Prosecution Insights
Last updated: April 19, 2026
Application No. 18/565,650

METHODS AND DEVICES FOR ELECTROPORATION FOR TREATMENT OF VENTRICULAR FIBRILLATION

Non-Final OA §103
Filed
Nov 30, 2023
Examiner
LANCASTER, LINDSAY REGAN
Art Unit
3794
Tech Center
3700 — Mechanical Engineering & Manufacturing
Assignee
Mayo Foundation for Medical Education and Research
OA Round
1 (Non-Final)
56%
Grant Probability
Moderate
1-2
OA Rounds
3y 10m
To Grant
82%
With Interview

Examiner Intelligence

Grants 56% of resolved cases
56%
Career Allow Rate
53 granted / 95 resolved
-14.2% vs TC avg
Strong +26% interview lift
Without
With
+26.2%
Interview Lift
resolved cases with interview
Typical timeline
3y 10m
Avg Prosecution
47 currently pending
Career history
142
Total Applications
across all art units

Statute-Specific Performance

§101
3.2%
-36.8% vs TC avg
§103
67.4%
+27.4% vs TC avg
§102
19.5%
-20.5% vs TC avg
§112
5.1%
-34.9% vs TC avg
Black line = Tech Center average estimate • Based on career data from 95 resolved cases

Office Action

§103
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. 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. Status of the Claims The current office action is made responsive to claims filed 11/30/2023 . Acknowledgement is made to the amendment of claims 2, 5, 11, 15-16, and 19 . Acknowledgement is made to the cancellation of claims 3-4, 17-18, and 20 . Acknowledgement is made to the withdrawal of claim s 11-16, 19, and 21-25 . Any claims listed above as cancelled have sufficiently overcome any rejections set forth in any of the prior office actions. Any claims listed above as withdrawn have been withdrawn from further consideration by the examiner, as these claims are drawn to a non-elected invention. Claims 1-2 and 5-10 are pending as rejected below . A complete action on the merits appears below. 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 . Claim 1-2, 5, 7-8, and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Krishnan (US 20060200118 A1) . Regarding claim 1, Patel teaches a catheter device (Fig. 1; medical device 10 ) comprising: a catheter shaft (Fig. 1; catheter body 10 ) ; a balloon member (Fig. 1; inflatable balloon 14 ) attached at a distal end portion of the catheter shaft ([0163]) ; one or more electrodes on an outer surface of the balloon or in an interior of the balloon member and configured to deliver pulsed-electric field non-thermal electroporation ablation energy to treat ventricular fibrillation of a heart ([0002]) ; and Patel further teaches the pressure within the balloon as being controllable ([0258]). However, Patel fails to specifically teach the catheter device as comprising a control system configure to adjust a pressure within the balloon member. Krishnan teaches the use of a catheter having an electrode for providing ablative RF energy and a balloon which is pressurized so as to provide an increased blood flow during an ablation procedure, ([0031]- [0032]) as increased blood flow provides a protective heat sink when provided in conjunction with the application of RF current ([0030]). Krishnan further teaches the balloon and the RF current as being provided based on the timing of the cycle provided from ECG signals ([0033]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the system having a catheter which at the distal end contains a balloon and electrodes for providing RF current with a system for controlling the pressure within the balloon , as is taught by Krishnan , into the catheter body having an inflatable balloon which is pressurized as is taught by Patel , to produce the predictable result of the balloon providing an increased blood flow to act as a protective heat sink during an RF ablation procedure , as is taught by Krishnan , as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Regarding claim 2 Krishnan teaches he catheter device of claim 1, wherein the control system is configured to pressurize and depressurize the balloon member in synchronization with an ECG of the heart ([0031]- [0033]) or based on a rate of change of pressure in a left ventricular cavity of the heart. Regarding claim 5, Krishnan teaches t he catheter device of claim 1, wherein the control system is configured to pressurize and depressurize the balloon member based on impedance changes in the heart or based on a timing cycle ([0031] teaches the IABP as increasing the balloon inflation during diastole). Regarding claim 7, Krishnan teaches t he catheter device of claim 1, wherein the control system is configured to pressurize and depressurize the balloon member based on a timing in order to inflate for a period and deflate for a specified time in order to allow for adequate perfusion of the heart and maintenance of blood pressure ([0031]- [0033]) . Regarding claim 8, Krishnan teaches t he catheter device of claim 1, wherein the control system is configured to pressurize and depressurize the balloon member in coordination with the heart's systole/diastole in order to augment ventricular output ([0030]- [0031]) . Regarding claim 10, Patel teaches t he catheter device of claim 1, wherein the balloon member comprises a porous material ([0161] teaches the wall of the inflatable balloon as being configured of a material with pores) in order to not constrict or impede blood flow in the heart that would otherwise lead to hemodynamic instability ( In accordance with MPEP 2114 this currently taught structure of a balloon member comprising a porous material , would provide the intended use of not constricting or impeding blood flow in the heart , as this limitation is a recitation of the intended use of the claimed invention, and as this prior art structure is capable of performing this intended use based on the recited characteristics of this element, currently reads on the provided claim limitation, unless otherwise shown that the prior art does not possess these characteristics ) . Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Krishnan (US 20060200118 A1) further in view of Lalonde (US 20130197499 A1). Regarding claim 6, Patel teaches t he catheter device of claim 1 . However, Patel fails to teach the catheter device wherein the control system is configured to pressurize and depressurize the balloon member based on impedance changes of a target tissue so as to automatically shut-off when ablation is completed. In accordance with the above modification of claim 1, Krishnan teaches the pressurizing and depressurizing of the balloon member as occurring automatically with the ablation ([0045]). However, Patel as currently modified fails to teach controlling the system based on impedance changes of a target tissue. Jackson teaches an apparatus for ablating tissue (Abstract). Jackson further teaches monitoring and controlling the ablation based on a change in tissue impedance ([0015], [0017]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the use of controlling an ablation procedure by impedance measurements , as is taught by Jackson, into the device which ablates tissue as is taught by Patel , to produce the predictable result of controlling an ablation procedure using a known parameter , as is taught by Jackson , as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Patel (US 20200316350 A1) in view of Krishnan (US 20060200118 A1) further in view of Jackson (US 20060095032 A1). Regarding claim 9, Patel teaches t he catheter device of claim 1 . However, Patel fails to teach the catheter device wherein the balloon member comprises an inner balloon with pores that is configured to inflate to a certain desired amount. Lalonde teaches a balloon catheter for receiving a fluid (Abstract). Lalonde further teaches a variety of structures for providing fluid into the balloon, such as an inner balloon having pores ([0034]). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date to have incorporated the inner balloon for providing fluid to a balloon of a catheter device , as is taught by Lalonde , into the catheter body having a balloon as is taught by Patel , to produce the predictable result of providing a balloon member of a catheter with fluid using a known structure for providing fluid to a balloon , as is taught by Lalonde , as it has been held that the incorporation and/or combination of prior art elements according to known methods to yield predictable results is an obvious modification. MPEP 2141(III). Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to FILLIN "Examiner name" \* MERGEFORMAT LINDSAY REGAN LANCASTER whose telephone number is FILLIN "Phone number" \* MERGEFORMAT (571)272-7259 . The examiner can normally be reached FILLIN "Work Schedule?" \* MERGEFORMAT Monday-Thursday 8-4 EST . Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, FILLIN "SPE Name?" \* MERGEFORMAT Linda Dvorak can be reached on FILLIN "SPE Phone?" \* MERGEFORMAT 571-272-4764 . The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300. Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000. /LINDA C DVORAK/ Primary Examiner, Art Unit 3794 /L.R.L./ Examiner, Art Unit 3794
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Prosecution Timeline

Nov 30, 2023
Application Filed
Apr 04, 2026
Non-Final Rejection — §103 (current)

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Study what changed to get past this examiner. Based on 5 most recent grants.

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Prosecution Projections

1-2
Expected OA Rounds
56%
Grant Probability
82%
With Interview (+26.2%)
3y 10m
Median Time to Grant
Low
PTA Risk
Based on 95 resolved cases by this examiner. Grant probability derived from career allow rate.

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