DETAILED ACTION
The following is a First Action, Non-Final Office Action on the merits.
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 .
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 121 as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 17/385937 provides adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application.
Accordingly, the claims are given the priority date of 7/27/2021.
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. 17/385937, filed on 7/27/2021.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “RF” to -radiofrequency (RF)- in ll. 4. Appropriate correction is required.
Claim 2 is objected to because of the following informalities: amend “then ablation” to -then the RF ablation- in ll. 2. Appropriate correction is required.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 & 3 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Govari et al. (2021/0330372).
Concerning claim 1, as illustrated in at least Fig. 1-4D, Govari et al. discloses a method for treatment of atrial fibrillation of the heart (RF ablation for treating atrial fibrillation using probe 22 comprised of a flexible guidewire 26, a flexible tube 32, and a flexible shaft 54; [0003-0004], [0044]), the method comprising:
inserting a guidewire from the superior vena cava or inferior vena cava into the vein of Marshall via a coronary sinus (physician 36 inserts guidewire 26 into the subject, and then navigates the guidewire into heart 28, where within the heart, the guidewire is navigated via coronary sinus 150 into ligament of Marshall vein 158 until a distal end of the guidewire is distal to target region 162 (e.g., within 10 mm of the target region); [0060]);
placing a RF ablation catheter, which has an ablation electrode formed on a distal part, in the vein of Marshall according to guidance of the guidewire (Once physician 36 has satisfactorily navigated the distal end of the guidewire to be distal to target region 162, in a tube threading step 104 the physician threads tube 32 over the guidewire, and continues the threading until a distal end of the tube is in proximity to target region 162 within the vein of Marshall, In an electrode traversal step 112, the physician inserts shaft 54, with at least one expandable electrode 64 connected to the shaft distal end, into tube 32, the physician continues to push on the proximal end of the shaft, so continuing the traversal of electrodes 64 through tube 32, until the electrodes exit the distal end of the tube, on exiting the tube distal end the electrodes may self-expand such that at least one of the electrodes contacts target region 162 within the vein of marshall 158; [0063-0066]); and
performing RF ablation around the vein of Marshall after connecting the RF ablation catheter to a RF generator (In an ablation step 120 the physician operates processor 44 and ablation module 66 to supply RF ablation electrical current to electrodes 64; [0070-0071]).
Concerning claim 3, Govari et al. disclose before or after the RF ablation, using a sensing electrode (74 and/or 76) formed on the RF ablation catheter (22), using a separate electrophysiology (EP) catheter, or using a ground catheter to sense an abnormal electrical signal of the vein of Marshall ([0052]; Fig. 2).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Govari et al. (2021/0330372), as applied to claim 1, in further view of Stewart et al. (2019/0223948).
Concerning claim 2, Govari et al. disclose the RF ablation is bipolar ablation or unipolar ablation ([0070]). Govari et al. fail to specifically disclose a ground catheter is placed in the left atrium before performing the RF ablation and then the bipolar ablation is performed between the RF ablation catheter and the ground catheter. However, Stewart et al. disclose RF ablation with a return electrode (14) catheter device (54) that can be positioned within the left atrium while the energy delivery electrode (12) of energy delivery device (16) is positioned at an epicardial location such as within a cardiac vein. At the time the invention was effectively filed, it would have been obvious one of ordinary skill in the art to modify the invention of Govari et al. such that a ground catheter is placed in the left atrium before performing the RF ablation and then the bipolar ablation is performed between the RF ablation catheter and the ground catheter in order to provide the benefit of a ground electrode that can be positionable independently of the energy delivery electrode and the treatment is performed within the tissue between the electrodes as taught by Stewart et al. ([0091]).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JAYMI E DELLA whose telephone number is (571)270-1429. The examiner can normally be reached on M-Th 6:00 am - 4:45 pm.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794
