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 .
Election/Restrictions
Applicant’s election without traverse of Patient-Specific Cutting Guide Species B, drawn to claims 1-21 in the reply filed on August 27, 2026 is acknowledged.
Claims 20-21 are drawn to the limitation including “a multiplicity of angled holes extending through the body.” This limitation appears to be found in the embodiment of Species C, Figs. 20-23. A multiplicity of angled holes extending through the body is described in [0057] of the present application. These claims appear directed to a non-elected invention and will be considered withdrawn.
Claims 1-19 will therefore be further treated on the merits.
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 12, 14, and 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 12 recites the limitation "the front of the body" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear in what orientation/direction the “front” of the body refers to. Appropriate clarification and correction is required.
Claim 14 recites the limitation "from the front to the back" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear in what orientation/direction the “front” and “back” of the body refers to. Appropriate clarification and correction is required.
Claim 16 recites the limitation "a top of the body" in line 2. There is insufficient antecedent basis for this limitation in the claim. It is unclear in what orientation/direction the “top” of the body refers to. Appropriate clarification and correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1-4, 7, 9, 12, 13, and 16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Pub. No. 2013/0150862 to Aram et al.
As to Claim 1, Aram discloses a patient-specific instrument guide (300, Figs. 15-19). The guide comprises a body (302) comprising a bone contact surface (312) configured to contact a bone surface of a patient [0083], and one or more cutting guides (320) configured to receive a saw blade, drill or reamer during cutting of the bone [0082].
As to Claim 2, Aram discloses a patient-specific instrument guide wherein the one or more cutting guides are comprised of a metal suitable for protecting the body from a saw blade during bone cutting (stainless steel described in [0082]).
As to Claim 3, Aram discloses a patient-specific instrument guide wherein the one or more cutting guides each includes a saw blade slot (326) configured to guide a saw blade during bone cutting [0082].
As to Claim 4, Aram discloses a patient-specific instrument guide wherein the body includes one or more guide slots (322) that each slidably receives one of the one or more cutting guides [0082].
As to Claim 7, Aram discloses a patient-specific instrument guide wherein the body is comprised of a 3D printable material [0065].
As to Claim 9, Aram discloses a patient-specific instrument guide wherein the bone contact surface is configured to optimally contact the surface of a specific bone of the patient [0086-0088].
As to Claim 12, Aram discloses a patient-specific instrument guide wherein one or more fixation holes (318) are disposed at the front of the body and extend to the bone contact surface [0081].
As to Claim 13, Aram discloses a patient-specific instrument guide wherein the one or more fixation holes (318) are configured to received fixation pins to hold the bone contact surface in direct contact with the bone (described in [0081]).
As to Claim 16, Aram discloses a patient-specific instrument guide wherein one or more positioning holes (analogous to 216, Fig. 12) are disposed along a top of the body and configured to receive positioning pins to assist a surgeon with optimally positioning the bone contact surface with the bone [0071].
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 5, 6, 8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2013/0150862 to Aram et al. in view of U.S. Patent Pub. No. 2020/0367910 to Hafez et al.
As to Claims 5, 6, 8, 10, and 11, Aram discloses the claimed invention except for wherein the one or more cutting guides comprises a horizontal cutting guide and a vertical cutting guide orientated to guide cutting a talus during a total ankle arthroplasty surgery, wherein the one or more cutting guides comprises a horizontal cutting guide oriented to guide cutting a tibia during a total ankle arthroplasty surgery, wherein the body is configured to be 3D printed according to medical imaging of a patient's anatomy, wherein the specific bone is a tibia for the purpose of a total ankle arthroplasty surgery, wherein the specific bone is a talus for the purpose of a total ankle arthroplasty surgery.
Hafez discloses a patient-specific instrument guide (Fig. 1, [0027]) wherein the one or more cutting guides comprises a horizontal cutting guide (1) and a vertical cutting guide (2) orientated to guide cutting a talus during a total ankle arthroplasty surgery [0027-0028]. The one or more cutting guides comprises a horizontal cutting guide (1) oriented to guide cutting a tibia during a total ankle arthroplasty surgery [0027-0028]. The body is configured to be 3D printed according to medical imaging of a patient's anatomy [0020]. The specific bone is a tibia or talus for the purpose of a total ankle arthroplasty surgery [0008] in order to provide for proper location, alignment, and placement necessary for cutting the talus [0017].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical cutting guide of Aram with the cutting guide modification of Hafez in order to provide for proper location, alignment, and placement necessary for cutting the talus.
Claims 14, 15, and 17-19 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Pub. No. 2013/0150862 to Aram et al. in view of U.S. Patent Pub. No. 2015/0182273 to Stemniski et al.
As to Claims 14, 15, and 17-19, Aram discloses the claimed invention except for wherein the cutting guide includes at least one angulated pin slot that extends from the front to the back of the cutting guide, wherein the at least one angulated pin slot is configured to fixate the cutting guide within the body, wherein the body includes one or more angled implant positioning holes that are configured to receive positioning pins, wherein the one or more angled implant positioning holes are configured to assist a surgeon with preparing properly angled holes to receive pegs of an implant, wherein the one or more angled implant positioning holes are configured to guide a surgeon with driving positioning pins into a bone at an optimal angle and separation distance, the positioning pins being configured to receive a cannulated drill for the purpose of drilling holes in the bone in preparation for coupling the implant to the bone.
Stemniski discloses a patient-specific instrument guide [0219] wherein the cutting guide (2142) includes at least one angulated pin slot (2146, 2148) that extends from the front to the back of the cutting guide (Fig. 58), and wherein the at least one angulated pin slot is configured to fixate the cutting guide within the body (2100, Fig. 59, [0219]). The body (of 2100) includes one or more angled implant positioning holes (2104, 2106) that are configured to receive positioning pins (298, 0215-0216]). One or more angled implant positioning holes (2104, 2106) are configured to assist a surgeon with preparing properly angled holes to receive pegs (298) of an implant [0220]. The one or more angled implant positioning holes (2104, 2106) are configured to guide a surgeon with driving positioning pins (298) into a bone at an optimal angle and separation distance [0220], the positioning pins being configured to receive a cannulated drill (e.g. 2212) for the purpose of drilling holes in the bone in preparation for coupling the implant to the bone [0200, 0220, 0227] in order to provide means for coupling the cutting guide to the guide body [0219] and provide target for attaching the implant [0220, 0227].
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the surgical cutting guide of Aram with the angulated pin modification of Stemniski in order to provide means for coupling the cutting guide to the guide body.
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
