DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
2. Claims 1-6 as originally filed on 11/29/2023 are pending, and have been examined on the merits.
Claim Objections
3. Claim 2 is objected to because of the following informalities:
a. In claim 2, lines 2-3, the recitation of “comprises a gripper operatively connection to said gripper control” should instead recite --comprises a gripper operatively connected to said gripper control--.
b. In claim 2, lines 3-4, the recitation of “said gripper extents within said leaflet receiving cavity” should instead recite --said gripper extends within said leaflet receiving cavity--.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
4. 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.
5. Claims 1-3, 5, & 6 are rejected under 35 U.S.C. 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor regards as the invention.
6. Claim 1 recites the limitation “said leaflet distal end” in line 4. There is insufficient antecedent basis for this recitation in the claim.
7. Claim 1 recites the limitation “said proximal control handle” in line 6. There is insufficient antecedent basis for this recitation in the claim.
8. Claim 1 recites the limitation “said grasping arm main shaft” in line 9. There is insufficient antecedent basis for this recitation in the claim.
9. Claim 1 recites the limitation “said cavity” in line 14. There is insufficient antecedent basis for this recitation in the claim.
10. Claim 1 recites the limitation “said laceration element” in line 14. There is insufficient antecedent basis for this recitation in the claim.
11. Claims 2, 3, & 5 are rejected as ultimately depending from a claim (claim 1) rejected under 35 U.S.C. 112(b).
12. Claim 5 recites the limitation “[t]he minimally invasive leaflet splitter” in line 1. There is insufficient antecedent basis for this recitation in the claim.
13. Claim 5 recites the limitation “said wire” in line 1. There is insufficient antecedent basis for this recitation in the claim.
14. Claim 6 recites the limitation “said leaflet distal end” in line 5. There is insufficient antecedent basis for this recitation in the claim.
15. Claim 6 recites the limitation “said grasping arm main shaft” in line 7. There is insufficient antecedent basis for this recitation in the claim.
16. Claim 6 recites the limitation “said cavity” in line 11. There is insufficient antecedent basis for this recitation in the claim.
Claim Rejections - 35 USC § 102
17. 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.
18. Claims 1, 2, 5, & 6 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. Patent Application Publication No. 2022/0233210 to Forrester (“Forrester”).
19. Regarding claim 1, and as best understood [see rejections under § 112(b) above], Forrester discloses a minimally invasive leaflet grasper for intracardiac implantation into a heart chamber for grasping a heart leaflet and modifying the leaflet, said leaflet grasper comprising:
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a proximal end [proximal end of flexible shaft (122) - ¶[0030]; FIG. 1] and a distal end [the end that comprises cutting grasper (116) - ¶[0038]; FIG. 3] and including a control handle on said leaflet grasper proximal end [controller coupled to the shaft proximal end, see claims 2-5], a grasping end [cutting grasper (116) - ¶¶ [0030], [0038]] on said leaflet distal end [FIG. 3], a catheter shaft [flexible shaft (122) - ¶[0030]] extending between said proximal end and said distal end [¶[0030]];
said proximal control handle includes a laceration movement control [for control of the one or more laceration components - see, e.g., claim 5 (“a controller coupled to the shaft proximal end, the controller configured to activate one or more lacerating components”)] and a grasper control [for control of actuating element (136) - see, e.g., claim 3 (“a controller coupled to the shaft proximal end, the controller configured to control the actuating member to rotate from the closed position to the open position”)];
said grasping end [(116)] includes a grasping end main shaft [base member (138) - ¶¶ [0031], [0038]; FIG. 3] and a grasping arm [actuating member (136) - ¶¶ [0031], [0038]; FIG. 3] wherein said grasping arm [(136)] and said grasping arm main shaft [(138)] define a leaflet receiving receptacle therebetween [see ¶[0038] (“When the target tissue is disposed between the base member 138 and the actuating member 136, the anchor component 302 may be configured to rotate about the hinge 206 and bind to the actuating member, as a mechanical clasp. Operation of the anchor component 302 in this way can help secure the target tissue between the base member 138 and the actuating member 136”); note also ¶[0038] (“the anchor component 302 can ensure the target tissue is disposed within the cutting grasper 116 so that the tissue is divided at an intended location”); FIG. 3] and wherein said grasping arm [(136)] moves from a first position adjacent said grasping arm main shaft [(138)] [see FIG. 2 (top)] to a second position wherein in said second position, said grasping arm extends away from said grasping arm main shaft [(138)] [see FIG. 2 (bottom); and FIG. 3]; and
said grasping end [(116)] further includes a laceration member on said grasping arm [(136)] [see ¶[0037] (“the cutting grasper 116 includes one or more lacerating components to divide targeted tissue. Examples of such lacerating components include, but are not limited to, one or more electrified wires and one or more blades, to name just a few. The lacerating components can be disposed on or within either or both of the base member 138 and/or the actuating member 136”)] for modifying the leaflet within said cavity;
and said laceration element [¶[0037]] is operatively connected to said laceration movement control [see claim 5] and said grasper arm [(136)] is operatively connected to said grasper control [see claim 3].
20. Regarding claim 2, Forrester discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forrester further discloses wherein said proximal control handle further includes a gripper control [¶[0038]] and said grasping end further comprises a gripper [anchor component (302) - ¶[0038]; FIG. 3] operatively connection to said gripper control wherein said gripper extents within said leaflet receiving cavity [FIG. 3].
21. Regarding claim 5, Forrester discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
As best understood [see rejection under § 112(b) above], Forrester further discloses
wherein said wire is a radiofrequency energized wire [¶[0037]].
22. Regarding claim 6, and as best understood [see rejections under § 112(b) above], Forrester discloses a method of utilizing a leaflet grasper for intracardiac implantation into a heart chamber for grasping and modifying a heart leaflet comprising the steps of:
inserting the leaflet grasper into a heart chamber [see ¶[0005] (“The cutting grasper extends from a distal end of the flexible shaft, which is configured to advance the cutting grasper through a vascular system of a patient and into a chamber of the patient's heart”)] wherein said leaflet grasper includes a proximal end [proximal end of flexible shaft (122) - ¶[0030]; FIG. 1] and a distal end [the end that comprises cutting grasper (116) - ¶[0038]; FIG. 3] and including a control handle on said leaflet grasper proximal end [controller coupled to the shaft proximal end, see claims 2-5], a grasping end [cutting grasper (116) - ¶¶ [0030], [0038]] on said leaflet distal end [FIG. 3], a catheter shaft [flexible shaft (122) - ¶[0030]] extending between said proximal end and said distal end [¶[0030]], said grasping end [(116)] includes a grasping end main shaft [base member (138) - ¶¶ [0031], [0038]; FIG. 3] and a grasping arm [actuating member (136) - ¶¶ [0031], [0038]; FIG. 3] wherein said grasping arm [(136)] and said grasping arm main shaft [(138)] define a leaflet receiving receptacle therebetween [see ¶[0038] (“When the target tissue is disposed between the base member 138 and the actuating member 136, the anchor component 302 may be configured to rotate about the hinge 206 and bind to the actuating member, as a mechanical clasp. Operation of the anchor component 302 in this way can help secure the target tissue between the base member 138 and the actuating member 136”); note also ¶[0038] (“the anchor component 302 can ensure the target tissue is disposed within the cutting grasper 116 so that the tissue is divided at an intended location”); FIG. 3] and wherein said grasping arm [(136)] moves from a first position [see FIG. 2 (top)] to a second position wherein in said second position, said grasping arm extends away from said grasping arm main shaft [(138)] [see FIG. 2 (bottom); and FIG. 3], and said grasping end [(116)] further includes a laceration member on said grasping arm [(136)] [see ¶[0037] (“the cutting grasper 116 includes one or more lacerating components to divide targeted tissue. Examples of such lacerating components include, but are not limited to, one or more electrified wires and one or more blades, to name just a few. The lacerating components can be disposed on or within either or both of the base member 138 and/or the actuating member 136”)] for modifying the leaflet within said cavity;
positioning said grasping end [(116)] adjacent the heart leaflet to be modified [¶[0031]; FIG. 1], opening said grasping arm [(136)] to said second position to receive the leaflet within said receptacle [¶¶ [0031], [0032]; FIG. 1];
closing said grasping arm [(136)] to said first position to secure the leaflet [¶[0032]; FIG. 1]; and
activating the laceration member to modify the leaflet [¶¶ [0032], [0037]; FIG. 1].
Claim Rejections - 35 USC § 103
23. 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.
24. The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
25. Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Forrester in view of U.S. Patent Application Publication No. 2021/0346045 to Abunassar ("Abunassar").
26. Regarding claim 3, Forrester discloses all of the limitations of claim 1 for the reasons set forth in detail (above) in the Office Action.
Forrester discloses that the catheter shaft [(122)] is flexible and can be advanced through the vascular system of a patient [e.g., Abstract, ¶¶ [0005], [0023], [0030]].
Forrester does not explicitly disclose:
wherein said catheter shaft is steerable and said proximal control handle includes a deflection knob operatively connected to said catheter shaft for altering an orientation of said catheter shaft.
However, the use of steerable catheter shafts was well known in the art, before the effective filing date of the claimed invention.
As one example, Abunassar, in a similar field of endeavor, teaches a leaflet grasping and cutting device [Abstract] comprising a handle (110), a steerable guide catheter (105) coupled thereto, and a control (120) on the handle (e.g., a dial) for controlling the movement and curvature of the distal end of the guide catheter [see ¶¶ [0034]-[0036]; FIG. 2].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Forrester such that catheter shaft is steerable and said proximal control handle includes a deflection knob operatively connected to said catheter shaft for altering an orientation of said catheter shaft, since such a modification would facilitate the procedure for a practitioner by enabling greater control over the catheter shaft as it is advanced through the vascular system (of a patient) toward the heart, which would help prevent inadvertent damage to the vasculature during advancement.
27. Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2020/0001053 to Rafiee (“Rafiee”) in view of Abunassar.
28. Regarding claim 4, and with reference to FIGS. 1A & 1B (reproduced below), Rafiee teaches a minimally invasive leaflet splitter for intracardiac implantation into a heart chamber for grasping a heart leaflet and modifying the leaflet, said leaflet splitter comprising:
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a proximal end [proximal end of catheter - ¶[0018]; FIGS. 1A-1B], a distal end [distal end of device comprising distal end of body (10) with atraumatic distal tip (24) - ¶[0019]; FIGS. 1A, 1B] and a catheter shaft [tubular main body (22) - ¶[0018]; FIGS. 1A, 1B] extending therebetween;
… wherein said catheter shaft [(22)] is deflectable [see ¶[0042] which notes that the distal end of the catheter can be deployed into a patient’s vasculature (and is therefore flexible/deflectable)]… and wherein said catheter shaft [(22)] defines at least one port configured for receipt of a guidewire [shaft (22) houses a lumen (e.g., second elongate inner body (20) - ¶[0020]) which allows for passage of a guidewire, which broadly means that the guidewire enters catheter shaft (22) (via an opening/port) - ¶¶ [0024]-[0025]];
a splitter end [distal end of first elongate inner body (10) with atraumatic distal tip (24) - ¶[0019]; FIGS. 1A, 1B] on said leaf splitter distal end wherein said splitter end is operatively connected to a [control]… which controls deflection of said splitter end [e.g., ¶[0041]] and wherein said splitter end and said catheter shaft [(22)] define a center lumen [center lumen of inner body (10) which is itself disposed within catheter shaft (22)] and wherein said splitter end is configured to wrap around itself to encircle the heart leaflet [see FIG. 1B; note also ¶¶ [0021], [0042] (“deploying the first elongate inner body so that the distal end of the first elongate inner body curls around the edge of the patient's valve leaflet”)]; and
a wire extending within said center lumen for encircling the leaflet [¶¶ [0023]-[0024]].
CONTROL HANDLE & DEFLECTABLE CATHETER SHAFT
Rafiee does not explicitly teach a control handle for controlling deflection of the catheter shaft, and therefore fails to teach the following emphasized claim limitations:
a control handle on said leaflet splitter proximal end having a deflection knob operatively connected to said catheter shaft and wherein said catheter shaft is deflectable and said control handle controls deflection of said catheter shaft and wherein said catheter shaft defines at least one port configured for receipt of a guidewire; [and]
a splitter end on said leaf splitter distal end wherein said splitter end is operatively connected to said control handle which controls deflection of said splitter end and wherein said splitter end and said catheter shaft define a center lumen and wherein said splitter end is configured to wrap around itself to encircle the heart leaflet.
However, the use of steerable catheter shafts was well known in the art, before the effective filing date of the claimed invention.
As one example, Abunassar, in a similar field of endeavor, teaches a leaflet grasping and cutting device [Abstract] comprising a handle (110), a steerable guide catheter (105) coupled thereto, and a control (120) on the handle (e.g., a dial) for controlling the movement and curvature of the distal end of the guide catheter [see ¶¶ [0034]-[0036]; FIG. 2].
It would have been obvious to one having ordinary skill in the art, before the effective filing date of the claimed invention, to modify Rafiee such that catheter shaft is steerable, or more particularly to include a control handle on said leaflet splitter proximal end having a deflection knob operatively connected to said catheter shaft and wherein said catheter shaft is deflectable and said control handle controls deflection of said catheter shaft, since such a modification would facilitate the procedure for a practitioner by enabling greater control over the catheter shaft as it is advanced through the vascular system (of a patient) toward the heart, which would help prevent inadvertent damage to the vasculature during advancement.
Conclusion
29. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bradford C. Blaise whose telephone number is (571)272-5617. The examiner can normally be reached on Monday - Friday 8 AM-5 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached on 571-272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bradford C. Blaise/Examiner, Art Unit 3794