Detailed Action
This is the final office action for US application number 18/692,477. Claims are evaluated as filed on January 15, 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 .
Response to Arguments
Applicant's arguments filed January 15, 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 and Bruse 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 the current amendments to claim 1, Examiner notes that there has either been a change in direction or a misunderstanding with what was discussed in the interview regarding the protrusion of claim 2 being claimed as transverse to the first slot, as the current amendments to claim 1 do not represent the protrusion 106 extending transversely to slot 114. Further, review of Applicant’s figures show that in Figs. 3 and 5 show that slot 114 has a sidewall that is continuous with protrusion 106 and thus does not seem to be transverse. Instead, review of Figs. 7-9 show that slot 118 is transverse to protrusion 106 due to the taper of claim 6. Instead the current amendment to claim 1 reads on protrusion 108, but such results in new matter in claims 3 and 4 as detailed in the below rejections.
With regards to Applicant’s argument that claims have been amended to overcome the rejections under 35 USC 112b (Remarks p. 6), Examiner notes that claim 7 has been amended to provide additional functional limitations and thus does not provide a definable structural limitation to enable interpretation under BRI and a definition of the structure has not been identified in the specification. Thus, the scope of claim 7 is still indefinite. Examiner suggests either amending claim 7 to provide a structural feature of the de-rotation device or cancelling claim 7 and amending claim 8 accordingly to depend from claim 1 and have appropriate antecedent basis for claim terms such as the de-rotation device and the second metatarsal. Examiner notes that claim 8 could also be amended to incorporate the recently added functional limitation of claim 7 if desired.
With regards to Applicant’s argument that claim 1 has been amended to incorporate the features of original claim 2 and clarified that the protrusion extends transverse to the first cutting slot (Remarks p. 7), Examiner disagrees. Original claim 2 was drawn to a protrusion extending downwardly from the metatarsal guide, i.e. protrusion 106 as shown in at least Figs. 1, 3, 4, 10 and 11, and there is no limitation in claim 1 requiring the protrusion to extend downwardly. Further, Fig. 3 shows dashed lines indicating that a surface of protrusion 106 is continuous with or defines the edge of the first cutting slot 114. Thus, it does not appear that 106 is transverse to 114 or to itself. Instead, the protrusion of claim 1 appears to be supported by the disclosure of protrusion 108. Examiner suggests that it may be intended to claim protrusion 106 as transverse to some unclaimed surface of the guide or slot that is not clear from the instant claims. Alternately it could be intended to claim the angle of the second cutting slot 118 in relative to protrusion 106, e.g. similar to original claim 2 + original claim 6.
With regards to Applicant’s argument that McAleer does not disclose all the features of amended claim 1 (Remarks p. 7), Examiner disagrees and directs Applicant to the rejection below for a more in-depth description of the limitations. Regarding the protrusion transverse to the first slot, Examiner notes that McAleer discloses that, for Fig. 14A, the opposite end of the two guide surfaces from pivot axis 252 may not be connected together (¶167) as well as that, when the guide is configured without a sliding connection 254 and/or lock 256, both of the guide surfaces may have an associated pinhole that allows each guide surface to be pin to an underlying bone for temporarily fixing the position of the guide surface during a surgical procedure (¶168). Further, fixation holes 264 are disclosed to allow the cut guide to be provisionally fixated to an underlying bone with receive a fixation pin (¶182) and are shown in at least Figs. 13 and 14A as being provided on a protrusion extending transversely from the slot of the guide to which they are connected. Thus, per the disclosure of paragraphs 167, 168, and 182 and evidenced by Figs. 13 and 14A, McAleer discloses a protrusion extending transverse to the first cutting slot as claimed.
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 3 and 4, the specification appears to lack proper antecedent basis for “a distal protrusion extending distally therefrom” of claim 3 line 2 that is in addition to “a protrusion extending transverse to the first cutting slot” of claim 1 lines 5-6. That is, the only structure shown on metatarsal cut guide 102 that extends transversely to slot 114 and protrudes appears to be distal protrusion 108, as protrusion 106 is shown in Figs. 3 and 5 as having a side surface that is continuous with a sidewall of slot 114 and thus does not appear to be transverse. However, paragraph 40 provides that 108 is the distal protrusion and there appears to be no other disclosure of a distal protrusion. Thus, the specification fails to provide proper antecedent basis for “a distal protrusion extending distally therefrom” of claim 3 line 2 that is in addition to “a protrusion extending transverse to the first cutting slot” of claim 1 lines 5-6. To address the lack of specification support for claims 3 and 4, Examiner suggests amending claim 1 to claim protrusion 160 and notes that review of Figs. 7-9 show that cuneiform slot 118 is transverse to protrusion 106 due to the slot taper of claim 6.
As to claim 16, the specification appears to lack proper antecedent basis for “an attachment arm” of line 8 that is in addition to “an attachment arm” of line 4. That is, a total of two attachment arms are claimed and the only disclosure appears of an attachment arm appears to be 130 (¶43). Thus, the specification fails to provide proper antecedent basis for “an attachment arm” of line 8 that is in addition to “an attachment arm” of line 4. Examiner suggests amending line 8 “[[an]]wherein the attachment arm pivotally attach[[ing]]es the ”.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “a distal protrusion extending distally therefrom” of claim 3 line 2 that is in addition to “a protrusion extending transverse to the first cutting slot” of claim 1 lines 5-6 and “an attachment arm” of claim 16 line 8 that is in addition to “an attachment arm” of claim 16 line 4 must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “de-rotation device” in claim 7.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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) 3, 4, and 16 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 3 and 4, “a distal protrusion extending distally therefrom” of claim 3 line 2 that is in addition to “a protrusion extending transverse to the first cutting slot” of claim 1 lines 5-6 appears to be new matter. That is, the only structure shown on metatarsal cut guide 102 that extends transversely to slot 114 and protrudes appears to be distal protrusion 108, as protrusion 106 is shown in Figs. 3 and 5 as having a side surface that is continuous with a sidewall of slot 114 and thus does not appear to be transverse. However, paragraph 40 provides that 108 is the distal protrusion and there appears to be no other disclosure of a distal protrusion. Thus, “a distal protrusion extending distally therefrom” of claim 3 line 2 that is in addition to “a protrusion extending transverse to the first cutting slot” of claim 1 lines 5-6 constitutes new matter. To address the new matter of claims 3 and 4, Examiner suggests amending claim 1 to claim protrusion 160 and notes that review of Figs. 7-9 show that cuneiform slot 118 is transverse to protrusion 106 due to the slot taper of claim 6.
As to claim 16, “an attachment arm” of line 8 that is in addition to “an attachment arm” of line 4 appears to be new matter. That is, a total of two attachment arms are claimed and the only disclosure appears of an attachment arm appears to be 130 (¶43). Thus, “an attachment arm” of line 8 that is in addition to “an attachment arm” of line 4 constitutes new matter. Examiner suggests amending line 8 “[[an]]wherein the attachment arm pivotally attach[[ing]]es the ”.
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) 7-15 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) 7 is/are unclear with regards to “de-rotation device” in line 2 and the intended scope as a definition does not appear to be disclosed to enable one to ascertain the scope and equivalents thereof. That is, paragraphs 48 and 49 discuss the intended use of “de-rotation device” 200 but are silent as to a definition of the structure encompassed. Examiner is interpreting this as referring a broad device similar to that of shown 200 and suggests amending to claim sufficient structure to enable a broadest reasonable interpretation.
Claim(s) 16 is/are unclear with regards to “the attachment arm” in line 9 and if such is intended to refer to the “an attachment arm” of line 4 or the “an attachment arm” of line 8. Examiner is interpreting this as referring to, and suggests amending line 8 as, “[[an]]wherein the attachment arm pivotally attach[[ing]]es the” or “wherein s from the metatarsal cut guide”
Claim(s) 8-15 is/are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for its/their dependence on one or more rejected base claims.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
As to claim 13, “the attachment portion has a ribbed surface” does not appear to further limit over the claim 12 line 3 recitation of “the attachment portion has a ribbed surface”. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5, and 7-13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by McAleer et al. (US 2021/0361330, hereinafter “McAleer”).
As to claim 1, 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 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).
As to claim 7, McAleer discloses a de-rotation device (Fig. 7A, ¶s 125-131) capable of rotating a first metatarsal relative to a second metatarsal (¶s 119 and 125).
As to claim 8, McAleer discloses that the de-rotation device comprises: a first arm (62) capable of attaching to the second metatarsal (¶s 128 and 130); and a second arm portion (64) pivotally attached to the first arm (via threads 70, Fig. 7A, ¶127 discloses 64 rotates, i.e. pivots. with respect to 62), 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 second arm comprises a metatarsal claw pivotally attached to a distal end (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 first arm has an attachment portion (68) at a distal end thereof (Fig. 7A); wherein the attachment portion has a ribbed surface (Fig. 7A, ¶130).
As to claim 13, McAleer discloses that the attachment portion has a ribbed surface (Fig. 7A, ¶130).
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 wherein the attachment arm pivotally attaches the metatarsal cut guide to the cuneiform cut guide (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), the attachment arm extending 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).
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As to claim 17, 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), the metatarsal cut guide having a protrusion (shown on the right end of the metatarsal cut guide in Fig. 14A, Fig. 14A) extending transverse to the first cutting slot (Fig. 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 discloses the hinged movable connection with the guides allowed to rotate relative to each other about pivot axis 252).
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) 3, 4, and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAleer.
As to claims 3 and 4, McAleer discloses the invention of claim 1 but is silent to a distal protrusion that is in addition to the protrusion of claim 1.
McAleer does teach having a total of two protrusions (Fig. 14) on a cut guide (Fig. 14A); wherein each protrusion comprises a fixation hole (264s) and extends beyond the fixation hole (Fig. 14A); wherein the fixation holes comprise a first fixation hole (left 264 as shown in Fig. 14A, Fig. 14A). As to claim 4, McAleer teaches a second fixation hole (right 264 as shown in Fig. 14A, Fig. 14A) positioned between the first cutting slot and the distal protrusion (as defined, Fig. 14A).
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 metatarsal cut guide of McAleer with a total of two protrusions that each comprise a fixation hole and extends beyond the fixation hole, 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).
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 claim 6, McAleer 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).
McAleer 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 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 (¶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 McAleer 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 McAleer would not operate differently with the claimed the dorsal to plantar taper at 2-degrees and since McAleer 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 (¶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).
Claim(s) 14 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAleer in view of Bruse (US 2022/0039816).
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 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: a first arm (16a) capable of attaching to a second metatarsal (Figs. 2 and 3, ¶s 17-18); and a second arm portion (16b) pivotally attached to the first arm (via 18, Figs. 1-3, ¶23), the second arm capable of pushing a first metatarsal toward the second metatarsal (Figs. 2-3, ¶25); wherein the second arm comprises a metatarsal claw (22 on 30b, Fig. 1) pivotally attached to a distal end (Figs. 1-3, ¶23), wherein the metatarsal claw comprises an arcuate face (Fig. 1, ¶21 discloses that 32b is a substantially vertical serrated spoon), wherein the metatarsal claw has a through opening (34) extending therethrough (¶s 23, 32-33, and 43); wherein the first arm has an attachment portion (22 on 30a, Fig. 1) at a distal end thereof (Figs. 1-4), wherein the attachment portion has a ribbed surface (¶21 discloses that 32a is a substantially vertical serrated spoon); wherein 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).
Conclusion
Applicant's amendment necessitated the 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 extension fee 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 date of this final action.
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/AMY R SIPP/Primary Examiner, Art Unit 3775