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 1-13 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 4-16, 18-22 of U.S. Patent No. 12004789B2 (referred herein as Pat. ‘789). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1 and 5 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-7 of Pat. ‘789. Pat. 789 recites a method for treating metatarsus adductus comprising: cutting an end of at least one of a second metatarsal and an intermediate cuneiform to create an opening between the end of the second metatarsal and the intermediate cuneiform (claim 1 Col. 45 lines 39,43-47 and claims 6-7); cutting an end of at least one of a third metatarsal and a lateral cuneiform to create an opening between the end of the third metatarsal and the lateral cuneiform (claim 1 Col. 45 lines 48-52 and claims 6-7); moving the second metatarsal and the third metatarsal in at least a transverse plane to close a metatarsus adductus angle (claim 1 Col. 45 lines 53-55); and fixating a moved position of the second metatarsal and the third metatarsal (claim 1 Col. 45 lines 56-57); and cutting an end of the other of the second metatarsal and the intermediate cuneiform and cutting an end of the other of the third metatarsal and the lateral cuneiform (claims 6-7).
Claims 2-4, 6-13 and 15-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2, 4-5, 8-16, 18-22 of Pat. ‘789 since they recite substantially similar limitations.
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-5, 9, 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Arthrex (Arthrex. (2018). Dorsal Midfoot Fusion Plates Surgical Techniques. https://www.arthrex.com/resources/LT1-00125-EN/dorsal-midfoot-fusion-plates?referringteam=foot_and_ankle., cited in parent application 17/325167)
Arthrex discloses a method for treating metatarsus adductus. Specifically in regards to claim 1, Arthrex discloses cutting an end of at least one of a second metatarsal and an intermediate cuneiform to create an opening between the end of the second metatarsal and the intermediate cuneiform; cutting an end of at least one of a third metatarsal and a lateral cuneiform to create an opening between the end of the third metatarsal and the lateral cuneiform (Pg. 2 Fig. 1-2 and explanations); moving the second metatarsal and the third metatarsal in at least a transverse plane to close a metatarsus adductus angle (Pg. 2 Fig. 3 and explanation); and fixating a moved position of the second metatarsal and the third metatarsal (Pg. 4-5 Fig. 10-17 and explanations).
In regards to claim 2, Arthrex discloses wherein moving the second metatarsal and the third metatarsal comprises moving the second metatarsal and the third metatarsal together as a joined bone group (Page 2 Fig. 3 and explanation).
In regards to claim 3, Arthrex discloses wherein moving the second metatarsal and the third metatarsal together as a joined bone group comprises moving the second metatarsal and the third metatarsal without significantly changing an intermetatarsal angle between the second metatarsal and the third metatarsal (Page 2 Fig. 3 and explanation).
In regards to claim 4, Arthrex discloses wherein moving the second metatarsal and the third metatarsal in at least the transverse plane comprises pivoting the second metatarsal and the third metatarsal in the transverse plane about a medial aspect of the second metatarsal (Page 2 Fig. 3 and explanation).
In regards to claim 5, Arthrex discloses cutting an end of the other of the second metatarsal and the intermediate cuneiform; and cutting an end of the other of the third metatarsal and the lateral cuneiform (Page 2 Fig. 1-2 and explanation).
In regards to claim 9, Arthrex discloses prior to fixating the moved position, compressing the end of the second metatarsal against the end of the intermediate cuneiform and compressing the end of the third metatarsal against the end of the lateral cuneiform (Page 2 Fig. 3 and explanation).
In regards to claim 15, Arthrex discloses provisionally fixating a moved position of the second metatarsal and the third metatarsal (Page 2 Fig. 3 to Page 3 Fig. 6 and explanations).
In regards to claim 16, Arthrex discloses wherein fixating the moved position of the second metatarsal and the third metatarsal comprises: applying at least one fixation device across a second tarsal-metatarsal joint between the second metatarsal and the intermediate cuneiform, and applying at least one fixation device across a third tarsal-metatarsal joint between the third metatarsal and the lateral cuneiform (Page 2 Fig. 4 to Page 3 Fig. 6 and explanations).
In regards to claim 17, Arthrex discloses applying at least one fixation device across the second tarsal-metatarsal joint comprises attaching a first plate to the second metatarsal and to the intermediate cuneiform, and applying at least one fixation device across the third tarsal-metatarsal joint comprises attaching a second plate to the third metatarsal and to the lateral cuneiform (as can be seen in Fig. 4-17 a plate composed of two small arms that act like two small plates are placed crossing the tarsometatarsal joints.) (Page 2-5 Fig. 4-17 and explanations).
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.
Claim(s) 6-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arthrex in view of Dacosta et al (US Patent Pub. 20140257509A1).
Arthrex discloses a method for treating metatarsus adductus comprising cutting an end of at least one of a second metatarsal and an intermediate cuneiform and a third metatarsal and a lateral cuneiform to form an opening between each bone group, moving the metatarsals to close a metatarsus adductus angle, and fixating the moved position of the bones. In regards to claims 6-8, Arthrex discloses cutting the ends of the second and third metatarsals and the end of the adjacent cuneiform bones (Page 2 Fig. 1-3 and their explanations). However, Arthrex is silent as to the cuts producing a wedge shaped bone piece.
Dacosta discloses a method for treating metatarsus adductus. Specifically in regards to claim 6-7, Dacosta discloses wherein: cutting the end of the metatarsal (84) and the cuneiform (82) to create the opening comprises cutting the end of at least one of the metatarsal (84) and the cuneiform (82), and wherein: cutting the end of the metatarsal (84) and the cuneiform (82) to create the wedge-shaped opening comprises making a cut angled in the transverse plane to create a wedge-shaped section of bone and removing the wedge-shaped bone prior to moving the metatarsal (Fig. 6-9 and 23; Para. [0003], [0055], [0058]-[0059]). In regards to claim 8, Dacosta discloses wherein: moving the metatarsal (84) in the transverse plane comprises closing the wedge-shaped opening between the end of the metatarsal (84) and the cuneiform (82) (Fig. 6-9 and 23; Para. [0059]). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of Arthrex by modifying the cuts made into both the second and third metatarsal joints to have a wedge-shaped opening as disclosed in Dacosta in order to be able to use a bone wedge that enables correction in both the dorsal-plantar plane and medial-lateral plane (Para. [0060]).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arthrex in view of Day et al (US Patent Pub. 20210282823A1).
Arthrex discloses a method for treating metatarsus adductus comprising cutting an end of at least one of a second metatarsal and an intermediate cuneiform and a third metatarsal and a lateral cuneiform to form an opening between each bone group, moving the metatarsals to close a metatarsus adductus angle, and fixating the moved position of the bones. In regards to claims 10-12, Arthrex discloses cutting the ends of the second and third metatarsals and the end of the adjacent cuneiform bones and holding them together (Page 2 Fig. 1-4 and their explanations). However, Arthrex is silent as to the specifics of what is used to compress the bones together.
Day discloses a method for treating metatarsus adductus. Specifically in regards to claim 10-11, Day discloses engaging a bone positioning guide (44 attached with 94/88/86/90) and with at the metatarsal (16-1) and a bone (16-2) other than the cut metatarsal (16-1), wherein moving the metatarsal (16-1) in the transverse plane comprises engaging the bone positioning guide (44 attached with 94/88/86/90) and wherein the bone positioning guide (44 attached with 94/88/86/90) is a compressor (94/88/86/90), and engaging the bone positioning guide (44 attached with 94/88/86/90) with at the metatarsal (16-1) comprises attaching the compressor the metatarsal (16-1) and cuneiform (18) (Fig. 8-18; and Para. [0064]-[0068]). In regards to claim 12, Day discloses wherein the bone positioning guide (44 attached with 94/88/86/90) is engaged with (a) a medial side of the metatarsal (16-1) and (b) a bone (16-2) other than the cut metatarsal (Fig. 18). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of Arthrex by modifying the movement of the second and third metatarsals to have been done by a guide with a compressor as disclosed in Day in order to allow for ease of movement of the metatarsal to thereby achieve a desired level of intramedullary reduction between these bones (Para. [0068]).
Claim(s) 18-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Arthrex.
Arthrex discloses a method for treating metatarsus adductus comprising cutting an end of at least one of a second metatarsal and an intermediate cuneiform and a third metatarsal and a lateral cuneiform to form an opening between each bone group, moving the metatarsals to close a metatarsus adductus angle, and fixating the moved position of the bones. However, this embodiment does not recite wherein the first metatarsal and medial cuneiform are treated. Arthrex also discloses another embodiment in which the first tarsometatarsal joint are treated (see Pg. 2 paragraph under Dorsal Midfoot Fusion Plates heading). Specifically in regards to claims 18-19, realigning a first metatarsal by at least; preparing an end of the first metatarsal; preparing an end of a medial cuneiform facing the first metatarsal; moving the first metatarsal in at least the transverse plane to close an intermetatarsal angle between the first metatarsal and the second metatarsal; and fixating a moved position of the first metatarsal; and wherein moving the first metatarsal in at least the transverse plane further comprises rotating the first metatarsal in a frontal plane (Page 2 Fig. 1-4 and their explanations). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the method treatment method of the second and third metatarsal joints of Arthrex by combining with the method of treating the first metatarsal joint as disclosed in a different embodiment of Arthrex so as to allow for all the joints to receive treatment.
Allowable Subject Matter
Claims 14 and 21 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The closest prior art of record the Arthrex reference discloses a method of treating metatarsus adductus that involves the cutting of the ends of the second and third metatarsals and the intermediate and lateral cuneiforms; moving the metatarsals in a transverse plane to close the metatarsus adductus angle; and fixing the moved positions of the metatarsals. However, the reference is silent as to the releasing of the soft tissue between the fourth and fifth metatarsals in the transverse plane and mobilizing an extensor digitorum brevis muscle from the extensor hallucis brevis and retracting the extensor digitorum brevis muscle. Therefore, the claims of the instant application have not been rejected using prior art because none of the references or reasonable combinations thereof could be found which disclose or suggest all of the features of the claims, and there is no reasonable motivation to modify the art of record to have these features. Furthermore, attempting to modify the references to have all the cited limitations would destroy the proposed inventions.
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
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