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.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-9 and 11, in the reply filed on 6 February 2026 is acknowledged.
Claims 10 and 12-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 6 February 2026.
Information Disclosure Statement
The Information Disclosure Statement filed on 7 January 2026 has been received and considered by the Examiner.
Specification
The title of the invention is not descriptive. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: “Multi-phase Composition of Permanently Polarized Hydroxyapatite with Brushite and a Process for its Production”.
Claim Interpretation
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.
Claim Rejections - 35 USC § 112
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.
Claims 3-4 are 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.
Claims 3 and 4 are defined by reference to figures 1(a) and 1(b), respectively. However, it is unclear what specific features of the respective features are required for a material to meet the limitations of these claims. As such, the scope of the claims are indefinite.
Furthermore, incorporation by reference to a specific figure or table "is permitted only in exceptional circumstances where there is no practical way to define the invention in words and where it is more concise to incorporate by reference than duplicating a drawing or table into the claim. Incorporation by reference is a necessity doctrine, not for applicant’s convenience." Ex parte Fressola, 27 USPQ2d 1608, 1609 (Bd. Pat. App. & Inter. 1993). MPEP 2173.05(s). In the instant case it is recommended to list the features of the X-ray scattering pattern and of the Raman spectrum that are essential to defining the scope of the claims.
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 composition comprising a permanently polarized hydroxyapatite and brushite or a brushite-like material. 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, the performing the polarization of hydroxyapatite anywhere in ranges of temperature and distance 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 contain permanently polarized hydroxy apatite and brushite or a brushite-like material, as analyzed for claim 1.
Conclusion
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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