DETAILED ACTION
Claims 1-2, 5, 7-20 are pending in the instant application.
Applicant's election with traverse of group I, claims 1-12 in the reply filed on 02/23/2026 is acknowledged. Examiner agrees to add claims 13-16.
The requirement is still deemed proper and is therefore made FINAL.
Claims 1-2, 5, 7-16 are examined. Claims 17-20 are withdrawn per 37 CFR 1.142(b).
The rejection of claims 2, 9, 12 under 35 U.S.C. 112 is withdrawn in view of applicant’s amendment and argument in paper dated on 08/05/2026.
The rejection of claims 1-3 8, 10-16 under 35 U.S.C. 102(a)(1) over Kohane et al. is withdrawn in view of applicant’s amendment and argument in paper dated on 08/05/2026.
4. NEW Claim Rejections - 35 USC § 103
The following is a quotation of the first paragraph of 35 U.S.C. 112:
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 of carrying out his invention.
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S.
1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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.
Claims 1-2, 5, 7-16 are rejected under 103(a) as being unpatentable over Kohane et al., US 20210275478 in view of Vetter et al., US 20140249093.
The teachings of Kohane et al., as set forth above with respect to claims 1-16 are relied upon and incorporate herein.
Kohane et al. does not teach (A) a composition that comprises voltage gated calcium channel modulators, (B) a composition wherein the polymer is cross linked and (C) a linker selected from beta-alanine, glycine, 5-aminovaleric acid, (8-amino-3,6-dioxaoctanoic acid), or (12-amino-4,7,10-trioxadodecanoic acid).
In regard to (A) Vetter et al. teaches drugs covalently linked to polymers via a linker (paragraph [0014]-[0020]). They specifically disclose preferable drugs as gabapentin and pregabalin (paragraph [0349]).
In regard to (B) Vetter et al. teaches the polymer (paragraph [0064]) along with preferred embodiments such as PEG and hyaluronic acid (paragraph [015]) and that polymer is preferably crosslinked (paragraph [0154]). Furthermore Vetter et al. teaches the polymer has a molecular weight of 0.2 kDa to 160 kDa (paragraph [0156]) which overlaps with the range of claim 7. Because both Kohane et al. and Vetter et al. teach the molecular weights of the polymer that overlap with the claimed range, it would have been obvious to one skill in the art to select a polymer having a molecular weight within the claimed range.
It would have been obvious to one ordinary skill in the art at the time the invention was filed to modify the conjugates of Kohane et al. to include a calcium channel modulator as taught by Vetter et al. because both references are directed to polymer-based drug delivery systems designed to provide sustained release of therapeutically active agents for pain management. Substituting one known class of ion channel modulators for another represents the use of a known element for its known purpose to yield predictable results. It would have been further obvious to employ cross linked polymer systems and to select appropriate linker species as taught by Vetter et al. because both references teach the polymer structure and linker composition may be modified to control drug release, rendering such modifications routine variations within the art. Therefore, it is known to use cross linked polymer to drug release.
Applicants’ amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicants are 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 extension fee 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 date of this final action.
5. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Niloofar Rahmani whose telephone number is
571-272-4329. The examiner can normally be reached on Monday through Friday from 8:30 am to 5:00 pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor, can be reached on 571-272-8394. The fax phone number for the organization where this application or proceeding is assigned is 703-872-9306.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/NILOOFAR RAHMANI/ Primary Examiner, Art Unit 1691
09/11/2026
