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 .
1. Claims 1-13, 15, 16, and 28-35 have been cancelled. Claims 14, 17, 26, and 36 have been amended. Claims 37 and 38 are new.
Claims 14, 17-27, and 36-38 are pending and under examination.
2. All objections/rejections pertaining to claims 15, 16, 34, and 35 are moot because the claims were cancelled with the reply filed on 08/12/2026.
The objections to claims 17 and 26 are withdrawn in response to the amendments filed on 08/12/2026.
The rejection of claim 36 under 35 U.S.C. 112(d) is withdrawn in response to the amendment to specify that the polypeptide comprises the T17I or L137F mutations.
Claim Rejections - 35 USC § 112(a) – written description
3. 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.
4. Claims 14, 17-27, and 36-38 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.
Adequate written description requires more than a mere statement that it is part of the invention. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC1993). The Guidelines for the Examination of Patent Application Under the 35 U.S.C.112, 1"Written Description Requirement" makes it clear that the written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species disclosures of relevant, identifying characteristics, i.e., structure or other physical and or chemical properties, functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the genus (Federal Register, Vol. 66, No. 4, pages 1099-1111, Friday January 5, 2001, see especially page 1106 3rd column). To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail such that the Artisan can reasonably conclude the inventors had possession of the claimed invention. Such possession may be demonstrated by describing the claimed invention with all its limitations using such descriptive means as words, structures, figures, diagrams, and/or formulae that fully set forth the claimed invention. Possession may be shown by an actual reduction to practice, showing that the invention was "ready for patenting", or by describing distinguishing identifying characteristics sufficient to show that the Applicants were in possession of the claimed invention (January 5, 2001, Fed. Reg., Vol. 66, No. 4, pp.1099-11). In analyzing whether the written description requirement is met for the genus claims, it is determined whether representative numbers of species have been described by their complete structure and functional characteristics.
Claims 14, 17-27, and 36-38 are drawn to a broad genus of polypeptides comprising the T17I and/or L137F mutations in SEQ ID NO: 7 and having at least 95, 97%, 98%, or 99% identity to SEQ ID NO: 7. The specification discloses that SEQ ID NO: 7 is the amino acid sequence of A. niger Alg3 glycosyltransferase, useful for protein production of polypeptides of interest in host cells; the mutations must result in improved yields for the protein of interest, without inactivating glycosylation activity (see p. 2; p. 3, lines 31-32; Fig. 3). The applicant has disclosed and reduced to practice only the T17I and/or L137F mutants. However, the claimed genus is much broader that the disclosed three mutants. It encompasses polypeptides obtained by introducing additional mutations in the T17I and/or L137F mutants, as long as the additional mutations result in polypeptides having at least 95% but less than 100% identity to SEQ ID NO: 7. The specification fails to describe any such species. Thus, the applicant is relying upon biological activity and the disclosure of three amino acid sequences to support the entire broadly claimed genus.
SEQ ID NO: 7 has a length of 413 aa. Thus, the single T17I or L137F mutants are about 99.76 identical to SEQ ID NO: 7 (one additional amino acid substitution would result in polypeptides about 99.52 identical to SEQ ID NO: 7), while the double T17I/L137F mutant is 99.76 identical to SEQ ID NO: 7 (one additional amino acid substitution in would result in polypeptides about 99.27% identical to SEQ ID NO: 7).
It is well known that minor structural differences among even structurally related compounds can result in substantially different biology. Amino acid insertions and deletions disrupt protein structure and could negatively affect function. For example, Seffernick (J Bacteriol, 2001, 183: 2405-2410) teaches that proteins that are 98% identical could have distinct activities (see Abstract). Witkowski (Biochemistry, 1999, 38: 11643-11650) teaches that a change of a single amino acid can result in a different function (see Abstract). Safi (Mol. Cell. Biol., 2008, 28: 2567-2578) teaches that a single amino acid substitution results in a different function (see Abstract). Denecke (Human Mutations, 2004, 23: 477-486) teaches that a single amino acid mutation in Alg3 can result in the activation of a cryptic donor splice site, generating in a truncated protein lacking luminal domains essential for activity (see Abstract; p. 480, Fig. 2; p. 483, column 2, second paragraph).
One of skill in the art would know that even proteins having 98% identity to SEQ ID NO: 7 could have distinct activities. One of skill in the art would have known that a single amino acid substitution in SEQ ID NO: 7 (i.e., resulting in more than 99% identity, see above) could render an inactive protein or a protein with a different activity. The applicant has not disclosed the requisite structural features of the mutant polypeptides which would maintain or improve the activity of the starting T17I and/or L137F mutants, a feature deemed essential for the instant invention. Therefore, one of skill in the art would not recognize the applicant to be in possession of the entire claimed genus of mutants.
Response to Arguments
5. The arguments have been but not found persuasive. The specification does not provide a representative number of species. The specification discloses three mutated polypeptides (T17I and/or L137F). However, this is not enough to support an entire genus of mutants. The claims encompass a broad genus of polypeptides with mutations in addition to T17I and/or L137F, which would maintain or improved the activity of the T17I and/or L137F mutants. The specification does not provide the necessary structure-function correlation and does not disclose any species belonging to this broad genus. Thus, one of skill in the art would not consider that the specification describes the claimed genus in sufficient detail, especially in view of the prior art indicating that even introducing a single mutation involving a single amino acid could inactivate Alg3 glycosyltransferase.
Conclusion
6. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action (specifically, including the new claims 37 and 38 in the grounds for rejection). Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 ILEANA POPA whose telephone number is (571)272-5546. The examiner can normally be reached 8:00 am to 4:30 pm.
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/ILEANA POPA/Primary Examiner, Art Unit 1633
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