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 . Claims 1-3, 5, and 8-19 are currently pending. The previous objections to the claims have been withdrawn due to the Applicant’s amendments to the claims.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 01/06/2026 has been entered.
Response to Arguments
Applicant's arguments filed 01/06/2026 have been fully considered but they are not persuasive. The Applicant argues that the OCU arrangement is not taught by the prior art of record however is silent as to how. All that appears to be mentioned is that the electrode pairs of Basu are not in fact in an OCU configuration. There is no detail provided on how the Applicant’s electrode configuration is physically any different from the one shown in Basu. Any electrode is fully capable of being utilized for pacing, sensing, stimulating, electroporation, as well as bi/mono/uni polar sensing; the physical electrode structure is identical in every way. These various sensing/stimulation types are not controlled by the electrodes themselves but rather the processor or generator they are electrically connected to. At present all that is required of claim 1 with respect to the OCU electrode arrangement is that there are at least three electrodes in an orthogonal orientation, the “close unipolar” portion of that limitation is simply functional language.
Claim Rejections - 35 USC § 102
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-2, 5, 8, 10, 12-14 and 16-19 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Basu et al. US Publication 2021/0077183 (hereinafter Basu).
Regarding claims 1 and 5, Basu discloses a cardiac mapping catheter (Figure 2B) comprising: an electrode array (Figure 2B at electrodes 230, 232, 234), a flexible support frame made of shape memory metal and a deformable surface (frame at 250, where 250 is made of nitinol as per [0054], with deformable surface 252, 254), wherein upon deployment from a sheath the electrode array conforms to a shape of a tissue to lie substantially flat when deployed against the tissue ([0040]).
Basu further details that the electrode array comprises electrode pairs (any combination of electrodes 230, 232, 234 as per Figures 2B-3) in an orthogonal close unipolar arrangement on the deformable surface (Figures 2B-3, 5 which shows the electrodes oriented at orthogonal locations in a “close” arrangement, they type of sensing has no bearing on the arrangement itself including mono/uni/bi polar sensing). It should be noted that three electrodes in an “L” configuration would meet the Applicant’s OCU electrode arrangement, which Basu also shows in Figure 2B.
Regarding claim 2, Basu discloses that the deformable surface is a flexible membrane ([0055][-[0056]).
Regarding claim 8, Basu further comprises a plurality of tines where the electrode pairs of the electrode array are position on each of a first side and second side of the tines (central layer 250 can be made of nitinol strips as per [0054] which are considered tines, and electrodes 232 and 234 are on different sides of the membrane as well as central layers 250 which again can be tines).
Regarding claim 10, Basu discloses that the single electrodes are substantially shaped as a thin disc (Figure 3 shows the electrodes 230, 232 in disc form) and mentions that a protrusion extending beyond the electrode 234 can be at a height of 20 microns to 2mm to prevent direct contact of the electrode to skin suggesting that at a minimum the height of the electrode must be shorter than the 20microns, and with the sizing in Figure 5 showing the electrodes are of a comparable height, the skilled artisan would have reasonably assumed that the height of the electrodes 232 and 230 were of the same claimed sizing range. Additionally, there appears to be no criticality for the claimed range, nor what is specifically encompassed by “about”. The courts have held that where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device.
Regarding claim 12, Basu discloses that the electrode array comprises a plurality of openings configured to allow fluid to pass through the electrode array (210 which details it can include a mesh to allow fluid to pass through, see [0067]).
Regarding claims 13-14, Basu discloses that 9the deformable surface is substantially s-shaped when furled within the sheath (given the shape and material being the same as claimed, the device shown in Figure 2A is fully capable of being furled into a sheath in an S-shape without any additional structural modifications).
Regarding claim 16, Basu discloses that the electrode array comprises an array of single electrodes (electrodes 230, 232) where pacing is considered intended use and the electrodes 230, 232, 234 are fully capable of pacing without any additional structural modification.
Regarding claim 17, Basu discloses that the flexible support frame is connected to either side of the deformable surface (250 can include a grid, or a solid layer extending fully between the deformable surface as per [0054], in either instance the support frame would be on both a “left” and “right” side of the overall device where the deformable surface 252, 254 extend across) .
Regarding claim 18, Basu discloses that the flexible support frame is retained within the deformable surface (250 is within the deformable surface including layers 252 and 254, see Figure 5).
Regarding claim 19, Basu discloses that each electrode pair comprises a first electrode in contact with the tissue and a second electrode separated from the first electrode (all of the electrodes are spaced as per Figures 2B-3, and as per Figure 5 the electrodes protrude to an extent and are capable of contacting tissue).
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim 3 is rejected under 35 U.S.C. 103 as being unpatentable over Basu.
Regarding claim 3, Basu discloses that the flexible membrane comprises a first layer having a first durometer number ([0055] at 252), and a second layer ([0055] at 254), but does not detail the material inherently having to be different with a different durometer. Basu however does mention that the first layer 252 can be polyimide as an example and that the second layer 242 can be made of polyester or polyether ketone which includes a different durometer.
Given that Basu does not explicitly mention that the materials can be different or the same, it would have simply been obvious to the skilled artisan before the effective filing date to try various combinations of the disclosed materials to achieve the desired flexibility/stiffness with the finite number of combinations available yielding predictable results (having a substrate that is flexible enough for implantation and tissue conformity). The options listed are what the skilled artisan is reasonably choosing from, not every material ever created by humanity (if the material listed was accurate it should be noted that in order for the layers to serve as intended they would need to be flexible, deformable, elastic/stretchable, biocompatible, and insulative in nature or they could not function as intended. The skilled artisan is simply choosing from the listed options explicitly disclosed for either of layers 252 and 254, and given they include different durometers associated with each of those materials, the limitation is considered met.
In the alternate, claim 3 is additionally rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Roger et al. US Publication 2011/0230747 (hereinafter Rogers).
Regarding claim 3, Basu discloses that the flexible membrane comprises a first layer having a first durometer number ([0055] at 252), and a second layer ([0055] at 254), but does not detail the material inherently having to be different with a different durometer. Basu however does mention that the first layer 252 can be polyimide as an example and that the second layer 242 can be made of polyester or polyether ketone which includes a different durometer.
Rogers teaches a planar implantable medical device that includes an electrode array (108) with a deformable surface made of two layers (104, 402) which can include two different durometers with one being smaller than the other ([0040] details that the two layers may include one of several finite options and any combination thereof of the materials listed). It would have been obvious to the skilled artisan before the effective filing date to utilize the material choice of the two layers of Roger with the two layers of Basu in order to afford various desired properties depending on the desired outcome (see Rogers et al. US Publication 2013/0041235 serving as a teaching reference as per [0046] which details that multiple layers can be utilized for various properties such as one for strength and mechanical stability while another may be better suited for waterproofing, these materials would inherently be different and come with an inherently different durometer).
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Rapoport et al. US Publication 2021/02113279 (hereinafter Rapaport).
Regarding claim 9, Basu teaches that the electrode 234 can include a secondary structure to help electrically isolate it such as well 270 in Figure 6 which can include a height of 20microns to 2mm, and as the electrode is placed on top of the layer 216, the skilled artisan would have concluded that the electrode height must be smaller than it to some extent (from a few microns to 1mm to fit within the range of the wall’s heigh in [0064]). Rappaport however does not explicitly device close the range. is silent on the exact electrode sizing. Rapaport discloses that the single electrodes have a thickness of about 25microns (0083] which includes a range of 5-500 microns). Therefore, it would have been obvious to the skilled artisan before the effective filing date to optimize the electrode sizing as taught by Rapaport with the electrodes of Basu as predictable results would have ensued (affording contact sensing without causing damage to surrounding tissue).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Highsmith US Publication 2021/0059745 (hereinafter Highsmith).
Regarding claim 11, Basu discloses that the electrodes are comprised of gold ([0056]) then coated with iridium oxide ([0058]), however are silent on the use of copper. Highsmith teaches a planar electrode array (Figure 4) that includes copper traces with an insulating coating ([0029][0031]) with gold electrodes plated with Iridium Oxide ([0044]). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the copper traces and insulation as taught by Highsmith with the device of Basu in order to greatly decrease the cost of the conductors/traces to the electrodes without reducing the overall conductivity. Plating is considered a product by process limitation, see MPEP 2113, where only the final product needs to be disclosed in the prior art, in this case the limitation is being read that gold must be in direct contact with the copper traces.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Basu in view of Olson et al. US Publication 2018/0116539 (hereinafter Olson).
Regarding claim 15, Basu discloses the deformable surface as mentioned above, with position sensors on both sides of the deformable surface (sensors 290 on the left and right sides of 212, see Figure 3), but is silent on the sensors specifically being magnetic sensors as they are wire coils that technically are electric in nature though they respond to electromagnetic fields. Olson teaches an electrode array that includes a flat deformable surface (Figure 1A) that includes two or more magnetic tracking sensors on opposing sides of the deformable surface ([0054] which mentions that multiple magnetic sensors 116 can be utilized within/along the individual tines 103 where side is being considered on a left/right basis). Therefore, it would have been obvious to the skilled artisan before the effective filing date to utilize the magnetic sensors as taught by Olson in lieu of the electric position sensors of Basu as predictable results would have ensued (position tracking of the device during deployment).
Conclusion
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/BRIAN M ANTISKAY/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794