Detailed Action
This office action is for US application number 18/692,477 evaluates the claims as filed on June 24, 2026.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on June 24, 2026 has been entered.
Response to Arguments
Applicant's arguments filed June 24, 2026 have been fully considered but they are not persuasive. The rejections in this office action have been amended to address the amended claims. Examiner asserts that McAleer, Fallin, Bruse, and Budoff teach all the newly-amended limitations and are capable of performing the functions as claimed. Examiner directs Applicant to the rejection below for a more in-depth description of the limitations.
With regards to Applicant’s argument that the claim amendments overcome the rejections in view of McAleer and Bruse (Remarks p. 6-8), Examiner notes that Fallin and Budoff have been provided as teaching references in the below rejections.
Specification
The specification is objected to as failing to provide proper antecedent basis for the claimed subject matter. See 37 CFR 1.75(d)(1) and MPEP § 608.01(o). Correction of the following is required:
As to claims 1 and 4-15, the specification appears to lack proper antecedent basis for “a joint spacer extending parallel to the cutting slot” of claim 1 line 10. That is, there is no disclosure of protrusion 106, which paragraphs 40, 43, and 50 disclose positioning in the joint, being parallel to the first cutting slot or any structure. Thus, the specification fails to provide proper antecedent basis for “a joint spacer extending parallel to the cutting slot” of claim 1 line 10. Examiner suggests amending as “a joint spacer extending substantially parallel to the cutting slot” as supported by Fig. 3 and 7.
As to claim 17, the specification appears to lack proper antecedent basis for “a joint spacer extending parallel to the cutting slot” of claim 17 line 11. That is, there is no disclosure of protrusion 106, which paragraphs 40, 43, and 50 disclose positioning in the joint, being parallel to the first cutting slot or any structure. Thus, the specification fails to provide proper antecedent basis for “a joint spacer extending parallel to the cutting slot” of claim 17 line 11. Examiner suggests amending as “a joint spacer extending substantially parallel to the cutting slot” as supported by Fig. 3 and 7.
Claim Objections
Claim(s) 1 is/are objected to because of the following informalities:
Claim 1 lines 7-9 should read “a distal protrusion extending transverse to the first cutting slot[[,]] such that the first metatarsal fixation hole is between the metatarsal cut guide and the distal protrusion”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1, 4-15, and 17 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
As to claims 1 and 4-15, “a joint spacer extending parallel to the cutting slot” of claim 1 line 10 appears to be new matter. That is, there is no disclosure of protrusion 106, which paragraphs 40, 43, and 50 disclose positioning in the joint, being parallel to the first cutting slot or any structure. Thus, “a joint spacer extending parallel to the cutting slot” of claim 1 line 10 constitutes new matter. Examiner suggests amending as “a joint spacer extending substantially parallel to the cutting slot” as supported by Fig. 3 and 7.
As to claims 1 and 4-15, “a joint spacer extending parallel to the cutting slot” of claim 17 line 11 appears to be new matter. That is, there is no disclosure of protrusion 106, which paragraphs 40, 43, and 50 disclose positioning in the joint, being parallel to the first cutting slot or any structure. Thus, “a joint spacer extending parallel to the cutting slot” of claim 17 line 11 constitutes new matter. Examiner suggests amending as “a joint spacer extending substantially parallel to the cutting slot” as supported by Fig. 3 and 7.
As to claims 8-15, “a first arm configured to attach to the second metatarsal; and a second arm portion pivotally attached to the first arm” of claim 8 of appears to be new matter. That is, there is no disclosure of such that are in addition to the first arm and the second arm of claim 7. Thus, “a first arm configured to attach to the second metatarsal; and a second arm portion pivotally attached to the first arm” of constitutes new matter. Examiner suggests amending as “wherein is configured to push the first metatarsal toward the second metatarsal”.
As to claims 9-15, “the second arm comprises a metatarsal claw attached to a distal end” of claim 9 appears to be new matter. That is, there is no disclosure of such that are in addition to the metatarsal claw of claim 7. Thus, “the second arm comprises a metatarsal claw attached to a distal end” of constitutes new matter. Examiner suggests amending as “the is attached to a distal end of the second arm”.
As to claims 12-15, “the first arm has an attachment portion at a distal end thereof” of claim 12 appears to be new matter. That is, there is no disclosure of such that are in addition to the attachment portion of claim 7. Thus, “the first arm has an attachment portion at a distal end thereof” of constitutes new matter. Examiner suggests amending as “the is at a distal end of the first arm.”.
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.
Claim(s) 16 and 17 is/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 pre-AIA the applicant regards as the invention.
Claim(s) 16 line 15/claim 17 line 1 is/are unclear with regards to what appears to what is intended to be “17” that was inadvertently lined/stricken out. Examiner is interpreting this as referring to, and suggests amending as, “17.”.
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 of this title, 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, 4-6, and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAleer et al. (US 2021/0361330, hereinafter “McAleer”) in view of Fallin et al. (US 2016/0242791, hereinafter “Fallin”).
The claimed phrase “formed” is being treated as a product by process limitation; that is the product reasonably appears to be either identical with or only slightly different than a product claimed in a product-by-process claim. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, a 35 USC 102/103 rejection may be made and the burden is shifted to applicant to show an unobvious difference. MPEP 2113.
As to claims 1 and 5, McAleer discloses a variable angle osteotomy system (60, 150, Figs. 7A and 14A, ¶167 discloses that the end opposite the pivot may not be connected together, ¶168 discloses that when configured without 254 and 256, both of the guide surfaces have a pin hole, and ¶182 discloses that 264 are holes for fixing the guide to bone with a pin, i.e. a pinhole) comprising: an osteotomy guide (150, Fig. 14A, ¶167 discloses that the end opposite the pivot may not be connected together, ¶168 discloses that when configured without 254 and 256, both of the guide surfaces have a pin hole, and ¶182 discloses that 264 are holes for fixing the guide to bone with a pin, i.e. a pinhole) comprising: a metatarsal cut guide (portion shown including 152A in Fig. 14A, Fig. 14A, ¶167) having a first cutting slot (shown including 152A in Fig. 14A, Fig. 14A, ¶152) extending therethrough (¶152 discloses use for cutting tool to cut a metatarsal end) and an attachment arm (left portion of the metatarsal cut guide as shown in light grey making a hook-shape around pivot axis 252 in Fig. 14A, Fig. 14), the metatarsal cut guide having a first metatarsal fixation hole (¶167 discloses that the end opposite the pivot may not be connected together, ¶168 discloses that when configured without 254 and 256, both of the guide surfaces have a pin hole, and ¶182 discloses that 264 are holes for fixing the guide to bone with a pin, i.e. a pinhole) and a distal protrusion extending transverse to the first cutting slot (¶167 discloses that the end opposite the pivot may not be connected together, ¶168 discloses that when configured without 254 and 256, both of the guide surfaces have a pin hole, and ¶182 discloses that 264 are holes for fixing the guide to bone with a pin, i.e. a pinhole, where the pinholes are provided on protrusions transverse to the slots as evidenced by Figs. 13 and 14A); and a cuneiform cut guide (portion shown including 154A in Fig. 14A, Fig. 14A, ¶167) having a second cutting slot (shown including 154A in Fig. 14A, Fig. 14A, ¶156) extending therethrough (¶156 discloses use for cutting tool to cut a cuneiform end), the cuneiform cutting guide being pivotally attached to the attachment arm (about pivot axis 252 as shown in Fig. 14A, Fig. 14A, ¶167 hinged movable connection with the guides allowed to rotate relative to each other about pivot axis 252) and having a first cuneiform fixation hole (left 264 as shown in Fig. 14A, Fig. 14A, ¶182). As to claim 5, McAleer discloses a second cuneiform fixation hole (right 264 as shown in Fig. 14A) extending therethrough adjacent to the second cutting slot (Fig. 14A, where ¶182 discloses that 264 are holes for fixing the guide to bone with a pin).
McAleer is silent to the first metatarsal fixation hole is between the metatarsal cut guide and the distal protrusion; and a joint spacer extending parallel to the cutting slot.
Fallin teaches as similar osteotomy system (Figs. 55-64) comprising: an osteotomy guide (400, Figs. 55-61) comprising: a metatarsal cut guide (left portion of 400 as shown in Fig. 55 and including 434, Figs. 55 and 58) having a first cutting slot (434, Figs. 55 and 58, ¶84) extending therethrough (Figs. 55 and 58, ¶84), the metatarsal cut guide having: a first metatarsal fixation hole (418, Figs. 55 and 58, ¶82) and a distal protrusion (portion to the left of 418 as shown in Fig. 55, figs. 55 and 58) extending transverse to the first cutting slot (Figs. 55 and 58) such that the first metatarsal fixation hole is between the metatarsal cut guide and the distal protrusion (Figs. 55 and 58); and a cuneiform cut guide (right portion of 400 as shown in Fig. 55 and including 430, Figs. 55 and 58) having a second cutting slot (430, Figs. 55 and 58, ¶84) extending therethrough (430, Figs. 55 and 58, ¶84), the cuneiform cutting guide having a first cuneiform fixation hole (416, 430, Figs. 55 and 58, ¶82).
McAleer, in an alternate embodiment, teaches a similar osteotomy system (Figs. 19-21, ¶214) comprising: an osteotomy guide (150) comprising: a metatarsal cut guide (lower portion of 150 as shown in Fig. 21 including 280 and 152 as labeled on Fig. 5A, Figs. 19-21, ¶214) having a first cutting slot (lower slot as shown in Fig. 21, i.e. 152 as labeled on Fig. 5A, Figs. 19-21) extending therethrough (¶93), the metatarsal cut guide having: a joint spacer (280, ¶214) extending parallel to the cutting slot (Figs. 19 and 20, ¶91 discloses cutting parallel to the end of the bone; and a cuneiform cut guide (upper portion of 150 as shown in Fig. 21 including 154 as labeled on Fig. 5A, Figs. 19-21, ¶214) having a second cutting slot (upper slot as shown in Fig. 21, i.e. 154 as labeled on Fig. 5A, Figs. 19-21) extending therethrough (¶93).
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to modify the distal protrusion of McAleer to extend distally of the first metatarsal fixation hole as taught by Fallin, since Applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of aiding in alignment of the guide relative to the bone (Fallin ¶s 81 and 84) to align the longitudinal axis parallel with the metatarsal axis (Fallin ¶84). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the metatarsal cut guide as disclosed by McAleer by adding the joint spacer as taught by McAleer, in an alternate embodiment, in order to aid in locating and orienting the guide relative to the joint space by inserting the joint spacer therein (McAleer ¶s 195 and 214).
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As to claim 4, the combination of McAleer and Fallin discloses the invention of claim 1 but is silent to a second fixation hole positioned between the first cutting slot and the distal protrusion.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to construct the assembly of the combination of McAleer and Fallin having a second fixation hole positioned between the first cutting slot and the distal protrusion, since mere duplication of the essential working parts of a device involves only routine skill in the art and one would be motivated to do so in order to provide additional fixation with the underlying bone (McAleer ¶182).
As to claim 6, the combination of McAleer and Fallin discloses the invention of claim 1 as well as that guide surface 154A can extend at parallel or at an angle in a dorsal to plantar direction (¶156), i.e. that the second cutting slot has a dorsal to plantar taper formed therein (¶156).
The combination of McAleer and Fallin is silent to the dorsal to plantar taper being 2-degrees.
It would have been an obvious matter of design choice before the effective filing date of the claimed invention to specify that the dorsal to plantar taper as disclosed by the combination of McAleer and Fallin is 2-degrees, since such a modification would have involved a mere change in the size of a component to guide a cutting tool to remove an end of an opposed cuneiform bone (McAleer ¶156). A change in size is generally recognized as being within the level of ordinary skill in the art. In other words, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the second cutting slot of the combination of McAleer and Fallin to have the dorsal to plantar taper at 2-degrees since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In the instant case, the second cutting slot of the combination of McAleer and Fallin would not operate differently with the claimed the dorsal to plantar taper at 2-degrees and since the combination of McAleer and Fallin discloses that such can be parallel or angled such would function appropriately with the claimed value to guide a cutting tool to remove an end of an opposed cuneiform bone (McAleer ¶156). Further, Applicant places no criticality on the claimed dorsal to plantar taper at 2-degrees, indicating simply that the 2-degree dorsal to plantar taper of slot 118 is shown in Fig. 9 (¶40).
As to claim 17, McAleer discloses a variable angle osteotomy guide (150, Fig. 14A) comprising: a metatarsal cut guide (portion shown including 152A in Fig. 14A, Fig. 14A, ¶167) having: a first cutting slot (shown including 152A in Fig. 14A, Fig. 14A, ¶152) extending therethrough (¶152 discloses use for cutting tool to cut a metatarsal end); a first attachment hole (¶167 discloses that the end opposite the pivot may not be connected together, ¶168 discloses that when configured without 254 and 256, both of the guide surfaces have a pin hole, and ¶182 discloses that 264 are holes for fixing the guide to bone with a pin, i.e. a pinhole, where the pinholes are provided on protrusions transverse to the slots as evidenced by Figs. 13 and 14A) located distally from the first cutting slot (¶s 167, 168, and 182; as evidenced by Figs. 13 and 14A); a protrusion extending transverse to the first cutting slot (¶167 discloses that the end opposite the pivot may not be connected together, ¶168 discloses that when configured without 254 and 256, both of the guide surfaces have a pin hole, and ¶182 discloses that 264 are holes for fixing the guide to bone with a pin, i.e. a pinhole, where the pinholes are provided on protrusions transverse to the slots as evidenced by Figs. 13 and 14A); and an attachment arm (left portion of the metatarsal cut guide as shown in light grey making a hook-shape around pivot axis 252 in Fig. 14A, Fig. 14); and a cuneiform cut guide (portion shown including 154A in Fig. 14A, Fig. 14A, ¶167) having: a second cutting slot (shown including 154A in Fig. 14A, Fig. 14A, ¶156) extending therethrough (¶156 discloses use for cutting tool to cut a cuneiform end), the cuneiform cutting guide being pivotally attached to the attachment arm (about pivot axis 252 as shown in Fig. 14A, Fig. 14A, ¶167 discloses the hinged movable connection with the guides allowed to rotate relative to each other about pivot axis 252); and first and second cuneiform attachment holes (left 264 as shown in Fig. 14A, right 264 as shown in Fig. 14A, Fig. 14A, ¶182 discloses that 264 are holes for fixing the guide to bone with a pin).
McAleer is silent to a second attachment hole located distally from the first cutting slot; the protrusion extending distally from the first and second metatarsal attachment holes; and a joint spacer extending parallel to the cutting slot.
Fallin teaches as similar osteotomy guide (400, Figs. 55-61) comprising: a metatarsal cut guide (left portion of 400 as shown in Fig. 55 and including 434, Figs. 55 and 58) having: a first cutting slot (434, Figs. 55 and 58, ¶84) extending therethrough (Figs. 55 and 58, ¶84),a first attachment hole (418, Figs. 55 and 58, ¶82) located distally from the first cutting slot (Figs. 55 and 58); and a protrusion (portion to the left of 418 as shown in Fig. 55, figs. 55 and 58) extending transverse to the first cutting slot (Figs. 55 and 58) and distally from the first metatarsal attachment hole (Figs. 55 and 58); and a cuneiform cut guide (right portion of 400 as shown in Fig. 55 and including 430, Figs. 55 and 58) having: a second cutting slot (430, Figs. 55 and 58, ¶84) extending therethrough (430, Figs. 55 and 58, ¶84), and a first cuneiform fixation hole (416, 430, Figs. 55 and 58, ¶82).
McAleer, in an alternate embodiment, teaches a similar osteotomy guide (150, Figs. 19-21, ¶214) comprising: a metatarsal cut guide (lower portion of 150 as shown in Fig. 21 including 280 and 152 as labeled on Fig. 5A, Figs. 19-21, ¶214) having: a first cutting slot (lower slot as shown in Fig. 21, i.e. 152 as labeled on Fig. 5A, Figs. 19-21) extending therethrough (¶93); and a joint spacer (280, ¶214) extending parallel to the cutting slot (Figs. 19 and 20, ¶91 discloses cutting parallel to the end of the bone; and a cuneiform cut guide (upper portion of 150 as shown in Fig. 21 including 154 as labeled on Fig. 5A, Figs. 19-21, ¶214) having a second cutting slot (upper slot as shown in Fig. 21, i.e. 154 as labeled on Fig. 5A, Figs. 19-21) extending therethrough (¶93).
It would have been an obvious matter of design choice to one skilled in the art before the effective filing date of the claimed invention to modify the protrusion of McAleer to extend distally of the first metatarsal attachment hole as taught by Fallin, since Applicant has not disclosed that such solve any stated problem or is anything more than one of numerous shapes or configurations a person ordinary skill in the art would find obvious for the purpose of aiding in alignment of the guide relative to the bone (Fallin ¶s 81 and 84) to align the longitudinal axis parallel with the metatarsal axis (Fallin ¶84). One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the metatarsal cut guide as disclosed by McAleer by adding the joint spacer as taught by McAleer, in an alternate embodiment, in order to aid in locating and orienting the guide relative to the joint space by inserting the joint spacer therein (McAleer ¶s 195 and 214). Further, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention was made to construct the assembly of the combination of McAleer and Fallin having a second fixation hole positioned between the first cutting slot and the distal protrusion, since mere duplication of the essential working parts of a device involves only routine skill in the art and one would be motivated to do so in order to provide additional fixation with the underlying bone (McAleer ¶182).
Claim(s) 7-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAleer in view of Bruse (US 2022/0039816).
As to claim 7, McAleer discloses the invention of claim 1 as well as a de-rotation device (Fig. 7A, ¶s 125-131) capable of rotating a first metatarsal relative to a second metatarsal (¶s 119 and 125), the de-rotation device comprising: an attachment portion (68) attached to a first arm (62, Fig. 7A), the first arm having a first locking arm (lower left portion of 72 as shown in Fig. 7A comprising threads 70, Fig. 7A, ¶127 discloses 64 rotates, i.e. pivots. with respect to 62); a metatarsal claw (66) attached to a second arm (64, Fig. 7A, ¶s 127-129), the first and second arm pivotally pinned to each other (via threads 70, Fig. 7A, ¶127 discloses 64 rotates, i.e. pivots. with respect to 62). As to claim 8, McAleer discloses that the second arm capable of pushing a first metatarsal toward the second metatarsal (¶s 127 and 128). As to claim 9, McAleer discloses that the metatarsal claw is pivotally attached to a distal end of the second arm (Fig. 7A, ¶s 127-129). As to claim 10, McAleer discloses that the metatarsal claw comprises an arcuate face (Fig. 7A, ¶129). As to claim 11, McAleer discloses that the metatarsal claw has a through opening extending therethrough (78, Fig. 7A, ¶131). As to claim 12, McAleer discloses that the attachment portion is at a distal end of the first arm (Fig. 7A). As to claim 13, McAleer discloses that the attachment portion has a ribbed surface (Fig. 7A, ¶130). As to claims 14 and 15, McAleer discloses the invention of claim 13 as well as a K-wire placed through the through opening of the metatarsal claw and through bone engaged with the metatarsal claw (¶131) and the K-wire inserted through a moved bone and into an adjacent bone (¶137). Further, McAleer discloses that, with typical metatarsus adductus deformities, the metatarsals may exhibit a substantially uniplanar misalignment in the transverse plane but that alternatively, the clinician may move one or more of the metatarsals being realigned in more than one plane, e.g. the clinician may adjust the rotational angle of the metatarsal(s) in the frontal plane and/or adjust the angle of the metatarsal(s) in the sagittal plane (¶119). Where the clinician performs a multi-planar realignment, the clinician may move one or more metatarsals in multiple planes simultaneously through a single movement, e.g., by moving the metatarsal in an arc or other movement pathway to adjust the position of the metatarsal in multiple planes (¶120). Further, McAleer discloses an actuator (76) being alternately positioned dorsally above the main body to facilitate positioning in an intermetatarsal space (¶131). As to claim 15, McAleer discloses that the through opening of the metatarsal claw is sized to allow a single K-wire to be inserted therethrough (¶s 131 and 137).
McAleer is silent to the second arm having a second locking arm connectable to the fist locking arm via an engaging member on the first locking arm. As to claim 14, McAleer is silent to the attachment portion has a through opening extending therethrough. As to claim 15, McAleer is silent to the through opening of the attachment portion is sized to allow a single K-wire to be inserted therethrough.
Bruse teaches a similar de-rotation device (10, Figs. 1-4) capable of positioning metatarsals (Figs. 2 and 3, ¶s 17-18), the device comprising: an attachment portion (22 on 30a, Fig. 1) attached to a first arm (16a), the first arm having a first locking arm (28a); a metatarsal claw (22 on 30b, Fig. 1) attached to a second arm (16b), the first and second arm pivotally pinned to each other (Figs. 1-3, ¶23), and the second arm having a second locking arm (28b) capable of connecting to the fist locking arm (Fig. 1, ¶19) via an engaging member on the first locking arm (“pawls” of ¶19, Fig. 1, ¶19). As to claim 8, Bruse teaches that the second arm capable of pushing a first metatarsal toward the second metatarsal (Figs. 2-3, ¶25). As to claim 9, Bruse teaches that the metatarsal claw is pivotally attached to a distal end of the second arm (Figs. 1-3, ¶23). As to claim 10, Bruse teaches that the metatarsal claw comprises an arcuate face (Fig. 1, ¶21 discloses that 32b is a substantially vertical serrated spoon). As to claim 11, Bruse teaches that the metatarsal claw has a through opening (34) extending therethrough (¶s 23, 32-33, and 43). As to claim 12, Bruse teaches that the attachment portion is at a distal end of the first arm (Figs. 1-4). As to claim 13, Bruse teaches that the attachment portion has a ribbed surface (¶21 discloses that 32a is a substantially vertical serrated spoon). As to claim 14, Bruse teaches that the attachment portion has a through opening (34) extending therethrough (Figs. 1-4, ¶s 23, 32-33, and 43). As to claim 15, Bruse teaches that the through opening of the metatarsal claw and the through opening of the attachment portion are each sized to allow a single K-wire to be inserted therethrough (Figs. 3 and 4, ¶23).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to replace the arms and actuator and modify the attachment portion as disclosed by McAleer with the arms and actuator and by adding a through opening as taught by Bruse in order to hold the first metatarsal in a multiplanar correction (Bruse ¶s 25 and 26, McAleer ¶s 119 and 120) and permit the wire feeding hardware to coupled/installed in the through opening in the metatarsal claw or the through opening in the attachment portion (Bruse ¶s 32 and 33) such that the surgical device and wire feeding hardware may be used on either the left of the right foot (Bruse ¶33).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAleer in view of Budoff (US 2012/0130383).
As to claim 16, McAleer discloses a variable angle osteotomy system (150, Fig. 14A) comprising: an osteotomy guide (150, Fig. 14A) comprising: a metatarsal cut guide (portion shown including 152A in Fig. 14A, Fig. 14A, ¶167) having a first cutting slot (shown including 152A in Fig. 14A, Fig. 14A, ¶152) extending therethrough (¶152 discloses use for cutting tool to cut a metatarsal end) and an attachment arm (left portion of the metatarsal cut guide as shown in light grey making a hook-shape around pivot axis 252 in Fig. 14A, Fig. 14); and a cuneiform cut guide (portion shown including 154A in Fig. 14A, Fig. 14A, ¶167) having a second cutting slot (shown including 154A in Fig. 14A, Fig. 14A, ¶156) extending therethrough (¶156 discloses use for cutting tool to cut a cuneiform end), the cuneiform cutting guide being pivotally attached to the attachment arm (about pivot axis 252 as shown in Fig. 14A, Fig. 14A, ¶167 discloses the hinged movable connection with the guides allowed to rotate relative to each other about pivot axis 252), and a pivot (at pivot axis 252 as shown in Fig. 14A, Fig. 14A, ¶167 discloses the hinged movable connection with the guides allowed to rotate relative to each other about pivot axis 252) attaching the metatarsal cut guide to the cuneiform cut guide (Fig. 14A, ¶167 discloses the hinged movable connection with the guides allowed to rotate relative to each other about pivot axis 252), wherein the attachment arm extends from the metatarsal cut guide on a first side of the second cutting slot, around the cuneiform cut guide, to a second side of the second cutting slot (see illustration of Fig. 14A which identifies the attachment are on each of the first and second sides of the second cutting slot, Fig. 14A).
McAleer is silent to the pivot is located entirely on the second side of the second cutting slot.
Budoff teaches a similar variable angle osteotomy system (Figs. 2-12) comprising: an osteotomy guide (Figs. 6-9) comprising: a first cut guide (including 116 and above as shown in Fig. 9, Fig. 9) having a first cutting slot (116) extending therethrough (Fig. 9, ¶s 71 and 72) and an attachment arm (right portion of 78 as shown in Fig. 9, Fig. 9); and a second cut guide (including 118 and below as shown in Fig. 9, Fig. 9) having a second cutting slot (118) extending therethrough (Fig. 9, ¶s 71 and 72), the second cutting guide being pivotally attached to the attachment arm (at axis 80, Fig. 9, ¶66); and a pivot (at axis 80, Fig. 9, ¶66) attaching the first cut guide to the second cut guide (Fig. 9, ¶66), wherein the attachment arm extends from the first cut guide on a first side of the second cutting slot, around the second cut guide, to a second side of the second cutting slot (Figs. 6-9) and wherein the pivot is located entirely on the second side of the second cutting slot (Fig. 9).
One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify the attachment arm, pivot, and corresponding portion of the cuneiform cut guide as disclosed by McAleer so that the pivot is located entirely on the second side of the second cutting slot as taught by Budoff in order to provide a known pivot arrangement for connecting pivotably cutting slots (Budoff Fig. 9, ¶66) to permit changing of the angle alpha to thereby change thickness of the bone fragment and thereby the degree of shortening of the bone (Budoff ¶71).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMY R SIPP whose telephone number is (313)446-6553. The examiner can normally be reached on Mon - Thurs 6-4.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached on (571)272-4705. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMY R SIPP/Primary Examiner, Art Unit 3775
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