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 .
Response to Amendment and Argument
The response filed on 1/2/26 has been entered.
Applicant’s arguments filed 1/2/26 have been fully considered but they are not deemed to be persuasive.
Claims 1-3, 7-12, 14, 16-18, 22 and 24 are pending in this office action.
Claims 1, 8 objected to because of the following informalities: is withdrawn based on the amendment to the claims.
The rejection of Claim 5 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph is withdrawn based on the amendment to the claims.
The rejection of Claim(s) 1-5, 12, 14, 16-18, 22-24 is/are rejected under 35 U.S.C. 102(a2) as being anticipated by Burdick et al. (US 2016/0279868) is withdrawn based on the amendment to the claims.
Necessitated by amendment 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.
Claim(s) 1-3, 7-12, 14, 16-18, 22 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Madl et al. (ACS Macro Lett (2020) 9(40) 619-626) in view of Burdick et al. (US 2016/0279868) and Liu et al. (j. Polymer Sci. PART A: Polymer Chemistry 2017, 55, 3105–3109 and further in view of Kharkar et al. (ACS Biomaterials Sci. and Eng. 2(2) 2016).
Madl teaches an injectable cucurbit[8]uril based supramolecule (see abstract) via thio-ene crosslinked with peptide ternary complexes (see abstract, as required by instant claim 8) as gelatin hydrogels encapsulated (as required by instant claim 1) wherein via thiol–ene reactions between preassembled CB[8]·FGGC peptide ternary complexes and grafted norbornenes (see abstract as required by claims 8-9)Chen teaches (CB[7]-AD) cross-linked supramolecular hydrogels (see abstract) via injection with an N-terminal phenylalanine and a C-terminal cysteine (as required by instant claim 10, see pg 3 last para) wherein the biopolymer is a polysaccharide (see pg 3 1st para) and the cells encapsulated (as required by instant claim 17, see pg 6, 3rd para) and also teaches the biopolymer is a gelatin (see pg 4, 2nd line).
However Madl fail to teach the specific biopolymer and the peptide as required by instant claims 11,14 and 16.
Burdick teaches a with regards to instant claim 1, flowable (see 0021, as required also by instant claim 24) biomaterial (ie., hydrogel, see 0005) comprising a polymer crosslinked non covalently and are reversible (see 0010 and 0170) in a supramolecular structure (see 0005) as a single injectable solution (see 0040) and also comprising the two component solution (see 0164, as required by instant claim 3), wherein the complex is formed by host-guest (see 0170, as required by instant claim 4) wherein the reactive group is a cyclodextrin and the other polymer is adamantane (see 00170021, 0047, as required by instant claim 5). Additionally Burdick teaches the biopolymer is a protein (i.e., collagen, as required by instant claim 12, see 0152), a hyaluronic acid (see claim 10, as required by instant claim 14) and the biopolymer is poly(ethylene glycol) (PEG) (as required by instant claim 16), cell encapsulated (as required by instant claim 17, see 0113-0114) in a defined 3D structure (see 0055; 0154, as required by instant claim 17), wherein the cells are stem cells (as required by instant claim 18, see 0108) and wherein the first and second solution adamantane:cylodextrin is 1:1 (see 0173. As required by instant claim 22).
However fails to teach that the biomaterial has reactive group of the first polymer is a Cucurbit[n}, where nis 5-8 and 10 (as required by instant claim 6-10).
Liu teaches supramolecular component such as cucurbit[n]uril, wherein the CB[n] is 8 shows that the CB[8] supramolecular ternary conjugates serve as dynamic crosslinkers responsible for the structured 3D (see pg. 3105; 3108, lft col. 2nd para, Fig. 1).
Kharkar teaches thiol-ene click hydrogels wherein ability to cross-link hydrogels with light using radically mediated thiol–ene reactions with norbornenes radically mediated. wherein the therapeutic is released by cleavage of the covalent linkage or by complete hydrogel degradation. With linker cleavage (e.g., enzymatic cleavage of a peptide linker), tethered molecules are released without altering the greater network structure. Thus one of ordinary skill in the art would have formed the cucurbit[8] in a peptide bond.
It would have been obvious to one of ordinary skill in the art to expand the teachings of Madl; to include Burdick Liu and Kharkar and modify the teaching to result in the instant claimed invention with a reasonable expectation of success because The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988). Therefore it would have been obvious to one of ordinary skill in the art at the time the invention was made to combine references absent explicit direction in a prior art reference. If, however, the level of skill is that of a pharmaceutical nanoparticle research scientist, as is the case here, then one can assume comfortably that such an educated artisan will draw conventional ideas from medicine, pharmacy, nanoparticle polymer chemistry— without being told to do so. Indeed, MPEP 2141.03 (I) states: “The “hypothetical ‘person having ordinary skill in the art’ to which the claimed subject matter pertains would, of necessity have the capability of understanding the scientific and engineering principles applicable to the pertinent art.” Ex parte Hiyamizu, 10 USPQ2d 1393, 1394 (Bd. Pat. App. & Inter. 1988).
Applicant’s argument have been considered, and is moot based on the new reference cited.
No claims are allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHIRLEY V GEMBEH whose telephone number is (571)272-8504. The examiner can normally be reached M-F 9am-6pm.
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/SHIRLEY V GEMBEH/Primary Examiner, Art Unit 1615 2/24/25