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 November 19, 2025, has been received. By way of this submission, Applicant has amended claims 22-23, and cancelled claims 1-3, 6-7, 9, 11, 16-21, and 35.
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 August 19, 2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on November 19, 2025 was filed after the mailing date of the first Office action on the merits on August 19, 2025. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 22 was previously objected to because of the following informalities.
Applicant's amendments to the claims have addressed this issue, and this objection is hereby withdrawn.
Claim Rejections - 35 USC § 112
Claims 22-23 and 32-34 were previously rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement.
Applicant's amendments to the claims have addressed this issue, and this objection is hereby withdrawn.
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 33-34 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. This is a new grounds of rejection.
Claims 33 and 34 recite the limitation of "the thrombolytic agent". There is insufficient antecedent basis for this claim, as parent claim 22 does not recite a thrombolytic agent.
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 the claimed peptide has properties that are not appreciated by Tymianski; specifically, the claimed peptide is resistant to degradation by plasmin when co-administered with a thrombolytic agent due to the inclusion of D-amino acids.
Applicant's arguments have been considered fully but are not found to be persuasive.
"[T]he discovery of a previously unappreciated property of a prior art composition, or of a scientific explanation for the prior art’s functioning, does not render the old composition patentably new to the discoverer." Atlas Powder Co. v. IRECO Inc., 190 F.3d 1342, 1347, 51 USPQ2d 1943, 1947 (Fed. Cir. 1999). MPEP 2112(I).
There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the relevant time, but only that the subject matter is in fact inherent in the prior art reference. Toro Co. v. Deere & Co., 355 F.3d 1313, 1320, 69 USPQ2d 1584, 1590 (Fed. Cir. 2004) ("[T]he fact that a characteristic is a necessary feature or result of a prior-art embodiment (that is itself sufficiently described and enabled) is enough for inherent anticipation, even if that fact was unknown at the time of the prior invention.") MPEP 2112(II).
Tymianski teaches the PSD-95 inhibitor Tat-NR2B9c, which has the sequence YGRKKRRQRRRKLSSIESDV (para. 0010), which encompasses both the claimed internalization peptide of YGRKKRRQRRR, and the inhibitor peptide of KLSSIESDV.
Tymianski further teaches that the peptide can be modified by substitution of one or more of the amino acids in the natural L-isomeric form with amino acids in the D-isomeric form (para. 0065). Tymianski also teaches a variant of the above PSD-95 inhibitor comprising the amino acid sequence rrrqrrkkr, in which these amino acids are D-amino acids, linked to the peptide IETAV (para. 0067). Tymianski also teaches that the peptide IESDV is also effective in inhibiting binding of NUDAR2B to PSD-95 (para. 0067).
Tymianski also teaches administering a thrombolytic agent such as tissue plasminogen factor (tPA) (para. 0086). Tymianski further teaches that the PSD-95 inhibitor and reperfusion can be administered at the same time, or within 15 minutes of each other (para. 0103).
As Tymianski teaches a peptide with identical composition of the instantly claimed peptide, it must also have the same functional properties. In re Spada, 911 F.2d 705, 709, 15 USPQ2d. While Tymianski may not recognize the asserted property of resistance to plasmin degradation due to the use of D-amino acids, this property is inherently present. As such, Tymianski anticipates this property of the claimed method.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). Applicant has not met this burden.
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
17/524,673 31-36, 38, 40-43
17/800,523 1-10, 17, 31-33, 42-43
17/800,883 1, 3, 10-13, 15, 19-21
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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. 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).
No claim is allowed.
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, 8:00 to 4:00.
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/PETER JOHANSEN/Examiner, Art Unit 1644