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 .
Election/Restrictions
Applicant’s election without traverse of Species C: implant 460 as per Fig. 4 in the reply filed on 5/29/26 is acknowledged. Claims 2, 23, 24, 25, and 26 are withdrawn from consideration by the examiner as being directed to a non-elected invention.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the embodiment of implant 460, the implant catheter/implant holder according to this embodiment must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The disclosure is objected to because of the following informalities:
The implant holder according to the embodiment of the implant 460 is not described.
Appropriate correction is required.
Claim Objections
Claims 16 and 28 are objected to because of the following informalities:
Claim 16 recites “wherein the implant holder further comprises engagement surface” should be changed to recite “wherein the implant holder further comprises an engagement surface”.
Claim 28 recites “wherein the implant holder further comprises engagement surface” should be changed to recite “wherein the implant holder further comprises an engagement surface”.
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.
Claim 21 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, or for pre-AIA the applicant regards as the invention.
Claim 21 recites the limitation "a third pair of channels configured to slidably receive a second portion of the second tether”. It is unclear how the third pair of channels is a different structure from the second pair of channels since both channels house the second tether and extend at proximal and distal portions.
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.
Claim 1 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 19 of U.S. Patent No. 12396855. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 19 of ‘855 anticipates claim 1 of the instant application.
Claims 15 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 and 19, respectively of U.S. Patent No. 12396855. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 19 of ‘855 anticipates claim 1 of the instant application.
Claim 22 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12396855. Although the claims at issue are not identical, they are not patentably distinct from each other because claim 1 of ‘855 anticipates claim 1 of the instant application.
19429313 claims
12396855 claims
1. A system, comprising:
an implant configured to be coupled to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a portion (free end) of the native heart valve leaflet between the atrial arm and the ventricular arm and (2) a leaflet enhancer, the ventricular arm being configured to move laterally relative to the atrial arm to define the space;
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder including an engagement surface, when the implant is in a delivery configuration, at least one of the atrial arm and the ventricular arm (second portion of the implant that would include the atrial or ventricular arm abuts the engagement surface see claim 19) is configured to abut the engagement surface and the leaflet enhancer is configured to extend distal to the engagement surface (see claim 19), a maximum lateral dimension of the distal assembly being defined by the implant when the implant is in the closed position.
14. A system, comprising:
an implant configured to be to delivered to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation through a gap within the native heart valve, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a free end of the native leaflet B between the atrial arm and the ventricular arm, the ventricular arm being configured to move laterally relative to the atrial arm to define the space; and (2) a leaflet enhancer
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder defining a pair of atrial channels configured to slidably receive an atrial tether, the atrial tether configured to be removably coupled to the atrial arm of the implant, the implant holder defining a first pair of ventricular channels and a second pair of ventricular channels separate from the first pair of ventricular channels, the first pair of ventricular channels and the second pair of ventricular channels configured to slidably receive a ventricular tether, the ventricular tether configured to be removably coupled to the ventricular arm of the implant,
a maximum lateral dimension of the distal assembly being defined by the implant when the implant is in the closed position.
18. The system of claim 14, wherein the implant holder includes a distal portion and proximal portion separate from the distal portion, the distal portion and the proximal portion defining an opening therebetween and connected by a connector extending across the opening, a portion of the implant configured to be disposed in the opening.
19. The system of claim 18, wherein the portion of the implant configured to be disposed in the opening is a first portion, a front side of the proximal portion of the implant holder includes an engagement surface, a second portion of the implant configured to abut the engagement surface.
15. A system, comprising:
an implant configured to be to delivered to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation through a gap within a native heart valve, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a portion (free end) of the native heart valve leaflet between the atrial arm and the ventricular arm, and (2) a leaflet enhancer, the ventricular arm being configured to move laterally relative to the atrial arm to define the space; and
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder defining a plurality of channels including a first pair of channels (atrial channels) and a second pair of channels (ventricular channels), the first pair of channels configured to slidably receive a portion of a first tether (atrial tether), and the second pair of channels configured to slidably receive a portion of a second tether (ventricular tether), the first tether removably coupleable to the atrial arm and the second tether removably coupleable to the ventricular arm.
14. A system, comprising:
an implant configured to be to delivered to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation through a gap within the native heart valve, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a free end of the native leaflet B between the atrial arm and the ventricular arm, the ventricular arm being configured to move laterally relative to the atrial arm to define the space; and
(2) a leaflet enhancer
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder defining a pair of atrial channels configured to slidably receive an atrial tether, the atrial tether configured to be removably coupled to the atrial arm of the implant, the implant holder defining a first pair of ventricular channels and a second pair of ventricular channels separate from the first pair of ventricular channels, the first pair of ventricular channels and the second pair of ventricular channels configured to slidably receive a ventricular tether, the ventricular tether configured to be removably coupled to the ventricular arm of the implant,
a maximum lateral dimension of the distal assembly being defined by the implant when the implant is in the closed position.
16. The system of claim 15, wherein the implant holder further comprises engagement surface, the atrial arm and the ventricular arm configured to abut the engagement surface when the implant is in a delivery configuration.
19. The system of claim 18, wherein the portion of the implant configured to be disposed in the opening is a first portion, a front side of the proximal portion of the implant holder includes an engagement surface, a second portion of the implant configured to abut the engagement surface.
22. A system, comprising:
an implant configured to be coupled to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a portion (free end) of the native heart valve leaflet between the atrial arm and the ventricular arm, and (2) a leaflet enhancer; and
an implant catheter including an implant holder at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly, the implant holder including a proximal portion and a distal portion defining an opening therebetween, the implant holder defining a plurality of channels, each channel of the plurality of channels configured to receive a respective portion of a plurality of tethers such that each of the plurality of tethers partially extends outside of the implant holder and across the opening (extends across the opening by extending outside the implant).
1. A system, comprising:
an implant configured to be coupled to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation, the implant including (1) an atrial arm and a ventricular arm collectively movable between a closed position and an open position and defining a space sufficient to capture a free end of the native leaflet between the atrial arm and the ventricular arm, and (2) a leaflet enhancer;
an implant catheter including an implant holder at a distal end thereof, the implant holder including a distal portion and a proximal portion collectively defining an opening therebetween the proximal portion and the distal portion connected by a connector extending across a portion of the opening, the front side of the implant holder including an engagement surface, a first portion of the implant configured to be disposed in the opening between the distal and the proximal portion, a second portion of the implant configured to abut the engagement surface,
the proximal portion of the implant holder defining a pair of atrial channels configured to slidably receive an atrial tether, the atrial tether configured to be removably coupled to the atrial arm of the implant,
the proximal portion of the implant holder defining a first pair of ventricular channels configured to slidably receive a first portion of a ventricular tether, the distal portion of the implant holder defining a second pair of ventricular channels separate from the first pair of ventricular channels and configured to slidably receive a second portion of the ventricular tether such that the ventricular tether extends through the first pair of ventricular channels, outside of the implant holder, and through the second pair of ventricular channels, the ventricular tether configured to be removably coupled to the ventricular arm of the implant.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3-7, 10-17, 20-22, 27-29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Goldfarb (US2019/0282237)
Regarding claim 1, Goldfarb discloses a system, comprising:
an implant (14) configured to be coupled to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation, the implant including an atrial arm (16) and a ventricular arm (18) collectively movable between a closed position and an open position ([0141], see Fig. 10A-13B) and defining a space sufficient to capture a portion of the native heart valve leaflet between the atrial arm and the ventricular arm ([0141]) and a leaflet enhancer (implant pledgets, [0169]), the ventricular arm being configured to move laterally relative to the atrial arm to define the space (see Figs. 10A-13B);
an implant catheter (300, where embodiment of delivery catheter 300 can be used with fixation device 14, [0176]) including an implant holder (coupling structure 320, [0176]) at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly ([0177]), the implant holder including an engagement surface (a surface of the coupling structure 320, see Fig. 48), when the implant is in a delivery configuration, at least one of the atrial arm and the ventricular arm is configured to abut the engagement surface and the leaflet enhancer is configured to extend distal to the engagement surface (see Fig. 48), a maximum lateral dimension of the distal assembly being defined by the implant when the implant is in the closed position (the lateral dimension is greatest when the implant is in the configuration as shown in Fig. 10B that is interpreted as the closed position, where this configuration is for delivery of the implant, [0135]).
Regarding claim 3, Goldfarb discloses the system of claim 1, wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween (the implant holder is a portion of the catheter 300 that has the coupling structure, where the proximal and distal portions are portions at a distal end of the coupling structure 320 and a portion proximal the distal end of the coupling structure 320; and the opening would be the lumen of the catheter 300, [0176]), a distance between a distal end of the implant and the distal portion of the implant holder is such that a moment arm for moving the ventricular arm to the open position is above a predetermined value with a lower force (the moment arm for moving the ventricular arm is capable of being above a predetermined value with a lower force).
Regarding claim 4, Goldfarb discloses the system of claim 1, wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween (the implant holder is a portion of the catheter 300 that has the coupling structure, where the proximal and distal portions are portions at a distal end of the coupling structure 320 and a portion proximal the distal end of the coupling structure 320; and the opening would be the lumen of the catheter 300, [0176]), the proximal portion of the implant holder defines a shape (the proximal portion of the coupling structure 320 is cylindrical in shape, see Fig. 48) corresponding to a shape of the implant such that the implant sits in the opening (the implant is has a shape as shown in Fig. 10B and the shape allows it to pass through the catheter 300; therefore corresponding to the shape of the coupling structure 320).
Regarding claim 5, Goldfarb discloses the system of claim 1, wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween (the implant holder is a portion of the catheter 300 that has the coupling structure, where the proximal and distal portions are portions at a distal end of the coupling structure 320 and a portion proximal the distal end of the coupling structure 320; and the opening would be the lumen of the catheter 300, [0176]), the distal portion of the implant holder includes an atraumatic distal end (nose 318 that is part of the implant holder can include a soft tip 284 that is atraumatic, [0189]).
Regarding claim 6, Goldfarb discloses the system of claim 1, further comprising: a first tether (line 90 for actuating element 16, [0196]) configured to be removably coupled to the atrial arm ([0201]); and a second tether (actuator rod 64) configured to be removably coupled to the ventricular arm ([0209]).
Regarding claim 7, Goldfarb discloses the system of claim 6, wherein tension applied to a proximal portion of the first tether moves the atrial arm of the implant toward the engagement surface (tension on the lines 90 pull the elements 16 against the surface of the shaft of the catheter, [0140]).
Regarding claim 10, Goldfarb discloses the system of claim 6, wherein implant holder defines a plurality of channels (lumens 342 for lines 90 and lumen 352, [0195]) including a first pair of channels (pair of lumens 342 for lines 90) and a second pair of channels (central lumen 352 and lumen of compression coil 326, [0187]), the first pair of channels configured to slidably receive a respective portion of the first tether (line 90 for actuating element 16, [0196]), and the second pair of channels configured to slidably receive a respective portion of the second tether ([0160]).
Regarding claim 11, Goldfarb discloses the system of claim 1, wherein the implant catheter is configured to be manipulated to position the implant within a gap defined between the native heart valve leaflet and another native leaflet of the heart valve such that a level of regurgitation can be determined by performing at least one of fluoroscopy imaging or echocardiography while the implant remains coupled to the implant catheter and is positioned within the gap, and before the implant captures the native heart valve leaflet between the atrial arm and the ventricular arm (the implant catheter is capable of being positioned to deliver the implant within a gap between the native leaflet and another leaflet of the heart valve, where an operator is capable of using imaging to determine the positioning of the implant).
Regarding claim 12, Goldfarb discloses the system of claim 11, wherein a level of regurgitation after the implant captures the native heart valve leaflet can be determined by performing at least one of fluoroscopy imaging or echocardiography (the level of regurgitation can be determined by an operator using imaging).
Regarding claim 13, Goldfarb discloses the system of claim 12, wherein the level of valve regurgitation determined before the implant captures the native heart valve leaflet is substantially similar to the level of valve regurgitation determined after the implant captures the native heart valve leaflet between the atrial arm and the ventricular arm (where the device 14 is intended to have the leaflets perform similar after the application, [0114]).
Regarding claim 14, Goldfarb discloses the system of claim 1, wherein the space between the atrial arm and the ventricular arm is sufficient to capture a length of the native heart valve leaflet ([0114]).
Regarding claim 15, Goldfarb discloses a system, comprising:
an implant (14) configured to be to delivered to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation through a gap within a native heart valve, the implant including an atrial arm (16) and a ventricular arm (18) collectively movable between a closed position and an open position ([0141], see Fig. 10A-13B) and defining a space sufficient to capture a portion of the native heart valve leaflet between the atrial arm and the ventricular arm ([0141]), and a leaflet enhancer (implant pledgets, [0169]), the ventricular arm being configured to move laterally relative to the atrial arm to define the space (see Figs. 10A-13B); and
an implant catheter (300, where embodiment of delivery catheter 300 can be used with fixation device 14, [0176]) including an implant holder (coupling structure 320, [0176]) at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly ([0177]), the implant holder defining a plurality of channels (lumens 342 for lines 90 and lumen 352, [0188], [0195]) including a first pair of channels (pair of lumens 342) and a second pair of channels (central lumen 352 and lumen of compression coil 326, [0187]), the first pair of channels configured to slidably receive a portion of a first tether (line 90 for actuating element 16, [0196]), and the second pair of channels configured to slidably receive a portion of a second tether (actuator rod 64), the first tether removably coupleable to the atrial arm ([0201]) and the second tether removably coupleable to the ventricular arm ([0209]).
Regarding claim 16, Goldfarb discloses the system of claim 15, wherein the implant holder further comprises an engagement surface (a surface of the coupling structure 320, see Fig. 48), the atrial arm and the ventricular arm configured to abut the engagement surface when the implant is in a delivery configuration (see Fig. 48).
Regarding claim 17, Goldfarb discloses the system of claim 16, wherein tension applied to a proximal portion of the first tether moves the atrial arm of the implant toward the engagement surface (tension is applied to close elements 16, [0141]).
Regarding claim 20, Goldfarb discloses the system of claim 15, wherein the plurality of channels are configured to receive a flushing fluid from a fluid source to prevent blood clots from forming therein (channels are capable of receiving flushing fluid to prevent blood clots).
Regarding claim 21, Goldfarb discloses the system of claim 15, wherein the implant holder includes a proximal portion and a distal portion defining an opening therebetween (the implant holder is a portion of the catheter 300 that has the coupling structure, where the proximal and distal portions are portions at a distal end of the coupling structure 320 and a portion proximal the distal end of the coupling structure 320; and the opening would be the lumen of the catheter 300, [0176]), the proximal portion defining the first pair of channels and the second pair of channels (the implant holder is a portion of the catheter 300 that has the coupling structure and would therefore include the first and second pair of channels/lumens 342, 352), the distal portion defining a third pair of channels configured to slidably receive a second portion of the second tether (lumens 342, 352 defined at another portion of the implant holder/coupling structure).
Regarding claim 22, Goldfarb discloses a system, comprising:
an implant (14) configured to be coupled to a native heart valve leaflet of a heart of a patient to reduce valve regurgitation, the implant including an atrial arm (16) and a ventricular arm (18) collectively movable between a closed position and an open position and defining a space sufficient to capture a portion of the native heart valve leaflet between the atrial arm and the ventricular arm, ([0141]) and a leaflet enhancer (implant pledgets, [0169]); and
an implant catheter (300, where embodiment of delivery catheter 300 can be used with fixation device 14, [0176]) including an implant holder (coupling structure 320, [0176]) at a distal end thereof, the implant holder configured to hold the implant to form a distal assembly ([0177]), the implant holder including a proximal portion and a distal portion defining an opening therebetween (the implant holder is a portion of the catheter 300 that has the coupling structure, where the proximal and distal portions are portions at a distal end of the coupling structure 320 and a portion proximal the distal end of the coupling structure 320; and the opening would be the lumen of the catheter 300, [0176]), the implant holder defining a plurality of channels (lumens 342 for lines 90 and lumen 352, [0188], [0195]), each channel of the plurality of channels configured to receive a respective portion of a plurality of tethers such that each of the plurality of tethers partially extends outside of the implant holder and across the opening (the lines 90 and the actuator rod 64 extend across the opening and outside the implant holder in order to attach to the implant 14, [0137], [0151], [0176]).
Regarding claim 27, Goldfarb discloses the system of claim 22, wherein a first tether (line 90 for actuating element 16, [0196]) of the plurality of tethers is configured to be removably coupled to the atrial arm ([0201]) and a second tether (actuator rod 64) of the plurality of tethers is configured to be removably coupled to the ventricular arm ([0209]).
Regarding claim 28, Goldfarb discloses the system of claim 27, wherein the implant holder further comprises an engagement surface (a surface of the coupling structure 320, see Fig. 48), the atrial arm and the ventricular arm configured to abut the engagement surface when the implant is in a delivery configuration (see Fig. 48).
Regarding claim 29, Goldfarb discloses the system of claim 28, wherein tension applied to a proximal portion of the first tether moves the atrial arm of the implant toward the engagement surface (tension is applied to close elements 16, [0141]).
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.
Claims 8, 9, 18, 19, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Goldfarb (US2019/0282237).
Regarding claim 8, Goldfarb discloses the system of claim 6, wherein compression applied to a proximal portion of the second tether (actuator is pushed distally to open distal elements 18, [0160]), and while the atrial arm of the implant abuts the engagement surface based on tension applied to the proximal portion of the first tether, moves the ventricular arm of the implant away from the atrial arm of the implant, thereby transitioning the implant towards the open position ([0136]). Goldfarb discloses the actuation of the second tether but instead teaches compression instead of tension. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second tether be tensioned, since there are a finite number of identified, predictable solutions where the result would have a reasonable expectation of success for the same purpose of actuating the second tether to actuate the arms of the implant.
Regarding claim 9, Goldfarb makes obvious the system of claim 8, wherein tension released from the proximal portion of the second tether moves the ventricular arm of the implant closer to the atrial arm of the implant (where the invention as modified would have the actuator 64 pushed the distal elements 18 would close, where this is interpreted as releasing tension since compression would be applied), thereby transitioning the implant from the open position towards the closed position ([0160]).
Regarding claim 18, Goldfarb discloses the system of claim 16, wherein compression applied to a proximal portion of the second tether (actuator is pushed distally to open distal elements 18, [0160]), after the atrial arm of the implant abuts the engagement surface, moves the ventricular arm of the implant away from the atrial arm of the implant, thereby transitioning the implant towards the open position ([0136]). Goldfarb discloses the actuation of the second tether but instead teaches compression instead of tension. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second tether be tensioned, since there are a finite number of identified, predictable solutions where the result would have a reasonable expectation of success for the same purpose of actuating the second tether to actuate the arms of the implant.
Regarding claim 19, Goldfarb makes obvious the system of claim 18, wherein tension released from the proximal portion of the second tether moves the ventricular arm of the implant closer to the atrial arm of the implant (where the invention as modified would have the actuator 64 pushed the distal elements 18 would close, where this is interpreted as releasing tension since compression would be applied), thereby transitioning the implant from the open position towards the closed position ([0160]).
Regarding claim 30, Goldfarb discloses the system of claim 29, wherein compression applied to a proximal portion of the second tether moves the ventricular arm of the implant away from the atrial arm of the implant (actuator is pushed distally to open distal elements 18, [0160]), thereby transitioning the implant towards the open position ([0136]). Goldfarb discloses the actuation of the second tether but instead teaches compression instead of tension. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have the second tether be tensioned, since there are a finite number of identified, predictable solutions where the result would have a reasonable expectation of success for the same purpose of actuating the second tether to actuate the arms of the implant.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MIKAIL A MANNAN whose telephone number is (571)270-1879. The examiner can normally be reached M-F 10-6.
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, Thomas Barrett can be reached at (571)272-4746. 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.
/M.A.M/Examiner, Art Unit 3774
/THOMAS C BARRETT/SPE, Art Unit 3799
Prosecution Insights