DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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 1-19 (all pending claims) rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 10,906,947 in view of Widmaier et al. (U.S. 2016/0222174 A1) (see IDS).
The present application claims priority to U.S. Patent No. 10,906,947.
Claim 1 is verbally identical to patented claim 1 except that claim recites at least 90% identity to SEQ ID NOS: 8 and 11. Regardless, claim 1 is anticipated by patented claim 1.
Claim 2 is anticipated by patented claim 2. Claim 3 is anticipated by patented claim 3. Claims 4, 5 and 7 are anticipated by patented claim 7 as far as SEQ ID NO: 110 has multiple sequences of SEQ ID NO: 13. Claim 6 is anticipated by patented claim 6. Claims 8 and 9 are anticipated by patented claims 4 and 5.
Claim 10 is anticipated by patented claim 12. Claim 16 is anticipated by patented claim 13. Claims 17-19 are anticipated by patented claim 14 as far as SEQ ID NO: 110 is a silk protein and comprises a repeat unit of a silk protein.
Claims 11-13 are anticipated by patented claims 9-11. Regarding claims 14-15, the patented claims do directly recite a method for producing a recombinant protein being the silk protein of SEQ ID NO: 110. Widmaier, abstract, relates to methods and compositions for directed to synthetic block copolymer proteins, expression constructs for their secretion, recombinant microorganisms for their production, and synthetic fibers (including advantageously, microfibers) comprising these proteins that recapitulate many properties of natural silk. The recombinant microorganisms can be used for the commercial production of silk-like fibers. “In some embodiments, a repeat domain comprises at least one repeat sequence. In some embodiments, the repeat sequence, N-terminal domain sequence, and/or C-terminal domain sequence is selected from SEQ ID NOs: 932-1398.” Widmaier, para. [0073]. SEQ ID NO: 1398 of Widmaier is identical to recited SEQ ID NO: 110. While the patented claims do directly recite a method for producing a recombinant protein being the silk protein of SEQ ID NO: 110, patented claim 11 directly recites producing of a recombinant protein having a repeat unit of a silk protein. As such, at the time of filing or invention an ordinarily skilled artisan would have been motivated to modify embodiments of patented claim 11 to be a silk protein taught in the art to be expressible in a microorganism including SEQ ID NO: 1398 (recited SEQ ID NO: 110), since any embodiment of the patented claims must be practiced with a specific recombinant protein and Widmaier teaches that recited SEQ ID NO: 110 is a suitable silk protein (protein with silk repeat units).
Examiner comment
Double patenting over claims of U.S. 11,306,127 has been evaluated. Claim 1 of ‘127 recites an expression construct encoding a recombinant protein with a secretion signal sequence comprising SEQ ID NO: 2 and SEQ ID NO: 9 (EXP1) that appears to produce a sequence identical to SEQ ID NO: 11, the recombinant protein being a silk protein. However, the patented claims are silent regarding a second protein comprising SEQ ID NO: 8 as recited. While SEQ ID NO: 8 is a standard alpha-mating factor signal sequence that is known in the prior art (as discussed in parent applications), there is not deemed to be sufficient motivation in the prior art in the absence of hindsight bias from the present disclosure to modify embodiments of the copending claims (that are otherwise complete) to encode an additional silk protein comprising SEQ ID NO: 8 (or 90% identity thereto).
The reasons for allowance set forth in the file wrapper of U.S. Patent No. 10,906,947 are incorporated herein by reference and are not commented on extensively. It is noted that SEQ ID NO: 8 and SEQ ID NO: 11 share over 80% identity, but do not share over 90% identity. This is noted to highlight that SEQ ID NO: 11 and sequence having 90% identity thereto are artificial secretion sequence constructs and are not understood to be fairly taught in the prior art for the reason set forth in the file wrapper of U.S. Patent No. 10,906,947. An alignment between SEQ ID NO: 8 (alpha-mating factor section sequence) and SEQ ID NO: 11 is as follows:
PNG
media_image1.png
235
628
media_image1.png
Greyscale
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p.
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, Robert Mondesi can be reached at (408) 918-7584. 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.
/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
Prosecution Insights