DETAILED ACTION
Pending Claims
Claims 1-12 are pending.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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 .
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 Rejections - 35 USC § 112, 2nd paragraph (b)
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 5-8, 11, and 12 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 claim 5, claim 5 recites the limitation "the filler (D)" in the adhesive composition of claim 1. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 6, claim 6 recites the limitation "the filler (D)" in the adhesive composition of claim 2. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 7, claim 7 recites the limitation "the filler (D)" in the adhesive composition of claim 3. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 11, claim 11 recites the limitation "the filler (D)" in the adhesive composition of 9. There is insufficient antecedent basis for this limitation in the claim.
For the purpose of the prior art search, claims 5-7 and 11 have been interpreted as: (5-7 & 11) a kit for hard tissue repair comprising the adhesive composition for hard tissue repair, wherein:
the polymerizable monomer (A) and part of the polymer powder (B) comprised in the composition for hard tissue repair are placed in the same member,
the polymerization initiator (C) is placed in one member,
the remaining part of the polymer powder (B) is placed in one member, and
the three members above form the kit for repair.
Regarding claims 8 and 12, the composition of claim 4 and the composition of claim 10 both include a filler (D). Claim 8 is drawn to a kit for the composition of claim 4, and claim 12 is drawn to a kit for the composition of claim 10. The kit limitations present three alternative embodiments where: the first embodiment specifies components (A) through (C); the second embodiment specifies components (A) through (D); and the third embodiment specifies components (A) through (D). It is unclear how the first kit embodiment accounts for component (D).
For the purposes of the prior art search, claims 8 and 12 have been interpreted as: (8 & 12) a kit for hard tissue repair comprising the adhesive composition for hard tissue repair wherein:
the polymerizable monomer (A) and the filler (D) are placed in one member,
the polymer powder (B) is placed in one member,
the polymerization initiator (C) is placed in one member, and
the three members above form the kit for repair;
alternatively:
the polymerizable monomer (A) is placed in one member,
the polymerization initiator (C) is placed in one member,
the polymer powder (B) and the filler (D) are placed in one member, and
the three members above forms the kit for repair.
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.
Claims 1-12 are rejected under 35 U.S.C. 103 as being unpatentable over Goto et al. (WO 2018/181821 A1 or US 2020/0030484 A1). All citations are directed to the equivalent US publication.
Regarding claims 1-3 and 9, Goto et al. disclose: (1) an adhesive composition for hard tissue repair (Abstract; paragraphs 0008-0010), comprising:
a polymerizable monomer (A) (paragraphs 0019-0034),
a polymer powder (B) (paragraphs 0035-0045), and
a polymerization initiator (C) (paragraphs 0046-0072),
wherein the polymerization initiator (C) comprises 100 parts by weight of alkoxydialkylboron (paragraphs 0070 & 0053), an alcohol having a boiling point of 60 to 180°C (paragraphs 0067-0070);
wherein the polymerizable monomer (A) is a (meth)acrylate ester or a combination of a (meth)acrylate ester and a polymerizable monomer containing an acidic group (paragraph 0020; see also paragraphs 0021-0029 & 0030-0033); and
wherein the polymer powder (B) is at least one polymer selected from homopolymer of alkyl (meth)acrylate, copolymer between alkyl (meth)acrylates, copolymer of alkyl (meth)acrylate with other polymerizable monomer, copolymer of alkyl (meth)acrylate with alkylene di(meth)acrylate, and copolymer of alkyl (meth)acrylate with diene monomer (paragraphs 0035-0036);
(2) wherein the alkoxydialkylboron comprised in the polymerization initiator (C) is butoxydibutylboron (paragraph 0053), the alcohol comprised in the polymerization initiator (C) is ethanol (paragraph 0069);
(3 & 9) wherein the adhesive composition for hard tissue repair comprises 20-70 parts by weight of the polymerizable monomer (A) (paragraph 0034: see “more preferably 20 to 45”), 20-70 parts by weight of the polymer powder (B) (paragraph 0045: see “particularly preferably 59 to 68.6”), and 1-20 parts by weight of the polymerization initiator (C) (paragraph 0072: see “more preferably 1.0 to 7.0”), wherein the total amount of the polymerizable monomer (A), the polymer powder (B), and the polymerization initiator (C) is 100 parts by weight.
Goto et al. fail to explicitly disclose: (1) 0.2-5 (per 100) parts by weight of the alcohol having a boiling point of 60 to 180°C. Rather, they disclose a preferable alcohol content of 0.5 to 20 parts by mass per 100 parts by mass of the boron compound (see paragraph 0070). In light of this, it has been found that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists – see MPEP 2144.05.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to formulate the composition of Goto et al. with the instantly claimed amount of alcohol (0.2-5 (per 100) parts by weight) because: (a) Goto et al. disclose a preferable alcohol content of 0.5 to 20 parts by mass per 100 parts by mass of the boron compound; and (b) it has been found that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Lastly, Goto et al. disclose the use of an alkoxydialkylboron compound (see paragraph 0053). They fail to explicitly disclose: (1) an alkoxydialkylboron having a purity of 97% or more. In light of this, it has been found that the mere purity of a product (or a composition thereof) does not render the product (or a composition thereof) nonobvious – see MPEP 2144.04 VII. Applicant shows that the purified material (see Examples 1-4 in Table 1) and the non-purified material (see Comparative Example 3) have nearly identical polymerization activity as indicated by curing time. The purified material has improved ignition properties (not smoking or small smoking/not coked/not ignited) over the non-purified material (smoking/not coked/not ignited). However, this modest improvement in only smoking characteristics does not appear to represent a significant or unexpected improvement.
Regarding claims 4, 8, 10, and 12, Goto et al. disclose the use of an inorganic filler (D) (see paragraphs 0073-0076). Goto et al. also disclose: (8 & 12) a kit for hard tissue repair comprising the adhesive composition for hard tissue repair wherein:
the polymerizable monomer (A) is placed in one member,
the polymerization initiator (C) is placed in one member,
the polymer powder (B) and the filler (D) are placed in one member, and
the three members above forms the kit for repair (see paragraphs 0118-0119). They fail to explicitly disclose: (4 & 10) 20-150 parts by weight of a filler (D) based on 100 parts by weight of the total amount of the polymerizable monomer (A), the polymer powder (B), and the polymerization initiator (C). Rather, they disclose an amount of 0.5 to 70 parts by mass (per 100 pbm) (see paragraph 0076). In light of this, it has been found that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists – see MPEP 2144.05.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the instantly claimed amount of filler (D) (20-150 parts by weight (per 100 pbw)) in the composition of Goto et al. because: (a) Goto et al. disclose an amount of 0.5 to 70 parts by mass (per 100 pbm); and it has been found that in the case where the claimed ranges “overlap or lie inside ranges disclosed by the prior art” a prima facie case of obviousness exists.
Regarding claims 5-7 and 11, Goto et al. fail to explicitly disclose: (5-7 & 11) a kit for hard tissue repair comprising the adhesive composition for hard tissue repair, wherein:
the polymerizable monomer (A) and part of the polymer powder (B) comprised in the composition for hard tissue repair are placed in the same member,
the polymerization initiator (C) is placed in one member,
the remaining part of the polymer powder (B) is placed in one member, and
the three members above form the kit for repair. Rather, they disclose a kit with three or more partitions (see paragraphs 0118 & 0021). They also contemplate an embodiment where (A) and (B) are contacted prior to coming in contact with (C) (see paragraph 0122). In light of this, the skilled artisan would have obviously envisaged the instantly claimed three-member configuration because it is a middle ground between the three partition A/B/C configuration and the A/B & C (prior contact) configuration. Furthermore, the skilled artisan would have recognized that kit design facilitates the sequence of adding ingredients. In light of this, it has been found that the selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results – see MPEP 2144.04 IV. C.
Therefore, the skilled artisan would have obviously envisaged the instantly claimed kit configuration from the teachings of Goto et al. because: (a) Goto et al. disclose a kit with three or more partitions; (b) Goto et al. contemplate an embodiments where (A) and (B) are contacted prior to coming in contact with (C); and (c) the instantly claimed three-member configuration is a middle ground between the three partition A/B/C configuration and the A/B & C (prior contact) configuration of Goto et al. Furthermore: (d) the skilled artisan would have recognized that kit design facilitates the sequence of adding ingredients; and (e) it has been found that the selection of any order of mixing ingredients is prima facie obvious in the absence of new or unexpected results.
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, 5-7, 9, and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 of U.S. Patent No. 12,582,745 in view of Goto et al. (WO 2018/181821 A1 or US 2020/0030484 A1).
Regarding claims 1-3 and 9, the teachings of Goto et al. are as set forth above and incorporated herein. Patented claims 1-5 correspond to claims (1 & 2), and patented claim 3 corresponds to claims (3 & 9). The patented claims fail to disclose: (1-3 & 9) 0.2-5 (per 100) parts by weight of an alcohol having a boiling point of 60 to 180°C. However, this would have been obviously satisfied in view of Goto et al. (see above analysis relating to paragraphs 0053 & 0070 of Goto et al.).
Regarding claims 5-7, and 11, the instantly claimed kit configuration of claims (5-7 & 11) would have been obviously envisaged in view of Goto et al. (see above analysis relating to paragraphs 0118-0112 of Goto et al.).
International Search Report
The international search report cited one X-reference. This reference has been considered.
Communication
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL J FEELY whose telephone number is (571)272-1086. The examiner can normally be reached Monday-Friday 8am-5pm.
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/MICHAEL J FEELY/Primary Examiner, Art Unit 1766
April 4, 2026
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