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 1-13) in the reply filed on 06 July 2026 is acknowledged.
Claims 14-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06 July 2026.
Claims 1-13 are under current consideration.
Claim Objections
Claim 1 is objected to because of the following informalities: the phrase “that comprises” in line 1 is duplicative of the earlier-recited “comprising”. Appropriate correction is required.
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 10 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 10 recites the broad recitation “amino-arginyl aspartic acid peptide”, and the claim also recites “(amino-RGD)” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 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 (i.e., changing from AIA to pre-AIA ) 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.
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 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) 1-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Liu et al. (CN 110193091 A; published 03 September 2019; citations herein to English machine translation dated and filed by applicant on 25 April 2025) in view of Addison et al. (WO 2021/189024 A1; published 23 September 2021) as evidenced by Liu et al. ‘714 (US 2009/0324714 A1; published 31 December 2009).
Liu et al. discloses injectable protein/polyethylene glycol-based hydrogel material comprising four-armed polyethylene glycol and gel buffer having functions of supporting cell growth, antibacterial, tissue adhesion, tissue shielding, and hemostasis (abstract; claim 1) wherein the protein is serum albumin (claim 5) wherein the gel buffer includes drug (claim 6) wherein the protein and gel buffer are in a gel-forming solution A and the four-armed polyethylene glycol with end-modified succinimide active ester groups and gel buffer are in a gel-forming solution B wherein A and B can be mixed to form hydrogel material (claim 7) wherein the four-armed modified PEG is in a concentration of 50-200 mg/ml (i.e., about 5-20 wt%) in liquid B and the solute/protein/serum albumin is in a concentration of 50-200 mg/ml (i.e., about 5-20 wt%) in liquid A (claim 8) wherein the four-armed polyethylene glycol can be 4arm PEG-NHS with weight average molecular weight of 5000-40,000 (pages 17-18) wherein the gel formation time is 26-230s (page 9).
Liu et al. does not disclose a nanoparticle as claimed.
Addison et al. discloses hydrogel forming formulations (title) for use as tissue sealants (abstract) which comprises a radiopaque agent preferably gold (claim 169) such as gold nanoparticles to provide the resulting hydrogel with the ability to be spectroscopically imaged (page 41 lines 5-10).
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 Liu et al. and Addison et al. as discussed above by including gold nanoparticles as in Addison et al. in a hydrogel forming composition of Liu et al. as discussed above such as solution A, with a reasonable expectation of success. A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to do so to include in the hydrogel a radiopaque agent that provides the resulting hydrogel with the ability to be spectroscopically imaged as suggested by Addison et al., to facilitate tissue sealing/adhesion given that the compositions of Liu et al. and Addison et al. are both directed to use of hydrogels for tissue adhesion.
Further regarding claim 1, the solution B of Liu et al. in view of Addison et al. thus comprises about 5-20 wt% 4-arm PEG-NHS, and gel buffer and drug, which corresponds to the precursor A of claim 1, and the solution A of Liu et al. in view of Addison et al. thus comprises about 5-20 wt% serum albumin and gold nanoparticles, which corresponds to the precursor B of claim 1, given that serum albumin is also a bioadhesive (i.e., a cell adhesion promoter), as evidenced e.g. by Liu et al. ‘714 at paragraph [0074] (“Proteins such as zein, serum albumin, and collagen may also be used as bioadhesives.”). See, e.g., Powell v. Home Depot U.S.A. Inc., 663 F.3d 1221, 100 USPQ2d 1742, 1748 (Fed. Cir. 2011) (finding that a single structure in a prior art reference satisfied two limitations in a claim).
Further regarding claim 1, the solution A and solution B of Liu et al. as discussed above are physically separated until they are mixed.
Regarding claim 7, the gold of Addison et al. is in the form of nanoparticles, and thus are in the nanometer size range, i.e., 1-1000 nm, which overlaps the claimed range of 1-100 nm, and a prima facie case of obviousness exists where prior art and claimed ranges overlap per MPEP 2144.05(I).
Regarding claim 8, 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 optimize the ability of the hydrogel of Liu et al. in view of Addison et al. as discussed above to be spectroscopically imaged by varying the concentration of gold nanoparticles used therefor through routine experimentation per MPEP 2144.05(II), with a reasonable expectation of success, given that Addison et al. teaches that radiopaque agent such as gold nanoparticles provides the resulting hydrogel with the ability to be spectroscopically imaged, i.e., a result-effective variable.
Regarding claim 9, the serum albumin (i.e., cell adhesion promoter) of Liu et al. is a protein.
Regarding claim 10, such recitation merely further limits the peptide, but does not limit the protein cell adhesion promoter, which can be serum albumin.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL B. PALLAY whose telephone number is (571)270-3473. The examiner can normally be reached Monday through Friday from 8:30 AM to 5:00 PM Eastern Time.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached at (571)272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL B. PALLAY/Primary Examiner, Art Unit 1617
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