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 .
Response to Arguments
Applicant’s arguments and amendments, see section I on page 17, filed 07/22/2026, with respect to the 35 U.S.C. 112(a) rejection of claims 37-41 have been fully considered and are persuasive. The rejection of 03/23/2026 has been withdrawn.
Applicant has amended claim to recite that the α-tricalcium phosphate is in “a powder form.” In response to Applicant’s amendment Examiner has added reference Engqvist (US Pub No.: 2012/0022023).
With respect to the arguments pertaining to the α-tricalcium phosphate, Engqvist (US Pub No.: 2012/0022023) is relied upon to teach the powdered α-tricalcium phosphate. Ishikawa is still relied upon to teach a vaterite as vaterite is disclosed in [0053], cited below, and in paragraphs [0067], [0226], [0313]. A “starting raw material” is not claimed in claim 37, as claim 37 only requires “a solid portion that contains vaterite and α-tricalcium phosphate.” As per the claim language of claim 37, the vaterite of Ishikawa will still read upon how the claim is worded. While Vaterite “is merely listed as an option for a composition of a product,” this is enough to read upon independent claim 37 that only requires that the solid portion of the kit “contains vaterite”
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a “starting raw material,” a formation of a “core portion,” or a limitation eliminating the presence of a macro form) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Incorporation of said details in the claims will overcome Ishikawa.
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.
Claim(s) 37, 39, and 40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa (US Pub No.: 2017/0252480) in view of Raddi (US Pub No.: 2020/0315923) and Engqvist (US Pub No.: 2012/0022023).
Regarding claim 37, Ishikawa (US Pub No.: 2017/0252480) discloses a bone defect reconstruction kit (inorganic compound in abstract used for bone reconstruction in [0007]-[0008]) comprising a solid portion that contains vaterite (a compound disclosed in vaterite in [0053]) and a-tricalcium phosphate (alpha type tricalcium phosphate disclosed in [0377]) and a liquid portion that contains phosphoric acid salt (calcium phosphoric acid in [0258], calcium phosphoric acid is a salt. Additionally, Calcium hydrogen phosphate, disclosed in [0347] is also considered a salt), wherein when the solid portion and liquid portion are mixed it becomes a paste, and the paste is set to form carbonate apatite (in [0347] and [0382], formation of a carbonate apatite in [0385] with known methods. Precipitation of carbonate apatite from vaterite in [0391]. Tricalcium phosphate for formation of Carbonate Apatite in [0384]-[0388], phosphoric acid for formation of carbonate apatite and [0249].
However, Ishikawa does not teach wherein when the solid portion and liquid portion are mixed it becomes a paste, and the paste is set to form carbonate apatite.
Instead, Raddi (US Pub No.: 2020/0315923) teaches wherein when the solid portion and liquid portion are mixed it becomes a paste (formation of a carbonate apatite in [0059]), and the paste is set to form carbonate apatite (carbonate apatite paste in [0059]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the paste material as presented in Raddi into Ishikawa for the purpose of providing a material with a “low crystallinity similar to bone” in [0059], with the paste being able to solidify when in contact with air as per [0167].
Ishikawa in view of Raddi also does not teach that the α-tricalcium phosphate is in powder form.
Instead, Engqvist teaches α-tricalcium phosphate is in powder form (in [0018] and [0037], a powder composition comprising alpha-tricalcium phosphate).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the powdered α-tricalcium phosphate for the purpose of providing a non-aqueous hydraulic cement composition (in the abstract), where a non-aqueous solution is quicker to prepare than an aqueous solution as per [0002] of Engqvist.
Regarding claim 39, Ishikawa in view of Raddi and Engqvist teach the bone defect reconstruction kit according to claim 37, wherein Ishikawa discloses the liquid portion (further details of an aqueous solution disclosed in [0546]-[0548]) contains at least one selected from, acid containing plural carboxy groups, hydrogen sulfite salt, cellulose derivative (celluloses, where carboxymethyl cellulose, hydroxymethyl cellulose, and hydroxyethyl cellulose are disclosed in [0547]), dextran sulfate salt (dextran in [0547]), chondroitin sulfate salt, alginic acid salt (alginic acid disclosed in [0547]), glucomannan.
Regarding claim 40, Ishikawa in view of Raddi and Engqvist teach the bone defect reconstruction kit according to claim 37, wherein Ishikawa discloses the volume of vaterite in the solid portion is 10-12 m3 or larger (in [0718 of Ishikawa]).
Claim(s) 38 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa (US Pub No.: 2017/0252480) in view of Raddi (US Pub No.: 2020/0315923) and Engqvist (US Pub No.: 2012/0022023) in further view of Kendall (US Patent No.: 8,691,175).
Regarding claim 38, Ishikawa in view of Raddi and Engqvist teach the bone defect reconstruction kit according to claim 37. However, Ishikawa does not teach wherein an amount of vaterite in the solid portion is 10 mass% or larger and 60 mass% or smaller.
Instead, Kendall (US Patent No.: 8,691,175) discloses a system to form solid products in the abstract and teaches wherein an amount of vaterite in the solid portion is 10 mass% or larger and 60 mass% or smaller (concentration of Vaterite in a composition between 50% weight and 99% weight in column 5 lines 42-59 and column 14 lines 54-67 to column 15 lines 1-4). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the vaterite composition of Kendall into the device taught by Ishikawa for the purpose of detailing a composition involving vaterite presented in Kendall is defined as having a high compressive strength as per column 14 lines 6-31. As the device of Ishikawa is an implantable device (in [0254]-[0255] of Ishikawa), a high compressive strength is required for the device of Ishikawa.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ishikawa (US Pub No.: 2017/0252480) in view of Raddi (US Pub No.: 2020/0315923) and Engqvist (US Pub No.: 2012/0022023) in further view of Hainsoff (US Pub No.: 2016/0221834).
Regarding claim 41, Ishikawa in view of Raddi and Engqvist teach the bone defect reconstruction kit according to claim 37. However, Ishikawa does not teach an instance wherein the vaterite's average diameter is 6 µm or smaller.
Instead, Hainsoff (US Pub No.: 2016/0221834) discloses a production of calcium carbonate in [0001] and teaches wherein the vaterite's average diameter is 6 µm or smaller (at the end of paragraph [0084] and in [0484]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the method of producing vaterite in the size disclosed in [0084] of Hainsoff into the device taught by Ishikawa in order to provide an “economically viable method to produce… calcium carbonate of high purity and yield” in [0002] as Hainsoff details a method of creating Vaterite particles that are used in regenerative medicine (in [0026] of Hainsoff), wherein the method of producing Vaterite in Hainsoff creates particles of a “controlled particle size” as per [0025], where said control allows for a complete conversion of gypsum to the calcium carbonate in [0098], wherein said calcium carbonate includes vaterite in [0026].
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Paynter (US Pub No.: 2017/0369329) discloses a vaterite concentration in [0159] and a use in bone regeneration in [0243]. Taira (US Pub No.: 2021/0023269) discloses a bone regeneration material in the abstract with material details in [0009].
THIS ACTION IS MADE FINAL. 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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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774
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