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 .
Status of Claims
This office action is responsive to the amendment filed on 12/10/2025. As directed by the amendment: claim 1 has been amended, no additional claims have been cancelled and no new claims have been added. Thus, claim 1 is the only presently pending claim in this application, and is examined in the Office Action.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the medical use honeycomb structure comprising a plurality of adjoining through-holes extending longitudinally (claim 1) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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.
Claim 1 is 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. Claim 1 sets forth the parameter of the medical use honeycomb structure comprises “a plurality of adjoining through-holes extending longitudinally in one direction” (emphasis added); however, this parameter was never disclosed in the originally filed disclosure. Specifically, the originally filed disclosure never mentions, suggests or illustrates a medical use honeycomb structure which has/comprises a plurality of “adjoining” longitudinally extending through-holes.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 1 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 1 sets forth the parameter of the medical use honeycomb structure comprises “a plurality of adjoining through-holes extending longitudinally in one direction” (emphasis added); however, this parameter is found to be confusing since it is not clear, structurally, what exactly is meant by the term “adjoining”. Specifically, how exactly are the through-holes adjoining, and/or what are the through-holes adjoining to/with, and/or where along the longitudinally extending through-holes are they adjoining; and the originally filed disclosure does not aid in clarify such a parameter, in fact it seems to be completely silent regarding such a parameter. Thus, one having ordinary skill in the art would not reasonably be apprised of the scope of the invention, thereby rendering the claim indefinite.
Examiner’s Notes
It is to be noted that in device/apparatus claims only the claimed structure of the final device bears patentable weight; intended use/functional language and/or method of manufacturing is considered to the extent that it further defines the claimed structure of the final device (see MPEP 2113 & 2114).
Examiner cites particular columns and line numbers in the references as applied to the claims below for the convenience of the applicant(s). Although the specified citations are representative of the teachings in the art and are applied to the specific limitations within the individual claim, other passages and figures may apply as well. It is respectfully requested that, in preparing responses, the applicant(s) fully consider the references in entirety as potentially teaching all or part of the claimed invention, as well as the context of the passage as taught by the prior art or disclosed by the examiner.
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Hakamatsuka et al. (US PG Pub. 2008/0099948), as disclosed in the IDS dated 03/16/2022, hereinafter Hakamatsuka, in view of Ishikawa et al. (US PG Pub. 2006/0225619), as previously disclosed, hereinafter Ishikawa.
Regarding claim 1, Hakamatsuka discloses a medical use honeycomb structure (10), illustrated in Figure 1, comprising a plurality of adjoining through-holes (11) extending longitudinally in one direction that is a longitudinal axis direction of the medical use honeycomb structure (10), wherein the adjoining through-holes (11) are polygonal hollow columns extending in the longitudinal axis direction, illustrated in Figures 1-2B ([0009]; [0012] & [0020]); but does not specifically disclose the medical use honeycomb structure substantially consisting of carbonate apatite. However, Hakamatsuka does state any material could be used as long as it has an affinity with biological tissue ([0041]).
However, Ishikawa teaches a carbonate apatite, obtained through dissolution-precipitation-type compositional conversion reaction, used in the same field of endeavor, i.e. bone substitute/repair material, having the properties of osteoconductivity, no histotoxicity, and mechanical strength appropriate for a bone prosthesis.
Thus, in view of the teachings of Ishikawa, it would have been obvious, and well within the capability of one having ordinary skill in the art before the effective filing date of the invention to determine an appropriate material for the medical use honeycomb structure, of Hakamatsuka, including containing carbonate apatite, obtained through dissolution-precipitation-type compositional conversion reaction, due to carbonate apatite having an affinity with biological tissue, specifically bone and the properties of osteoconductivity, no histotoxicity, and mechanical strength appropriate for a bone prosthesis; and it is to be noted that it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (MPEP 2144.07).
Response to Arguments
Applicant’s arguments with respect to claim 1 have been considered but are moot because the arguments do not apply to the current rejections presently used in the Office Action. Specifically, Applicant has amended independent claim 1 to recite, in part, that the plurality of through-holes extend longitudinally in a direction that is a longitudinal axis direction of the medical use honeycomb structure. In response to Applicant’s amendment, Examiner now cites the prior art of Hakamatsuka, in addition to the prior art of Ishikawa; rejecting independent claim 1 as being unpatentable over Hakamatsuka in view of Ishikawa.
Conclusion
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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/DINAH BARIA/Primary Examiner, Art Unit 3774 02/10/2026