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 Arguments
Objections to the specification have been withdrawn in light of the cancelation of claims 4 and 15.
The previous objection of claims 3, 10 and 16 due to minor informalities has been withdrawn in light of applicant’s amendments made 12/30/2025. Additional objections have been made in light of applicant’s amendments made 12/30/2025.
The previous rejection of claim(s) 1-20 over 35 U.S.C. 112(b) as being indefinite has been overcome in light of the amendments made to claim(s) 1 and the cancelation of claims 9, 10-12, 16 and 20 on 12/30/2025. Additional rejections have been made in light of applicant’s amendments made 12/30/2025.
Additional objections and/or 35 U.S.C. 112(b) rejections are made in light of the amendments filed 12/30/2025.
Applicant's arguments filed 12/30/2025 have been fully considered but they are not persuasive. Applicant argues that Drapeau et al. (US 2020/0214733 A1) in view of Weiss (US 2007/0049952 A1) fails to disclose wherein the accessory tool is configured to travel down a vessel lumen to a situs of an aortic valve, grasp a native aortic valve leaflet, and exert a pulling action to draw the native aortic valve leaflet towards the cutting element, wherein the cutting element is configured to perform resection of the native aortic valve leaflet for removal of the native aortic valve leaflet, such that the cutting element is configured to re-shape the situs of the aortic valve before deployment of an aortic valve replacement during a transcatheter valve replacement (TAVR) procedure.
In response to applicant's argument that there is no disclosure or suggestion of a cutting element resecting a native aortic valve leaflet, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. In the instant case, the tissue removal device 10 of Drapeau is found equivalent to the claimed resection apparatus structurally and is fully capable and sized appropriately for use in a TAVR procedure. For example, paragraph [0006] recites “Tissue removal devices and methods are provided that deliver improved tissue resection with minimal unwanted destruction to adjacent nerve and/or soft tissue. The tissue removal devices and methods provided allow the device to be easily positioned in an optimal location.” In other words, the device is used for tissue resection in a patient’s body. Further, applicant recites in paragraph [0023] that “the accessory tool is configured to pass through an introducer (not shown) of at least a range of 14f to 18f for use with a standard TAVR deployment catheter. Drapeau discloses the dimensions of the device 10 will depend on the site from which tissue must be removed (thus, may be changed depending on the use for the device) and that the device may be sized to fit through a space of about 3-5 mm or about 5-7 mm ([0065]). A 14f introducer has a diameter of 4.67 mm and a 18f introducer has a diameter of 6 mm. Thus, applicant’s apparatus is sized to fit through an introducer between 4.67 mm and 6 mm for removal of a native aortic valve leaflet and the device 10 of Drapeau is also sized to fit through a space between 3 mm and 7 mm. Accordingly, the device 10 of Drapeau is appropriately sized for TAVR. Because the device 10 of Drapeau is used for resecting tissue, is sized for deployment to an aortic valve, and is structurally equivalent to the apparatus as claimed, the device 10 is found to meet the intended use claimed limitations.
Accordingly, applicant’s arguments over Drapeau and Weiss are not found persuasive.
Election/Restrictions
Newly submitted claim 24 is directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
This application contains claims directed to the following patentably distinct species:
Species A: Fig. 1
Species B: Fig. 2
The species are independent or distinct because Species A includes laser cutting catheter with a ring of fibers while Species B includes a cutting sheath within a protective sleeve. In addition, these species are not obvious variants of each other based on the current record. Newly submitted claim 24 is directed to Species A, which the previously examined claims are directed to Species B.
There is a serious search and/or examination burden for the patentably distinct species as set forth above because at least the following reason(s) apply:
(a) the inventions have acquired a separate status in the art due to their recognized divergent subject matter (for example, a separate field of search would be necessary and the prior art applicable to one invention would not likely be applicable to another invention as a cutting edge within a protective sleeve would require a separate search than a laser cutter comprising a ring of fibers);
(b) the inventions require a different field of search (for example, searching different classes/subclasses or electronic resources, or employing different search queries with different search terms for the different inventions (i.e. “ring”, “fibers”, “ablation”, “protective sleeve”, “inside”, etc.)).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claim 24 is withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Claim Objections
Claim 3 is objected to because of the following informalities: Claim 3 recites “the aortic valve leaflet” in line 7 which should read “the native aortic valve leaflet”. 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 3 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 applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "the portion of the aortic valve leaflet tissue" in lines 2-3. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the interior of the protective sleeve" in line 4. There is insufficient antecedent basis for this limitation in the claim.
Claim 3 recites the limitation "the distal end of the catheter" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 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.
Claim(s) 1-3, 5-6, 14 and 21-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Drapeau et al. (US 2020/0214733 A1).
Regarding claim 1, Drapeau discloses an apparatus comprising: a cutting element (cutting surface 222; Fig. 13); and an accessory tool (grasping members 30) comprising a set of grasping elements (grasping fingers 32), wherein the accessory tool (30) is configured to travel down a vessel lumen to a situs of an aortic valve (as the device 10 is used within the body and is sized to fit within a 14f or an 18f lumen, similar to applicant ([0023]), because the device 10 may fit within a lumen of about 3-5 mm; [0065]), grasp a native aortic valve leaflet, and exert a pulling action (as grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]), to draw the native aortic valve leaflet towards the cutting element (by pulling 30 towards 222, as grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]), wherein the cutting element (222) is configured to perform resection of the native aortic valve leaflet for removal of the native aortic valve leaflet (as the tissue removal device 10 is provided for improved tissue resection; [0006] and is sized appropriately and capable of being used for a TAVR procedure; [0065]), such that the cutting element (222) is configured to re-shape the situs of the aortic valve before deployment of an aortic valve replacement during a transcatheter valve replacement (TAVR) procedure (as the cutting element 222 resects tissue, which would inherently change the shape of the tissue being treated and the device 10 is capable of being deployed to an aortic valve, depending on a user’s manipulation of the device as it is sized appropriately to fit within a patients aortic valve).
Regarding claim 2, Drapeau discloses wherein the cutting element (222) is configured to perform the resection while the native aortic valve leaflet is held by the set of grasping elements (as grasping members 30 are deployed to secure tissue and bring it into contact with cutting surface 222; [0069]).
Regarding claim 3, Drapeau discloses wherein the pulling action of the accessory tool (30) is configured to draw a portion of aortic valve leaflet tissue in a first direction (towards opening 214) into an interior space of a protective sleeve (including opening 214 and tip 216; as fingers 32 of grasping members 30 pull grasped tissue as they are brought back to the retracted position; [0063]) simultaneously as a distal end of a catheter (cannula 212) moves in an opposite, second direction (towards grasping members 30) towards the native aortic valve leaflet (as the grasping members 30 are slidable along the longitudinal axis of the cannula and can be slid out of the opening to capture tissue and bring it into contact with cutting surface 222 which is within the tip 216; [0061]; [0069]; and the cannula 212 can be moved distally via user manipulation).
Regarding claim 5, Drapeau discloses wherein the cutting element (222) comprises a manual mechanical cutter (as cutting cannula 220, which includes cutting surface 222, may be axially movable within cannula 212 or may be fixedly attached to an inner surface of cannula 212 to be mechanically moved by a user; [0068]).
Regarding claim 6, Drapeau discloses wherein the cutting element (222) comprises a powered mechanical cutter (as cutting surface 222 can be energized with an electrical energy source; [0068]).
Regarding claim 14, Drapeau discloses wherein the accessory tool (30) is configured to pass through an introducer comprising a range of 14f to 18f and configured for use with a TAVR deployment catheter (as the dimensions of the device depend on the site from which tissue must be removed and can be 3 mm, which would fit through a 14F introducer that has an outer diameter of 4.67 mm; [0065]; [0040]).
Regarding claim 21, Drapeau discloses a protective sleeve (including opening 214 and tip 216), wherein the cutting element (222) is positioned inside the protective sleeve (Fig. 13), wherein the accessory tool (30) is configured to exert the pulling action to draw a portion of the native aortic valve leaflet into the protective sleeve (via retraction of grasping members 30; [0069]; [0063]), wherein the cutting element (222) is configured to perform the resection of the portion of the native aortic valve leaflet that is drawn into the protective sleeve (as the cutting surface 222 cuts tissue it is in contact with, which may be the native aortic valve leaflet), wherein the resection is configured to be performed within the protective sleeve to prevent tissue damage outside the protective sleeve (as the grasping members 30 are slidable along the longitudinal axis of the cannula and can be slid out of the opening to capture tissue and bring it into contact with cutting surface 222 which is within the tip 216; [0061]; [0069]).
Regarding claim 22, Drapeau discloses a catheter (cannula 212) comprising a proximal end and a distal end (Fig. 13), wherein the protective sleeve (214, 216) is disposed at the distal end of the catheter (Fig. 13).
Regarding claim 23, Drapeau discloses wherein the set of grasping elements (32) comprises two grasping elements (three grasping finger 32 are shown in Fig. 13; therefore, Drapeau comprises at least two) each comprising a first end (proximal end) and an opposite, second end (distal end), wherein, at the first end, the two grasping elements (32) are coupled to one another (at the proximal end of 30, 32 are at least operatively coupled to one another to open and close and be retracted and extended together; [0063]), wherein, at the second end (distal end), the two grasping elements are configured to be positioned on opposite sides of the native aortic valve leaflet and capture the native aortic valve leaflet therebetween (as the grasping members 30 are manipulable to be brought into contact and grasp tissue; [0061]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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) 8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Drapeau et al. (US 2020/0214733 A1) in view of Weiss (US 2007/0049952 A1).
Regarding claim 8, Drapeau fails to disclose a hemostatic valve configured to allow the accessory tool (30) to pass through the vessel lumen and seal off arterial pressure.
However, Weiss teaches a hemostatic valve (access seal) on a proximal end of a catheter configured to allow an accessory tool (clamp 22) to pass through a vessel lumen and seal off arterial pressure ([0046]; Figs. 2-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the cannula 212 of Drapeau to include a hemostatic valve as taught by Weiss in order to allow the accessory tool and/or other instrumentation therethrough without leakage.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/SARAH A LONG/Primary Examiner, Art Unit 3771
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