CTFR 18/190,025 CTFR 87231 DETAILED ACTION Notice of Pre-AIA or AIA Status 07-03-aia AIA 15-10-aia The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA. Response to Amendment Claims 1-3, 5, 7-11, 14, 15, 17, and 21-28 are pending in the application. Claims 1, 5, 7, 11, and 15 have been amended. Claims 4, 6, 12, 13, 16, 18-20 have been canceled. Claims 21-28 are newly added. Claims 1-3, 5, 7-11, 14, 15, 17, and 21-28 are rejected. Claim Rejections - 35 USC § 103 07-06 AIA 15-10-15 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. 07-20-aia AIA 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. 07-23-aia AIA 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. 07-20-02-aia AIA 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. 07-21-aia AIA Claim (s) 1, 2, 5, 7-9, 14, 15, 17, 22-24, 26, and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited St. Goar et al (US Pat. No. 6,629,534) in view of applicant cited Gammie (WO 2013/003228) . PNG media_image1.png 648 1136 media_image1.png Greyscale Regarding claim 1 , St. Goar teaches a method comprising: inserting a needle (222) into a ventricle of a heart (See Fig. 51; Col. 33, lines 10-29), the needle configured to deliver a first anchoring element (226/240), a second anchoring element (228), and a tethering suture (220/244) to the ventricle, the tethering suture tethered between the first anchoring element and the second anchoring element (See Figs. 50-54; Col. 33, lines 10-60); penetrating a first leaflet of a heart valve with the needle (See Fig. 51; Col. 33, lines 10-29); penetrating a second leaflet of the heart valve with the needle (See Fig. 51; Col. 33, lines 10-29); deploying the first anchoring element (226) at a distal 1 side of the second leaflet; retracting the needle from the first leaflet and the second leaflet (See Col. 33, lines 35-46); deploying the second anchoring element at a proximal side of the first leaflet (See Figs. 51 and 52; Col. 33, lines 30-49); cinching the tethering suture to cause a desired amount of valve coaptation (See Col. 33, lines 30-50); and locking the tethering suture (See Col. 33, lines 18-25). St. Goar teaches a variety of different anchoring elements for applying to the valve leaflets (See Figs. 50-68; Col. 33, line 10 through Col. 38, line 34). St. Goar does not explicitly teach the first anchoring and second anchoring elements comprises respective first and second sutureform wrapped at least partially around the needle. Gammie teaches an analogous device and method for treating valve leaflets which employs first and second anchoring elements (175 and 176) which are sutureforms wrapped at least partially around a deployment needle (165) (See Figs. 11-22; pages 15-16) with a tethering suture (168) between the two anchoring elements. Gammie teaches this anchor is advantageous since it is entirely formed by the suture which allows it to be low profile for delivery and expand into a bulky knot which is effectively retained in the tissue (See pages 15-17). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by St. Goar and substitute the wrapped sutureform anchor as taught by Gammie instead of the disclosed anchor, since St. Goar already contemplates a wide variety of anchor types. Additionally, to do so would be a simple substitution of one known anchor and suture device for another. Furthermore, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Regarding claim 2 , modified St. Goar teaches the method as required by claim 1 as set forth above and further teaches the needle is inserted into the ventricle via a septum 2 (See Fig. 8; Col. 2, line 67 through Col. 3 line 6; Col. 8, lines 10-18; Col. 14, lines 46-62). Alternatively, it would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by St. Goar to include having the needle inserted into the ventricle viz a septum since a variety of techniques are known in the art for ventricular access. Having the needle access the ventricle via a septum is merely a simple substitution of one known access point for another to achieve predictable results. Regarding claim 5 , modified St. Goar teaches the method of claim 1 as set forth above and further teaches the tethering suture (168) extends from the first sutureform (175). (See Gammie Figs. 10-15; pages 15-17). Regarding claim 7 , modified St. Goar teaches the method of claim 6 as set forth above and further teaches the tethering suture is configured to pass at least partially through a lumen formed by coils of the second sutureform (176). (See Gammie Figs. 10-15; pages 15-17, particularly Figs. 14(a)-14(c)). Regarding claim 8 , St. Goar teaches the method of claim 1 as set forth above but does not explicitly teach extending a pusher along an outer surface of the needle to press the first anchoring element and the second anchoring element off of the needle. St. Goar teaches a sleeve (230) which is inside the lumen of the needle and pushes the anchoring elements out of the needle (See Figs. 50-52; Col. 33, lines 10-47). Gammie teaches an analogous method of treating heart leaflets featuring a needle (165) with two anchors (175 and 176) and a pusher (177) extending along an outer surface of the needle (see Figs. 11-12) to press the first and second anchoring elements off the needle (See also pages 15-17). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of St. Goar to substitute the external pusher as taught by Gammie for the internal pushing sleeve as taught by St. Goar since both internal and external pushers are art known equivalents and to do so would be a simple substitution of one known pusher for another. Furthermore, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Regarding claim 9 , modified St. Goar teaches the method as required by claim 1 as set forth above and further teaches needle (222) comprises an internal lumen and an aperture to the internal lumen (See Fig. 50, note the phantom view of sleeve 230 which is inside the needle and cut out slots which hold anchors 226 and 228) (See also Col. 33, lines 10-60). Regarding claim 14 , modified St. Goar teaches the method as required by claim 1 as set forth above and further teaches the first anchoring element, the second anchoring element and the tethering suture are formed from a single suture (820, 821) (See St. Goar Figs. 55A and 55B; Col. 33, line 60 through Col. 34, line 20). Additionally St. Goar as modified above to use the sutureform anchor of Gammie teaches the sutureform anchor is a single suture. (See Gammie Figs. 10-15; pages 15-17). Regarding claim 21 , modified St. Goar teaches the method as required by claim 1 as set forth above and further teaches prior to deploying the first anchoring element at the distal side of the second leaflet: advancing the needle to position the first sutureform beyond the second leaflet and to position the second sutureform at the proximal side of the first leaflet (See St. Goar Fig. 51 and Gammie Figs. 17-21; pages 16-18); and advancing a pusher (177) along the needle to press the second sutureform, the first leaflet, and the second leaflet towards the first sutureform. (See also pages 15-17). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of St. Goar to substitute the external pusher as taught by Gammie for the internal pushing sleeve as taught by St. Goar since both internal and external pushers are art known equivalents and to do so would be a simple substitution of one known pusher for another. Furthermore, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Regarding claim 22 , modified St. Goar teaches the method as required by claim 1 as set forth above and further teaches retracting the needle while the pusher (177) maintains contact with the second sutureform (See Gammie Fig. 12) to deploy the first anchoring element at the distal side of the second leaflet; and further retracting the needle while the pusher maintains contact with the second sutureform to deploy the second anchoring element at the proximal side of the first leaflet. (See Gammie pages 15-16; Fig. 12) Regarding claim 23 , modified St. Goar teaches the method as required by claim 1 as set forth above but does not explicitly teach prior to inserting the needle into the ventricle of the heart, extending a pusher comprising an inner lumen along the needle to at least partially enclose the needle, the first sutureform, and the second sutureform; prior to penetrating the first leaflet, retracting the pusher to expose a tip of the needle and the first sutureform; and after penetrating the first leaflet, advancing the pusher to press the first sutureform through the first leaflet. Gammie teaches an analogous method of treating heart leaflets featuring a needle (165) with two anchors (175 and 176) and a pusher (177) extending along an outer surface of the needle (see Figs. 11-12) to press the first and second anchoring elements off the needle (See also pages 15-17). With specific regard to the limitation “a pusher…at least partially enclose the needle, the first sutureform, and the second sutureform” it is noted that Gammie teaches the pusher 177 covers the trailing ends of the suture which forms both the first and second sutureform and thus “at least partially encloses” the sutureforms. Gammie also teaches after the needle penetrates the leaflets, the pusher aids in pressing the suture anchors through the leaflet. (See Figs. 11-19; pages 16-18) It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of St. Goar to substitute the external pusher as taught by Gammie for the internal pushing sleeve as taught by St. Goar since both internal and external pushers are art known equivalents and to do so would be a simple substitution of one known pusher for another. Furthermore, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Regarding claim 24 , modified St. Goar teaches the method of claim 23 above but does not explicitly teach after deploying the first anchoring element, retracting the pusher to expose the second sutureform. It is widely known and employed in the medical arts to have an anchor or implant held within a pusher or sleeve prior to deployment. This is known to be advantageous because the implant is well contained within the outer tube which reduces the likelihood of premature deployment and also reduces damage to other healthy tissue outside the site of deployment. It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method of St. Goar such that the second sutureform is held in the pusher until after the first sutureform is deployed since containing implants/anchors within an outer protective sleeve is widely known and used in the art as an advantageous means of protecting the implant as well as surrounding tissues during a procedure. Regarding claim 26 , modified St. Goar teaches the method of claim 23 above and further teaches the tethering suture (168) extends from the first sutureform (See Gammie Figs. 15; pages 15-16). Regarding claim 28 , modified St. Goar teaches the method of claim 23 above and further teaches the first anchoring element, the second anchoring element, and the tethering suture are formed from a single suture (168) (See Gammie Figs. 15; pages 15-16). Regarding claim 15 , St. Goar teaches a system (See Figs. 50-68) comprising: a first anchoring element (226/240), a second anchoring element (228), and a tethering suture (220/244) tethered between the first anchoring element and the second anchoring element (See Figs. 50-52; Col. 33, lines 10-60); and a needle (222) configured to: penetrate a first leaflet of a heart valve within a ventricle of a heart (See Fig. 51; Col. 33, lines 10-29); penetrate a second leaflet of the heart valve See Fig. 51; Col. 33, lines 10-29); deliver the first anchoring element (226) at a distal side 3 of the second leaflet; and deliver the second anchoring element at a proximal side of the first leaflet (See Figs. 51 and 52; Col. 33, lines 30-49). St. Goar teaches a variety of different anchoring elements for applying to the valve leaflets (See Figs. 50-68; Col. 33, line 10 through Col. 38, line 34). St. Goar does not explicitly teach the first anchoring and second anchoring elements comprises respective first and second sutureform wrapped at least partially around the needle. Gammie teaches an analogous device and method for treating valve leaflets which employs first and second anchoring elements (175 and 176) which are sutureforms wrapped at least partially around a deployment needle (165) (See Figs. 11-22; pages 15-16) with a tethering suture (168) between the two anchoring elements. Gammie teaches this anchor is advantageous since it is entirely formed by the suture which allows it to be low profile for delivery and expand into a bulky knot which is effectively retained in the tissue (See pages 15-17). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by St. Goar and substitute the wrapped sutureform anchor as taught by Gammie instead of the disclosed anchor since St. Goar already contemplates a wide variety of anchor types. Additionally, to do so would be a simple substitution of one known anchor and suture device for another. Furthermore, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Regarding claim 17 , modified St. Goar teaches the system as required by claim 15 as set forth above, but St. Goar but does not explicitly teach a pusher configured to extend along an outer surface of the needle to press the first anchoring element and the second anchoring element off of the needle. St. Goar teaches a sleeve (230) which is inside the lumen of the needle and pushes the anchoring elements out of the needle (See Figs. 50-52; Col. 33, lines 10-47). Gammie teaches an analogous method of treating heart leaflets featuring a needle (165) with two anchors (175 and 176) and a pusher (177) extending along an outer surface of the needle (see Figs. 11-12) to press the first and second anchoring elements off the needle (See also pages 15-17). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the system of St. Goar to substitute the external pusher as taught by Gammie for the internal pushing sleeve as taught by St. Goar since both internal and external pushers are art known equivalents and to do so would be a simple substitution of one known pusher for another. Furthermore, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B) . 07-22-aia AIA Claim s 10, 11, and 27 is/are rejected under 35 U.S.C. 103 as being unpatentable over applicant cited St. Goar et al (US Pat. No. 6,629,534) in view of applicant cited Gammie (WO 2013/003228) as applied to claim s 1 and 23 above and further in view of Gammie et al (US PG Pub 2020/0261073) herein after referred to as Gammie ‘073 . Regarding claims 10, 11, and 27 , modified St. Goar teaches the method required by claims 1 and 2 as set forth above but does not explicitly teach the tethering suture is further configured to form a first knot between the first anchoring element and the second anchoring element to prevent sliding of the second element relative to the first element. St. Goar does teach an embodiment where sutures alone are used to affix the leaflets and knots are advance to tighten the suture (See Col. 32, lines 5-25). St. Goar also teaches additional embodiments where the sutures attached to the anchors are “tied-off” (See Fig. 58; Col. 34, line 49 through Col. 35, line 5). Gammie ‘073 teaches an analogous method of treating heart valve leaflets including a first anchoring element (131) a second anchoring element (131’) and a tethering suture (132, 133, 134, and 135). Gammie ‘073 further teaches the tethering suture is configured to from a first knot (157) between the first anchoring element and the second anchoring element (See Fig. 12; paragraphs [0034]-[0040]) and further teaches the suture is configured to form a second knot 4 (159) between the first anchoring and second anchoring elements (See Fig. 12) to prevent sliding of the second anchoring element relative to the first anchoring element. It would have been obvious to one of ordinary skill in the art before the effective filing date to further modify the method as taught by St. Goar to add first and second knots between the first and second anchors as taught by Gammie ‘073 so as to ensure proper positioning of the anchors and prevent unwanted movement . 07-21-aia AIA Claim (s) 25 is/are rejected under 35 U.S.C. 103 as being unpatentable over Gammie et al (US PG Pub 2019/0261979) herein after referred to as “Gammie ‘979” in view of applicant cited St. Goar et al (US Pat. No. 6,629,534) . PNG media_image2.png 766 564 media_image2.png Greyscale PNG media_image3.png 590 772 media_image3.png Greyscale Regarding claim 25, Gammie ‘979 teaches a method comprising: inserting a needle (165) into a ventricle of a heart (See Fig. 5), the needle configured to deliver a first anchoring element comprising a first sutureform (175) wrapped at least partially around the needle (See Fig. 11), a second anchoring element comprising a second sutureform (176) wrapped at least partially around the needle (See Fig. 11), and a tethering suture (168) to the ventricle, the tethering suture tethered between the first anchoring element and the second anchoring element (See Figs. 11-12G, 15 and 22); penetrating a first leaflet of a heart valve with the needle (See Figs. 12B & 12C); penetrating a second leaflet of the heart valve with the needle (See Fig. 22; paragraph [0076]); advancing the needle to position the first sutureform beyond the second leaflet and to position the second sutureform proximal to the first leaflet and the second leaflet (See Figs. 12C &12D); advancing a pusher (177) along the needle to press the second sutureform, the first leaflet, and the second leaflet towards the first sutureform (See Figs. 12B & 12C); retracting the needle while the pusher maintains contact with the second sutureform to deploy the first anchoring element; (See Fig. 12D) further retracting the needle while the pusher maintains contact with the second sutureform to deploy the second anchoring element (See Figs. 12D-12F) cinching the tethering suture to cause a desired amount of valve coaptation; and locking the tethering suture (See Fig. 21; paragraph [0075]). (See also paragraphs [0072]-[0073]) Gammie ‘979 does not explicitly teach the first anchoring element is deployed at a distal side of the second leaflet and the second sutureform is deployed at a proximal side of the first leaflet. Gammie ‘979 teaches the sutureform anchors may be deployed in a variety of ways including on both sides of a single leaflet (See Figs. 14C and 20) or in an “Alfieri” technique (edge-to-edge repair) where both leaflets are drawn together (See Fig. 22; paragraphs [0061], [0076], [0084]). Gammie ‘979 also contemplates several bulky knots may be installed in the annulus and tied together. (See paragraph [0077]). St. Goar teaches an analogous method of repairing heart valve leaflets by deploying anchoring elements to the leaflets, tensioning them and locking them in the desired position. St. Goar teaches deploying the first anchoring element (226) at a distal side of the second leaflet and deploying the second anchoring element at a proximal side of the first leaflet (See Figs. 51 and 52; Col. 33, lines 30-49). St Goar teaches the anchors may be deployed on the undersides of the leaflets (See Figs. 52, 55, and 66) or on the upper sides of the leaflets (See Figs. 72 and 81). It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the method as taught by Gammie ‘979 to have the anchors be deployed on the undersides of the leaflets as taught by St. Goar since it is known in the art that anchors may be deployed on either the upper (atrial) side of the leaflets and the underside (ventricular) side of the leaflet depending on the particular circumstances. Additionally, to do so would be a simple substitution of one known deployment location for another. Furthermore, a person of ordinary skill in the art would have recognized the interchangeability of the element shown in the prior art for the corresponding element disclosed in the specification. (See MPEP §2183). As stated in KSR Int'l Co. v. Teleflex Inc. , 550 U.S. 398,416 (2007) ("when [an application] claims a structure already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result") (citing United States v. Adams , 383 U.S. 39, 50-51 (1966)). See also MPEP §2143(I)(B). Response to Arguments Applicant’s arguments with respect to the claim(s) have been considered but are moot. The 102 anticipation rejection of the claims under St. Goar is no longer being applied. The rejection has been revised in light of the newly added claim limitations. The remainder of applicant’s arguments amount to an allegation of patentability based on the alleged deficiencies of the primary reference. For the reasons set forth above, this is unpersuasive. Conclusion 07-40 AIA 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 RACHEL S. HIGHLAND whose telephone number is (571)270-3254. The examiner can normally be reached on Monday through Thursday between 9:30am and 2:30pm . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. 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For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /R.S.H/Examiner, Art Unit 3774 /SARAH W ALEMAN/Primary Examiner, Art Unit 3774 Application/Control Number: 18/190,025 Page 2 Art Unit: 3774 Application/Control Number: 18/190,025 Page 3 Art Unit: 3774 Application/Control Number: 18/190,025 Page 4 Art Unit: 3774 Application/Control Number: 18/190,025 Page 5 Art Unit: 3774 Application/Control Number: 18/190,025 Page 6 Art Unit: 3774 Application/Control Number: 18/190,025 Page 7 Art Unit: 3774 Application/Control Number: 18/190,025 Page 8 Art Unit: 3774 Application/Control Number: 18/190,025 Page 9 Art Unit: 3774 Application/Control Number: 18/190,025 Page 10 Art Unit: 3774 Application/Control Number: 18/190,025 Page 11 Art Unit: 3774 Application/Control Number: 18/190,025 Page 12 Art Unit: 3774 Application/Control Number: 18/190,025 Page 13 Art Unit: 3774 Application/Control Number: 18/190,025 Page 14 Art Unit: 3774 Application/Control Number: 18/190,025 Page 15 Art Unit: 3774 Application/Control Number: 18/190,025 Page 16 Art Unit: 3774 Application/Control Number: 18/190,025 Page 17 Art Unit: 3774 Application/Control Number: 18/190,025 Page 18 Art Unit: 3774 1 It is noted that “proximal” and “distal” are relative terms. It is further noted that while "distal" is often used to describe the portion of a device farthest from the operator, it is also used in the medical art to describe the portion closest to the operator. Further, “proximal” and “distal” are defined by Merriam-Webster in relation to the center of the body. It is further noted that applicant’s own specification defines the distal side of the leaflet as relative to the entry point of the delivery device (See paragraph [0182] as published). In the instant case, the deployment location of distal anchor 226 can reasonably be considered the “distal side of the second leaflet” since it is distal to the tip of the delivery device. 2 MPEP §2111 requires claim limitations be given their “broadest reasonable interpretation in light of the specification”. Additionally, claim terms are given their “plain meaning” unless applicant has provided a special definition. However, it is improper to import claim limitations from the specification into the claims. Although applicant’s specification teaches access through the ventricular septum, since the claim only requires “a septum”, access via the atrial septum as taught by St. Goar is sufficient to meet the limitation as currently claimed. 3 See footnote 1 above 4 It is noted that Gammie ‘073 teaches a plurality of knots (157 and 159) between the two anchors. Note further that both 157 and 159 are each formed of multiple knots and described as “a stack of knots” (See paragraph [0040])
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