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 .
Allowable Subject Matter
Claims 12-14 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, and upon overcoming the double patenting rejection.
The following is a statement of reasons for the indication of allowable subject matter:
The prior art fails to teach or disclose the limitations including but not limited to, wherein the device further comprises a fulcrum body rotatably coupled to the spacer body within a bounded range of rotation of less than 90 degrees, the fulcrum body being configured to be inserted in an intermetatarsal space between the metatarsal and an adjacent metatarsal .
Claims 15-20 are allowable over the prior art.
The following is a statement of reasons for the indication of allowable subject matter: The prior art fails to teach or disclose the method steps including but not limited to, adjusting a position of the at least one guide surface relative to the spacer body via a movable connection, preparing an end of the metatarsal by guiding a bone preparation instrument along the at least one guide surface defined by the bone preparation guide body, and preparing an end of the opposed cuneiform by guiding the bone preparation instrument along the at least one guide surface defined by the bone preparation guide body.
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 1-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 12-23, 29 and 34-37 of U.S. Patent No. 12,193,683.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose a bone cutting and joint realignment instrument. The instrument comprises a spacer body configured to be inserted into a joint space between a metatarsal and an opposed cuneiform of a foot, a bone preparation guide body affixed to the spacer body with the spacer body extending downwardly from the bone preparation guide body, the bone preparation guide body defining at least one guide surface configured to be positioned over at least one of the metatarsal and the opposed cuneiform. The bone preparation guide body is affixed to the spacer body via a movable connection.
Although the claims at issue are not identical, they are not patentably distinct from each other because both the present application and granted patent disclose method. The method comprises inserting a bone cutting and joint realignment instrument into joint spaces of the foot, the bone cutting and joint realignment instrument comprising a spacer body, a bone preparation guide body affixed to the spacer body, wherein inserting the bone cutting and joint realignment instrument into joint spaces of the foot comprises inserting the spacer body between a metatarsal and an opposed cuneiform of the foot, and concurrently positioning at least one guide surface defined by the bone preparation guide body over one or both of the metatarsal and opposed cuneiform, preparing an end of the metatarsal by guiding a bone preparation instrument along the at least one guide surface defined by the bone preparation guide body, preparing an end of the opposed cuneiform by guiding the bone preparation instrument along the at least one guide surface defined by the bone preparation guide body, moving the metatarsal relative to the adjacent metatarsal, and applying at least one fixation device across a tarsometatarsal joint between a prepared end of the metatarsal and a prepared end of the opposed cuneiform.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2019/0336140 to Dacosta et al. in view of U.S. Patent Pub. No. 2020/0046412 to Nachtrab et al.
As to Claim 1, Dacosta discloses a bone cutting and joint realignment instrument (100, Fig. 1, [0128-0129]). The instrument comprises a spacer body (128) configured to be inserted into a joint space between a metatarsal and an opposed cuneiform of a foot (described in [0134, [0180]]), and a bone preparation guide body (114) affixed to the spacer body with the spacer body extending downwardly from the bone preparation guide body (Figs. 1-4, [0129]). The bone preparation guide body (114) defines at least one guide surface (130, 140) configured to be positioned over at least one of the metatarsal and the opposed cuneiform [0135, 0180].
As to Claim 4, Dacosta discloses a bone cutting and joint realignment instrument further comprising a handle (450) connected to the bone preparation guide body (analogous to 414, Fig. 69, [0169]).
As to Claim 5, Dacosta discloses a bone cutting and joint realignment instrument wherein the bone preparation guide body (414) has a length extending from a first end (near 432, Fig. 69) to a second end (near 408, Fig. 69), the spacer body (analogous to 418, [0169]) is affixed to the bone preparation guide body (414) at the first end, and the handle is connected to the first end of the bone preparation guide body (connected at 432, Fig. 69, [0170]).
As to Claim 6, Dacosta discloses a bone cutting and joint realignment instrument wherein the spacer body (128) defines a first portion (near ref. 128, Fig. 3) configured to extend into the joint space between the metatarsal and the opposed cuneiform (described in [0134, [0180]]) and a second portion (near ref. 120, Fig. 3) configured to extend above the joint space, the second portion being offset from the at least one guide surface defined by the bone preparation guide body (Fig. 3).
As to Claim 7, Dacosta discloses a bone cutting and joint realignment instrument wherein the at least one guide surface (130, 140) defined by the bone preparation guide body (Figs. 1-4) has a thickness extending from a top end (near refs. 130, 140. Fig. 3) to a bottom end (near refs. 136, 146, Fig. 3), the spacer body (128) has a length extending from a top end to a bottom end (Figs. 1-4), and the top end of the spacer body is approximately coplanar with or located vertically below the bottom end of the at least one guide surface (configuration seen in Figs. 3-4).
As to Claim 8, Dacosta discloses a bone cutting and joint realignment instrument wherein the bone preparation guide body comprises at least a first guide surface (140) configured to be positioned over the metatarsal (602) and a second guide surface (130) configured to be positioned over the opposed cuneiform (604, [0180]), the first and second guide surfaces being separated from each other by a distance configured to span a tarsometatarsal joint (Figs. 1-4, [0180]).
As to Claim 10, Dacosta discloses a bone cutting and joint realignment instrument wherein the bone preparation guide body (414) further comprises a first facing guide surface (102) spaced apart from the first guide surface (140) to define a first cutting slot therebetween (122), and a second facing surface spaced (102) apparent from the second guide surface (130) to define a second cutting slot (116) therebetween (Fig. 1, [0130]).
As to Claims 1-11, Dacosta discloses the claimed invention except for wherein the bone preparation guide body is affixed to the spacer body via a movable connection, wherein the bone preparation guide body is configured to move perpendicularly relative to the spacer body via the movable connection, further comprising an actuator operable to adjust a position of the bone preparation guide body relative to the spacer body, wherein the first guide surface and the second guide surface each have a thickness less than 2 mm.
It would have been obvious to one having ordinary skill in the art at the time the invention was made to construct the first guide surface and the second guide surface to each have a thickness less than 2 mm., and the first facing guide surface and the second facing guide surface to each have a thickness less than 2 mm, since Dacosta discloses general conditions in ([0132], slots being 0.58-0.92 mm, and [0011]), and it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Nachtrab discloses a bone cutting and joint realignment instrument (604, [0095-0096]) wherein a bone preparation guide body (626) is affixed to a spacer body (614) via a movable connection (via adjustment knob 606, [0095, 0096, 0104]). The bone preparation guide body (626) is configured to move perpendicularly relative to the spacer body via the movable connection (adjustment described in [0112]). An actuator (606) is operable to adjust a position of the bone preparation guide body relative to the spacer body [0105] in order to allow for adjustment of the guide as the spacer is inserted into the joint space [0112, 0113].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the bone cutting and joint realignment instrument of Dacosta with the movable spacer body modification of Nachtrab in order to allow for adjustment of the guide as the spacer is inserted into the joint space.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER J BECCIA whose telephone number is (571)270-7391. The examiner can normally be reached Mon - Fri 8:30-5:00.
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/CHRISTOPHER J BECCIA/ Primary Examiner, Art Unit 3775
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