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 § 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) 21-33 and 35-40 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fallin et al. (US 2016/0199076; “Fallin”), in view of Davison et al. (US 2013/0296872; “Davison”).
Claim 21, Fallin discloses a system (Fig. 18) for correcting a deformity in a patient's foot (abstract), the system comprising: a guide (200) including: a first bone engagement surface (Figs. 16 and 18; lower surface 230 over the cuneiform bone 306) shaped to match a first contour on a first bone of the patient's foot (Figs. 16-18; paragraph [0052]) ; and a second bone engagement surface (Figs. 16 and 18; lower surface 230 over the metatarsal bone 300) shaped to match a second contour on a second bone of the patient's foot (Figs. 16-18; paragraph [0052]); a first fixation element (302, could be placed through the hole going into the cuneiform) configured to extend through the guide and into the first bone (Fig. 18); and a second fixation element (the other pin 302) configured to extend through the guide and into the second bone (Fig. 18).
However, Fallin does not disclose forming the engagement surfaces from a virtual bone model.
Davison teaches forming a cut guide with engagement surfaces using a virtual bone model (paragraphs [0051]-[0055]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the engagement surfaces of Fallin using a virtual bone model, as taught by Davison, in order to ensure the perfect fit and match to help make cuts exactly where it was planned (paragraphs [0051]-[0055).
Claim 22, Fallin in view of Davison discloses the system of claim 21, Fallin discloses further comprising a first guide feature (Fig. 15; any edge or slot on the guide) to guide a resection of the first bone (Fig. 15).
Claim 23, Fallin in view of Davison discloses the system of claim 22, Fallin discloses further comprising a second guide feature (Fig. 15; any edge or slot on the guide) to guide a resection of the second bone (Fig. 15).
Claim 24, Fallin in view of Davison discloses the system of claim 21, Fallin discloses further comprising a first aperture (Fig. 15; 222) for receiving the first fixation element (Figs. 15-18).
Claim 25, Fallin in view of Davison discloses the system of claim 24, Fallin discloses further comprising a second aperture (Fig. 15; any of 224, 226, or 228) for receiving the second fixation element (Figs. 15-18).
Claim 26, Fallin in view of Davison discloses the system of claim 21, Fallin discloses wherein the first bone is a cuneiform (Fig. 18; paragraph [0058]; 306) and the second bone is a metatarsal (Fig. 18; paragraph [0058]; 300).
Claim 27, Fallin in view of Davison discloses the system of claim 21, Fallin discloses further comprising an implant (Fig. 20; 308, 314, and 316) for placement on the first and second bones (Fig. 21; plate is shown only on the metatarsal but it is capable of being placed on the cuneiform as well, and a screw could be placed in the cuneiform while the plate is entirely on the metatarsal if desired).
Claim 28, Fallin discloses a system (Fig. 18) for correcting a deformity in a patient's foot (abstract), the system comprising: a cutting guide (200) including: a first bone engagement surface (Figs. 16 and 18; lower surface 230 over the cuneiform bone 306) shaped to match a first contour on a first bone of the patient's foot (Figs. 16-18; paragraph [0052]) ; and a second bone engagement surface (Figs. 16 and 18; lower surface 230 over the metatarsal bone 300) shaped to match a second contour on a second bone of the patient's foot (Figs. 16-18; paragraph [0052]); and a first guide feature (Fig. 15; any edge or slot on the guide) that, with the first bone engagement surface overlying the first contour, is positioned to guide resection of at least one of the bones of the patient's foot as part of a correction osteotomy for correcting the deformity (Figs. 15-18).
However, Fallin does not disclose forming the engagement surfaces from a virtual bone model.
Davison teaches forming a cut guide with engagement surfaces using a virtual bone model (paragraphs [0051]-[0055]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the engagement surfaces of Fallin using a virtual bone model, as taught by Davison, in order to ensure the perfect fit and match to help make cuts exactly where it was planned (paragraphs [0051]-[0055).
Claim 29, Fallin in view of Davison discloses the system of claim 28, Fallin discloses further comprising a first fixation element (302, could be placed through the hole going into the cuneiform) configured to extend through the guide and into the first bone (Fig. 18).
Claim 30, Fallin in view of Davison discloses the system of claim 29, Fallin discloses further comprising a second fixation element (the other pin 302) configured to extend through the guide and into the second bone (Fig. 18).
Claim 31, Fallin in view of Davison discloses the system of claim 30, Fallin discloses further comprising a first aperture (Fig. 15; 222) for receiving the first fixation element (Figs. 15-18) and a second aperture (Fig. 15; any of 224, 226, or 228) for receiving the second fixation element (Figs. 15-18).
Claim 32, Fallin in view of Davison discloses the system of claim 28, Fallin discloses wherein the first bone is a cuneiform (Fig. 18; paragraph [0058]; 306) and the second bone is a metatarsal (Fig. 18; paragraph [0058]; 300).
Claim 33, Fallin in view of Davison discloses the system of claim 28, Fallin discloses further comprising an implant (Fig. 20; 308, 314, and 316) for placement on the first and second bones (Fig. 21; plate is shown only on the metatarsal but it is capable of being placed on the cuneiform as well, and a screw could be placed in the cuneiform while the plate is entirely on the metatarsal if desired).
Claim 35, Fallin discloses a system (Fig. 18) for correcting a deformity in a patient's foot (abstract), the system comprising: a guide (200) including: a first bone engagement surface (Figs. 16 and 18; lower surface 230 over the cuneiform bone 306) shaped to match a first contour on a cuneiform of the patient's foot (Figs. 16-18; paragraph [0052]) ; and a second bone engagement surface (Figs. 16 and 18; lower surface 230 over the metatarsal bone 300) shaped to match a second contour on a metatarsal of the patient's foot (Figs. 16-18; paragraph [0052]); a first fixation element (302, could be placed through the hole going into the cuneiform) configured to extend through the guide and into the cuneiform (Fig. 18; paragraph [0058]); and a second fixation element (the other pin 302) configured to extend through the guide and into the metatarsal (Fig. 18; paragraph [0058]).
However, Fallin does not disclose forming the engagement surfaces from a virtual bone model.
Davison teaches forming a cut guide with engagement surfaces using a virtual bone model (paragraphs [0051]-[0055]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to form the engagement surfaces of Fallin using a virtual bone model, as taught by Davison, in order to ensure the perfect fit and match to help make cuts exactly where it was planned (paragraphs [0051]-[0055).
Claim 36, Fallin in view of Davison discloses the system of claim 35, Fallin discloses further comprising a first guide feature (Fig. 15; any edge or slot on the guide) to guide a resection of the cuneiform (Fig. 15).
Claim 37, Fallin in view of Davison discloses the system of claim 36, Fallin discloses further comprising a second guide feature (Fig. 15; any edge or slot on the guide) to guide a resection of the metatarsal (Fig. 15).
Claim 38, Fallin in view of Davison discloses the system of claim 35, Fallin discloses further comprising a first aperture (Fig. 15; 222) for receiving the first fixation element (Figs. 15-18).
Claim 39, Fallin in view of Davison discloses the system of claim 38, Fallin discloses further comprising a second aperture (Fig. 15; any of 224, 226, or 228) for receiving the second fixation element (Figs. 15-18).
Claim 40, Fallin in view of Davison discloses the system of claim 35, Fallin discloses further comprising an implant (Fig. 20; 308, 314, and 316) for placement on the cuneiform and metatarsal (Fig. 21; plate is shown only on the metatarsal but it is capable of being placed on the cuneiform as well, and a screw could be placed in the cuneiform while the plate is entirely on the metatarsal if desired).
Response to Arguments
In response to Applicant’s argument that Fallin in view of Davison fails to disclose the first and second bone engagement surfaces are formed form a virtual bone model, the Examiner respectfully disagrees. Davison, paragraphs [0051]-[0052] are very clear that the guide can be patient specific and to create a patient specific guide they use a virtual bone model, this way the guide can mirror the shape of the bone it is placed on. This teaching in combination of the guide of Fallin discloses all the limitations of the claim as noted in the rejections above.
Furthermore, to provide peace of mind to the Applicant that creating a guide with engagement surfaces formed from a virtual bone model is not a new invention, there are numerous examples in the prior art, such as US Patent Applications 2014/0257309, 2016/0345987, 2017/0135706 which all teach this type of stuff. This was strictly limiting the search to guides, but if you open it up to implants placed on bones the number of matching sources is even greater, and much of the art states how you can use this technique on implants and/or guides or any device that will be required to fit on the bone during a procedure.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Applicant's amendment necessitated any new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached at (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Zade Coley/Primary Examiner, Art Unit 3775
Prosecution Insights