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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 31-34 in the reply filed on 01 June 2026 is acknowledged. Accordingly, claims 35-50 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 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.
Claim 34 is 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.
Claim 34 recites a “chemical-based” drug in the last line of the claim. The claim is indefinite because the scope of the claim is unclear. It is not clear which drugs are considered chemical-based and which ones are not, or what a chemical-based drug’s distinct features would be, such that one of ordinary skill in the art would know when a drug infringes on the claimed invention. At best, page 26, line 25 of the instant Specification lists exemplary classes of drugs that are considered to be a “chemical-based” drug. Moreover, it is further unclear how a “chemical-based” drug differs from the other types of therapeutic agent recited in claim 34. For example, it is unclear to the Examiner how a chemotherapeutic differs from a “chemical-based” drug. Clarification is requested.
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 31-34 are rejected under 35 U.S.C. 103 as being unpatentable over Francis et al. (US 2018/0161252 A1, 06/14/2018, IDS reference of 11/29/2023) (hereinafter Francis) in view of Cai et al. (CN 105596294 A, 05/25/2016) (hereinafter Cai).
Francis discloses an array ([0031]) of dissolvable microneedles that can penetrate the skin surface (abs), comprising hyaluronic acid (HA) that is cross-linked, including disulfide-crosslinked HA. The disulfide crosslinking may be by any suitable method and derivatization scheme ([0038]). The microneedles may be affixed to a substrate layer ([0040]).
Francis differs from the instant claims insofar as not explicitly disclosing wherein the disulfide-crosslinked HA comprises a specific structure as instantly claimed.
However, Cai discloses hyaluronic acid linked by disulfide bond (HA-s-s-NH2) with a structure of:
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([0043]),
which provides drug-loaded structures with good biocompatibility (abs).
Accordingly, it would have bene obvious to one of ordinary skill in the art to have included a structure of the HA-s-s-NH2 of Cai in the microneedles of Francis, since it is a known and effective disulfide-linked hyaluronic acid structure suitable to deliver drugs with good biocompatibility as taught by Cai.
Regarding claim 32, Francis further discloses wherein the microneedles have a height of about 100-1500 µm, and a base of about 50 µm - 600 µm ([0018]). Accordingly, the claimed ranges (i.e. height of about 100 µm to about 1,500 µm and a base having a radius of about 100 µm to about 1,500 µm) would have been obvious to one of ordinary skill in the art since they overlap with the ranges of the prior art. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. See MPEP § 2144.05(I).
Regarding claim 33, Francis further discloses wherein suitable polymers for the substrate layer include poly(lactic-co-glycolic acid) (PLGA) ([0042]-[0044]).
Regarding claim 34, Francis further discloses wherein the microneedles may contain one or more therapeutic agents or compounds (i.e. active ingredient) ([0027]), including proteins ([0058]).
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 31-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-53 of copending Application No. 18/278,903 (reference application) in view of Francis et al. (US 2018/0161252 A1, 06/14/2018, IDS reference of 11/29/2023) (hereinafter Francis) and Cai et al. (CN 105596294 A, 05/25/2016) (hereinafter Cai). Although the claims at issue are not identical, they are not patentably distinct from each other because the copending claims recite a plurality of microneedles projecting from a polymeric, biodegradable substrate, wherein the plurality of microneedles comprises a degradable hyaluronic acid polymer comprising a disulfide bond coupled to a terminal amine group, and an immunoregulator, and thus read on the pending claims.
Moreover, in any case, the features of the copending claims are known in the art. As noted in the current rejections, the teachings of Francis and Cai render obvious claims 31-34. Therefore, as claims 34-53 of copending Application No. 18/278,903, Francis, and Cai all disclose a degradable hyaluronic acid polymer with disulfide linkage, it would have been obvious to one of ordinary skill in the art to have modified the copending application and to include the teachings of Francis and Cai 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 because the patentably indistinct claims have not in fact been patented.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
McAllister et al. (US 2018/0133447 A1, 05/17/2018, IDS reference of 11/29/2023), directed to drug delivery devices comprising separable microneedles and a substrate, wherein the release rate of the drug may be altered by the porosity within the microneedle.
Prausnitz and Lee (WO 2008/011625 A2, 01/24/2008, IDS reference of 11/29/2023), directed to dissolvable/swellable microneedle devices comprising a base substrate and one or more microneedles extending from the base substrate.
Li et al. (“Redox-sensitive micelles self-assembled from amphiphilic hyaluronic acid-deoxycholic acid conjugates for targeted intracellular delivery of paclitaxel,” March 2012, IDS reference of 11/29/2023), directed to a method of delivering actives wherein the shell comprises hyaluronic acid linked with disulfide bond.
Conclusion
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.
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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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