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
Claims 1-18 are pending. Claims 1-5 are under examination.
Election/Restrictions
Applicant’s election without traverse of claims 1-5 in the reply filed on 12/21/2025 is acknowledged. Claims 6-18 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 12/21/2025.
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.
Claim 5 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 5, the phrase "preferably " renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claims 1-5 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 claim(s) contains 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 inventor(s), at the time the application was filed, had possession of the claimed invention.
Claims 1-5 encompass a phytase variant having at least 80% 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.
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 20% 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 claimed phytase variants with increased thermostability compared to SEQ ID NO:1. 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
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