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
The amendment filed 05/13/2026 has been entered. Claims 19 and 20 are newly added. Claims 1-20 are pending. Claims 6-18 are withdrawn. Claims 1-5, 19, and 20 are under examination.
Response to Arguments
Applicant's arguments filed 05/13/2026 have been fully considered but they are not persuasive. With regard to the rejection of claims 1-5 under 35 USC 112(a), Applicant has amended the claims to recite a phytase variant with at least 90% sequence identity to instant SEQ ID NO:1. However, SEQ ID NO:1 is 410 amino acids in length, therefore, a sequence with up to 10% divergence may have approximately 41 amino acid mutations. Applicant has not demonstrated possession of all amino acid sequences with up to 10% divergence from instant SEQ ID NO:1. Moreover, one of ordinary skill in the art would not be able to predict what amino acids may be substituted at the amino acid positions recited in instant claim 1. Applicant has only demonstrated possession of variants with up to 15 amino acid substitution mutations (Table 1), and has only reduced to practice the activity of four phytase variants at temperatures above 70˚C (Table 3). Therefore, Applicant may consider amending claim 1 to require a sequence comprising 96% sequence identity to instant SEQ ID NO:1 and an amino acid substitution selected from N33C, Q45P, E54C/A, A89T, A101C, K139L/C, A166R, A175T, A176K, Y179C, Q184R, T185Q, L202C, A262N, S280M, N340R, S393P, L397F, Q398R, and S412Q, as recited in instant claim 3.
Claim Rejections - 35 USC § 112(a)
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.
(MAINTAINED REJECTION)
Claims 1-5, 19, and 20 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventors, at the time the application was filed, had possession of the claimed invention.
Claims 1-5, 19, and 20 encompass a phytase variant having at least 90% sequence identity with SEQ ID NO:1, and an amino acid substitution in at least one position selected from positions 33, 45, 54, 89, 101, 139, 166, 176, 179, 184, 185, 202, 262, 280, 340, 393, 397, 398, and 412, wherein the phytase variant has improved thermostability compared to SEQ ID NO:1. Claim 3 limits the substitution mutation to one selected from X33C, X45P, X54C/A, X89T, X101C, X139L/C, X166R, X175T, X176K, X179C, X184R, X185Q, X202C, X262N, X280M, X340R, X393P, X397F, X398R, and X412Q; or N33C, Q45P, E54C/A, A89T, A101C, K139L/C, A166R, A175T, A176K, Y179C,Q184R, T185Q, L202C, A262N, S280M, N340R, S393P, L397F, Q398R, and S412Q. Claim 4 limits the substitution mutation to two substitution mutations selected from X33C and X179C, or X54C and X101C, or X139C and X202C; or X175T and X184R, or X280M and X397F, or X280M and X398R; or N33C and Y179C, or E54C and Al01C, or K139C and L202C, or A175T and Q184R, or S280M and L397F, or S280M and Q398R. Claim 5 recites that the phytase variant of claim 1 further comprises at least one additional amino acid substitution in at least one position selected from the positions 45, 89, 166, 175, 176, 184, 185, 280, 340, 393, 397, 398, and 412. Claim 19 limits the amino acid substitution of claim 5 to X45P, X89T, X166R, X175T, X176K, X184R, X185Q, X280M, X340R, X393P, X397F, X398R, or X412Q. Claim 20 limits the amino acid substitution of claim 19 to Q45P, A89T, A166R, A175T, A176K, Q184R, T185Q, S280M, N340R, S393P, L397F, Q398R, or S412Q.
MPEP 2163.05 II states “the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species. A ‘representative number of species’ means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that ‘only describe[d] one type of structurally similar antibodies’ that ‘are not representative of the full variety or scope of the genus.’). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us].’”
The instant specification only reduces to practice the activity of four phytase variants at temperatures above 70˚C (Table 3). The specification does not disclose every possible active phytase variant with increased thermostability and up to 10% sequence divergence from instant SEQ ID NO:1, and does not disclose every possible substitution mutation at the recited amino acid residues that results in an active phytase variant with increased thermostability. Therefore, the specification does not disclose the entire genus of phytase variants with increased thermostability compared to SEQ ID NO:1, as claimed. The instant specification does not disclose what structural properties are required for increased thermostability, or disclose which regions of SEQ ID NO:1 are the active site residue(s) for conserving the claimed enzyme activity. Therefore, the disclosed species are not representative of the entire genus of claimed phytase variants.
Paloheimo (EP 3670653 A1; cited in the IDS filed 01/12/2024) teaches polypeptides having phytase activity (para. [0001]) and teaches a sequence, SEQ ID NO:1, with 100% sequence identity to instant SEQ ID NO:1 (p. 19). However, Paloheimo does not disclose substitution mutations that result in an active phytase with improved thermostability compared to instant SEQ ID NO:1. Paloheimo does not disclose phytase variants with up to 20% sequence divergence from instant SEQ ID NO:1 that maintain phytase activity and have improved thermostability.
In summary, neither the instant specification, nor the prior art, discloses a structure-function relationship between conserved amino acid residues in the claimed enzyme structure and conserved enzyme activity at increased temperatures. One of ordinary skill in the art cannot reasonably predict which residues of SEQ ID NO:1 may be modified to generate a functional phytase variant with increased thermostability compared to SEQ ID NO:1. Based on the instant disclosure, those skilled in the art would not conclude that the applicant was in possession of all claimed variants.
Conclusion
THIS ACTION IS MADE FINAL. 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 RACHEL EMILY MARTIN whose telephone number is (703)756-1416. The examiner can normally be reached M-Th 8:30-16:00, F 8:30-10:00 EST.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/RACHEL EMILY MARTIN/Examiner, Art Unit 1657
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