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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/15/2025has been entered.
Response to Amendment
This Office action is in response to the applicant’s communication filed 04/30/2025.
Status of the claims:
Claims 1, 2, 4 – 8, 10 – 18, and 20 – 23 are pending in the application.
Claims 6 – 9, 10 – 18, and 20 are withdrawn.
Claim 1 is amended.
Claim 23 is new.
Claim Objections
The objections to claims 4 in the previous action dated 06/17/2025 have been withdrawn in light of the Applicant’s amendments filed 09/15/2025. Specifically, the objection to claim 1, regarding the phrases “at least one of a hole, an aperture, a hook or a ring”, “the soft tissue structure”, and “the application” have been withdrawn as the appropriate corrections have been made. However, new objections have been set forth below in light of Applicant’s amendments.
Claims 1, 4, 21, and 23 are objected to because of the following informalities:
Claims 1 and 23 recites “in bone” in line 2 and “to bone” 8, although the lines are understood by the Examiner to mean “in a bone” and “to the bone”, respectively, the Examiner suggests the lines be amended to read “in a bone” and “to the bone” for the purpose of having proper antecedent basis for the claimed terms and for the purpose of maintaining consistent language throughout the claims;
Claim 4 recites “wherein application of the at least two substantially opposed forces causes” in line 6, although the line is understood by the Examiner to be a functional limitation and not a method step and to read “wherein the application of the at least two substantially opposed forces are configured to cause”, the Examiner suggests the line be amended to read “wherein the application of the at least two substantially opposed forces are configured to cause” for the purpose of providing proper antecedent basis for the claimed terms;
Claim 21 recites “tensioning …. causes” in lines 10 – 11, although the line is understood by the Examiner to be a functional limitation and not a method step and to read “tensioning …. is configured to cause”, the Examiner suggests the line be amended to read “tensioning …. is configured to cause” for the purpose of maintaining consistent language throughout the claims;
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.
The rejection of claims 1, 2, 4, 5, and 21 – 22 under U.S.C 35 112(b) regarding indefiniteness, recited in the previous action dated 06/17/2025 have been withdrawn in light of the Applicant’s amendments filed 09/15/2025. Specifically, the rejection of claim 1, regarding the lack of clarity in the phrase "wherein the suture material and the soft tissue apply the at least two substantially opposed forces", has been withdrawn and the rejection of claims 2, 4, 5, and 21 – 22 has been withdrawn as the claims are no longer dependent on an indefinite claim.
Claim Rejections - 35 USC § 103
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 2, 4, 5, 21, 22, and 23 are rejected under 35 U.S.C. 103 as being unpatentable over Diaz (US 2020/0214828 A1) (previously cited) and in view of McLawhorn (US 2010/0145362 A1).
Regarding claim 1, Diaz discloses a suture anchor (anchoring device 12A/12B) (abstract, paragraphs [0049], [0050], [0067 – 0073], and Figs. 1, 11A/B, 14A/B) (Examiner’s note: paragraph [0069] states wherein the device of Figs. 14A/B can comprise the same structure as that of the device in Figs. 11A/B, therefore the Examiner is relying upon the body of the device shown in Figs. 11A/B and the method of attaching the tissue to the anchor as described in the embodiment of Fig. 14A/B. Additionally, the recitations for both Figs. 14A/B and Figs. 11A/B are cited by the Examiner) comprising:
an elongate body (body 22A/B) configured to be implanted in bone (paragraph [0062]), the elongate body having a distal end and a proximal end (Fig. 11A/B), the elongate body including at least one barb (barbs 34) arranged on an outer surface thereof (paragraph [0063]);
wherein at least a portion of the elongate body is configured to be attached to a soft tissue structure (tendon graft 2) in need of being reattached to bone (paragraphs [0050 – 0052] and [0067 – 0073]), wherein the elongate body has a delivery configuration (expanded configuration shown in Fig. 11A – paragraph [0041]) that is different than a deployed configuration (collapsed configuration shown in Fig. 11B – paragraph [0042]), and
wherein a change in the configuration is effected by the application of at least two substantially opposed forces body (Examiner’s note: it should be understood that the preceding limitation is functional and requires only that the structure of the prior art be capable of functioning as claimed; with that said, the body 22A/B can be compressed by two opposing forces).
However, Diaz is silent regarding (i) a suture-engaging structure comprising at least one of a ring configured to engage a suture material to enable the soft tissue structure to be attached to the suture anchor via the suture material, wherein the suture material engages the suture-engaging structure at a location proximal to a distal end of the soft tissue structure that is attached to the elongated body, and (ii) wherein the application of the opposed force is configured to be applied by the suture material and the soft tissue structure being tensioned. With respect to (i), Diaz teaches, in paragraph [0076], another embodiment comprising a suture material (sutures 14) attached to the deices 12A/12B wherein the suture ends may be tied together to augment the repair. That is, as is understood in known repair procedures without sutures, the repaired tendon has a tendency to stretch or elongate over time. In the embodiments herein, use of the sutures 14 can provide additional support to counter the tendon elongation. Thus, the additional support provided by the sutures 14 increases the strength of the repair and minimizes tendon creep.
As to the above, McLawhorn teaches suture anchor (tracking device 20; which equate to the devices 12A/B of Diaz) comprising an elongate body (main body 22; which equates to the body 22A/B of Diaz) with a suture engaging structure (loop member 70) comprising a ring (loop member 70) at a proximal end of the elongate body configured to engage a suture material (suture 90) configured to be tensioned to another suture anchor (tracking device 20) (paragraphs [0027 – 0028], [0053 – 0055], and Fig. 10).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the proximal ends of the suture anchor’s elongate bodies of Diaz to incorporate the suture engaging structure and the suture material of McLawhorn, for the purpose of being able to connect / tie the two anchor bodies (devices 12A/B) of Diaz together in order to increase the strength of the repair and minimize tendon creep (paragraph [0076] – Diaz). Additionally, with respect to (ii), it should be understood that the limitation is functional and requires only that the structure of the prior art be capable of functioning as claimed. With that said, the modification makes obvious wherein the suture material on the proximal end of one of the body portions 22A/B of the devices 12A/B of Diaz can be tensioned in the opposite direction as a force on the tendon such that the elongate body changes configuration. Therefore, the modification encompasses the claim above.
Regarding claim 2, as discussed above, the combination of Diaz and McLawhorn makes obvious the suture anchor of claim 1. Additionally, Diaz discloses wherein the elongate body defines an internal cavity (lumen 18) configured to engage the soft tissue structure (tendon 2) in the deployed configuration (compressed configuration – shown in Fig. 11B) (paragraph [0073]).
Regarding claim 4, as discussed above, the combination of Diaz and McLawhorn makes obvious the suture anchor of claim 1. Additionally, Diaz discloses wherein the elongate body (body 22A/B) comprises a first portion (body portion 22A) having a proximal end and a distal end and a second portion (body portion 22B) having a proximal end and a distal end (Figs. 11A/B and 14A/B), the distal end of the second portion being hinged to the distal end of the first portion (paragraphs [0069] and [0071]), wherein the elongate body defines a cavity (lumen 18) configured to receive and seat soft tissue (paragraphs [0067], [0073], and Figs. 14A/B). Furthermore, as discussed above, it would have been obvious to modify the device of Diaz to incorporate the suture engaging structure and suture material at the proximal end thereof based on the teachings of Diaz; the combination makes obvious wherein application of the at least two substantially opposed forces (tensioning force via the suture and a pushing force via the tendon) causes the first portion and the second portion to pivot closer to each other (Examiner’s note: it should be understood that the limitation is functional and requires only that the structure of the prior art be capable of functioning as claimed. With that said, the modification makes obvious wherein the suture material on the proximal end of one of the body portions 22A/B of the devices 12A/B of Diaz can be tensioned in the opposite direction as a force on the tendon such that the elongate body changes configuration. Therefore, the modification encompasses the claim above).
Regarding claim 5, as discussed above, it would have been obvious to modify the device of Diaz to incorporate the suture engaging structure and suture material at the proximal end thereof based on the teachings of McLawhorn. Additionally, the combination encompasses wherein the at least two substantially opposed forces include a first force and a second force (tensioning force via the suture and a pushing force via the tendon, respectively), and wherein the first force and the second force are offset from each other by about 100 to 180 degrees (Examiner’s note: the upward force of the suture material (suture 14) and downward force of the soft tissue structure (tendon graft 2) are 180 degrees apart).
Regarding claim 21, as discussed above, the combination of Diaz and McLawhorn makes obvious the suture anchor of claim 1. Additionally, Diaz discloses wherein the proximal ends of each of the first portion and the second portion (body portions 22A/B) are in closer proximity to each other in the deployed configuration (collapsed configuration shown in Fig. 11B – paragraph [0042]) than in the delivery configuration (expanded configuration shown in Fig. 11A – paragraph [0041]) (see annotated Figs. 11A/B),
wherein the at least one barb (barbs 34) protrudes from the first portion (body portion 22A) and another of the at least one barb (barbs 34) protrudes from the second portion (body portion 22B) (paragraph [0063], [0068 – 0073], and Figs. 11A/B and 14A/B),
the distal ends of each of the first and second portions (body portions 22A/B) being in closer proximity to each other in the deployed configuration than in the delivery configuration (see annotated Figs. 11A/B), and
wherein tensioning the first portion in a first direction and tensioning the second portion in a second direction that is substantially opposed to the first direction causes the first and second portions to pivot relative to each other to transform the elongate body from the delivery configuration to the deployed configuration (Examiner’s note: pushing the body portion 22A (i.e., the first portion) to the left (i.e., the first direction) (when looking at the annotated Fig. 11A/B) and pushing the body portion 22B (i.e., the second portion) to the right (i.e., the second, opposite, direction) (when looking at the annotated Fig. 11A/B) will cause the portions to pivot relative to each other and move to the deployed (i.e., the compressed) configuration from the delivery (i.e., the expanded) configuration).
Annotated Figures 11A and 11B of Diaz
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Regarding claim 22, as discussed above, the combination of Diaz and McLawhorn makes obvious the suture anchor of claim 1. Additionally, Diaz discloses wherein a dimension (diameter) of the elongate body (body 22A/B) decreases when the elongate body is transformed from the delivery configuration to the deployed configuration (Figs. 11A/B and annotated Figs. 11A/B).
Regarding claim 23, Diaz discloses a suture anchor (anchoring device 12A/12B) (abstract, paragraphs [0049], [0050], [0067 – 0073], and Figs. 1, 11A/B, 14A/B) (Examiner’s note: paragraph [0069] states wherein the device of Figs. 14A/B can comprise the same structure as that of the device in Figs. 11A/B, therefore the Examiner is relying upon the body of the device shown in Figs. 11A/B and the method of attaching the tissue to the anchor as described in the embodiment of Fig. 14A/B. Additionally, the recitations for both Figs. 14A/B and Figs. 11A/B are cited by the Examiner) comprising:
an elongate body (body 22A/B) configured to be implanted in bone (paragraph [0062]), the elongate body having a distal end and a proximal end (Fig. 11A/B), the elongate body including at least one barb (barbs 34) arranged on an outer surface thereof (paragraph [0063]), the elongate body (body 22A/B) comprises a first portion (body portion 22A) having a proximal end and a distal end and a second portion (body portion 22B) having a proximal end and a distal end (Figs. 11A/B and 14A/B), the distal end of the second portion being hinged to the distal end of the first portion (paragraphs [0069] and [0071]);
wherein at least a portion of the elongate body is configured to be attached to a soft tissue structure (tendon graft 2) in need of being reattached to bone (paragraphs [0050 – 0052] and [0067 – 0073]), wherein the elongate body has a delivery configuration (expanded configuration shown in Fig. 11A – paragraph [0041]) that is different than a deployed configuration (collapsed configuration shown in Fig. 11B – paragraph [0042]), and
wherein a change in the configuration is effected by the application of at least two substantially opposed forces body (Examiner’s note: it should be understood that the preceding limitation is functional and requires only that the structure of the prior art be capable of functioning as claimed; with that said, the body 22A/B can be compressed by two opposing forces);
wherein the elongate body defines a cavity (lumen 18) configured to receive and seat soft tissue (paragraphs [0067], [0073], and Figs. 14A/B).
However, Diaz is silent regarding (i) a suture-engaging structure comprising at least one of a ring configured to engage a suture material to enable the soft tissue structure to be attached to the suture anchor via the suture material, wherein the suture material engages the suture-engaging structure at a location proximal to a distal end of the soft tissue structure that is attached to the elongated body, and (ii) wherein the suture material and the soft tissue structure are configured to be tensioned to apply the at least two substantially opposed forces and wherein the application of the opposed forces causes the first portion and the second portion to pivot closer to each other. With respect to (i), Diaz teaches, in paragraph [0076], another embodiment comprising a suture material (sutures 14) attached to the deices 12A/12B wherein the suture ends may be tied together to augment the repair. That is, as is understood in known repair procedures without sutures, the repaired tendon has a tendency to stretch or elongate over time. In the embodiments herein, use of the sutures 14 can provide additional support to counter the tendon elongation. Thus, the additional support provided by the sutures 14 increases the strength of the repair and minimizes tendon creep.
As to the above, McLawhorn teaches suture anchor (tracking device 20; which equate to the devices 12A/B of Diaz) comprising an elongate body (main body 22; which equates to the body 22A/B of Diaz) with a suture engaging structure (loop member 70) comprising a ring (loop member 70) at a proximal end of the elongate body configured to engage a suture material (suture 90) configured to be tensioned to another suture anchor (tracking device 20) (paragraphs [0027 – 0028], [0053 – 0055], and Fig. 10).
It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the claimed invention, to modify the proximal ends of the suture anchor’s elongate bodies of Diaz to incorporate the suture engaging structure and the suture material of McLawhorn, for the purpose of being able to connect / tie the two anchor bodies (devices 12A/B) of Diaz together in order to increase the strength of the repair and minimize tendon creep (paragraph [0076] – Diaz). Additionally, with respect to (ii), it should be understood that the limitation is functional and requires only that the structure of the prior art be capable of functioning as claimed. With that said, the modification makes obvious wherein the suture material on the proximal end of one of the body portions 22A/B of the devices 12A/B of Diaz can be tensioned in the opposite direction as a force on the tendon such that the elongate body changes configuration / the two portions pivot closer to each other. Therefore, the modification encompasses the claim above.
Response to Arguments
Applicant’s arguments, filed 09/15/2025, with respect to the rejection of claims 1, 2, 4 – 5, 21, and 22 have been considered but are moot as the arguments are directed to Applicant’s amendments, and the previous rejection of the claims has been withdrawn in light of said amendments. Specifically, the rejections were withdrawn because Diaz does not disclose a suture engaging structure on the proximal end of the elongate body / proximal of the distal end of the elongate body. It is noted that a new rejection has been made over Diaz and McLawhorn. The teachings of McLawhorn are relied upon for teaching the newly added limitations as discussed above.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Andrew Restaino whose telephone number is (571)272-4748. The examiner can normally be reached Mon - Fri 8:00 - 4:00 ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Houston can be reached on 571-272-7134. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Andrew Restaino/Primary Examiner, Art Unit 3771