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 .
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 1-7 and 9-14 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12171913B2, referred herein as Pat. ‘913. Although the claims at issue are not identical, they are not patentably distinct from each other because :
Claims 1-2 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of Pat. ‘913. Pat. ‘913 recites a composition having a desired shape and a mean grain size [claim 1 col. 9 lines 5-7], said composition consisting essentially of by weight: WC present from 85 to 95 total weight percent [claim 1 col. 9 line 7-8]; Cr₃C₂ and Mo₂C each alone, or in combination being present from 0 to 2 total weight percent [claim 1 col. 9 line 9-10], and Ni constituting the remainder [claim 1 col. 9 line 10-11]; the average grain size being between 200 and 1200 nm with a particle dispersion index of between 0.02 and 1.2, or between 0.02 and 0.6 [claim 1 col. 9 line 11-13].
Claims 4-14 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2-11 of Pat. ‘913 for reciting substantially similar limitations.
Claims 1 and 3 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 12 of Pat. ‘913. Pat. ‘913 recites a composition having a desired shape and a mean grain size [claim 12 col. 10 lines 1-3], said composition consisting essentially of by weight: WC present from 85 to 95 total weight percent [claim 12 col. 10 line 3-4]; Cr₃C₂ and Mo₂C each alone, or in combination being present from 0 to 2 total weight percent [claim 12 col. 10 line 5-6], and Ni constituting the remainder [claim 12 col. 10 line 6-7]; the average grain size being between 200 and 1200 nm with a particle dispersion index of between 0.02 and 1.2 [claim 12 col. 10 line 7-9]; and wherein Cr₃C₂ and Mo₂C are all present and constitute in total more than 0 and less than 1 total wight percent [claim 12 col. 10 lines 9-11].
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.
Claim(s) 1-2 and 4-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirchandani et al (US Patent Pub. 20070082229A1) in view of Yamauchi (US Patent Pub. 20180258992A1).
Mirchandani discloses a surgical article. Specifically in regards to claim 1-2, Mirchandani discloses a composition having a desired shape and a mean grain size, said composition consisting essentially of by weight: WC present from 85 to 95 total weight percent; Cr₃C₂ and Mo₂C each alone, or in combination being present from 0 to 2 total weight percent, and Ni constituting the remainder; the average grain size being between 200 and 1200 nm (Mirchandani recites that the cemented carbide with a removal of the binder at and near the surface removes the bio-incompatibility limitation of cemented carbides, and hence makes them useful as surgical instruments. The reference also recites has WC with a grain size of 0.1-25 microns and comprises 50-98% by weight of the with the balance being a metallic binder comprising Ni, i.e. comprises 2-50% by weight. Mirchandani does not recite a weight percentage of the Cr3C2, Mo2C elements thus meeting the limitation as recited.) (Claim 7-8; Para. [0007]-[0008]; [0014]; [0038]; [0052]). However, the reference is silent as to the dispersion index of between 0.02 and 1.2.
Yamauchi discloses a method capable of being used for creating a surgical article. Specifically in regards to claim 1-2, Yamauchi discloses composition having a desired shape and a mean grain size with a particle dispersion index of between 0.02 and 1.2, or wherein the index is between 0.02 and 0.6 (Yamauchi recites the dispersion index S of the fibrous particles 5 is 0.1 to less than 1 in the intermediate area 32 of the sliding layer 3, more preferably 0.1 to 0.9.) (Para. [0044]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the particles of the invention of Mirchandani to behave PDI of 0.1-0.9 as taught in Yamauchi in order to “[e]xhibit such a property that it has lower strength (lower resistance to deformation) to a load applied parallel to the sliding surface, and it has higher strength (high resistance to deformation) to a load applied perpendicular to the sliding surface” (Para. [0044]).
In regards to claims 4-7, Mirchandani discloses wherein the desired shape is a surgical drill, a smooth trocar, a threaded trocar, a Kirschner pin, a dental drill bit, a rongeur, a surgical saw blade, a cutter sleeve, a bone clamp, a hip implant, a knee implant, a shoulder implant, an ankle implant, an elbow implant, a spinal implant, a bone screw, a bone pin, a trauma plate, dental drill bit, a saw guide, a drill guide, a saw guide, a screw, a pin, a pedicle screw, or an intramedullary nail (Mirchandani discloses wherein the method can be used to create surgical instruments based on binder-depleted cemented carbides. Embodiments include surgical instruments such as scalpels, scissors, tweezers, forceps, knives, blades, saws, suture instruments, scalpers, probes, dental instruments, etc.) (Para. [0052] and claims 7).
In regards to claim 8, Mirchandani recites wherein VC present from 0 to 1 percent by total weight (Mirchandani recites additions of other transition metal carbides such as TiC, TaC, NbC, VC, etc. are sometimes made to enhance certain properties.) (Para. [0038]).
In regards to claim 9, Mirchandani in view of Yamauchi disclose forming a surgical article according to claim 1 having a tissue contacting portion as recited above (Mirchandani: Para. [0001],[0049]).
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirchandani in view of Yamauchi as applied to claim 1 above, and further in view of Majagi et al (US Patent 6521353B1).
Mirchandani in view of Yamauchi disclose method of creating a surgical article as recited above. However, the combination of references are silent as to wherein Cr₃C₂ and Mo₂C are all present and constitute in total more than 0 and less than 1 total weight percent.
Majagi discloses a method capable of being used for creating a surgical article. Specifically in regards to claim 3, Majagi discloses composition having a desired shape and a mean grain size, and wherein Cr₃C₂ and Mo₂C are all present and constitute in total more than 0 and less than 1 total weight percent (Majagi recites wherein the use of a grain growth inhibitor material composition preferably contains carbide elements that are present in the composition in the amounts of about 0.5 to about 3 weight percent Mo.sub.2 C, and 0.5% weight percent for Cr.sub.3 C.sub.2.) (Table 3 and Col. 3 line 46-65). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combined method by modifying the use of the surgical article of Mirchandani to have Cr₃C₂ and Mo₂C are all present and constitute in total more than 0 and less than 1 total weight percent as taught in Majagi since limiting grain growth of the material, particularly of the WC grains, is important during processing so that small grain sizes, high hardness, high magnetic coercivity, and low porosity may be attained (Col. 3 lines 46-49).
Claim(s) 10-11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirchandani in view of Yamauchi as applied to claim 1 above, and further in view of Suttin et al (US Patent Pub. 20160157964A1).
Mirchandani in view of Yamauchi disclose method of creating a surgical article to be used in cutting tissue of a subject in the course of a surgical procedure. However, the combination of references are silent as to the next steps in a surgical procedure.
Suttin discloses a method of cutting tissue of a subject in the course of a surgical procedure. Specifically In regards to claim 10, Suttin discloses wherein said surgical article (132/155) is rotated or oscillated (Para. [0064] and Fig. 7). In regards to claim 11, Suttin discloses selectively coupling said surgical article (132/150) to a robotic arm (140 of 100) prior to said step of rotating or oscillation said surgical article (132/150) (Para. [0064] and Fig. 7). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combined method by modifying the use of the surgical article of Mirchandani to be used in a robotic surgical procedure as taught in Suttin since robotic computer assistance tends to be more precise than regular surgery, allowing for: increased safety, by using computers and technology to assist them during surgery, the surgeon is less likely to injure the surrounding tissue and be more accurate.
Claim(s) 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirchandani in view of Yamauchi as applied to claim 1 above, and further in view of Frey et al (US Patent Pub. 20160030067A1).
Mirchandani in view of Yamauchi disclose a surgical article capable of being used in a method of modifying tissue of a subject in the course of a surgical procedure. Specifically in regards to claim 12-13, Mirchandani in view of Yamauchi discloses providing a surgical article according to claim 1 above for placement in contact with the tissue of the subject (Mirchandani: Para. [0001],[0049]). However, the combination of references are silent as to the next steps in a surgical procedure.
Frey discloses a method of modifying tissue of a subject in the course of a surgical procedure. Specifically in regards to claim 12, Frey discloses placing said surgical article (110) in contact with the tissue (Fig. 5c) of the subject; and retaining said surgical article (110) in vivo and in contact with the tissue of the subject (Fig. 4a-6b; and Para. [0216]-[0222]). In regards to claim 13, Frey discloses removing a portion of the tissue (Fig. 5c-6b) of the subject to expose a tissue surface and said surgical article (110) is complementary to the tissue surface (114) (Fig. 4a-6b; Para. [0216], [0219]-[0221]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combined method by modifying the use of the surgical article of Mirchandani to be used in a method of removing tissue and to have a patient conforming surface as taught in Frey since patient-specific cutting guides providing means to achieve quick and controlled removal of bone; providing spatial orientation of cutting tools used during the procedure; ensuring correct orientation of cuts, both through controlled guiding of the instrument and visualization during the pre-surgical planning process; providing accurate calculation of deformity correction, prior to cutting; providing accurate bone resection, which in turn ensures deformity correction; depth controlled cutting restrictions to protect neural and vascular elements; controlled cutting vector and avoiding contact or injury to neural elements; and ability to provide approach for cuts in a posterior, anterior, posterior lateral, transforaminal or direct lateral approach (Para. [0222]).
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mirchandani in view of Yamauchi and Frey as applied to claim 13 above, and further in view of Suttin.
Mirchandani in view of Yamauchi and Frey disclose a method of modifying tissue of a subject in the course of a surgical procedure by using a cemented carbide surgical article as recited above. However, the combination of references are silent as to the next steps in a surgical procedure involving a robot.
Suttin discloses a method of modifying tissue of a subject in the course of a surgical procedure. Specifically in regards to claim 14, Suttin discloses a rotating or oscillating said surgical article (132/155) while the tissue contacting portion engages the tissue of the subject and wherein said removing step is performed robotically (140 of 100) (Para. [0064] and Fig. 7). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the combined method by modifying the use of the cutting tool of the combination to be used with a robotic surgical assistant as taught in Suttin since robotic computer assistance tends to be more precise than regular surgery, allowing for: increased safety, by using computers and technology to assist them during surgery, the surgeon is less likely to injure the surrounding tissue and be more accurate.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775