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 .
Priority
Priority to foreign application JP2022-065131 filed 04/11/2022 is acknowledged. Further, it is acknowledged that present application is a 371 of international PCT/JP2023/014061 filed 04/05/2023.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 10/08/2024 and 07/13/2026 are acknowledged. The information disclosure statement filed 10/08/2024 fails to comply with 37 CFR 1.98(a)(3)(i) because it does not include a concise explanation of the relevance, as it is presently understood by the individual designated in 37 CFR 1.56(c) most knowledgeable about the content of the information, of each reference listed that is not in the English language. It has been placed in the application file, but the information referred to therein has not been considered.
Elections/Restrictions
Applicant’s election of species A in the reply filed on 07/13/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Further, the written response to the restriction requirement was incomplete because a species was not elected for each group A, B, C, and D. During a telephone conversation with Peter M. Jay on 08/10/2026, an election was made for group A to prosecute the methods of claim 7 and 10, for group B applicant selected calcium hydrogen phosphate dihydrate, for group C disodium hydrogen phosphate, and for group D for ammonium alginate. Affirmation of this election must be made by applicant in replying to this Office Action. Claims 8, 9, 11-16, and 20 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
Claims 7, 10, and 17-19 are pending and under current examination.
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.
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.
Claim(s) 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa (JP H07289627 A; see machine translation retrieved on 08/11/2026) in view of Chin (JP 2002143291 A; see machine translation retrieved on 08/12/2026)
Regarding claim 7, Ishikawa teaches a hardening composition that is used in medical care (see abstract). Ishikawa teaches that calcium phosphates (i.e. octacalcium phosphate, see claim 2) have excellent biocompatibility, but do not have shape imparting properties, so attempts have been made to mix the calcium phosphates with polymers (para. [0003]). The composition of Ishikawa comprises a calcium component in the powder part, that is combined with a kneading liquid that comprises alginic acid (i.e. biocompatible polymer, para. [0024]). Ishikawa teaches that the source of calcium ions can be from calcium hydrogen phosphate dihydrate (para. [0008]), and that the kneaded product (i.e. mixed slime) is filled in a bone defect (para. [0025]) or molding (para. [0055]).
Ishikawa further describes that the composition can comprise phosphate ions in the kneading liquid, disclosing a composition where calcium hydrogen phosphate is reacted with a disodium hydrogen phosphate solution (see Example 8, para. [0066]). Ishikawa describes that the calcium ions react with the phosphate ions to form apatite (para. [0027]), which is stable and the crystals of the apatite are entangled with each other to be cured (para. [0021]).
Ishikawa does not teach with sufficient specificity to anticipate and so the claims are obvious. It would be obvious to one with ordinary skill in the art before the effective filing date to rearrange the teachings of Ishikawa with a reasonable expectation of success to obtain the composition of the instant claims.
A reference is analyzed using its broadest teachings. MPEP 2123 [R-5]. “[W]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious”. KSR v. Teleflex, 127 S,Ct. 1727, 1740 (2007)(quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious”, the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR v. Teleflex, 127 S.Ct. 1727, 1741 (2007). The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742. A person of ordinary skill in the art who is not an automaton is capable of producing the method of the instant claims with predictable results.
Claim(s) 10 and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa (JP H07289627 A) in view of Chin (JP 2002143291 A; see machine translation retrieved on 08/12/2026).
Ishikawa teaches the claimed invention as above, and further teaches that after the product is mixed it is placed in a mold (para. [0055]). However, Ishikawa fails to teach that the mixed and molded product is freeze-dried.
Regarding claim 10, Chin teaches a composite that has good biocompatibility and strength, and can be used to regenerate a bone (see abstract). Chin describes a method of producing a porous composite with atelocollagen (i.e. biocompatible polymer) and hydroxyapatite (i.e. calcium phosphate) that is frozen and freeze-dried (para. [0024]). Following the freeze-drying of the structure, the composite of Chin is immersed in a disodium hydrogen phosphate solution, which exposes the calcium ions to phosphate ions, allowing for the formation of hydroxyapatite to form on the surface of the structure (para. [0022]).
Ishikawa and Chin are considered to be analogous to the claimed invention because they are in the same field of compositions with calcium phosphates that are used in bone regeneration. It would have been obvious to one of ordinary skill in the art at the time of the effective filing date to combine the composition of Ishikawa with the freeze-drying method of formulation taught in Chin, because Chin teaches a method of forming a composite with calcium ions and a biocompatible polymer, that has good biocompatibility, strength, and is effective in bone regeneration. The person of ordinary skill in the art would have a reasonable expectation of success in incorporating the method of Chin with the formulation of Ishikawa, since both formulations have the same components and are used in bone regeneration purposes. See MPEP § 2143(I)(a).
Regarding claim 17 and 18, as above, Ishikawa teaches that the source of calcium ions in the composition can be from calcium hydrogen phosphate dihydrate (para. [0008]). Further, Ishikawa teaches that the calcium ions react with phosphate ions from disodium hydrogen phosphate solution (see Example 8, para. [0066]).
Regarding claim 19, Ishikawa describes that the alginic acid (i.e. biocompatible polymer) can be ammonium alginate (para. [0007]).
Conclusion
Claims 7, 10, and 17-19 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Makenna Miller whose telephone number is (571)272-9852. The examiner can normally be reached Mon-Fri 7:30-5:00 EST.
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/BETHANY P BARHAM/Supervisory Patent Examiner, Art Unit 1611
/M.R.M./Examiner, Art Unit 1611
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