Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 06/12/2025 has been entered.
Claims 50-59 are pending and are under consideration.
Priority
The prior non-final rejection mailed 07/31/2024 denied this application’s priority claims because claims 50-59 lacked written description and contained an insufficient enabling disclosure. Hence, applicant’s earliest date of priority was deemed to be the actual filing date of March 7, 2022. (See ¶ 3, non-final mailed 07/31/2024). This previous denial of priority is henceforth removed. Priority to the present claims is now October 15, 2010 based on the parent application of 12/906041. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 61/252625, fails to provide adequate support in the manner provided by pre-AIA 35 U.S.C. 112, first paragraph because the ‘625 provisional application does not provide support for the deposited monoclonal antibody. There is no mention of the claimed referenced hybridoma (I-4371, also known as Mab5) in said provisional application. Thus, the effective date of priority of the present application is 10/15/2010, the date US application 12/906041 was filed.
Rejections Withdrawn
The rejection of claim 51 under 35 USC 112(b) is withdrawn in view of applicant’s amendments. It is clear that claim 51 is drawn to a humanized version of the monoclonal antibody of claim 1 retaining all of the CDRs.
The rejection of claim 51 under 35 USC 112(a) is withdrawn in view of applicant’s amendments and arguments filed 06/12/2025.
In ¶ 11 of the final action mailed 02/12/2025, the examiner rejected claims 50-69 under 35 USC 112(a). However, this appears to be typographical error because only claims 50-59 were pending. In any case, the rejection of claims 50-59 under 35 USC 112(a) for an inadequate deposit statement is withdrawn in view of applicant’s arguments and the submission by Eric Thieulin on 06/12/2025.
The rejection of claims 50-57 under pre-AIA 35 USC 102(b) or in the alternative under 35 USC 102(e) as being anticipated by US Patent No. 10,370,444 (see ¶ 12-14, final action mailed 02/12/2025) is withdrawn in view of applicant’s arguments and the reasons set forth herein. As set forth above, the effective date of priority of the current application is October 15, 2010, thus there is no proper 102(b) publication date as the ‘444 patent was published August 6, 2019. Regarding 102(e), US Patent No. 10,370,444 was filed 09/28/2016 and its earliest possible effective filing date that predates the current application is based on provisional application 61/317245, filed March 24, 2010. However, provisional application 61/317245 also does not mention the claimed referenced hybridoma (I-4371 also known as Mab5). Thus, the earliest possible effective filing date of 10,370,444 is March 23, 2011 which does not predate the current application’s effective filing date. See below:
PNG
media_image1.png
688
740
media_image1.png
Greyscale
Rejections Maintained
Claims 50-59 remain rejected on the grounds of nonstatutory obviousness-type double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,370,444 (Houhou et al.) for the reasons of record in ¶16 in the action mailed 02/12/2025. Applicants argue that because the present application has an earlier effective filing date, and thus an earlier expiration of the statutory patent term compared to Houhou et al., a patent issuing from the present application would not extend beyond the statutory term of Houhou. This argument has been considered but is not found persuasive because the MPEP states that a complete response to a nonstatutory double patenting (NSDP) rejection is either a reply by applicant showing that the claims subject to the rejection are patentably distinct from the reference claims, or the filing of a terminal disclaimer. MPEP 804. There is no provision for removal of a non-statutory double patenting rejection based on differences in filing dates. Applicants further argue that US Patent 10,370,444 is abandoned and expired due to non-payment of maintenance fees. Thus, applicants argue, “there is no possibility of multiple suits against an accused infringer by different assignees of patens claiming patentably indistinct variations of the same invention”. This argument has been considered but is not found persuasive because applicants would still be extending their patent rights beyond the term to which they are entitled. Further, the patent office has remedies for the revival of patents for failure to pay maintenance fees. See 37 CFR 1.137. Applicants also argue that the present application is directed to a different class of invention. Applicants argue that in parent application 12/906041, the office restricted the antibodies from methods of treating colorectal cancer. This argument has been considered but is not found persuasive because parent application 12/906041 is not in the same filing family as the application associated with US Patent 10370444. The ‘444 patent was filed as application number 15/278246 and has no continuity with parent application 12/906041. Thus, the prohibition under 35 USC 121 would not apply.
The rejection in ¶17 in the action mailed 02/12/2025 appears to require applicant to establish common ownership according to MPEP Chart II-B_FTI (MPEP 804). This requirement is removed. Applicants have asserted that the applications were commonly assigned at the time the applications were filed.
New Rejections
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 50-59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, and 9-11 of U.S. Patent No. 10533050. Although the claims at issue are not identical, they are not patentably distinct from each other because US Patent 10533050 lays claim to methods of use of the currently claimed antibodies produced by hybridoma I-4371. For example, Claim 1 of US Patent 10533050 is drawn to a method of reducing recurrence of liver cancer in a subject comprising administering the Mab5 monoclonal antibody. Table 1B of the patent indicates that mAb5 is derived from the currently claimed I-4371 hybridoma. Similarly, claim 9 is drawn to a method of inhibiting proliferation of a liver cancer stem cell comprising administering the monoclonal antibody mAb5 either in vitro or in vivo. Thus, it would have been obvious to use the monoclonal antibody as currently claimed to inhibit the growth of liver cancer or liver cancer stem cell growth. Likewise, it would have been obvious to make the antibodies and package them into a kit for the purposes of pharmaceutical interventions. The portion of the specification of the reference that describes subject matter that falls within the scope of a reference claim may be relied upon to properly construe the scope of that claim. In particular, when ascertaining the scope of the reference’s claim(s) to a compound, the examiner should consider the reference’s specification, including all of the compound’s uses that are disclosed. See Sun Pharm. Indus., 611 F.3d at 1386-88, 95 USPQ2d at 1801-02. It is noted that US Patent 10533050 has an earlier effective filing date of July 26, 2010 based on Provisional application 61/367851; however, said provisional application does not mention Mab5 or hybridoma I-4371 and thus would not receive benefit to the provisional application in terms of potential prior art under pre-AIA considerations.
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GARY B NICKOL, Ph.D. whose telephone number is (571)272-0835. The examiner can normally be reached M-F 9AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Julie Wu can be reached at 571-272-5205. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/GARY B NICKOL/Primary Examiner, Art Unit 1643