DETAILED ACTION
Applicant's preliminary amendments and remarks, filed 2/6/26, are fully acknowledged by the Examiner. Currently, claims 21-34 and 36-41 are pending with claims 1-20 and 35 canceled, claims 21-34 and 36-41 added. The following is a complete response to the 2/6/26 communication.
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 (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.
Claim Objections
Claims 21 and 37 are objected to because of the following informalities: A “;” or “,” should precede “a cap” in the claims. Appropriate correction is required.
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.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kowalski (US 2015/0057563) in view of Stewart (US 2013/0030425).
Regarding claim 41, Kowalski teaches an ablation system adapted to deliver electroporation energy treatment to a target tissue, the system comprising:an electrode array (array 38) comprising: (b) a mapping array comprising one or more pacing-recording electrodes (electrodes 38), the mapping array configured to be positioned adjacent to the target tissue and measure signal corresponding to a treatment zone of the target tissue (par. [0035] phrenic nerve in range of pacing in area 101);
a catheter configured to position the electrode array at the target tissue (32 to position electrode array 38);
one or more energy generators configured to provide electroporation energy to activate the electroporation electrode (par. [0034] power generator); and one or more hardware processors configured to be in electrical communication with the one or more pacing-recording electrodes (processing device 26 to in communication with electrodes 24), the one or more hardware processors configured to:generate a pacing signal at the one or more pacing-recording electrodes (pacing signal at pacing electrodes 38 as in at least par. [0028]);detect signal of the one or more pacing-recording electrodes responsive to application of the energy treatment (detect a signal according to injury detection of the nerve); anddetermine whether additional treatment is needed based on the detected signal (par. [0031] adjust ablation according to detected signal).Kowalski is silent regarding (a) an electroporation electrode adapted to deliver electroporation energy the target tissue, and detecting electroporation energy.However, Stewart teaches the use of electrosurgical energy via electroporation to treat tissue (pulsing electroporation energy as in par. [0044]).It would have been obvious to one of ordinary skill in the art to modify Kowalski with the electroporation of Stewart, as a method of delivering radiofrequency energy as desired by Kowalski to treat tissue.
Allowable Subject Matter
Claims 21-34 and 37-40 are allowed.
Collins (US 2002/0107511), Kappel (US 2014/0046320), Phan (US 6,529,756), Rioux (US 2005/0171525), Kowalski, Stewart, and de Graff (US 2011/0034912) are the closest prior art of record found. However, Rioux fails to teach the mesh located between the one or more inner layers and the one or more outer layers, and the mesh of wires extends past a distal end of the catheter body. Rather, Rioux shows a conductive layer separate from the balloon conductivity (par. [0036]), and not a mesh. Other art, such as Laughner (US 2017/0143415) teaches mesh layers in catheters for stiffness, but not for conductivity. Examiner has not found any piece of art that discloses, fairly suggests, or makes obvious the arrangement. See also related cases 15/369,309 and 18/461,431.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BO OUYANG whose telephone number is (571)272-8831. The examiner can normally be reached M-F 8-5 EST.
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/BO OUYANG/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794