DETAILED ACTION
The present application is being examined under the pre-AIA first to invent provisions.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 8/14/23;4/15/24;11/4/25 are in compliance with the provisions of 37 CFR 1.97(b). Accordingly, the IDSs are being considered by the Examiner.
Claim Objections
Claim 13 is objected to because of the following informalities: configured help to (suggested correct language; “to help”). Appropriate correction is required.
Claim Rejections - 35 USC § 103
4. 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 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.
5. The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
6. 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 pre-AIA 35 U.S.C. 103(a) 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.
7. Claims 9-13, 16, 20-22, 24-28 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mayse et al. (US 8,088,127) (“Mayse”) in view of Stein et al. (US 8,975,233) (“Stein”).
(claims 9,20,24) The disclosure of Mayse reads over all of Applicant’s claims except as specifically combinable with Stein as will be addressed. Mayse discloses that the embodiments disclosed can be combined to provide further embodiments C30L37-65 and discloses that the treatment system 198 can be used in the vascular system (within blood vessels) C30L1-15.
Thus, Mayse discloses: A method of treating a target tissue, the method including: advancing an ablation system through a target vessel until a distal end of the ablation system lies near the target tissue, the ablation system including injection needles 625, the ablation system designed to allow injection of ablative fluid through the injection needles C14L62-C15L17; (Fig. 10B).
Mayse does not directly disclose centering the ablation system with respect to the target vessel by expanding an expandable structure (balloon) near the distal end of the ablation system. Stein, in the analogous art, teaches a similar delivery system having an expandable structure in addition to the two needles and a guiding catheter (Fig. 3G, for example). The expandable structure is expanded to center the ablation system with respect the target vessel (Fig. 3G) C8L8-13; after advancing the balloon toward the lumen wall the injection needles are advanced circumferentially outward at least partially through a wall of the target vessel and into the target tissue to inject ablative fluid into the target tissue through the injection needles C8L50-C9L15. Therefore, it would have been obvious to a person having ordinary skill in the art at the time the invention was made to have modified the device of Mayse to include an expandable structure to center the ablation system with respect to the target vessel (a manually expanding mechanical structure) to offer greater control over the system; control of linear and circumferential spacing (diameter-increasing structure) and control of depth (Stein C3L11-40).
Claims 10,21: the ablative fluid of Mayse comprises alcohol, C14L62-C15L17
Claims 11,22: the ablation system comprises three (at least two) injection needles, 625, Fig. 10B
Claim 12: from Stein, above, the expandable structure 1330 is near the distal end of the ablation system (Fig. 3G)
Claim 13: the expandable structure 1330 of Stein is capable of ensuring that the injection needles will be engaged circumferentially around the target vessel, Fig. 3G
Claim 16: the balloon of Stein is capable of being inflated to be slightly less than a diameter of the target vessel because the balloon is delivered in a deflated position (C7L61-64) it can be inflated as desired (claim 26—inflated with saline is well known in the art)
Claim 25: balloon is deflated (Stein C7L61-62 balloon is delivered and thus also removed in deflated configuration C8L8-13)
Claim 27: Stein, nerve denervation may be used to manage hypertension C1L32
Claim 28: the injection needles of Stein penetrate a fixed distance C13L40-49
Again, this combination with Mayse is to offer greater control over the system (control of depth—Stein C3L11-40).
8. Claims 14-15, 17-19, 23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Mayse in view of Stein.
The combination of Mayse/Stein teaches the invention as substantially claimed. However, the specifics of the shape and composition of the balloon itself is not taught. Such a modification to have conical, cylindrical balloon and low-pressure elastic balloon, non-compliant or semi-compliant balloon would all perform equally well in the combination. Accordingly, it would have been prima facie obvious to a person having ordinary skill in the art at the time the invention was made to have modified the balloon of Stein to any shape and composition because such a modification would have been considered a mere design consideration which fails to patentable distinguish over Mayse/Stein.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DEANNA K HALL whose telephone number is (571)272-2819. The examiner can normally be reached M-F 8:30am- 4:30pm EST.
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/DEANNA K HALL/Primary Examiner, Art Unit 3783
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