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 .
DETAILED ACTION
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 02/19/2026 has been entered.
Status of Claims
The amendments and arguments filed on 02/19/2026 are acknowledged and have been fully considered. Claims 1-4, 7-19, and 21-23 are now pending. Claims 5-6 and 20 are canceled; claim 1 is amended; claims 8-19 and 21 are withdrawn; claims 22-23 are new.
Claims 1-4, 7, and 22-23 will be examined on the merits herein.
Objections/Rejections Withdrawn
Rejections and/or objections not reiterated from previous Office Actions are hereby withdrawn.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, and constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—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 or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 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.
Claims 1-4, 7, and 22-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites the limitation of “wherein the hydrogel composition does not include stem cells” however, the specification and overall disclosure does not teach that the composition does not include stem cells. There are mentions of studies that included stems cells within the specification, but the limitation of having a composition without the use of stem cells is not explicitly taught and as such is considered new matter. If applicant contends there is support for this limitation, then applicant is requested to specify the page and line of said support. In accordance to MPEP 714.02, applicant should specifically point out to where in the disclosure a support for any amendment made to the claims can be found.
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.
Claims 1-3 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over WO 2016022807 A1 (Khademhosseini, 2016) in view of Annabi (2017).
In regard to claims 1-3 and 22, Khademhosseini teaches a crosslinked methacryloyl-substituted gelatin hydrogel, an antibacterial agent (i.e., antimicrobial) and silicate nanoparticles (see Khademhosseini, abstract; 0012-0015). The composition is taught to comprise a photoinitiator such as eosin Y (see Khademhosseini, paragraph 0017).
The teachings of Khademhosseini are silent on the use of an antimicrobial peptide.
Annabi teaches a hydrogel comprising crosslinked gelatin (i.e. gelatin methacryloyl) with an antimicrobial peptide, Tet213 (see Annabi, abstract; Synthesis of MeTro/GelMA hydrogels).
In regards to claims 1-3 and 22, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Khademhosseini with the teachings of Annabi as the use of antimicrobial peptides in hydrogels is well-known in the art (see Annabi, page 230, column 1, paragraph 2) and Khademhosseini teaches that the hydrogel comprises antibacterial agents. Further it is taught that the hydrogels with the antimicrobial peptide have the benefits of preventing infection and promoting healing of chronic wounds (see Annabi, conclusion). It would be obvious to one with ordinary skill in the art to use the teachings of Annabi with the teachings of Khademhosseini to incorporate the antimicrobial peptide of Annabi according to the known method of making hydrogels to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016022807 A1 (Khademhosseini, 2016) in view of Annabi (2017) as detailed above for claims 1-3 and 22 in further view of Zhang (2017).
The teachings of Khademhosseini and Annabi have been described supra.
The teachings of Khademhosseini and Annabi are silent on the use of a metal ion as a crosslinking agent as claimed by claim 4.
Zhang teaches a hydrogel comprising crosslinkable gelatin being crosslinked with Fe3+ (see Zhang, abstract; 3.2 Preparation and Mechanical Property of Gelatin-UPy-Fe Hydrogels).
In regards to claim 4, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the teachings of Khademhosseini and Annabi with the teachings of Zhang as crosslinking gelatin with Fe3+ has known benefits such as enhancing the mechanical strength of the hydrogel when compared to conventionally crosslinked hydrogels (see Zhang, page 2, column 1, paragraph 2). As such, it would be obvious to one with ordinary skill in the art to combine the teachings of Khademhosseini and Annabi with the method of crosslinking of Zhang to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over WO 2016022807 A1 (Khademhosseini, 2016) in view of Annabi (2017) as detailed above for claims 1-3 and 22 in further view of Li et al. (2011).
The teachings of Khademhosseini and Annabi have been described supra.
The teachings of Khademhosseini and Annabi are silent on the use of the osteoinductive agent comprising lithium magnesium sodium silicate (i.e., the generic of Laponite ®) as claimed by claim 7.
In regards to claim 7, Li teaches a method of making hydrogels with drug delivery properties (see Li, abstract) comprising laponite (see Li, introduction).
In regards to claim 7, it would have been prima facie obvious to a person of ordinary skill in the art, before the effective filing date of the claimed invention, to formulate a hydrogel as instantly claimed as the use of laponite in a hydrogel is well-known in the art and has the benefit of having increased drug encapsulation efficiency and release efficiency, among others (see Li, conclusions; abstract). Further, it the laponite of Li is a specific type of silicate nanoparticles, which are taught to be in the composition of Khademhosseini and Annabi. As such, it would be within the purview of one with ordinary skill in the art to modify the method of Li to use the methacrylated gelatin of Khademhosseini and Annabi. One with ordinary skill in the art would be motivated to combine the teachings of Khademhosseini and Annabi with the Laponite of Li according to the known method of making hydrogels with Laponite to yield predictable results with a reasonable expectation of success. One with ordinary skill in the art would be motivated to combine prior art elements according to known methods to yield predictable results.
Allowable Subject Matter
Claim 23 is objected to as being dependent upon a rejected base claim 1, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Claim 23 is limited to only the compounds listed in the claim as it is written with a closed transition (i.e., consists of) and as such seems to be free of the art at this point.
Response to Arguments
Applicant's arguments filed 02/19/2026 have been fully considered but they are not persuasive in view of the modified grounds of rejection as necessitated by amendment.
Applicant’s arguments with respect to references Tuan and Krishnan have been considered but are moot because the new ground of rejection does not rely on these references applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
As the rejections of record have been modified as necessitated by amendment, the claims remain rejected as discussed above.
Conclusion
No claims allowed.
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/ISIS A GHALI/Primary Examiner, Art Unit 1611
/A.A.A./ Examiner, Art Unit 1611
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