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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 02/06/2026 has been entered.
Response to Arguments
Applicant's arguments filed 06/13/2025 have been fully considered but they are not persuasive. With respect to the applicants arguments on pages 17-21, it is stated that Ishikawa does not disclose using a vaterite and tricalcium phosphate to create a carbonate apatite. In response, examiner modified the rejection in view of Ishikawa below. As per Ishikawa, there is a formation of carbonate apatite in in [0347] and [0382]. Additionally, formation of formation of a carbonate apatite is disclosed within paragraph [0384] “by a known method.” Said known methods include a precipitation of carbonate apatite from vaterite in [0391], using tricalcium phosphate for formation of carbonate apatite in [0384]-[0390], and using a phosphoric acid for formation of carbonate apatite and [0249] and [0377]. Additionally, claim 57 states that one or more of these materials may be used for a bone reconstruction. As such, it is argued that using tricalcium phosphate and vaterite to create a carbonate apatite is present in Ishikawa and known in the art as Ishikawa does teach the use of both materials in the creation of a carbonate apatite. Raddi (US Pub No.: 2020/315923) was also relied upon to teach a carbonate apatite paste.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 37-41 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 37-41 are rejected as, in claim 37 line 4, it is stated “wherein when the solid and liquid portion are mixed it becomes a paster….” As a “paster” is not present in the specification, the “paster” is assumed to be a “paste.” Correction to “wherein when the solid and liquid portion are mixed, it becomes a paste…” will overcome this rejection.
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).
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 paster, 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 paster, 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 paster (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].
Regarding claim 39, Ishikawa in view of Raddi 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 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) in further view of Kendall (US Patent No.: 8,691,175).
Regarding claim 38, Ishikawa in view of Raddi 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) in further view of Hainsoff (US Pub No.: 2016/0221834).
Regarding claim 41, Ishikawa in view of Raddi 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].
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/AREN PATEL/Examiner, Art Unit 3774
/YASHITA SHARMA/Primary Patent Examiner, Art Unit 3774