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 Invention I and Species E, FIGS. 39-54, in the reply filed on 07 January 2026, is acknowledged.
Claims 20 and 40, directed to nonelected Invention II, were withdrawn by Applicant. Claims 1-19 are further withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Claims 1 and 17 recite an actuation portion, an engagement portion, and a coupling portion, which are directed to Species A-C. Election was made without traverse in the reply filed on 07 January 2026.
Priority
The priority date is 09 April 2021.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the first portion comprising at least one bore configured to receive a stabilization wire (claim 38) in addition to a bore of the first actuator configured to receive a stabilization wire (claim 37), must be shown or the feature(s) canceled from the claim(s). The drawings show that the first actuator has a bore 4144 configured to receive a stabilization wire but no additional bore in the first portion. No new matter should be entered.
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.
Claim Objections
Claims 22-26, 34, and 37-39 are objected to because of the following informalities: improper antecedence and language. Appropriate correction is required. The following amendments are suggested:
Claim 22 / line 2: “the first actuator.”
Claim 23 / lines 2-3: “through the first bore such that the stabilization wire is configured to releasably couple”
Claim 24 / lines 2-3: “at least the one of the plurality of stabilization wires”
Claim 25 / lines 1-2: “wherein the manipulation of the first actuator within the aperture moves at least the one of the plurality of stabilization wires”
Claim 25 / lines 3-4: “a second position
Claim 34 / line 3: “along the shared common axis.”
Claim 37 / line 14: “received by releasably couple with the recess”
Claim 37 / line 15: “the second portion along the longitudinal axis”
Claim 39 / line 2: “at least one aperture”
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 32-34 are rejected under 35 U.S.C. 112(b) 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.
As to claim 32, the limitation “the protrusion of the second actuator” (line 3) renders the claims indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as “a protrusion of the second actuator”.
As to claim 33, the limitation “the bore of the second portion” (line 2) renders the claims indefinite because it lacks proper antecedent basis in the claims. For examination purposes, the limitation will be interpreted as “a bore of the second portion”.
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 therefore, subject to the conditions and requirements of this title.
Claims 24-26 are rejected under 35 U.S.C. 101 because they are drawn to non-statutory subject matter. In claim 24, lines 1-2, applicant positively recites part of a human, “manipulation of the first actuator within the aperture applies a rotational force to the first metatarsal”. Thus claims 24-26 include a human within their scope and are non-statutory.
A claim directed to or including within its scope a human is not considered to be patentable subject matter under 35 U.S.C. 101. The grant of a limited, but exclusive property right in a human being is prohibited by the Constitution. In re Wakefield, 422 F.2d 897, 164 USPQ 636 (CCPA 1970).
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 a range of movement of the first actuator is defined by an aperture (aperture in 35 that receives 32) (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 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 bore such that the stabilization wire releasably couples 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 applies a rotational force to the first metatarsal via at least one of the plurality of stabilization wire 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 the 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 the 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 about 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 37-39 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 releasably and couple with the recess such that manipulation of the second actuator translates the first portion and the second portion about 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 38, Carlo discloses the surgical clamp according to claim 37, wherein the first portion comprises at least one bore (140) configured to receive a stabilization wire (600) (par. [0054], [0074]), FIGS. 8 and 32.
As to claim 39, Carlo discloses the surgical clamp according to claim 37, wherein the second portion comprises at least 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 a range of movement of the first actuator is defined by an aperture (350), 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 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 bore such that the stabilization wire releasably couples 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) applies a rotational force to the first metatarsal via at least one of the plurality of stabilization wire 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 manipulation of the first actuator within the aperture moves at least 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 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 a range of movement of the first actuator is defined by an aperture (arcuate aperture through 108) (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 the 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 the 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 about 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
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