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 1-7 and 11-15) in the reply filed on 1/15/2026 is acknowledged.
Groups II-III (claims 8-10 and 16) are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 1/15/2026.
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 2 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.
Claim 2 recites “the high-molecular polymer is any one or more selected from the group consisting of gelatin, dopamine, 3-(4-hydroxyphenyl)propionic acid, tyramine…” which renders the claim indefinite because dopamine, 3-(4-hydroxyphenyl)propionic acid, and tyramine are not high-molecular polymer; and it is not clear if the limitation really needs high-molecular polymer or not. For the purpose of further examination, based on the broadest reasonable interpretation, the limitation of high-molecular polymer is not considered as necessary.
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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) 1-4, 6-7, 11-13 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al (“Injectable hyaluronic acid–tyramine hydrogels for the treatment of rheumatoid arthritis”, Acta Biomaterialia 7 (2011) 666–674) in view of Jessop et al (US 20200230289 A1).
Regarding claims 1-4, 6-7, 11-13 and 15, Kim teaches a preparation method of injectable tyramine modified hyaluronic acid (HA–Tyr) hydrogels: HA–Tyr conjugate was synthesized by reacting HA with Tyr; then, HA–Tyr hydrogels were prepared by radical crosslinking reaction using H2O2 and horse-radish peroxidase [abstract].
The examiner submits that hyaluronic acid (HA) reads on the claimed high-molecular weight polymer as specified in claim 2; Tyramine (Tyr) reads on the claimed donor as specified in claim 11; horse-radish peroxidase reads on the claimed peroxidase as specified in claim 4.
Kim teaches that the method comprises dissolving HA and Tyr in distilled water, adding EDC and NHS, reacting overnight (corresponding to the recited 6 hours to 12 hours in claim 13) to form the HA–Tyr conjugate, dialyzing and lyophilizing (i.e., freeze drying, noted by the examiner) to obtain the modified HA [P667 2.2]. This method is similar to the method as recited in claims 7, 6 and 15, except that Kim does not teach “removing oxygen” or “reacting in inert gas”. However, Kim teaches using distilled water, which has the same effect as removing oxygen and reacting in inert gas using non-distilled water. In other words, if non-distilled water was use, it would have been obvious to one of ordinary skill in the art at the time of filing to remove oxygen and carry out the reaction in inert gas, in order to achieve the same result as using distilled water.
Kim teaches H2O2 instead of the claimed metal peroxide.
In the same field of endeavor, Jessop teaches forming hydrogels by crosslinking HA with a peroxide and a peroxidase [0006, 0009]. The HA is can be tyramine-substituted HA [0013]. The peroxide includes H2O2 and magnesium peroxide [0027].
It is prima facie obvious to substitute equivalents for the same purpose where the equivalence is recognized by the prior art. See MPEP 2144.06. Since Jessop recognized H2O2 and magnesium peroxide are equivalent for the same purpose of crosslinking HA to form a hydrogel, it would have been obvious for one of ordinary skilled in the art at the time of filing to substitute H2O2 with magnesium peroxide in Kim’s method.
Magnesium peroxide reads on the recited metal peroxide as specified in claims 3 and 12.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kim et al as applied to claim 1 above, further in view of Hong et al (“Visible-light-induced hyaluronate hydrogel for soft tissue fillers”, International Journal of Biological Macromolecules 165 (2020) 2834–2844).
Regarding claim 14, Kim teaches the method of claim 7 as stated above. Kim is silent about the molecular weight cut-off in dialysis.
In the same field of endeavor, Hong teaches a method for making HA hydrogel for biomedical application comprising synthesis of HA-Tyr conjugate, dialyzing with molecular weight cut-off of 12,000-13,000 [P2835, 2.2].
It would have been obvious to one of ordinary skill in the art at the time of the invention to form a HA-Tyr conjugate according to Kim including a molecular weight cut-off of 12,000-13,000 in dialyzing, as Hong demonstrates this range to be suitable for similar HA-Tyr conjugate for the modified HA hydrogel. This represents the use of a suitable range of molecular weight cut-off in HA-Tyr conjugate which is compositionally similar to those of Hong and which is used in similar application. "The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results." KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 416-21 (2007). See MPEP 2141. The molecular weight cut-off of 12,000-13,000 falls within the claimed range of 8,000 to 14,000.
Allowable Subject Matter
Claim 5 is 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:
Dependent claim 5 is directed to a preparation method of a metal peroxide composite injectable hydrogel, comprising: dissolving a modified high-molecular polymer, a metal peroxide and a peroxidase in a solvent, mixing evenly, and standing to prepare the hydrogel; wherein, the modified high-molecular polymer is a high-molecular polymer grafted with a phenolic hydroxyl group, wherein a mass ratio of the modified high-molecular polymer, the metal peroxide and the peroxidase is (150-200): (5-200): 0.32.
There is no prior art that teaches or makes obvious the aforementioned limitations as claimed.
The closest prior art is the disclosure of Kim et al (“Injectable hyaluronic acid–tyramine hydrogels for the treatment of rheumatoid arthritis”, Acta Biomaterialia 7 (2011) 666–674) in view of Jessop et al (US 20200230289 A1).
Kim in view of Jessop teaches the method recited in claim 1, as stated in the 103 rejection.
However, neither Kim nor Jessop teaches or suggests wherein a mass ratio of the modified high-molecular polymer, the metal peroxide and the peroxidase is (150-200): (5-200): 0.32.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JIANGTIAN XU whose telephone number is (571)270-1621. The examiner can normally be reached Monday-Thursday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Jones can be reached on (571) 270-7733. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JIANGTIAN XU/Primary Examiner, Art Unit 1762