D22\u002DBanner_Pharmacaps,_Inc_Citizen_Petition_to_the_Food_and_Drug_Administration\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 22, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMTRiMzNkZTgtYzI3ZS00NjQ1LWEwYjQtMDM1ZjdmM2Y1ODRmOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1021\u002D22\u002DBanner_Pharmacaps%2C_Inc_Citizen_Petition_to_the_Food_and_Drug_Administration/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMTRiMzNkZTgtYzI3ZS00NjQ1LWEwYjQtMDM1ZjdmM2Y1ODRmOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 16, \u000A \u0022e2e_number\u0022: \u00221021\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221021\u0022, \u000A \u0022title\u0022: \u0022Banner Pharmacaps, Inc. Citizen Petition to the Food and Drug Administration\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1021_Banner.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 17, \u000A \u0022summary\u0022: [\u000A \u00229\u0027\u003B \u005C\u0022um Dockets Management Branch (HFA—305) Food and Drug Administration Department of Health and Human Services 5630 Fishers Lane Room 1061 Rockville, MD 20852\u0022, \u000A \u0022220 mg (equivalent to 200 mg Naproxen) soft gelatin capsules is suitable for submission as an Abbreviated New Drug Application (ANDA), pursuant to 21 CFR §314.94\u003B (2) The Reference Listed Drug (RLD) on which the contents of this petition is based is Bayer Corporation’s Aleve® (Naproxen Sodium, 220 mg) tablets\u003B (3) Therefore, a request is being made to Change the dosage form from tablet to soft gelatin capsule.\u0022, \u000A \u0022in support of this petition, the following information is being provided: (1) The proposed drug product is a soft gelatin capsule with the same active ingredient, the same strength, and the same route of administration as that of the RLD, Aleve® (Naproxen Sodium, 220 mg) tablets.\u0022, \u000A \u0022(3) Labeling for the proposed drug product and the RLD will differ with respect to dosage form, inactive ingredients, and manufacturer/distributor identification and contact information.\u0022, \u000A \u0022Other information I Each softgei contains: sodium 20 mg Store between 20\u002D25°C (GB\u002D77°F) Avoid high humidity and excessive heat [40°C (104°F)] See side panel for lot number and expiration date.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1022\u002D23\u002DWikipedia,_Robert_Pauli_Scherer,_httpsenwikipediaorgwikiRobert_Pauli_Scherer_January_8,_2018\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 23, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNWQ5N2Y2YjktNzExMy00MDU2LTk4M2YtMTU4MzUxZDAyOTdlOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1022\u002D23\u002DWikipedia%2C_Robert_Pauli_Scherer%2C_httpsenwikipediaorgwikiRobert_Pauli_Scherer_January_8%2C_2018/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNWQ5N2Y2YjktNzExMy00MDU2LTk4M2YtMTU4MzUxZDAyOTdlOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 1, \u000A \u0022e2e_number\u0022: \u00221022\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221022\u0022, \u000A \u0022title\u0022: \u0022Wikipedia, Robert Pauli Scherer, https://en.wikipedia.org/wiki/Robert_Pauli_Scherer (January 8, 2018)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1022_ Robert Pauli Scherer_Wikipedia.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 2, \u000A \u0022patents\u0022: [\u000A \u00227902616\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Robert Pauli Scherer In 1933 the prolific inventor Robert Pauli Scherer (1906\u002D1960) invented the rotary die enca sulation process, revolutionizing the soft\u002Dgelatin encapsulation field.\u0022, \u000A \u0022He founded the R. P. Scherer Corporation to commercialize his invention.\u0022, \u000A \u0022Scherer Corporation was acquired by Cardinal Health, Inc. in 1998, and was a significant part of the Pharmaceutical Technologies \u0026 Services segment.\u0022, \u000A \u0022The Phannaceutical Technologies \u0026 Services segment of Cardinal Health was acquired by the Blackstone Group in 200~11 and subsequently named Catalent Phanna Solutions.\u0022, \u000A \u0022Text is available under the Creative Commons Attribution\u002DShareAiike License\u003B additional terms may apply.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1023\u002D24\u002DRMC_Dawson_et_al,_Data_for_Biochemical_Research_Oxford_Clarendon_Press_1959\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 24, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYjA4ZGI2MmMtNmIzNS00MGRhLTlmODgtYWUxM2M3ZGQxNWYxOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1023\u002D24\u002DRMC_Dawson_et_al%2C_Data_for_Biochemical_Research_Oxford_Clarendon_Press_1959/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYjA4ZGI2MmMtNmIzNS00MGRhLTlmODgtYWUxM2M3ZGQxNWYxOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 6, \u000A \u0022e2e_number\u0022: \u00221023\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221023\u0022, \u000A \u0022title\u0022: \u0022R.M.C. Dawson et al., Data for Biochemical Research (Oxford: Clarendon Press 1959)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1023_Dawson.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 7, \u000A \u0022patents\u0022: [\u000A \u00225858539\u0022, \u000A \u00225215315\u0022, \u000A \u00225595950\u0022, \u000A \u00229255513\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022© Oxford University Press I959\u0022, \u000A \u0022Phosphate esters, including nucleotides 4.\u0022, \u000A \u0022Lipids and fatty acids 8.\u0022, \u000A \u0022Metal chelating agents 16.\u0022, \u000A \u0022\u0027Drugs and other pharmacologically active compounds 18.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1024\u002D25\u002DJarkko_Rautio_et_al,_In_Vitro_Evaluation_of_Acyloxyalkyl_Esters_as_Dermal_Prodrugs_of_Ketoprofen_and_Naproxen,_Journal_of_Pharmaceutical_Sciences,_Vol_87,_No_12,_1622_1628_December_1998\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 25, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMGQ2NDM3MTAtN2FjNS00NDBlLWJjODktYjhkZjUwYTY4NWNhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1024\u002D25\u002DJarkko_Rautio_et_al%2C_In_Vitro_Evaluation_of_Acyloxyalkyl_Esters_as_Dermal_Prodrugs_of_Ketoprofen_and_Naproxen%2C_Journal_of_Pharmaceutical_Sciences%2C_Vol_87%2C_No_12%2C_1622_1628_December_1998/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMGQ2NDM3MTAtN2FjNS00NDBlLWJjODktYjhkZjUwYTY4NWNhOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 7, \u000A \u0022e2e_number\u0022: \u00221024\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221024\u0022, \u000A \u0022title\u0022: \u0022Jarkko Rautio et al., ¿¿¿In Vitro Evaluation of Acyloxyalkyl Esters as Dermal Prodrugs of Ketoprofen and Naproxen,¿¿¿ Journal of Pharmaceutical Sciences, Vol. 87, No. 12, 1622\u002D1628 (December 1998)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1024_Rautio.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 8\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1025\u002D26\u002DLetter_from_Sharon_Hertz,_Department_Of_Health__Human_Services,_to_Roche_Palo_Alto_LLC_regarding_NDA_18_965_November_10,_2004\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 26, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvM2JmNjAxNTUtZTE5My00MzQ2LTg4MWMtYzE0MmYwZDIzNTUyOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1025\u002D26\u002DLetter_from_Sharon_Hertz%2C_Department_Of_Health__Human_Services%2C_to_Roche_Palo_Alto_LLC_regarding_NDA_18_965_November_10%2C_2004/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvM2JmNjAxNTUtZTE5My00MzQ2LTg4MWMtYzE0MmYwZDIzNTUyOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u00221025\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221025\u0022, \u000A \u0022title\u0022: \u0022Letter from Sharon Hertz, Department Of Health \u0026 Human Services, to Roche Palo Alto LLC regarding NDA 18\u002D965 (November 10, 2004)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1025_Dept. Health 2004 Ltr.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 4\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1026\u002D27\u002DUS_Patent_No_3,035,973_Klotz\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 27, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZDAwNWQwZjktN2IxZS00N2ZhLWJhZTMtNTMzMzNhMWJlYjBhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1026\u002D27\u002DUS_Patent_No_3%2C035%2C973_Klotz/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvZDAwNWQwZjktN2IxZS00N2ZhLWJhZTMtNTMzMzNhMWJlYjBhOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 2, \u000A \u0022e2e_number\u0022: \u00221026\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221026\u0022, \u000A \u0022title\u0022: \u0022U.S. Patent No. 3,035,973 (¿¿¿Klotz¿¿¿)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1026_US3035973.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 3, \u000A \u0022summary\u0022: [\u000A \u0022unless used promptly, hundreds of thousands of dollars have been ·lost on \u005C\u0022rcmmsn due to tlle leakitl£ of the solution of dioetyl sodium sulfosucci nate from soft gdatin capsules, where even one Ienker messes up the whole container and makes it unsalcablc.\u0022, \u000A \u0022For example, it appeared possible that the dioctyl sodium sulfosuccinate in solu tion in Lie core might gradually pass into the glycerine in the gelatin snd cause loss of adhesion of the heat and 65 Indeed, this pre.•.sun!\u0022, \u000A \u0022o:: .lo!ln~r~L._ Corn~\u002D­ Mincral ~· ~ Curn~ ... \u005C\u0022 ~ Extended te~ts using non\u002Daqueous oil solutions of cal cium dioctyl sulfosuccinate in glycerine or like plastic ized ~oft gelatin capsules under conditions encountered in storage in this field has shown them to be substantially free from Ienker\u003B.\u0022, \u000A \u0022However, since the concentration necessary to produce 240 mg. calcium dioctyl sulfosuccinate in the convenient number 8 capsule is very near the saturation point, the addition of a small amount, e.g. 1\u002D10 percent by volume, of glyceryl monooleate may be desirable and is in fact preferred to consistently insure a solution which will not \u005C\u0022gel\u005C\u0022 at lowered temperatures.\u0022, \u000A \u0022To aid in stabilizing the suspension 15 small amount~ of viscosifying (suspending) agents such as ·hydrogenated vegetable oil, white be~ and the like can be added to the composition in accordance with standard practices in this art if desired.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1027\u002D28\u002DH_Sevelius_et_al,_Bioavailability_of_Naproxen_Sodium_and_Its_Relationship_to_Clinical_Analgesic_Effects,_10_Br_J_Clin_Pharmac_259_263_1980\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 28, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYTg2ZTU3NDMtNWMyZS00MDc0LTgyODgtNDk5YzExODY1OGNiOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1027\u002D28\u002DH_Sevelius_et_al%2C_Bioavailability_of_Naproxen_Sodium_and_Its_Relationship_to_Clinical_Analgesic_Effects%2C_10_Br_J_Clin_Pharmac_259_263_1980/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYTg2ZTU3NDMtNWMyZS00MDc0LTgyODgtNDk5YzExODY1OGNiOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 5, \u000A \u0022e2e_number\u0022: \u00221027\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221027\u0022, \u000A \u0022title\u0022: \u0022H. Sevelius et al., ¿¿¿Bioavailability of Naproxen Sodium and Its Relationship to Clinical Analgesic Effects,¿¿¿ 10 Br. J. Clin. Pharmac. 259\u002D263 (1980)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1027_Sevelius.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 6, \u000A \u0022summary\u0022: [\u000A \u0022Studies with single 200 to 600 mg doses of naproxen have shown it to be at least as effective as single standard doses of aspirin or other standard reference analgesics in patients with moderate or severe postoperative pain resulting from ortfiopaedic (Ruedy \u0026 McCullough, 1973), dental (Ruedy, 1973), and other surgical procedures (Mahler, Forrest, Brown, Shroff, Gordon, Brown \u0026 James, 1976\u003B Stetson, Robinson, Wardell \u0026 Lasagna, 1973).\u0022, \u000A \u0022At the beginning and end of the study, each volunteer underwent a complete physical examination including routine blood 0306\u002D\u002D5251/80/100259\u002D05 $01.00 ©Macmillan Journals Ltd 1980 Petitioner \u002D Catalent Pharma Solutions Ex. 1027, Pg.\u0022, \u000A \u0022This long half\u002Dlife is particularly useful when naproxen is used for chronic anti inflammatory therapy, since the drug can be administered on a twice daily regimen and still reach adequate steady\u002Dstate plasma levels to maintain therapeutic efficacy.\u0022, \u000A \u0022For analgesia, it may be desirable to reach quickly and maintain high plasma levels in order to obtain fast and continuous maximum therapeutic benefits.\u0022, \u000A \u0022It has the advantage of allowing one rapidly to achieve and then maintain therapeutic plasma levels of the drug thereby minimizing fluctuations which might lead to some loss of analgesic effect.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1028\u002D29\u002DBanner_Pharmacaps_Inc_NDA_21_920,_Naproxen_Sodium_Capsules\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 29, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYjkyZDY4OTMtNTAwZC00ODkzLTllOWQtZDc5ODZhM2U0ZmExOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1028\u002D29\u002DBanner_Pharmacaps_Inc_NDA_21_920%2C_Naproxen_Sodium_Capsules/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYjkyZDY4OTMtNTAwZC00ODkzLTllOWQtZDc5ODZhM2U0ZmExOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 12, \u000A \u0022e2e_number\u0022: \u00221028\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221028\u0022, \u000A \u0022title\u0022: \u0022Banner Pharmacaps Inc. NDA 21\u002D920, Naproxen Sodium Capsules\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1028_Patent Owner\u0027s New Drug Application 021920.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 13, \u000A \u0022summary\u0022: [\u000A \u0022LEGAL BASIS FOR SUBMISSION: 505 (b)(2) RLD: Aleve® (naproxen sodium) Tablets , 220 mg, Bayer Healthcare, NDA 20\u002D204 10.\u0022, \u000A \u0022Description of How the Drug Product is Intended to be Used The naproxen sodium capsules are orally administered for temporary relief of minor aches and pains due to: headache, backache, muscular aches, common cold, minor pain of arthritis, toothache, and menstrual cramps\u003B and temporary reduction of fever.\u0022, \u000A \u0022C. Basis for Approvability or Not\u002DApproval Recommendation The CMC information of the drug substance naproxen sodium was referenced to the DMF 11940.\u0022, \u000A \u0022The submitted drug product stability data for 18 months conform to the established acceptance criteria.\u0022, \u000A \u0022The submitted stability data and the statistical analysis were considered adequate to support the proposed 24\u002Dnionth expiration dating period.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1029\u002D30\u002DRobert_Thornton_Morrison__Robert_Neilson_Boyd,_Organic_Chemistry_4th_ed,_Allyn_and_Bacon,_Inc_1983\u0022, \u000A \u0022number\u0022: \u002201\u002D14\u002D2018\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 30, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1504675/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTM4YTRjZTEtNmE5Ni00YTI4LTljMDktNDRkMTE1ZDYyZGIwOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2018\u002D00421/Inter_Partes_Review_of_U.S._Pat._9693978/01\u002D14\u002D2018\u002DPetitioner/Exhibit\u002D1029\u002D30\u002DRobert_Thornton_Morrison__Robert_Neilson_Boyd%2C_Organic_Chemistry_4th_ed%2C_Allyn_and_Bacon%2C_Inc_1983/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTM4YTRjZTEtNmE5Ni00YTI4LTljMDktNDRkMTE1ZDYyZGIwOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/14/2018\u0022, \u000A \u0022date_added\u0022: \u00221/14/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 24703, \u000A \u0022pages\u0022: 4, \u000A \u0022e2e_number\u0022: \u00221029\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221029\u0022, \u000A \u0022title\u0022: \u0022Robert Thornton Morrison \u0026 Robert Neilson Boyd, Organic Chemistry (4th ed., Allyn and Bacon, Inc. 1983)\u0022, \u000A \u0022filename\u0022: \u0022Ex. 1029_Organic Chemistry.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 24703, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 5, \u000A \u0022summary\u0022: [\u000A \u00221 of 4 ,\u002D I Organic Chemistry Fourth Edition\u0022, \u000A \u00221973, 1966, 1959 by Allyn and Bacon copyright ?s Ave~ue, Newton, Mass~chusetts 02159.\u0022, \u000A \u0022Ali 1983 Inc., 7 Wei d No part of the matenal protected by th · .\u0022, \u000A \u0022mec an~ca , mcluding ~ recording, or by any mformat10n storage and or by pho~ocopytn~~m without written permission from the retneval sys \u0027 copyright owner.\u0022, \u000A \u0022Library of Congress Cataloging in Publication Data Morrison, Robert Thornton Organic chemistry.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }\u000A ]\u000A }\u000A]'); var docket_report_needs_download = false; var docket_report_rendered = false; // Used by some docket reports var docket_report_organized = null; /** * Downloads the docket information using an ajax call. When the call * completes, makes the callback. * returns true if the ajax call was made, false if it already exists. */ function download_docket_report(callback, force) { if(!docket_report_needs_download && !force) { return false; } // progress_loader(true, 5, "downloaddoc"); $.getJSON("/get_docket.ajax", {id:5350415818686464}, function() {}) .success(function(result) { // progress_loader(false, null, "downloaddoc"); if(result.success) { docket_report_needs_download = false; docket_report = result.docket.docket_report; docket_report_organized = result.docket.organized_report; parties_by_type = result.parties_by_type; parties = result.parties; if(callback) callback(); } else { show_error_usermsg(result.error); } }) .error(function(jqXHR) { // progress_loader(false, null, "downloaddoc"); if(jqXHR.readyState >= 4) show_error_usermsg("Error Getting Docket Information"); }); return true; } /** * Get additional information about this docket if we are tracking it. **/ var docket_track_info = null; function get_docket_track_info(callback) { if(!callback) { callback = function () { console.log("Finished get_docket_track_info"); }; } if(!user_alert_id) { return callback({}); } if(docket_track_info != null) { return callback(docket_track_info); } $.getJSON("/edit_dockets.ajax", {id:user_alert_id}, function(result) { if(result.success && result.docket) { docket_track_info = result.docket; return callback(docket_track_info); } else { docket_track_info = false; return callback(docket_track_info); } }); } /** * Wrap dates in a calendar widget which makes them easy to calendar. */ var re_date = new RegExp( "(" + // First date format, e.g.: Sep. 1, 2012 "(?:(?:january|jan\\.?|february|feb\\.?|march|mar\\.?|april|apr\\.|" + "may|june|jun\\.?|july|jul\\.?|august|aug\\.?|september|sept?\\.?|"+ "october|oct\\.?|november|nov\\.?|december|dec\\.?)" + "[\\s,]+[0123]?\\d[\\s,]+\\d\\d\\d?\\d?)|" + "(?:[01]?\\d[/\\-][0123]?\\d[/\\-]\\d\\d\\d?\\d?))" + // Optional ending stuff "([,\\s]*(?:at\\s+)?(\\d+(?:[\\:\\d]+)?\\s*[apm\.]*))?", "ig"); function wrap_dates(m, dt, at, tm, offset, string) { // Determine if we're in a tag. var openB = string.lastIndexOf("<", offset); var closeB = string.lastIndexOf(">", offset); if(openB != -1 && (closeB == -1 || closeB < openB)) { // We're in a tag, do not wrap. return m; } // Special case for PACER dockets which often use entered and filed on. for(k in {"(Filed on ":1, "(Date Filed: ":1, "(Entered: ":1, ") Modified on ":1, "Signed by Judge ":1}) { var filed_on = string.lastIndexOf(k, offset); if(filed_on != -1) { // This is not a real deadline. return m; } } // Try generating a rudimentary title for this deadline. 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Inter Partes Review of U.S. Pat. 9,693,978 IPR2018-00421 Patent Trial and Appeal Board Patent Trial and Appeal Board /cases/PTAB/IPR2018-00421/Inter_Partes_Review_of_U.S._Pat._9693978/ 6a899bbeb8eb9fd1fd3042007012715df54d42b876f8bfea5cfee293
Inter Partes Review of U.S. Pat. 9,693,978
IPR2018-00421 | Patent Trial and Appeal Board
Application No. 14977808
Inventors Nachiappan Chidambaram, Aqeel Fatmi