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 .
DETAILED ACTION
This application is a 371 of PCT/US20/52396.
The amendment filed on April 29, 2025 has been entered.
Election/Restrictions
Applicant elected Group I, claims 1-16, 19, 21, 23-29, and 37, directed to an engineered ketoreductase variant without traverse in the reply filed on October 17, 2024. In response to the Species Elections, Applicant elected SEQ ID NO: 4 (associated with Species Election I), substitution at position 196 (associated with Species Election II), even numbered sequences (associated with Species Election III), and odd numbered sequences (associated with Species Election IV). All claims not directed to an engineered ketoreductase variant associated with SEQ ID NO: 4 will be withdrawn from consideration.
Claims 3-16 and 29-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and/or species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 17, 2024.
Status of the Claims
Claims 1-16, 19, 21, 23, and 26-37 are pending.
Claims 3-16 and 29-36 are withdrawn.
Claims 1-2, 19, 21, 23, 26-28, and 37 are under examination.
Terminal Disclaimer
The terminal disclaimer filed on April 29, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 10,961,550 has been reviewed and is NOT accepted.
The terminal disclaimer does not comply with 37 CFR 1.321 because:
This application was filed on or after September 16, 2012. The person who signed the terminal disclaimer is not the applicant, the patentee or an attorney or agent of record. See 37 CFR 1.321(a) and (b).
It is suggested that a power of attorney that gives power to the attorney who is signing the terminal disclaimer, along with another copy of the terminal disclaimer, or file a terminal disclaimer that is signed by the Applicant.
Response to Amendments/Arguments
Claim Objections
Applicant’s arguments, see page 9 of the Remarks, filed April 29, 2025, with respect to claims 1-2 have been fully considered and are persuasive. Claims 1-2 have been amended to recite “SEQ ID NO:4” and delete percent identity other than “95”. Therefore, the objections of claims 1-2 have been withdrawn.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 26-27 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 26-27 depend from claim 24, which has been cancelled. Therefore, the limitations of claims 26-27 are highly unclear and claims 26-27 have not been considered under other statutes.
Claim Rejections - 35 USC § 112(a)
Applicant’s arguments, see pages 9-10 of the Remarks, filed April 29, 2025, with respect to claims 23-27 have been fully considered and are persuasive. The claims have been amended to recite that the engineered ketoreductase variants have at least 95% sequence identity to SEQ ID NO:4 and comprise a L196K/H/R amino acid substitution. Applicant's argument that the specification provides numerous examples to support the claimed genus has been found persuasive. Therefore, the rejection of claims 23 and 28 under 35 U.S.C. 112(a) has been withdrawn.
Claim Rejections - 35 USC § 101
Applicant’s arguments, see page 10 of the Remarks, filed April 29, 2025, with respect to claims 1, 23-28, and 37 have been fully considered and are persuasive. Claim 1 has been amended to recite that the engineered ketoreductase variants have at least 95% sequence identity to SEQ ID NO:4 and comprise a L196K/H/R amino acid substitution. Therefore, 1, 23-28, and 37 no longer read of a naturally occurring in Lentilactobacillus farraginis disclosed by Sun (previously cited on form PTO-892). Thus, the rejection of claims 1, 23, 28, and 37 under 35 U.S.C. 101 has been withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see pages 10-11 of the Remarks, filed April 29, 2025, with respect to claims 1-2, 23-28, and 37 have been fully considered and are persuasive. Claim 1 has been amended to recite that the engineered ketoreductase variants have at least 95% sequence identity to SEQ ID NO:4 and comprise a L196K/H/R amino acid substitution. Gohel (US Patent No. 9,102,963 B2 – cited previously on form PTO-892) does not disclose such engineered ketoreductase variants. Therefore, the rejection of claims 1-2, 23, 28, and 37 under 35 U.S.C.102(a)(1)/(a)(2) has been withdrawn.
Claim Rejections - 35 USC § 103
Applicant’s arguments, see pages 11-12 of the Remarks, filed April 29, 2025, with respect to claims 1-2, 19, 21, 23-28, and 37 have been fully considered and are persuasive. Claim 1 has been amended to recite that the engineered ketoreductase variants have at least 95% sequence identity to SEQ ID NO:4 and comprise a L196K/H/R amino acid substitution, wherein the engineered ketoreductase variants have the ability to convert one or more iso-α-acid substrates to corresponding dihydro-(rho)-iso- α-acid products as compared to the ketoreductase of SEQ ID NO: 4. Savile (US Patent No. 8,426,178 B2 – cited previously on form PTO-892) does not teach or suggest such engineered ketoreductase variants. Therefore, the rejection of claims 1-2, 23, 28, and 37 under 35 U.S.C.102(a)(1)/(a)(2) has been withdrawn.
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 1-2, 23, and 28 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 10,961,550 B2. Although the claims at issue are not identical, they are not patentably distinct from each other because:
Regarding claims 1 and 2, SEQ ID NO: 150 of US ’550 shares 247/252 identities (98%) and has K residue at position 196, and further comprises substitutions at positions 87, 110, and 145 and has an improved capability to convert an iso-α-acid to a dihydro-(rho)-iso-α-acid compared to SEQ ID NO:4, which is identical to SEQ ID NO:4 of the instant application (see US ‘550 at claim 1 and 17 and Table 6). Claims 1 and 17 of US ‘550 recite a process; an ordinary artisan would at once envisage a ketoreductase, a product, or SEQ ID NO: 150 from the process. Accordingly, the instant claims overlap in scope with issued claims.
Regarding claim 23, a recitation of intended and expected results fully is satisfied by all species within the scope of instant claim 1 sharing at least 95% sequence identity with instant SEQ ID NO: 4 and having any substitution at position 196, such as SEQ ID NO: 150 of US ‘550 (see Id.).
Regarding claim 28, US ‘550 discloses the gene or polynucleotide for the ketoreductase (see Id.).
In response to the previous Office Action, Applicant has traversed the above rejection. Applicants should note that the rejection has been amended in light of the amendment of the claims.
Applicant argues that the pending claims as amended are not identical to any of the claims of US Patent No. 10,961,550 (reference patent) since the pending claims are directed to a composition while the claims of the reference patent are directed to a process.
This is not found persuasive. According to MPEP 804. Il. B. 2, a nonstatutory double patenting rejection is appropriate where a claim in an application under examination claims subject matter that is different, but not patentably distinct, from the subject matter claimed in a prior patent or a copending application. The claim under examination is not patentably distinct from the reference claim(s) if the claim under examination is anticipated by the reference claim(s). In the instant case, the ketoreductase variants recited in the claims of the application under examination are anticipated by the ketoreductase variants recited in the claims of the reference patent. Therefore, the claims under examination are not patentably distinct from the claims of the reference patent.
Applicant requests withdrawal of the above rejection in view of the filing of a terminal disclaimer of US Patent No. 10,961,550.
This is not found persuasive. The terminal disclaimer filed on April 29, 2025 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 10,961,550 has been reviewed and is NOT accepted, see above.
Therefore, the rejection has been maintained.
Applicant’s arguments, see page 13 of the Remarks, filed April 29, 2025, with respect to claims 1-2, 23-27, and 37 have been fully considered and are persuasive. Claim 1 has been amended to recite that the engineered ketoreductase variants have at least 95% sequence identity to SEQ ID NO:4. The ketoreductase of SEQ ID NO:414 or 416 of US ‘346 does not have at least 95% sequence identity to SEQ ID NO:4 of the instant application. Therefore, the nonstatutory double patenting rejection of claims 1-2, 23, and 37 as being unpatentable over claims 1-4 of US Patent No. 12,173,346 has been withdrawn.
Applicant’s arguments, see page 13 of the Remarks, filed April 29, 2025, with respect to claims 1-2 and 23-27 have been fully considered and are persuasive. Claim 1 has been amended to recite that the engineered ketoreductase variants have at least 95% sequence identity to SEQ ID NO:4. The ketoreductase of SEQ ID NO:414 or 416 of US ‘625 does not have at least 95% sequence identity to SEQ ID NO:4 of the instant application. Therefore, the nonstatutory double patenting rejection of claims 1-2 and 23 as being unpatentable over claims 1-4 of US Patent No. 11,591,625 B2 has been withdrawn.
Conclusion
Claims 1-16, 19, 21, 23, and 26-37 are pending.
Claims 3-16 and 29-36 are withdrawn.
Claims 1-2, 23, and 26-28 are rejected.
Claims 19, 21, and 37 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT B MONDESI whose telephone number is (408)918-7584. The examiner can normally be reached Monday to Thursday 7:30-5:30 ; Friday 8-10 am.
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/ROBERT B MONDESI/Supervisory Patent Examiner, Art Unit 1652