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 . 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.
Election/Restrictions
Applicant’s election of Group I, claim 9, in the reply filed on 10/15/2025, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 9, 11-12 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Moseley et al (US 2007/0178171 A1), in view of Sandell et al (US 2012/0129761 A1).
Moseley taught a particulate composition adapted for forming a bone graft substitute cement, upon mixing with an aqueous solution. The particulates included i) a calcium sulfate hemihydrate powder; ii) a monocalcium phosphate monohydrate powder; and iii) a β-tricalcium phosphate powder [abstract]. The powders and liquid were mixed to form a homogenous composition [claim 1].
The particulate composition set, upon mixing with an aqueous solution, in about 3 to about 25 minutes (e.g., reads on work time upon mixing with aqueous solution) [0015]., As defined by the Vicat needle drop test, the bone graft substitute cements set in about 3 to about 25 minutes [0090, 0109-0110] (e.g., reads on Vicat set time upon mixing with aqueous solution).
Moseley did not teach a Gillmore set time, as recited in claim 9.
Sandell taught bone cement compositions [title] comprising dry powders of calcium sulfate hemihydrate, monocalcium phosphate monohydrate [0056] and calcium triphosphate [claim two]. The composition was capable of hardening, upon mixing with an aqueous liquid [abstract]. Gillmore needles were used for characterization of setting time, which, after mixing (e.g., powders with aqueous liquid), was about 5-20 minutes [0091-0093].
Since Moseley taught a particulate composition adapted for forming a bone graft substitute cement upon mixing with an aqueous solution, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Moseley, the Gillmore set time, as taught by Sandell. The ordinarily skilled artisan would have been motivated to characterize the setting time, as taught by Sandell [0091-0093].
The instant claim 9 recites a work time, upon mixing with aqueous solution, of 3-5 minutes; Vicat set time of 3-8 minutes; Gillmore set time of 6-20 minutes.
The instant claim 11 recites a Vicat set time, upon mixing with aqueous solution, of 7 or more minutes.
The instant claim 12 recites a Gillmore set time, upon mixing with aqueous solution, of 10 or more minutes.
The instant claim 16 recites a Gillmore set time, upon mixing with aqueous solution, of 10-20 minutes.
Moseley taught that the particulate composition sets upon mixing with an aqueous solution in about 3 to about 25 minutes (e.g., reads on work time upon mixing with aqueous solution); Vicat set times, in about 3 to about 25 minutes; Sandell taught the Gillmore setting time, which, after mixing with aqueous liquid, was about 5-20 minutes. In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Nonstatutory Double Patenting
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 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,973,949, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 9,446,170, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 7,291,179, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-36 of U.S. Patent No. 7,507,257, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-55 of U.S. Patent No. 7,754,246, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-33 of U.S. Patent No. 8,685,464, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-28 of U.S. Patent No. 8,025,903, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-24 of U.S. Patent No. 7,658,768, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-77 of U.S. Patent No. 9,180,224, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-41 of U.S. Patent No. 8,685,465, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-47 of U.S. Patent No. 9,446,170, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Claims 9, 11-12 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-25 of U.S. Patent No. 10,973,949, in view of Moseley et al (US 2007/0178171 A1) and further in view of Sandell et al (US 2012/0129761 A1).
Although the claims at issue are not identical, they are not patentably distinct from each other because the instant claims require work, Vicat and Gillmore set times, which are not required of the issued claims.
Moseley taught that the particulate composition sets upon mixing with an aqueous solution in about 3 to about 25 minutes (e.g., reads on work time upon mixing with aqueous solution); Vicat set times, in about 3 to about 25 minutes; Sandell taught the Gillmore setting time, which, after mixing with aqueous liquid, was about 5-20 minutes.
The ordinarily skilled artisan would have been motivated to include, within the issued claims, work, Vicat and Gillmore set times, as taught by Moseley and Sandell. The ordinarily skilled artisan would have been motivated to characterize the set times, as taught by the combined Moseley and Sandell.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612