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 .
Claims 1, 4, 6, 9, 11, 17-20, 23, 25, 30, 33-34, 54-57, 62-63, 68-73, and 77-79 are pending; claims 30, 62-63, 68-73, and 77-79 are withdrawn. In addition, claims 1, 4, 6, 9, 11, 17-20, 23, 25, 33-34, and 54-57 are currently withdrawn.
Applicant’s arguments, filed 04 June 2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Election/Restrictions
Newly submitted claims 1, 4, 6, 9, 11, 20, 23, 25 are directed to an invention/a species that is independent or distinct from the invention originally claimed for the following reasons:
In the response dated 22 January 2026, Applicant had elected elamipretide (D-Arg-Dmt-Lys-Phe-NH2) as the single species of oligopeptide or peptidomimetic. Accordingly, amended claim 1, reciting wherein the oligopeptide is selected from the group consisting of compound III and compound IV, and wherein the peptidomimetic is compound I, does not read on the elected species.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 1 and 25 will be interpreted as reciting the original election of elamipretide. Newly recited species are withdrawn from consideration as being directed to a non-elected invention/species. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1, 4, 6, 9, 11, 17-20, 23, 25, 33-34, and 54-57 are rejected under 35 U.S.C. 103 as being unpatentable over Schiffman et al. (WO 2019/246141 A1, 12/16/219, IDS reference) (hereinafter Schiffman).
Note: for citation purposes, the US equivalent (US 2021/0100907 A1) will be cited in place of WO 2019/246141 A1.
The text of previous rejections not included in this action can be found in a prior Office action. The rationales of the rejections of these claims remain the same as those given in the Non-Final Rejection dated 04 March 2026.
Response to Arguments
Regarding applicant’s remarks, applicant mainly argues that the prior art does not disclose the claims as amended, which recites non-elected species. However, as discussed above, the claims have been constructively elected for prosecution based on originally elected species. Accordingly, Applicant’s arguments are not found to be persuasive.
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 1, 4, 6, 9, 11, 17-20, 23, 25, 33-34, and 54-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 12,252,553, claims 1-8 of U.S. Patent No. 11,555,053, and claims 1-15 of U.S. Patent No. 10,683,326 in view of Schiffman et al. (WO 2019/246141 A1, 12/16/219, IDS reference) (hereinafter Schiffman).
The patented claims differ from the pending claims insofar as not explicitly teaching all the features of the claimed invention, such as instantly claimed biodegradable silica hydrogel composite.
However, these features are known in the art. As noted in the current rejections, the teachings of Schiffman render obvious claims 1, 4, 6, 9, 11, 17-20, 23, 25, 33-34, and 54-57.
Therefore, as claims 1-8 of U.S. Patent No. 12,252,553, claims 1-8 of U.S. Patent No. 11,555,053, claims 1-15 of U.S. Patent No. 10,683,326, and Schiffman all disclose compositions comprising elamipretide, it would have been prima facie obvious to one of ordinary skill in the art to have modified the patented claims and to include the teachings of Schiffman as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
Claims 1, 4, 6, 9, 11, 17-20, 23, 25, 33-34, and 54-57 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4, 6-10, 13-18, 22-24, and 28-33 of copending Application No. 18/010,526 and claims 14-29 and 46-47 of copending Application No. 19/053,773 in view of Schiffman et al. (WO 2019/246141 A1, 12/16/219, IDS reference) (hereinafter Schiffman).
The copending claims differ from the pending claims insofar as not explicitly teaching all the features of the claimed invention, such as instantly claimed biodegradable silica hydrogel composite.
However, these features are known in the art. As noted in the current rejections, the teachings of Schiffman render obvious claims 1, 4, 6, 9, 11, 17-20, 23, 25, 33-34, and 54-57.
Therefore, as claims 1-2, 4, 6-10, 13-18, 22-24, and 28-33 of copending Application No. 18/010,526, claims 14-29 and 46-47 of copending Application No. 19/053,773, and Schiffman all disclose sustained release compositions comprising elamipretide or compositions comprising elamipretide, it would have been prima facie obvious to one of ordinary skill in the art to have modified the copending claims and to include the teachings of Schiffman as discussed in the rejections above, because all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as instantly claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art." See MPEP 2144.06(I).
This is a provisional nonstatutory double patenting rejection.
Response to Arguments
Regarding applicant’s remarks, applicant mainly argues that the prior art does not disclose the claims as amended, which recites non-elected species. However, as discussed above, the claims have been constructively elected for prosecution based on originally elected species. Accordingly, Applicant’s arguments are not found to be persuasive.
Citation of Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Leino et al. (US 2018/0311150 A1, 11/1/2018, IDS reference), directed to shear-thinning hydrogels.
Conclusion
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 LUCY TIEN whose telephone number is (571)272-8267. The examiner can normally be reached Monday - Thursday 8:30 AM - 6:30 PM EST.
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, SAHANA KAUP can be reached at (571) 272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/LUCY M TIEN/Examiner, Art Unit 1612
/SAHANA S KAUP/Supervisory Primary Examiner, Art Unit 1612
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