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 .
Specification
The disclosure is objected to because of the following informalities: The continuation data listed in Paragraph 1 of the specification for Application No. 18/312,502, filed May 4, 2023, should be updated, as Application No. 18/312,502 is now U.S. Patent No. 11,925,401. Appropriate correction is required.
Claim Interpretation
Note: “stiff” in claims 1 and 20, and “high stiffness” in claim 11 will be interpreted as having a stiffness of 0.5 GPa to 15 GPa {see instant specification [0054; 0068]}.
Note: “reaction temperature is physiological condition” in claim 1 will be interpreted as at most 40 oC {see instant specification [0070; 00162]}.
Note: “low melting point” in claim 7 will be interpreted as having a melting point of at most 100 oC {see instant specification [0055]}.
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 5-6 and 11-20 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.
The term “short-chain” in claims 5, 11 and 20 is a relative term which renders the claim indefinite. The term “short” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear which chain length constitutes a short-chain cross-linker, therefore claims 5, 11 and 20 are indefinite. Accordingly, dependent claims 12-19 are indefinite.
The term “long-chain” in claims 5, 11 and 20 is a relative term which renders the claim indefinite. The term “long” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is unclear which chain length constitutes a long-chain cross-linker, therefore claims 5, 11 and 20 are indefinite. Accordingly, dependent claims 12-19 are indefinite.
Claim 6: it is unclear if activation by a free-radical initiator (ex. redox system without light) precludes the step b) of photopolymerization in claim 1. Therefore claim 6 is indefinite.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claim(s) 1-7 and 10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadatmanesh et al. (WO 2021/016508) in view of Rabiner et al. (US 2013/0023877).
Regarding claims 1-7 and 10: Saadatmanesh et al. (WO ‘508) discloses a method of treating bone fractures [abstract], wherein a small hole is drilled (ex. laparoscopically) into a bone. A carbon fiber sleeve is inserted into the hole, and a biocompatible resin is injected into the sleeve [pg. 6, ln. 4-14]. The resin containing crosslinkable (meth)acrylate monomers [pg. 12, ln. 2-12], PMMA [pg. 11, ln. 26-30] and a photoinitiator are photopolymerized in situ [pg. 12, ln. 2-12] at a temperature lower than body temperature (lower than 40 oC) [pg. 3, ln. 24-30]. Saadatmanesh et al. (WO ‘508) discloses addition of gold nanoparticles to the monomer mixture prior to polymerization [pg. 14, ln. 2-4]. Saadatmanesh et al. (WO ‘508) discloses removal of the polymerized implant and carbon sleeve from the medullary shaft of the bone [pg. 13, ln. 25-30], wherein RF waves (13.56 MHz - 50 GHz) are used to depolymerize the implant containing gold nanoparticles. The resulting depolymerized polymer containing gold nanoparticles is removed from the bone [pg. 13, ln. - pg. 14, ln. 8].
Saadatmanesh et al. (WO ‘508) does not disclose photopolymerizing using a diffusive light guide. However, Rabiner et al. (US ‘877) discloses a photodynamic bone stabilization system, wherein a catheter having a cooling medium, a pressurizing medium and a light-conducting fiber is used to initiate polymerization of monomers [abstract; 0005]. Saadatmanesh et al. (WO ‘508) and Rabiner et al. (US ‘877) are analogous art because they are concerned with a similar technical difficulty, namely in situ photopolymerization of monomers for bone repair. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined a catheter having a cooling medium, a pressurizing medium and a light-conducting fiber for initiating polymerization of monomers, as taught by Rabiner et al. (US ‘877) in the invention of Saadatmanesh et al. (WO ‘508), and would have been motivated to do so since Rabiner et al. (US ‘877) discloses the photodynamic bone stabilization system allows for the control/prevention of polymerization shrinkage without temperature rise [0042-0044].
“Products of identical chemical composition can not have mutually exclusive properties.” A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) [see MPEP 2112.01].
Claim(s) 8-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Saadatmanesh et al. (WO 2021/016508) in view of Rabiner et al. (US 2013/0023877) as applied to claim 8 above, and further in view of D’Agostino et al. (US 2017/0239396).
Regarding claims 8-9: Saadatmanesh et al. (WO ‘508) and Rabiner et al. (US ‘877) disclose the basic claimed method [as set forth above with respect to claim 1]; wherein Saadatmanesh et al. (WO ‘508) discloses crosslinkable (meth)acrylate monomers [pg. 12, ln. 2-12].
Saadatmanesh et al. (WO ‘508) does not disclose the specific (meth)acrylate monomer of instant claims 8-9. However, D’Agostino et al. (US ‘396) discloses resin injectable matrix materials for treating bone fractures [abstract; 0440; 0444], wherein the resin can contain a mixture of prepolymerized acrylic resins (ex. PMMMA) and monomers such as butyl acrylate and ethylene glycol dimethacrylate [0440]. Saadatmanesh et al. (WO ‘508) and D’Agostino et al. (US ‘396) are analogous art because they are concerned with a similar technical difficulty, namely injectable monomers for bone repair. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined butyl acrylate and ethylene glycol dimethacrylate as monomers, as taught by D’Agostino et al. (US ‘396) in the invention of Saadatmanesh et al. (WO ‘508), and would have been motivated to do so since D’Agostino et al. (US ‘396) discloses monomers such as butyl acrylate and ethylene glycol dimethacrylate for an injectable resin matrix material [0440; 0444].
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.
Claim 20 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,925,401. Although the claims at issue are not identical, they are not patentably distinct from each other because the claimed system of U.S. Patent No. 11,925,401 substantially overlaps in scope with the instant claimed system. While U.S. Patent No. 11,925,401 does not specifically claim: about 50-80% w/w or v/v of a resin solution; about 1-50% w/w or v/v of a comonomer; about 0.1-20% w/w or v/v of short-chain crosslinkers; about 0.1-40% w/w or v/v of long-chain crosslinkers; and about 0.1-5% w/w or v/v of a photoinitiator, in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists. 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); In re Geisler, 116 F.3d 1465, 1469-71, 43 USPQ2d 1362, 1365-66 (Fed. Cir. 1997) [See MPEP 2144.05].
Allowable Subject Matter
Claim 11 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
Claims 12-19 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: The combination of Saadatmanesh et al. (WO 2021/016508), Rabiner et al. (US 2013/0023877) and D’Agostino et al. (US 2017/0239396) does not disclose a method of repairing a bone fracture comprising a photocurable polymeric resin comprising about 50-80% w/w or v/v of a resin solution; about 1-50% w/w or v/v of a comonomer; about 0.1-20% w/w or v/v of short-chain crosslinkers; about 0.1-40% w/w or v/v of long-chain crosslinkers; and about 0.1-5% w/w or v/v of a photoinitiator with sufficient specificity. Such a reconstruction of the claims would be based on improper hindsight reasoning.
See attached form PTO-892.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL F PEPITONE whose telephone number is (571)270-3299. The examiner can normally be reached on 7:00 AM - 3:30 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Mark Eashoo can be reached on 571-272-1197. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEPITONE/Primary Examiner, Art Unit 1767
