Patent Application 17266899 - A CLAMP AND CABLE - Rejection
Patent Application 17266899 - A CLAMP AND CABLE
Title: A CLAMP AND CABLE
Application Information
- Invention Title: A CLAMP AND CABLE
- Application Number: 17266899
- Submission Date: 2025-05-16T00:00:00.000Z
- Effective Filing Date: 2021-02-08T00:00:00.000Z
- Filing Date: 2021-02-08T00:00:00.000Z
- National Class: 606
- National Sub-Class: 074000
- Examiner Employee Number: 88339
- Art Unit: 3775
- Tech Center: 3700
Rejection Summary
- 102 Rejections: 1
- 103 Rejections: 3
Cited Patents
The following patents were cited in the rejection:
Office Action Text
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 .
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 “the channels being not covered by the internal face of the jaws when the jaws are in the closed position” as recited in claims 1, 21, and 43 must be shown or the feature(s) canceled from the claim(s). 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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1, 21, and 43 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. The claims recite the limitation the “the channels being not covered by the internal face of the jaws when the jaws are in the closed position” however, all the figures presented with the specification as originally filed only show the jaws in the open position or clasping a bone and therefore do not reflect how the channel would be viewed if the jaws were closed. In addition, the specification as originally filed does not appear to discuss that the jaws being in the closed position without a bone therebetween.
Claims 2, 4, 6-7, 9, 12, 14-16, 22-25, 27, 38-39, and 41 are rejected as under 112(a) since they do not remedy the issues recited above.
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.
Claim(s) 1, 6-7, 9, 12, and 14-16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated over Vanden Hock et al (US Patent Pub. 20050192474A1).
Vanden Hock discloses a device capable of being used as a bone clamp for use in fixation of a fractured bone or prevention of a fracture of a bone. Specifically in regards to claim 1, Vanden Hock recites a clamp (50) comprising a pair of handles (see Fig. 3) joined together at a pivot point, the handles each having an arcuate jaw (80’/82’, Fig. 10), each arcuate jaw (80’/82’) comprising a first end (end closes to pivot) having an opening at a proximal end of the jaw (80’/82’) in communication with a second end (end furthest from pivot) having an opening at a distal end of the jaw (80’/82’), the first and second ends in communication via a channel (98’/138’), in which the channel (98’/138’) is configured to accommodate a suture (72), and characterized in that the channel (98’/138’) is open continuously along its entire length and which runs uncovered continuously along its entire length through an internal face (face seen in Fig. 6,8,10) of each arcuate jaw (80’/82’) (Fig. 5-8 and 10; and Para. [0026]-[0030],[0044]-[0047]). Wherein the channels (98’/138’) are not covered by the surface of the internal face when the jaws (80’/82’) are in a closed position (As can be seen in Fig. 5- 10, the channels when the jaws are closed would be facing the material that is in between the jaws and not the face of the other jaw.) (Fig. 5-10).
In regards to claim 6, Vanden Hock discloses wherein at least one internal face comprises a plurality of ridges (102’) running perpendicular to the channel (98’/138’) (Fig. 10).
In regards to claim 7, Vanden Hock discloses wherein the arcuate jaws (80’/82’) have an arc measuring between 11.25° and 270° (Fig. 10).
In regards to claim 9, Vanden Hock discloses wherein the handles can slide relative to each other in the same plane at the pivot point (point adjacent 80’/82’) where central parts of the handles are connected together via a coupling connector and a slot (slot created in each arm to house the other, shown in fig. 3) (Fig. 3-6).
In regards to claim 12, Vanden Hock discloses wherein at least one channel (98’/138’) is inclined at an angle of between about 0.01° to about 45° relative to the central line of the corresponding arcuate jaw (80’/82’) (As can be seen in Fig. 10 of Vanden Hock the channel appears similar in shape as applicant’s channels shown in Fig. 2 as originally filed.) (Fig. 10).
In regards to claim 14, Vanden Hock discloses wherein only one channel (98’/138’) is inclined at an angle of between about 0.01° to about 45° relative to the central line of the corresponding arcuate jaw (80’/82’) (As can be seen in Fig. 10 of Vanden Hock the channel appears similar in shape as applicant’s channels shown in Fig. 2 as originally filed.) (Fig. 10).
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) 2, 4, and 15-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vanden Hoek in view of Fedotov (US Patent 5188636).
Vanden Hoek discloses a clamp having handles with an arcuate jaw at one end, wherein the jaws have an entirely open channel throughout the length of the inner surface. However, the reference is silent as to the ends of the jaws being flared and having a ledge, or wherein there is a sleeve on the jaws.
Fedotov discloses an instrument capable of being used as a bone clamp for use in fixation of a fractured bone or prevention of fracture of a bone. Specifically, Fedotov recites the clamp (20) comprising a pair of handles (24/25) joined together at a pivot point (23), the handles (24/25) each having an arcuate jaw (27/28), each arcuate jaw (28/27) comprising a first end (end closest to 23) having an opening (opening for 47) at a proximal end of the jaw (27/28) in communication with a second end (end furthest from 23) having an opening (66/65) at a distal end of the jaw (27/28), the first end (end closest to 23) and second end (end furthest from 23) in communication via a channel (29/30) (Fig. 1-10; and Col. 5 line 4-21,45-52; Col. 6 line 9-44). In regards to claims 2 and 4, Fedotov discloses wherein at least one of the second ends (ends furthest from 23) is flared (Fig. 5), and wherein at least one of the first ends (end closest to 23) is flared (As can be seen in Fig. 1, the end of the jaws 27/28 closest to pivot pin 23 is flared.) (Fig. 1). In regards to claim 15, Fedotov discloses a ledge (ledge of jaws 27/28 shown creating opening for 23) extending outwards from an inside face of one jaw (27/28) between the first end (end closest to 23) and central part of one of the pair of handles (24/25) (Fig. 1). In regards to claim 16, Fedotov discloses a retractable sleeve (31/32) extending from the distal end (end furthest from 23) of one jaw (27/28) to the distal end (End furthest from 23) of the other jaw (27/28) (Fig. 4, Col. 5 lines 53-66, Col. 6 lines 9-19, Col. 6 line 62 to Col. 7 line 32). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the clamp (50) of Vanden Hoek to have flared and ledged clamp ends, and a sleeve as taught in Fedotov in order to have a means to aid in the advancement of the sutures and needles through the tool and protect the sutures during advancement (Col. 3 lines 6-18); wherein the flared end allows for the jaws to fit within narrow spacing and ledges guide suture into jaws.
Claim(s) 21-25, 27, 38-39, and 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vanden Hoek in view of Burkhart (US Patent 5222962).
Vanden Hock discloses a cable for use with an instrument capable of being used as a bone clamp for use in fixation of a fractured bone or prevention of fracture of a bone. Specifically in regards to claim 21 and 23-25, Vanden Hock recites a clamp (50) comprising a pair of handles (see Fig. 3) joined together at a pivot point, the handles each having an arcuate jaw (80’/82’, Fig. 10), each arcuate jaw (80’/82’) comprising a first end (end closes to pivot) having an opening at a proximal end of the jaw (80’/82’) in communication with a second end (end furthest from pivot) having an opening at a distal end of the jaw (80’/82’), the first and second ends in communication via a channel (98’/138’), in which the channel (98’/138’) is configured to accommodate a suture (72), and characterized in that the channel (98’/138’) is open continuously along its entire length and which runs uncovered continuously along its entire length through an internal face (face seen in Fig. 6,8,10) of each arcuate jaw (80’/82’) (Fig. 5-8 and 10; and Para. [0026]-[0030],[0044]-[0047]). The cable (72) comprising a body and a tip (74), characterized in that the tip (74) is stiffened and has a beveled end point, wherein the tip (74) has a cross-sectional-shape adapted to engage with the channel (98’/138’) of the clamp (50) having a similar cross-sectional shape (Fig. 5; and Para. [0026],[0036],[0046],[0049]). Wherein the channels (98’/138’) are not covered by the surface of the internal face when the jaws (80’/82’) are in a closed position (As can be seen in Fig. 5- 10, the channels when the jaws are closed would be facing the material that is in between the jaws and not the face of the other jaw.) (Fig. 5-10). However, the reference silent as to the needle body have an radius of curvature.
Burkhart discloses a cable for use with a clamp. Specifically in regards to claim 21, Burkhart discloses a clamp (12) having a pair of jaws (22a/22b), and the cable (32) comprising a body (body of 30) and a tip (pointed end of 30), and wherein the tip has a cross-sectional shape adapted to engage the channel (34/28/30a) of the clamp (12) having a similar cross-sectional shape (Fig. 1-3 and 5a; and Col. 2 line 45 to Col. 3 line 25, Col. 3 line 61 to Col. 4 line 20). In regards to claim 23 and 24, Burkhart discloses wherein the tip further comprises an uncurved portion (straight portion of 30) between the cable body (32) and the tip (pointed end of 30), and wherein the tip is curved between the uncurved portion (straight portion of 30) and the beveled end point (see Fig. 1), and the curved portion between the uncurved portion (straight portion of 30) and the beveled end point (see Fig. 1) of the tip has an arc that matches that of an arc of the arcuate jaws (22a/22b) of the clamp (12) (Burkhart recites channel 28 is preferably either slanted as seen in FIGS. 1 and 2 with the axis of said channel meeting the longitudinal axis of the jaws in a non-normal fashion, or may even be slightly arcuate, concave toward nose portion (20a) and (20b) of jaws (12). Such a curve in channel (28) would be provided to generally match curve of needle (30) to make for an easier fi.) (Fig. 1; Col. 2 line 57 to Col. 3 line 9). In regards to claim 25, Burkhart discloses wherein the tip has an arc measuring between 11.25° and 270° (see curvature of needle 30 in Fig.1). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the needle (74) of Vanden Hoek to have a curved body as disclosed in Burkhart in order to allow for the use of curved needles easier and allow for the surgeon to manipulate the needle remotely (Col. 1 lines 15-25).
In regards to claim 22, Vanden Hoek discloses wherein the beveled end point (pointed end of 74) further comprises edges and sides that are adapted to match the cross-sectional shape of the openings (opening for 98’/138’) at the first end and the opening at the second end of the bone clamp (50) (Fig. 5).
In regards to claims 27 and 38, Vanden Hoek in view of Burkhart discloses a cable for use with a bone clamp as recited above. Further they recite wherein the curvature diameter of the tip (pointed end of 74, Vanden Hoek Fig. 5) is configured to be slightly larger to being no more than 50% smaller than the diameter of a bone being clamped; or configured to be no more than 50% smaller than the diameter of a bone being clamped. It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the combination by modifying the tip (pointed end of 74) of Vanden Hoek to have varying curvature diameters in relation to the bone size since this would allow the tip to better match the proposed bone to be fixed and because a mere change in the size of the plate components is recognized as being within the level of ordinary skill in the art (see In re Rose, 105 USPQ 237 (CCPA 1955)).
In regards to claim 39, Vanden Hoek discloses wherein the tip (tip of 74) is fixed to the body ( body of 72) of the cable (72) by welding, gluing, snap-fit, threaded or male to female connections (As can be seen in Fig. 5, the needle 74 is attached to the suture 72. The claimed phrase “tip is fixed to the body of the cable by welding, gluing, snap-fit, threaded or male to female connections” is being treated as a product by process limitation; that is the patentability of a product does not depend on its method of production. As set forth in MPEP 2113, product by process claims are not limited to the manipulation of the recited steps, only the structure implied by the steps. Once a product appearing to be substantially the same or similar is found, and a rejection is made the burden is shifted to applicant to show an unobvious difference. see MPEP 2113.) (Fig. 5; and Para. [0026]).
In regards to claim 41, Vanden Hoek discloses wherein the tip (tip of 74) has a cross-sectional shape selected from a square, a rectangle, a triangle, an ellipse, a pentagon, a hexagon, a heptagon, an octagon, a star shape, substantially flat, oval, flattened with rounded edges, or combinations thereof (Fig. 5).
Claim(s) 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vanden Hoek in view of Songer et al (US Patent 4966600).
Vanden Hoek discloses a tool capable of being used in a method for fixing a fracture or preventing a fracture of a bone. Specifically in regards to claim 43, Vanden Hoek affixing a clamp (50) comprising a pair of handles (handles having finger rings) joined together at a pivot point, the handles each having an arcuate jaw (80’/82’), each arcuate jaw (80’/82’) comprising a first end (end closest to pivo) having an opening (opening for 98’/138’) at a proximal end of the jaw (80’/82’) in communication with a second end (end furthest from pivot) having an opening (opening for 98’/138’) at a distal end of the jaw (80’/82’), the first and second ends in communication via a channel (98’/138’), in which the channel (98’/138’) is configured to accommodate a suture (72), and characterized in that each channel (98’/138’) is open continuously along its entire length and which runs uncovered continuously along its entire length through an internal face (face seen in Fig. 8 and 10) of each arcuate jaw (80’/82’) to the surgical site (Fig. 5-8 and 10; and Para. [0026]-[0030],[0044]-[0047]). Wherein the channels (98’/138’) are not covered by the surface of the internal face when the jaws (80’/82’) are in a closed position (As can be seen in Fig. 5- 10, the channels when the jaws are closed would be facing the material that is in between the jaws and not the face of the other jaw.) (Fig. 5-10). Passing a cable (72) comprising a body (body of 72) and a tip (tip of 74), characterized in that the tip is stiffened and has a beveled end point (pointed end of 74), wherein the tip is curved (needle 74 is shaped to fit in channel 160’) and wherein the tip has a cross-sectional shape adapted to engage with the channel (98’/138’) of the clamp (50) having a similar cross-sectional shape, through the channels (98’/138’) of the clamp (40) (Fig. 5; and Para. [0026],[0036],[0046],[0049]). However, the reference is silent as to the surgical site being a bone or wherein a crimp is applied and crimped to the cable.
Songer discloses a method a method for fixing a fracture or preventing fracture of a bone. In regards to claim 43, Songer discloses affixing a clamp ( 10) against a bone (40), and passing a cable (30) through the clamp (10); applying a crimp (28) to the cable (30); tightening the cable (30); and crimping the crimp (28) to fasten the cable (30) in place (Fig. 1-6; and Col. 4 lines 14-31 and 47-68; col. 5 lines 1-18; col. 5 line 61 to Col. 6 lines 13). It would have been obvious to one having ordinary skill in the art at the time the invention was filed to modify the method of Vanden Hoek by having the site be a bone and adding a crimp to the cable in view of Songer in order to have a means to permanently hold the loop of cable at the desired level of tightness (Col. 5 lines 15-18) and to allow for a wider range of use for the clamp.
Response to Arguments
Applicant’s amendments filed on 2/20/25 have overcome the previous 112(b) rejection of claim 21 which is now withdrawn.
Applicant’s arguments with respect to the claims have been considered but are not persuasive. Applicant argues that the Vanden Hoek reference does not demonstrate that each channel is not covered by the surface of the internal face of the opposing jaw when the jaws are in a closed position (Remarks Pg. 8-10 and 14-16). However, all the figures presented with the specification as originally filed only show the jaws in the open position or clasping a bone and therefore do not reflect how the channel would be viewed if the jaws were closed. In addition, the specification as originally filed does not appear to discuss that the jaws being in the closed position without a bone therebetween. Therefore, there appears to be no support for the new limitation.
In addition, applicant's argument that the channel in their application is meant to allow for the use of cerclage a bone in two directions since the channels are never colinear, is merely a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In response to applicant's argument that the references fail to show certain features of the invention, namely non-colinear channels for the passage of the needle, it is noted that the features upon which applicant relies are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant argues against the combination of Vanden Hoek and Fedotov (Remarks pg.10-11) since they are both clamps meant to be used on tissue instead of bone. This argument is being interpreted as reciting an intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case applicant has not point to what in the structure of either clamp would make it unsuitable for use in bone and therefore, it is unpersuasive.
In the Remarks at Pg. 12-14, applicant argues against the Burkhart reference citing that it is a clamp that is meant to tightly grip the needle as opposed to allowing passage of the needle. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case the Burkhart reference is only brought in to demonstrate that it is well known in the art that needles can have a radius of curvature it is not brought in for how the clamp itself is operated as argued by applicant. The Vanden Hoek reference is not meant to bodily incorporate the operational use of the Burkhart clamp instead it is brought in to modify the needle structure.
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 MARCELA I SHIRSAT whose telephone number is (571)270-5269. The examiner can normally be reached M-F 9:00am-5:30pm MST.
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/MARCELA I. SHIRSAT/ Primary Examiner, Art Unit 3775
