DETAILED ACTION
Receipt is acknowledged of applicant’s Preliminary Amendment filed 9/20/2024.
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 .
Information Disclosure Statement
The IDS filed 11/6/2024 has been considered. A signed copy is enclosed herewith.
Status of the Claims
Claims 1-9 have been amended. No claims were cancelled. Claims 10-13 are newly added. Accordingly, claims 1-13 remain pending in the application and are currently under examination.
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 12 and 13 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.
Regarding claims 12 and 13, the phrase "typically" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 8 recites, “for repairing damages to tooth dentin”. Claim 8 depends on claim 1. Claim 1 sets out a method for repairing and regenerating dentin”. Thus, claim 1 already sets out the limitations of claim 8 and, as such, does not further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1-13 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of copending Application No. 18/849347 in view of Yu et al. (“Biomineralization of Collagen-Based Materials for Hard Tissue Repair”, Int. J. Mol. Sci. 2021, 22(2), 944, pp. 1-17; hereafter as “Yu”).
The instant claims are drawn to a method for repairing and regenerating dentin comprising implanting or injecting or applying an effective amount to a site in which there is a need for a dentin repair an effective amount of a composition comprising: uncrosslinked and non-denatured collagen microparticles comprising more than 90% by weight of collagen; biomimetic hydroxyapatite or biomimetic hydroxyapatite precursors or amorphous calcium phosphate; and a physiologically compatible aqueous solvent.
The copending claims are drawn to a composition comprising: collagen microparticles comprising more than 90% by weight of collagen; biomimetic hydroxyapatite or biomimetic hydroxyapatite precursors or amorphous calcium phosphate; and a physiologically compatible aqueous solvent and a method for repairing and regenerating mineralized tissue, comprising injecting or implanting an effective amount of the composition of claim 1 in an individual in need of treatment thereof. The copending claims further recite, “non-denatured and uncrosslinked collagen”.
The copending claims do not explicitly recite, “a method for repairing or regenerating dentin”.
Yu teaches that hydroxyapatite reinforced collagen fibrils serve as the basic building blocks of natural bone and dentin (abstract). Yu teaches that mineralization of collagen fibrils play an essential role in ensuring the structural and mechanical functionalities of hard tissues such as bone and dentin (abstract). Yu teaches biomimetic collagen-hydroxyapatite-based materials provide a promising treatment for remineralization of dentin for tooth defect repair (page 2, 2nd paragraph). Yu also teaches that biomimetic mineralization of collagen becomes an essential strategy for developing bioinspired materials for both orthopedic and dental applications (page 2, 2nd paragraph).
Both the copending application and Yu are drawn to compositions comprising collagen and hydroxyapatite for the repair of mineralized tissue, thus, it would have been prima facie obvious to one or ordinary skill in the art before the effective filing date of the claimed invention to repair/regenerating dentin using the composition of the copending application with a reasonable expectation of success. A skilled artisan would have been motivated to do so because Yu teaches mineralized tissue including bone and dentin are made up of collagen and hydroxyapatite and compositions comprising such may be effective in both orthopedic and dental applications.
Thus, the claims of the instant application are unpatentable over the copending claims in view of Yu.
This is a provisional nonstatutory double patenting rejection.
Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Nassif et al. (US 2018/0071430 A1, Mar. 15, 2018, hereafter as “Nassif”) teaches a method of tissue repair (cartilage, intervertebral disc, joints) or wrinkle/dermal filler treatment comprising injecting/implanting a composition comprising a suspension of non-denatured uncrosslinked collagen particles (abstract; [0010], [0012] and [0075]-[0078]). Nassif does not teach a method for repairing or regenerating dentin nor does Nassif teach biomimetic hydroxyapatite or biomimetic hydroxyapatite precursors or amorphous calcium phosphate.
Rudin et al. (WO 2007/009477 A1, Jan. 25, 2007, hereafter as “Rudin”) teaches a composition comprising collagen and hydroxyapatite particles for bone implant, dental cement/filling material or wound healing applications (abstract; page 14, lines 23-25). Rudin is silent to uncrosslinked and non-denatured collagen microparticles comprising more than 90% by weight of collagen.
Conclusion
All claims have been rejected; no claims are allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CASEY HAGOPIAN whose telephone number is (571)272-6097. The examiner can normally be reached on M-F 9:00 am - 5:00 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sue Liu can be reached on 571-272-5539. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see https://ppair-my.uspto.gov/pair/PrivatePair. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/CASEY S HAGOPIAN/Examiner, Art Unit 1617
Prosecution Insights