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 .
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/484082, fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. 63/484092 does not disclose a positioning instrument as required in claims 12-19. The effective filing date of claims 1-11 and 20 is 2/9/23 while the effective filing date of claims 12-19 is 8/30/23.
Drawings
The drawings are objected to because:
reference numeral 119 not found in the drawings.
Lead line for 118 in figure 2 is not pointing to the cavity
Lead lines for 468 and 470 in Fig. 12 are not pointing to the openings
Lead line for 444 in Fig. 12 is not pointing to the distal portion
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.
Specification
The disclosure is objected to because of the following informalities:
In [0063], “projections 130” should be “projections 132”.
In [0067], “slot 154” should be “slot 152”
In [0079], “step 160” should be “step 316”
Appropriate correction is required.
Claim Objections
Claim 14 is objected to because of the following informalities:
Claim 14, line 5, “the second” should be “a second opening”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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.
Claims 1-14, 18-19 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites the limitation "the distal portion" in line 6. There is insufficient antecedent basis for this limitation in the claim. It is unclear if the limitation should be “a distal portion” or “the lateral portion” thereby rendering the claim indefinite. For examination purposes, “the distal portion” will be interpreted as “the lateral portion”.
Dependent claims 2-14 are rejected under 112(b) as they contain all the deficiencies of claim 1 from which they depend.
Claim 4 recites “a first bone” and “a second bone”. However, claim 1 has already established first and second bones and therefore it is unclear if claim 4 refers to the same first and second bones as recited in claim 1 or a different set of bones. For examination purposes, a first bone and a second bone of claim 4 will be interpreted as any two bones, not necessarily the same bones as the first and second bones of claim 1.
Dependent claims 5-14 are rejected under 112(b) as they contain all the deficiencies of claim 4 from which they depend.
Claim 6, line 2-3 recite “increases or decreases a distance between the proximal portion and the medial portion” (emphasis added). The medial portion contains the proximal portion and is not a distinguished structure from the medial portion. The scope of the claim is unclear as to what part of the medial portion the distance is changing from. As best understood for examination purposes, the “medial portion” for line 3 will be interpreted as “the distal portion”.
Dependent claims 7-14 are rejected under 112(b) as they contain all the deficiencies of claim 6 from which they depend.
Claim 18 requires a “third actuator”, however no previous actuators have been recited in the claim therefore it is unclear whether three actuators are required in claim 18 or if “third” is just a name only and does not describe the quantity of actuator. For examination purposes, “third” will be interpreted as only the name of the actuator, not that three actuators are required.
Dependent claim 19 are rejected under 112(b) as they contain all the deficiencies of claim 18 from which they depend.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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) 1-4 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Boffeli et al. (US Publication No. 2021/0369287 A1)
Regarding Claim 1, Boffeli discloses an alignment system (Fig. 2B), comprising: an alignment instrument (30), comprising:
a lateral portion (34+36); and
a medial portion (40+42), wherein the medial portion is releasably and slidably couplable with the lateral portion [0067];
wherein the [lateral] portion (34) and the medial portion (40+42) are couplable with first and second bones (50, 52) of a patient and actuatable to apply a compression therebetween the first and second bones [0062].
Regarding Claim 2, the lateral portion (34+36) comprises: an upper portion (34); and a lower portion (36), wherein the lower portion is slidably adjustable and releasably coupled with the upper portion [0061].
Regarding Claim 3, the medial portion (40+42) comprises: a proximal portion (42); and a distal portion (40), wherein the distal portion is slidably adjustable and releasably coupled with the proximal portion [0067].
Regarding Claim 4, the proximal portion (42) is capable of being releasably couplable with a first bone (54) of a patient (Fig. 2A shows that the slots of 44 line up with the medial cuneiform 54 and a fixation means such as a pin or blade can be passed through the slots into bone 54 to releasably couple distal portion 44 with this bone) and the distal portion (40) is releasably couplable with a second bone (50) of a patient.
Claim(s) 1-6, 15-18, 20 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Denham et al. (US Publication No. 2021/0330311 A1)
First interpretation Regarding Claim 1, Denham discloses an alignment system (Fig. 19), comprising: an alignment instrument (see below), comprising:
a lateral portion (see below); and
a medial portion (see below), wherein the medial portion is releasably and slidably couplable with the lateral portion (at connection 42);
wherein the [lateral] portion and the medial portion are couplable with first and second bones (shown coupled with cuneiform 115 and metatarsal 117) of a patient and actuatable to apply a compression therebetween the first and second bones (compression shown applied between figures 18 and 19).
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First interpretation Regarding Claim 2, the lateral portion (shown above) comprises: an upper portion (shown below); and a lower portion (shown below), wherein the lower portion is slidably adjustable and releasably coupled with the upper portion (via ratchet connection).
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First interpretation Regarding Claim 3, the medial portion (shown above) comprises: a proximal portion (35); and a distal portion (32), wherein the distal portion is slidably adjustable and releasably coupled with the proximal portion [0043] (Fig. 10).
Second interpretation Regarding Claim 1, Denham discloses an alignment system (Fig. 19), comprising: an alignment instrument (see below), comprising:
a lateral portion (see below); and
a medial portion (see below), wherein the medial portion is releasably and slidably couplable with the lateral portion part of the lateral can be detached from part of the medial)
wherein the [lateral] portion and the medial portion are couplable with first and second bones (shown coupled with metatarsal 119 and metatarsal 117) of a patient and actuatable to apply a compression therebetween the first and second bones (via ratchet connection 72).
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Second interpretation Regarding Claim 2, the lateral portion (shown above) comprises: an upper portion (shown above); and a lower portion (shown above), wherein the lower portion is slidably adjustable and releasably coupled with the upper portion (via ratchet connection).
Second interpretation Regarding Claim 3, the medial portion (shown above) comprises: a proximal portion (shown above); and a distal portion (shown above), wherein the distal portion is slidably adjustable and releasably coupled with the proximal portion (at the area of 42).
Second interpretation Regarding Claim 4, the proximal portion (shown above) is capable of being releasably couplable with a first bone (cuneiform 115) of a patient (Fig. 19) and the distal portion (shown above) is releasably couplable with a second bone (metatarsal 117) of a patient.
Second interpretation Regarding Claim 5, the medial portion (shown above) further comprises: a first actuator (67) threadably engaged with the proximal portion and the distal portion (Fig. 1) [0044].
Second interpretation Regarding Claim 6, the first actuator (67) is configured such that actuation of the first actuator increases or decreases a distance between the proximal portion and the [distal] portion (shown in Fig. 18-19).
Regarding Claim 15, Denham discloses an alignment system (Fig. 8), comprising: an alignment instrument (40), comprising: a lateral portion comprising an upper portion and lower portion slidably adjustable and releasably couplable with one another (shown below); a medial portion (shown below) adjustable and releasably couplable with the lateral portion and comprising a distal portion (shown below) and a proximal portion (shown below); wherein the distal portion and the proximal portion are couplable with first and second bones of a patient (via K-wires 210, 211, 200) and actuatable to apply a compression therebetween the first and second bones (shown in Fig. 18-19 between metatarsal and cuneiform); and a retention element (82) releasably couplable with the upper portion of the lateral portion of the alignment instrument and configured to engage with a third bone of the patient ( metatarsal 119 or 118, [0049], Fig. 10); and a positioning instrument (50) (fig. 3) [0042].
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Regarding Claim 16, the positioning instrument comprises a substantially wedge-shaped geometry (55 has wedge shape shown in Fig. 2) and a texture disposed on an angled surface thereof (“texture” can include any surface roughness or contour, it is inherent that a texture of some kind exists on an angled surface of the wedge 55).
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Regarding Claim 17, the distal portion comprises an extension extending substantially upward from the distal portion, wherein the extension comprises: a first prong; and a second prong, wherein the second prong is separated from the first prong by a slot; wherein the first and second prongs comprise a curvature comprising a consistent radius along a length thereof (see below).
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Regarding Claim 18, further comprising: a third actuator (31) (Fig. 3) positioned at least partially within the slot, wherein the third actuator is translatable along a curved path defined by the first and second prongs [0043].
Regarding Claim 20, Denham discloses a surgical method, comprising: coupling a retention member (82) with a first bone of a patient (metatarsal 119 shown in figure below); coupling a lateral portion of an alignment instrument with the retention member (shown coupled below); coupling a medial portion of the alignment instrument with the lateral portion of the alignment instrument (shown coupled below); coupling a distal aspect of the medial portion of the alignment instrument with a second bone of the patient (metatarsal 117 using K-wire 211); coupling a proximal aspect of the medial portion of the alignment instrument with a third bone (cuneiform 115 using K-wire 200) of the patient; actuating the alignment instrument to apply compression between the second and third bones (shown in Fig. 18-19); and applying fixation across the second and third bones (shown in Fig. 23).
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Claim(s) 1-2 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Schmidt et al. (US Publication No. 2023/0240720 A1).
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding Claim 1, Schmidt discloses an alignment system (100), comprising: an alignment instrument (110, Fig. 1), comprising:
a lateral portion (see below); and
a medial portion (see below), wherein the medial portion is releasably and slidably couplable with the lateral portion [0054];
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wherein the [lateral] portion and the medial portion are couplable with first and second bones (204, 206) of a patient and actuatable to apply a compression therebetween the first and second bones [0043].
Regarding Claim 2, the lateral portion comprises: an upper portion (see below); and a lower portion (see below), wherein the lower portion is slidably adjustable and releasably coupled with the upper portion (lower portion slid up through hole in upper portion 154 via actuation of threaded knob [0047]).
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Claim(s) 1-8, 15 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stemniski et al. (US Publication No. 2015/0182273 A1).
As to claim 1, Stemniski discloses an alignment system, comprising:
an alignment instrument (see 100, Fig 29, adjustment device 100 for positioning of tools, para [0162]), comprising:
a lateral portion (see right portion comprising 130 and 134, Fig 29); and
a medial portion (see left portion comprising 110 and 120, Fig 29), wherein the medial portion is releasably and slidably couplable with the lateral portion (see how 120 is releasably and slidably couplable with 130 due to screw 123 and knob 121a or b, Fig 29, rotation of 121a or b rotates screw 123 to move 130 in the medial-lateral direction, para [0165]);
wherein the [lateral] portion and the medial portion are couplable with first and second bones of a patient (see how 110 is couplable with a first bone via pins 150, Fig 37, para [0164]; see how 134 is couplable with a second bone via pins 297, Fig 37, para [0178]) and actuatable to apply a compression therebetween the first and second bones (see how 110 and 134 may be moved relative to each other to apply a compression between first and second bones, Fig 37, frame 130 may move in a medial-lateral direction relative to 120, para [0165]).
As to claim 2, Stemniski discloses the alignment system of claim 1, wherein the lateral portion comprises:
an upper portion (see an upper surface of 130, Fig 29); and
a lower portion (see 134, Fig 29), wherein the lower portion is slidably adjustable and releasably coupled with the upper portion (see how 134 is slidably and releasably coupled via screw 133, Fig 29, screw 133 rotates to move 134 in the anterior-posterior direction, para [0166]).
As to claim 3, Stemniski discloses the alignment system of claim 2, wherein the medial portion comprises:
a proximal portion (see 110, Fig 29); and
a distal portion (see 120, Fig 29), wherein the distal portion is slidably adjustable and releasably coupled with the proximal portion (see how 120 is slidably and releasably coupled via screw 113, Fig 29, rotation of screw 113 advances or retracts 120 in the proximal-distal direction, para [0164]).
As to claim 4, Stemniski discloses the alignment system of claim 3, wherein the proximal portion is releasably couplable with a first bone of a
patient (see how 110 is releasably couplable with a first bone via pins 150, Fig 29, Fig 37) and the distal portion is releasably couplable with a second bone of a patient (see how 120 is coupled with 134 such that it is releasably couplable with a second bone via pins 297, Fig 37).
As to claim 5, Stemniski discloses the alignment system of claim 4, wherein the medial portion further comprises:
a first actuator (see screw 133 and knob 111, Fig 29) threadably engaged with the proximal portion and the distal portion (see how 133 is threadably engaged with 110 and 120, Fig 29, 110 has adjustment knob 111 connected to screw 113 and 120 is attached with a leadscrew nut that screw 113 drives, para [0163]).
As to claim 6, Stemniski discloses the alignment system of claim 5, wherein the first actuator is configured such that actuation of the first actuator increases or decreases a distance between the proximal portion and the [distal] portion (rotation of knob 111 rotates screw 113 to advance or retract 120 in the proximal-distal direction, para [0164]).
As to claim 7, Stemniski discloses the alignment system of claim 6, further comprising a second actuator (see knob 121a,b and screw 123, Fig 29) threadably engaged with the medial portion and the lateral portion of the alignment instrument (see how 123 is threadably engaged with 120 and 130, Fig 29, 120 has knob 121a,b attached to screw 123 and 130 is attached to a leadscrew nut that 123 drives, para [0165]).
As to claim 8, Stemniski discloses the alignment system of claim 7, wherein the second actuator is configured such that actuation of the second actuator increases or decreases a distance between the medial portion and the lateral portion (rotation of knob 121a or 121b rotates screw 123 to move 130 in the medial-lateral direction, para [0165]).
As to claim 15, Stemniski discloses an alignment system, comprising:
an alignment instrument (see 100, Fig 29, adjustment device 100 for positioning of tools, para [0162]), comprising:
a lateral portion (see right portion comprising 130 and 134, Fig 29) comprising an upper portion (see 134, Fig 29) and lower portion (see a lower surface of 130, Fig 29) slidably adjustable and releasably couplable with one another (see how 134 is slidably and releasably coupled via screw 133, Fig 29, screw 133 rotates to move 134 in the anterior-posterior direction, para [0166]);
a medial portion (see left portion comprising 110 and 120, Fig 29) adjustable and releasably couplable with the lateral portion (see how 120 is releasably and slidably couplable with 130 due to screw 123 and knob 121a or b, Fig 29, rotation of 121a or b rotates screw 123 to move 130 in the medial-lateral direction, para [0165]) and comprising a distal portion (see 120, Fig 29) and a proximal portion (see 110, Fig 29);
wherein the distal portion and the proximal portion are couplable with first and second bones of a patient (see how 110 is couplable with a first bone via pin 150, Fig 37; see how 120 is coupled to 134 such that it is couplable with a second bone via pin 297, Fig 37, fixation pins 150, para [0164]; fixation pins 297, para [0178]) and actuatable to apply a compression therebetween the first and second bones (see how movement of 120 in a proximal-distal direction relative to 110 is configured to also move 134 such that compression may be applied between first and second bones, Fig 37, 120 can advance or retract in the proximal-distal direction, para [0164]; 130 and 134 are connected with 120, para [0165]-[0166]); and
a retention element (see 287, Fig 37, fixation pins 287, para [0178]) releasably couplable with the upper portion of the lateral portion of the alignment instrument (see how 287 is releasably couplable with 134 via 290, Fig 37, guide 290 mounted to 134 to receive fixation pins 287, para [0178]) and configured to engage with a third bone of the patient (see how 287 is configured to engage a third bone, Fig 37, fixation pins 287, para [0178]); and
a positioning instrument (see 210 which can be attached to 134, Fig 38; tibia trial 210 to assess ligament laxity of the ankle joint, para [0183]-[0184]).
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) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stemniski et al. (US Publication No. 2015/0182273 A1).
As to claim 16, Stemniski discloses the instrument system of claim 15, wherein the positioning instrument comprises a substantially wedge- shaped geometry (see how 210 has an angled/wedge-shaped geometry, Fig 31-32) but does not explicitly teach and a texture disposed on an angled surface thereof.
Stemniski teaches wherein the angled surface is part of a mounting portion (see angled front surface 213, Fig 39, Fig 31, anterior mounting portion 213, para [0168]) but does not specify whether the surface is smooth or has a texture. However, it would have been obvious to a person having ordinary skill in the art to modify the positioning instrument such that it has a texture disposed on an angled surface thereof in order to provide texture to improve gripping and manipulation of the mounting portion.
Claim(s) 9-12 and 17-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stemniski et al. (US Publication No. 2015/0182273 A1) in view of Garlock et al. (US Publication No. 2016/0367270 A1).
As to claim 9, Stemniski discloses the alignment system of claim 8, but does not teach wherein the distal portion comprises an extension extending substantially upward from the distal portion, wherein the extension comprises:
a first prong; and
a second prong, wherein the second prong is separated from the first prong by a slot; wherein the first and second prongs comprise a curvature comprising a consistent radius along a length thereof. Stemniski teaches wherein the alignment system is used for positioning of tools (para [0162]).
Garlock further teaches an alignment system for positioning a surgical instrument (see targeting guide assembly 22, Fig 8, Abstract, para [0038]) comprising a distal portion (see a distal portion 26, Fig 8, bracket 26, para [0023]) comprising an extension (see extension 24, Fig 2B, Fig 8, bracket 24, para [0023]) extending substantially upward from the distal portion (see how 24 extends substantially upward from 26, Fig 8), wherein the extension comprises a first prong (see a first prong/arm 48, Fig 3A, Fig. 8, first arm 48, para [0028]) and a second prong (see a second prong 50, Fig 3A, Fig 8, second arm 50, para [0028]), wherein the second prong is separated from the first prong by a slot (see how the prongs are separated by slot 30, Fig 8, 48 and 50 are spaced apart to establish slot 30, para [0028]), wherein the first and second prongs comprise a curvature comprising a consistent radius along a length thereof (see curvature comprising a consistent radius along a length of 24, Fig 3A, slot 30 extends along a curved axis, para [0023]) such that a cannula guide body may be mounted for movement within the slot to locate a cannula at a desired position (para [0023]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the system such that the distal portion further comprises an extension extending substantially upward from the distal portion, wherein the extension comprises: a first prong; and a second prong, wherein the second prong is separated from the first prong by a slot; wherein the first and second prongs comprise a curvature comprising a consistent radius along a length thereof as taught by Garlock in order to provide a slot for mounting a cannula guide body to locate a cannula instrument at a desired position.
As to claim 10, Stemniski and Garlock teach the alignment system of claim 9, and Garlock teaches further comprising:
a third actuator positioned at least partially within the slot (see 28 positioned at least partially within slot 30, Fig 2A-B), wherein the third actuator is translatable along a curved path defined by the first and second prongs (see how 28 is translatable along a curved path defined by the slot 30 of the prongs, Fig 2A-B, cannula guide body 28 movable along curvilinear path defined by the slot 30, para [0023]).
As to claim 11, Stemniski and Garlock teach the alignment system of claim 10, and Garlock teaches wherein the third actuator comprises: a cannulation extending therethrough along a longitudinal axis from a first end to a second end (see how 28 includes a cannulation 70 extending along a longitudinal axis from a first end to a second end to receive a cannula 25, Fig 5A, Fig 8, para [0023], bore 70 to receive a cannula 25, para [0034]); and
a locking mechanism adjustable between locked and unlocked positions (see 32, Fig 2A, guide knob 32 secured to 28 to lock 28 into position, para [0025]), wherein the unlocked position permits translation of the third actuator within the slot (32 may be gripped for maneuvering 28 within the slot 30, para [0025]) and the locked position retains the third actuator at a point along the length of the slot (32 may be used to lock 28 into position, para [0025]).
As to claim 12, Stemniski and Garlock teach the alignment system of claim 11, and Stemniski teaches further comprising:
a positioning instrument (see 210 which can be attached to 134, Fig 38; tibia trial 210 to assess ligament laxity of the ankle joint, para [0183]-[0184]), comprising:
a wedge-shaped geometry (see how 210 has an angled/wedge-shaped geometry, Fig 31-32) which inherently has a texture; an angled surface (see angled front surface 213, Fig 39, Fig 31, anterior mounting portion 213, para [0168]) ; and
a handle extending from the wedge-shaped geometry (see an upper handle part of 213 with holes 214 for attachment, Fig 30-31).
As to claim 17, Stemniski teaches the instrument system of claim 16, but does not teach wherein the distal portion comprises an extension extending substantially upward from the distal portion, wherein the extension comprises:
a first prong; and a second prong, wherein the second prong is separated from the first prong by a slot; wherein the first and second prongs comprise a curvature comprising a consistent radius along a length thereof. Stemniski teaches wherein the alignment system is used for positioning of tools (para [0162]).
Garlock further teaches an alignment system for positioning a surgical instrument (see targeting guide assembly 22, Fig 8, Abstract, para [0038]) comprising a distal portion (see a distal portion 26, Fig 8, bracket 26, para [0023]) comprising an extension (see extension 24, Fig 2B, Fig 8, bracket 24, para [0023]) extending substantially upward from the distal portion (see how 24 extends substantially upward from 26, Fig 8), wherein the extension comprises a first prong (see a first prong/arm 48, Fig 3A, Fig 8, first arm 48, para [0028]) and a second prong (see a second prong 50, Fig 3A, Fig B, second arm 50, para [0028]), wherein the second prong is separated from the first prong by a slot (see how the prongs are separated by slot 30, Fig 8, 48 and 50 are spaced apart to establish slot 30, para [0028]), wherein the first and second prongs comprise a curvature comprising a consistent radius along a length thereof (see curvature comprising a consistent radius along a length of 24, Fig 3A, slot 30 extends along a curved axis, para [0023]) such that a cannula guide body may be mounted for movement within the slot to locate a cannula at a desired position (para [0023]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the system such that the distal portion further comprises an extension extending substantially upward from the distal portion, wherein the extension comprises: a first prong; and a second prong, wherein the second prong is separated from the first prong by a slot; wherein the first and second prongs comprise a curvature comprising a consistent radius along a length thereof as taught by Garlock in order to provide a slot for mounting a cannula guide body to locate a cannula instrument at a desired position.
As to claim 18, Stemniski and Garlock teach the alignment system of claim 17, and Garlock teaches further comprising: a third actuator positioned at least partially within the slot (see 28 positioned at least partially within slot 30, Fig 2A-B), wherein the third actuator is translatable along a curved path defined by the first and second prongs (see how 28 is translatable along a curved path defined by the slot 30 of the prongs, Fig 2A-B, cannula guide body 28 movable along curvilinear path defined by the slot 30, para [0023]).
As to claim 19, Stemniski and Garlock teach the alignment system of claim 18, and Garlock teaches wherein the third actuator comprises: a cannulation extending therethrough along a longitudinal axis from a first end to a second end (see how 28 includes a cannulation 70 extending along a longitudinal axis from a first end to a second end to receive a cannula 25, Fig 5A, Fig 8, para [0023], bore 70 to receive a cannula 25, para [0034]); and
a locking mechanism adjustable between locked and unlocked positions (see 32, Fig 2A, guide knob 32 secured to 28 to lock 28 into position, para [0025]), wherein the unlocked position permits translation of the third actuator within the slot (32 may be gripped for maneuvering 28 within the slot 30, para [0025]) and the locked position retains the third actuator at a point along the length of the slot (32 may be used to lock 28 into position, para [0025]).
Claims 13-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Stemniski et al. (US Publication No. 2015/0182273 A1) in view of Garlock et al. (US Publication No. 2016/0367270 A1) in further view of Bays et al. (US Publication No. 2019/0328435 A1).
As to claim 13, Stemniski and Garlock teach the alignment system of claim 12, but do not explicitly teach wherein the alignment system comprises at least one of an intramedullary nail or a plate configured to couple with the first bone and the second bone. Stemniski teaches wherein a fixation pin is configured to couple with the first bone and the second bone (para [0164]) and wherein the system is used to position drilling and cutting tools (para [0162]) for an orthopedic procedure such as ankle replacement surgery (para [0002]).
Bays further teaches an alignment system for an orthopedic procedure (bone positioning guide for positioning bones during a medical procedure such as bone alignment, para [0067]), wherein the system includes an alignment instrument for positioning cutting tools (a bone preparation guide to align a tissue removing instrument can be provided with a bone positioning guide, para [0080]), wherein the system is useful to prepare bones for a bone alignment and fusion procedure (para [0087]), and wherein the system further comprises at least one of an intramedullary nail or a plate configured to couple with at least one bone (position of bones can be fixed with bone fixation devices such as bone plate and intramedullary nail, para [0096]) in order to fix the positions of the bones after preparing the bones using the alignment instrument (preparation guide used to prepare ends of bones, para [0094]; after preparing ends of bones, the position of the bones can be fixed, para [0096]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the system such that it comprises at least one of an intramedullary nail or a plate configured to couple with the first bone and the second bone as taught by Bays in order to fix the positions of the first bone and second bone to use the system in a bone alignment and fusion procedure.
As to claim 14, Stemniski, Garlock and Bays teach the alignment system of claim 13, but Stemniski does not teach wherein the proximal portion comprises:
a first opening extending from a medial surface therethrough to a lateral surface,
wherein the first opening comprises a longitudinal axis having a trajectory configured to facilitate implantation of the intramedullary nail; and
a second opening extending from the medial surface therethrough to the lateral surface, wherein the second opening comprises a longitudinal axis having a trajectory configured to facilitate implantation of the plate.
Stemniski teaches wherein the proximal portion may be coupled with fixation devices such as fixation pins (110 is configured to be attached to fixation pins 150, para [0164]) and wherein the system includes multiple openings to guide insertion of fixation devices such as fixation pins (see openings in coupled cut guide 290 for fixation pins 287 and 297, Fig 37; cut guide 290 is mounted to 134 and has holes 292 to receive fixation pins 287 and pin holes for receiving fixation pins 297, para [0178]) but does not teach the proximal portion including first and second openings extending from a medial surface therethrough to a lateral surface.
Bays teaches wherein at an intramedullary nail and a plate are configured to couple with at least one bone (position of bones can be fixed with more than one bone fixation devices such as bone plate and intramedullary nail, para [0096]) in order to fix the positions of the bones after preparing the bones using the alignment instrument (preparation guide used to prepare ends of bones, para [0094]; after preparing ends of bones, the position of the bones can be fixed, para [0096]).
Accordingly, it would have been obvious to a person having ordinary skill in the art to modify the proximal portion such that it comprises at least a first opening extending from a medial surface therethrough to a lateral surface and a second opening extending from the medial surface therethrough to the lateral surface in order to provide multiple openings for guiding the insertion of fixation devices into a desired position during a procedure. As modified, the first opening comprises a longitudinal axis having a trajectory configured to facilitate implantation of the intramedullary nail and the second opening comprises a longitudinal axis having a trajectory configured to facilitate implantation of the plate.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. See Form PTO-892.
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/JACQUELINE T JOHANAS/Primary Patent Examiner, Art Unit 3773
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