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 .
Response to Amendment
The amendment received on 11/21/2024 is acknowledged. Claims 3-19 have been amended. Claims 1-19 are currently pending and have been treated on the merits.
Claim Objections
Claim 4 is objected to because of the following informalities:
The term “IP6” is used without first using the full term for which it is an abbreviation.
Appropriate correction is required.
Claim Rejections - 35 USC § 101/112 (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.
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claim 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 “A use of the variant polypeptide of claim 1 the enzyme composition thereof in the manufacturing of feedstuff, foodstuff, feed additive, dietary supplement, or a pharmaceutical.” It is unclear what applicant is claiming by the expression “A use of”, it is unclear if a composition, manufacture or method is being claimed, and what steps may be involved. No steps are claimed. It is unclear what the metes and bounds of the invention are as it is unclear what is being claimed and whether it falls under a statutory class of invention.
Claim 15 is rejected under 35 U.S.C. 101 because it is unclear if the claim is directed to a statutory class of invention. It is unclear if a process is being claimed, and if so what steps are entailed.
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.
Claim 8 and 9 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.
Regarding claim 8 and the limitation “a set of amino acid substitutions specified in Table 1”, Claims should be complete unto themselves whenever possible for purposes of clarity. In the instant case there is no need to refer to a table listing mutations when such substitutions can be written out, See MPEP 2173.05(s).
Regarding claim 9 and the limitation “wherein the variant polypeptide comprises the substitutions selected from: Q30R, K74Q, R94L, T118L, N176P, L179K, K180N, D204N, W211V, S212G,Q224E, V253Y, E315G, and A380P; or b-Q30R, R94L, T118L, N176P, L179K, K180N, D204N, W211V, S212G, Q224E,V253Y, E315G, L352M, and A380P; or E Q30R, K74Q, R94L, T118L, N176P, L179K, K180N, D204N, W211V, S212G,Q224E, V253Y, E315G, L352M, and A380P; or d-Q30R, K74Q, S80P, R94L, T118L, N176P, L179K, K180N, D204N, W211V,S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G, L352M, and A380P; or e-Q30R, D35N, S80P, R94L, T118L, N176P, L179K, K180N, D204N, W211V,S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G, L352M, and A380P; orf-Q30R, S80P, R94L, T118L, N176P, L179K, K180N, K183A, D204N, W211V,S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G, L352M, and A380P; or g- Q30R, S80P, R94L, T118L, N176P, L179K, K180N, D204N, W211V, S212G,Q224E, Q227E, V253Y, K276M, Q287S, E315G, L352M, and A380P; or l Q30R, K74Q, S80P, R94L, T118L, N176P, L179K, K180N, K183A, D204N,W211V, S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G, L352M, andA380P; orQ30R, R94L, T118L, N126H, N176P, L179K, K180N, D204N, W211V, S212G,Q224E, V253Y, E315G, L352M, and A380P; orQ30R, R94L, T118L, N176P, L179K, K180N, E182K, D204N, W211V, S212G,Q224E, V253Y, E315G, L352M, and A380P; or kQ30R, K74Q, S80P, R94L, T118L, N176P, L179K, K180N, E182K, K183A,D204N, W211V, S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G,L352M, and A380P; or L Q30R, D35N, K74Q, S80P, R94L, T118L, N176P, L179K, K180N, E182K,K183A, D204N, W211V, S212G, Q224E, Q227E, V253Y, K276M, Q287S,E315G, L352M, and A380P; or m. Q30R, D35N, K74Q, S80P, R94L, T118L, S120R, N176P, L179K, K180N,E182K, K183A, D204N, W211V, S212G, Q224E, Q227E, V253Y, K276M,Q287S, E315G, L352M, and A380P; or -Q30R, D31C, K74Q, S80P, R94L, T118L, N176P, L177C, L179K, K180N,D204N, W211V, S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G,L352M, and A380P; or e-Q30R, D35N, K74Q, S80P, R94L, T118L, S120R, N176P, L179K, K180N,E182K, K183A, D204N, W211V, S212G, Q224E, Q227E, V253Y, K276M,Q287S, E315G, L352M, and A380P; or p- Q30R, S80P, R94L, T118L, V140C, N176P, L179K, K180N, V200C, D204N,W211V, S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G, L352M, andA380P; org Q30R, D35N, S80P, R94L, T118L, N176P, L179K, K180N, V200I, D204N,W211V, S212G, Q224E, Q227E, V253Y, K276M, Q287S, E315G, L352M, andA380P; or rQ30R, A56S, V67I, K74Q, R94L, D107N, T118L, D154N, Q174E, N176P,L179K, K180N, A202S, D204N, W211V, S212G, Q224E, V253Y, L271I,Q285E, G302A, E315G, N344D, A380P, and G395A; or e7Q30R, A56S, V67I, R94L, D107N, T118L, D154N, Q174E, N176P, L179K,K180N, A202S, D204N, W211V, S212G, Q224E, V253Y, L271I, Q285E,G302A, E315G, N344D, L352M, A380P, and G395A; or t-Q30R, A56S, V67I, K74Q, R94L, D107N, T118L, D154N, Q174E, N176P,L179K, K180N, A202S, D204N, W211V, S212G, Q224E, V253Y, L271I,Q285E, G302A, E315G, N344D, L352M, A380P, and G395A; or Q30R, A56S, V67I, K74Q, S80P, R94L, D107N, T118L, D154N, Q174E,N176P, L179K, K180N, A202S, D204N, W211V, S212G, Q224E, Q227E, V253Y, L271I, K276M, Q285E, Q287S, G302A, E315G, N344D, L352M,A380P, and G395A; or Q30R, A56S, V67I, S80P, R94L, D107N, T118L, D154N, Q174E, N176P,L179K, K180N, A202S, D204N, W211V, S212G, Q224E, Q227E, V253Y,L271I, K276M, Q285E, Q287S, G302A, E315G, N344D, L352M, A380P, andG395A; or wQ30R, D35N, A56S, V67I, K74Q, S80P, R94L, D107N, T118L, D154N, Q174E,N176P, L179K, K180N, A202S, D204N, W211V, S212G, Q224E, Q227E, V253Y, L271I, K276M, Q285E, Q287S, G302A, E315G, N344D, L352M,A380P, and G395A; or Q30R, D35N, A56S, V67I, S80P, R94L, D107N, T118L, D154N, Q174E,N176P, L179K, K180N, A202S, D204N, W211V, S212G, Q224E, Q227E, V253Y, L271I, K276M, Q285E, Q287S, G302A, E315G, N344D, L352M,A380P, and G395A; or Q30R, D35N, A56S, V67I, S80P, R94L, D107N, T118L, Si20R, D154N, Q174E,N176P, L179K, K180N, A202S, D204N, W211V, S212G, Q224E, Q227E,V253Y, L271I, K276M, Q285E, Q287S, G302A, E315G, N344D, L352M,A380P, and G395A; or zQ30R, A56S, V67I,S80P, R94L, D107N, T118L, D154N, N176P, L179K,K180N, A202S, D204N, W211V,S212G, Q224E, Q227E, V253Y, L271I,K276M, Q285E, Q287S, G302A, E315G, N344D, L352M, A380P, and G395A;or Q30R, A56S, V67I,S80P, R94L, D107N, T118L, N126H, D154N, Q174E,N176P, L179K, K180N, A202S, D204N, W211V,S212G, Q224E, Q227E, V253Y, L271I, K276M, Q285E, Q287S, G302A, E315G, N344D, L352M,A380P, and G395A; R94L and T118L/I; or Q174E, N176P, L179K, and K180N; orA202S and D204N; or A202S, D204N, S212G/A, and V253Y/Q; or ff L271I and G302A; or gg. Q285E and Q287S/K; or E315G and A380P; orQ30R, S80P, R94L, T118L, N176P, L179K, K180N, D204N, W211V, S212G,Q224E, Q227E, V253Y, K276M, T277A, Q287S, E315G, and A380P”, it is unclear as currently worded which substitutions are being selected, and where they are being selected from. It is unclear if all of the substitutions from a group are required. What is being claimed is further rendered indefinite by the overlapping nature of the different groups of substitutions many of the groups fall within the scope of other groups as comprising of language is used. It would provide clarity to either structure the claim similar to claim 6 or to arrange the groupings similar to claim 8.
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 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 23-43 of of copending Application No. 18578970 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because ‘970 claims variants sequences having at least 80% identity toSeq ID: 1, and specifically claims variants at the 224 residue and Q224E specifically (Claim 32, 33). Regarding further substitutions, ‘970 teaches specific variants at most or all of the residues claimed in dependent claims (see claim 23-35), with any additional residues falling within the scope of the claims as 80% identity to Seq ID: 1 is claimed. ‘970 further claims host cells including filamentous fungus Pezizomycotina (claim 36), as well as compositions comprising the variants and methods of manufacture and use in feed and for degrading phytic acid or phytate (Claims 37-43). The claims of ‘970 thus render obvious the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHARLES Z CONSTANTINE whose telephone number is (571)270-5533. The examiner can normally be reached Mon-Fri 9-5.
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/CHARLES Z CONSTANTINE/Examiner, Art Unit 1657
/ROBERT J YAMASAKI/Primary Examiner, Art Unit 1657
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