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.
No matches to elected SEQ ID NO 21 were found so the search was expanded to non-elected species.
Claims 17-18, 20, 22-24, 26-28, and 32 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/5/26.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The IDS filed on 9/26/23 has been fully considered except where references have been lined through.
Drawings
The drawings are objected to because the figures are not properly labeled.
37 CFR 1.84 (u)(1) states “The different views must be numbered in consecutive Arabic numerals, starting with 1, independent of the numbering of the sheets and, if possible, in the order in which they appear on the drawing sheet(s). Partial views intended to form one complete view, on one or several sheets, must be identified by the same number followed by a capital letter. View numbers must be preceded by the abbreviation "FIG." Where only a single view is used in an application to illustrate the claimed invention, it must not be numbered and the abbreviation "FIG." must not appear.”
In the instant case, the view numbers for Figures are preceded by the word "Figure" instead of the abbreviation "FIG.".
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
To show possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus (MPEP 2163). The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species sufficient to show the applicant was in possession of the claimed genus (Id.). A “representative number of species” means that the species which are adequately described are representative of the entire genus (Id.). The specification describes a variety of point mutations of SEQ ID NO 2 (claim 14). As evidenced by Lipases, lipases are found in nearly every organism. Therefore, there is essentially an unlimited amount of substituents that can be made to lipases. The specification further fails to disclose any common mechanism or structure-function relationship that would allow one skilled in the art to identify substituents of lipases found in every organism. As such, the specification fails to describe a representative number of species that would evidence possession of the full scope of substituents of lipases that can be found in any organism.
Therefore, one of ordinary skill in the arts would be unable to immediately envisage the claimed product substituents of lipases found in every organism. As such, the specification fails to possession of the full scope of substituents of lipases that can be found in any organism.
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 1, 3, 5, 10-16 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.
Regarding claim 1, claim 1 requires “a first substituent of a lipase”. Per the definition provide in instant specification [0017], this phrase could encompass the point mutation alone, i.e. simply a mutation such as D156G in any lipase rather than a protein of SEQ ID NO 2 with a D156G mutation. Further, it is unclear if the claim would encompass any lipase capable of simply aligning to SEQ ID NO 2 and further comprising a mutation in the claimed location.
Regarding claims 10 and 12, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 5 and 12 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Balumuri (WO 20151811192A, of record).
Regarding claim 1, 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 231 (first substituent, claim 1).
Regarding claim 5, Balumauri teaches the lipase can be substituted at position 204 with glutamic acid, lysine, leucine, proline, or arginine (claim 2).
Regarding claim 12, Balumauri teaches that one or more substitutions (third) can be made at position 156 (claim 9).
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, 5, 10 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Balumuri as applied to claims 1, 5, and 12 above, and further in view of Balumuri (WO 20151811192A, of record).
Regarding claims 3, 5, and 10, 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 claims 14-16, 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.
Conclusion
No claims are allowed
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