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 .
Election/Restrictions
Applicant’s election without traverse of Group 1, claims 1, 3, 5, 10-16 and the species of SEQ ID 21, and leucine in the reply filed on 1/5/26 is acknowledged.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 7/17/26 has been fully considered except where references have been lined through.
Response to Amendment
The objections the drawings are overcome by amendment.
The rejection of the claims under 35 USC 112(a) and (b) is overcome by amendment.
Amended claims 1, 3, 5, 10-16 are under examination herein.
Claim Rejections - 35 USC § 112
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 15 is 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.
Claim 15 recites the limitation "the sixth amino acid substitution" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner believes this “the sixth” is intended to refer to “the second” and will be examined as such.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Modified rejection necessitated by amendment. Claims 1 and 5 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Balumuri (WO 20151811192A, of record).
Regarding claims 1 and 5, Balumuri teaches lipase variants (title) Balumuri teaches a match to claimed SEQ ID NO 2 (appendix). Balumuri teaches the lipase can be substituted at position 204 with alanine (claim 9; p15 9th paragraph).
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 3, 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Balumuri as applied to claims 1 and 5, above, and further in view of Balumuri (WO 20151811192A, of record).
Regarding claims 3, 5, 10-11, while Balumuri does not explicitly teach the substituents at the claimed positions, Balumuri teaches that high throughput screening and site directed mutagenesis can be used to easily and rapidly determine the importance of individual amino acids (p18 paragraphs 1-2). Therefore, it is prima facia obvious to incorporate conservative substitutions at any position along SEQ ID NO 2 in the absence of new or unexpected results. There is a reasonable expectation of success as Balumuri teaches that high throughput screening and site directed mutagenesis can be used to easily and rapidly determine the importance of individual amino acids.
Regarding claim 12, Balumauri teaches that one or more substitutions (third) can be made at position 156 (claim 9).
Regarding claim 13, Balumauri teaches the additional substitutions can be at position 237 and 239 (abstract)
Regarding claims 14, Balumuri teaches a 99.6% match to claimed SEQ ID NO 3, comprising the S237N substitution, only missing a L239T mutation (appendix). Balumuri teaches that substitutions at one or more positions including 239 can be incorporated (six or more substitutions) (claim 1). Balumuri teaches that high throughput screening and site directed mutagenesis can be used to easily and rapidly determine the importance of individual amino acids (p18 paragraphs 1-2).
It is obvious to one of ordinary skill in the arts to experiment within the inventive confines of Balumuri to mutate position L239T in SEQ ID NO 3. All of the claimed components were known in the arts at the time of filing of instant invention and would be yield nothing more than predictable results with a reasonable expectation of success to one of ordinary skill in the arts. Balumuri further teaches that individual amino acid importance can be quickly and easily determined.
Regarding claims 15 and 16, Balumuri teaches the substitutions can be at position 243 with asparagine (p15 10th paragraph). Balumuri teaches the substitution can additionally be at position 245 (p31-32 bridging paragraph). While while Balumuri does not explicitly teach the threonine at the claimed position 245, Balumuri teaches that high throughput screening and site directed mutagenesis can be used to easily and rapidly determine the importance of individual amino acids (p18 paragraphs 1-2).
Response to Arguments
Applicant's arguments filed 7/17/26 have been fully considered but they are not persuasive.
Applicant argues that the 102 should be withdrawn in view of the claim amendments (p10 paragraphs 3-5). This is not persuasive, see the 102 rejection above.
Applicant argues that Balumuri does not teach the claimed point mutations required by amended claim 1 (p11 2nd full paragraph). This is not persuasive, see the rejection of claim 1 above. Applicant argues improper hindsight reasoning (p11 2nd full paragraph). In response to Applicant's argument that the Examiner's conclusion of obviousness, is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. In re McLaughlin, 443 F.2d 1392; 170 USPQ 209 (CCPA 1971).
Applicant argues a variety of features that are not reflected in the claims regarding improved activities (p11-12 birding paragraph). MPEP 716.01(c) makes clear that arguments of counsel cannot take the place of evidence in the record. Further, MPEP 2145 teaches that although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. Applicant can amend the claims to recite the desired functional limitations or provide a declaration regarding unexpected results to give this argument additional weight.
Conclusion
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 TREVOR L KANE whose telephone number is (571)272-0265. The examiner can normally be reached M-F 7:00 am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/TREVOR KANE/ Examiner, Art Unit 1657
/ROBERT J YAMASAKI/ Primary Examiner, Art Unit 1657
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