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 .
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 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.
DETAILED ACTION
Claims 1-6, 8-10, 14, 17-19, 21, 22, 24-28, 62-69, 71, and 72 are pending, claims 7, 11-13, 15, 16, 20, 23, 29-61, 70, and 73-85 are canceled in this application. This application is a national stage entry of PCT/US2022/042036, filled on 08/30/2022. This application claims priority to provisional application 63/238,911, filed on 08/31/2021.
Election/Restrictions
Applicant's election with traverse of group I, claims 1-6, 8-10, 14, 17-19, 21, 22, and 24-28, in the reply filed on 03/02/2026, is acknowledge.
The traversal is on the ground(s) that groups I and II share same general inventive concept and share same special technical features. The inventions listed as Groups I and II do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, because the special technical feature in all groups is shown in prior art (US 2021/0154322 A1) as previously disclosed in the restriction requirement dated 01/28/2026.
The restriction requirement dated 01/28/2026 also required a species election of a single guest-terminated star polymer within claims 1, 14, 22, 24, 25, and 28; however, no election is made in the response dated 03/02/2026 which is treated as a clear admission on the record that the species are obvious variants; thus, if the examiner finds one of the inventions unpatentable over the prior art, the admission may be used in a rejection under 35 U.S.C. 103(a) of the other invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 62-69, 71, and 72 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected invention, there being no allowable generic or linking claim.
Claims 1-6, 8-10, 14, 17-19, 21, 22, and 24-28 will presently be examined to the extent they read on the elected subject matter of record.
Claim Objections
Claim 10 is objected to because of the following informalities: an extra “wherein”. Appropriate correction is required.
Claims 2 and 26 are objected to because of the following informalities: “ketone”, “acrylate”, and furfuryl” are recited twice. Appropriate correction is required.
Claim Rejections - 35 USC 112/Second paragraph
The following is a quotation of the second paragraph 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.
Claim 14 is rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which applicant regards as the invention.
Claim 14 recites the limitation “guest star polymer” which is inconsistent with the recitation of “guest-terminated star polymer” in claim 1 from which it depends.
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.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 1-6, 8-10, 14, 17-19, 21, 22, and 24-28 are rejected under 35 U.S.C. 103(a) as being unpatentable over Webber et al. (WO 2019/195728 A1) in view of Burdick et al. (US 2015/0202299 A1).
Webber et al. teach shear-thinning and self-healing (the claimed bonds with the claimed property under mechanical stress in the instant claims 1, 8, 9, and 25) hydrogel which flows upon applied shear, such as extrusion through tubing or a syringe (the claimed injectable in the instant claim 1) (paragraph 230) comprising
a thermos-responsive polymer as a 1st polymer conjugated to cucurbit[n]uril moiety (paragraph 71 and claims 1-5); wherein the cucurbit[n]uril moiety is modified with azide (the claimed host molecule with the claimed 2nd functional group in the instant claims 1, 3, 25 and 27) (paragraph 64) and the thermos-responsive 1st polymer being polyethylene glycol (PEG) (the claimed water-soluble polymer in the instant claims 1, 10, 14, 22, and 25) (paragraph 68) and modified with azide group (the instant claims 2 and 26) (paragraph 120);
a multi-armed polyethylene glycol (PEG) as a 2nd polymer comprising at least 6 functional groups such as adamantane (the instant claims 4 and 28) and exemplified an PEG8a-N-Ada, an 8-armed PEG terminated with Ada (adamantane) through azide (the claimed gest-terminated star polymer in the instant claims 1, 10, 14, 22, and 25), (paragraph 75, example 14, and figure 28A)
wherein 2nd polymer binding to cucurbit[n]uril moiety (the wherein clause in the instant claims 1 and 25) (paragraph 76 and claim 10);
a drug is disposed within the hydrogel network (figure 25A) including a peptide (the claimed biological cue in the instant claim 17-19) (paragraph 81 and 85).
Webber et al. do not specify the same host molecule in the instant claim 5 (cucurbit[n]uril vs the claimed β-cyclodextrin) the same water-soluble polymer in the instant claim 6 (PEG vs the claimed hyaluronic acid), and the mechanical stability in the instant claim 21.
This deficiency is cured by Burdick et al. who teach both cucurbit[n]uril and β-cyclodextrin being suitable hydrophobic cavity moieties (host) (paragraph 34-36, figure 11, example 2, and claims 1 and 21-23) and both PEG and hyaluronic acid being suitable hydrophilic polymers to be conjugated with cucurbit[n]uril and β-cyclodextrin (paragraph 38, -40 and claim 7) in a settable, shear-thinning guest-host-based hydrogel comprising a host-polymer and a guest-polymer linked through a plurality of host-guest pairings of non-covalent bonding moieties (abstract and claims 1 and 27), wherein the host-guest pairing of moiety including β -cyclodextrin/adamantane group pair (paragraph 36), the cured hydrogels exhibit a higher stability or lower diffusivity than the pre-cured (i.e., settable, shear thinning) hydrogel (paragraph 45 and 73).
It would have been prima facie obvious before the effective filing date of the claimed invention to a person of ordinary skill in the art to combine the teachings in Webber et al. and Burdick et al. to replace cucurbit[n]uril and PEG in the hydrogel taught by Webber et al. with β-cyclodextrin and hyaluronic acid, respectively, and to specify the higher mechanical stability of the cured hydrogels in comparison to the pre-cured hydrogel. Both cucurbit[n]uril and β-cyclodextrin being suitable hydrophobic cavity moieties and both PEG and hyaluronic acid being suitable hydrophilic polymers to be conjugated with cucurbit[n]uril and β-cyclodextrin in a settable, shear-thinning guest-host-based hydrogel having a higher stability or lower diffusivity than the pre-cure were well known to a person of ordinary skill in the art before the effective filing date of the claimed invention. The motivation for specifying it flows from its having been used in the prior art, and from its being recognized in the prior art as useful for the same purpose.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to HONG YU whose telephone number is (571)270-1328. The examiner can normally be reached on 9 am - 5:30 pm.
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/HONG YU/
Primary Examiner, Art Unit 1614
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