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 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: resection feature in claims 1-3 and 12; attachment feature in claims 1, 10 and 12; resection features in claim 6; and engagement feature 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 § 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.
Claim(s) 1-3, 10, 12-14, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graser, U.S. Patent 5,843,085 in view of Kunz et al., U.S. PG-Pub 2014/0343403.
Regarding claim 1, Graser discloses an apparatus for remediating a bone condition present in a patient’s foot, comprising: a resection guide (75) comprising: a body having an anterior side, a posterior side, a medial side, a lateral side, a superior side, and an inferior side; a first resection feature (20) configured to guide a cutting tool to form a first osteotomy in a metatarsal (230), the first resection feature extending through the resection guide from the medial side to the lateral side along a first trajectory; a second resection feature (80) configured to guide a cutting tool to form a second osteotomy in the metatarsal, the second resection feature extending through the resection guide form the medial side to the lateral side along a second trajectory; a third resection feature (30) configured to guide a cutting tool to form a third osteotomy in the metatarsal, the third resection feature extending through the resection guide from the medial side to the lateral side along a third trajectory; and a bone attachment feature (K-wire via pin holes 50 and 60) configured to secure the resection guide to the metatarsal (Figs. 2A-2D and Col. 6 lines 11-18).
Graser does not disclose wherein at least one of the first trajectory and the second trajectory are at least partially determined based on using a three-dimensional bone model of at least a portion of the metatarsal, the three-dimensional bone model based on medical imaging of the patient’s foot and representing at least a portion of the patient’s foot.
Kunz et al. discloses designing a guidance tool for intraoperative use during bone or joint surgery that is specific to the anatomy of the patient being treated, the process comprising creating a 3-D surface model of the patient’s anatomy, using the 3-D surface model to preoperatively determine a trajectory for placement at a predetermined trajectory relative to the patient’s anatomy and adjusting the design as necessary to achieve a correct fit (paragraph [0010]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify at least one of the first and second trajectories of Graser to at least be partially determined based on using a three-dimensional bone model of at least a portion of the metatarsal, the three-dimensional bone model based on medical imaging of the patient’s foot and representing at least a portion of the patient’s foot in view of Kunz et al. to permit the apparatus to be designed as necessary to achieve a correct fit and to determine proper trajectory placement.
Regarding claim 2, Graser discloses wherein the third resection feature (30) intersects the first resection feature (20) and the second resection feature (80) at an intersection angle (90) of between about 45 and about 135 degrees (Fig. 2A and Col. 6, lines 2-5).
Regarding claim 3, Graser discloses the invention essentially as claimed except for wherein the third resection feature intersects both the first resection feature and the second resection feature at an intersection angle of about 90 degrees. However, Graser does disclose wherein the third resection feature (80) intersects both the first resection feature (20) and the second resection feature (30) at an intersection angle (90) of about 180 degrees or less (Fig. 2A and Col. 6, lines 1-2).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the intersection angle of Graser to be about 90 degrees, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 10, Graser discloses wherein the bone attachment feature (K-wire via pin holes 50 and 60) is configured to form at least one hole in the bone, the at least one hole configured to serve as an anchor hole for a fixation device (Fig. 2A and Col. 6 lines 11-18).
Regarding claim 12, Graser discloses an apparatus for remediating a bone condition present in a patient’s foot, comprising: a body (75) having an anterior side, a posterior side, a medial side, a lateral side, a superior side, and an inferior side; a resection feature (20, 80, 30) configured to guide a cutting tool to form a wedge osteotomy in a metatarsal, the wedge osteotomy forming a wedge bone fragment; and a bone attachment feature (K-wire via pin holes 50 and 60) configured to secure the resection guide to the metatarsal (Figs. 2A-2D and Col. 6 lines 11-18).
Graser does not disclose wherein at least one of a position, an orientation, and a configuration of the resection feature relative to the body is determined based at least in part on a three-dimensional bone model of at least a portion of the metatarsal, the three-dimensional bone model based on medical imaging of the patient’s foot and representing at least a portion of an anatomy of the patient’s foot.
Kunz et al. discloses designing a guidance tool for intraoperative use during bone or joint surgery that is specific to the anatomy of the patient being treated, the process comprising creating a 3-D surface model of the patient’s anatomy, using the 3-D surface model to preoperatively determine a trajectory for placement at a predetermined trajectory relative to the patient’s anatomy and adjusting the design as necessary to achieve a correct fit (paragraph [0010]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the resection feature of Graser such that at least one of a position, an orientation, and a configuration of the resection feature relative to the body is determined based at least in part on a three-dimensional bone model of at least a portion of the metatarsal, the three-dimensional bone model based on medical imaging of the patient’s foot and representing at least a portion of an anatomy of the patient’s foot in view of Kunz et al. to permit the apparatus to be designed as necessary to achieve a correct fit and to determine proper trajectory placement.
Regarding claims 13 and 14, Graser discloses wherein the resection feature (20, 80, 30) is configured to form a shelf in a head of a metatarsal (fully capable of forming a shelf if using a saw blade making a cut with 80 and 30 with the portion of 30 extending past 80 towards pin hole 50 forming the shelf); and wherein the resection feature is configured to form a planar surface on a proximal side of the wedge osteotomy, the planar surface configured to engage with the shelf during fusion to provide increased bone contact for fusion of the wedge osteotomy (Fig. 2A).
Regarding claim 16, the limitations of claim 16 further define the functional language of line 6 of claim 12; therefore, Graser as modified in view of Kunz et al. discloses such limitations.
Regarding claim 17, Graser discloses the resection features (20, 80, 30) comprising a first section extending through the resection guide (75) form the medial side to the lateral side, the first section comprising: a first leg (20) extending through the resection guide along a first trajectory; a second leg (80) extending through the resection guide along a second trajectory; and a second section extending through the resection guide from the medial side to the lateral side (via 30), the second section intersecting the first leg at a first turn having a first intersection angle and the second leg at a second turn having a second intersection angle (both 90), the second section extending through the resection guide along a third trajectory (via 30) (Figs. 2A-2D).
Claim(s) 4-6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graser, U.S. Patent 5,843,085 in view of Kunz et al., U.S. PG-Pub 2014/0343403 as applied above, and further in view of Goldberg et al., U.S. PG-Pub 2022/0313453.
Regarding claim 4-6, Graser in view of Kunz et al. discloses the invention essentially as claimed except for wherein the first trajectory converges with the second trajectory at a vertex having a wedge angle, and the third trajectory intersects the first trajectory and the second trajectory to form a wedge osteotomy, the wedge angle determined based, at least in part, on the three-dimensional bone model; wherein the vertex is prepositioned to be between a lateral cortex of the metatarsal and the resection guide when the resection guide is designed for the metatarsal; and wherein the vertex is prepositioned such that the first resection feature and the second resection feature are configured to guide the cutting tool for form osteotomies that define a living hinge at a cortex of the metatarsal.
Goldberg et al. discloses trajectories (112, 114, 116) converging at a vertex having a wedge angle to form a wedge osteotomy determined based, at least in part, on the bone model, the vertex being positioned between a lateral cortex of bone and a resection guide when the resection guide is designed for the bone, and such that the vertex is prepositioned such that a osteotomy formed in two of the resection features is configured to form a living hinge at a cortex of the bone for the purposes of permitting the trajectories to depend at least partially on geometric properties and/or relationships between anatomical points to get an ideal osteotomy location (examiner annotated Fig. 4 below and paragraph [0048], [0059]).
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It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the first and second trajectories of Graser such that the first trajectory converges with the second trajectory at a vertex having a wedge angle, and the third trajectory intersects the first trajectory and the second trajectory to form a wedge osteotomy, the wedge angle determined based, at least in part, on the three-dimensional bone model; wherein the vertex is prepositioned to be between a lateral cortex of the metatarsal and the resection guide when the resection guide is designed for the metatarsal; and wherein the vertex is prepositioned such that the first resection feature and the second resection feature are configured to guide the cutting tool for form osteotomies that define a living hinge at a cortex of the metatarsal further in view of Goldberg et al. to permit the trajectories to depend at least partially on geometric properties and/or relationships between anatomical points to get an ideal osteotomy location.
Claim(s) 7-9 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graser, U.S. Patent 5,843,085 in view of Kunz et al., U.S. PG-Pub 2014/0343403 as applied above, and further in view of Iannotti et al., U.S. PG-Pub 2019/0069913.
Regarding claims 7-9 and 15, Graser in view of Kunz et al. discloses wherein the resection guide (75) comprises a bone engagement surface on one of a lateral side and a medial side of the body configured to engage with at least a portion of the metatarsal at a position (Figs. 2A-2B of Graser), but does not disclose the bone engagement surface substantially matching a model position of a model of the resection guide engaging the three-dimensional bone model and configured to at least partially match a contour of a surface of the metatarsal when the resection guide is positioned for use.
Iannotti et al. discloses a guide having a bone engagement surface (520) configured to match a contour of a surface of bone to provide the guide with at least one of location and stabilization assistance with respect to patient tissue (Fig. 5 and paragraph [0062]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the bone engagement surface of Graser to substantially match a model position of a model of the resection guide engaging the three-dimensional bone model and configured to at least partially match a contour of a surface of the metatarsal when the resection guide is positioned for use further in view of Iannotti et al. to permit the guide with at least one of location and stabilization assistance with respect to patient bone.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graser, U.S. Patent 5,843,085 in view of Kunz et al., U.S. PG-Pub 2014/0343403 as applied above, and further in view of Kulwin, U.S. PG-Pub 2023/0027816.
Regarding claim 11, Graser in view of Goldberg et al. discloses the third resection feature (30) being closed on both ends (Fig. 2A of Graser), but does not disclose the third resection feature comprising an open end.
Kulwin discloses a resection guide having resection features (150) having a closed end and an open end (Figs. 2-3) to allow for a wider range of saw blade use (paragraph [0038]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the third resection feature of Graser to have an open end further in view of Kulwin to permit allowing for a wider range of saw blade use.
Allowable Subject Matter
Claim 18 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Response to Arguments
Applicant’s arguments, see Remarks, filed 20 August 2026, with respect to the rejection of claims 6, 10 and 18 under 35 U.S.C. 101 have been fully considered and are persuasive. The rejection of claims 6, 10 and 18 under 35 U.S.C. 101 has been withdrawn.
Applicant’s arguments, see Remarks, filed 20 August 2026, with respect to the rejection(s) of claim(s) 1 and 12 under 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made to Graser, U.S. Patent 5,843,085 in view of Kunz et al., U.S. PG-Pub 2014/0343403.
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 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 Eric Gibson whose telephone number is (571)270-5274. The examiner can normally be reached Monday-Thursday ~6:00 A.M. to 4:00 P.M. (CST).
If attempts to reach the examiner by telephone are unsuccessful, please contact the examiner’s supervisor, Kevin Truong, at (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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/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
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