Source: http://www.patentdocs.org/2007/01/index.html
Timestamp: 2018-02-18 08:35:15
Document Index: 346659419

Matched Legal Cases: ['§ 1', '§ 1', '§ 1', '§ 1', '§ 154', '§ 1', '§ 154', '§ 1', '§ 1', '§ 1', '§ 1', '§1', '§ 1', '§ 1']

Patent Docs: January 2007
Posted at 04:44 PM in District Court | Permalink | Comments (0) | TrackBack (0)
USPTO News: Revised Procedure Regarding Notice of Omitted Items
In a January 30, 2007 notice, the U.S. Patent and Trademark Office announced revised procedures relating to what patent applicants and practitioners must do in response to the dreaded Notice of Omitted Items. This Notice is what every practitioner fears, as it reflects a determination by the Office of Initial Patent Examination (OIPE) that the application has a defect that, potentially, cannot be corrected.
Under the new procedure the Office allows for three types of responses: (1) petition for filing date of deposit under 37 C.F.R. § 1.53(e) (i.e., that the alleged missing item was in fact deposited); (2) petition for a later filing date (i.e., petition under 37 C.F.R. § 1.182, supplemental oath/declaration referring to omitted item); and (3) accept the application as deposited by filing an appropriate amendment. Appropriate amendments include substitute specifications that renumber pages, drawings, claims, and/or remove references to the omitted matter (see additional examples and explanations here). Such amendments should comply with 37 C.F.R. §§ 1.121 and 1.125. An indexed PDF version of 37 C.F.R. can be downloaded here (however, it is large and may take time depending on your network connection).
The change in procedure is only reflected in the third course of action. Formerly, applicants and practitioners did not have to file any response in order to accept the application as filed. If the Office received neither petition under options (1) or (2), the applicant was deemed to have constructively elected the third option. However, because there existed no required time for response, the Office would receive amended applications after examination and/or publication which hindered prosecution. Now there must be an active election of one of the three options by filing a response with the Office.
The Notice of Omitted Items now has a due date for response, which is extendable under 37 C.F.R. § 1.136. Therefore, in order to toll the date a response must be filed with the Office within the extended period for response. As an added bonus, and to exacerbate further the gnashing of teeth, the Office considers the Notice of Omitted items a notice or action under 35 U.S.C. § 154(b)(2)(C)(ii) or 37 C.F.R. § 1.704(b). Therefore, extensions of time taken for the reply to the Notice will reduce patent term adjustment under 35 U.S.C. § 154(b)(2)(C)(ii) or 37 C.F.R. § 1.704(b).
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Vanderbilt and Michigan Join Sigma-Aldrich RNAi Program
PharmaLive has reported that Vanderbilt-Ingram Cancer Center and the University of Michigan added their names to the list of members currently involved in Sigma-Aldrich's RNAi Partnership Program. The Program was set up by Sigma-Aldrich to provide members with access to its functional genomics portfolio, which comprises shRNA libraries that target over 30,000 human and mouse genes. Sigma-Aldrich hopes the Program will enhance RNAi-related research at select academic institutions by offering its members access to background information, search tools, workshops, and techniques relating to RNAi technology. The Program also provides its members with special pricing on RNAi products. Other members of the Program include the Cleveland Clinic, Washington University of St. Louis, Princeton University, the Wistar Institute, and Rutgers University. Those interested in becoming members of the RNAi Partnership Program can check out this link.
Posted at 09:33 PM in Biotech/Pharma Business | Permalink | Comments (0) | TrackBack (1)
Monday & Tuesday - Biotechnology 2007 (Law Seminars International) - San Francisco, CA
Monday & Tuesday - BIO-Asia Partnering Conference (Biotechnology Industry Organization) - Tokyo, Japan
EFS-Web Document Indexing Online Training
On January 30, 2007 at 1:00pm (EST) the USPTO will provide online training regarding proper document indexing when submitting filings using EFS-Web. Proper indexing of documents is important for minimizing potential errors and delays in the Patent Office's processing of submissions by EFS-Web.
Since enrollment for this event was closed in a little more than an hour, at the conclusion of the event, Patent Docs will provide highlights of the broadcast as well as links to supplemental information that the Office may provide.
Posted at 04:15 PM in Conferences & CLE's, Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)
ACS National Meeting in Chicago
The American Chemical Society is holding its Spring 2007 meeting on March 25-29 in Chicago, Illinois. According to the ACS website, over 12000 attendees are expected. We note that our colleagues Steve Sarussi and Brad Crawford will be giving presentations at the meeting on March 28th during a session entitled: "Ensuring the Effective Patent Protection of Innovative Molecular Technology." In particular, Mr. Sarussi will be speaking about: "Threshold intellectual property issues for the V.P. of R&D at small pharmaceutical companies," and Mr. Crawford will be speaking about: "International patent protection and strategy."
For more information, visit the ACS website by clicking here.
Posted at 11:26 AM in Conferences & CLE's | Permalink | Comments (0) | TrackBack (0)
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Changes to USPTO Electronic Filing Rules
In a rule change that is sure please patent practitioners living in Hawaii, the U.S. Patent and Trademark Office (USPTO) announced several amendments to Title 37 of the Code of Federal Regulations (C.F.R.) relating to EFS-Web correspondence. In particular, the following sections of 37 C.F.R. have been amended: §§ 1.4 (signature requirement; form usage/modification), 1.6 (U.S. national stage correspondence; filings; follow-on communications), 1.8 (certificate of transmission by EFS-Web, local time of filer controls timeliness of response), and 1.33 (e-mail acknowledgement of correspondence between the USPTO and correspondence address). To review the Federal Register notice regarding these rules changes consult this link.
The most significant change is introduced by new sections 1.8(a)(1)(i)(C) and 1.6(a)(4), which effectively allow a practitioner to use EFS-Web Certifications like Certificates of Mailing under 37 C.F.R. § 1.8. Thus, correspondence as described in § 1.8 and the EFS-Web "Legal Framework" can be submitted with the proper certification statement and will be considered timely filed as long as such correspondence is "transmitted prior to expiration of the set period of time by being: transmitted via the Office electronic filing system in accordance with §1.6(a)(4)" (37 C.F.R. § 1.8(a)(1)(i)(C)). Accordingly, the filer needs to include a certificate for each piece of correspondence stating the date of transmission. NOTE: The "receipt date" stamp will still reflect the date and time of the submission at the USPTO. Therefore, for example, applications having critical bar dates should be submitted by EFS with respect to the time and date at the USPTO, not the practitioner's particular local time, or by Express Mail under 37 C.F.R. § 1.10.
For information regarding and clarification of this procedure, the USPTO encourages practitioners to review the "Legal Framework" for EFS-Web at this link.
The USPTO advises that filers should be generally cautious regarding e-filings. For example, when using EFS-Web to file correspondence with the Office, the filer should make sure to receive (and save) the USPTO-generated E-filing acknowledgement. Should the filer be unsure about the whether the filing was received by the USPTO, he or she should review the application on Private PAIR to confirm the filing, and retrieve a copy of the e-filing acknowledgement. Additionally, if a practitioner attempts a transmission when the electronic filing system is inactive (repair, maintenance, etc.), alternative methods of filing should be used (e.g., Facsimile, Express Mail-Post Office to Addressee, First Class Mail).
Posted at 03:01 PM in Patent Office Rules & Procedures | Permalink | Comments (0) | TrackBack (0)
Federal Circuit Proposes New Rules for Electronic Filing
On January 22, 2007, the Federal Circuit announced a proposal to amend its rules by adopting Federal Circuit Rules 28(a)(15) and (16), 28(j), 30(k), and 31(b), (e), and (f); and by deleting Federal Circuit Rule 32(e). According to the Court's announcement, the rule changes would require parties represented by counsel to file a digital version of every brief and appendix, unless counsel could certify that such submission would not be practical or would constitute a hardship. The Court's requirements for the filing of paper copies of the briefs and appendices would continue unchanged. Proposed Rule 30(k) would result in the posting of digital versions of all briefs and appendices on the Federal Circuit's website, provided that such briefs and appendices are not redacted, sealed, or otherwise restricted by court order. In conjunction with the adoption of the proposed rules, the Court has also proposed to withdraw Federal Circuit Rule 32(e), which at present permits the filing of briefs on CD-ROM media. Comments regarding the proposed rules changes should be sent to the Office of the Clerk of the United States Court of Appeals for the Federal Circuit, and must be received by the close of business on February 16, 2007.
Posted at 09:00 AM in Federal Circuit, Patent Litigation | Permalink | Comments (0) | TrackBack (0)
Ortho-McNeil Pharmaceutical, Inc. v. Caraco Pharmaceutical Laboratories, Ltd. (Fed. Cir. 2007)
In an appeal from a District Court decision granting summary judgment in favor of Defendant-Appellee Caraco Pharmaceutical Laboratories, Ltd. (Caraco), the Federal Circuit concluded that the District Court did not err in construing the term "about 1:5" or in finding no literal infringement or infringement under the doctrine of equivalents, and thus, affirmed the District Court's grant of summary judgment of non-infringement.
Plaintiff-Appellant Ortho-McNeil Pharmaceutical, Inc. (Ortho) owns U.S. Patent No. 5,336,691 (the '691 patent), which relates to a pharmaceutical composition comprising certain weight ratios of the analgesics tramadol and acetaminophen (Ortho sells this composition under the trademark Ultracet®). The '691 patent discloses that "[c]ertain ratios [of tramadol and acetaminophen] result in a composition which exhibits synergistic analgesic effects," and that "[t]he most preferred ratios are from about 1:19 to 1:50." The '691 patent also discloses that ratios of "about 1:1 and about 1:5 are encompassed by the present invention."
Seeking approval to market a pharmaceutical composition containing tramadol and acetaminophen having a weight ratio of no less than 1:7.5 and an average weight ratio of 1:8.67, Caraco filed an Abbreviated New Drug Application (ANDA) with the FDA. In response, Ortho filed suit against Caraco, alleging that the filing of the ANDA infringed claim 6 of the '691 patent. The asserted claim recites a pharmaceutical composition comprising tramadol and acetaminophen in a weight ratio of "about 1:5." Caraco then moved for summary judgment of non-infringement.
The threshold issue in this case involves the proper construction of the term "about 1:5." Before the District Court, Ortho argued that "about 1:5" means "approximately 1:5, and . . . encompasses a range of ratios of at least 1:3.6 to 1:7.1," and Caraco countered that the term means "approximately 1:5, subject perhaps to minor measuring errors of, say, 5 or 10%." Relying on Ortho's experts, who testified that those of ordinary skill in the art would understand that the term "about 1:5" encompasses a range of ratios between 1:3.6 and 1:7.1, the District Court construed the term "about 1:5" to mean "approximately 1:5, encompassing a range of ratios no greater than 1:3.6 to 1:7.1."
Based on its construction of the term "about 1:5," the District Court concluded that the composition described in Caraco's ANDA did not literally infringe the '691 patent. In addition, the District Court determined that Caraco's composition - having an average weight ratio of 1:8.67 - did not infringe the '691 patent under the doctrine of equivalents, since such a finding would render the "about 1:5" limitation meaningless.
With regard to the District Court's construction of the term "about 1:5," the Federal Circuit considered the intrinsic and extrinsic evidence in the case, and determined that the District Court had not erred in construing the term "about 1:5" to mean "approximately 1:5, encompassing a range of ratios no greater than 1:3.6 to 1:7.1." In reaching this determination, the Federal Circuit noted that "[t]he intrinsic evidence points to a meaning for the term 'about 1:5' that is narrow because the 1:5 weight ratio, along with the 1:1 weight ratio, is distinctly claimed and distinguished from other broader weight ratios in the patent." In particular, the Court noted that because some of the claims in the '691 patent recite a single weight ratio and some claims recite ranges of weight ratios, "one of ordinary skill in the art would understand the inventors intended a range when they claimed one and something more precise when they did not." The Court also noted that while the inventors tested ratios of 1:1, 1:3, 1:5, 1:5.7, and 1:15, "the patentees chose to specifically claim ratios of 1:1 and 1:5" rather than "claim[] a ratio range of 'about 1:1 to about 1:5,' or even a ratio range of 'about 1:3 to about 1:5.'"
With regard to the District Court's decision to grant summary judgment of non-infringement, the Federal Circuit first determined that under the District Court's claim construction, "there can be no literal infringement because Caraco's formulation must have a weight ratio of tramadol to acetaminophen of no less than 1:7.5." Turning to the issue of infringement under the doctrine of equivalents, the Federal Circuit agreed with the District Court that to expand the weight ratio of "about 1:5" to encompass a composition having an average weight ratio of 1:8.76 "would eviscerate the limitation." The Federal Circuit, therefore, concluded that the District Court properly granted summary judgment of non-infringement in favor of Caraco.
Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Lab., Ltd. (Fed. Cir. 2007)
Panel: Circuit Judges Schall and Gajarsa and Chief Judge McKinney
Opinion by Chief Judge McKinney
Posted at 10:46 PM in Claim Construction, Federal Circuit, Infringement - Literal or DOE | Permalink | Comments (1) | TrackBack (0)