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 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.
Claim(s) 1-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perler et al. (US 2022/0211387; “Perler”).
Claim 1, Perler discloses a resection guide (Figs. 19A-19C) for remediating a condition present in a patient (Figs. 19A-19C; abstract), the resection guide comprising: a bone engagement feature (Fig. 19C; 1926, 1928) configured to engage at least a portion of at least one foot bone to position the resection guide (paragraph [0206]); wherein the bone engagement feature is at least partially determined based on a model of a patient's foot (paragraphs [0078]-[0081], [0094], and [0206]), the model defined based on medical imaging of the patient's foot (paragraphs [0078]-[0081], [0094], and [0206]); a resection feature (Fig. 19A; 1960 and/or 1970) extending through the resection guide from a superior side (upper side) of the resection guide to an inferior side (lower side), the resection feature configured to guide a cutting tool to form a first osteotomy in a first bone along a first trajectory (Figs. 19A-20; paragraphs [0211]-[0213]); a first bone attachment feature (Fig. 20; 1956) configured to engage the first bone (Fig. 20); and a second bone attachment feature (another pin 1956) configured to engage a second bone (Fig.205).
Claim 2, Perler discloses the resection guide of claim 1, wherein the resection feature is configured to provide visibility of an anatomical structure inferior to the resection guide when in use (Figs. 19A-19C; the surgeon can look into the slots to see the bone below or use some other type of camera).
Claim 3, Perler discloses the resection guide of claim 1, further comprising a window (Fig. 20; 2012) extending from the superior side of the resection guide to the inferior side (Figs. 19A-19H), the window providing visibility of an anatomical structure inferior to the resection guide when in use (Figs. 19A-20).
Claim 4, Perler discloses the resection guide of claim 3, wherein the window comprises an opening (Fig. 20; 2012) coupled to the resection feature (Fig. 20).
Claim 5, Perler discloses the resection guide of claim 3, wherein the window is capable of providing visibility of a distal end of the first bone and a proximal end of the second bone (Fig. 20; note how the box 2012 and the guide is capable of being aligned where the box lies directly over the two bones).
Claim 6, Perler discloses the resection guide of claim 1, wherein the bone engagement feature is on an inferior side (Fig. 20; bone facing side) of the resection guide (Fig. 20) and is configured to extend from a medial surface of the at least one foot bone, over a dorsal surface of the at least one foot bone, and to a lateral surface of the at least one foot bone (Fig. 20; paragraph [0206]).
Claim 7, Perler discloses the resection guide of claim 1, wherein the resection feature is configured to guide the cutting tool to form a second osteotomy in the second bone along a second trajectory (Figs. 19A-20).
Claim 8, Perler discloses the resection guide of claim 7, wherein the second bone attachment feature is positioned relative to the first bone attachment feature such that reduction of the first osteotomy and the second osteotomy aligns the second bone attachment feature and the first bone attachment feature and rotates the second bone within a frontal plane (Fig. 20; paragraphs [0235], [0239], and [0286]-[0294]; note that two of the pins will always be aligned in some manner relative to each other and when only two pins are used the distal bone can rotate relative to the pivot point of the proximal pin).
Claim 9, Perler discloses the resection guide of claim 1, further comprising an alignment guide (Fig. 21A; but also one of the pins 1956 could meet this limitation) configured to identify a position of the second bone relative to a third bone of the patient (Fig. 21A; but also one of the pins 1956 could meet this limitation).
Claim 10, Perler discloses the resection guide of claim 1, further comprising a landmark registration feature (Fig. 20; where 1954 points; also one of the pins could be considered as this feature) configured to engage a landmark of the patient (Fig. 20; the feature 1954 or the pin 1956 can engage anything it is placed into contact with).
Claim 11, Perler discloses the resection guide of claim 10, wherein the landmark registration feature extends from a distal side (the right side of the guide is the distal side and the pins are also extending from the top of the distal side) of the resection guide, the landmark registration feature configured to engage a base of one of the first bone and the second bone (Fig. 20; the feature 1954 or the pin 1956 can engage anything it is placed into contact with).
Claim 12, Perler discloses the resection guide of claim 10, wherein the landmark comprises a feature of an implant deployed in the patient in a prior surgical procedure (Fig. 20; the feature 1954 or the pin 1956 can engage an implant of this nature).
Claim 13, Perler discloses a resection guide (Figs. 19A-20) for remediating a condition present in a patient (Figs. 19A-19C; abstract), the resection guide comprising: a resection feature (Fig. 19A; 1960 and/or 1970) extending through the resection guide from a superior side (upper side) of the resection guide to an inferior side (lower side), the resection feature configured to guide a cutting tool to form a first osteotomy in a first bone along a first trajectory (Figs. 19A-20; paragraphs [0211]-[0213]); wherein the resection feature is at least partially determined based on a model of a patient's foot paragraphs [0078]-[0081], [0094], and [0206], the model defined based on medical imaging of the patient's foot paragraphs [0078]-[0081], [0094], and [0206]; a soft tissue engagement feature (Fig. 20; 2002) configured to engage at least a portion of soft tissue when the resection guide is used (Fig. 20; all sorts of soft tissue is located in that area); a first bone attachment feature (Fig. 20; at least one of the proximal openings 1950) configured to accept a first fastener (1956) that engages the first bone (Fig. 20); and a second bone attachment feature (Fig. 20; at least one of the distal opening 1950) configured to accept a second fastener (1956) that engages a second bone (Fig. 20).
Claim 14, Perler discloses the resection guide of claim 13, wherein the resection feature comprises an accommodation feature (Fig. 19B; 1918) comprising a first surface (side that 1918 points towards) and a second surface (either the top surface of the guide or the other side surface that 1910 points towards) that connect at an edge (top edge or the edge that 1918 is pointing towards, depending on what surfaces you choose to meet the claim), wherein the second surface is angled relative to the first surface such that the second surface avoids contact with one or more anatomical structures of the patient when the resection guide is positioned for use (the device can be placed just about anywhere in a human body, also the bone in the foot could be altered in a number of ways which would result in this structure being capable of preforming that function).
Claim 15, Perler discloses the resection guide of claim 13, further comprising a window (Fig. 20; 2012) extending from the superior side of the resection guide to the inferior side (Figs. 19A-19H), the window providing visibility of an anatomical structure inferior to the resection guide when in use (Figs. 19A-20).
Claim 16, Perler discloses the resection guide of claim 13, wherein the resection feature comprises a radiolucent portion (paragraph [0199], a handful of radiolucent material listed, e.g. plastic, and the entire device can be made from the same material) configured to provide medical imaging visibility of an anatomical structure inferior to the resection guide when in use (Fig. 20; paragraph [0199]).
Claim 17, Perler discloses the resection guide of claim 13, further comprising an alignment guide (Fig. 21A; but also one of the pins 1956 could meet this limitation) configured to indicating a corrected position of the second bone relative to another bone of the patient (Fig. 21A; but also one of the pins 1956 could meet this limitation).
Claim(s) 18 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith et al. (US 2019/0274745; “Smith”).
Claim 18, Smith discloses a resection guide (Fig. 6A; 150) for remediating a condition present in a patient (Fig. 20; abstract), the resection guide comprising: a bone engagement feature (bone contacting surface of the guide) configured to engage at least a portion of at least one foot bone to position the resection guide (Fig. 120); a soft tissue engagement feature (outer edges of the body) configured to retain at least a portion of soft tissue within an operating field (Fig. 6A, the tissue can be pushed aside with the edges); a proximal slot (Fig. 5; 160) configured to guide a cutting tool to form a first osteotomy a cuneiform (Fig. 20; paragraph [0074]), the proximal slot extending through the resection guide from a superior side (top side) to an inferior side (bone contacting side) along a first trajectory (Fig. 8); a distal slot (Fig. 5; 164) configured to guide a cutting tool to form a second osteotomy in a metatarsal (paragraph [0074]), the distal slot extending through the resection guide from the superior side to the inferior side along a second trajectory (Fig. 8); a resection window (Fig. 5; 170) between the proximal slot and the distal slot (Fig. 5), the resection window extending from the superior side to the inferior side (Figs. 5 and 6A), the resection window configured to enable observation of an articular surface of both the cuneiform and the metatarsal (paragraph [0076]); a first bone attachment feature (Fig. 5; any of the holes that 182, or 180 point towards)) configured to accept a first fastener that engages the cuneiform (Figs. 5, 6A, and 20; paragraphs [0077]-[0078]); and a second bone attachment feature (the same holes at the other side of the device 184 and 180) configured to accept a second fastener that engages metatarsal (Figs. 5, 6A, and 20; paragraphs [0077]-[0078]).
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.
Claim(s) 4-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Perler et al. (US 2022/0211387; “Perler”), in view of Smith et al. (US 2019/0274745; “Smith”).
Claim 4, Perler discloses the resection guide of claim 3.
However, Perler does not disclose the H-shaped opening in the resection guide.
Smith teaches a resection feature (Fig. 5) and a window (170) wherein the window comprises an opening (the open space connecting the window and guide slots) coupled to the resection feature (Figs. 5 and 6A).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the resection guide of Perler to include the window with an opening to the resection feature, as taught by Smith, in order to allow a practitioner to have a visual path to bones during bone preparation and/or to receive instruments (paragraph [0076]).
Claim 5, Perler discloses the resection guide of claim 3. However, Perler does not disclose the window providing visibility to the two bones.
Smith teaches Smith teaches a resection feature (Fig. 5) and a window (170), wherein the window is configured to provide visibility of a distal end of the first bone and a proximal end of the second bone (Fig. 21; paragraph [0076]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the resection guide of Perler to include the window with an opening to the resection feature, as taught by Smith, in order to allow a practitioner to have a visual path to bones during bone preparation and/or to receive instruments (paragraph [0076]).
Claim(s) 19-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Smith et al. (US 2019/0274745; “Smith”), in view of Perler et al. (US 2022/0211387; “Perler”).
Claim 19, Smith discloses the resection guide of claim 18.
However, Smith does not disclose the limitations of claim 18.
Perler teaches a resection guide with slots having trajectories wherein one of the first trajectory and the second trajectory is at least partially determined based on a revised model of a patient's foot, the revised model defined based on changes made by a surgical procedure performed prior to using the resection guide for a second surgical procedure on a patient's foot (paragraph [0179]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to adjust the slot trajectories of Smith, to be determined by a revised model of a patients foot, as taught by Perler, in order to make a patient specific cutting guide that will give best results for the patient (paragraphs [0179]-[0180]).
Claim 20, Smith discloses the resection guide of claim 18.
However, Smith does not disclose using the models to adjust trajectories required by claim 20.
Perler teaches wherein at least one of the first trajectory and the second trajectory is at least partially determined based on a tarsometatarsal (TMT) joint axis, the TMT joint axis determined based on a model of a patient's foot (paragraphs [0177]-[0196]).
It would have been obvious to one having ordinary skill in the art at the time the invention was made to adjust the slot trajectories of Smith, using a model of the patient’s foot and how the bones are aligned, as taught by Perler, in order to make a patient specific cutting guide that will give best results for the patient (paragraphs [0177]-[0196]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Zade Coley whose telephone number is (571)270-1931. The examiner can normally be reached M-F (9-5) PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kevin Truong can be reached 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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/Zade Coley/Primary Examiner, Art Unit 3775