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 .
Claim Rejections - 35 USC § 112
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 11-16 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.
Claim 11, “a resection” should be --the resection-- and “a resected tibia” should be --the resected tibia--.
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) 1-2, 4-6, and 11-13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Luna et al. (US 2014/0336658; “Luna”), in view of Lang (US 2017/0258526).
Claim 1, Luna discloses a surgical method for total ankle replacement (TAR) (abstract), comprising: obtaining a TAR implant (Fig. 99), wherein the TAR implant comprises: a tibial component (Fig. 99; 1100) comprising a tibial engagement surface (upper surface) and at least one bone engagement projection (Fig. 96; 1104); a talar component (Fig. 96; 1200) with a talar engagement surface (Fig. 99; lower surface) and a talar articulation surface (Fig. 97; surface that 1200 points towards); and a tibial insert (Fig; 96; 1300) configured to removably couple with the tibial component (paragraphs [0235]-[0253]) and comprising tibial articulation surface (Fig. 96; lower surface of 1300 that engages talar component 1200) that articulates with the talar articulation surface (Fig. 96; paragraphs [0235]-[0253]); making an incision to expose an ankle joint with a first tibia bone and a second talar bone (paragraph [0256]); aligning a joint alignment guide with the first tibia bone (paragraphs [0259]-[0267]; preparing the first tibia and second talar bones for receiving the TAR implant (paragraphs [0256]-[0290]); coupling a tibial sizing block (Fig. 30; 210, 230; paragraphs [0167]-[0168]) with a tibial alignment base (100); performing a resection of the first tibia bone to form a resected tibia (Fig. 37; paragraph [0179]); performing a resection to the second talar bone to form a resected talus (Fig. 39C; paragraphs [0185]-[0186]); trialing the TAR implant with the resected tibia and the resected talus via a TAR trial and guide system to determine sizes for the tibial component (Figs. 30-40; paragraphs [0167]-[0184], the talar component and the tibial insert (paragraphs [0189]-[0201]).
However, Luna does not disclose conducting pre-operative templating.
Lang teaches conducting pre-operative templating (paragraph [0205]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to combine a step of conducting pre-operative templating, as taught by Lang, in the method of Luna, in order to help establish a pre-operative plan and have a better understanding of the surgical site prior to performing surgery on the site (paragraph [0205).
However, Luna does not disclose closing the incision.
Official notice is being taken that this is a step that always occurs in these types of surgical procedures. It is such a common practice to close the incision, that many patent applications do not include this step. One of ordinary skill would expect the reference to actually state they do not close the incision, if that were to be the case.
Claim 2, Luna in view of Lang disclose the method of claim 1, Luna discloses further comprising: continuing the incision while releasing soft tissue (paragraph [0256]; as the tissue is cut it is being released from itself as the two sides separate along the cut line).
Claim 4, Luna in view of Lang disclose the method of claim 1, Luna discloses wherein the aligning comprises; an initial alignment; a fine alignment; and an additional alignment step (paragraphs [0145]-[0160]; multiple alignments taking place that can meet initial, fine, and additional alignments).
Claim 5, Luna in view of Lang disclose the method of claim 1, Luna discloses wherein making an incision to expose the ankle joint with the first tibia bone and the second talar bone comprises: beginning the incision proximal to the ankle joint; and terminating the incision distal to the talonavicular joint (paragraph [0140]).
Claim 6, Luna in view of Lang discloses the method of claim 1, Luna discloses a total ankle replacement (TAR) trial and bone preparation guide system, comprising a tibial trial and bone preparation first component (210) comprising: a base portion (211) comprising a first side with a first tibial engagement surface (upper surface of element 211) configured to engage a resected distal tibia and at least one bone aperture formation guide through hole (212) extending from the first tibial engagement surface to a second tibial insert engagement side (Figs. 30-31; paragraphs [0167]-[0168]); and an arm portion (213) extending proximally from an anterior portion of the base portion configured to engage an anterior side of the resected distal tibia (Figs. 30-32; paragraphs [0167]-[0168]); and a talar trial and bone preparation second component (240, 250) comprising: a first talar engagement surface (lower surface of 240, 250) on a distal side of the second component configured to engage a portion of a resected talus (Figs. 39A-39C; paragraphs [0183]-[0184]); a posterior trial articulation surface (251) on a proximal side of the second component that is anteriorly-posteriorly arcuately convex (Fig. 34); an anterior window (248) extending through the second component between the proximal side and the distal side thereof (Figs. 39A-39C; paragraphs [0183]-[0184]); a posterior cut slot (254) extending through the second component between the proximal side and the distal side thereof that is angled posteriorly as in extends from the proximal side to the distal side (Fig. 34; paragraph [0170]); and a plurality of pin apertures (253) extending through the second component between the proximal side and the distal side (Fig. 34; paragraphs [0170]).
Claim 11, Luna in view of Lang discloses the method according claim 1, Luna discloses wherein performing a resection of the first tibia bone to form a resected tibia comprises utilizing a resection guide (Fig. 37; paragraph [0179]).
Claim 12, Luna in view of Lang discloses the method according claim 11, wherein the resection guide comprises: a body having a first side and an opposite second side; said body having a plurality of alignment pin through-holes extending from said first side to said second side of said body with openings on said first side of said body and openings on said second side of said body; said body having a plurality of guide through-holes extending from said first side to said second side to define a first pattern of guide through-holes with openings on said first side of said body and openings on said second side of said body; and wherein when said plurality of alignment pin through-holes of said body is supported on a plurality of alignment pins attached to the first tibia bone, said openings of the guide through-holes on said second side of said body face the first tibia bone and said openings of the guide through-holes on said first side face away from said first tibia bone so that said first pattern of guide through-holes is operable for receiving a drill for use in resecting the at least a portion of the first tibia bone (Fig. 37).
Claim 13, Luna in view of Lang discloses the method according claim 12, Luna discloses wherein performing a resection of the first tibia bone to form a resected tibia comprises: supporting the resection guide on a plurality of alignment pins attached to the first tibia bone, the resection guide having the first pattern of guide through-holes; and guiding a drill through the plurality of guide through-holes in the resection guide and into at least a portion of the first tibia bone (Figs. 35-37; paragraphs [0162]-[0181]).
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 1-20 of U.S. Patent No. 12133804. Although the claims at issue are not identical, they are not patentably distinct from each other because they contain the same language. Current claim 3 is the same as the patented claim 1. Claim 7 is the same as patented claim 19. Claim 14 is the same as patented claim 20. All other claims also match up to the patented claims.
Allowable Subject Matter
Claim 3 requires the incision to be done in a very specific manner to identify particular nerves and tendons and to perform the incision based on those tissue parts which is not disclosed in the prior art.
Claim 7 requires a method step related to the tibial component which is not disclosed in the prior art. In a related case geared towards the apparatus, this limitation was rejected. While the interpretation met the apparatus claim due to some parts being capable of performing the functions, Luna does not actually disclose the method steps occurring. Claims 8-10 and 17-20 depend from claim 7, so are allowable for the same reasons.
Claim 14 requires a method step of removing a first resection guide and putting a second resection guide with an offset pattern of holes compared to the first guide and guiding a drill through the second guide. This feature, as claimed, is not taught by the prior art. Claims 15-16 depend from claim 14, so are allowable for the same reasons.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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/Zade Coley/Primary Examiner, Art Unit 3775