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 the invention of Group V, claims 8-10, in the reply filed on 04/30/2026 is acknowledged.
Claim Status
The amendment of 04/30/2026 has been entered. Claims 1-10 are pending in this US patent application. Claims 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 04/30/2026.
Claims 8-10 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 05/13/2024 and 02/16/2026 have been received and considered.
Claim Interpretation
The claims currently under examination are methods of using the protein deamidase of claim 1. Part (II) of claim 1 recites “a polypeptide including an amino acid sequence in which one or several amino acids are substituted, added, inserted, or deleted in the amino acid sequences” of part (I) of claim 1, “and having an activity of catalyzing a deamidation reaction of a glutamine residue of a protein.” The Examiner notes that one of the definitions of the word “several” provided by Merriam-Webster is “more than one” (https://www.merriam-webster.com/dictionary/several, accessed 07/13/2026). While the instant specification provides examples of how many amino acids constitute “several” amino acids (see, for example, paragraph 0023 of the instant specification as filed), examples do not constitute an explicit definition of a word that overcomes the plain and ordinary meaning of the word, as shown in this instance by the dictionary definition. As such, any polypeptide with an activity of catalyzing a deamidation reaction of a protein will be interpreted to read on the polypeptide of claim 1 because the full scope of part (II) of claim 1, which recites that “several” (i.e., more than one) amino acids may be modified, allows for the deletion of all residues of the sequences recited in part (I) of claim 1 and their replacement with the residues of the sequence of another protein deamidase.
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.
Claims 8-10 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 8-10 recite methods of allowing the protein deamidase of claim 1 to act on a protein. The protein deamidase of claim 1 is defined broadly but is required to have an activity of catalyzing a deamidation reaction of a glutamine residue of a protein. Part (II) of claim 1 recites that the protein deamidase is a polypeptide including an amino acid sequence in which “one or several amino acids are substituted, added, inserted, or deleted” in the deaminase sequence recited in part (I) of claim 1. No further sequence identity with SEQ ID NO: 1 is required in part (II), nor are the modifications to the protein sequence limited in any way. Part (III) of claim 1 recites any polypeptide with at least 70% sequence identity to the sequence recited in part (I) that has an activity of catalyzing a deamidation reaction of a glutamine residue of a protein. The instant specification indicates that very few protein deamidases have been identified by the time of filing, the protein deamidase discussed in the application is newly discovered by the inventors, and the active site of the enzyme contains a serine residue where other protein deamidases contain a cysteine residue (specification as filed, pages 1-3). The only other structural information provided in the instant specification is that Ser64, His105, and Asp124 “contribute” to the activity of the deamidase (specification as filed, paragraph 0026). A vast range of structural possibilities lie between the disclosed information, which is that the polypeptide of SEQ ID NO: 1 is a protein deamidase and S64/H105/D124 are important residues for activity, and any polypeptide in which any modifications are made to the sequence of SEQ ID NO: 1 (which includes entirely replacing the sequence of SEQ ID NO: 1 with another sequence given the breadth of the recitation) or any polypeptide with at least 70% sequence identity to SEQ ID NO: 1 or the specifically recited fragments in which the polypeptides also have protein deamidase activity. As such, Applicant has not demonstrated that they were in possession of the entire breadth of claim 1 at the time of invention. Because all of the limitations of claim 1 are contained within the methods of claims 8-10, these claims have also failed to satisfy the written description requirement. Therefore, claims 8-10 are rejected under 35 U.S.C. 112(a).
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.
Claims 8-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yamaguchi et al., Appl. Environ. Microbiol 66(8): 3337-3343 (2000; cited on the IDS filed 05/13/2024).
Yamaguchi teaches the reaction of a protein deamidating enzyme from Chryseobacterium proteolyticum sp. nov. with casein (see entire document, including page 3339, left column, paragraph 2, to right column, paragraph 1; reads on claims 8-10; the Examiner notes that casein is a protein [cf. claim 8] that may be interpreted as a food material, an industrial material, or a pharmaceutical material [cf. claims 9-10]; see Claim Interpretation above for the Examiner’s interpretation of “the protein deamidase according to claim 1” as recited in claims 8-10). As such, claims 8-10 are anticipated by Yamaguchi and are rejected under 35 U.S.C. 102(a)(1).
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 8-10 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 8-10 of copending Application No. 18/275587 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because the claims of ‘587 recite a method of using a protein deamidase enzyme, and the instant claims are sufficiently broad to read on any protein deamidase enzyme (see above under Claim Interpretation). As such, the instant claims are ‘anticipated’ by the cited claims of ‘587 and are provisionally rejected on the ground of nonstatutory double patenting.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 07/13/2026
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