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 .
Response to Amendment
This Office Action is responsive to the amendment filed on 09 June 2026. As directed by the amendment: claims 1-20 and 40 are withdrawn, claims 21-25, 32-34, 37, and 39 are amended, and claim 38 is cancelled. Claims 1-37, 39, and 40 currently stand pending in the application.
The cancellation of claim 38 has rendered moot the drawing objection, which is correspondingly withdrawn.
The amendments to the claims are sufficient to overcome the previous claim objections, which are correspondingly withdrawn. Further claim objections are presented below.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 112(b), which are correspondingly withdrawn.
The amendments to the claims are sufficient to overcome the rejections under 35 U.S.C. 101, which are correspondingly withdrawn.
Response to Arguments
Applicant's arguments filed 09 June 2026 have been fully considered but they are not persuasive. As to the rejections under 35 U.S.C. 102(a)(2) as anticipated by U.S. Patent No. US 11,849,933 to Denham et al., Applicant contends that the holding portion 35 of Denham is not received within an aperture; rather the rail 32 passes through the holding portion 35. Examiner respectfully submits that the holding portion 35 (the claimed first actuator) is disposed at least partially (at a distal rail of 35) within an aperture or opening in the side of the rail 32, as seen in FIG. 11.
As to the rejections under 35 U.S.C. 102(a)(1) as anticipated by WO 2020/180598 to Carlo III et al., Applicant contends that Carlo fails to disclose a second actuator with a coupling mechanism that is received through the bore of the second portion and received within the recess of the first portion to translate the first portion and the second portion along the longitudinal axis of the second portion. Applicant contends that the member 102 of Carlo is received within the passage 158 in the second arm member 106, rather than the actuator 4124 of the present claims being received within the recess of the first portion 4104. Examiner respectfully submits that the rejection maps the second actuator to features 114, 112 of Carlo, comprising a coupling mechanism 112 that is received through the bore (through 104 that receives 112) of the second portion (the rest of the clamp, including 104, 102, 106, 112, 114) and received within the recess (concavity under 108, FIG. 1) of the first portion (108) to translate the first portion and the second portion along the longitudinal axis of the second portion (pulling the second actuator upward translates the second actuator as part of the second portion upward relative to the first portion and thus the second portion comprising the second actuator translates relative to the first portion, which can be interpreted depending on perspective as the first portion and the second portion translating relative to each other, par. [0059]).
As to the rejections under 35 U.S.C. 103 as unpatentable over Carlo, Applicant contends that Carlo fails to disclose the first actuator that slides along the elongated aperture to constrain the actuator’s range of motion, because the nut 331 and retainer 334 of the first actuator 308 are tightened to secure the retainer and nut to the arcuate portion. Examiner respectfully submits that the nut and the retainer are tightened to the arcuate portion after the first actuator has been slid into the desired position along the aperture 350, to lock the first actuator in position (par. [0064]). In other words, before the first actuator is locked in position, it is free to slide along the aperture. The aperture defines a range of movement of the first actuator since the first actuator must only slide along the aperture. Even if the first actuator is tightened and secured to the arcuate portion/aperture, the aperture would still define a range of movement of the first actuator, which in the secured configuration would have no range of movement. The range of movement of the first actuator could also be interpreted as the movement of the nut and retainer toward each other when threadedly tightened together; this range of movement is defined by the aperture because the movement occurs through the aperture and therefore must be along the aperture axis.
Claim Objections
Claims 37 and 39 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 37 / line 13: “releasably couple with the bore of the second portion,”
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim 21-24 and 29-36 are rejected under 35 U.S.C. 102(a)(2) as anticipated by U.S. Patent No. US 11,849,933 to Denham et al. (hereinafter, “Denham”).
As to claim 21, Denham discloses a surgical system, comprising a clamp, FIG. 8, comprising: a first portion (30) comprising a first actuator (35) configured to interface with a first metatarsal of a patient, FIGS. 1 and 9-10, wherein the first actuator is disposed at least partially within an aperture (opening in the side of rail 32 in which part of the first actuator is slidably disposed, FIG. 11) that defines a range of movement of the first actuator (col. 6 / lines 1-9); a second portion (40), comprising an extension (arcuate portion that extends to the right off of 40) having a retention mechanism (82) configured to interface with a second metatarsal of the patient (col. 5 / lines 44-49), FIG. 8; wherein the second portion is releasably coupled with the first portion (at 42) and the first and second portions are translatable relative to one another via a second actuator (67) (col. 4 / lines 62-65); and a plurality of stabilization wires configured to be received by at least one of the first portion and the second portion, FIGS. 8-9.
As to claim 22, Denham discloses the surgical system according to claim 21, wherein the first actuator comprises a first bore (133) disposed about a longitudinal axis (axis of the first bore) of the first actuator.
As to claim 23, Denham discloses the surgical system according to claim 22, wherein the first bore is configured to receive one of the plurality of stabilization wires into and through the first bore such that the stabilization wire is configured to releasably couple the first actuator with the first metatarsal (col. 5 / lines 28-32), FIG. 8.
As to claim 24, Denham discloses the surgical system according to claim 23, wherein manipulation of the first actuator within the aperture is configured to apply a rotational force to the first metatarsal via at least the one of the plurality of stabilization wires to manipulate the first metatarsal from a first position to a second position.
As to claim 29, Denham discloses the surgical system according to claim 21, wherein the second actuator is disposed at an end of the second portion opposite the first portion (the second actuator is disposed at an end of the second portion and the second portion is opposite the first portion).
As to claim 30, Denham discloses the surgical system according to claim 21, wherein the second portion comprises a bore (longitudinal recess along 60 in which threads 64 are disposed) extending through the second portion along a longitudinal axis thereof, FIG. 1.
As to claim 31, Denham discloses the surgical system according to claim 30, wherein the second actuator comprises a protrusion (67) having a first coupling mechanism (threads on 67), the protrusion configured to be received by and extend through the bore, wherein the protrusion is configured to releasably couple with the second portion via the bore (col. 6 / line 67 – col. 7 / line 9).
As to claim 32, Denham discloses the surgical system according to claim 29, wherein the first portion (at the end of the first portion at 42) comprises a recess (recess in 42 that receives 67) comprising a second coupling mechanism (threads that engage 67), the recess configured to receive and releasably couple with a portion of a protrusion of the second actuator (col. 6 / line 67 – col. 7 / line 2).
As to claim 33, Denham discloses the surgical system according to claim 32, wherein the recess of the first portion and a bore (longitudinal recess along 60 in which threads 64 are disposed) of the second portion share a common axis of the protrusion when both are releasably coupled with the protrusion of the second actuator, FIG. 1.
As to claim 34, Denham discloses the surgical system according to claim 33, wherein manipulation of the second actuator translates the first portion relative to the second portion along the shared common axis (col. 6 / line 67 – col. 7 / line 9).
As to claim 35, Denham discloses the surgical system according to claim 21, wherein the first and second actuators each comprise a texture disposed on one or more outer surfaces thereof (a texture is the feel of a surface; the first actuator has a texture because it has surfaces, even if it is a smooth texture, and the second actuator has a texture from the threads).
As to claim 36, Denham discloses the surgical system according to claim 31, wherein the second portion comprises one or more protuberances (one protuberance 20) each comprising an aperture (122) configured to receive one of the plurality of stabilization wires, FIGS. 1 and 8.
Claims 37 and 39 are rejected under 35 U.S.C. 102(a)(1) as anticipated by WIPO International Publication No. WO 2020/180598 to Carlo III et al. (hereinafter, “Carlo”).
As to claim 37, Carlo discloses a surgical clamp, FIG. 1, comprising a first portion (108) having a substantially curved geometry, FIG. 1, the first portion comprising: a recess (concavity under 108, FIG. 1) positioned at a proximal end of the first portion (a proximal end of the recess, where it is coupled to 184 in FIG. 1, is at a proximal end of the first portion); an elongated aperture (arcuate aperture through 108) positioned at a distal end of the first portion (at least part of the elongated aperture, where it receives 134, is at a distal end of the first portion), FIG. 8; and a first actuator (134) disposed at least partially within the elongated aperture such that the elongated aperture defines a range of movement of the first actuator (since 112 slides within the elongated aperture to define the range of movement of 134 relative to 112), wherein the first actuator comprises a bore (140) extending therethrough along a longitudinal axis thereof and configured to receive a stabilization wire (600) (par. [0054], [0074]), FIGS. 8 and 32; a second portion (the rest of the clamp, including 104, 102, 106, 112, 114), comprising: an extension (106) comprising a pair of protrusions (162 and inwardly curving distal tip) at a distal end thereof, FIG. 1; a bore (through 104 that receives 112) extending along a longitudinal axis (axis of 104) of the second portion (at 104); and a second actuator (114, 112) comprising a coupling mechanism (112) configured to be received through and releasably couple with the bore, wherein the coupling mechanism is further configured to be received by and releasably coupled with the recess such that manipulation of the second actuator translates the first portion and the second portion along the longitudinal axis of the second portion (pulling the second actuator upward translates the second actuator as part of the second portion upward relative to the first portion and thus the second portion comprising the second actuator translates relative to the first portion, which can be interpreted depending on perspective as the first portion and the second portion translating relative to each other, par. [0059]).
As to claim 39, Carlo discloses the surgical clamp according to claim 37, wherein the second portion comprises at least one aperture (space between 162 and inwardly curving distal tip) configured to receive a stabilization wire (interpreted as language of intended use; fully capable of receiving a stabilization wire of an appropriate size therethrough).
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.
Claims 21-29 and 32-35 are rejected under 35 U.S.C. 103 as being unpatentable over WIPO International Publication No. WO 2020/180598 to Carlo III et al. (hereinafter, “Carlo”).
As to claim 21, Carlo discloses a surgical system, comprising a clamp, FIG. 27, comprising: a first portion (304) comprising a first actuator (308) configured to interface with a first metatarsal of a patient (par. [0064]), shown for example in FIG. 34, wherein the first actuator is disposed at least partially within an aperture (350) that defines a range of movement of the first actuator, FIG. 28; a second portion (354), comprising an extension (356) having a retention mechanism (inwardly facing protrusion 362 and inwardly facing tip), FIG. 27, configured to interface with a second metatarsal of the patient, shown for example in FIG. 34; wherein the second portion is releasably coupled with the first portion and the first and second portions are translatable relative to one another via a second actuator (button 164 discussed in another embodiment, par. [0058]); and a stabilization wire (600) configured to be received by at least one of the first portion (at 308, par. [0064]) and the second portion.
As to claim 22, Carlo discloses the surgical system according to claim 21, wherein the first actuator (308) comprises a first bore (340a,340b) disposed about a longitudinal axis of the first actuator (par. [0064]), FIG. 29.
As to claim 23, Carlo discloses the surgical system according to claim 22, wherein the first bore is configured to receive one of the plurality of stabilization wires into and through the first bore such that the stabilization wire is configured to releasably couple the first actuator with the first metatarsal (par. [0064]), shown for example in FIGS. 33-34.
As to claim 24, Carlo discloses the surgical system according to claim 23, wherein manipulation of the first actuator (308) within the aperture (350) is configured to apply a rotational force to the first metatarsal via at least the one of the plurality of stabilization wires to manipulate the first metatarsal from a first position to a second position (rotation of the actuator to apply a rotational force to the first metatarsal via the wire is shown in another embodiment in FIGS. 35A-35B).
As to claim 25, Carlo discloses the surgical system according to claim 24, wherein the manipulation of the first actuator within the aperture moves at least the one of the plurality of stabilization wires from a first position forming a first angle with a transverse plane to a second position forming a second angle with the transverse plane, wherein the first angle is different than the second angle (because the first actuator and the wire therein can move within the arcuate aperture from a first to a second angle with the transverse plane).
As to claim 26, Carlo discloses the surgical system according to claim 25, wherein the first angle is greater than the second angle (any two positions within the aperture can be chosen as the first and second angles so that the first angle is greater than the second angle).
As to claim 27, Carlo discloses the surgical system according to claim 21, wherein the retention mechanism is disposed at a distal end of the extension, FIG. 27, and comprises a pair of curved protrusions (each inwardly facing protrusion/tip has a curved surface) defining a recess therebetween.
As to claim 28, Carlo discloses the surgical system according to claim 27, wherein the protrusions are curved towards the first portion of the clamp, FIG. 27.
As to claim 29, Carlo discloses the surgical system according to claim 21, wherein the second actuator is disposed at an end of the second portion opposite the first portion (the second actuator is at an end of the second portion that is opposite or on the other end of 302 as the same end of the first portion).
As to claim 35, Carlo discloses the surgical system according to claim 21, wherein the first and second actuators each comprise a texture (a texture is the feel of a surface; the actuators have a texture because they have surfaces, even if it is a smooth texture) disposed on one or more outer surfaces thereof.
Carlo is silent as to a plurality of the stabilization wires.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the system with a plurality of the stabilization wires, to be used interchangeably through the first bore of the first actuator, since the mere duplication of the essential working parts of a device involves only routine skill in the art, and providing a plurality of the stabilization wires to the system would allow use of a new wire in the event one wire is bent or otherwise rendered unusable.
As to claim 21, in another interpretation, Carlo discloses a surgical system, comprising a clamp, FIG. 1, comprising: a first portion (108) comprising a first actuator (108 including 134) configured to interface with a first metatarsal of a patient, FIG. 34, wherein the first actuator is disposed at least partially within an aperture (arcuate aperture through 108) that defines a range of movement of the first actuator (par. [0076]), FIGS. 8 and 35A-35B; a second portion (the rest of the clamp, including 104, 102, 106, 112, 114), comprising an extension (106) having a retention mechanism (156) configured to interface with a second metatarsal of the patient, FIG. 34; wherein the second portion is releasably coupled with the first portion (releasably locked together, and releasably coupled because they can be disassembled) and the first and second portions are translatable relative to one another via a second actuator (114, 112) (pulling the second actuator upward translates the second actuator as part of the second portion upward relative to the first portion and thus the second portion comprising the second actuator translates relative to the first portion, par. [0059]); and a stabilization wire (600) configured to be received by at least one of the first portion (at 134, par. [0064]), FIG. 32, and the second portion.
As to claim 29, Carlo discloses the surgical system according to claim 21, wherein the second actuator is disposed at an end of the second portion opposite the first portion (knob 114 of the second actuator is disposed at a superior end of the second portion opposite the inferior first portion, FIG. 1).
As to claim 32, Carlo discloses the surgical system according to claim 29, wherein the first portion comprises a recess (concavity under 108, FIG. 1) comprising a second coupling mechanism (arcuate inferior surface 136 of 108), the recess configured to receive and releasably couple with a portion (184) of a protrusion (112) of the second actuator (par. [0059]), FIG. 1.
As to claim 33, Carlo discloses the surgical system according to claim 32, wherein the recess of the first portion and a bore (bore through 104 that receives 112) of the second portion (at 104) share a common axis of the protrusion (112) when both are releasably coupled with the protrusion of the second actuator, FIG. 1.
As to claim 34, Carlo discloses the surgical system according to claim 33, wherein manipulation of the second actuator translates the first portion relative to the second portion along the shared common axis (pulling the second actuator upward translates the second actuator as part of the second portion upward relative to the first portion and thus the second portion comprising the second actuator translates relative to the first portion, par. [0059]).
Carlo is silent as to a plurality of the stabilization wires.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to provide the system with a plurality of the stabilization wires, to be used interchangeably through the first bore of the first actuator, since the mere duplication of the essential working parts of a device involves only routine skill in the art, and providing a plurality of the stabilization wires to the system would allow use of a new wire in the event one wire is bent or otherwise rendered unusable.
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 TRACY L KAMIKAWA whose telephone number is (571)270-7276. The examiner can normally be reached M-F 10:00-6:30 PM.
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/TRACY L KAMIKAWA/Examiner, Art Unit 3775
Prosecution Insights