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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/30/2026 has been entered.
Status of Claims
Claim amendment filed on 01/30/2026 is acknowledged.
Claim 1 is amended. Claim 3 remains cancelled. Claim 2 is now cancelled.
Claims 1 and 4-15 are pending and being examined on the merits herein.
Priority
The instant application 18028650, filed on 03/27/2023, is a 371 of PCT/KR2021/001110, filed on 01/27/2021, which claims foreign priority to Republic of Korea 10-2020-0127278, filed on 09/29/2020.
Claim Objection
Claim 1 is objected to because of the following informalities:
Claim 1 recites “more than 55wt% and 80wt% or less” and “20wt% or more and less than 45wt%”. It would make the language more readable if the word “or” is avoided when word “and” is used in the same phrase, e.g., “more than 55wt% up to 80wt%” and “at least 20wt% up to less than 45wt%”.
Appropriate correction is required.
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.
Claims 1 and 4-15 are rejected under 35 U.S.C. 103 as being unpatentable over Ryu et al. (US20160051725, 02/25/2016, IDS of 03/27/2023) in view of Bohner et al. (CA2642940 or WO2008077257, 07/03/2008; PTO-892).
Ryu teaches a bone graft composition comprising an injectable hydrogel with a combination of calcium phosphate compound particles and poloxamer and HPMC and a preparation method thereof (e.g., Abstract; Claim 13; Claims 16-20).
For Claims 1 and 5, Ryu specifies the bone graft composition comprising A) 30-55 wt% of calcium phosphate compound particles; and B) 45-70 wt% of a biodegradable hydrogel containing, based on 100 parts by weight of the hydrogel, 25-35 parts by weight of poloxamer and 0.5-2 parts by weight of hydroxypropyl methylcellulose (HPMC) (e.g., [0019-0021]; Claim 1; Claim 13) (corresponding to instant claim 5). Ryu discloses that calcium phosphate compound in the composition is tricalcium phosphate (TCP), monocalcium phosphate, tetracalcium phosphate, dicalcium phosphate, hydroxyapatite (HA), or a combination of two or more thereof ([0027-0028]; Claim 5) (corresponding to calcium phosphate compound particles and species in a combination of two or more, and biodegradable hydrogel in instant claim 1). Ryu teaches TCP particles are in the range of 45 to 75 um diameter (e.g., Claim 8; [0031-0032] )(overlapping with first population diameter range 45 um to 100 um in instant claim 1).
For Claim 4, Ryu teaches TCP particles have a porosity of 60% or higher [0032] (same as the range in instant claim 4).
For Claims 7-8 and 13-14, Ryu teaches that the bone graft composition may comprise physiologically active substance bone morphogenetic protein (e.g., Claim 11; [0041-0042]), including BMP-2, BMP-3, BMP-3b, BMP-4, BMP-5, BMP-6, BMP-7, BMP-8, BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, BMP-15, BMP-16, BMP-17, BMP-18, or a combination of two or more thereof (e.g., Claims 12 and 15).
For Claims 9-12 and 15, Ryu indicates that the resulted putty-type bone graft composition prepared can be placed in a syringe and injected into a desired position (e.g., [0070]; [0103], Fig. 4c-4f) for use in bone implantation [0074-0076], and it can be provided as a kit [0077] comprising the composition and an injection tool such as a syringe, a tube (e.g., Claim 17), or the like [0078-0079].
Ryu does not teach the composition comprising the amounts as more than 55 wt% up to 80 wt% of calcium phosphate compound particles with less than 45 wt% of biodegradable hydrogel while hydrogel is more than 20wt% as recited in instant claim 1, or the second population of calcium phosphate compound particles with diameter of 200 um to 6,000 um in instant claim 1. Ryu does not directly teach the hydrogel is a material having a non-crosslinked structure without a swelling property in the injectable bone graft composition as recited in instant claim 6.
Bohner throughout the reference teaches preparation of a pasty bone replacement material comprising biocompatible substance forming a hydrogel, and solid particles suitable as a bone replacement material (e.g., Abstract) which can be injectable (e.g., Pg. 7, middle; Pg. 1, bottom).
Bohner teaches the materials can be injected including hydraulic calcium phosphate cements consisting of one or several calcium phosphate, including dicalcium phosphate dihydrate, dicalcium phosphate, tricalcium phosphate, hydroxyapatite, and many others (e.g., Claims 38-39; pg.8, top) (corresponding to calcium phosphate materials in instant claim 1), in form of powders or spherical particles, and a low-viscosity hydrogel (e.g., Pg. 1, bottom paragraph), present as a mixture with hydrogel comprising swellable substance, e.g., gelatin (e.g., Claim 18; Pg. 3, bottom), hyaluronic acid (e.g., Claim 21; Pg. 4, top), hydroxypropylmethyl cellulose (Pg. 14, Example 3) (corresponding to hydrogel materials in instant claim 5). Bohner indicates that the porosity of the solid particles is between 60 -90%, preferably between 68 and 84% (e.g., Claim 34; Pg. 5, middle) (corresponding to instant claim 4).
Bohner indicates that the weight relationship between the hydrated hydrogel and the solid particles is preferably larger than 0.6 (e.g., Pg. 10, 4th paragraph), which results in many possible amount ranges, for instance, when the ratio is 0.6-0.7 and calcium phosphate is set at 60%, the corresponding hydrogel amount can be 37%-42%, overlapping with the weight amounts of calcium phosphate particles and hydrogel in instant claim 1. Bohner specifies that it is possible to mix the solid particles with two different size populations, e.g., particles with an average diameter between 125 and 250 micrometers and particles with an average diameter between 500 and 710 micrometers (e.g., Pg. 5, bottom) (corresponding to two particle size populations in instant claim 1, overlapping with second population diameter of 200 um to 6,000 micrometers).
Bohner teaches that the solid precursor should be sterile for surgical use, and sterilization approaches such as autoclaving (=steam sterilization) is done as the best possible technique due to the good homogeneity of the sterilization method, absence of toxicity, and the ability to retain the molecular integrity of the powder substance, indicating that the autoclaving is done in such a way that it does not lead to a molecular weight loss of the hydrogel greater than 70% (e.g., Pg. 9, bottom half), preferably the autoclaving does lead to a decrease of the molecular weight of said swellable substance of minimum 30% and of maximum 70% (e.g., Pg. 10, top half), suggesting that the swellable substance loses swelling property and subjects to have non-crosslinked structure, corresponding to instant claim 6.
Further regarding instant claim 6, since the hydrogel gel material taught by prior art constitutes the same ingredients in the bone grafting compositions, e.g., poloxamer, cellulose (as HPMC) in Ryu; gelatin, hyaluronic acid, and HPMC in Bohner, the non-crosslinked structure without swelling property is inherent property of the hydrogel, as MPEP 2112.01.II states "[p]roducts of identical chemical composition cannot have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable, as indicated in MPEP 2112.01.II. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id. (Applicant argued that the claimed composition was a pressure sensitive adhesive containing a tacky polymer while the product of the reference was hard and abrasion resistant. "The Board correctly found that the virtual identity of monomers and procedures sufficed to support a prima facie case of unpatentability of Spada' s polymer latexes for lack of novelty.").
It would have been prima facie obvious for one with ordinary skills in the art prior to effective filing date to incorporate calcium phosphate particles in two different diameter sizes from Bohner’s teaching into the composition taught by Ryu to arrive at current invention. Because Ryu using one size population of particles shows some difficulty to make the product injectable and the amounts of hydrogel requires to be linked to calcium phosphate compounds when tested with TCP from 70 wt%, 60 wt%, 50 wt%, 40 wt%, down to 30 wt% (e.g., Example 3, [0102]), artisans in the field would try to explore to optimize and solve the problem, while Bohner show injectable composition specifying that using different sizes of particles has the advantage that it guarantees the compactness of the bone replacement material; the interstitial pore volume (pore dead volume) which results from the use of large-grain material can thus be reduced to a minimum; it is also possible to affect the degradation period of the bone replacement material through the use of solid particles of various sizes such as smaller particles are resorbed faster than larger particles (e.g., Bohner, Pg. 5, bottom). It would have motivated artisans in the field to experiment different particles sizes as well as mixing two particle populations in different sizes, optimization would have provided reasonable expectation of success based on the teachings. This renders obviousness as “use of known technique to improve similar devices (methods, or products) in the same way” or as “applying a known technique to a known device (method, or product) ready for improvement to yield predictable results”. See MPEP §2143. (I)(C) and (I)(D).
Generally, differences in concentration or temperature will not support the patentability of subject matter encompassed by the prior art unless there is evidence indicating such concentration or temperature is critical. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). MPEP §2144.05(I) states that “A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.” See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003). For this instance, the calcium phosphate particle size ranges overlap with those taught in prior art, the porosity range appears to be the same as prior art, and the calcium phosphate compound and biodegradable hydrogel amounts all overlap with those taught by prior art. MPEP §2144.05 (II) states that “[i]t would have been prima facie obvious for one of ordinary skill in the art to optimize additive amount through nothing more than “routine experimentation,” because of a reasonable expectation of success resulting from the optimization for desirable features of intended use of the composition See Peterson, 315 F.3d at 1330, 65 USPQ2d at 1382; In re Hoeschele, 406 F.2d 1403, 160 USPQ 809 (CCPA 1969).
Response to Arguments
Applicant’s remarks/arguments filed on 01/30/2026 have been fully considered.
In light of claim amendment and applicant’s remarks, the office action has taken new ground of rejections as presented above, applicant’s traversal of previous rejections based upon “two populations” having different particle sizes and the calcium phosphate percentages in the composition have been responded above in the office action, combining new reference Bohner et al. (CA2642940 or WO2008077257, 07/03/2008) with Ryu, instead of Giorno and Schlossberg in previous office action. Please refer to the entire office action as a complete response to the arguments.
Conclusion
No claims are allowed.
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/DX.Z./ Examiner, Art Unit 1616
/SUE X LIU/ Supervisory Patent Examiner, Art Unit 1616
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