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 .
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-18 in the reply filed on 26 March 2026 is acknowledged.
Claims 19 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 26 March 2026.
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 § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 6, 10 and 18 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Claim 6 recites “wherein the vertex is prepositioned such that an osteotomy formed in two of the resection features forms a living hinge at a cortex of the bone.”
Claim 10 recites “wherein the bone attachment feature forms at least one hole in the bone, the at least one hole configured to serve as an anchor hole for a fixation device.”
Claim 18 recites “wherein the second section is positioned within the resection guide such that the second section protects sesamoids that are plantar to a head of the metatarsal from dissection.”
It appears bones are being positively recited as limitations of the claims. It is suggested application amend the claims such that the bones are functionally recited, i.e. “is configured to form a living hinge at a cortex of the bone,” “is configured to form at least one hole in the bone,” and “is configured to protect sesamoids that are plantar to a head of the metatarsal from dissection.”
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) 1-6, 10, 12-14, and 16-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Graser, U.S. Patent 5,843,085 in view of Goldberg et al., U.S. PG-Pub 2022/0313453.
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 bone, 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 bone, 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 bone, 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 bone (Figs. 2A-2D and Col. 6 lines 11-18).
Graser does not disclose wherein at least one of the first trajectory, the second trajectory, and the third trajectory are at least partially determined based on a bone model of at least a portion of the bone, the bone model based on medical imaging of the patient’s foot and configured to resemble an anatomy of the patient’s foot.
Goldberg et al. discloses designing patient specific cut guides to have trajectories (112, 114, 116) determined based on a bone model of at least a portion of a bone that is based on medical imaging of a patient and configured to resemble an anatomy of the patient’s foot as such permits the cut line trajectories to depend at least partially on geometric properties and/or relationships between anatomical points to get an ideal osteotomy location (Fig. 4 and paragraph [0048], [0059]).
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, second, and third trajectories of Graser to be at least partially determined based on a bone model of at least a portion of the bone, the bone model based on medical imaging of the patient’s foot and configured to resemble an anatomy of the patient’s foot 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.
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 4-6, 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 (examiner annotated Fig. 4 below and paragraph [0048], [0059]).
PNG
media_image1.png
382
348
media_image1.png
Greyscale
Therefore, the combination of Graser as modified in view of Goldberg et al. (see claim 1 above) discloses the limitations of claims 4-6 for the purposes of to permitting the trajectories to depend at least partially on geometric properties and/or relationships between anatomical points to get an ideal osteotomy location.
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 bone (Figs. 2A-2D and Col. 6 lines 11-18).
Graser does not disclose the wedge osteotomy at least partially determined based on a bone model of at least a portion of the metatarsal.
Goldberg et al. discloses designing patient specific cut guides to have trajectories (112, 114, 116) determined based on a bone model of at least a portion of a bone that is based on medical imaging of a patient and configured to resemble an anatomy of the patient’s foot as such permits the cut line trajectories to depend at least partially on geometric properties and/or relationships between anatomical points to get an ideal osteotomy location (Fig. 4 and paragraph [0048], [0059]).
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 cutting trajectories are configured to guide the cutting tool to form the wedge osteotomy based on a bone model of at least a portion of the metatarsal in view of Goldberg et al. to permit forming the wedge osteotomy at an ideal location.
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 5 of claim 12; therefore, Graser as modified in view of Goldberg et al. discloses such limitations.
Regarding claims 17 and 18, 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); and wherein the second section is positioned within the resection guide such that the second section is configured to protect sesamoids that are plantar to a head of the metatarsal from dissection (Figs. 2A-2D).
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 Goldberg et al., U.S. PG-Pub 2022/0313453 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 Goldberg 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 bone 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 bone model and configured to at least partially match a contour of a surface of the bone 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 bone model and configured to at least partially match a contour of a surface of the bone 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 Goldberg et al., U.S. PG-Pub 2022/0313453 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.
Conclusion
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/ERIC S GIBSON/ Primary Examiner, Art Unit 3775
Prosecution Insights