DETAILED ACTION
Status of the Application
Receipt is acknowledged of Applicants’ Amendments and Remarks, filed 13 November 2025, in the matter of Application N° 17/420,589. Said documents have been entered on the record. The Examiner further acknowledges the following:
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1, 3, 4, 6, 8-13, 15, 17, 18, 20, 23, 25, 28, 41, and 43-50 are pending, where claims 13, 15, 17, 18, 20, 23, 25, 28, 41, and 43 remain withdrawn from consideration.
No claims have been added or canceled.
Claims 1, 3, and 47 have been amended. All three claims have been amended to remove “about”. Claim 47 has been additionally amended to clarify that the composition is an implantable scaffold comprising a “scaffold structure” which consists of fluorapatite, fluorohydroxyapatite, or mixtures thereof, and optionally, a binder or initiator.
The amendments add no new matter.
Thus, claims 1, 3, 4, 6, 8-12, and 44-50 continue to represent all claims currently under consideration.
Information Disclosure Statement
No new Information Disclosure Statements (IDS) have been filed for consideration.
Withdrawn Rejections
Rejection under 35 USC 102
Applicants’ amendments to the claims are persuasive in overcoming the previously maintained anticipation rejection over Denry. Said rejection is withdrawn.
Rejection under 35 USC 103
Applicants’ remarks discussing the scope of the claimed scaffold of independent claim 47 have been fully considered and are persuasive in overcoming the limitations to the claim and those that depend therefrom. Said rejections are withdrawn only over claims 47-50.
Maintained Rejections
The following rejections are maintained from the previous Office Correspondence dated 13 August 2025 since the art that was previously cited continues to read on the amended and previously recited limitations.
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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. Applicants are 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, 3, 4, 6, 8-12, and 44 are rejected under 35 U.S.C. 103 as being unpatentable over Denry (WO 2011/031821 A1; of record), further in view of Li et al. (US Pre-Grant Publication Nº 2002/0187104 A1). [emphasis added to reflect claims removed from rejection]
The limitations of claims 1, 3, 4, 6, and 44 are discussed above. Claim 8 recites that the implantable scaffold further comprises one or more bone growth dopants. Claims 9-11 recite that said dopants are further defined as being such compounds as an autograft material such as demineralized bone matrix, and bone morphogenic protein-2 (BMP-2).
The limitations of Denry are discussed above. Of particular note, is that the bioactive and bioresorbable scaffold compositions practiced by Denry are used in producing dental and orthopedic implants, craniomaxillofacial applications, and spinal grafting, in order to promote bone in-growth and repair (e.g., oral surgery). See ¶[0037]. Such is considered to additionally teach the intended use limitations of claim 12.
Where the teachings of Denry are limited is with respect to the “dopant” limitations recited by claims 8-11. Denry does disclose producing a “doped” sintered scaffold implant that promotes osteogenic growth. However, the active agents that are relied upon to facilitate this are taken from the environment and stimulated by the doping of the scaffold material with niobium oxide (Ni2O5). The use of niobium oxide creates a highly crystallized and complex topography that enhances musculoskeletal engineering.
Deficiency towards the limitations of claim 8-11 are considered to be remedied by Li, who like Denry, teaches producing an implantable, bioresorbable scaffolding material.
The implantable scaffolding material of Li is taught as comprising an osteogenic protein as a first biologically active agent, and a calcium phosphate material as a carrier (see e.g., Abstract; claim 1). Osteogenic proteins are taught as being selected from such bone morphogenic proteins as BMP-2 (see e.g., claims 2 and 3). Additional materials disclosed as being included in the scaffolding matrix include collagen, keratins, and demineralized bone matrix (see e.g., claim 16). The calcium phosphate material is further defined as being selected from fluorapatite (see e.g., claim 5).
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing an implantable scaffolding such as that which is instantly claimed. The skilled artisan would have been motivated to modify the teachings of Denry, particularly since both references are directed to providing scaffolding structures that promote osteogenic growth. Denry as noted, produces a doped topography the helps stimulate musculoskeletal growth. Li on the other hand, produces a scaffolding material that contains the osteogenic material formulated within. A person of ordinary skill in the art would thus reasonably expect the resulting composition to produce definitive tissue growth upon placement in the desired location.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Claims 1, 3, 4, 6, 8-12, and 44-46 are rejected under 35 U.S.C. 103 as being unpatentable over Denry (WO 2011/031821 A1; of record) in view of Li et al. (US Pre-Grant Publication Nº 2002/0187104 A1; of record) and Van Dyke et al. (US Pre-Grant Publication Nº 2011/0217356 A1). [emphasis added to reflect claims removed from rejection]
The limitations of the amended invention are discussed above.
The limitations of Denry and Li are discussed above.
Of particular note, is that the bioactive and bioresorbable scaffold compositions practiced by Denry are used in producing dental and orthopedic implants, craniomaxillofacial applications, and spinal grafting, in order to promote bone in-growth and repair (e.g., oral surgery). See ¶[0037]. Such is considered to additionally teach the intended use limitations of claim 12.
Where the teachings of Denry are limited is with respect to the “dopant” limitations recited by claims 8-11. Denry does disclose producing a “doped” sintered scaffold implant that promotes osteogenic growth. However, the active agents that are relied upon to facilitate this are taken from the environment and stimulated by the doping of the scaffold material with niobium oxide (Ni2O5). The use of niobium oxide creates a highly crystallized and complex topography that enhances musculoskeletal engineering.
Deficiency towards the limitations of claim 8-11 are considered to be remedied by Li, who like Denry, teaches producing an implantable, bioresorbable scaffolding material.
The implantable scaffolding material of Li is taught as comprising an osteogenic protein as a first biologically active agent, and a calcium phosphate material as a carrier (see e.g., Abstract; claim 1). Osteogenic proteins are taught as being selected from such bone morphogenic proteins as BMP-2 (see e.g., claims 2 and 3). Additional materials disclosed as being included in the scaffolding matrix include collagen, keratins, and demineralized bone matrix (see e.g., claim 16). The calcium phosphate material is further defined as being selected from fluorapatite (see e.g., claim 5).
Denry is additionally deficient with respect to the newly added keratose hydrogel limitations of claims 45 and 46.
Li again bridges the gap in teaching, but only so far. Therein, Li additionally discloses that the composition will further comprise a supplemental material selected from such solid structures as films and gels (see e.g., claim 15). Paragraphs [0069]-[0072] provided added definition to the supplementary material, including in ¶[0071] that said material may applied as a coating to the calcium phosphate (e.g., fluorapatite) body, for example as a post-fabrication coating to retard resorption time or otherwise affect the bioceramic material properties. Applied as a coating composition, the person of ordinary skill in the art will also recognize that it may be used to control the release and/or resorption of the osteogenic protein contained therein.
Bioerodible polymers are disclosed that are suitable for forming the solid structures (e.g., films and gels), such as keratins. However, Li does not expressly disclose that such a keratin barrier may be composed of keratose.
Van Dyke remedies this final gap disclosing gel compositions that are used for the controlled release of a compound of interest, wherein the gel composition comprises a keratin composition such as keratose (see e.g., Abstract; claims 1-3).
Claim 9 discloses that the compound of interest to be released comprises a growth factor. Paragraph [0047] further defines growth factors as including, for instance, bone morphogenic protein-2 (BMP-2). See also Figures 3, 4, and 11.
Based on the combined teachings of the references, the Examiner submits that a person of ordinary skill in the art would have had a reasonable expectation of success at producing the instantly claimed composition.
Regarding the disclosure of Van Dyke, ¶[0017] discussing Figure 4, for instance, reports bioactivity data of released growth factor from keratin biomaterials, specifically disclosing BMP2 loaded with keratin gels and scaffold and implanted in a subject (i.e., rat femur).
What this is considered to convey to the person of ordinary skill is that it was known, ahead of the effective filing date of the instant invention, to not only coat fluorapatite scaffold implant structures with a controlled release gel composition, but also that it would be instrumental in controlling the release of such osteogenic compounds as BMP-2.
Denry provides the requisite disclosure for the fluorapatite scaffolding structure, while Li discloses adding osteogenic proteins such as BMP-2 to promote such growth on implementation. Li additionally discloses adding film/gel coating structure to the fluorapatite carrier, which the ordinarily skilled artisan will readily understand will be instrumental in controlling release of a compound of interest. Lastly, Van Dyke discloses that such gels are known to be formed using keratose.
Therefore, the invention as a whole would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, and absent a clear showing of evidence to the contrary.
Response to Arguments
Applicants’ arguments with regard to the rejection of claims 1, 3, 4, 6, 8-12, and 44-46 under 35 USC 103(a) as being unpatentable over the combined teachings of Denry et al. and Li et al., and further in view of Van Dyke et al. have been fully considered, but they are not persuasive.
Applicants’ remarks directed to the combined teachings of Denry and Li acknowledge that Li was relied upon for its disclosure of the recited dopants (e.g., BMP-2).
Applicants rely upon their remarks directed to the anticipation rejection in traversal of the obviousness rejection. To this end, the Examiner respectfully maintains that the amendments to claims 1 and 3 do not overcome the rejections.
Applicants also argue that the reference provides disclosure suggesting that heating the practiced compositions above the recited temperature range is detrimental to the crystallinity of the practiced fluorapatite nanocrystals and that such a warning would have signaled the ordinarily skilled artisan to not rely on the teachings of Denry. In support of their position, Applicants cite properties achieved by observing the recited product-by-process limitations of sintering at a temperature range above 1150ºC.
Having considered the remarks and evidence, the Examiner submits that the scope of the claimed composition is not commensurate with the evidence provided in the instant specification. Of note, is that the scope to the fluoridated apatite structure recited by claim 1 is “consisting essentially of.” The Examiner, as previously discussed continues to interpret the scope of this structure as “comprising” in view of Applicants’ failure to point those components that are excluded from the claimed composition.
The Examiner considers the evidence persuasive for the composition recited by claim 47 owing to the specificity of the scaffold structure as amended.
Applicants’ arguments, for the above reasons, are found unpersuasive. Said rejection is therefore maintained.
Nonstatutory 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 § 2146 et seq. 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 4, 6, 8, 12, 44, and 47 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3, 5, 6, 8, 9, 12, 19-22, 24, 25, 28, 33, 37, and 43 of copending Application No. 17/420,579 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because both the instant claims and that of the reference ‘579 application encompass an implant structure comprising fluoridated apatite whose structure exhibits a surface morphology and porosity consistent with having been sintered at about 950 °C or more.
The key difference between the instant claims and that of the reference application is that the latter more specifically uses fluoridated apatite as a coating component to the implantable scaffold. The instantly claimed scaffold is a more generically recited fluoridated apatite structure and does not claim it necessarily as the body or a coating overlaid on a body. Based on this disclosure in the copending application, the Examiner submits that were the ‘579 application available as prior art, it would readily anticipate the instantly claimed composition.
The limitations of instant claim 3 are read on directly by claim 5 of the reference application.
The limitations of instant claim 4 are read on directly by claims 6 and 7 of the reference application.
The limitations of instant claim 6 are read on directly by claims 8 and 9 of the reference application.
The limitations of instant claim 12 are read on directly by claims 2 and 3 of the reference application.
Lastly, the method of manufacturing limitations recited by claims 12, 19-22, 24, and 25, as well as the method of treating limitations of claims 28, 33, 37, and 42 of the reference ‘579 application, are considered to expressly disclose the composition recited by instant claims 1, 3, 4, 6, and 8.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicants’ filed response to the rejection of claims 1, 3, 4, 6, 8, 12, 44, and 47 on the grounds of nonstatutory double patenting over the copending teachings of 17/420,579 has been fully considered, but is not persuasive.
Applicants traverse the rejection on the ground that the filed amendments to the claims are sufficient in overcoming the rejection.
The Examiner has reconsidered the above rejection in view of amendments made to both the instant and copending applications and respectfully submits that the rejection is maintained for the reasons already of record.
Allowable Subject Matter
Claims 48-50 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
All claims under consideration remain rejected; no claims are allowed.
Conclusion
THIS ACTION IS MADE FINAL. Applicants are 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 extension fee 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.
Correspondence
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Jeffrey T. Palenik whose telephone number is (571) 270-1966. The Examiner can normally be reached on 9:30 am - 7:00 pm; M-F (EST).
If attempts to reach the Examiner by telephone are unsuccessful, the Examiner’s supervisor, Robert A. Wax can be reached on (571) 272-0623. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Jeffrey T. Palenik/
Primary Examiner, Art Unit 1615