DETAILED ACTION
This action is pursuant to the claims filed on 01/05/2026. Claims 1-8 and 11-12 are pending. A first action on the merits of claims 1-8 and 11-12 is as follows.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/05/2026 has been entered.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/09/2025 and 01/05/2026 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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 and 5 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Tobey (U.S. PGPub No. 2020/0038101).
Regarding claim 1, Tobey teaches an end effector at a distal end of a catheter and being configured to be delivered through vasculature in a collapsed configuration and expand at an intracardiac treatment site to a deployed configuration (Fig 14), the end effector comprising: a plurality of linear spine segments each carrying electrodes thereon and configured such that in the deployed configuration the spine segments are parallel to each other and approximately planar such that the electrodes are positioned to define an electrode array (Fig 14, parallel and planar arms 940/944 with electrodes 942 thereon); and a first irrigation tube distinct from the spine segments, extending parallel to the spine segments ([0118] Fig 17 irrigating tip 1240 disclosed to be provided in place of central inner shaft 950 of Fig 14), and comprising a first central irrigation port positioned within the electrode array (Fig 14/17, irrigation opening 1242 is located between arms 940/944 of end effector 930, thus being positioned within the electrode arrray) and configured to be in contact with blood and to direct irrigation fluid outwardly to the electrodes and to tissue at the intracardiac treatment site (Fig 17, irrigation opening 1242 of port 1240 is positioned within electrode array and capable of being in contact with blood to direct fluid outwardly to electrodes at an intracardiac site).
Regarding claim 5, Tobey teaches the end effector further comprising: a plurality of loop members each comprising two of the spine segments and two ends affixed to a shaft of the catheter (Fig 14, arms 940/944 define two loop members affixed to shaft.
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(s) 2-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobey (U.S. PGPub No. 2020/0038101) in view of Tegg (U.S. PGPub No. 2010/0168647).
Regarding claims 2-4, Tobey teaches the device of claim 1.
Tobey fails to teach the first irrigation tube comprising a plurality of pores comprising the first central irrigation port and distributed longitudinally through the electrode array on the first irrigation tube; a distal irrigation port positioned in a distal direction in relation to the electrode array; and a proximal irrigation port positioned in a proximal direction in relation to the electrode array.
In related prior art, Tegg teaches a similar device wherein a similar first irrigation tube comprising a plurality of pores comprising the first central irrigation port (Fig 2b port 34a) and distributed longitudinally through the electrode array on the first irrigation tube (Fig 2b port 34b, 34a, and 34’a of Fig 3b [0042]); a distal irrigation port positioned in a distal direction in relation to the electrode array (Fig 3b ports 34’a disclosed in [0042]); and a proximal irrigation port positioned in a proximal direction in relation to the electrode array (Fig 2b port 34b). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation tube of Tobey in view of Tegg to incorporate the irrigation tube of Tegg comprising a plurality of pores including central, distal, and proximal ports to arrive at claims 2-4. Doing so would advantageously provide irrigation fluid delivery at various positions of the end effector and electrode array to ensure adequate coverage of fluid over the end effector ([0042]).
Regarding claim 6, Tobey teaches the device of claim 5 as stated above.
Tobey fails to teach a distal end of the first irrigation tube being affixed to a distal segment of at least one of the plurality of loop members.
In related prior art, Tegg further teaches a distal end of the first irrigation tube being affixed to a distal segment of at least one of the plurality of loop members (Fig 2b, irrigation tube connected to distal end of catheter end effector). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation tube of Tobey in view of Tegg to incorporate the irrigation tube of Tegg affixed to a distal segment of a loop member with longitudinal pores thereon to arrive at claim 6. Doing so would advantageously provide irrigation fluid delivery at various positions of the end effector and electrode array to ensure adequate coverage of fluid over the end effector ([0042]).
Claim(s) 7-8 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobey in view of Tegg, and in further view of Pappone (U.S. PGPub No. 2018/0042667).
Regarding claims 7-8, Tobey teaches the device of claim 1 as stated above. Tobey teaches a plurality of loop members each comprising two of the spine segments and two ends affixed to a shaft of the catheter (Fig 14, comprising two loop members defined by two spine segments 940/944 fixed to shaft).
Tobey fails to teach wherein a distal end of the first irrigation tube is affixed to a distal segment of at least one of the plurality of loop members.
In related prior art, Tegg further teaches a distal end of the first irrigation tube being affixed to a distal segment of at least one of the plurality of loop members (Fig 2b, irrigation tube connected to distal end of catheter end effector); the first irrigation tube comprising a central irrigation port (Fig 2b and 3b, pores 34a-b and 34’a). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation tube of Tobey in view of Tegg to incorporate the irrigation tube of Tegg affixed to a distal segment of a loop member with longitudinal pores thereon. Doing so would advantageously provide irrigation fluid delivery at various positions of the end effector and electrode array to ensure adequate coverage of fluid over the end effector ([0042]).
Tobey fails to teach the end effector further comprising: a second irrigation tube extending parallel to the spine segments such that at least one spine segment of the linear spine segments is positioned between the first and second irrigation tubes, the second irrigation tube comprising a second central irrigation port; and a third irrigation tube extending parallel to the spine segments such that at least one spine segment of the linear spine segments is positioned between the first and third irrigation tubes, the third irrigation tube comprising a third central irrigation port; the end effector further comprising: wherein a distal end of the first irrigation tube is affixed to a distal segment of at least one of the plurality of loop members, wherein a distal end of the second irrigation tube is affixed to a distal segment of at least one of the plurality of loop members, and wherein a distal end of the third irrigation tube is affixed to a distal segment of at least one of the plurality of loop members.
In related prior art, Pappone teaches a similar end effector further comprising: a first irrigation tube (Fig 4 irrigation tube 161); a second irrigation tube extending parallel to the spine segments such that at least one spine segment of the linear spine segments is positioned between the first and second irrigation tubes (Fig 4, second irrigation tube 162 for second fluid sac 159, such that linear segment 104 is positioned between the two irrigation tubes); and a third irrigation tube extending parallel to the spine segments such that at least one spine segment of the linear spine segments is positioned between the first and third irrigation tubes (Fig 4, third irrigation tube 163 for third fluid sac 158, such that linear segment 103 is positioned between the two irrigation tubes; examiner notes interpreting tube 162 as the ‘first’ irrigation tube and 161/163 as the second/third irrigation tube arrives at the claimed arrangement of spine segments between the first/second irrigation tube and between the first/third irrigation tube); a plurality of loop members each comprising two of the spine segments and two ends affixed to a shaft of the catheter (Fig 4, outer spines define a loop and inner spines define a loop, both affixed to catheter shaft), wherein a distal end of the first irrigation tube is affixed to a distal segment of at least one of the plurality of loop members (Fig 4 [0065], distal end of tubing 161 is affixed to distal end of spine 105 via mounting portion 166-1), wherein a distal end of the second irrigation tube is affixed to a distal segment of at least one of the plurality of loop members (Fig 4 [0065], distal end of tubing 162 is affixed to distal end of spine 104/103 via mounting portion 166 disclosed in [0065]), and wherein a distal end of the third irrigation tube is affixed to a distal segment of at least one of the plurality of loop members (Fig 4 [0065], distal end of tubing 163 is affixed to distal end of spine 102 via mounting portion 166-1). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Tobey in view of Tegg and Pappone to incorporate second and third irrigation tubes with a central irrigation port extending parallel to the spine segments with distal ends of each irrigation tube affixed to one of the loop members as claimed to arrive at claims 7-8. Doing so would be obvious to one of ordinary skill in the art as the use of a plurality of irrigation tubes with central ports therein is well-known in the art to yield the predictable results of providing irrigation fluid in a more uniform manner across the length and width of the end effector of the catheter (Pappone [0062]; Tegg [0042]).
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobey in view of Potter (U.S. PGPub No. 2014/0200441).
Regarding claim 11, Tobey teaches the device of claim 1 as stated above.
Tobey fails to teach a first plurality of irrigation holes on a proximal portion of the irrigation tube each comprising a first diameter; and a second plurality of irrigation holes on a distal portion the irrigation tube distal to the proximal portion each comprising a second diameter greater than the first diameter.
In related prior art, Tegg a first plurality of irrigation holes on a proximal portion of the irrigation tube each comprising a first diameter (Fig 2b, port 34b having first diameter); and a second plurality of irrigation holes on a distal portion the irrigation tube distal to the proximal portion each comprising a second diameter (Fig 3b ports 34’a are distal ports having a second diameter). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation tube of Tobey in view of Tegg to incorporate the irrigation tube of Tegg comprising a plurality of pores including central, distal, and proximal ports. Doing so would advantageously provide irrigation fluid delivery at various positions of the end effector and electrode array to ensure adequate coverage of fluid over the end effector ([0042]).
Tobey/Tegg fail to teach wherein the second diameter is greater than the first diameter.
In related prior art, Potter teaches an irrigation tubing comprising a first plurality of irrigation holes on a proximal portion of the irrigation tube each comprising a first diameter (Figs 27-28, proximal ports have first diameter on a proximal portion of the irrigation tubing); and a second plurality of irrigation holes on a distal portion the irrigation tube distal to the proximal portion each comprising a second diameter greater than the first diameter (Fis 27-28, distal ports have larger diameter than proximal ports on a distal part of the irrigation tubing). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the irrigation tube of Tobey in view of Tegg and Potter to incorporate the proximal and distal irrigation ports respectively of different diameters to arrive at the device of claim 11. Doing so would be obvious to one of ordinary skill in the art as the use of a plurality of irrigation holes with varying sizes is well-known in the art to yield predictable results therein ([0089] disclosing sideholes can vary in size).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Tobey in view of Wu (U.S. PGPub No. 2018/0303361).
Regarding claim 12, Tobey teaches the device of claim 1 as stated above.
Tobey fails to teach the electrodes each comprising a predetermined porosity to allow for irrigation fluid to flow out of each electrode.
In related prior art, Wu teaches a similar device wherein each electrode comprises a predetermined porosity to allow for irrigation fluid to flow out of each electrode (Fig 6, irrigated ring electrodes 371 with fluid ports 85 define porosity). Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the ring electrodes of Tobey in view of Wu to incorporate irrigation tubing supplying irrigation fluid to porous ring electrodes to arrive at the device of claim 12. Doing so would advantageously enable an electrode to provide irrigation fluid directly to a treatment site to prevent overheating during ablation (Fig 6 of Wu).
Response to Arguments
Applicant’s arguments, see remarks, filed 01/05/2026, with respect to the rejection(s) of claim(s) 1-8 and 11-12 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of the Tobey reference.
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794