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 .
Response to Amendment
In light of Applicant’s amendment, claim(s) 1-3, 10, and 17 is/are amended. Claims 1-20 are now pending examination.
The objections to the claims are withdrawn in light of Applicant’s amendment.
Response to Arguments
Applicant’s arguments, filed 2/26/2026, with respect to the rejection(s) of claim(s) 1, 10, and 17 under U.S.C. 102 and 103 have been fully considered and are persuasive. Examiner agrees the limitation “an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom” overcomes the previous rejections as written. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Forrester in view of Montpetit for claim 1 and Forrester in view of Montpetit and Prabhu for claims 10 and 17. Further, prosecution has been reopened as the objection to claim 3, which was previously objected to for being otherwise allowable aside from its dependence on a rejected claim, has been withdrawn and is now rejected.
Claim Objections
Claim 3 is objected to because of the following informalities:
Claim 3 line 2 “the cutting elements” should read “the cutting element”.
Appropriate correction is required.
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) 1 and 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forrester (US 20220233210 A1) (previously of record) in view of Montpetit (US 20050192633 A1).
Regarding claim 1, Forrester discloses a cutting mechanism (200) configured for severing leaflet tissue (118) at a cardiac valve, the cutting mechanism comprising:
a cutting arm (138) having a length and including an actuatable cutting element (lacerating component) disposed within the cutting arm and actuatable to laterally extend therefrom, the actuatable cutting element configured to sever targeted leaflet tissue (Figure 2; Paragraph 0037);
a central hinge (206) disposed distal with respect to the cutting element (Figure 2; Paragraph 0034);
a grasping arm (136) connected to the central hinge and extending therefrom to a free end (unhinged end of 136) (Figure 2; Paragraph 0033), the grasping arm being rotatable about the central hinge so as to be selectively moveable between a closed position and an open position to vary an angle between the grasping arm and the cutting arm (Figure 2; Paragraph 0034),
wherein the angle is greater in the open position as compared to the closed position (Figure 2),
wherein in the closed position, the grasping arm is positioned at least partially against the cutting arm (Paragraph 0051), and
further wherein the cutting mechanism is configured to enable grasping of leaflet tissue between the cutting arm and the grasping arm and to enable the severing of grasped leaflet tissue via actuation of the cutting element (Paragraph 0037).
Forrester fails to disclose an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom.
However, Montpetit is directed to a cutting instrument and teaches an actuatable cutting element (80) disposed within the cutting arm (62) and actuatable to laterally extend therefrom (the distal end of 80 extends towards the central axis of the device, thus is seen as laterally extending) (Figure 2C-D; Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester such that an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom, as taught by Montpetit, as both references and the claimed invention are directed to surgical cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester with the teachings of Montpetit by incorporating an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom in order to sever tissue, as Forrester is silent to the structure of its laceration components.
Regarding claim 4, Montpetit further discloses wherein the cutting element comprises a sharpened edge (edge of blade 80) (Figure 2C-D; Paragraph 0052).
Claim(s) 2-3, 9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forrester in view of Montpetit and further in view of Nakao (US 20070073185 A1) (noted on IDS).
Regarding claim 2, Forrester as modified by Montpetit discloses the cutting mechanism of claim 1, but fails to explicitly disclose wherein the central hinge comprises a linkage assembly configured to convert axial movement of a control rod along a longitudinal axis of the cutting arm into lateral movement of the grasping arm.
Nakao is directed to a cutting device and teaches wherein the central hinge (52) comprises a linkage assembly (65) configured to convert axial movement of a control rod (8a) along the longitudinal axis of the cutting arm (11) into lateral movement of the grasping arm (55) (Paragraph 0057; 0062).
The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Regarding claim 3, Montpetit further teaches wherein the cutting arm (62) comprises a slot (84), and wherein the cutting elements extends laterally outward from the slot when actuated (Figure 2C-D; Paragraph 0052).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester with the teachings of Montpetit by incorporating wherein the cutting arm comprises a slot, and wherein the cutting elements extends laterally outward from the slot when actuated in order to prevent premature cutting of the tissue by keeping the blade hidden until desired.
Regarding claim 9, Forrester as modified by Montpetit discloses the cutting mechanism of claim 1 but fails to explicitly disclose wherein the cutting element is spring-loaded so as to be capable of actuation from a non-deployed to a deployed state via controlled release of spring energy.
However, Nakao teaches wherein the cutting element (needle 11) is spring-loaded (Paragraph 0102). When combined with the features Forrester and Montpetit, the device would be capable such that the cutting element is spring-loaded so as to be capable of actuation from a non-deployed to a deployed state via controlled release of spring energy.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester as modified by Montpetit such that the cutting element is spring-loaded, as taught by Nakao, as both references and the claimed invention are directed to cutting instruments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Claim(s) 1 and 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forrester in view of Kappus (US 20120296371 A1).
Regarding claim 1, Forrester discloses a cutting mechanism (200) configured for severing leaflet tissue (118) at a cardiac valve, the cutting mechanism comprising:
a cutting arm (138) having a length and including an actuatable cutting element (lacerating component) disposed within the cutting arm and actuatable to laterally extend therefrom, the actuatable cutting element configured to sever targeted leaflet tissue (Figure 2; Paragraph 0037);
a central hinge (206) disposed distal with respect to the cutting element (Figure 2; Paragraph 0034);
a grasping arm (136) connected to the central hinge and extending therefrom to a free end (unhinged end of 136) (Figure 2; Paragraph 0033), the grasping arm being rotatable about the central hinge so as to be selectively moveable between a closed position and an open position to vary an angle between the grasping arm and the cutting arm (Figure 2; Paragraph 0034),
wherein the angle is greater in the open position as compared to the closed position (Figure 2),
wherein in the closed position, the grasping arm is positioned at least partially against the cutting arm (Paragraph 0051), and
further wherein the cutting mechanism is configured to enable grasping of leaflet tissue between the cutting arm and the grasping arm and to enable the severing of grasped leaflet tissue via actuation of the cutting element (Paragraph 0037).
Forrester fails to disclose an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom.
However, Kappus is directed to a cutting instrument and teaches an actuatable cutting element (190) disposed within the cutting arm (120) and actuatable to laterally extend therefrom (the distal end of 190 extends towards the central axis of the device, thus is seen as laterally extending) (Figure 2A-B; Paragraph 0054; 0057).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester such that an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom, as taught by Kappus, as both references and the claimed invention are directed to surgical cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester with the teachings of Kappus by incorporating an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom in order to sever tissue, as Forrester is silent to the structure of its laceration components.
Regarding claim 5, Forrester as modified by Kappus teaches the cutting mechanism of claim 1, but fails to explicitly disclose wherein the grasping arm has an opening therein extending from the free end of the grasping arm toward the central hinge, the opening in the grasping arm being disposed such that when the cutting mechanism is in the closed position a first portion of the grasping arm is disposed on a first side of the cutting arm and a second portion of the grasping arm is disposed on a second, opposite side of the cutting arm.
However, Kappus is directed to a surgical cutter and teaches wherein the grasping arm (110) has an opening (115a) therein extending from the free end of the grasping arm toward the central hinge (95), the opening in the grasping arm being disposed such that when the cutting mechanism (190) is in the closed position a first portion of the grasping arm (labeled in Annotated Figure 2B) is disposed on a first side (labeled in Annotated Figure 2B) of the cutting arm (120) and a second portion of the grasping arm(labeled in Annotated Figure 2B) is disposed on a second, opposite side (labeled in Annotated Figure 2B) of the cutting arm (Figure 2B; Paragraph 0054; 0057).
ANNOTATED FIGURE 2B
PNG
media_image1.png
285
600
media_image1.png
Greyscale
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester as modified by Montpetit such that wherein the grasping arm has an opening therein extending from the free end of the grasping arm toward the central hinge, the opening in the grasping arm being disposed such that when the cutting mechanism is in the closed position a first portion of the grasping arm is disposed on a first side of the cutting arm and a second portion of the grasping arm is disposed on a second, opposite side of the cutting arm, as taught by Kappus, as both references and the claimed invention are directed to cutting devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester as modified by Montpetit with the teachings of Kappus by incorporating wherein the grasping arm has an opening therein extending from the free end of the grasping arm toward the central hinge, the opening in the grasping arm being disposed such that when the cutting mechanism is in the closed position a first portion of the grasping arm is disposed on a first side of the cutting arm and a second portion of the grasping arm is disposed on a second, opposite side of the cutting arm in order to provide a for alignment of the knife blade/cutting element prior to cutting (Kappus Paragraph 0054).
Claim(s) 10-11 and 17-20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forrester in view of Montpetit and in view of Prabhu (US 20180092661 A1) (noted on IDS).
Regarding claim 10, Forrester discloses a cutting mechanism (200) configured for severing leaflet tissue (118) at a cardiac valve, the cutting mechanism comprising:
a cutting arm (138) having a length and including an actuatable cutting element (lacerating component) disposed within the cutting arm and actuatable to laterally extend therefrom, the actuatable cutting element configured to sever targeted leaflet tissue (Figure 2; Paragraph 0037);
a central hinge (206) disposed distal with respect to the cutting element (Figure 2; Paragraph 0034);
a grasping arm (136) connected to the central hinge and extending therefrom to a free end (unhinged end of 136) (Figure 2; Paragraph 0033), the grasping arm being rotatable about the central hinge so as to be selectively moveable between a closed position and an open position to vary an angle between the grasping arm and the cutting arm (Figure 2; Paragraph 0034),
wherein the angle is greater in the open position as compared to the closed position (Figure 2),
wherein in the closed position, the grasping arm is positioned at least partially against the cutting arm (Paragraph 0051), and
further wherein the cutting mechanism is configured to enable grasping of leaflet tissue between the cutting arm and the grasping arm and to enable the severing of grasped leaflet tissue via actuation of the cutting element (Paragraph 0037).
Forrester fails to disclose a guide catheter having a proximal end and a distal end, wherein the distal end of the guide catheter is steerable to a position above a cardiac valve, a handle coupled to the proximal end of the guide catheter, the handle comprising at least one control operatively connected to the cutting mechanism to enable actuation of the grasping arms between the closed position and the open position and/or to enable actuation of the cutting element and wherein the cutting mechanism is routable through the guide catheter and configured to extend beyond the distal end of the guide catheter and an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom.
However, Montpetit is directed to a cutting instrument and teaches an actuatable cutting element (80) disposed within the cutting arm (62) and actuatable to laterally extend therefrom (the distal end of 80 extends towards the central axis of the device, thus is seen as laterally extending) (Figure 2C-D; Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester such that an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom, as taught by Montpetit, as both references and the claimed invention are directed to surgical cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester with the teachings of Montpetit by incorporating an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom in order to sever tissue, as Forrester is silent to the structure of its laceration components.
Further, Prabhu is directed to a valve cutting device and teaches a guide catheter (102) having a proximal end and a distal end, wherein the distal end of the guide catheter is steerable to a position above a cardiac valve (Figure 1; Paragraph 0034); a handle (104) coupled to the proximal end of the guide catheter, the handle comprising at least one control (108+additional controls) operatively connected to the cutting mechanism to enable actuation of the grasping arms between the closed position and the open position and/or to enable actuation of the cutting element (Paragraph 0034); and a cutting mechanism (412) routable through the guide catheter and configured to extend beyond the distal end of the guide catheter (Paragraph 0036; 0046).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester as modified by Montpetit such that a guide catheter having a proximal end and a distal end, wherein the distal end of the guide catheter is steerable to a position above a cardiac valve, and place Forrester’s cutting mechanism as modified by Montpetit through the guide catheter configured to extend beyond the distal end of the guide catheter, as taught by Prabhu, as both references and the claimed invention are directed to cutting devices. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester with the teachings of Prabhu by incorporating a guide catheter having a proximal end and a distal end, wherein the distal end of the guide catheter is steerable to a position above a cardiac valve in order to position and steer the cutting mechanism near a targeted cardiac valve (Prabhu Paragraph 0008; 0036).
Regarding claim 11, Prabhu further teaches wherein the control is operatively connected to the cutting mechanism to enable actuation of the cutting element (112) (Paragraph 0034).
Regarding claim 17, Forrester discloses a method of severing leaflet tissue (118) at a cardiac valve within a body (Figure 1), the method comprising:
providing a system (200) for severing leaflet tissue, the system comprising:
a cutting mechanism comprising:
a cutting arm (138) having a length extending along a longitudinal axis, the cutting arm including an actuatable cutting element;
a central hinge (206) disposed distal with respect to the cutting arm (Paragraph 0034); and
a grasping arm (136) connected to the central hinge and extending therefrom to a free end (unhinged end of 136), the grasping arm being rotatable about the central hinge so as to be selectively moveable (Paragraph 0033); and
actuating the cutting element of the cutting mechanism to sever the grasped leaflet tissue (Paragraph 0032).
Forrester fails to explicitly disclose a guide catheter having a proximal end and a distal end; positioning the guide catheter such that the distal end of the guide catheter is positioned near a targeted cardiac valve and extending the cutting mechanism beyond the distal end of the guide catheter and an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom.
However, Prabhu is directed to a leaflet cutting mechanism and teaches a guide catheter (902) having a proximal end and a distal end (Figure 11A-D; Paragraph 0065); and positioning the guide catheter such that the distal end of the guide catheter is positioned near a targeted cardiac valve (Paragraph 0060; 0064); extending the cutting mechanism beyond the distal end of the guide catheter (Figure 11A-D; Paragraph 0065); and actuating the cutting element of the cutting mechanism to sever the grasped leaflet tissue (Figure 11C; Paragraph 0066).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester such that to include a guide catheter having a proximal end and a distal end; positioning the guide catheter such that the distal end of the guide catheter is positioned near a targeted cardiac valve and extending the cutting mechanism beyond the distal end of the guide catheter as taught by Prabhu, as both references and the claimed invention are directed to cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester with the teachings of Prabhu by incorporating a guide catheter having a proximal end and a distal end; positioning the guide catheter such that the distal end of the guide catheter is positioned near a targeted cardiac valve and extending the cutting mechanism beyond the distal end of the guide catheter in order to shield the cutting implements to prevent premature cutting of tissue.
Furthermore, Montpetit is directed to a cutting instrument and teaches an actuatable cutting element (80) disposed within the cutting arm (62) and actuatable to laterally extend therefrom (the distal end of 80 extends towards the central axis of the device, thus is seen as laterally extending) (Figure 2C-D; Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester as modified by Prabhu such that an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom, as taught by Montpetit, as both references and the claimed invention are directed to surgical cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester as modified by Prabhu with the teachings of Montpetit by incorporating an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom in order to sever tissue, as Forrester is silent to the structure of its laceration components.
Regarding claim 18, Forrester further discloses wherein the grasping arm (136) is positioned on a ventricular side of the targeted leaflet tissue (118) and the cutting arm (138) is positioned on an atrial side of the targeted leaflet tissue when the leaflet tissue is grasped by the cutting mechanism (116). (Paragraph 0031).
Regarding claim 19, Forrester further discloses wherein the cutting mechanism is advanced at least partially through the leaflet by actuation of the grasping arm between open and closed positions to grasp and cut the leaflet tissue (Paragraph 0042).
Regarding claim 20, Forrester further discloses wherein the system includes a plurality of grasping arms (136, 302), wherein one grasping is positioned on a ventricular side of the targeted leaflet tissue and the cutting arm is positioned on an atrial side of the targeted leaflet tissue when the leaflet tissue is grasped by the cutting mechanism (Figure 3; Paragraph 0031; 0038).
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Forrester, in view of Montpetit and Prabhu, as applied to claim 10 above, and further in view of Nakao.
Regarding claim 13, Forrester, as modified by Montpetit and Prabhu teaches the system of claim 10, but fails to explicitly disclose wherein the cutting element is spring-loaded so as to be capable of actuation from a non-deployed to a deployed state via the at least one control in the handle.
However, Nakao teaches wherein the cutting element (needle 11) is spring-loaded (Paragraph 0102). When combined with the features of the handle of Prabhu, would be capable of actuation from a non-deployed to a deployed state via the at least one control in the handle.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Forrester, as modified by Montpetit and Prabhu such that the cutting element is spring-loaded, as taught by Nakao, as both references and the claimed invention are directed to cutting instruments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-12 and 14-16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. US 12048448 B2 in view of Koloszi and Montpetit.
Regarding claim 1, claim 1 of US 12048448 B2 claims a cutting mechanism configured for severing leaflet tissue at a cardiac valve (Col 15, line 19-20), the cutting mechanism comprising:
a cutting arm having a length and including an actuatable cutting element configured to sever targeted leaflet tissue (Col 15, line 21-24);
a central hinge disposed distal with respect to the cutting element (Col 15, line 25-26);
a grasping arm connected to the central hinge and extending therefrom to a free end, the grasping arm being rotatable about the central hinge so as to be selectively moveable between a closed position and an open position (Col 15, line 27-26),
further wherein the cutting mechanism is configured to enable grasping of leaflet tissue between the cutting arm and the grasping arm and to enable the severing of grasped leaflet tissue via actuation of the cutting element (Col 15, line 37-41).
US 12048448 B2 fails to explicitly disclose varying an angle between the grasping arm and the cutting arm wherein the angle is greater in the open position as compared to the closed position, wherein in the closed position, the grasping arm is positioned at least partially against the cutting arm and an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom.
However, Koloszi teaches the grasping arm being rotatable about the central hinge so as to be selectively moveable between a closed position (Figure 4), and an open position to vary an angle between the grasping arm and the cutting arm (Figure 5), wherein the angle is greater in the open position as compared to the closed position (Figure 4-5), wherein in the closed position, the grasping arm is positioned at least partially against the cutting arm (Figure 4).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 12048448 B2 with the teachings of Koloszi by incorporating varying an angle between the grasping arm and the cutting arm wherein the angle is greater in the open position as compared to the closed position, wherein in the closed position, the grasping arm is positioned at least partially against the cutting arm in order to prevent premature piercing of tissue.
Further, Montpetit is directed to a cutting instrument and teaches an actuatable cutting element (80) disposed within the cutting arm (62) and actuatable to laterally extend therefrom (the distal end of 80 extends towards the central axis of the device, thus is seen as laterally extending) (Figure 2C-D; Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify claim 1 of US 12048448 B2 such that an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom, as taught by Montpetit, as the reference and the claimed invention are directed to surgical cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 1 of US 12048448 B2 with the teachings of Montpetit by incorporating an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom in order to sever tissue, as Forrester is silent to the structure of its laceration components.
Regarding claim 2, claim 11 of US 12048448 B2 further claims wherein the central hinge comprises a linkage assembly configured to convert axial movement of a control rod along a longitudinal axis of the cutting arm into lateral movement of the grasping arm (Col 16, line 20-24).
Regarding claim 3, claim 12 of US 12048448 B2 further claims wherein the cutting arm comprises a slot, but fails to explicitly disclose wherein the cutting elements extends laterally outward from the slot when actuated.
However, Montpetit further teaches wherein the cutting arm (62) comprises a slot (84), and wherein the cutting elements extends laterally outward from the slot when actuated (Figure 2C-D; Paragraph 0052).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Forrester with the teachings of Montpetit by incorporating wherein the cutting arm comprises a slot, and wherein the cutting elements extends laterally outward from the slot when actuated in order to prevent premature cutting of the tissue by keeping the blade hidden until desired.
Regarding claim 4, claim 14-16 of US 12048448 B2 further claim wherein the cutting element is selected from a group comprising a sharpened edge, a tapered needle, and a wire loop configured to provide radio frequency current energy (Col 16, lines 33-39).
Regarding claim 5 claim 1 of US 12048448 B2 claims the cutting mechanism of claim 1, but fails to claim wherein the grasping arm has an opening therein extending from the free end of the grasping arm toward the central hinge, the opening in the grasping arm being disposed such that when the cutting mechanism is in the closed position a first portion of the grasping arm is disposed on a first side of the cutting arm and a second portion of the grasping arm is disposed on a second, opposite side of the cutting arm.
However, Koloszi teaches wherein the grasping arm of the cutting mechanism comprises a first grasping arm (56) and a second grasping arm (58), the first grasping arm and the second grasping arm being disposed such that, when the cutting mechanism is in the closed position, a first grasping arm is disposed on a first side of the cutting arm and a second grasping arm is disposed on a second, opposite side of the cutting arm (Figure 4; Col 4, lines 53-60).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 12048448 B2 with the teachings of Koloszi by incorporating wherein the grasping arm has an opening therein extending from the free end of the grasping arm toward the central hinge, the opening in the grasping arm being disposed such that when the cutting mechanism is in the closed position a first portion of the grasping arm is disposed on a first side of the cutting arm and a second portion of the grasping arm is disposed on a second, opposite side of the cutting arm in order to conceal the cutting arm to prevent premature piercing of tissue.
Regarding claim 6, claim 2 of US 12048448 B2 claims wherein the grasping arm of the cutting mechanism comprises a first grasping arm and a second grasping arm, the first grasping arm and the second grasping arm being disposed such that when the cutting mechanism is in the closed position, the first grasping arm is disposed on a first side of the cutting arm and a second grasping arm is disposed on a second, opposite side of the cutting arm (Col 15, lines 50-56).
Regarding claim 7, claim 3 of US 12048448 B2 further claims wherein the cutting element is disposed on a portion of the cutting arm between the first and second grasping arms to enable cutting of leaflet tissue disposed between the first and second grasping arms (Col 15, line 57-61).
Regarding claim 8, claim 5 of US 12048448 B2 further claims a cross bar extending between the first and second grasping arms (Col 15, line 62-64).
Regarding claim 9, claim 10 of US 12048448 B2 further claims wherein the cutting element is spring-loaded so as to be capable of actuation from a non-deployed to a deployed state via controlled release of spring energy (Col 16, lines 16-19).
Regarding claim 10, claim 21 of US 12048448 B2 claims a system for severing leaflet tissue at a cardiac valve (Col 16, line 47-48), the system comprising:
a guide catheter having a proximal end and a distal end, the distal end of the guide catheter being configured to be steerable to a position at a cardiac valve (Col 16, line 49-51); and
a handle coupled to the proximal end of the guide catheter, the handle comprising a control operatively connected to a cutting mechanism (Col 17, line 18-21);
the cutting mechanism is routable through the guide catheter and is configured to extend beyond the distal end of the guide catheter, the cutting mechanism comprising (Col 16, line 52-54):
a cutting arm having a length extending along a longitudinal axis, the cutting arm including an actuatable cutting element configured to severe targeted leaflet tissue upon sufficient contact with the targeted leaflet tissue (Col 16, line 55-59);
a central hinge disposed distal with respect to the cutting element of the cutting arm (Col 16, line 60-61);
a grasping arm connected to the central hinge and extending therefrom to a respective free end, the grasping arm being rotatable about the central hinge so as to be selectively moveable between a closed position in which the grasping arm is at least partially positioned against the cutting arm, and an open position (Col 16, line 62-Col 17 line 4),
wherein the cutting mechanism is configured to enable grasping of leaflet tissue between the cutting arm and the grasping arm and to enable the severing of grasped leaflet tissue via actuation of the cutting element (Col 17 line 13-17).
US 12048448 B2 fails to explicitly claim wherein an angle formed between the grasping arm and the cutting arm at the central hinge is greater in the open position as compared to the closed position.
However, Koloszi teaches wherein an angle formed between the grasping arm and the cutting arm at the central hinge is greater in the open position as compared to the closed position (Figure 4-5).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 12048448 B2 with the teachings of Koloszi by incorporating an angle formed between the grasping arm and the cutting arm at the central hinge is greater in the open position as compared to the closed position, which is a standard means of operation of a device with such a configuration, in order to conceal the cutting arm to prevent premature piercing of tissue.
Further, Montpetit is directed to a cutting instrument and teaches an actuatable cutting element (80) disposed within the cutting arm (62) and actuatable to laterally extend therefrom (the distal end of 80 extends towards the central axis of the device, thus is seen as laterally extending) (Figure 2C-D; Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify claim 1 of US 12048448 B2 such that an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom, as taught by Montpetit, as the reference and the claimed invention are directed to surgical cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 1 of US 12048448 B2 with the teachings of Montpetit by incorporating an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom in order to sever tissue, as Forrester is silent to the structure of its laceration components.
Regarding claim 11, claim 21 of US 12048448 B2 further claims wherein the control is operatively connected to the cutting mechanism to enable actuation of the grasping arm between the closed position and the open position and/or to enable actuation of the cutting element (Col 17 line 19-24).
Regarding claim 12, claim 21 of US 12048448 B2 further claims an auxiliary arm connected to the central hinge and disposed opposite the grasping arm, the auxiliary arm being mechanically connected to the cutting element such that movement of the auxiliary arm as the cutting mechanism moves between the open position and the closed position causes advancement and retraction of the cutting element relative to the cutting arm (Col 17 line 5-12).
Regarding claim 14, claim 21 of US 12048448 B2 claims system of claim 10, but fails to explicitly claim wherein the grasping arm of the cutting mechanism comprises a first grasping arm and a second grasping arm, the first grasping arm and the second grasping arm being disposed such that when the cutting mechanism is in the closed position, the first grasping arm is disposed on a first side of the cutting arm and the second grasping arm is disposed on a second, opposite side of the cutting arm.
However, Koloszi teaches wherein the grasping arm of the cutting mechanism comprises a first grasping arm (56) and a second grasping arm (58), the first grasping arm and the second grasping arm being disposed such that, when the cutting mechanism is in the closed position, a first grasping arm is disposed on a first side of the cutting arm and a second grasping arm is disposed on a second, opposite side of the cutting arm (Figure 4; Col 4, lines 53-60).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 12048448 B2 with the teachings of Koloszi by incorporating wherein the grasping arm has an opening therein extending from the free end of the grasping arm toward the central hinge, the opening in the grasping arm being disposed such that when the cutting mechanism is in the closed position a first portion of the grasping arm is disposed on a first side of the cutting arm and a second portion of the grasping arm is disposed on a second, opposite side of the cutting arm in order to conceal the cutting arm to prevent premature piercing of tissue.
Regarding claim 15, claim 21 of US 12048448 B2 claims system of claim 14, but fails to explicitly claim wherein the cutting mechanism further comprises a cross bar extending between the first grasping arm and the second grasping arm, the cross bar being aligned with the cutting element when the cutting mechanism is in the closed position.
However, Kolozsi further teaches a cross bar (70+72) extending between the first and second grasping arms, the cross bar being aligned with the cutting element when the cutting mechanism is in the closed position (Figure 4-5; Col 4, lines 56-59).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 12048448 B2 with the teachings of Koloszi by incorporating wherein the cutting mechanism further comprises a cross bar extending between the first grasping arm and the second grasping arm, the cross bar being aligned with the cutting element when the cutting mechanism is in the closed position in order to allow relative movement between the arms (Kolozsi Col 4, line 56-66).
Regarding claim 16, claim 21 of US 12048448 B2 claims system of claim 14, but fails to explicitly claim wherein the cutting mechanism further comprises a cross bar extending between the first grasping arm and the second grasping arm, the cross bar being positioned closer to the central hinge than the cutting element when the cutting mechanism is in the closed position.
However, Kolozsi teaches wherein cross bar extending between the first grasping arm and the second grasping arm, the cross bar being positioned closer to the central hinge than the cutting element when the cutting mechanism is in the closed position (Figure 4-5; Col 4, lines 56-59).
It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified US 12048448 B2 with the teachings of Koloszi by incorporating wherein the cutting mechanism further comprises a cross bar extending between the first grasping arm and the second grasping arm, the cross bar being positioned closer to the central hinge than the cutting element when the cutting mechanism is in the closed position in order to allow relative movement between the arms (Kolozsi Col 4, line 56-66).
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 21 of U.S. Patent No. US 12048448 B2 in view of Nakao and Montpetit.
Regarding claim 13, claim 21 of US 12048448 B2 claims system of claim 10, but fails to explicitly claim wherein the cutting element is spring-loaded so as to be capable of actuation from a non-deployed to a deployed state via the at least one control in the handle.
However, Nakao teaches wherein the cutting element (needle 11) is spring-loaded (Paragraph 0102). When combined with the features of the handle of US 12048448 B2, would be capable of actuation from a non-deployed to a deployed state via the at least one control in the handle.
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify US 12048448 B2 such that the cutting element is spring-loaded, as taught by Nakao, as both references and the claimed invention are directed to cutting instruments. The rationale to support a conclusion that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. KSR, 550 U.S. at 416, 82 USPQ2d at 1395; B/E Aerospace, Inc. v. C&D Zodiac, Inc., 962 F.3d 1373, 1379, 2020 USPQ2d 10706 (Fed. Cir. 2020); Sakraida v. AG Pro, Inc., 425 U.S. 273, 282, 189 USPQ 449, 453 (1976); Anderson’s-Black Rock, Inc. v. Pavement Salvage Co., 396 U.S. 57, 62-63, 163 USPQ 673, 675 (1969); Great Atl. & P. Tea Co. v. Supermarket Equip. Corp., 340 U.S. 147, 152, 87 USPQ 303, 306 (1950). "[I]t can be important to identify a reason that would have prompted a person of ordinary skill in the relevant field to combine the elements in the way the claimed new invention does." KSR, 550 U.S. at 418, 82 USPQ2d at 1396.
Further, Montpetit is directed to a cutting instrument and teaches an actuatable cutting element (80) disposed within the cutting arm (62) and actuatable to laterally extend therefrom (the distal end of 80 extends towards the central axis of the device, thus is seen as laterally extending) (Figure 2C-D; Paragraph 0052).
A person of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify claim 1 of US 12048448 B2 such that an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom, as taught by Montpetit, as the reference and the claimed invention are directed to surgical cutting instruments. It would be obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 1 of US 12048448 B2 with the teachings of Montpetit by incorporating an actuatable cutting element disposed within the cutting arm and actuatable to laterally extend therefrom in order to sever tissue, as Forrester is silent to the structure of its laceration components.
Allowable Subject Matter
Claims 6-8, 12, and 14-16 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter:
Regarding claim 6, a modification to Forrester to include “wherein the grasping arm of the cutting mechanism comprises a first grasping arm and a second grasping arm, the first grasping arm and the second grasping arm being disposed such that, when the cutting mechanism is in the closed position, a first grasping arm is disposed on a first side of the cutting arm and a second grasping arm is disposed on a second, opposite side of the cutting arm” would not be obvious, due to the placement of the arms relative to one another. One of ordinary skill in the art would not be motivated to split the grasping arm 136 into two arms and have them on opposite sides of cutting arm 138 as there would be no added benefit and would result in an unnecessarily complicated device. Thus, claim 6 is objected to for containing allowable subject matter and claims 7-8 are objected to due to their dependence on claim 6. Further, claim 14 is directed to similar subject matter as claim 6 and is objected to for the same reasons, along with claims 15-16 which depend from claim 14.
Regarding claim 12, no references teach an auxiliary arm connected to the central hinge and disposed opposite the one or more grasping arms, the auxiliary arm being mechanically connected to the cutting element such that movement of the auxiliary arm as the cutting mechanism moves between the open position and the closed position causes advancement and retraction of the cutting element relative to the cutting arm. The closest prior art, Nakao, teaches a retractable cutting arm with a cutting element, but does not include an auxiliary arm attached to the central hinge to control the actuation of the cutting element. It would not have been obvious to modify Nakao’s device disclosed above to include an auxiliary arm connected to the central hinge to actuate the cutting element from the distal end because actuation is controlled at the proximal end of Nakao’s device. Further, none of the other prior art devices disclose a retractable cutting element, so the addition of an auxiliary arm to control actuation of the cutting element would be unnecessary and therefore not obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ZEHRA JAFFRI whose telephone number is (571)272-7738. The examiner can normally be reached 8 AM-5:30 PM.
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, DARWIN EREZO can be reached on (571) 272-4695. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. 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.
/Z.J./Examiner, Art Unit 3771
/KATHERINE H SCHWIKER/Primary Examiner, Art Unit 3771
Prosecution Insights