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 with traverse of Group I, drawn to a composition for preparing an organic-inorganic complex hydrogel, in the reply filed on 2/12/2026 is acknowledged. The traversal is on the ground(s) that Bian et al. (Pub. No.: US 2018/0169141 A1), which was cited in the Requirement for Restriction/Election of 12/12/2025, does not disclose the shared technical feature; and therefore, the technical feature is a special technical feature that makes a contribution over the prior art. The examiner respectfully disagrees. The overall shared technical feature of the present application was determined to be an organic-inorganic complex hydrogel, which is recited by paras. 0063-0064 of Bian et al. This technical feature is further recited by the prior art references listed below, thus further confirming that the groups lack the same or corresponding special technical features as they do not make a contribution over the prior art. Claims 7-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected groups, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/12/2026. The requirement is still deemed proper and is therefore made FINAL.
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.
Claim(s) 1-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee Donghyun et al. (“Injectable biodegradable gelatin-methacrylate/β-tricalcium phosphate composite for the repair of bone defects,” Chemical Engineering Journal, vol. 365, 4 February 2019, pages 30-39; provided by the Applicant in the Information Disclosure Statement of 1/7/2025; hereinafter “Lee”).
Lee teaches the following regarding claim 1: a composition for preparing an organic-inorganic complex hydrogel (pgs. 31-32) comprising a biocompatible polymer (pgs. 31-32) having a photocrosslinkable functional group (via UV light); and a calcium phosphate-based ceramic powder (β-TCP) (pgs. 31-32).
Regarding claims 1 and 2, Lee teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that a weight of the calcium phosphate-based ceramic powder is equal to or greater than a weight of the biocompatible polymer. The optimization of parameters is a routine practice that would be obvious for a person of ordinary skill in the art to employ. It would have been customary for one of ordinary skill to determine the optimal amounts of each ingredient of the composition needed to achieve the desired results and promote regeneration. Thus, absent some demonstration of unexpected results from the claimed parameters, the optimization of the amounts of the calcium phosphate-based ceramic powder and the biocompatible polymer, would have been obvious at the time of applicant's invention in view of the teachings of Lee. It is well-established that merely selecting proportions and ranges is not patentable absent a showing of criticality. In re Becket, 33 USPQ 33; In re Russell, 169 USPQ 426.
Lee teaches the following regarding claim 2: the composition for preparing an organic-inorganic complex hydrogel according to claim 1, wherein the weight ratio of the biocompatible polymer and the calcium phosphate-based ceramic powder is1:1 or more and less than 1:20 (pg. 32).
Lee teaches the following regarding claim 3: the composition for preparing an organic-inorganic complex hydrogel according to claim 1, wherein the biocompatible polymer is at least one selected from the group consisting of alginate, hydroxypropylmethylcellulose (HPMC), hydroxyethylcellulose (HEC), methyl cellulose, carboxymethylcellulose (CMC), gelatin, collagen, fibrinogen, chitosan, agar, matrigel, starch, pectin, polyvinyl alcohol, polyurethane, poly(ethylene glycol), poly(propylene glycol), hyaluronan and poly(vinylpyrrolidone) (pgs. 31-32).
Lee teaches the following regarding claim 4: the composition for preparing an organic-inorganic complex hydrogel according to claim 1, wherein the calcium phosphate-based ceramic powder is at least one selected from the group consisting of α-TCP (a-tricalcium phosphate), β-TCP (β -tricalcium phosphate), hydroxyapatite, DCPD (dicalcium phosphate dihydrate), MCPM (monocalcium phosphate monohydrate), DCPA (dicalcium phosphate anhydrous) and BCP (biphasic calcium phosphate) (pgs. 31-32).
Lee teaches the following regarding claim 6: the composition for preparing an organic-inorganic complex hydrogel according to claim 1, wherein the composition further includes at least one of a functional member (e.g., hydroxyapatite) and a cell (pgs. 31-32, 37).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lee in view of Murphy (Pub. No.: US 2008/0095817 A1).
Lee teaches the limitations of the claimed invention, as described above. However, it does not explicitly recite that the calcium phosphate-based ceramic powder is α -TCP (α -tricalcium phosphate). Murphy teaches that it is well known in the art that hydrogels formed for tissue regeneration comprise different minerals, including α-TCP (a-tricalcium phosphate) and/or β-TCP (β-tricalcium phosphate) (paras. 0024-0025, 0032-0033), for the purpose of promoting bone regeneration and providing the composition with the desired dissolution rate and patterns. It would have been obvious to one having ordinary skill in the art to modify the composition of Lee to comprise α-TCP, as taught by Murphy, in order to promote bone regeneration and provide the composition with the desired dissolution rate and patterns. In addition, it has been held that a simple substitution of one known element for another to obtain predictable results, in the instant case, replacing one type of calcium phosphate-based ceramic for another, is generally considered to be within the level of ordinary skill in the art.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Ann Hu whose telephone number is (571) 272-6652. The examiner can normally be reached on Monday-Friday (9:00 am-5:30 pm EST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Jerrah Edwards, at (408) 918-7557. The fax phone number for the organization where this application or proceeding is assigned is (571) 273-8300.
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/ANN HU/Primary Examiner, Art Unit 3774
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