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 to the previous Office action, dated March 31, 2026, has been received. By way of this submission, Applicant has amended claims 33-34.
Claims 22-23 and 32-34 are pending in the application and under examination before the Office.
The rejections of record can be found in the previous Office action, dated December 31, 2025.
Claim Rejections - 35 USC § 112
Claims 33-34 were previously 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.
Applicant's amendments to the claims have addressed this issue, and this rejection is hereby withdrawn.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 22-23 and 33-34 are rejected under 35 U.S.C. 103 as being unpatentable over Tymianski (US20160228499A1).
Applicant argues that Tymianski does not recognize the problem from co-administration of a thrombolytic agent and a PSD-95 inhibitor together, and Applicant's use of D-amino acids as part of the claimed method overcomes this problem. Applicant further argues that the inherent but unrecognized property of the claimed D-amino acid peptide cannot provide motivation for coadministration with a thrombolytic agent.
Applicant's arguments have been considered fully but are not found to be persuasive.
Tymianski is explicit in teaching combinations of a PSD-95 inhibitor and thrombolytic agents such as tPA for treatment of ischemic stroke (para. 0086: "Treatment of ischemic strokes with a PSD-95 inhibitor can be combined with reperfusion therapy. Such reperfusion can be achieved using the intravenous or intra-arterial administration of thrombolytic agents such as tPA, streptokinase or urokinase, by using mechanical means to re-open blocked arteries, or by other means to enhance the collateral circulation to an ischemic brain area. By administering the PSD-95 inhibitor, there is more time available time to perform a brain scan to determine presence of ischemic stroke, and then administer tPA or administer another reperfusion therapy if appropriate. Thus, more subjects with ischemic stroke can benefit from tPA treatment or from another therapy that enhances brain reperfusion and at the same time benefit from treatment with a PSD-95 inhibitor.").
The ability of D-amino acids within a peptide to resist proteolytic degradation is also known in the art. Bonny (US20120058137A1) teaches that polypeptides composed of D-enantiomeric amino acids and L-enantiomeric amino acids are resistant to proteolytic breakdown (para. 0057). Guichard (Proc Natl Acad Sci U S A. 1994 Oct 11;91(21):9765–9769) teaches that the high susceptibility of peptides to proteolysis limits their effectiveness, and the substitution of D-amino acids is a known method of overcoming this limitation (page 9765, left column, first paragraph). Meyer (US20090281036A1) teaches that D-enantiomeric amino acids in peptides confer resistance to proteolytic breakdown (para. 0016). Meyer also teaches that the D-enantiomeric form of TAT-NR2B9c shows increased efficacy over the L-form (para. 0048 and Figure 2). Bach (Proc Natl Acad Sci U S A. 2012 Feb 28;109(9):3317-22, cited in IDS) teaches that using D-amino acids in the internalization peptide of YGRKKRRQRRR prevents degradation (page 3318, right column, second paragraph and Figure 2A).
It is also noted that claim 22 does not require coadministration with a thrombolytic agent; claim 22 only requires administration of the peptide.
The problem of proteolytic degradation of therapeutic peptides, and an appropriate solution, namely the use of D-amino acids, was clearly known in the art. It is therefore expected that a version of the claimed peptide would possess similar functions of resistance to proteolytic degradation. For this reason, the property that Applicant asserts cannot be said to be unexpected. The application of a known solution to a known problem is prima facie obvious.
This rejection is therefore maintained.
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 22-23 and 32-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over the following U.S. patents and patent applications in view of Tymianski:
Conflicting patent Conflicting
or application claims
8,080,518 1,5, 7-9, 11-13
8,940,699 1,5, 12
10,064,910 1, 5-6, 11-16, 23-27
10,967,041 1, 4-5, 8-12, 22
17/800,523 1-10, 17, 31-33, 42-43
18/271,407 62
Applicant argues that Tymianski does not remedy the alleged deficiencies of the cited conflicting patents or patent applications. This is not found persuasive, for reasons described supra.
The above rejections are therefore maintained.
The previous rejections on the ground of nonstatutory double patenting to applications 17/524,673 and 17/800,883 are withdrawn, as these applications are abandoned.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Belmares (US20080274977A1) teaches that the peptide YGRKKRRQRRRKLSSIESDV (Tat-NR2B9c) is useful in treatment of ischemic stroke (para. 0019-0021).
Garman (US20170119845A1) that that the peptide Tat-NR2B9c (YGRKKRRQRRRKLSSIESDV) is useful in treating stroke (para. 0004). Garman further teaches that this peptide may have 1, 2, 3, 4, 5, at least 50%, or all D-amino acid residues (para. 0048).
No claim is allowed.
THIS ACTION IS MADE FINAL. 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 PETER JOHANSEN whose telephone number is (571)272-0280. The examiner can normally be reached Monday-Friday, 7:00 to 3:00.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Samira Jean-Louis can be reached at (571) 270-3503. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PETER JOHANSEN/Examiner, Art Unit 1644
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