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 .
Applicant’s response and filing of the RCE (amendments and arguments) are acknowledged.
Claims 19, 21-35, 39 pending and examined on the merits, with claims 36-38 withdrawn.
The Terminal Disclaimers filed over U.S. Patent No. 10,815,282 and 11,198,712 have overcome the double patenting rejections.
The examiner is open to interview to advance prosecution on the merits.
Parent U.S. Application No. 17,028,769 issued as U.S. Patent No. 11,198,712 and grandparent U.S. Application No. 16,145,251 issued as U.S. Patent No. 10,815,282, for which an Obviousness Double Patenting rejection is applied below over each (though methods of use in each, while here the product is elected, a composition comprising the elected peptide species here of SEQ ID NO: 1 is employed therein and renders such prima facie obvious here to arrive at the same).
Election/Restrictions - Maintained
Applicant’s election without traverse of Group I, claims 19-35, as drawn to the elected species peptide SEQ ID NO: 1 (peptide; SEQ ID NO: 17, nucleic acid thereto) in the reply filed on 12/8/23 is acknowledged; claims 37-39 withdrawn as being drawn to non-elected subject matter. The claims have been examined on the merits as drawn thereto, the ‘next’ species searched upon finding SEQ ID NO: 1 allowable is that of any peptide % identity thereto (see 35 USC 112(a) written description rejection below).
Allowable Subject Matter – Elected SEQ ID NO: 1 (Peptide; SEQ ID NO: 17, Nucleic Acid)
The below constitute the reasons for allowance in the parent ‘282 patent and equally applies here (pending overcoming the rejections of record here via a terminal disclaimer over the parent, and amendments/persuasive arguments over claims 9-10, 15-16 and 18 (e.g. cancellation without prejudice of the phrase “having at least 80% identity to any one of” the former and cancellation without prejudice of claim 18):
The following is an examiner’s statement of reasons for allowance:
With the amendments as filed after final and the approval of the examiner’s amendments above, and arguments tied thereto found persuasive, the instantly claimed invention is not found reasonably taught or suggested by the prior art of record. The prior art of record of Zhang ("DSSylation, a novel protein modification targets proteins induced by oxidative stress, and facilitates their degradation in cells", Protein & Cell, Springer Asia, Beijing, CN, vol. 5, no. 2, 11 February 2014 (2014-02-11), pages 124-140, XP035734439JSSN: 1674-800X, DOI: 10.1007/SI3238-013-0018-8) and Gong ("DSSylation, a Novel Guide for Protein Degradation",PROTEIN CELL, vol. 5, no. 2, 29 January 2014 (2014-01-29), XP035734440) was directed to a similar though distinct 70mer protein labeled “deleted split hand/split foot 1” (DSS1, instant SEQ ID NO: 4), while the instantly claimed invention is drawn to the 89mer “secretory” deleted split hand/split foot 1 protein (and now correctly claimed acronym sDSS 1; instant SEQ ID NO: 1 and corresponding other 89mer non-human primate versions SEQ ID NOS: 5-16 reflected in instant claim 44.). While the two proteins bear the same initial 58 amino acid residues, the remaining C-terminal 31 residues of instantly claimed sDSS1 are not present in Zhang and Gong’s DSS1 (see response page 6). While the two additional secondary references cited of record (sequence database amino acid structures only) indicate the prior art knew of sDSS1, Zhang and Gong only discuss DSS1 and the necessity of ATP for function (see each reference respectively and response page 8). Therefore, the prior art did not appreciate applicant’s discovery that the larger sDSS1, with the different C-terminal structure, does not require ATP enzyme mediation, allowing it to function “extracellularly” (as now expressly claimed, support in at least Table 2). As such, one of ordinary skill in the art would not have had a reasonable expectation that Zhang and Gong’s DSS1 would function “extracellularly” without something more (e.g. ATP enzyme presence; see response page 8). By extension then, one of ordinary skill in the art would not have had reasonable expectation that the former could carry out the now expressly claimed method of reducing apoptosis or promoting cell survival of a live cell exposed [“extracellularly”] to the pathogenic polypeptides selected from the group consisting of (4): advanced oxidation protein products (AOPP), amyloid-beta, amylin, and glycosylated protein (each tested with positive results reflected in art accepted models (see specification Figures 5B, 5D, 6C-6E, 7, and 8 and Examples 4-7 and response pages 6-8) upon extracellular application of human sDSS1 (SEQ ID NO: 1), with a reasonable expectation of the same by other known non-human primate sDSS1’s). For at least the reason(s) set forth above, the instantly claimed invention is hereby allowed.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
Claim Rejections - 35 USC § 112(a)(i)/(pre-AIA ) – Written Description, Maintained
The following is a quotation 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.
Claims 19, 21-35, and 39 remain/is 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
To provide evidence of possession of a claimed genus, the specification must provide sufficient distinguishing/identifying characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
In this case, the now amended to “at least 95% sequence identity” remains rejected as to e.g. elected peptide SEQ ID NO: 1, is not found in applicants possession nor guidance as to what positions may be substituted with what amino acid and retain function. As Gong ("DSSylation, a Novel Guide for Protein Degradation",PROTEIN CELL, vol. 5, no. 2, 29 January 2014 (2014-01-29), XP035734440) states regarding a related peptide (DSS1, similar to sDSS1 instantly claimed), even small changes can alter or remove function:
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328
421
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Thus, without guidance as to where these changes can be made and with what, possession is a lacking as to 80-99% sequence identity modified peptides. The specification does not provide adequate written description of the claimed genus.
With the exception of the fully sequenced peptides disclosed that may be conjugated, the skilled artisan cannot envision the detailed chemical structure of the encompassed variants of 95% sequence identity nor the other pathogenic peptides that may be conjugated by sDSS1, and therefore conception is not achieved until reduction to practice has occurred, regardless of the complexity or simplicity of the method of isolation. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method of isolating it. The compound itself is required. See Fiers v. Revel, 25 USPQ2d 1601 at 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Therefore, the full breadth of the claims are not presently deemed to have been in Applicant’s ‘possession’ and found to meet the written description provision of 35 U.S.C. §112. \
Response to Amendment and Arguments
Applicant’s amendment and arguments have been fully considered but not yet found persuasive. Peptide SEQ ID NO: 1 is the following:
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495
474
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While applicant has presented certain representative examples in claim 39 and relied on Example 10 from the Training Materials as support, every case is decided on a case by case basis. The examiner still does not find the record clear as to what amino acids of the 89 are critical/essential and not open to substitution, even conservatively potentially.
As previously stated, while there are a number of examples provided (SEQ ID NOS: 5-16), what evidence remains lacking is where such are modified and with what relevant to the function retained therein. Further nexus to function relevant to substitutions of the amino acid sequence of SEQ ID NO: 1 are needed as to what modifications can be made without affecting function. The examiner is open to weigh any and all further evidence thereto. The examiner requests an interview to go over the evidence of record.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MAURY AUDET whose telephone number is (571)272-0960. The examiner can normally be reached on M-Th. 7AM-5:30PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, James Alstrum-Acevedo can be reached on 571-272-5548. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MAURY A AUDET/Primary Examiner, Art Unit 1654
