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 .
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.
Amendments
Applicant’s amendments to the claims and the title filed on 8 July 2026 have been entered and considered for this action. The previous objection to the title of the invention is withdrawn. The prior rejections of claims 3 and 4 under 35 USC § 112(b) are withdrawn.
Claim Interpretation
As previously set forth, the term “brushite-like” is interpreted according to the definition provided in lines 17-20 of page 4 of the specification: a calcium phosphate material that presents in the Raman spectrum peaks at 878, 848, and 794 cm-1.
It is noted that claim 3 recites specific values of 2-theta at which the brushite of claim 1 displays wide angle x-ray scattering peaks. While it is recognized that the values of 2-theta at which x-ray scattering is observed will depend on the frequency (wavelength) of x-rays being scattered, neither the claim itself nor the specification reveal what frequency or wavelength of x-ray is used to obtain these scattering angles. Therefore, the claim will be given its broadest reasonable interpretation, which is that the recited features are observed using any wavelength or frequency of x-ray irradiation.
Response to Arguments
Applicant's arguments filed 8 July 2026 with respect to independent claim 1 have been fully considered but they are not persuasive.
Applicant argues on pages 9 and 10 that Yamashita teaches away from the conditions that would necessarily yield a multi-phase material comprised of permanently polarized apatite and brushite and/or a brushite like material. In particular, Applicant argues that statements within paragraph [014] of Yamashita “constitute an explicit teaching away.” However, disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971).
Yamashita is explicit that temperatures up “to about 1000 °C” may be used in their method ([0013]), and Yamashita further teaches that “when it is desired to perform the polarization treatment in a short time, it is preferable to use a higher treatment temperature” ([0014]). The fact that Yamashita then describes that the “the temperature is generally preferably 500 °C or less, and more preferably 400 °C or less” is a merely a statement of preferred embodiments that does not constitute a teaching away from the broader range disclosed by Yamashita.
Applicant further argues that Yamashita also teaches away from a multi-phase composition because such compositions are incompatible with Yamashita’s desired applications in structural biomedical implants. However, no evidence within Yamashita is cited as supporting this assertion. Furthermore, other teachings in the prior art suggest that multi-phase compositions comprised of brushite and hydroxyapatite are actually beneficial for teeth and bones tissue regeneration (Sarkar et al. J. Biomater. Appl. 2016, 30(6), 823-837; cited in the PTO-892 and Office action mailed 9 December 2025). Therefore, the production of a multi-phase composition containing brushite and polarized hydroxy apatite cannot be considered as antithetical to the stated purpose of Yamashita.
Applicant's arguments with respect to dependent claims 2-9 and 11, page 11 of the reply, have been fully considered but they are also not persuasive.
Applicant’s first argument is premised on the alleged shortcomings of Yamashita, which is unpersuasive for the same reasons as analyzed above for claim 1.
Applicant further argues unexpected results achieved when the composition of claim 1 is utilized as a multi-phase catalyst to support the allowability of claim 2. However, claim 2 is drawn to the same composition as claim 1, and only further requires that it be capable of acting as a catalyst. While it might be argued that Yamashita alone does not render a process in which the material is used as a catalyst obvious, such a process is not under examination at this time.
Furthermore, it is noted that the claims cover a wide range of compositions, but comparative catalytic data is provided for what appears to be only one multi-phase composition (C-2). Therefore, any argument for unexpected catalytic behavior would not be commensurate in scope with the range of compositions covered by the claim. See MPEP 716.02(d).
Applicant’s request for an acknowledgement that the IDS filed 26 June 2023 and 26 September 2025 is noted. These IDS documents were acknowledged in the restriction requirement mailed 9 December 2025, but copies of the considered forms were mistakenly not attached at that time. Applicant is thanked for recognizing the oversight, which is corrected herein.
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.
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 1-9 and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Yamashita et al. (JP 2009279259 A; Foreign patent document #1 on the IDS filed 7 January 2026). The English machine translation provided by Applicant with the IDS filing is referenced in the analysis below.
Regarding claim 1, Yamashita teaches a process wherein hydroxyapatite ([0028]) is polarized by heating to 400°C in a DC electric field of 5 kV/cm for 1 hour between platinum electrodes with a gap of 1 mm between the positive electrode and the hydroxyapatite material ([0054]-[0055]). Yamashita further teaches that the temperature at which the polarization is performed can be anywhere in the range of 20 °C to 1000 °C ([0013]) and that the distance between the electrode ad the ceramic material can be in the range of 0.1 mm to 5 cm ([0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to perform the polarization treatment at a temperature in the range of 900 °C to 1000 °C with a distance from the hydroxyapatite to the positive electrode of 4 cm, as performed in the methods of the instantly disclosed invention (p. 24-25 of the specification), which would generate a multi-phase composition comprising a permanently polarized hydroxyapatite phase and brushite or a brushite-like phase. One of ordinary skill in the art would have been motivated to do so because Yamashita teaches that these temperatures can be used successfully.
It is noted that the courts have stated where the claimed ranges “overlap or lie inside the ranges disclosed by the prior art” a prima facie case of obviousness exists (see In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990); Titanium Metals Corp. of America v. Banner, 778 F2d 775. 227 USPQ 773 (Fed. Cir. 1985) (see MPEP 2144.05.01). Therefore, performing the polarization of hydroxyapatite anywhere in ranges of temperature and distances to the electrodes taught by Yamashita is an obvious variant of the specific embodiment recited in Yamashita’s Example A1.
Regarding claims 2-9, Yamashita teaches a method that is substantially identical to the method used to synthesize the composition of the instant invention, and therefore would yield compositions with substantially identical properties, including those characteristics that define the instant claims.
Once a reference teaching product appearing to be substantially identical is made the basis of a rejection, and the examiner presents evidence or reasoning to show inherency, the burden of production shifts to the applicant. "[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of [their] claimed product. Whether the rejection is based on inherency’ under 35 U.S.C. 102, on prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same, and its fairness is evidenced by the PTO’s inability to manufacture products or to obtain and compare prior art products." In re Best, 562 F.2d 1252, 1255, 195 USPQ 4380, 483-34 (CCPA 1977)), see MPEP 2112. Applicant has not clearly shown an unobvious difference between the instant invention and the prior art’s product.
Regarding claim 11, Yamashita teaches a composition obtained by a process comprising the steps of (a) providing a sample of hydroxyapatite and/or amorphous calcium phosphate ([0028] and [0051]); (b) sintering the sample of hydroxyapatite and/or amorphous calcium phosphate provided in step (a) (obtained powder was uniaxially compressed and then sintered ; [0052]); (c) applying an electric field of 5 kV/cm to the sample of hydroxyapatite or amorphous calcium phosphate obtained in step (b) (a DC electric field (electric field gradient) of 5 kV/cm was applied; [0055]); (d) cooling the sample of hydroxyapatite and/or calcium phosphate obtained in step (c) (the sample was cooled to room temperature; [0055]); wherein for performing step (c) the sample of hydroxyapatite and/or amorphous calcium phosphate obtained in step (b) is arranged between a positive electrode and a negative electrode that are used for applying the electric field during step (c), such that the sample of hydroxyapatite and/or amorphous calcium phosphate obtained in step (b) is spaced from the positive electrode (bulk sample is in contact with only one platinum electrode, while the other platinum electrode is not in contact with the bulk sample; [0054] and Fig. 3) . Because the method detailed by Yamashita is substantially identical to the method of the instant invention, it will also yield a multi-phase compositions that contains a permanently polarized hydroxyapatite phase and brushite or a brushite-like phase, as analyzed for claim 1.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Nicholas A Piro whose telephone number is (571)272-6344. The examiner can normally be reached Mon-Fri, 8:00 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sally Merkling can be reached at (571) 272-6297. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICHOLAS A. PIRO/Assistant Examiner, Art Unit 1738
/PAUL A WARTALOWICZ/Primary Examiner, Art Unit 1735
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