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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 11/04/2025 has been entered.
Response to Amendment
This office action is responsive to the amendment filed on 11/04/2025. As directed by the amendment: claims 1, 3, 9, 19, 21-25, and 27-28 have been amended and claims 8 and 11-18 have been cancelled. Thus, claims 1-7, 9-10, and 19-28 are presently pending in this application.
Response to Arguments
Applicant’s arguments, see page 6, filed 11/04/2025, with respect to the USC 112b rejections have been fully considered and are persuasive. The amendments to the claims overcome the issues of clarity within the claims. The USC 112b rejections have been withdrawn.
Applicant's arguments, see pages 6-7, filed 11/04/2025, with respect to the rejection of claim 1 under 35 U.S.C. 102(a)(1) as being anticipated by Larsen et al (US 5993459 A), herein referenced to as “Larsen” have been fully considered but they are not persuasive.
The applicant has amended claim 1 to further recite “wherein actuation of the actuation member is configured to first deploy the tissue anchor into the first tissue and then unlock the housing cover for access to the coupling means”. Firstly, this language is considered functional language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The examiner submits that the device of Larsen is capable of this as in Larsen the user has control of when the housing cover is removed after the anchor is deployed distally. Hence, a user would be able to deploy the anchor and then unlock the housing cover. The applicant argues that Fig. 24 shows that the once the anchor is located in the shaft distal end, the cap is unlocked. The examiner disagrees, as functionally, a second stage of unlocking 150 is disengaging it from the flange of 130 which engages 150 to 130.
As such the rejection of claim 1 will be maintained.
Applicant's arguments, see pages 7-9, filed 11/04/2025, with respect to the rejections of claims 7 and 9 under 35 U.S.C. 103 as being unpatentable over Larsen in view of Brown et al (US 20210228200 A1), herein referenced to as “Brown” have been fully considered but they are not persuasive.
The applicant argues that it would not obvious to one of ordinary skill in the art to modify Larsen to incorporate the teachings of Brown and have the anchoring implant be a soft anchor. They argue that a key feature of Larsen is that the anchor is pushed into tissue via shaft 230 and that it would not be possible to push a soft anchor in this manner. As this would cause the anchor to buckle or deform. The applicant further argues, that a soft anchor would not be able to be pushed into predrilled bore without an outer tube.
The examiner respectfully disagrees.
As explained in Larsen the anchor isn’t used to drill into the bone but rather placed into an opening created by a drill bit (see Figs. 28-30, col. 8, lines 58-67 and col. 9, lines 1-10). As such, modifying the anchor into a soft anchor wouldn’t prevent the device of Larsen as operating as designed. As a soft anchor can be pushed into a hole and still operate as an anchor, as shown by Brown.
Furthermore, the anchor 20 in Larsen is supported by an outer tube (see Figs. 30-31) there an additional outer tube 231a + b (see Figs. 26 and 30-31), hence a soft anchor would still be supported and surrounded when inserted into the bore.
As such the rejection of the claim will be maintained.
Applicant's arguments, see page 10, filed 11/04/2025, with respect to the rejection of claim 19 under 35 U.S.C. 103 as being unpatentable over by Larsen in view of Martinek have been fully considered but they are not persuasive.
The applicant has amended claim 1 to further recite “wherein actuation of the actuation member is configured to first deploy the tissue anchor into the first tissue and then unlock the housing cover for access to the coupling means”. Firstly, this language is considered functional language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The examiner submits that the device of Larsen is capable of this as in Larsen the user has control of when the housing cover is removed after the anchor is deployed distally. Hence, a user would be able to deploy the anchor and then unlock the housing cover. The applicant argues that Fig. 24 shows that the once the anchor is located in the shaft distal end, the cap is unlocked. The examiner disagrees, as functionally, Fig. 23 can represent a “deployed” state of the tissue anchor 10, in this case deploying past the housing, which occurs before 150 is unlocked.
As such the rejection of claim 1 will be maintained.
Applicant's arguments, see page 11, filed 11/04/2025, with respect to the rejection of claim 25 under 35 U.S.C. 103 being unpatentable over by Larsen in view of Martinek and Brown have been fully considered and are persuasive.
The examiner agrees that Larsen in view of Martinek and Brown does not explicitly teach “wherein actuation of the actuation member is configured to deploy the soft anchor via the deployment member into the first tissue and is also configured to proximally retract a cover key to release hold on the removable cover”.
However, upon further consideration, a new ground(s) of rejection is made in view of Larsen in view of Martinek, Zlock et al (US 5944739 A), and Brown.
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 “wherein actuation of the actuation member is configured to first deploy the tissue anchor into the first tissue and then unlock the housing cover for access to the coupling means”, “retract the cover key proximally and away from the housing”, and “the actuation member is configured to proximally retract the cover key out of the housing” 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 Objections
Claim 21 objected to because of the following informalities:
Claim #
Line #
Current
Suggested change
21
3
“the repair member”
“the flexible member”
Appropriate correction is required.
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 1-7, 9-10, 19-24, and 28 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 claim language “wherein actuation of the actuation member is configured to first deploy the tissue anchor into the first tissue and then unlock the housing cover” in claims 1 and 19 does not have adequate support in the specification. Instead, the specification supports simultaneously deploying the tissue anchor and unlocking the housing cover (see applicant’s patent application publication [0052], “Deploying may concomitantly unlock the housing cover. Deploying may axially retract a tube to concomitantly expose the tissue anchor to the first tissue and unlock the housing cover.”). See also in applicant’s specification ([0039]-[0040] and [0044]). This contradicts the newly amended limitation. Appropriate correction is required.
Claims 2-7 and 9-10 are rejected as being dependent on claim 1.
Claims 20-24 are rejected as being dependent on claim 19.
The claim language “retract the cover key… away from the housing” in claim 28 does not have adequate support in the specification. The cover key as described in the specification is not removed away from the housing of the device at any point of actuation (see Figs. 5 and 6B). Instead, the applicant has support for the cover key being removed from the removable cover as seen in Fig. 6B. Appropriate correction is required.
The claim language “retract the cover key out of the housing” in claim 28 does not have adequate support in the specification. The cover key as described in the specification is not removed from the housing of the device at any point of actuation (see Figs. 5 and 6B). Instead, the applicant has support for the cover key being removed from the removable cover as seen in Fig. 6B. Appropriate correction is required.
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.
Claim 3 is 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 3 recites the limitation "the cover key" in ll 4. There is insufficient antecedent basis for this limitation in the claim. The cover key is not positively recited in claim 1, which claim 3 is dependent on, and is not positively recited within claim 3 either. For the purpose of prior art examination this limitation will be interpreted as “a cover key”. Appropriate correction is required.
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.
Claim(s) 1, 3, and 5-6 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Larsen et al (US 5993459 A), herein referenced to as “Larsen”.
Claim 1
Larsen discloses: A tissue repair system (see Figs. 1-35, col. 3, lines 40-49) for securing a first tissue to a second tissue (see col. 3, lines 40-49, soft tissue to bone), comprising: an instrument 200 + 100 (see Figs. 4 and 6-10, col. 4, lines 58-65) including a handle 202 (see Figs. 4 and 6-10, col. 4, lines 58-65) at a proximal end proximal end of 200 (see Fig. 4, col. 4, lines 60-65), a shaft 201 (see Figs. 4 and 6-10, col. 4, lines 60-65) extending distally from the handle 202, the instrument 200 + 100 also including a housing 100 + 240 (see Figs. 4 and 6, see col. 4, lines 58-60, col. 5, lines 11-14) with a cover 150 (see Figs. 5, 11-13, and 16-18, col. 5, lines 63-66); a tissue anchor 10 (see Figs. 1-10, col. 4, lines 10-12, col. 5, lines 11-18) disposed at a distal end distal end of 201 of the shaft 201 (see Figs. 25-26 and 29-33), the tissue anchor 10 operatively coupled to an actuation member 220 (see Figs. 4 and 6-9, col. 5, lines 19-20) of the handle 202 via a deployment member 230 (see Figs. 20-21, col. 8, lines 23-32); and a repair member 30 (see Figs. 1-10, col. 4, lines 34-39), configured to couple the tissue anchor 10 to the second tissue (see col. 3, lines 39-49, the suture can be used to attach to soft tissue), the repair member 30 defining a first end the end of 30 coupled to 10 (see Figs. 32-33) operatively coupled to the tissue anchor 20 and a second end the end of 30 coupled to 50 (see Figs. 11-12) operatively coupled to at least one coupling means 50 (see Figs. 1-12, col. 5, lines 63-65, meets the 112f definition of a needle); the second end the end of 30 coupled to 50 and coupling means 50 housed within the instrument housing 100 + 240 and wherein actuation of the actuation member 220 is configured to first deploy (see Figs. 28-30, col. 8, lines 58-67) the tissue anchor 10 into the first tissue (see col. 8, lines 58-67, the bone) and then unlock the housing cover 150 for access to the coupling means 50.
The language, " and then unlock the housing cover for access to the coupling means," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Larsen meets the structural limitations of the claim, and is capable of unlocking the housing cover after the deployment of the tissue anchor, as (see Figs. 18 and 20-23, as 220 is actuated, 230 is pushed distally which also pushes 160 distally and away from the back wall 154 of 150, which allows the removably attachable cap 150 to be removed), and then fully unlocking 150 by removing 150 from the snap fit ridges 118 (see Figs. 5 and 24).
Claim 3
Larsen discloses: The tissue repair system of claim 1, see 102 rejection above. Larsen further discloses: wherein the shaft distal end the distal end of 210 (see Figs. 24 and 25) houses the tissue anchor 10 therein (see Figs. 24-25), and wherein actuation of the actuation member 220 axially moves the shaft 210 to expose (see Figs. 30-31, the tissue anchor is exposed in Fig. 31) the tissue anchor 10 while axially moving a cover key the portion of 160 that contacts the back wall 154 of 150 (see Figs. 18 and 20-23) to release the housing cover 150.
Claim 5
Larsen discloses: The tissue repair system of claim 1, see 102 rejection above. Larsen further discloses: wherein the housing cover includes a slot 119 (see Fig. 5, col. 6, lines 1-25, the space of 150 that coincides with the space of 119) for engaging the repair member 30, such that removing the housing cover 150 removes a portion the portion of 30 within 150 (see Fig. 5, removing the housing cover then allows a user to remove a portion of the repair member, otherwise the portion of the repair member is not removable) of the repair member 30.
Claim 6
Larsen discloses: The tissue repair system of claim 1, see 102 rejection above. Larsen further discloses: wherein the coupling means 50 is selected from a group comprising a needle (50 is a needle), a threading member (a needle is a form of a threading member), a cortical button (will not be examined here due to being an optional claim limitation) and another tissue anchor (will not be examined here due to being an optional claim limitation).
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) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Brown et al (US 20210228200 A1), herein referenced to as “Brown”.
Claim 7
Larsen discloses: The tissue repair system of claim 1, see 102 rejection above. Larsen does not explicitly disclose: wherein the tissue anchor is a soft anchor and the deployment member includes a flexible member repeatedly interwoven through the soft anchor.
However, Brown in a similar field of invention teaches a tissue repair system (see Figs. 21A-21C) with a tissue anchor 160 (see Figs. 14-17) and a deployment member 120 (see Figs. 27-31). Brown further teaches: wherein the tissue anchor 160 is a soft anchor (see Figs. 14-17, [0088], the implant is a soft anchoring implant) and the deployment member 120 includes a flexible member the flexible portion of 120 woven through 160 (see Figs. 14-17 and 27-31) repeatedly interwoven through the soft anchor 160.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Brown and have the anchoring implant be a soft anchor and have the deployment member include a flexible member repeatedly interwoven through the soft anchor. Motivation for such can be found in Brown as the structure in the soft anchor, namely, a cylindrical, helically wound braid allows for a structure that can collapse and elongate naturally due to the alignment of the braids (see [0090]), allowing for a radially expanded implant in the deployed state (see Fig. 17) which can improve sealing openings and/or provide for a more stable anchor (see Figs. 32-33).
Claim(s) 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Brown as applied to claim 7 above, and further in view of Feezor et al (US 20150272567 A1), herein referenced to as “Feezor”.
Claim 9
The combination of Larsen and Brown teaches: The tissue repair system of claim 7, see 103 rejection above. The combination of Larsen and Brown does not explicitly teach: wherein the flexible member includes a frangible portion adjacent the tissue anchor, configured to fracture at a predetermined value indicative of tissue anchor deployment.
However, Feezor in a similar field of invention teaches a tissue repair system (see Figs. 19-20 and 23-24) with a tissue anchor 100 (see Figs. 19-20 and 23-24) with a flexible member 300 (see Figs. 23-24). Feezor further teaches: wherein the flexible member 300 includes a frangible portion 308 (see Fig. 24, [0135) adjacent the tissue anchor 100, configured to fracture at a predetermined value (see [0135], configured to preferentially fail and collapse at sufficiently high loads) indicative of tissue anchor deployment (see [0065] and [0099], the collapse indicates a locking of the sutures, and deployment of the tissue anchor).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Feezor and teach a tissue repair system with the flexible member includes a frangible portion adjacent the tissue anchor, configured to fracture at a predetermined value indicative of tissue anchor deployment. Motivation for such can be found in Feezor as this allows a predetermined force to lock sutures within the tissue anchor (see [0065]).
Claim(s) 2, 4, 10, 19-21, and 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Martinek et al (US 20050240199 A1), herein referenced to as “Martinek”.
Claim 2
Larsen discloses: The tissue repair system of claim 1, see 102 rejection above. Larsen further discloses: further comprising a housing cover key 160 (see Figs. 5, 13, 16-18, and 20-24, col. 5, lines 52-67) operatively coupled (see Figs. 18-24, 160 is coupled to 230 which is coupled to 220, and a distal force pushes 210 + 230 distally, which operates 160) to the actuation member 220, the housing key 160 moveable between a first position (Fig. 20) and second position (Fig. 24), where in the first position the housing cover key locks the housing cover and wherein actuation of the actuation member removes the cover key to unlock the housing cover.
The language, " where in the first position the housing cover key locks the housing cover and wherein actuation of the actuation member removes the cover key to unlock the housing cover," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Larsen meets the structural limitations of the claim, and is capable of the housing cover key 160 locking the housing cover 150 in the first position (see Fig. 18) as in this position 160 abuts and presses against 150 due to the spring force from 140, which would cause a retention force on the 150 onto the snap-fit ridges of 118, as the force of the cap being driven back from the spring would incur an opposite reactive force of the notches 152 on the ridges 118. Then when 160 is advanced distally against the spring force, this removes the force on 150, hence unlocking it.
Larsen does not explicitly disclose: in the first position the housing cover key is disposed through an opening of the housing cover and wherein actuation of the actuation member removes the cover key from the opening.
However, Martinek in a similar field of invention teaches a tissue repair system (see Figs. 2-19) with a repair member 300 (see Fig. 2), a housing cover 108 (see Figs. 1-3 and 19), a housing cover key 160 (see Figs. 1-3 and 19), and an actuation member 156 (see Figs. 1-3 and 19), where in the first position (see Figs. 1, 3, and 10) the housing cover key 160 locks the housing cover 108 (see Figs. 1, 3, and 10) and a second position (see Fig. 11, actuation to the second position of 160 is distal axial translation, similar to that as shown in Larsen’s housing cover key 160). Martinek further teaches: in the first position (see Figs. 1, 3, and 10) the housing cover key 160 is disposed through an opening 152 (see Figs. 1-3 and 10-11, [0058]) of the housing cover 108 and wherein actuation (see Fig. 11, actuation of 156, removes the flanges 160 of 156 from 154) of the actuation member 156 removes the cover key 156 from the opening 154.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the housing cover of Larsen to incorporate the teachings of Martinek and teach a tissue repair system with the housing cover having an opening in which the housing cover key is disposed through. Motivation for such can be found in Martinek as this allows for active ejection of the cover due to storing of energy (see [0060]).
Claim 4
Larsen discloses: The tissue repair system of claim 1, see 102 rejection above. Larsen further discloses: wherein the housing cover 150 defines an external circumferential surface 150 has an external circumferential surface (see Fig. 5) of the instrument 200 + 100.
Larsen does not explicitly disclose: the housing cover configured to conceal the coupling means.
However, Martinek in a similar field of invention teaches a tissue repair system (see Figs. 2-19) with a repair member 300 (see Fig. 2), a housing cover 108 (see Figs. 1-3 and 19) and a coupling means 302 (see Figs. 2-19, meets the 112f definition of a needle). Martinek further teaches: the housing cover 108 configured to conceal the coupling means 302 (see Figs. 2-19, [0055]-[0056]).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Martinek and teach a tissue repair system with the housing cover configured to conceal the coupling means. Motivation for such can be found in Martinek as the cover can serve as internal needle parks (see [0055]) and allow a physician to separate the needle away from the remaining device to utilize in a sterile environment such as a surgical drape (see [0006], [0057], [0078], and [0080]).
Claim 10
Larsen discloses: The tissue repair system of claim 1, see 102 rejection above. Larsen does not explicitly disclose: wherein the repair member includes at least two flexible members, defining at least four flexible member limbs, each limb terminating with a coupling means that is a needle.
However, Martinek in a similar field of invention teaches a tissue repair system (see Figs. 2-19) with a repair member 300 (see Fig. 2) and a coupling means 302 (see Figs. 2-19, meets the 112f definition of a needle). Martinek further teaches: wherein the repair member 300 includes at least two flexible members there are two sutures 300 (see Fig. 2, [0048]), defining at least four flexible member limbs there are 2 limbs per flexible members, totaling at least 4 flexible limbs, each attached to a needle 302 (see Figs. 2, 7, 19, and 21), each limb terminating with a coupling means 302 that is a needle 302 is a needle (see Figs. 2, 7, 19, and 21).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Martinek and have wherein the repair member includes at least two flexible members, defining at least four flexible member limbs, each limb terminating with a coupling means that is a needle. Motivation for such can be found in Martinek as this allows for use of more suture length to be tied down to the bone tissue and bone anchor (see [0080]).
Claim 19
Larsen discloses: A tissue repair system (see Figs. 1-35, col. 3, lines 40-49) for securing a first tissue to a second tissue (see col. 3, lines 40-49, soft tissue to bone), comprising: an instrument 200 + 100 (see Figs. 4 and 6-10, col. 4, lines 58-65) including a handle 202 (see Figs. 4 and 6-10, col. 4, lines 58-65) at a proximal end proximal end of 200 (see Fig. 4, col. 4, lines 60-65), a shaft 201 (see Figs. 4 and 6-10, col. 4, lines 60-65) extending distally from the handle 202, the instrument 200 + 100 also including a housing 100 + 240 (see Figs. 4 and 6, see col. 4, lines 58-60, col. 5, lines 11-14) with a cover 150 (see Figs. 5, 11-13, and 16-18, col. 5, lines 63-66); a tissue anchor 10 (see Figs. 1-10, col. 4, lines 10-12, col. 5, lines 11-18) housed within a distal end distal end of 201 of the shaft 201 (see Figs. 25-26 and 29-33), the tissue anchor 10 operatively coupled to an actuation member 220 (see Figs. 4 and 6-9, col. 5, lines 19-20) of the handle 202 via a deployment member 230 (see Figs. 20-21, col. 8, lines 23-32); and a flexible member 30 (see Figs. 1-10, col. 4, lines 34-39) defining a first end the end of 30 coupled to 10 (see Figs. 32-33) operatively coupled to the tissue anchor 20 and a second end the end of 30 coupled to 50 (see Figs. 11-12) operatively coupled to at least one coupling means 50 (see Figs. 1-12, col. 5, lines 63-65, meets the 112f definition of a needle); and wherein actuation of the actuation member 220 is configured to first deploy (see Figs. 28-30, col. 8, lines 58-67) the tissue anchor 10 into the first tissue (see col. 8, lines 58-67, the bone) and then move a cover key the portion of 160 that contacts 154 of 150 (see Figs. 5, 13, 16-18, and 20-24, col. 5, lines 52-67) to unlock the housing cover and thereby provide access to the coupling means.
The language, " and then move a cover key to unlock the housing cover for access to the coupling means," constitutes functional claim language, indicating that the claimed device need only be capable of being used in such a manner. The claim, however, is an apparatus claim, and is to be limited by structural limitations. The Office submits that the device of Larsen meets the structural limitations of the claim, and is capable of unlocking the housing cover after the deployment of the tissue anchor, as (see Figs. 18 and 20-23, as 220 is actuated, 230 is pushed distally which also pushes 160 distally and away from the back wall 154 of 150, which allows the removably attachable cap 150 to be removed), and then fully unlocking 150 by removing 150 from the snap fit ridges 118 (see Figs. 5 and 24).
Larsen does not explicitly disclose: the second end and the coupling means covered by the cover.
However, Martinek in a similar field of invention teaches a tissue repair system (see Figs. 2-19) with a flexible member 300 (see Fig. 2), a cover 108 (see Figs. 1-3 and 19), a housing cover key 160 (see Figs. 1-3 and 19), an actuation member 156 (see Figs. 1-3 and 19), a second end a second end of 300 connected to 302 (see Figs. 2, 7, 10, 11, and 19) of a flexible member 300 (see Figs. 2, 7, 10, 11, and 19), and a coupling means 302 (see Figs. 2-19, meets the 112f definition of a needle). Martinek further teaches: the second end a second end of 300 connected to 302 and the coupling 302 means covered by the cover 108 (see Figs. 2, 7, 10, 11, and 19).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Martinek and teach a tissue repair system with the second end and the coupling means covered by the cover. Motivation for such can be found in Martinek as the cover can serve as internal needle parks (see [0055]) and allow a physician to separate the needle away from the remaining device to utilize in a sterile environment such as a surgical drape (see [0006], [0057], [0078], and [0080]).
Claim 20
The combination of Larsen and Martinek teaches: The tissue repair system of claim 19, see 103 rejection above. Larsen further discloses: wherein the coupling means 50 is selected from a group comprising a needle (50 is a needle), a threading member (a needle is a form of a threading member), a cortical button (will not be examined here due to being an optional claim limitation) and another tissue anchor (will not be examined here due to being an optional claim limitation).
Claim 21
The combination of Larsen and Martinek teaches: The tissue repair system of claim 19, see 103 rejection above. Larsen further discloses: wherein the housing cover includes a slot 119 (see Fig. 5, col. 6, lines 1-25, the space of 150 that coincides with the space of 119) for engaging the flexible member 30, such that removing the housing cover 150 removes a portion the portion of 30 within 150 (see Fig. 5, removing the housing cover then allows a user to remove a portion of the repair member, otherwise the portion of the repair member is not removable) of the flexible member 30 (see claim objection above) from the instrument.
Claim 23
The combination of Larsen and Martinek teaches: The tissue repair system of claim 19, see 103 rejection above. Larsen does not explicitly disclose: wherein the flexible member includes at least two flexible members, defining at least four flexible member limbs, each limb terminating with a coupling means that is a needle.
However, Martinek in a similar field of invention teaches a tissue repair system (see Figs. 2-19) with a flexible member 300 (see Fig. 2) and a coupling means 302 (see Figs. 2-19, meets the 112f definition of a needle). Martinek further teaches: wherein the flexible member 300 includes at least two flexible members there are two sutures 300 (see Fig. 2, [0048]), defining at least four flexible member limbs there are 2 limbs per flexible members, totaling at least 4 flexible limbs, each attached to a needle 302 (see Figs. 2, 7, 19, and 21), each limb terminating with a coupling means 302 that is a needle 302 is a needle (see Figs. 2, 7, 19, and 21).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Martinek and have wherein the repair member includes at least two flexible members, defining at least four flexible member limbs, each limb terminating with a coupling means that is a needle. Motivation for such can be found in Martinek as this allows for use of more suture length to be tied down to the bone tissue and bone anchor (see [0080]).
Claim(s) 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Martinek as applied to claim 19 above, and further in view of Brown.
Claim 22
The combination of Larsen and Martinek teaches: The tissue repair system of claim 19, see 103 rejection above. The combination of Larsen and Martinek does not explicitly teach: wherein the tissue anchor is a soft anchor and the deployment member includes a flexible member repeatedly interwoven through the soft anchor.
However, Brown in a similar field of invention teaches a tissue repair system (see Figs. 21A-21C) with a tissue anchor 160 (see Figs. 14-17) and a deployment member 120 (see Figs. 27-31). Brown further teaches: wherein the tissue anchor 160 is a soft anchor (see Figs. 14-17, [0088], the implant is a soft anchoring implant) and the deployment member 120 is another flexible member the flexible portion of 120 woven through 160 (see Figs. 14-17 and 27-31) repeatedly interwoven through the soft anchor 160.
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Brown and have the anchoring implant be a soft anchor and have the deployment member include a flexible member repeatedly interwoven through the soft anchor. Motivation for such can be found in Brown as the structure in the soft anchor, namely, a cylindrical, helically wound braid allows for a structure that can collapse and elongate naturally due to the alignment of the braids (see [0090]), allowing for a radially expanded implant in the deployed state (see Fig. 17) which can improve sealing openings and/or provide for a more stable anchor (see Figs. 32-33).
Claim(s) 24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Martinek as applied to claim 19 above, and further in view of Zlock et al (US 5944739 A), herein referenced to as “Zlock”.
Claim 24
The combination of Larsen and Martinek teaches: The tissue repair system of claim 19, see 103 rejection above. The combination of Larsen and Martinek does not explicitly teach: wherein actuation of the actuation member is configured to retract the cover key proximally and away from the housing to unlock the cover.
However, Zlock in a similar field of invention teaches a tissue repair system 10 (see Figs. 1, 8-9, and 41-42) with an actuation member 144 + 24 (see Figs. 1, 8-9, and 41-42) with a cover key 154 (see Figs. 8-9 and 41-42), a housing 176a (see Figs. 41-42, 176a is a housing as it an enclosed portion that covers another portion, in this case the cover key 154 in Fig. 41) and a cover 48 (see Figs. 41-42, 48 covers the coupling member 72, which after actuation is exposed in Fig. 42). Zlock further teaches: wherein actuation of the actuation member 144 + 24 (see Figs. 41-42, col. 12, lines 14-31) is configured to retract the cover key 154 proximally and away from the housing 176a to unlock the cover 48 (see Figs. 41-42, col. 12, lines 14-31, 154 is moved proximally and away from 176a, and this unlocks 130 from 48 to be able to be moved away from 48).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Zlock and teach a tissue repair system with actuation of the actuation member is configured to retract the cover key proximally and away from the housing to unlock the cover. Motivation for such can be found in Zlock as this allows for selective exposure of needles in the device (see col. 12, lines 14-31).
Claim(s) 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Larsen in view of Martinek and Brown.
Claim 25
Larsen discloses: A tissue repair system (see Figs. 1-35, col. 3, lines 40-49) for securing a first tissue to a second tissue (see col. 3, lines 40-49, soft tissue to bone), comprising: an instrument 200 + 100 (see Figs. 4 and 6-10, col. 4, lines 58-65) including a handle 202 (see Figs. 4 and 6-10, col. 4, lines 58-65) at a proximal end proximal end of 200 (see Fig. 4, col. 4, lines 60-65), a shaft 201 (see Figs. 4 and 6-10, col. 4, lines 60-65) extending distally from the handle 202, the instrument 200 + 100 also including a housing 100 + 240 (see Figs. 4 and 6, see col. 4, lines 58-60, col. 5, lines 11-14) with a cover 150 (see Figs. 5, 11-13, and 16-18, col. 5, lines 63-66); a tissue anchor 10 (see Figs. 1-10, col. 4, lines 10-12, col. 5, lines 11-18) housed within a distal end distal end of 201 of the shaft 201 (see Figs. 25-26 and 29-33), the tissue anchor 10 operatively coupled to an actuation member 220 (see Figs. 4 and 6-9, col. 5, lines 19-20) of the handle 202 via a deployment member 230 (see Figs. 20-21, col. 8, lines 23-32); and a flexible member 30 (see Figs. 1-10, col. 4, lines 34-39) defining a first end the end of 30 coupled to 10 (see Figs. 32-33) operatively coupled to the tissue anchor 20 and a second end the end of 30 coupled to 50 (see Figs. 11-12) operatively coupled to a coupling means 50 (see Figs. 1-12, col. 5, lines 63-65, meets the 112f definition of a needle); the second end and the coupling means housed within the instrument housing 100 + 240 (see Figs. 4, 6, the end of 30 coupled to 50 is within the housing by not extending outside of the housing, likewise with the coupling means 50) and wherein actuation of the actuation member 220 is configured to deploy (see Figs. 28-30, col. 8, lines 58-67) the tissue anchor 10 via the deployment member 230 into the first tissue (see col. 8, lines 58-67, the bone) and a cover key 160 (see Figs. 5, 13, 16-18, and 20-24, col. 5, lines 52-67).
Larsen does not explicitly disclose: the anchor is a soft anchor; the second end and the coupling means covered by the removable cover and the actuation member is also configured to proximally retract a cover key to release hold on the removable cover and provide access to the coupling means.
However, Martinek in a similar field of invention teaches a tissue repair system (see Figs. 2-19) with a flexible member 300 (see Fig. 2), a removable cover 108 (see Figs. 1-3 and 19), a housing cover key 160 (see Figs. 1-3 and 19), an actuation member 156 (see Figs. 1-3 and 19), a second end a second end of 300 connected to 302 (see Figs. 2, 7, 10, 11, and 19) of a flexible member 300 (see Figs. 2, 7, 10, 11, and 19), and a coupling means 302 (see Figs. 2-19, meets the 112f definition of a needle). Martinek further teaches: the second end a second end of 300 connected to 302 and the coupling 302 means covered by the removable cover 108 (see Figs. 2, 7, 10, 11, and 19).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Martinek and teach a tissue repair system with the second end and the coupling means covered by the cover. Motivation for such can be found in Martinek as the cover can serve as internal needle parks (see [0055]) and allow a physician to separate the needle away from the remaining device to utilize in a sterile environment such as a surgical drape (see [0006], [0057], [0078], and [0080]).
The combination of Larsen and Martinek does not explicitly teach: the anchor is a soft anchor; the actuation member is also configured to proximally retract a cover key to release hold on the removable cover and provide access to the coupling means.
However, Zlock in a similar field of invention teaches a tissue repair system 10 (see Figs. 1, 8-9, and 41-42) with an actuation member 144 + 24 (see Figs. 1, 8-9, and 41-42) with a cover key 154 (see Figs. 8-9 and 41-42), a housing 176a (see Figs. 41-42, 176a is a housing as it an enclosed portion that covers another portion, in this case the cover key 154 in Fig. 41) a coupling means 72 (see Figs. 41-42), and a removable cover 48 (see Figs. 41-42, 48 covers the coupling member 72, which after actuation is exposed in Fig. 42). Zlock further teaches: the actuation member 144 + 24 (see Figs. 41-42, col. 12, lines 14-31) is also configured to proximally retract the cover key 154 to release hold on the removable cover 48 and provide access to the coupling means 72 (see Figs. 41-42, col. 12, lines 14-31, 154 is moved proximally and away from 176a, and this unlocks 130 from 48 to be able to be moved away from 48, which then provides access to 72).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Zlock and teach a tissue repair system with the actuation member is also configured to proximally retract a cover key to release hold on the removable cover and provide access to the coupling means. Motivation for such can be found in Zlock as this allows for selective exposure of needles in the device (see col. 12, lines 14-31).
The combination of Larsen, Martinek, and Zlock does not explicitly teach: the anchor is a soft anchor.
However, Brown in a similar field of invention teaches a tissue repair system (see Figs. 21A-21C) with a tissue anchor 160 (see Figs. 14-17) and a deployment member 120 (see Figs. 27-31). Brown further teaches: wherein the tissue anchor 160 is a soft anchor (see Figs. 14-17, [0088], the implant is a soft anchoring implant).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Brown and have the anchoring implant be a soft anchor. Motivation for such can be found in Brown as the structure in the soft anchor, namely, a cylindrical, helically wound braid allows for a structure that can collapse and elongate naturally due to the alignment of the braids (see [0090]), allowing for a radially expanded implant in the deployed state (see Fig. 17) which can improve sealing openings and/or provide for a more stable anchor (see Figs. 32-33).
Claim 26
The combination of Larsen, Martinek, Zlock, and Brown teaches: The tissue repair system of claim 25, see 103 rejection above. Larsen further discloses: wherein the coupling means 50 is selected from a group comprising a needle (50 is a needle), a threading member (a needle is a form of a threading member), a cortical button (will not be examined here due to being an optional claim limitation) and another tissue anchor (will not be examined here due to being an optional claim limitation).
Claim 27
The combination of Larsen, Martinek, Zlock, and Brown teaches: The tissue repair system of claim 25, see 103 rejection above. Larsen further discloses: wherein the housing cover includes a slot 119 (see Fig. 5, col. 6, lines 1-25, the space of 150 that coincides with the space of 119) for engaging the flexible member 30.
Larsen does not explicitly disclose: such that removing the removable cover also draws a portion of the flexible member away from the instrument.
However, Martinek in a similar field of invention teaches a tissue repair system (see Figs. 2-19) with an instrument 102 (see Figs. 2 and 19), a flexible member 300 (see Fig. 2), a removable cover 108 (see Figs. 1-3 and 19), and a portion the portion of 300 connected to 302 and is drawn away from the handle (see Fig. 19) of a flexible member 300. Martinek further teaches: such that removing the removable cover 108 also draws a portion the portion of 300 connected to 302 and is drawn away from the handle (see Fig. 19) of the flexible member 300 away from the instrument 102 (see Fig. 19).
It would have been obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Larsen to incorporate the teachings of Martinek and teach a tissue repair system with the removing the removable cover also draws a portion of the flexible member away from the instrument. Motivation for such can be found in Martinek as this allows for draping specific needles attached to the suture to surgical drapes to separate and delineate the lengths of suture (see [0078]).
Claim 28
The combination of Larsen, Martinek, Zlock and Brown teaches: The tissue repair system of claim 25, see 103 rejection above. Zlock further teaches: wherein actuation of the actuation member 144 + 24 (see Figs. 41-42, col. 12, lines 14-31) is configured to proximally retract the cover key 154 out of the housing 176a (see Figs. 41-42, 176a is a housing as it an enclosed portion that covers another portion, in this case the cover key 154 in Fig. 41) into the instrument handle 22 (see Figs. 41-42, during moving out of 176a, the cover key moves into the instrument handle 22 before into 176b) to release hold on the removable cover 48 (see Figs. 41-42, col. 12, lines 14-31, 154 is moved proximally and away from 176a, and this unlocks 130 from 48 to be able to be moved away from 48).
Conclusion
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RAIHAN R. KHANDKER
Examiner
Art Unit 3771
/RAIHAN R KHANDKER/Examiner, Art Unit 3771