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 .
Priority
This application claims priority from foreign application EP21162698.1 filed 03/15/2021.
Status of Claims
Claims 1-9 are pending.
Information Disclosure Statement
The Information Disclosure Statements filed on 08/10/2023, 08/14/2023, 09/04/2024 have been considered by the examiner.
Drawings
The drawings are objected to because the hand drawn reference numbers are difficult to read. For example, the lower case bs look like 6s, 1s and 7s look too similar, sometimes 1s have the bar at the bottom and other times they do not, and Figure 4 has a lower case g.
Specification
The abstract of the disclosure is objected to because it contains reference numbers. A new copy is needed with no reference numbers. Correction is required. See MPEP § 608.01(b).
Claim Objections
Dependent claims 2-5 and 7-9 objected to because of the following informality: grammatical errors. The dependent claims should be amended to start with something like: “The apparatus” or “The use” or The method of using (see 112 below).
Independent claim 6 is objected to because the preamble is not a complete phrase. The applicant is advised to amend claim 6 to say “A method of using the apparatus of claim 1”.
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.
Claims 5-9 are 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 5 is rendered indefinite because the phrase “the narrow portion” lacks antecedent basis. The applicant is advised to amend claim 5 to say “a narrow portion”.
Claim 6 is rendered indefinite for antecedent basis issues. The apparatus of claim 1 is already defined in claim 1. Therefore claim 6 should recite: the apparatus of claim 1.
Additionally, the leaflets are not positively claimed in claim 1. Therefore claim 6 should recite: proximally orienting leaflets in line 3. The recitation in lines 4 and 6 should stay the same because of line 4.
Finally, the cute leaflet portions are not positively claimed in line 5 of claim 6. So claim 6 should recite removing cut leaflet portions in line 6.
Claim 7 is rendered indefinite because the phrase “the positioning of the anchoring valve stent” lacks antecedent basis. The applicant is advised to amend claim 7 to say “proceeded by positioning of the anchoring valve stent”.
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, 6, and 8 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Spector WO 2020/234763 A1.
1. Spector discloses a transcatheter resection apparatus 10 for native or bioprosthetic heart valves (Figures 9A-E) comprising a leaflet grasping system (12) and a leaflet cutting device (14), said grasping system and said cutting device being coaxially and longitudinally movable relatively to each other (Figures 9A-E show them moving longitudinally, along the axis, and coaxially, away from the central axis) and wherein said grasping system is longitudinally oriented, characterized by the fact that the grasping system comprises a fixed portion (outer portion of tubular member 53) and a rotating portion (24); said fixed portion being adapted to grasp a leaflet face (Figures 9A-E show the fixed portion engaging the inner surface of the leaflets) and said rotating portion being adapted to grasp the opposite leaflet face (Figures 9A-E show the outer pivoting portion engaging the outer surface of the leaflets).
6. Spector discloses a method of using the apparatus of claim1, comprising the following steps: proximally orienting the leaflets (Figures 9A and B show the leaflets being oriented proximally along the longitudinal axis), grasping of the leaflets by the grasping system (Figures 9B-C), cutting of the leaflets with the cutting device (Figures 9D-E), removing the cut leaflet portions (Spector doesn’t specifically say the leaflets are removed, but this is the entire purpose of cutting the leaflet, the free portions are inherently removed because they are no longer connected to the rest of the valve ).
8. Spector discloses a method of 6, wherein said leaflets are grasped on both faces (Figures 9A-E show the grasping system engages both the inner and outer surface of the leaflets).
Allowable Subject Matter
Claims 2-4 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.
Claims 5, 7, and 9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The prior art fails to disclose the grasping system is positioned within the cutting device, the use of barbs, or an anchoring valve stent
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHRISTOPHER D PRONE whose telephone number is (571)272-6085. The examiner can normally be reached Monday-Friday 10 am - 6 pm (HST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melanie R Tyson can be reached at (571)272-9062. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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CHRISTOPHER D. PRONE
Primary Examiner
Art Unit 3774
/Christopher D. Prone/Primary Examiner, Art Unit 3774
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