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 .
This Office Action is responsive to the Amendment filed 22 July 2026. Claims 1-20 are currently under consideration. The Office acknowledges the amendments to claims 1, 2, 5-7, 14, 16, and 20.
Claim Objections
Claims 14 and 16 are objected to because of the following informalities:
In claim 14, line 11: “the deployment site” should apparently read --a deployment site--.
In claim 16, lines 10-11: “the curved proximal end of the anchor in the shape of a loop” should apparently read --the proximal end that curves in the shape of a loop-- or merely --the proximal end--.
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.
Claims 7-9, 11, 15, 19, and 20 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 “wherein said proximal anchor portion is curved in a direction transverse to and away from said medial portion.” It is not clear if this curved portion is intended to be the same as the “curves in the shape of a loop” recited in claim 1 or to be a separate curvature.
Claim 8 recites the limitation “wherein said proximal anchor portion has a free end extending away from said medial portion to be graspable to remove said anchor from the deployment site.” It is not clear if this is intended to be the same as the free end and loop for removal recited in claim 1 or to be a separate end.
Claims 9 and 11 are rejected by virtue of their dependence upon at least one rejected base claim.
Claim 15 recites the limitation “wherein said proximal anchor portion has a free end extending away from said medial portion of said anchor to be graspable by said retrieval device to remove said anchor from the deployment site.” It is not clear if this is intended to be the same as the shape of a loop for removal recited in claim 14 or to be a separate end.
Claim 19 recites the limitation “grasping a proximal free end of the anchor extending away from the anatomical tissue with an anchor-engaging element of a retrieval device.” It is not clear if this is intended to be the same as the grasping the curved proximal end of the anchor in the shape of a loop recited in claim 16 or to be a separate step.
Claim 20 recites the limitation “a retrieval feature on a proximal portion of the anchor.” It is not clear if this is intended to be the same as the proximal end that curves in the shape of a loop recited in claim 16 or to be a separate feature.
Claim 20 also recites the limitation “a proximal portion of the anchor.” It is not clear if this is intended to be the same as the proximal anchor portion recited in claim 16 or to be a separate portion.
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-13 are rejected under 35 U.S.C. 103 as being unpatentable over DeVries et al. (U.S. Pub. No. 2004/0044364 A1; cited in the IDS filed 27 March 2024; hereinafter known as “DeVries”), in view of Overes et al. (U.S. Pub. No. 2013/0072989 A1; cited in the previous Office action; hereinafter known as “Overes”).
Regarding claim 1, Devries discloses an anchor 1 capable of extending through anatomical tissue at a deployment site (Abstract; Fig. 2), said anchor comprising: a distal end 13 forming a distal anchor portion; a proximal end 11 forming a proximal anchor portion; and a medial portion 12, between the distal end and the proximal end, configured to extend through anatomical tissue; wherein: said anchor is shiftable between an elongated delivery configuration and a deployed configuration; at least said distal anchor portion is formed when said anchor shifts into the deployed configuration by bending into a configuration extending transverse to said medial portion ([0044]-[0047]); and a free end 11’ of said proximal anchor portion extends away from the deployment site to facilitate access thereto for removal of the anchor from the deployment site (Figs. 18A-B; [0100]). Devries fails to disclose that the proximal end of the anchor curves in the shape of a loop for removal of the anchor, though Devries does teach that other suitable coupling methods may be used, such as a hook ([0100]). Overes discloses a similar device (Abstract; Figs. 1, 3-5) comprising an anchor 101 comprising a proximal end 118 that curves in the shape of a loop for removal of the anchor in order to be hooked and held by a removal instrument and to be easily identified and differentiated from the remainder of the anchor ([0018]; [0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of Devries with such a looped proximal end, as taught by Overes, in order to be hooked and held by a removal instrument and to be easily identified and differentiated from the remainder of the anchor. This further would have been a simple substitution of one known prior art element for another with predictable results, as both coupling mechanisms are known in the art and would have effectively the same functionality.
Regarding claim 2, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said distal anchor portion is curved (Figs. 2B, 16; [0044]; [0047]).
Regarding claim 3, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said distal anchor portion is curved in a direction transverse to and away from said medial portion (Figs. 2B, 16; [0044]; [0047]).
Regarding claim 4, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that distal anchor portion has a free end 15 directed away from said medial portion (Fig. 2; [0046]-[0047]).
Regarding claim 5, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said distal anchor portion has a free end 15 configured to extend along the anatomical tissue (Fig. 2; [0046]-[0047]).
Regarding claim 6, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further that said distal anchor portion has a free end 15 configured to be embedded into the anatomical tissue (Fig. 2; [0046]; capable of being so embedded).
Regarding claim 7, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said proximal anchor portion is curved in a direction transverse to and away from said medial portion (Figs. 2A, 16; [0044]; [0047]).
Regarding claim 8, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and further discloses that said proximal anchor portion has a free end extending away from said medial portion to be graspable to remove said anchor from the deployment site (Devries: Figs. 18A-B, [0100]; Overes: Figs. 1, 3-5, [0018] [0020]).
Regarding claim 9, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said anchor is shiftable from the deployed configuration to the delivery configuration upon being pulled into a lumen of a tubular element for removal from the deployment site (Fig. 18A-B; [0100]; capable of such intended use).
Regarding claim 10, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said anchor is formed from a shape memory material ([0050]; [0096]).
Regarding claim 11, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said anchor is formed from a wire ([0048]; [0050]-[0051]).
Regarding claims 12 and 13, the combination of Devries and Overes discloses the invention as claimed, see rejection supra, and Devries further discloses that said medial portion comprises a suture, wherein said anchor is removable from the deployment site upon cutting the suture ([0061]; [0081]-[0082]; [0085]-[0086]; anchor would be removable upon cutting the suture).
Claims 14-20 are rejected under 35 U.S.C. 103 as being unpatentable over McLawhorn (U.S. Pub. No. 2010/0140320 A1), in view of Overes.
Regarding claim 14, McLawhorn discloses a system (Abstract; Figs. 1-3, 12, 13), said system comprising: an anchor 20/220 having a distal end 42 forming a distal anchor portion, a proximal end 32 forming a proximal anchor portion, and a medial portion 22 between the distal anchor portion and the proximal anchor portion, said anchor being shiftable between an elongated delivery configuration and a deployed configuration ([0029]-[0035]; [0064]); a delivery device 50 comprising a flexible tubular element defining a lumen 54 therethrough, the lumen configured to retain said anchor in the elongated delivery configuration therein ([0041]-[0043]); and a retrieval device 50 comprising an anchor-engaging element 262 configured to engage said proximal anchor portion to proximally retract the anchor from the deployment site, and a tubular element defining a lumen 54 therethrough configured to retain said anchor in the elongated delivery configuration ([0071]-[0072]; [0075]; [0080]). McLawhorn fails to disclose that the proximal end of the anchor curves in the shape of a loop for removal of the anchor, though McLawhorn does teach a coupling method for removal that includes a loop and a hook ([0069]-[0071]). Overes discloses a similar device (Abstract; Figs. 1, 3-5) comprising an anchor 101 comprising a proximal end 118 that curves in the shape of a loop for removal of the anchor in order to be hooked and held by a removal instrument and to be easily identified and differentiated from the remainder of the anchor ([0018]; [0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of McLawhorn with such a looped proximal end, as taught by Overes, in order to be hooked and held by a removal instrument and to be easily identified and differentiated from the remainder of the anchor. This further would have been a simple substitution of one known prior art element for another with predictable results, as having a hook on the anchor and a loop on the retrieval device (as in McLawhorn) or having a loop on the anchor and a hook on the retrieval device (as in Overes) is simply swapping the coupling features between the components and would have effectively the same functionality.
Regarding claim 15, the combination of McLawhorn and Overes discloses the invention as claimed, see rejection supra, and further discloses that said proximal anchor portion has a free end extending away from said medial portion of said anchor to be graspable by said retrieval device to remove said anchor from the deployment site (McLawhorn: Fig. 12, [0064]-[0069]; Overes: Figs. 1, 3-5, [0018]-[0020]).
Regarding claim 16, McLawhorn discloses a method of deploying an anchor with respect to anatomical tissue, and subsequently removing the anchor from the anatomical tissue (Abstract; Figs. 1-3, 12, 13), said method comprising: delivering the anchor 20/220 in an elongated delivery configuration to the anatomical tissue; deploying the anchor to allow the anchor to shift from the elongated delivery configuration to a deployed configuration in which at least a distal anchor portion 42 is formed extending transverse to and away from a medial portion of the anchor, wherein the anchor comprises a proximal anchor portion having a proximal end 32/250 for removal of the anchor ([0029]-[0035]; [0064]; [0069]-[0071]); and removing the anchor after a selected period of time by withdrawing the anchor proximally to cause the distal anchor portion to return to the elongated delivery configuration and be withdrawn proximally through the anatomical tissue and withdrawn therefrom ([0071]-[0072]; [0075]; [0080]). McLawhorn fails to disclose that the proximal end curves in the shape of a loop and removing the anchor by grasping the curved proximal end of the anchor in the shape of a loop, though McLawhorn does teach removal of the anchor by grasping a loop with a hook ([0069]-[0071]). Overes discloses a similar method (Abstract; Figs. 1, 3-5) that deploys an anchor 101 comprising a proximal end 118 that curves in the shape of a loop for removal of the anchor, and removing the anchor by grasping the curved proximal end of the anchor in the shape of a loop, in order to allow the proximal end to be hooked and held by a removal instrument and to be easily identified and differentiated from the remainder of the anchor ([0018]; [0020]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the invention of McLawhorn with such a looped proximal end and grasping this end for removal of the anchor, as taught by Overes, in order to allow the proximal end to be hooked and held by a removal instrument and to be easily identified and differentiated from the remainder of the anchor. This further would have been a simple substitution of one known prior art element for another with predictable results, as having a hook on the anchor and a loop on the retrieval device (as in McLawhorn) or having a loop on the anchor and a hook on the retrieval device (as in Overes) is simply swapping the coupling features between the components and would have effectively the same functionality.
Regarding claim 17, the combination of McLawhorn and Overes discloses the invention as claimed, see rejection supra, and McLawhorn further discloses delivering the anchor in a delivery device 50 defining a lumen 54 configured to retain the anchor in the elongated delivery configuration, the delivery device having a tissue-penetrating distal end 52 configured to penetrate through the anatomical tissue to deliver the distal end of the anchor to a distal side of the anatomical tissue to expand transverse to a medial portion of the anchor extending through the anatomical tissue ([0041]-[0043]).
Regarding claim 18, the combination of McLawhorn and Overes discloses the invention as claimed, see rejection supra, and McLawhorn further discloses withdrawing the delivery device proximally and/or advancing the anchor distally from the lumen of the delivery device to deploy the distal end of the anchor distal to the anatomical tissue ([0045]; [0051]).
Regarding claims 19 and 20, the combination of McLawhorn and Overes discloses the invention as claimed, see rejection supra, and further discloses grasping a proximal free end of the anchor extending away from the anatomical tissue with an anchor-engaging element of a retrieval device and engaging an anchor-engaging retrieval feature on the anchor-engaging element with a retrieval feature on the proximal portion of the anchor (McLawhorn: [0071]; Overes: [0018], [0020]).
Response to Arguments
Applicant’s arguments with respect to the objection to claim 7 and the rejections of claims 1-20 under 35 U.S.C. 112(b) and claims 5 and 6 under 35 U.S.C. 101 have been fully considered and are persuasive in light of the amendments. The objection and rejections have been withdrawn.
Applicant’s arguments with respect to the rejections under 35 U.S.C. 102 have been fully considered and are persuasive in light of the amendments. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made, as detailed supra.
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 THADDEUS B COX whose telephone number is (571)270-5132. The examiner can normally be reached M-F 9am-6pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jason M. Sims can be reached at (571)272-7540. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THADDEUS B COX/Primary Examiner, Art Unit 3791
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