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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 4, 6-7, 12-13, and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang (CN 110498936 A, attached with machine translation).
Regarding claims 1, 4, 6-7, and 12-13, Zhang teaches a hydrogel and method of making it using sodium hyaluronate and sodium alginate (claims 1-2). The hyaluronic acid is dissolved in DI water to 0.3-2 wt%, then adipic acid dihydrazide is added in amounts of 8-25 times the weight of hyaluronic acid, the pH is adjusted to 5.0-7.4 using NaOH and/or HCl, then 1-ethyl-(3-dimethylaminopropyl) carbodiimide is added in an amount 1-4 times the weight of hyaluronic acid, and after reacting, the solution is dialyzed to provide a modified hyaluronic acid, HA-ADH (claim 2). Separately, sodium alginate is dissolved in DI water to 0.3-2 wt%, sodium periodate is added in amounts 0.5-1 times the weight of sodium alginate, and the product is purified by dialysis, producing a modified alginate, Alg-CHO (claim 2). The hydrogel is then prepared by dissolving the modified hyaluronic acid in buffer solution, and dissolving the modified Alg-CHO in buffer solution, and combining the mixed solutions to form a hydrogel (claim 2). HA-ADH and Alg-CHO may be combined in a 1:1 ratio, which is equivalent to a ratio of 5:5 (p. 6, Ex. 1). The buffer solution may be PBS (p. 6).
Regarding claim 17, Zhang remains as applied to claims 1 and 12 above. Zhang is silent as to the viscosity of the hydrogel. Nevertheless, Zhang teaches a hydrogel that is made of identical ingredients, in identical amounts, prepared in an identical manner to the claimed hydrogel. Therefore, Zhang’s hydrogel will necessarily possess the same viscosity characteristics as the claimed hydrogel. Products of identical chemical composition cannot have mutually exclusive properties. See MPEP 2112.
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.
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claim 1 above, and further in view of Weisbrod (US 20230110994 A1) and Im (US 20190388558 A1).
Regarding claim 2, Zhang remains as applied to claim 1 above. Zhang is silent as to use of ethylene diamine and 1-hydroxybenzotriazole (HOBt) in the modification of hyaluronic acid. In the same field of endeavor, Im teaches crosslinking hyaluronic acid with ethylene diamine (p. 3, [0029]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to select the ethylene diamine of Im to modify the hyaluronic acid of Zhang, to arrive at the claimed invention, and to significantly reduce the breakdown of hyaluronic acid, as taught by Im (p. 3, [0030]). In the same field of endeavor, Weisbrod teaches that hyaluronic acid may be modified using HOBt and EDC for hydrogel applications (p. 56, [0877]; p. 36, [0564]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the hyaluronic acid of Zhang and the modification of Weisbrod to arrive at the claimed invention, and because of the art-recognized suitability for the intended use. See MPEP 2144.07.
Claims 9-11 and 14-16 are rejected under 35 U.S.C. 103 as being unpatentable over Zhang as applied to claim 1 above, and further in view of Stone (US 20260151542 A1) and Sanchez Ordonez (US 20230338619 A1).
Regarding claims 9-11 and 14-16, Zhang remains as applied to claim 1 above. Zhang is silent as to addition of further components to the composition. In the same field of endeavor, Stone teaches mixing cells and growth factor with hyaluronic acid-based hydrogel (Abstract; p. 3, [0027]). In the same field of endeavor, Sanchez Ordonez teaches a biocompatible hydrogel suitable for use in a printing system that may include alginate and hyaluronic acid in addition to ECM proteins (p. 5, [0062], [0066]). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to combine the cells and growth factor of Stone, and the proteins (macromolecules) of Sanchez Ordonez with the hydrogel of Zhang to arrive at the claimed invention, and because of the art-recognized suitability for the intended use. See MPEP 2144.07.
Allowable Subject Matter
Claims 3, 5, and 8 are objected to as being dependent upon a rejected base claim, 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: The closest prior art is Zhang in view of Im, Weisbrod, Stone, and Sanchez Ordonez. The combined prior art teaches a similar composition and method, but fails to disclose dialyzing each of the modified hyaluronic acid and the modified alginate separately in an 11,000-15,000 Da dialysis bag, and fails to disclose the claimed concentration of HA-NH2. No further prior art has been located that reads on these claim limitations. As such, the instant claims contain limitations not found in the prior art, and would be allowable if rewritten.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ELIZABETH K AMATO whose telephone number is (571)270-0341. The examiner can normally be reached 8:30 am - 4:30 pm M-F.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rob Jones can be reached at (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ELIZABETH K. AMATO
Examiner, Art Unit 1762
/ROBERT S JONES JR/Supervisory Patent Examiner, Art Unit 1762
Prosecution Insights