Source: https://www.docketalarm.com/cases/PTAB/IPR2017-01673/Inter_Partes_Review_of_U.S._Pat._6790459/
Timestamp: 2018-07-16 04:49:38
Document Index: 594412300

Matched Legal Cases: ['§ 42', '§ 42', '§ 42', '§ 42', '§ 42', '§ 103', '§ 42', '§102', '§ 103']

Inter Partes Review of U.S. Pat. 6,790,459, IPR2017-01673 (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:6103442744541184}, 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 || 6103442744541184 ); }); 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:"IPR2017-01673" }); // 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. 6,790,459.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 Refund Approval None: Notice of Refund (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00222/5/2018\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002202\u002D05\u002D2018\u002DBoard\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Refund_Approval\u002D13\u002DNotice_of_Refund\u0022, \u000A \u0022number\u0022: \u002202\u002D05\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTA5NjM4OTAtYzcwYi00OGY2LTg4OTEtNTlmOTgzNjQ3N2Q5OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/02\u002D05\u002D2018\u002DBoard/Refund_Approval\u002D13\u002DNotice_of_Refund/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTA5NjM4OTAtYzcwYi00OGY2LTg4OTEtNTlmOTgzNjQ3N2Q5OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00222/5/2018\u0022, \u000A \u0022date_added\u0022: \u00222/5/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 77905, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u002213\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Notice of Refund\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022IPR2017\u002D01673 Notice.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 77905, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022parties_from_title\u0022: [\u000A [\u000A \u0022AUROBINDO PHARMA USA INC.\u0022\u000A ], \u000A [\u000A \u0022Andrx Corporation, \u005CnAndrx Labs, LLC \u005CnAndrx Laboratories, Inc. \u005CnAndrx Laboratories (NJ), Inc. \u005CnAndrx EU Ltd. \u005CnAndrx Pharmaceuticals, LLC, \u005CnTeva Pharmaceutical Industries Inc.\u0022\u000A ]\u000A ], \u000A \u0022num_pages\u0022: 4, \u000A \u0022parties\u0022: {\u000A \u0022petitioner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Steven Moore\u0022, \u000A \u0022email\u0022: \u0022steven.moore@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022John Winterle\u0022, \u000A \u0022email\u0022: \u0022john.winterle@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Alan Gardner\u0022, \u000A \u0022email\u0022: \u0022alan.gardner@withersworldwide.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Withers LLP\u0022\u000A }\u000A ], \u000A \u0022patent owner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022David Cavanaugh\u0022, \u000A \u0022email\u0022: \u0022david.cavanaugh@wilmerhale.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Jonathan Roses\u0022, \u000A \u0022email\u0022: \u0022jonathan.roses@wilmerhale.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022David Chavous\u0022, \u000A \u0022email\u0022: \u0022dchavous@chavousiplaw.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022David Giordano\u0022, \u000A \u0022email\u0022: \u0022davidg@giordanolawllc.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Wilmer Cutler Pickering Hale and Dorr LLP\u0022\u000A }\u000A ]\u000A }, \u000A \u0022patents\u0022: [\u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Petitioner’s request for a refund of certain post\u002Dinstitution fees paid on January 31st, 2018 in the above proceeding is hereby granted.\u0022, \u000A \u0022The amount of $14,000 has been refunded to Petitioner’s deposit account.\u0022, \u000A \u0022The parties are reminded that unless otherwise permitted by 37 C.F.R. § 42.6(b)(2), all filings in this proceeding must be made electronically in the\u0022, \u000A \u0022Case IPR2017\u002D01673 Patent 6,790,459 Patent Trial and Appeal Board End to End (PTAB E2E), accessible from the Board Web site at http://www.uspto.gov/PTAB.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Refund Approval\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Petitioner Refund Request None: Request for Refund (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00221/31/2018\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002201\u002D31\u002D2018\u002DPetitioner\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Refund_Request\u002D12\u002DRequest_for_Refund\u0022, \u000A \u0022number\u0022: \u002201\u002D31\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYWY0NTBkYTctOWU2ZS00OGQwLTlkYTMtNTIwZGI5ODUwOGI4OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/01\u002D31\u002D2018\u002DPetitioner/Refund_Request\u002D12\u002DRequest_for_Refund/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYWY0NTBkYTctOWU2ZS00OGQwLTlkYTMtNTIwZGI5ODUwOGI4OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00221/31/2018\u0022, \u000A \u0022date_added\u0022: \u00221/31/2018\u0022, \u000A \u0022e2e_submitter_id\u0022: 72324, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u002212\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Request for Refund\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022\u0027459 Request for Refund.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72324, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 4, \u000A \u0022patents\u0022: [\u000A \u00226126124\u0022, \u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Patent No. 6,790,459 Petitioner\u0027s Request for Refund AUROBINDO PHARMA USA INC. requests a refund of the $14,000 post\u002D institution fee in the non\u002Dinstituted inter partes review No. IPR20 17\u002D01673.\u0022, \u000A \u0022Please credit the refund to deposit account No. 506\u002D744.\u0022, \u000A \u0022Dated: January 30,2018 Respectfully submitted, Registration No.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Refund Request\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Board Institution Decision None: DECISION\u005CnDenying Institution of Inter Partes Review\u005Cn37 C.F.R. sec 42.108 (PUBLIC)\u0022, \u000A \u0022date\u0022: \u002212/29/2017\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002212\u002D29\u002D2017\u002DBoard\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Institution_Decision\u002D11\u002DDECISIONDenying_Institution_of_Inter_Partes_Review37_CFR_sec_42108\u0022, \u000A \u0022number\u0022: \u002212\u002D29\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYjliMjNmMzAtMmVhOC00ZThmLTliNzYtYzQ3OWQyMjhjMTc2OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/12\u002D29\u002D2017\u002DBoard/Institution_Decision\u002D11\u002DDECISIONDenying_Institution_of_Inter_Partes_Review37_CFR_sec_42108/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYjliMjNmMzAtMmVhOC00ZThmLTliNzYtYzQ3OWQyMjhjMTc2OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u002212/29/2017\u0022, \u000A \u0022date_added\u0022: \u002212/29/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 48865, \u000A \u0022pages\u0022: 18, \u000A \u0022e2e_number\u0022: \u002211\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022DECISION\u005CnDenying Institution of Inter Partes Review\u005Cn37 C.F.R. sec 42.108\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022IPR2017\u002D01673 DDI (mailed).pdf\u0022, \u000A \u0022e2e_submitter\u0022: 48865, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [\u000A {\u000A \u0022outcome\u0022: [\u000A \u0022denied\u0022\u000A ], \u000A \u0022type\u0022: \u0022Petition Institution\u0022\u000A }, \u000A {\u000A \u0022snippet\u0022: \u0022For the foregoing reasons, we conclude that Petitioner has not established a reasonable likelihood of prevailing on its assertion that claims 1–21 of the ’459 patent are unpatentable\u0022, \u000A \u0022claims\u0022: [\u000A 1, \u000A 2, \u000A 3, \u000A 4, \u000A 5, \u000A 6, \u000A 7, \u000A 8, \u000A 9, \u000A 10, \u000A 11, \u000A 12, \u000A 13, \u000A 14, \u000A 15, \u000A 16, \u000A 17, \u000A 18, \u000A 19, \u000A 20, \u000A 21\u000A ], \u000A \u0022outcome\u0022: [\u000A \u0022denied\u0022\u000A ], \u000A \u0022claims_instituted\u0022: false, \u000A \u0022type\u0022: \u0022Petition Institution\u0022\u000A }, \u000A {\u000A \u0022snippet\u0022: \u0022the Petition is denied as to all challenged claims of the ’459 patent and no trial is instituted\u0022, \u000A \u0022outcome\u0022: [\u000A \u0022denied\u0022\u000A ], \u000A \u0022type\u0022: \u0022Petition Institution\u0022\u000A }\u000A ], \u000A \u0022judges\u0022: [\u000A \u0022Devon Zastrow Newman\u0022, \u000A \u0022Susan Mitchell\u0022, \u000A \u0022Tina Hulse\u0022\u000A ], \u000A \u0022num_pages\u0022: 19, \u000A \u0022parties\u0022: {\u000A \u0022petitioner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Steven J. Moore\u0022, \u000A \u0022email\u0022: \u0022steven.moore@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Hans Peter Hoffmann\u0022, \u000A \u0022email\u0022: \u0022peter.hoffmann@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022John Winterle\u0022, \u000A \u0022email\u0022: \u0022john.winterle@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Alan Gardner\u0022, \u000A \u0022email\u0022: \u0022alan.gardner@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022WITHERS BERGMAN\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Withers LLP\u0022\u000A }\u000A ], \u000A \u0022patent owner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022David L. Cavanaugh\u0022, \u000A \u0022email\u0022: \u0022David.Cavanaugh@wilmerhale.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Jonathan B. Roses\u0022, \u000A \u0022email\u0022: \u0022Jonathan.Roses@wilmerhale.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Wilmer Cutler Pickering Hale and Dorr LLP\u0022\u000A }, \u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022David A. Chavous\u0022, \u000A \u0022email\u0022: \u0022dchavous@chavousiplaw.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Chavous Intellectual Property Law LLC\u0022\u000A }, \u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022David A. Giordano\u0022, \u000A \u0022email\u0022: \u0022davidg@giordanolawllc.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Wilmer Cutler Pickering Hale and Dorr LLP\u0022\u000A }\u000A ]\u000A }, \u000A \u0022parties_from_title\u0022: [\u000A [\u000A \u0022AUROBINDO PHARMA USA INC.\u0022\u000A ], \u000A [\u000A \u0022ANDRX LABS, LLC\u0022\u000A ]\u000A ], \u000A \u0022patents\u0022: [\u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The ’459 patent relates to a method for treating patients with non\u002D insulin\u002Ddependent diabetes mellitus (NIDDM) by administering a controlled release oral dosage form containing preferably a biguanide drug such as metformin on a once daily basis.\u0022, \u000A \u0022Having considered Petitioner’s arguments and evidence, we are not persuaded that Petitioner has established a reasonable likelihood of prevailing on its assertion that claim 1 would have been obvious over the combination of Cheng, Timmins, Tucker, and Lewis.\u0022, \u000A \u0022Instead, Petitioner and its declarant merely state, for example, that a person of ordinary skill in the art “would recognize the routine ease of obtaining a Tmax using the dosage form of [Cheng] as recited in the claims of the ’459 patent.” Pet. 43.\u0022, \u000A \u0022As such, Petitioner and its declarant, Dr. Akhlaghi, conclude that a person of ordinary skill in the art would recognize that the Cmax and AUC of two 1000 mg tablets of Cheng would be within the ranges recited in claim 1.\u0022, \u000A \u0022Taken as a whole, we are not persuaded that Petitioner has shown sufficiently that a person of ordinary skill in the art would have combined Tucker with Cheng, Timmins, and Lewis to achieve the claimed invention.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Institution Decision\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Patent Owner Preliminary Response None: Patent Owner\u0027s Preliminary Response (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPatent Owner Exhibit 2001: Letter from FDA Approving NDA 21\u002D574 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPatent Owner Exhibit 2002: Approved Fortamet Label (PUBLIC)\u0022, \u000A \u0022date\u0022: \u002210/11/2017\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002210\u002D11\u002D2017\u002DPatent_Owner\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Preliminary_Response\u002D10\u002DPatent_Owners_Preliminary_Response\u0022, \u000A \u0022number\u0022: \u002210\u002D11\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNjhkMGVkNjQtNzE2MC00ZjlmLTllYTQtNWMyNGE4NDY0YTY3OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/10\u002D11\u002D2017\u002DPatent_Owner/Preliminary_Response\u002D10\u002DPatent_Owners_Preliminary_Response/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNjhkMGVkNjQtNzE2MC00ZjlmLTllYTQtNWMyNGE4NDY0YTY3OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u002210/11/2017\u0022, \u000A \u0022date_added\u0022: \u002210/11/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 16119, \u000A \u0022pages\u0022: 41, \u000A \u0022e2e_number\u0022: \u002210\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Patent Owner\u0027s Preliminary Response\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u00222017\u002D10\u002D11\u002D138US2\u002DPO\u002DPreliminary\u002DResponse.PDF\u0022, \u000A \u0022e2e_submitter\u0022: 16119, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [\u000A {\u000A \u0022type\u0022: \u0022Preliminary Response\u0022\u000A }\u000A ], \u000A \u0022num_pages\u0022: 42, \u000A \u0022patents\u0022: [\u000A \u00226760459\u0022, \u000A \u00226284275\u0022, \u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Finally, in a third Office Action, the Examiner rejected the claims as allegedly obvious over, inter alia, Lewis in combination with secondary references DFC and Chiao (Remington, 1995), stating that “it would have been obvious to one skilled in the art at the time of the invention to combine [Lewis] with Chiao and DFC… with the motivation of providing controlled delivery of metformin over a desired period of time to lower blood glucose levels when an individual is in the fed state.” Office Action mailed July 14, 2003 for the ’625 application, at 3\u002D4 (Ex. 1006 at 195\u002D96).\u0022, \u000A \u0022In the same Office Action, the Examiner rejected the claims as allegedly obvious over Cheng and DFC, stating that “it would have been obvious to one skilled in the art at the time of the invention to manipulate the release profile of [Cheng] in accordance with the teachings in [U.S. Patent No. 3,845,770] and lower blood glucose levels accordingly with the motivation of providing controlled delivery of metformin over a desired period of time and to administer the compositions at dinner or at a fed state with the motivation of regulating sugar levels.” Id. at 4\u002D5 (Ex. 1006 at 196\u002D97).\u0022, \u000A \u0022The term “AUC0\u002D24” should be construed to mean “the area under the plasma concentration\u002Dtime curve, as calculated by the trapezoidal rule over the complete 24\u002Dhour interval.” This proposed construction likewise comes directly from the express definition that Applicant set forth in the ’459 patent.\u0022, \u000A \u0022Accordingly, because the Petition does not establish that a POSA would have been motivated to modify the disclosure of Cheng based on Timmins, Tucker, and Lewis, to arrive at a dosage form having the claimed mean Tmax range with any reasonable expectation of success, Ground II should be denied.\u0022, \u000A \u0022Conclusion The Board should deny institution of the Petition because the asserted grounds are fundamentally deficient and rely on (a) a reference that does not qualify as prior art, and (b) arguments and positions previously considered and rejected by the Patent Office.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Preliminary Response\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D2001\u002D17\u002DLetter_from_FDA_Approving_NDA_21_574\u0022, \u000A \u0022number\u0022: \u002210\u002D11\u002D2017\u002DPatent_Owner\u0022, \u000A \u0022filing_party\u0022: \u0022Patent Owner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 17, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWFjZWU2NDItZDQ3OC00YzIzLTgwNzgtYTc1YjU4OTE1MjA5OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/10\u002D11\u002D2017\u002DPatent_Owner/Exhibit\u002D2001\u002D17\u002DLetter_from_FDA_Approving_NDA_21_574/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWFjZWU2NDItZDQ3OC00YzIzLTgwNzgtYTc1YjU4OTE1MjA5OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u002210/11/2017\u0022, \u000A \u0022date_added\u0022: \u002210/11/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 16119, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u00222001\u0022, \u000A \u0022e2e_exhibit\u0022: \u00222001\u0022, \u000A \u0022title\u0022: \u0022Letter from FDA Approving NDA 21\u002D574\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex._2001_\u002D_Apr._27,_2004_Letter_from_FDA_Approving_NDA_21\u002D574.PDF\u0022, \u000A \u0022e2e_submitter\u0022: 16119, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 4, \u000A \u0022summary\u0022: [\u000A \u0022Attention: Josephine Cucchiaro, Ph.D. Vice President, Regulatory Affairs 401 Hackensack Avenue, 9th Floor Hackensack, NJ 07601 Dear Dr. Cucchiaro: Please refer to your new drug application (NDA) dated December 17, 2002, received December 19, 2002, submitted under section 505(b) of the Federal Food, Drug, and Cosmetic Act for Fortamet™ (metformin HCl) Extended\u002DRelease Tablets, 500 mg and 1000 mg. We acknowledge receipt of your submissions dated February 26, and April 14, 19, and 22, 2004.\u0022, \u000A \u0022This new drug application provides for the use of Fortamet (metformin HCl) Extended\u002DRelease Tablets as an adjunct to diet and exercise to lower blood glucose in patients with type 2 diabetes mellitus.\u0022, \u000A \u0022Page 2 All applications for new active ingredients, new dosage forms, new indications, new routes of administration, and new dosing regimens are required to contain an assessment of the safety and effectiveness of the product in pediatric patients unless this requirement is waived or deferred.\u0022, \u000A \u0022For administrative purposes, all submissions related to this pediatric postmarketing study commitment must be clearly designated “Required Pediatric Study Commitments.” In addition, submit three copies of the introductory promotional materials that you propose to use for this product.\u0022, \u000A \u0022Send one copy to this division, the Division of Metabolic and Endocrine Drug Products, and two copies of both the promotional materials and the package insert directly to: Division of Drug Marketing, Advertising, and Communications, HFD\u002D42 Food and Drug Administration 5600 Fishers Lane Rockville, MD 20857 We remind you that you must comply with reporting requirements for an approved NDA (21 CFR 314.80 and 314.81).\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D2002\u002D18\u002DApproved_Fortamet_Label\u0022, \u000A \u0022number\u0022: \u002210\u002D11\u002D2017\u002DPatent_Owner\u0022, \u000A \u0022filing_party\u0022: \u0022Patent Owner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 18, \u000A \u0022e2e_download_link\u0022: \u0022https://ptab.uspto.gov/ptabe2e/rest/petitions/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNzA1MjAwZTEtNjI1Yi00NDBkLWJmM2EtNDBlODAyYTY0YWEzOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/10\u002D11\u002D2017\u002DPatent_Owner/Exhibit\u002D2002\u002D18\u002DApproved_Fortamet_Label/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNzA1MjAwZTEtNjI1Yi00NDBkLWJmM2EtNDBlODAyYTY0YWEzOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u002210/11/2017\u0022, \u000A \u0022date_added\u0022: \u002210/11/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 16119, \u000A \u0022pages\u0022: 37, \u000A \u0022e2e_number\u0022: \u00222002\u0022, \u000A \u0022e2e_exhibit\u0022: \u00222002\u0022, \u000A \u0022title\u0022: \u0022Approved Fortamet Label\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex._2002_\u002D_Apr._27,_2004_Approved_Fortamet_Label.PDF\u0022, \u000A \u0022e2e_submitter\u0022: 16119, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 38, \u000A \u0022summary\u0022: [\u000A \u0022FORTAMET should be temporarily discontinued in patients undergoing radiologic studies involving intravascular administration of iodinated contrast materials, because use of such products may result in acute alteration of renal function.\u0022, \u000A \u0022The risk of lactic acidosis may, therefore, be significantly decreased by regular monitoring of renal function in patients taking FORTAMET (metformin hydrochloride) Extended\u002D Release Tablets and by use of the minimum effective\u0022, \u000A \u0022Levels of fasting venous plasma lactate above the upper limit of normal but less than 5 mmol/L in patients taking FORTAMET do not necessarily indicate impending lactic acidosis and may be explainable by other mechanisms, such as poorly controlled diabetes or obesity, vigorous physical activity, or technical problems in sample handling.\u0022, \u000A \u0022Patients should be advised to discontinue FORTAMET immediately and to promptly notify their health practitioner if unexplained hyperventilation, myalgia, malaise, unusual somnolence, or other nonspecific symptoms occur.\u0022, \u000A \u0022You should not take FORTAMET if: • You have some forms of kidney or liver problems • You have congestive heart failure which is treated with medications, e.g., digoxin (Lanoxin) or furosemide (Lasix) • You drink alcohol excessively (all the time or short\u002D term “binge” drinking) • You are seriously dehydrated (have lost a large amount of body fluids) • You are going to have, within a few days, certain x\u002Dray tests with injectable contrast agents • You are going to have surgery • You develop a serious condition such as a heart attack, severe infection, or a stroke • You are 80 years of age or older and have NOT had your kidney function tested\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Board Notice None: NOTICE OF ACCEPTING CORRECTED PETITION (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00227/19/2017\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002207\u002D19\u002D2017\u002DBoard\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Notice\u002D9\u002DNOTICE_OF_ACCEPTING_CORRECTED_PETITION\u0022, \u000A \u0022number\u0022: \u002207\u002D19\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvODVjNWQ2NmYtYzFhZi00MzJlLWFlNGQtNmU3NjA5NzVjYTRkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/07\u002D19\u002D2017\u002DBoard/Notice\u002D9\u002DNOTICE_OF_ACCEPTING_CORRECTED_PETITION/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvODVjNWQ2NmYtYzFhZi00MzJlLWFlNGQtNmU3NjA5NzVjYTRkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00227/19/2017\u0022, \u000A \u0022date_added\u0022: \u00227/19/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 5046, \u000A \u0022pages\u0022: 2, \u000A \u0022e2e_number\u0022: \u00229\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022NOTICE OF ACCEPTING CORRECTED PETITION\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022IPR2017\u002D01673 New corrected petition.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 5046, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022parties_from_title\u0022: [\u000A [\u000A \u0022AUROBINDO PHARMA USA, INC.\u0022\u000A ], \u000A [\u000A \u0022ANDRX LABS, LLC\u0022, \u000A \u0022TEVA PHARMACEUTICAL USA INC.\u0022, \u000A \u0022SHIONOGI INC.\u0022\u000A ]\u000A ], \u000A \u0022num_pages\u0022: 4, \u000A \u0022parties\u0022: {\u000A \u0022petitioner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Steven J. Moore\u0022, \u000A \u0022email\u0022: \u0022steven.moore@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Hans Peter Hoffmann\u0022, \u000A \u0022email\u0022: \u0022peter.hoffmann@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022John Winterle\u0022, \u000A \u0022email\u0022: \u0022john.winterle@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Alan Gardner\u0022, \u000A \u0022email\u0022: \u0022alan.gardner@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Withers Bergman\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Withers LLP\u0022\u000A }\u000A ], \u000A \u0022patent owner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022David L. Cavanaugh\u0022, \u000A \u0022email\u0022: \u0022david.cavanaugh@wilmerhale.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Jonathan B. Roses\u0022, \u000A \u0022email\u0022: \u0022jonathan.roses@wilmerhale.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022David A. Chavous\u0022, \u000A \u0022email\u0022: \u0022dchavous@wilmerhale.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022David A. Giordano\u0022, \u000A \u0022email\u0022: \u0022davidg@wilmerhale.com\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Wilmer Cutler Pickering Hale and Dorr LLP\u0022\u000A }\u000A ]\u000A }, \u000A \u0022patents\u0022: [\u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The corrected petition filed on July 18, 2017 in the above proceeding is accepted.\u0022, \u000A \u0022The parties are reminded that unless otherwise permitted by 37 C.F.R. § 42.6(b)(2), all filings in this proceeding must be made electronically in Patent Trial and Appeal Board End to End (PTAB E2E), accessible from the Board Web site at http://www.uspto.gov/PTAB.\u0022, \u000A \u0022Case IPR2017\u002D01673 Patent 6,790,459 B1 must register with PTAB E2E.\u0022, \u000A \u0022Information regarding how to register with and use PTAB E2E is available at the Board Web site.\u0022, \u000A \u0022If there are any questions pertaining to this notice, please contact Lawrence J.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Notice\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Petitioner Corrected Petition None: CORRECTED PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,790,459 UNDER 35 U.S.C. 311\u002D319 AND 37 C.F.R. 42.1\u002D.80, 42.100\u002D.123 (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00227/18/2017\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002207\u002D18\u002D2017\u002DPetitioner\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Corrected_Petition\u002D8\u002DCORRECTED_PETITION_FOR_INTER_PARTES_REVIEW_OF_US_PATENT_NO_6,790,459_UNDER_35_USC_311_319_AND_37_CFR_421_80,_42100_123\u0022, \u000A \u0022number\u0022: \u002207\u002D18\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvODUzNTc4OTQtNjIxZC00YTI5LWJiZDYtNTA3Njg5ZTZiMmUzOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/07\u002D18\u002D2017\u002DPetitioner/Corrected_Petition\u002D8\u002DCORRECTED_PETITION_FOR_INTER_PARTES_REVIEW_OF_US_PATENT_NO_6%2C790%2C459_UNDER_35_USC_311_319_AND_37_CFR_421_80%2C_42100_123/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvODUzNTc4OTQtNjIxZC00YTI5LWJiZDYtNTA3Njg5ZTZiMmUzOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00227/18/2017\u0022, \u000A \u0022date_added\u0022: \u00227/18/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72324, \u000A \u0022pages\u0022: 66, \u000A \u0022e2e_number\u0022: \u00228\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022CORRECTED PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,790,459 UNDER 35 U.S.C. 311\u002D319 AND 37 C.F.R. 42.1\u002D.80, 42.100\u002D.123\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022CORRECTED PETITION \u0027459\u002D5638518_9\u002D2.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72324, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 132, \u000A \u0022patents\u0022: [\u000A \u00226866866\u0022, \u000A \u00226475521\u0022, \u000A \u00226270805\u0022, \u000A \u00226284275\u0022, \u000A \u00225638518\u0022, \u000A \u00226790459\u0022, \u000A \u00225955106\u0022, \u000A \u00226099862\u0022, \u000A \u00226099859\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The specifications of both patents describe the invention as a composition for treating patients having non\u002Dinsulin\u002Ddependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug such as metformin, on a once\u002Da\u002Dday basis.\u0022, \u000A \u0022(Amended) A method for lowering blood glucose levels in human patients needing treatment for non\u002Dinsulin\u002Ddependent diabetes mellitus (NIDDM), comprising orally administering to human patients on a once\u002D a\u002Dday basis at least one oral controlled release dosage form comprising an effective dose of at least one suitable anti hyperglycemic agent or a pharmaceutically acceptable salt thereof and a controlled release carrier, wherein the dosage form provides a mean time to maximum plasma concentration (Tmax) of [metformin] the agent at from 5.5 to 7.5 hours after administration.\u0022, \u000A \u0022Claim 1, the only independent claim read as follows: l. (Twice Amended) A method for lowering blood glucose levels in human patients needing treatment for non\u002Dinsulin\u002Ddependent diabetes mellitus (NIDDM), comprising orally administering to human patients on a once\u002Da\u002Dday basis at least one oral controlled release dosage form [at least one suitable an effective dose of comprising antihyperglycemic agent] metformin or a pharmaceutically acceptable salt thereof and an effective amount of a controlled release carrier to control the release of said metformin or pharmaceutically acceptable salt thereof from said dosage form, wherein following oral administration of a single dose, the dosage form provides a mean time to maximum plasma concentration (Tmax) of [agent] metformin at from 5.5 to 7.5 hours after administration following dinner.\u0022, \u000A \u0022The WO 00/12097 publication notes that the disclosed tablet provides continuous therapeutic levels of an antihyperglycemic drug to an animal in need of such treatment over a twelve or twenty four hour period, the same as evidenced by the \u0027459 patent in Figures 1, 2 and 4.\u0022, \u000A \u0022(Page 5, ll. 13\u002D14) In respect of claims 14 and 15, Lewis et al., the ‘989 publication, describes a modified release composition used for the treatment of Type 2 diabetes in which an insulin sensitizer such as glitazone is administered in combination with metformin to achieve prolonged bioavailability of the drug.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Corrected Petition\u0022, \u000A \u0022e2e_lock_control\u0022: 0\u000A }\u000A ]\u000A }, \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: \u00227/12/2017\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002207\u002D12\u002D2017\u002DBoard\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Notice_of_Filing_Date_Accorded_to_Petition\u002D7\u002DNotice_of_Accord_Filing_Date\u0022, \u000A \u0022number\u0022: \u002207\u002D12\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYWUyMTA1MTctMGIzZC00MTliLWI4ZmYtM2I4M2FiZjM5ODk2OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/07\u002D12\u002D2017\u002DBoard/Notice_of_Filing_Date_Accorded_to_Petition\u002D7\u002DNotice_of_Accord_Filing_Date/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYWUyMTA1MTctMGIzZC00MTliLWI4ZmYtM2I4M2FiZjM5ODk2OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00227/12/2017\u0022, \u000A \u0022date_added\u0022: \u00227/12/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 5046, \u000A \u0022pages\u0022: 5, \u000A \u0022e2e_number\u0022: \u00227\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Notice of Accord Filing Date\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022IPR2017\u002D01673 Excessive Word Count.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 5046, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022parties_from_title\u0022: [\u000A [\u000A \u0022AUROBINDO PHARMA USA, INC.\u0022\u000A ], \u000A [\u000A \u0022ANDRX LABS, LLC\u0022, \u000A \u0022TEVA PHARMACEUTICAL USA INC.\u0022, \u000A \u0022SHIONOGI INC.\u0022\u000A ]\u000A ], \u000A \u0022num_pages\u0022: 10, \u000A \u0022parties\u0022: {\u000A \u0022petitioner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Steven J. Moore\u0022, \u000A \u0022email\u0022: \u0022steven.moore@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Hans Peter Hoffmann\u0022, \u000A \u0022email\u0022: \u0022peter.hoffmann@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022John Winterle\u0022, \u000A \u0022email\u0022: \u0022john.winterle@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Alan Gardner\u0022, \u000A \u0022email\u0022: \u0022alan.gardner@withersworldwide.com\u0022\u000A }, \u000A {\u000A \u0022name\u0022: \u0022Withers Bergman\u0022\u000A }\u000A ], \u000A \u0022name\u0022: \u0022Withers LLP\u0022\u000A }\u000A ], \u000A \u0022patent owner\u0022: [\u000A {\u000A \u0022counsel\u0022: [\u000A {\u000A \u0022name\u0022: \u0022David L. Cavanaugh\u0022\u000A }\u000A ], \u000A \u0022other\u0022: [\u000A \u00221875 Pennsylvania Avenue, NW\u0022, \u000A \u0022Washington DC 20006\u0022\u000A ], \u000A \u0022name\u0022: \u0022Wilmer, Cutler, Pickering, Hale and Dorr LLP\u0022\u000A }\u000A ]\u000A }, \u000A \u0022patents\u0022: [\u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The petition for covered business method patent review in the above proceeding has been accorded the filing date of June 23, 2017.\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 \u0022David L. Cavanaugh Wilmer, Cutler, Pickering, Hale and Dorr LLP 1875 Pennsylvania Avenue, NW Washington DC 20006\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 Mandatory Notice None: PO Mandatory Notices (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPatent Owner Power of Attorney None: Andrx Power of Attorney (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPatent Owner Power of Attorney None: Teva Power of Attorney (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPatent Owner Power of Attorney None: Shionogi Power of Attorney (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00227/10/2017\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002207\u002D10\u002D2017\u002DPatent_Owner\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Mandatory_Notice\u002D6\u002DPO_Mandatory_Notices\u0022, \u000A \u0022number\u0022: \u002207\u002D10\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTBiMzEzYmMtOTY1My00MWVhLWI3NTMtMmI2MWJhY2MyNTNkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/07\u002D10\u002D2017\u002DPatent_Owner/Mandatory_Notice\u002D6\u002DPO_Mandatory_Notices/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNTBiMzEzYmMtOTY1My00MWVhLWI3NTMtMmI2MWJhY2MyNTNkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00227/10/2017\u0022, \u000A \u0022date_added\u0022: \u00227/10/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 16119, \u000A \u0022pages\u0022: 8, \u000A \u0022e2e_number\u0022: \u00226\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022PO Mandatory Notices\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u00222017\u002D07\u002D10_PO_Mandatory_Notice_IPR2017\u002D01673_(US_6,790,759).PDF\u0022, \u000A \u0022e2e_submitter\u0022: 16119, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 16, \u000A \u0022patents\u0022: [\u000A \u00226866866\u0022, \u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Pursuant to 37 C.F.R. § 42.8, Patent Owner Andrx Labs, LLC, respectfully submits the following Mandatory Notices.\u0022, \u000A \u0022Based on the Patent Owner\u0027s current understanding, the real parties\u002Din\u002D interest (“RPI”) are Andrx Labs, LLC, Teva Pharmaceuticals USA Inc., and Shionogi Inc.\u0022, \u000A \u0022The Patent Owner continues its investigation regarding entities which should be named as RPIs and will update these Mandatory Notices if and as needed.\u0022, \u000A \u0022Additionally, Patent Owner identifies the following matters that relate or\u0022, \u000A \u0022Electronic service on lead and back up counsel is approved and preferred.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Mandatory Notice\u0022, \u000A \u0022e2e_lock_control\u0022: 2\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Power_of_Attorney\u002D3\u002DAndrx_Power_of_Attorney\u0022, \u000A \u0022number\u0022: \u002207\u002D10\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTFiZjQwNjktYWIwMy00MTEyLTg1YjUtZDY0ODEwMWQwMDVhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: 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\u0022num_pages\u0022: 6, \u000A \u0022patents\u0022: [\u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Patent No. 6,790,459 Aner Labs, LLC, the patent owner of US.\u0022, \u000A \u0022Patent No. 6,790,459, hereby appoints the following attorneys and/or agents to prosecute the above captioned inter partes review and transact all business in the US.\u0022, \u000A \u0022Patent and Trademark Office connected herewith: I All practitioners at Customer Number 148630 Please address all communications to: Chavous Intellectual Property Law LLC PO.\u0022, \u000A \u0022The individual listed below has the authority to execute this document on behalf of Andrx Labs LLC.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Power of Attorney\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Power_of_Attorney\u002D4\u002DTeva_Power_of_Attorney\u0022, \u000A \u0022number\u0022: \u002207\u002D10\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWU3YTM5MTYtNTc0NS00MGYwLWEyZmMtNGE1MGNmZTJlYWVhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/07\u002D10\u002D2017\u002DPatent_Owner/Power_of_Attorney\u002D4\u002DTeva_Power_of_Attorney/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWU3YTM5MTYtNTc0NS00MGYwLWEyZmMtNGE1MGNmZTJlYWVhOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00227/10/2017\u0022, \u000A \u0022date_added\u0022: \u00227/10/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 16119, \u000A \u0022pages\u0022: 2, \u000A \u0022e2e_number\u0022: \u00224\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Teva Power of Attorney\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u00222017\u002D07\u002D10_\u002D_Executed_Patent_Owner_POA_(Teva)_IPR2017\u002D01673_(US_6,790,459).PDF\u0022, \u000A \u0022e2e_submitter\u0022: 16119, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 4, \u000A \u0022patents\u0022: [\u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Patent No. 6,790,459, hereby appoints the following attorneys and/or agents to prosecute the above captioned inter partes review and transact all business in the US.\u0022, \u000A \u0022Patent and Trademark Office connected herewith: \u002D All practitioners at Customer Number 148630 Please address all communications to: Chavous Intellectual Property Law LLC PO.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Power of Attorney\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Power_of_Attorney\u002D5\u002DShionogi_Power_of_Attorney\u0022, \u000A \u0022number\u0022: \u002207\u002D10\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNWRmNTA1YWUtNTYxYS00Y2E0LWJmZDEtZjkyMjQ2MDgzMjBkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/07\u002D10\u002D2017\u002DPatent_Owner/Power_of_Attorney\u002D5\u002DShionogi_Power_of_Attorney/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNWRmNTA1YWUtNTYxYS00Y2E0LWJmZDEtZjkyMjQ2MDgzMjBkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00227/10/2017\u0022, \u000A \u0022date_added\u0022: \u00227/10/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 16119, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u00225\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Shionogi Power of Attorney\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u00222017\u002D07\u002D10_\u002D_Executed_Patent_Owner_POA_(Shionogi)_IPR2017\u002D01673_(US_6,790,759).PDF\u0022, \u000A \u0022e2e_submitter\u0022: 16119, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 6, \u000A \u0022patents\u0022: [\u000A \u00226866866\u0022, \u000A \u00227522650\u0022, \u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u00220 Back\u002Dup Counsel: Jonathan B.\u0022, \u000A \u0022For: Shionogi Inc. :3 Dated: 3149\u003B ’05 249/\u003B Name: Andrew Zoltan Title: Vice President, Intellectual Property \u0026 Litigation\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Power of Attorney\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }\u000A ]\u000A }, \u000A {\u000A \u0022comp_contents\u0022: false, \u000A \u0022contents\u0022: \u0022Petitioner Petition None: PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,790,459\u005Cr\u005CnUNDER 35 U.S.C. 311\u002D319 AND 37 C.F.R. 42.1\u002D.80, 42.100\u002D.123 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Power of Attorney None: Power of Attorney for Patent No. 6,790,459 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1001: Ex 1001 \u002D US6790459B1 to Cheng et al (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1002: Ex 1002 \u002D WO1999047125A1 to Cheng et al (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1003: Ex 1003 \u002D WO2000028989A1 to Lewis et al (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1004: Ex 1004 \u002D US6099862 to Chen et al (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1005: Ex 1005 \u002D Tucker1981BJClinPharm_p235 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1006: Ex 1006 \u002D File History 6790459\u002D09705625 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1007: Ex 1007 \u002D File History\u002DUS6866866 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1008: Ex 1008 \u002D CFAC 12\u002D1228 7\u002D2\u002D12 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1009: Ex 1009 \u002D Akhlaghi Declaration (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1010: Ex 1010 Akhlaghi CV (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1011: Ex 1011 \u002D WO2000012097A1 to Chen et al (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1013: Ex 1013 \u002D WO1999047128A1 (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1014: Ex 1014 \u002D US6475521B1 to Timmins et al (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1015: Ex 1015 \u002D GLUCOPHAGE 21202lbl (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1016: Ex 1016 \u002D US6866866B1 to Chen et al (PUBLIC), \u005Cn\u003Cbr\u003E\u005CnPetitioner Exhibit 1017: Ex 1017 \u002D File History\u002DPatent Appl\u002D11225741 (PUBLIC)\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: []\u000A }, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\u002DPetitioner\u0022, \u000A \u0022exhibits\u0022: [\u000A {\u000A \u0022exhibit\u0022: \u0022Petition\u002D1\u002DPETITION_FOR_INTER_PARTES_REVIEW_OF_US_PATENT_NO_6,790,459UNDER_35_USC_311_319_AND_37_CFR_421_80,_42100_123\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNDc2YWViMmEtMThhMS00NjcyLWFmYjQtOWRjNTJkYTQzZDE3OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Petition\u002D1\u002DPETITION_FOR_INTER_PARTES_REVIEW_OF_US_PATENT_NO_6%2C790%2C459UNDER_35_USC_311_319_AND_37_CFR_421_80%2C_42100_123/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNDc2YWViMmEtMThhMS00NjcyLWFmYjQtOWRjNTJkYTQzZDE3OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 67, \u000A \u0022e2e_number\u0022: \u00221\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022PETITION FOR INTER PARTES REVIEW OF U.S. PATENT NO. 6,790,459\u005Cr\u005CnUNDER 35 U.S.C. 311\u002D319 AND 37 C.F.R. 42.1\u002D.80, 42.100\u002D.123\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Petition for Inter Partes Review of US6790459.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \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 []\u000A ], \u000A \u0022num_pages\u0022: 134, \u000A \u0022parties\u0022: {\u000A \u0022petitioner\u0022: [\u000A {\u000A \u0022name\u0022: \u0022Withers\u0022\u000A }\u000A ], \u000A \u0022patent owner\u0022: []\u000A }, \u000A \u0022patents\u0022: [\u000A \u00226866866\u0022, \u000A \u00226475521\u0022, \u000A \u00226270805\u0022, \u000A \u00226284275\u0022, \u000A \u00225638518\u0022, \u000A \u00226790459\u0022, \u000A \u00225955106\u0022, \u000A \u00226099862\u0022, \u000A \u00226099859\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022......31 Ground 2: Claims 1\u002D21 are Unpatentable Under 35 U.S.C. § 103(a) As Being Obvious Over WO 99/47125)(\u005C\u0022Cheng et al.\u005C\u0022) (Ex. 1002) In View of WO 99/47128 (\u005C\u0022Timmins et al.\u005C\u0022) (Ex. 1013), Tucker et al., “Metformin kinetics in healthy subjects and in patients with diabetes mellitus.” University Department of Therapeutics: The Royal Hallamshire Hospital, Sheffield, S10 2JF.\u0022, \u000A \u0022The specifications of both patents describe the invention as a composition for treating patients having non\u002Dinsulin\u002Ddependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug such as metformin, on a once\u002Da\u002Dday basis.\u0022, \u000A \u0022(Amended) A method for lowering blood glucose levels in human patients needing treatment for non\u002Dinsulin\u002Ddependent diabetes mellitus (NIDDM), comprising orally administering to human patients on a once\u002D a\u002Dday basis at least one oral controlled release dosage form comprising an effective dose of at least one suitable anti hyperglycemic agent or a pharmaceutically acceptable salt thereof and a controlled release carrier, wherein the dosage form provides a mean time to maximum plasma concentration (Tmax) of [metformin] the agent at from 5.5 to 7.5 hours after administration.\u0022, \u000A \u0022The WO 00/12097 publication notes that the disclosed tablet provides continuous therapeutic levels of an antihyperglycemic drug to an animal in need of such treatment over a twelve or twenty four hour period, the same as evidenced by the \u0027459 patent in Figures 1, 2 and 4.\u0022, \u000A \u0022(Page 5, ll. 13\u002D14) In respect of claims 14 and 15, Lewis et al., the ‘989 publication, describes a modified release composition used for the treatment of Type 2 diabetes in which an insulin sensitizer such as glitazone is administered in combination with metformin to achieve prolonged bioavailability of the drug.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Petition\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Power_of_Attorney\u002D2\u002DPower_of_Attorney_for_Patent_No_6,790,459\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvN2Q2MTgxYmQtYWZmNC00ZjkwLTg1NmUtMDhmZjk2YTUxNWI0OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Power_of_Attorney\u002D2\u002DPower_of_Attorney_for_Patent_No_6%2C790%2C459/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvN2Q2MTgxYmQtYWZmNC00ZjkwLTg1NmUtMDhmZjk2YTUxNWI0OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 3, \u000A \u0022e2e_number\u0022: \u00222\u0022, \u000A \u0022e2e_exhibit\u0022: null, \u000A \u0022title\u0022: \u0022Power of Attorney for Patent No. 6,790,459\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022PoA for Patent no 6,790,459 IPR2017\u002D00.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 6, \u000A \u0022patents\u0022: [\u000A \u00226790459\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Petitionfor Inter Partes Review of United States Patent No. 6, 790, 459\u0022, \u000A \u0022Patent No. 6,790,459 to Chen Issue Date: September 14, 2004 “W \u005C\u0022~ Title: Methods For Treating Diabetes Via Administratiot‘ifiof Controlled Release Metformin\u0022, \u000A \u0022§ 42.10(b), Petitioner, Aurobindo Pharma USA Inc., having a principal place of business at 279 Princeton\u002DHightstown Rd, East Windsor, NJ 08520, hereby appoints the following practitioners associated with Withers Bergman LLP, as its attorneys to transact all business in the United States Patent \u0026Trademark Office associated with an inter partes review of US.\u0022, \u000A \u0022ardner withersworldwide.com Withers Bergman Suite 400 1700 East Putnam Avenue\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Power of Attorney\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1001\u002DEx_1001___US6790459B1_to_Cheng_et_al\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTY0NTE3ZDgtNjMxYS00Njg3LWFkNzgtOWQ4ZjkyZDZlYmI0OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1001\u002DEx_1001___US6790459B1_to_Cheng_et_al/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTY0NTE3ZDgtNjMxYS00Njg3LWFkNzgtOWQ4ZjkyZDZlYmI0OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 22, \u000A \u0022e2e_number\u0022: \u00221001\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221001\u0022, \u000A \u0022title\u0022: \u0022Ex 1001 \u002D US6790459B1 to Cheng et al\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1001 \u002D US6790459B1 to Cheng et al.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 44, \u000A \u0022patents\u0022: [\u000A \u00225308348\u0022, \u000A \u00225858398\u0022, \u000A \u00226709978\u0022, \u000A \u00225006790\u0022, \u000A \u00225591454\u0022, \u000A \u00225024843\u0022, \u000A \u00226270805\u0022, \u000A \u00225766871\u0022, \u000A \u00225631224\u0022, \u000A \u00225955106\u0022, \u000A \u00225545413\u0022, \u000A \u00225120548\u0022, \u000A \u00225512293\u0022, \u000A \u00225071607\u0022, \u000A \u00226475521\u0022, \u000A \u00225413572\u0022, \u000A \u00225691386\u0022, \u000A \u00225091190\u0022, \u000A \u00225650170\u0022, \u000A \u00225178867\u0022, \u000A \u00225968851\u0022, \u000A \u00225543156\u0022, \u000A \u00225674900\u0022, \u000A \u00226790459\u0022, \u000A \u00226010718\u0022, \u000A \u00226099859\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Amethod for treating patients having non\u002Dinsulin\u002Ddependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a bigu\u002D anide drug such as metformin, on a once\u002Da\u002Dday basis.\u0022, \u000A \u0022The dosage form provides a mean time to maximum plasma concentration (Tmax) of the drug Which occurs at a 5.5 to 7.5 hours after oral administration on a once\u002Da\u002Dday basis to human patients.\u0022, \u000A \u0022In the prior art, many techniques have been used to provide controlled and extended\u002Drelease pharmaceutical dosage forms in order to maintain therapeutic serum levels of medicaments and to minimize the effects of missed doses of drugs caused by a lack of patient on compliance.\u0022, \u000A \u0022It is an additional object of other embodiments of the present invention to provide a controlled or sustained release formulation for an antihyperglycemic drug that obtains peak plasma levels from 5.5 to 7.5 hours after administration under various conditions.\u0022, \u000A \u0022The flux enhancing agent increases the volume of fluid imbibed into the core to enable the dosage form to dispense substantially all of the antihyperglycemic drug through the passageway and/or the porous membrane.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1002\u002D2\u002DEx_1002___WO1999047125A1_to_Cheng_et_al\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYmYwYWFlMzEtMDJkZi00NWY1LTljMzctMDcyNTY2NGRkNzA1OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1002\u002D2\u002DEx_1002___WO1999047125A1_to_Cheng_et_al/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvYmYwYWFlMzEtMDJkZi00NWY1LTljMzctMDcyNTY2NGRkNzA1OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 30, \u000A \u0022e2e_number\u0022: \u00221002\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221002\u0022, \u000A \u0022title\u0022: \u0022Ex 1002 \u002D WO1999047125A1 to Cheng et al\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1002 \u002D WO1999047125A1 to Cheng et al.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 60, \u000A \u0022patents\u0022: [\u000A \u00225858398\u0022, \u000A \u00225071607\u0022, \u000A \u00226404446\u0022, \u000A \u00225650170\u0022, \u000A \u00225178867\u0022, \u000A \u00228121620\u0022, \u000A \u00228389085\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Slovenia Slovakia Senegal Swaziland Chad Togo Tajikistan Turkmenistan Turkey Trinidad and Tobago Ukraine Uganda United States of America Uzbekistan Viet Nam Yugoslavia Zimbabwe\u0022, \u000A \u0022In the prior art, many techniques have been used to provide controlled and extended—release pharmaceutical dosage forms in order to maintain therapeutic serum levels of medicaments and to minimize the effects of missed doses of drugs caused by a lack of patient compliance.\u0022, \u000A \u0022The basic osmotic device described in the above cited patents have been refined over time in an effort to provide greater control of For example United States the release of the active ingredient.\u0022, \u000A \u0022It is an additional object of the present invention to provide a controlled or sustained release formulation for an antihyperglycemic drug that obtains peak plasma levels approximately 8—12 hours after administration.\u0022, \u000A \u0022semipermeable polymer flux enhancer plasticizer 50—98% 0—40% 0\u002D20% 50—99% 0—40% 0—25% 75\u002D95% 3—15% 2—10% 75—95% 2—20% 2—15% The dosage forms prepared according to the present invention should exhibit the following dissolution profile when tested in a USP type 2 apparatus at 75 rpms in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37°C: Time (hours)\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1003\u002D3\u002DEx_1003___WO2000028989A1_to_Lewis_et_al\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMTNiNDM0N2MtMmUyMS00MTk3LWI4YjUtYjQzODIwMWY5ZjVjOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1003\u002D3\u002DEx_1003___WO2000028989A1_to_Lewis_et_al/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMTNiNDM0N2MtMmUyMS00MTk3LWI4YjUtYjQzODIwMWY5ZjVjOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 26, \u000A \u0022e2e_number\u0022: \u00221003\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221003\u0022, \u000A \u0022title\u0022: \u0022Ex 1003 \u002D WO2000028989A1 to Lewis et al\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1003 \u002D WO2000028989A1 to Lewis et al.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 52, \u000A \u0022patents\u0022: [\u000A \u00226087801\u0022, \u000A \u00229201591\u0022, \u000A \u00229203355\u0022, \u000A \u00225264451\u0022, \u000A \u00229608243\u0022, \u000A \u00225952356\u0022, \u000A \u00229601811\u0022, \u000A \u00225232945\u0022, \u000A \u00229067271\u0022, \u000A \u00226576398\u0022, \u000A \u00225603496\u0022, \u000A \u00226920490\u0022, \u000A \u00225955106\u0022, \u000A \u00225965584\u0022, \u000A \u00229202501\u0022, \u000A \u00225502078\u0022, \u000A \u00225478852\u0022, \u000A \u00225104888\u0022, \u000A \u00229601698\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022MACKENZIE, Donald, Colin [GB/GB]\u003B SmithKline Before the expiration of the time limit for amending the Beecham Pharmaceuticals, New Frontiers Science Park claims and to be republished in the event of the receipt of South, Third Avenue, Harlow, Essex CM19 SAW (GB).\u0022, \u000A \u0022Slovenia Slovakia Senegal Swaziland Chad Togo Tajikistan Turkmenistan Turkey Trinidad and Tobago Ukraine Uganda United States of America Uzbekistan Viet Nam Yugoslavia\u0022, \u000A \u0022Suitable dosages, preferably unit dosages, of the insulin sensitiser and the other antidiabetic agent, such as the alpha glucosidase inhibitor, a biguanide or insulin secretagogue, include the known permissible doses for these compounds as described or referred to in reference texts such as the British and US Pharmacopoeias, Remington’s Pharmaceutical Sciences (Mack Publishing Co.), Martindale The Extra Pharmacopoeia (London, The Pharmaceutical Press) (for example see the 3 lst Edition page 341 and pages cited therein) or the above mentioned publications.\u0022, \u000A \u0022The compositions are formulated to provide the modified release of active agents according to the appropriate methods required, for example those disclosed in Sustained and Controlled Release Drug Delivery Systems, Editor Joe R Robinson, Volume 7, published by Marcel Dekker under the title Drugs and the Pharmaceutical Sciences, Controlled Drug Delivery, 2nd Edition’ edited by Joe Robinson and Vince Lee, Marcel Dekker, 1987 and ’Drug Delivery to the Gastrointestinal Tract’ Editors: J G Hardy, S S. Davis and C G Wilson also with reference to texts such as the British and US Pharmacopoeias, Remington’s Pharmaceutical Sciences (Mack Publishing Co.), Martindale The Extra Pharmacopoeia (London, The Pharmaceutical Press) (for example see the 3lst Edition page 341 and pages cited therein) and Harry’s Cosmeticology (Leonard Hill Books).\u0022, \u000A \u0022A composition according to any one of claims 1 to 15, wherein the insulin secretagogues is a sulphonylurea selected from glibenclamide, glipizide, gliclazide, glimepiride, tolazamide, tolbutamide, acetohexamide, carbutamide, chlorpropamide, glibornuride, gliquidone, glisentide, glisolamide, glisoxepide, glyclopyamide and glycylamide, glipentide.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1004\u002D4\u002DEx_1004___US6099862_to_Chen_et_al\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMGFmOWQ1ZDAtMTI3ZS00OGFlLWIwMGUtZDYwMzhkZTNjZjAxOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1004\u002D4\u002DEx_1004___US6099862_to_Chen_et_al/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMGFmOWQ1ZDAtMTI3ZS00OGFlLWIwMGUtZDYwMzhkZTNjZjAxOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 9, \u000A \u0022e2e_number\u0022: \u00221004\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221004\u0022, \u000A \u0022title\u0022: \u0022Ex 1004 \u002D US6099862 to Chen et al\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1004 \u002D US6099862 to Chen et al.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 18, \u000A \u0022patents\u0022: [\u000A \u00225260275\u0022, \u000A \u00225308348\u0022, \u000A \u00225688518\u0022, \u000A \u00225108756\u0022, \u000A \u00225141752\u0022, \u000A \u00225030452\u0022, \u000A \u00229608243\u0022, \u000A \u00225591454\u0022, \u000A \u00225024843\u0022, \u000A \u00225356913\u0022, \u000A \u00225631224\u0022, \u000A \u00229701797\u0022, \u000A \u00225614578\u0022, \u000A \u00225545413\u0022, \u000A \u00225667804\u0022, \u000A \u00225120548\u0022, \u000A \u00229609823\u0022, \u000A \u00225185158\u0022, \u000A \u00225082668\u0022, \u000A \u00225071607\u0022, \u000A \u00226099862\u0022, \u000A \u00225413572\u0022, \u000A \u00225691386\u0022, \u000A \u00225110597\u0022, \u000A \u00225091190\u0022, \u000A \u00225650170\u0022, \u000A \u00225178867\u0022, \u000A \u00225668117\u0022, \u000A \u00225512293\u0022, \u000A \u00225543156\u0022, \u000A \u00225674900\u0022, \u000A \u00225629319\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022In the prior art, many techniques have been used to provide controlled and extended\u002Drelease pharmaceutical dosage forms in order to maintain therapeutic serum levels of medicaments and to minimize the effects of missed doses of drugs caused by a lack of patient compliance.\u0022, \u000A \u0022More specifically, page 753 of the 50th edition of the Physicians” Desk Reference states that if adequate glycemic control is not attained with GLUCOPHAGE® monotherapy, the combination of GLUCOPHAGE® and a sulfonylurea such as glyburide may have a synergistic effect, since both active ingredients act to improve glucose toler\u002D ance by different mechanism.\u0022, \u000A \u0022FIG. 1 is a graph which depicts the dissolution profile in simulated intestinal fluid (SIF), pH 7.5 phosphate buffer of the formulation described in Example 1 as tested according to the procedure described in United States Pharmacopeia XXIII, Apparatus 2 @ 75 rpm.\u0022, \u000A \u0022The mixture of metformin HCl and sodium The dosage forms prepared according to the present invention should exhibit the following dissolution profile when tested in a USP type 2 (paddle) apparatus at 75 rpms in 900 ml of simulated intestinal fluid (pH 7.5 phosphate 20 buffer) and at 37° C.:\u0022, \u000A \u0022Acontrolled release pharmaceutical tablet as defined in claim 1 that exhibits the following dissolution profile when tested in a USP type 2 apparatus at 75 rpms in 900 ml of simulated intestinal fluid, pH 7.5 phosphate buffer and at 37°\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, 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\u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 14, \u000A \u0022e2e_number\u0022: \u00221005\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221005\u0022, \u000A \u0022title\u0022: \u0022Ex 1005 \u002D Tucker1981BJClinPharm_p235\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1005 \u002D Tucker1981BJClinPharm_p235.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 28, \u000A \u0022summary\u0022: [\u000A \u0022Metformin has been recommended as the drug of choice because the risk of developing lactic acidosis during treatment is less than that re sulting from the use of phenformin (British Medical Journal, 1977\u003B Phillips, Thomas \u0026 Harding, 1977\u003B Bergman, Boinan \u0026 Wiholm, 1978).\u0022, \u000A \u0022Oral administration (a) Single dose (Groups I\u002DIII) Plasma drug concentration\u002Dtime curves were fitted graphically by a triexponential equation with one negative and two positive terms in a similar manner to the i. v. data.\u0022, \u000A \u0022Lower urinary recoveries and higher faecal re coveries after the 1.5 g compared to the 0.5 g oral dose in Group I subjects (Table 3) suggest that increasing dosage is accompanied by a decrease in the absorption of metformin.\u0022, \u000A \u0022This may partially account for the poor correlation found by Irsigler, Kritz, Regal \u0026 Kaspar (1979) between serum biguanide levels and raised blood lactate concentrations in diabetic pa tients.\u0022, \u000A \u0022Renal clearance values for the drug well in excess of creatinine clear ance implicate tubular secretion of this highly ionised compound as a major mechanism of urinary excre tion.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A 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\u0022summary\u0022: [\u000A \u0022Patent and Trademark Office\u003B U.S. DEPARTMENT OF COMMERCE Under the Paperwork Reduction Act of 1995, no persons are required to respond to a collection of information unless it displays a valid OMB control number.\u0022, \u000A \u0022To\u003B ANDRX LABS, LLC The document was recorded in the United States Patent and Trademark Office at Reel 013783 , Frame 0187 , or for which a copy thereof is attached.\u0022, \u000A \u0022I hereby certify that this correspondence is being facsimile transmitted to the USPTO or deposited with the United States Postal Service with sufficient postage as first class mail in an envelope addressed to: Commissioner for Patents, P.O.\u0022, \u000A \u0022\u003B Telephone 954—762\u002D6211 m Roberta Loomar Title and Company Vice President, Chief Compliance Officer and Assistant General Counsel\u003B Andrx Corporation NOTE: Signatures of all the inventors or assignees of record of the entire interest or their representative(s) are required.\u0022, \u000A \u0022ccepted from anyone other than the ap Iicant\u003B a registered anomeg or agent\u003B or the aSSIgnee or other party in interest as shown y the records of the United tates Patent and Trademark Office.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1007\u002D7\u002DEx_1007___File_History_US6866866\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNjVmODEyNDctYjk0Yy00MTNjLWIwNmMtMGRjYzUzMTFlZWVlOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: 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\u0022num_pages\u0022: 444, \u000A \u0022patents\u0022: [\u000A \u00225141691\u0022, \u000A \u00225858398\u0022, \u000A \u00226390859\u0022, \u000A \u00226099859\u0022, \u000A \u00229211111\u0022, \u000A \u00225071607\u0022, \u000A \u00229610824\u0022, \u000A \u00225955106\u0022, \u000A \u00226866866\u0022, \u000A \u00226024511\u0022, \u000A \u00226254275\u0022, \u000A \u00226284275\u0022, \u000A \u00226475521\u0022, \u000A \u00226010718\u0022, \u000A \u00226099862\u0022, \u000A \u00225691386\u0022, \u000A \u00225650170\u0022, \u000A \u00225178867\u0022, \u000A \u00226099115\u0022, \u000A \u00227464000\u0022, \u000A \u00225688518\u0022, \u000A \u00226099882\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022A composition for treating patients having non\u002Dinsulin\u002D dependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing prefer\u002D ably a biguanide drug such a s metformin, on a once\u002Da\u002Dday basis.\u0022, \u000A \u0022In the prior art, many techniques have been used to provide controlled and extended\u002Drelease pharmaceutical dosage forms in order to maintain therapeutic serum levels of medicaments and to minimize the effects of missed doses of drugs caused by a lack of patient compliance.\u0022, \u000A \u0022In certain other able salt thereof, the doses of drug which exhibit the above disclosed mean fluctuation indexes can bc any cEective close embodiments, the once\u002Da\u002Dday metformin therapy of the present invention may be used concomitantly with a administered to a patient with NIDDM for the reduction of sulfonylurea, e.g., when diet and monotherapy with a sul\u002D SO serum glucose levels.\u0022, \u000A \u0022An oral dosage form according to the invention may be The term “membrane” means a membrane that is perme\u002D provided as, for example, granules, spheroids, beads, pellets able to both aqueous solutions or bodily fluids and to the ss (hereinafter collectively referred to as “multiparticulates”) active drug or pharmaceutical ingredient (e.g. the formula\u002D and/or particles.\u0022, \u000A \u0022The efficacy of metformin XT, 2000 mg which exhibits the following dissolution profiles whcn given once daily after breakfast, however, appeared to be tested in a USP type 2 apparatus at 75 rpm in 900 ml of comparable to or slightly less than that of GLUCOPHAGE simulated intestinal fluid @H 7.5 phosphate buffer) and at 37 given b i d .\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1008\u002D8\u002DEx_1008___CFAC_12_1228_7_2_12\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTkyYWZhNjUtOGZkMy00OGY1LWI1NDUtZTJlYTBhZjAwMDE0OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1008\u002D8\u002DEx_1008___CFAC_12_1228_7_2_12/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTkyYWZhNjUtOGZkMy00OGY1LWI1NDUtZTJlYTBhZjAwMDE0OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 17, \u000A \u0022e2e_number\u0022: \u00221008\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221008\u0022, \u000A \u0022title\u0022: \u0022Ex 1008 \u002D CFAC 12\u002D1228 7\u002D2\u002D12\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1008 \u002D CFAC 12\u002D1228 7\u002D2\u002D12.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 34, \u000A \u0022patents\u0022: [\u000A \u00226866866\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The applicant indicated that the examiner agreed during the interview “that [pending] claim 5, which had an upper Tmax of 7.0 hours and which value is directly supported by the working examples, is patentably distinct over the Cheng, et al. reference.” J.A.\u0022, \u000A \u0022The court explained that because the prior art references were previously before the PTO, Lupin faced an “‘added burden of overcoming the deference that is due to a qualified government agency presumed to have done its job.’” Id. at *16\u002D17 (quoting Pharmastem Therapeu\u002D tics, Inc. v. Viacell, Inc., 491 F.3d 1342, 1366 (Fed. Cir. 2007)).\u0022, \u000A \u0022Such secondary considerations as commer\u002D cial success, long felt but unsolved needs, failure of others, etc., might be utilized to give light to the cir\u002D cumstances surrounding the origin of the subject matter sought to be patented.\u0022, \u000A \u0022There need not be “precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the infer\u002D ences and creative steps that a person of ordinary skill in the art would employ.” Id. at 418.\u0022, \u000A \u0022This notion stems from our suggestion that the party challenging a patent in court “bears the added burden of overcoming the deference that is due to a qualified government agency presumed to have done its job.” Pharmastem, 491 F.3d at 1366 (internal quotation marks omitted).\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: 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\u0022pages\u0022: 88, \u000A \u0022e2e_number\u0022: \u00221009\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221009\u0022, \u000A \u0022title\u0022: \u0022Ex 1009 \u002D Akhlaghi Declaration\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1009 \u002D Akhlaghi Declaration.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 176, \u000A \u0022patents\u0022: [\u000A \u00226866866\u0022, \u000A \u00226475521\u0022, \u000A \u00229143835\u0022, \u000A \u00226270805\u0022, \u000A \u00226284275\u0022, \u000A \u00226099859\u0022, \u000A \u00226790459\u0022, \u000A \u00225955106\u0022, \u000A \u00226099862\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022The ‘128 publication, therefore qualifies as prior art to the ‘459 patent claims under 35 U.S.C. §102(a) (Ex. 1013) Tucker et al., “Metformin kinetics in healthy subjects and in patients with diabetes mellitus.” University Department of Therapeutics: The Royal Hallamshire Hospital, Sheffield, 810 21F.\u0022, \u000A \u0022As noted in the Abstract, the \u0027459 patent discloses a \u005C\u0022[a] method for treating patients having non\u002Dinsulin\u002Ddependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing preferably a biguanide drug, such as metformin, on a once\u002Da\u002Dday basis.\u0022, \u000A \u0022The W0 00/ 12097 publication notes that the disclosed tablet provides continuous therapeutic levels of an antihyperglycemic drug to an animal in need of such treatment over a twelve or twenty four hour period, the same as evidenced by the \u0027459 patent in Figures 1, 2 and 4.\u0022, \u000A \u0022Ground 2: Claims 1\u002D21 are Unpatentable Under 35 U.S.C. § 103(a) As Being Obvious Over WO 99/47125)(\u005C\u0022Cheng et al.\u005C\u0022) (Ex. 1002) In View of WO 99/47128 (\u005C\u0022Timmins et al. \u005C\u0022) (Ex. 1013), Tucker et al., “Metformin kinetics in healthy subjects and in patients with diabetes mellitus.” University Department of Therapeutics: The Royal Hallamshire Hospital, Sheffield, 810 ZJF.\u0022, \u000A \u0022As directly exemplified in Examples 1\u002D3 of the \u0027459 patent, the tablet dosage form comprises a core containing metformin hydrochloride (active drug), povidone (binder), sodium lauryl sulfate (flux enhancer) and magnesium stearate (lubricant).\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1010\u002D10\u002DEx_1010_Akhlaghi_CV\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\u002DPetitioner\u0022, \u000A \u0022filing_party\u0022: \u0022Petitioner\u0022, \u000A \u0022e2e_exhibit_sequence\u0022: 10, \u000A \u0022e2e_download_link\u0022: 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\u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 76, \u000A \u0022patents\u0022: [\u000A \u00225190457\u0022, \u000A \u00226231166\u0022, \u000A \u00229631927\u0022, \u000A \u00229431828\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u00221996 Physicochemical characteristics of ingredients of an antacid suspension, consultant for Park Davis Pharmaceuticals in collaboration with Dr. Elizabeth 2001\u002D2003 2003 2005 Gipps, University of Sydney 1997\u002D1998 Droplet size determination of nebulized solutions of Salbutamol and Ipratropium Bromide using Marple \u002D Miller cascade impactor, in collaborating with Dr. Kim Chan, University of Sydney Pharmacokinetics of intravenous immunoglobulin (IVIG), I have analyzed the pharmacokinetic data from several phase III studies conducted by Bio Products Limited, UK ‘ Member of Mycophenolic Acid TDM Advisory Board (Opticept clinical trial, an 800 patient trial conducted by Roche Laboratories to evaluate the need for mycophenolic acid therapeutic drug monitoring) Consulting on a case study conducted at the Department of Emergency Medicine, RI hospital on the elimination of carboxy hemoglobin Expert witness in a personal injury case involving cyclosporine generic substitution and risk of organ rejection Expert witness in a patent dispute case between two major pharmaceutical companies 2005\u002D2007 2007 F. Akhlaghi CVJune 2017 Page 4\u0022, \u000A \u0022Macwan JS, Akhlaghi F. Development of a simple method for analysis of atorvastatin (ATV) and metabolites in acid and lactone forms by liquid chromatography\u002Dtandem mass spectrometry (LC\u002DMS/MS)\u003B Poster presentation at the PIP Pharmaceutical Sciences 2010 World Congress/AAPS Annual Meeting and Exposition, November 14 \u002D 18, 2010, New Orleans, LA.\u0022, \u000A \u0022Chitnis SD, Akhlaghi F. Development and validation of a simple method for quantitative estimation of sirolimus in human whole blood using liquid chromatography\u002Dtandem mass spectrometry (LC\u002DMS/MS)\u003B Poster presentation at the FIP Pharmaceutical Sciences 2010 World Congress/AAPS Annual Meeting and Exposition, November 14 \u002D 18, 2010, New Orleans, LA.\u0022, \u000A \u0022Chitnis SD, Moll V, Schniedewind B, Christians U, Akhlaghi F. Diabetic kidney transplant recipients exhibit elevated levels of tacrolimus metabolites\u003B Poster presentation at the FIP Pharmaceutical Sciences 2010 World Congress/AAPS Annual Meeting and Exposition, November 14 \u002D 18, 2010, New Orleans, LA.\u0022, \u000A \u0022Thudium KE, Akhlaghi F. Development and validation of an assay for determination of urinary 6 beta hydroxycortisol to cortisol ratio, a noninvasive marker for CYP3A activity\u003B Poster presentation at the FIP Pharmaceutical Sciences 2010 World Congress/AAPS Annual Meeting and Exposition, November 14 \u002D 18, 2010, New Orleans, LA.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1011\u002D11\u002DEx_1011___WO2000012097A1_to_Chen_et_al\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNmJkMTBmZjUtOWNlYi00ZGJlLWE1M2MtY2FlOTBmN2IwMTE5OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: 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\u0022num_pages\u0022: 66, \u000A \u0022patents\u0022: [\u000A \u00225591454\u0022, \u000A \u00229010065\u0022, \u000A \u00229608243\u0022, \u000A \u00229103247\u0022, \u000A \u00225071607\u0022, \u000A \u00225955106\u0022, \u000A \u00226900339\u0022, \u000A \u00225545413\u0022, \u000A \u00225922769\u0022, \u000A \u00225674900\u0022, \u000A \u00225024843\u0022, \u000A \u00225654005\u0022, \u000A \u00226042796\u0022, \u000A \u00229717975\u0022, \u000A \u00225091190\u0022, \u000A \u00225500222\u0022, \u000A \u00229640080\u0022, \u000A \u00229611448\u0022, \u000A \u00226417590\u0022, \u000A \u00227566896\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Slovenia Slovakia Senegal Swaziland Chad Togo Tajikistan Turkmenistan Turkey Trinidad and Tobago Ukraine Uganda United States of America Uzbekistan Viet Nam Yugoslavia\u0022, \u000A \u0022More specifically, page 753 of the 50th edition of the Physicians’ Desk Reference states that if adequate glycemic control is not attained with GLUCOPHAGE® monotherapy, the combination of GLUCOPHAGE® and a sulfonylurea such as glyburide may have a synergistic effect, since both active ingredients act to improve glucose tolerance by different mechanism.\u0022, \u000A \u0022is a graph which depicts the dissolution profile in simulated intestinal fluid (SIF), pH 7.5 phosphate buffer of the formulation described in Example 1 as tested according to the procedure described in United States Pharmacopeia XXIII, Apparatus 2 @ 75 rpm.\u0022, \u000A \u0022FIG. 2 is a graph which depicts the dissolution profile in simulated intestinal fluid (SIF), pH 7.5 phosphate buffer of the formulation described in Example 2 as tested according to the procedure described in United States Pharmacopeia XXIII, Apparatus 2 @ 75 rpm.\u0022, \u000A \u00223\u002D15% 2\u002D10% 75\u002D95% 2\u002D15°/o 2\u002D20% The dosage forms prepared according to the present invention should exhibit the following dissolution profile when tested in a USP type 2 (paddle) apparatus at 75 rpms in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37°C: Time (hours)\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1013\u002D12\u002DEx_1013___WO1999047128A1\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOGM3Zjg1OTQtN2JlMC00YTQ1LTg0NzgtZDA2OGFmOGUyMjJhOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1013\u002D12\u002DEx_1013___WO1999047128A1/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOGM3Zjg1OTQtN2JlMC00YTQ1LTg0NzgtZDA2OGFmOGUyMjJhOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 43, \u000A \u0022e2e_number\u0022: \u00221013\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221013\u0022, \u000A \u0022title\u0022: \u0022Ex 1013 \u002D WO1999047128A1\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1013 \u002D WO1999047128A1.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 86, \u000A \u0022patents\u0022: [\u000A \u00225614492\u0022, \u000A \u00229427589\u0022, \u000A \u00225346701\u0022, \u000A \u00229318755\u0022, \u000A \u00225232704\u0022, \u000A \u00225594016\u0022, \u000A \u00225631224\u0022, \u000A \u00225645858\u0022, \u000A \u00225007790\u0022, \u000A \u00229718814\u0022, \u000A \u00225484608\u0022, \u000A \u00225582837\u0022, \u000A \u00225169638\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Re: Bioadhesive s stems Polycarbophil has been identified as a suitable polymer for encouraging adhesion of orally administered dosage forms to the gastric mucosa, thereby prolonging residence time for a system designed to slowly deliver drug to absorptive sites in the proximal small intestine (Longer et al, J. Pharm. Sci., 74, 406—411 (1985)).\u0022, \u000A \u0022On imbibing fluid the system swells over a short period of time to a size that will encourage prolonged gastric retention, allowing sustained delivery of contained drug to absorption sites in the upper gastrointestinal tract.\u0022, \u000A \u0022In the case of metformin, it is desirable to provide a dosage form that allows extended delivery of the drug and has a prolonged gastric residence via swelling of the system rather than unfolding or expanding of a folded device, and that may be manufactured on a commercial scale.\u0022, \u000A \u0022Suitable larger polypeptides and proteins for use in the controlled release formulations of the present invention include insulin, calcitonin, elcatonin, calcitoningene related peptide and porcine somatostatin as well as analogs and homologs thereof.\u0022, \u000A \u0022After stirring the slurry for an hour at ambient temperature, the product was filtered off, washed with ethanol and dried under vacuum to form the metformin (2:1) succinate salt as a free flowing white crystalline solid in 89 M% yield and melting point of 246—247°C.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1014\u002D13\u002DEx_1014___US6475521B1_to_Timmins_et_al\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNWNkYmI5NzctMDM5NC00OWVkLTg4ZDUtNGE5ZjEzNTI3NjI0OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1014\u002D13\u002DEx_1014___US6475521B1_to_Timmins_et_al/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvNWNkYmI5NzctMDM5NC00OWVkLTg4ZDUtNGE5ZjEzNTI3NjI0OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 16, \u000A \u0022e2e_number\u0022: \u00221014\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221014\u0022, \u000A \u0022title\u0022: \u0022Ex 1014 \u002D US6475521B1 to Timmins et al\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1014 \u002D US6475521B1 to Timmins et al.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 32, \u000A \u0022patents\u0022: [\u000A \u00229318755\u0022, \u000A \u00225739135\u0022, \u000A \u00225582837\u0022, \u000A \u00226475521\u0022, \u000A \u00229718814\u0022, \u000A \u00225007790\u0022, \u000A \u00225575987\u0022, \u000A \u00225712279\u0022, \u000A \u00225006530\u0022, \u000A \u00225712396\u0022, \u000A \u00225177080\u0022, \u000A \u00225484608\u0022, \u000A \u00225760246\u0022, \u000A \u00226031004\u0022, \u000A \u00225169638\u0022, \u000A \u00225614492\u0022, \u000A \u00229427589\u0022, \u000A \u00225631224\u0022, \u000A \u00225885983\u0022, \u000A \u00225385929\u0022, \u000A \u00225563440\u0022, \u000A \u00225346701\u0022, \u000A \u00225982493\u0022, \u000A \u00225273995\u0022, \u000A \u00225594016\u0022, \u000A \u00225595872\u0022, \u000A \u00225686104\u0022, \u000A \u00225645858\u0022, \u000A \u00226099862\u0022, \u000A \u00225827875\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022Prior Art Gastro\u002DRetentive Systems It would be desirable to provide a dosage form that inherently has the property of extended gastric residence, possessing some resistance to the pattern of waves of motility present in the gastrointestinal tract that serve to propel material through it.\u0022, \u000A \u0022On imbibing fluid the system swells over a short period of time to a size that will encourage prolonged gastric retention, allowing sustained delivery of contained drug to absorption sites in the upper gastrointestinal tract.\u0022, \u000A \u0022In the case of metformin, it is desirable to provide a dosage form that allows extended delivery of the drug and has a prolonged gastric residence via swelling of the system rather than unfolding or expanding of a folded device, and that may be manufactured on a commercial scale.\u0022, \u000A \u0022Suitable larger polypeptides and proteins for use in the controlled release formulations of the present invention include insulin, calcitonin, elcatonin, calcitoningene related peptide and porcine somatostatin as well as analogs and homologs thereof.\u0022, \u000A \u0022After stirring the slurry for an hour at ambient temperature, the product was filtered off, washed with ethanol and dried under vacuum to form the metformin (2:1) succinate salt as a free flowing white crystalline solid in 89 M% yield and melting point of\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1015\u002D14\u002DEx_1015___GLUCOPHAGE_21202lbl\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTU4ZTUzYjctMmRmZS00NzU1LWFkZTctOTIyMTY1YzFlNzM1OzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1015\u002D14\u002DEx_1015___GLUCOPHAGE_21202lbl/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvOTU4ZTUzYjctMmRmZS00NzU1LWFkZTctOTIyMTY1YzFlNzM1OzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 29, \u000A \u0022e2e_number\u0022: \u00221015\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221015\u0022, \u000A \u0022title\u0022: \u0022Ex 1015 \u002D GLUCOPHAGE 21202lbl\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1015 \u002D GLUCOPHAGE 21202lbl.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 58, \u000A \u0022summary\u0022: [\u000A \u0022Summary of Mean Percent Change From Baseline of Major Serum Lipid Variables at Final Visit (29\u002Dweek studies) GLUCOPHAGE vs Placebo Combined GLUCOPHAGE/Glyburide vs Monotherapy\u0022, \u000A \u0022Response to FDA Comments of 10 12 00.doc – CLEAN DRAFT 10 13 00 Page 9 of 29 In contrast to sulfonylureas, body weight of individuals on GLUCOPHAGE tended to remain stable or even decrease somewhat (see Tables 2 and 3).\u0022, \u000A \u0022A 24\u002Dweek, double\u002Dblind, placebo\u002Dcontrolled study of GLUCOPHAGE XR, taken once daily with the evening meal, was conducted in patients with type 2 diabetes who had failed to achieve glycemic control with diet and exercise (HbA1c 7.0\u002D10.0%, FPG 126\u002D 270 mg/dL).\u0022, \u000A \u0022Such decrease, possibly due to interference with B12 absorption from the B12\u002Dintrinsic factor complex, is, however, very rarely associated with anemia and appears to be rapidly reversible with discontinuation of GLUCOPHAGE or Vitamin B12 supplementation.\u0022, \u000A \u0022Initial and periodic monitoring of hematologic parameters (e.g., hemoglobin/ hematocrit and red blood cell indices) and renal function (serum creatinine) should be performed, at least on an annual basis.\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1016\u002D15\u002DEx_1016___US6866866B1_to_Chen_et_al\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMDEyMjMyODEtMzk2Yy00NGVlLWJlOGYtYjExY2Q4NTJhNzZkOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1016\u002D15\u002DEx_1016___US6866866B1_to_Chen_et_al/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMDEyMjMyODEtMzk2Yy00NGVlLWJlOGYtYjExY2Q4NTJhNzZkOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 21, \u000A \u0022e2e_number\u0022: \u00221016\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221016\u0022, \u000A \u0022title\u0022: \u0022Ex 1016 \u002D US6866866B1 to Chen et al\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1016 \u002D US6866866B1 to Chen et al.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 42, \u000A \u0022patents\u0022: [\u000A \u00226099859\u0022, \u000A \u00225071607\u0022, \u000A \u00225006866\u0022, \u000A \u00225955106\u0022, \u000A \u00226866866\u0022, \u000A \u00226284275\u0022, \u000A \u00226475521\u0022, \u000A \u00226010718\u0022, \u000A \u00226099862\u0022, \u000A \u00228955216\u0022, \u000A \u00225650170\u0022, \u000A \u00225178867\u0022, \u000A \u00225688518\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022A composition for treating patients having non\u002Dinsulin\u002D dependent diabetes mellitus (NIDDM) by administering a controlled release oral solid dosage form containing prefer\u002D ably a biguanide drug such as metformin, on a once\u002Da\u002Dday basis.\u0022, \u000A \u0022In the prior art, many techniques have been used to provide controlled and extended\u002Drelease pharmaceutical dosage forms in order to maintain therapeutic serum levels of medicaments and to minimize the effects of missed doses of drugs caused by a lack of patient compliance.\u0022, \u000A \u0022It is an additional object of other embodiments of the present invention to provide a controlled or sustained release formulation for an antihyperglycemic drug that obtains peak plasma levels from 5.5 to 7.5 hours after administration under various conditions.\u0022, \u000A \u0022The controlled release oral dosage form of claim 1, which exhibits the following dissolution profiles when tested in a USP type 2 apparatus at 75 rpm in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37\u0022, \u000A \u0022The controlled release oral dosage form of claim 1, which exhibits the following dissolution profiles when tested in a USP type 2 apparatus at 75 rpm in 900 ml of simulated intestinal fluid (pH 7.5 phosphate buffer) and at 37\u0022\u000A ]\u000A }, \u000A \u0022type\u0022: \u0022Exhibit\u0022, \u000A \u0022e2e_lock_control\u0022: 1\u000A }, \u000A {\u000A \u0022exhibit\u0022: \u0022Exhibit\u002D1017\u002D16\u002DEx_1017___File_History_Patent_Appl_11225741\u0022, \u000A \u0022number\u0022: \u002206\u002D23\u002D2017\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/1493275/documents/d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWMxZTk3OTItNmUyNi00NDI4LTg4MDQtMDM3NDM3MmE5ZGQxOzEuMA\u003D\u003D/download\u0022, \u000A \u0022link\u0022: \u0022/cases/PTAB/IPR2017\u002D01673/Inter_Partes_Review_of_U.S._Pat._6790459/06\u002D23\u002D2017\u002DPetitioner/Exhibit\u002D1017\u002D16\u002DEx_1017___File_History_Patent_Appl_11225741/\u0022, \u000A \u0022e2e_object_id\u0022: \u0022d29ya3NwYWNlOi8vU3BhY2VzU3RvcmUvMWMxZTk3OTItNmUyNi00NDI4LTg4MDQtMDM3NDM3MmE5ZGQxOzEuMA\u003D\u003D\u0022, \u000A \u0022date\u0022: \u00226/23/2017\u0022, \u000A \u0022date_added\u0022: \u00226/23/2017\u0022, \u000A \u0022e2e_submitter_id\u0022: 72304, \u000A \u0022pages\u0022: 319, \u000A \u0022e2e_number\u0022: \u00221017\u0022, \u000A \u0022e2e_exhibit\u0022: \u00221017\u0022, \u000A \u0022title\u0022: \u0022Ex 1017 \u002D File History\u002DPatent Appl\u002D11225741\u0022, \u000A \u0022e2e_show_download_link\u0022: true, \u000A \u0022filename\u0022: \u0022Ex 1017 \u002D File History\u002DPatent Appl\u002D11225741.pdf\u0022, \u000A \u0022e2e_submitter\u0022: 72304, \u000A \u0022security\u0022: \u0022PUBLIC\u0022, \u000A \u0022analyze\u0022: {\u000A \u0022doc_types\u0022: [], \u000A \u0022num_pages\u0022: 638, \u000A \u0022patents\u0022: [\u000A \u00225225261\u0022, \u000A \u00226011049\u0022, \u000A \u00225835515\u0022, \u000A \u00225225201\u0022, \u000A \u00229223655\u0022, \u000A \u00225071607\u0022, \u000A \u00226284275\u0022, \u000A \u00227131120\u0022, \u000A \u00226991831\u0022, \u000A \u00225512353\u0022, \u000A \u00226917116\u0022, \u000A \u00226866866\u0022, \u000A \u00228112257\u0022, \u000A \u00225043552\u0022, \u000A \u00225650170\u0022, \u000A \u00226099859\u0022, \u000A \u00229102022\u0022, \u000A \u00226125143\u0022, \u000A \u00225837379\u0022, \u000A \u00225955106\u0022, \u000A \u00225225251\u0022, \u000A \u00226099862\u0022, \u000A \u00225178867\u0022\u000A ], \u000A \u0022summary\u0022: [\u000A \u0022It would have been obvious to one of ordinary skill in the art to combine the disclosures as such with an expected result of a sustained release composition capable of reducing serum glucose levels over an extended period of time.\u0022, \u000A \u0022These modifications would have been obvious to one of ordinary skill in the art since the “985 and ‘379 patents provide similar carrier formulations comprising cellulose ethers, and active compound useful in treating patients with NIDDM.\u0022, \u000A \u0022See generally: Col. 3, line 15 (\u005C\u0022The unitary core osmotic tablet of the invention which contain nifedipine as the medicament has been demonstrated to have bioequivalent pharmacokinetic performance (i.e. maintain a sustained 24 hour drug plasma levels)”.\u0022, \u000A \u0022Application/Control Number: 11/225,741 Art Unit: 1618 Page 5 have been obvious to produce a controlled release formulation as disclosed in the ‘985 patent with an expected result of a tablet useful in treating various disorders including serum glucose regulation.\u0022, \u000A \u0022It would have been obvious to one of ordinary skill in the art to combine the disclosures as such with an expected result of a sustained release composition capable of reducing serum glucose levels over an extended period of time.\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:6103442744541184}, 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. Start broad. var title = $("
Inter Partes Review of U.S. Pat. 6,790,459 IPR2017-01673 Patent Trial and Appeal Board PTAB /cases/PTAB/IPR2017-01673/Inter_Partes_Review_of_U.S._Pat._6790459/ a290705dbc2f4459aa28f0a1ed36ab9cd6985364edc0cd08b81b7f17
IPR2017-01673 | Patent Trial and Appeal Board