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 have been received on 07/10/2024 and these drawings have been objected to
under 37 CFR 1.84 for the following reasons: the drawings contain solid black shading, which should not
be present “except when used to represent bar graphs or color” (MPEP 608.02(v)). Additionally, details of the drawings are hard to make out, such as in Fig. 3 and Figs. 5-9. New corrected drawings in compliance with 37 CFR 1.121(d) are required in this application because of the reasons stated above. Applicant is advised to employ the services of a competent patent draftsperson outside the Office, as the U.S. Patent and Trademark Office no longer prepares new drawings. The corrected drawings are required in reply to the Office action to avoid abandonment of the application. The requirement for corrected drawings will not be held in abeyance.
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 7 and 10-18 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 7 recites the limitation "the joint" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the joint" in line 9. There is insufficient antecedent basis for this limitation in the claim.
Regarding claim 12, the claim is indefinite because the ending of the claim does not make grammatical sense as it recites “are locked to each ratcheting” and appears to be a typo, therefore the metes and bounds of the claim cannot be ascertained. For examination purposes, claim 12 will presume to read as “are locked to each other using a ratchet mechanism” to track with claim 3, similar to how claims 11 and 13 track to claims 2 and 4.
Claims 11-18 are indefinite by virtue of their dependency on indefinite base claim 10.
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) 1-4, 6-8, 10-13, and 15-17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US 2009/0192608 A1 to Paulos (hereinafter “Paulos”).
Regarding claim 1, Paulos discloses (see abstract; Figs. 1-15; and [0012]-[0023] & [0042]-[0056]) a proximal biceps clip (32) for a biceps tendon (see at least [0042]-[0044]), comprising: a first portion (40) and a second portion (42); first ends of the first portion and the second portion being hingedly connected together (at 44, see Figs. 12/14 and [0046]); second ends of the first portion and the second portion being locked to each other (via structures 46/48/50/60/62/64, see Figs. 11-14 and [0046]-[0047] & [0050]); a capture region (68 + 72) defined by inner surfaces (68 and 72) of the first portion and the second portion (see Figs. 12-13 and [0048]); a grip region defined by outer surfaces of the first portion and the second portion (via 84, see Figs. 12/14 and [0052]); the proximal biceps clip being larger than a bicipital groove of a humeral head (see [0042]/[0054] & Fig. 10); wherein a tendon (20) captured between the first portion and the second portion locked together secures the tendon in place by wedging the biceps clip into the bicipital groove preventing the proximal tendon from retracting down into the bicipital groove as it is larger than the clip device (see Figs. 9/10 & 14/15 and see [0042]/[0052]/[0054]).
Paulos further discloses (claim 2) wherein teeth (66/70) or ridges are provided on the inner surface of the first portion and the second portion at the groove to improve grasping of the biceps tendon (see Figs. 12-15 and [0048]/[0050]); (claim 3) wherein the respective second ends of the first portion and the second portion are locked to each other using a ratchet mechanism (via structures 46/48/50/60/62/64, see Figs. 11-14 and [0046]-[0047] & [0050]); (claim 4) wherein the second ends of the first portion and the second ends are releasably locked to each other (via structures 46/48/50/60/62/64, see Figs. 11-14 and [0046]-[0047] & [0050]); (claim 6) wherein the proximal biceps clip is made of biocompatible material (see [0046]); (claim 7) wherein the proximal biceps clip is wedged inside the joint (see Figs. 9/10 & 14/15 and see [0012]/[0042]/[0052]/[0054]); (claim 8) wherein the proximal biceps clip is deployed arthroscopically (see [0042]/[0055]).
Regarding claim 10, Paulos discloses (see abstract; Figs. 1-15; and [0012]-[0023] & [0042]-[0056]) a method for deploying a proximal biceps clip (32) for a biceps tendon (see at least [0042]-[0044]), comprising the steps of: providing a clip (32) having a first portion (40) and a second portion (42); first ends of the first portion and the second portion being hingedly connected together (at 44, see Figs. 12/14 and [0046]); second ends of the first portion and the second portion being locked to each other (via structures 46/48/50/60/62/64, see Figs. 11-14 and [0046]-[0047] & [0050]); a capture region (68 + 72) being defined by inner surfaces (68 and 72) of the first portion and the second portion; a grip region defined by outer surfaces of the first portion and the second portion (via 84, see Figs. 12/14 and [0052]); the proximal biceps clip being larger than a bicipital groove of a humeral head (see [0042]/[0054] & Fig. 10); arthroscopically pulling the biceps tendon out through the joint (see Fig. 1 and [0042]); securing the clip to the biceps tendon in locked fashion whereby the biceps tendon is captured between the first portion and the second portion locked together (see Figs. 9 & 14-15 and [0042]/[0049]-[0055]); releasing the biceps tendon with clip locked thereto to permit it to partially retract back into the bicipital groove (see Figs. 9/10 and [0042]/[0049]-[0055]); wedging the biceps clip into the bicipital groove thereby preventing the proximal tendon from further retracting down into the bicipital groove because it is larger than the clip device (see Figs. 9/10 and [0042]/[0049]-[0055]).
Paulos further discloses (claim 11) wherein teeth (66/70) or ridges are provided on the inner surface of the first portion and the second portion at the groove to improve grasping of the biceps tendon (see Figs. 12-15 and [0048]/[0050]); (claim 12) wherein the respective second ends of the first portion and the second portion are locked to each other using a ratchet mechanism (via structures 46/48/50/60/62/64, see Figs. 11-14 and [0046]-[0047] & [0050]); (claim 13) wherein the second ends of the first portion and the second ends are releasably locked to each other (via structures 46/48/50/60/62/64, see Figs. 11-14 and [0046]-[0047] & [0050]); (claim 15) wherein the proximal biceps clip is made of biocompatible material (see [0046]); (claim 16) the step of wedging the proximal biceps clip inside the joint at the bicipital groove (see Figs. 9/10 & 14/15 and see [0012]/[0042]/[0052]/[0054]); and (claim 17) wherein the proximal biceps clip is deployed arthroscopically (see [0042]/[0055]).
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.
Claim(s) 5 and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paulos in view of US 2011/0112558 A1 to Whayne et al. (hereinafter “Whayne”).
Paulos discloses the invention substantially as claimed as discussed above, however, with respect to claim 5, Paulos fails to specifically disclose wherein the outer surfaces of the first portion and the second portion each define a recess configured and arranged for locating a gripping instrument to facilitate closure and locking of the clip on the biceps tendon. Whayne discloses (see abstract; Figs. 21A-22C; and [0076]-[0084]), in the same field of endeavor, a biceps clip (280, Figs. 21A-B) comprising a first portion ("left" arm, pointed to by #280 in Fig. 21B) and a second portion ("right" arm, pointed to by #280 in Fig. 21A), wherein the outer surfaces of the first portion and the second portion each define a recess (282) configured and arranged for locating a gripping instrument (300) to facilitate closure and locking of the clip on the biceps tendon (see Figs. 21A-22C and [0076]-[0084]) for the purpose of providing notches in the clip to engage protrusions of the deployment device to assist in deployment, repositioning, or removal (see [0077]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paulos' clip with the outer recesses as taught by Whayne in order to provide notches in the clip to engage protrusions of the deployment device to assist in deployment, repositioning, or removal.
Paulos discloses the invention substantially as claimed as discussed above, however, with respect to claim 14, Paulos fails to specifically disclose wherein the outer surfaces of the first portion and the second portion each define a recess configured and arranged for locating a gripping instrument to facilitate closure and locking of the clip on the biceps tendon. Whayne discloses (see abstract; Figs. 21A-22C; and [0076]-[0084]), in the same field of endeavor, a biceps clip (280, Figs. 21A-B) comprising a first portion ("left" arm, pointed to by #280 in Fig. 21B) and a second portion ("right" arm, pointed to by #280 in Fig. 21A), wherein the outer surfaces of the first portion and the second portion each define a recess (282) configured and arranged for locating a gripping instrument (300) to facilitate closure and locking of the clip on the biceps tendon (see Figs. 21A-22C and [0076]-[0084]) for the purpose of providing notches in the clip to engage protrusions of the deployment device to assist in deployment, repositioning, or removal (see [0077]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paulos' clip with the outer recesses as taught by Whayne in order to provide notches in the clip to engage protrusions of the deployment device to assist in deployment, repositioning, or removal.
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Paulos in view of US 12,011,154 B1 to Anakwenze (hereinafter “Anakwenze”).
Paulos discloses the invention substantially as claimed as discussed above, however, with respect to claim 9, Paulos fails to specifically disclose holes for suturing the clip for a secondary fixation of the biceps tendon and clip in place. Anakwenze discloses, in the same field of endeavor of bicep tendon repair (see Col. 7, lines 5-13), the use of a fastener (101) for securing the tendon, wherein the fastener further comprises holes (125/127) for suturing the fastener for secondary fixation of the biceps tendon and the fastener in place (see Fig. 1 and Col. 4, lines 19-23 & Col. 7, lines 5-13) for the purpose of providing holes in the fastener though which suture may be inserted to allow additional attachment by passing suture through the soft tissue such that the fastener can simultaneously affix soft tissue directly to bone while also serving as a suture anchor (see Col. 4, lines 19-23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paulos' clip with the suture holes as taught by Anakwenze in order to provide holes in the clip though which suture may be inserted to allow additional attachment by passing suture through the soft tissue such that the clip can simultaneously affix soft tissue directly to bone while also serving as a suture anchor.
Paulos discloses the invention substantially as claimed as discussed above, however, with respect to claim 18, Paulos fails to specifically disclosethe step of: providing suture holes in the clip; and suturing the biceps tendon and clip in place for a secondary fixation. Anakwenze discloses, in the same field of endeavor of bicep tendon repair (see Col. 7, lines 5-13), the use of a fastener (101) for securing the tendon, wherein the fastener further is provided with holes (125/127); and suturing the fastener for secondary fixation of the biceps tendon and the fastener in place (see Fig. 1 and Col. 4, lines 19-23 & Col. 7, lines 5-13) for the purpose of providing holes in the fastener though which suture may be inserted to allow additional attachment by passing suture through the soft tissue such that the fastener can simultaneously affix soft tissue directly to bone while also serving as a suture anchor (see Col. 4, lines 19-23). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Paulos' clip with the suture holes as taught by Anakwenze in order to provide holes in the clip though which suture may be inserted to allow additional attachment by passing suture through the soft tissue such that the clip can simultaneously affix soft tissue directly to bone while also serving as a suture anchor.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SHAUN L DAVID whose telephone number is (571)270-5263. The examiner can normally be reached M-F 10AM-6:30PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Darwin Erezo can be reached at 571-272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SHAUN L DAVID/Primary Examiner, Art Unit 3771