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 previous rejection of Claim 17 under 35 U.S.C. §102(a)(1)/(a)(2) as being anticipated by Wlodawer et al., in the Non-Final Office Action mailed on 21 August 2025, is withdrawn in view of Applicants' amendment on 10 November 2025
Claims 17, 25-27, 31, 33 and 46-59 are pending.
Claims 17, 48, 55 and 58 are rejected.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 26 August 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the Examiner.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. §119(e) or under 35 U.S.C. §120, §121, or §365(c) is acknowledged. As noted in the Non-Final Office Action mailed 21 August 2025, Applicant has claimed the benefit of the filing date of the prior application, and designates the instant application as a "CON" of 17/019,497.
Applicant has complied with all of the conditions for receiving the benefit of an earlier filing date under 35 U.S.C. §120 or §365(c).
Claims 17, 25-27, 31, 33 and 46-59 have the effective filing date of 08 June 2015.
Specification
The abstract of the disclosure is objected to because it contains grammatical and/or typographical errors.
The abstract reads: "Polypeptides, and methods for their use, are disclosed that have an amino acid sequence at least 75% identical to the amino acid sequence of SEQ ID NO.: 1, are provided, wherein (a)the polypeptide degrades... ", which may be amended to: "Polypeptides, and methods for their use, are disclosed that have an amino acid sequence at least 75% identical to the amino acid sequence of SEQ ID NO.: 1, wherein: (a) the polypeptides degrade... ; and (c) the polypeptides comprise ... "
Appropriate correction is required.
Claim Objections
Claims 25-27, 31, 33 and 46-59 are objected to as being dependent (directly or indirectly) upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claim Rejections - 35 U.S.C. § 112
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.
Claims 48, 55 and 58 are 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 pre-AIA the applicant regards as the invention.
Claims 48, 55 and 58 recite: "..., wherein the C-terminal histidine tag comprises the amino acid sequence GSTENLYFQSGALEHHHHHH (SEQ ID NO: 139)."
These claims contain parentheses or quotation marks which raises the question as to which term is required by the claim. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by the parentheses is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Examiner's Comment
As noted in the Non-Final Office Action mailed 21 August 2025, no prior art was found with regard to a polypeptide having the amino acid substitution, 130A, 131M, 179, 210Q, 260Q or 274T, the polypeptide being at least 90% identical to the amino acid sequence of SEQ ID NO: 71.
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.
Claim 17 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of Patent No. 10,793,846 B2.
The claimed subject matter of instant Application No. 17/931,704 is:
Claim 17. A polypeptide comprising an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 71, wherein:
(a) residue 278 is Ser, residue 78 is Glu, and residue 82 is Asp; and
(b) the polypeptide comprises an amino acid change from SEQ ID NO: 71 at one
or more residues selected from the group consisting of 32D/N/Q/H, 72S, 73A/D/E/G/L/M/N/Q/R/T, 75A, 79S/T/A, 80L/T, 81A/T/V, 128A/T, 130A, 131M, 165A/D/E/K/N/Q/R/T/Y, 169A/N/S/Q/T, 179A/D/E/F/N/Q/S/T, 210Q, 213S/Q, 217S, 235K, 257S, 260A/E/N/Q, 267V, 272R, and 274A/L/M/Q/R/T/V.
The claimed subject matter of Patent No. 10,793,846 is:
Claim 15. A polypeptide comprising an amino acid sequence at least 90% identical to the amino acid sequence of SEQ ID NO: 71, wherein:
(a) residue 278 is Ser, residue 78 is Glu, and residue 82 is Asp; and
(b) the polypeptide comprises an amino acid change from SEQ ID NO: 71 at one
or more residues selected from the group consisting of 274A/L/M/Q/R/T/V, 32D/N/Q/H, 73E, 75A, 79S/T/A, 80L/T, 81A/T/V, 130A, 131M, 165A/E/Q/R/Y, 169N/S/Q/T, 179F/Q, 210Q, 213S/Q, 217S, 235K, 260E/N/Q, 267V and 272R.
Although the claims are not identical, they are not patentably distinct from each other because, as demonstrated above in the claim sets from each application, the polypeptide comprising an amino acid sequence at least 90% identical to SEQ ID NO.: 71, in Patent No. 10,793,846 B2 recites species modifications that anticipate the polypeptide comprising an amino acid sequence at least 90% identical to SEQ ID NO.: 71, recited in instant Application No. 17/931,704.
Response to Arguments
Applicant’s arguments, pg. 6, filed on 10 November 2025, with respect to the obviousness-type double patenting rejection, have been fully considered, but they are not persuasive. Applicant remarks (pg. 6) that Applicant has amended claim 17 to reflect the scope acknowledged as novel and non-obvious by the Office. Thus, Applicant respectfully requests reconsideration and withdrawal of the rejection.
However, in response to Applicant, the novel and/or non-obvious nature of amended claim 17 is not relevant to the consideration of whether it should be rejected under the guidelines for determining a non-statutory type double patenting rejection. See MPEP 804 (I) which provides instances where a double patenting issue can be raised; and MPEP 804 (II) which states the requirements of a double patenting rejection.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. 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 SHARON M PAPCIAK whose telephone number is (571)272-6235. The examiner can normally be reached M-F 8:30am-5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Louise Humphrey can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LOUISE W HUMPHREY/Supervisory Patent Examiner, Art Unit 1657
/SMP/Examiner, Art Unit 1657