Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined pursuant to the first inventor to file provisions of the AIA .
DETAILED ACTION
Request for Continued Examination
A Request for Continued Examination pursuant to 37 CFR § 1.114, including the fee set forth in 37 CFR § 1.17(e), was filed in this application after final rejection. Because this application is eligible for continued examination pursuant to 37 CFR § 1.114, and Applicants have timely paid the fee set forth in 37 CFR § 1.17(e), the finality of the previous Office Action has been withdrawn pursuant to 37 CFR § 1.114. Applicant's submission filed on 14 January 2026 has been entered.
Status of the Claims
Applicants filed claims 1 – 8, 10 – 13, and 15 - 27 with the instant application according to 37 CFR § 1.114, on 14 January 2025. In an Amendment entered with the Request for Continued Examination, Applicants amended claims 1 and 13, and added new claim 28. Claims 13 and 15 – 25 remain withdrawn as being directed to a non-elected invention. Consequently, claims 1 - 8, 10 – 12, and 26 - 28 are available for active consideration.
REJECTIONS WITHDRAWN
Rejections Pursuant to 35 U.S.C. § 103
The obviousness rejections set forth in the Action of 16 September 2025 are hereby withdrawn in light of Applicants’ amendment of the claims.
NEW GROUNDS OF REJECTION
Rejections Pursuant to 35 U.S.C. § 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 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.
Claims 1 and 28, and claims 2 – 8, 10 – 12, 26, and 27, dependent therefrom, are rejected pursuant to 35 U.S.C. § 112(a) as failing to comply with the written description requirement. The claims contain subject matter that was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventors, at the time the application was filed, had possession of the claimed invention.
In an amendment filed with the Request for Continued Examination, Applicants amended claim 1, and added new claim 28, which claims recite limitations directed to the bone regeneration material of the invention “consisting of” a solid phase of hydroxyapatite. The transitional phrase, “consisting of,” excludes any element, step, or ingredient not specified in the claim. In re Gray, 53 F.2d 520, 11 USPQ 255 (CCPA 1931); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("consisting of" defined as "closing the claim to the inclusion of materials other than those recited except for impurities ordinarily associated therewith"). In addition, a claim that depends from a claim that “consists of” the recited elements or steps cannot add an element or step. See MPEP § 2111.03 II.
Although Applicants provided references to the specification for support for other amendments to claims 1 and 28, Applicants’ Response filed 14 January 2026 did not point to any specific disclosure to support the restrictive “consisting of” transitional phrase. Although the PTO has the initial burden of presenting evidence or reasons why persons skilled in the art would not recognize in the disclosure a description of the invention defined by the claims, when filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP §§ 714.02, 2163.06 (“Applicant should therefore specifically point out the support for any amendments made to the disclosure.”).
In this context, it is the Examiner’s position that one of ordinary skill in the relevant art, upon review of Applicants’ specification, would recognize that the invention disclosed therein is not limited to bone regeneration material that only contains a solid phase of hydroxyapatite of natural origin.
More specifically, Applicants’ specification provides multiple disclosures of the use of the broader “comprising,” and “consisting essentially of” transitional phrases. For example, at p. 1, ll. 19 – 20, the specification states: “[t]he present invention relates to a bone regeneration material comprising a first solid phase of hydroxyapatite of natural origin;” see also, p. 7, ll. 18 – 19 (“it [the bone regeneration material] according to the invention being characterised in that it further comprises a second solid synthetic phase of calcium phosphate intended to enrich said first phase); p. 10, ll. 18 – 19 (“the bone regeneration material according to the invention being characterised in that it further comprises at least one therapeutic agent”); see also, p. 1, ll. 25 – 27 (“a method for reparation of a bone defect in a patient, comprising the use of the bone regeneration material consisting essentially of natural hydroxyapatite from natural origin); p. 20, ll. 7 – 8 (“[a] bone regeneration material has been obtained according to the present invention and consisting essentially of a hydroxyapatite solid phase”).
The Examiner further notes that Example 3 discloses a bone regeneration material obtained from bovine bones that is treated to remove organic content, subjected to sieving, sintered at 820° C for 45 – 60 minutes, and then “rinsed and/or enriched in calcium and phosphate by distinct immersion steps (see p. 21, ll. 19 – 20). With respect to this last step, the specification, at p. 17, ll. 9 – 14, teaches that “[t]he materials comprising a first solid phase of hydroxyapatite of natural origin and a second synthetic solid phase of calcium phosphate have been obtained by successive and alternate soakings for a duration of 5 minutes of the first solid phase of hydroxyapatite of natural origin (hydroxyapatite particles) in separate baths of Ca(NO3)2·4 H2O (1M, pH=10) and of NaH2PO4·H2O (0.5M, pH=10). The first bath makes it possible to enrich the hydroxyapatite calcium (Ca2+) particles of natural origin, the second phosphorus (PO43-) bath.” Thus, based on this specific teaching, Example 3 is read to disclose the preparation of bone regeneration material comprising a first solid phase of hydroxyapatite of natural origin, and a second synthetic phase of calcium phosphate, the second phase arising from immersing the first phase in the separate baths.
Consequently, Applicants’ specification fails to provide adequate written support for the currently claimed combination. Instant claims 1 – 8, 10 – 12, and 26 - 28 now recite limitations, which were not clearly disclosed in the specification as filed, and now change the scope of the instant disclosure as filed. Such limitations recited in the amended claims, which did not appear in the specification, as filed, introduce new concepts and violate the description requirement of the first paragraph of 35 U.S.C § 112. Applicants are required to provide sufficient written support for the limitations recited in the present claims in the specification or claims, as-filed, or remove these limitations from the claims in response to this Office Action.
Claims 7, 8, 10 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
Claims 7 and 10, dependent from claim 1, recite limitations directed to a bone regeneration material “being enriched by a second solid phase” (claim 7), and “further comprising at least one therapeutic agent.”
These claims are indefinite because one of ordinary skill in the art would be uncertain as to how a material “consisting of” a solid phase of hydroxyapatite could further comprise a second solid phase, or a therapeutic agent.
Claim 8, dependent from claim recites a limitation directed to “the first phase of hydroxyapatite.”
There is insufficient antecedent basis for this limitation in the claim.
Appropriate correction or cancellation of the claims is required.
Obviousness-Type Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP §§ 706.02(l)(1) - 706.02(l)(3) for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 3, 10, 27, and 28 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 5 of co-pending Application No. 19/287,889 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 3, and 5 of the ‘889 application are directed to a bone regeneration material comprising a first solid phase of hydroxyapatite of natural origin which is macroporous having pores of diameters greater than or equal to 50 µm, preferably pores of diameters of between 50 and 100 µm, said bone regeneration material being characterised in that it further comprises a second synthetic solid phase of calcium phosphate intended to enrich said first phase, wherein the first solid phase of hydroxyapatite of natural origin has a specific surface area of greater than 4 m2/g, wherein the first phase of hydroxyapatite of natural origin
is hydroxyapatite obtained from a bone material of natural origin, in particular from a bone material of animal origin, and wherein the material further comprises at least one therapeutic agent.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
NO CLAIM IS ALLOWED.
CONCLUSION
Any inquiry concerning this communication or any other communications from the examiner should be directed to Daniel F. Coughlin whose telephone number is (571)270-3748. The examiner can normally be reached on M-F 8:30 am - 5:30 pm.
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, David J Blanchard, can be reached on (571)272-0827. The fax phone number for the organization where this application or proceeding is assigned is (571)273-8300.
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/DANIEL F COUGHLIN/
Examiner, Art Unit 1619
/DAVID J BLANCHARD/ Supervisory Patent Examiner, Art Unit 1619