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 .
Status of Claims
Claim amendment filed on 09/05/2025 is acknowledged.
Claim 1 is amended. Claim 3 is cancelled.
Claims 1-2 and 4-15 are pending and being examined on 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.
Withdrawn Rejections
Previous claim 3 rejection under 35 U.S.C. 112 is withdrawn because Applicant’s amendment has overcome the rejection.
New Rejections
The following are new rejections necessitated by Applicant’s amendments.
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 1-2 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 Giorno (US20130218291, 08/22/2013) and Schlossberg et al. (WO2017165612, 09/28/2017, PTO-892).
Ryu teaches a bone graft composition comprising a hydrogel with a combination of calcium phosphate compound particles and poloxamer and HPMC and a preparation method thereof (Abstract). 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) ([0019-0021]; Claim 1), and Ryu indicates that the resulted putty-type bone graft composition prepared can be placed in a syringe and injected into a desired position [0070] 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, or the like [0078-0079] (corresponding to instant claims 1, 5, 9-12, 15). 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 instant claim 2). Ryu teaches TCP particles are in the range of 45 to 75 um diameter [0031-0032] (overlapping with first population diameter range 45 um to 100 um in instant claim 1) and have a porosity of 60% or higher [0032] (same as the range in instant claim 4). Ryu teaches that the bone graft composition may comprise physiologically active substance bone morphogenetic protein [0041-0042] (corresponding to instant claims 7-8 and 13-14).
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. However, with the same ingredients of hydrogel in the composition taught by prior art, 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.").
Ryu does not teach the bone graft comprising a mixture of calcium phosphate compound particles with two populations having mean diameters i) 45 um to 100 um and ii) 200 um to 6,000 um as recited in instant claim 1.
Giorno teaches bone graft material made from preferred biocompatible and biodegradable copolymer particles such as poly(D,L-lactic-co-glycolic acid) or polylactic co-glycolic acid (PLGA), and many others [0011] with bioceramic particles (e.g., Abstract; [0020]) and the bone graft material can be mixed with another hydrogel to form a paste (e.g., [0098]. Giorno indicates the invention also works with polymers of diameters from 50-400 um and with bioceramic particles having diameters of 150-1000 um (overlapping with the diameter ranges of the two populations of particles in instant claim 1) and optional salt particles having diameters from 50-300 um [0073]. Giorno teaches that the most preferred range of bioceramic particles is between about 150 μm to about 400 μm. The size of the particles depends in part on the rate of in vivo absorption. HA (hydroxyapatite) is known to absorb very slowly, whereas TCP and calcium sulfate are known to be absorbed faster. If HA is used alone, smaller particles are preferred, but when faster absorbing materials are used, larger particles are preferred [0083]. Therefore, Giorno suggests that mixtures of different sizes of calcium phosphate as well as mixed types of calcium phosphate compounds can become desirable based upon different absorbing speed in bone graft needs. Giorno further states that those of skill in the art are familiar with the use of bone graft materials and the teaching can be used in the same manner as any other bone graft material [0098].
Schlossberg teaches controlled production of spherical calcium phosphate, magnesium phosphate and strontium phosphate particles as bone graft substitutes in dental and orthopedic fields (e.g., Abstract; [0002]), wherein calcium phosphate can be TCP, TTCP, and others [0011]. Schlossberg discloses the substantially spherical particles resulting from dual asymmetric centrifugation may include substantially spherical particles ranging in size of 1000-2000 um, 500-1000 um, 250-500 um, 25-250 um, and <=25 um (conversion 1 mm = 1000 um) [0056]. Schlossberg also teaches the method of preparing a moldable material comprising substantially spherical calcium phosphate particles as a heterogeneous mixture having particles size ranging from about 25 um to about 2000 um (e.g., Claim 38).
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 different diameter sizes based on combined teachings of Giorno and Schlossberg into the composition taught by Ryu to arrive at current invention. Because Giorno uses at least two populations of particles with different sizes, and suggests that mixtures of different sizes as well as different types of calcium phosphate compounds can be advantageous and desirable for different absorbing speeds in vivo of the bone graft, and states that the teaching can be used in the same manner as any other bone graft material for those of skill in the art familiar with the use of bone graft materials [0098], in addition to Giorno’s teaching, Schlossberg teaches the method to prepare different sizes of calcium phosphate particles and implement heterogenous mixture of particles with different sizes in the composition, these teachings would have motivated scientists in the field to experiment different particles sizes as well as mixing two particle populations in different sizes because 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, and the porosity range appears to be the same as prior art. The calcium phosphate compound and biodegradable hydrogel amounts are different from 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 arguments regarding rejections under 35 U.S.C. 103 filed on 09/05/2025 have been fully considered but are moot because of the new ground of rejections presented above in this office action. Please refer to the entire office action presented above as complete response to the arguments.
Conclusion
No claim is allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/DX.Z./Examiner, Art Unit 1616
/ERIN E HIRT/Primary Examiner, Art Unit 1616
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