DETAILED ACTION
This action is pursuant to the claims filed on 11/07/2024. Claims 1-20 are pending. A first action on the merits of claims 1-20 is as follows.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 08/20/2026, 05/13/2026, 12/18/2025, 08/04/2025, 11/22/2024, 11/07/2024 are 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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3, 5, and 18 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites the limitation "a sixth leg", “a seventh leg”, “an eight leg”, “a ninth leg”. However, the scope of claim 3 fails to recite any of legs one through five such that the scope of this claim is indefinite. The recitation of a sixth through ninth leg makes it unclear if the claim requires nine total legs or just four legs that are arbitrarily labeled a sixth through ninth leg.
Claim 5 recites “a tenth leg”, “an eleventh leg”, “a twelfth leg”, “a thirteenth leg”. However, the scope of claim 3 fails to recite any of legs one through nine such that the scope of this claim is indefinite. The recitation of a tenth through thirteenth leg makes it unclear if the claim requires thirteen total legs or just four legs that are arbitrarily labeled as tenth through thirteenth legs.
Claim 18 recites “a plurality of electrodes disposed on the flexible circuit”. It is unclear if this recitation is further limiting of “a plurality of generally planar electrodes” of claim 1 or if this is reciting a second and distinct plurality of electrodes from claim 1.
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) 19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Subramaniam (U.S. PGPub. No. 2015/0105645).
Regarding claim 19, Subramaniam teaches An end effector for a catheter, the end effector comprising: an insulative material; a framework disposed in the insulative material, the framework being substantially planar along a longitudinal axis (Fig 2 splines 26 with insulative polymer backing 52 [0032]); and location sensing loops disposed generally parallel to the framework and separated from the framework by the insulative material ([0036] and Fig 2 electrodes 28 on splines separated from splines by insulation define “location sensing loops” disposed parallel to the splines), the location sensing loops comprising: a center loop extending along the longitudinal axis and comprising a cumulative center loop surface area (Fig 2, center loop interpreted as electrodes 28 on innermost splines 26 defining a center loop with a cumulative surface area); a first side loop extending along the longitudinal axis and comprising a first cumulative side loop surface area (Fig 2, first side loop interpreted as electrodes 28 on middle splines forming a loop with a surface area; said loop interpreted as a “side” loop given it is to the side of the center loop); and a second side loop extending along the longitudinal axis and comprising a cumulative second side loop surface area (Fig 2, second side loop interpreted as electrodes 28 on outer splines forming a loop with a surface area; said loop interpreted as a “side” loop given it is to the side of the center loop), the cumulative center loop surface area, the cumulative first side loop surface area, and the cumulative second side loop surface area each being within a range of about one-hundred to about three-hundred millimeters squared ([0030] planar assembly has length of approximately 20 to 40 mm an dan expanded width of approximately 10 to 25 mm yielding a surface area range of 200 mm2 to 1000 mm2).
Subramaniam fails to explicitly teach the surface area of each loop is within a range of about one hundred to three-hundred millimeters squared.
It would have been obvious to one having ordinary skill in the art at before the effective filing date of the claimed invention to provide the surface area of each loop to be within 100 to 300 mm2, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). One would have done so to provide an appropriate dimension of the generally planar electrode assembly 24 for cardiac mapping as claimed as para. [0030] of Subramaniam contemplates providing narrower or wider widths as well as longer or short lengths to be used as needed for the assembly.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Subramaniam (U.S. PGPub. No. 2015/0105645) in view of Basu (U.S. PGPub No. 2021/0077183).
Regarding claim 20, in view of the combination of claim 19 above.
Subramaniam fails to teach the center loop comprising one or more center loop coils, each center loop coil defining a center loop surface area, the first side loop comprising one or more first side loop coils, each first side loop coil defining a first side loop surface area, and the second side loop comprising one or more second side loop coils, and each second side loop coil defining a second side loop surface area, wherein the cumulative center loop surface area comprises a sum of the center loop surface areas of the one or more center loop coils, the cumulative first side loop surface area comprises a sum of the first side loop surface areas of the one or more first side loop coils, and the cumulative second side loop surface area comprises a sum of the second side loop surface areas of the one or more second side loop coils.
In related prior art, Basu teaches a similar planar end effector comprising a plurality of coils for position sensing (Fig 3 [0059-0060] set of position sensors each of which comprise three orthogonal coils). 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 center, first side, and second side loops of Subramaniam in view of Basu to incorporate one or more coils on each loop of Subramaniam such that each coil of each corresponding loop defines a part of the cumulative surface area of each loop as claimed to arrive at claim 20. Providing each loop with corresponding one or more coils of Basu would advantageously outfit the device of Subramaniam with position sensors to determine precise positions of each loop with electromagnetic position sensing as is known in the art ([0059-0060]).
Allowable Subject Matter
Claims 1-2, 4, and 6-17 are allowed.
Claims 3, 5, and 18 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: Regarding claims 1-18, the Subramaniam, Basu, Selkee (U.S. PGPub No. 2020/0345262), Sterrett (U.S. Patent No. 10,595,738), and Spector (U.S. PGPub No. 2023/0190166) references fail to teach a substantially planar framework having a first and second opposing surfaces; a plurality of generally planar electrodes aligned along each of the first planar surface and second planar surface such that each electrode is spaced apart from the first planar surface or the second planar surface; and location sensing loops spaced apart from the framework and coupled to the insulative material, the location sensing loops comprising: a center loop disposed over the longitudinal axis over an area near a distal portion of the insulative material; and a pair of side loops disposed generally symmetrical about the longitudinal axis, each side loop extending from a proximal portion to a distal portion of the insulative material along the longitudinal axis. While the Subramaniam reference discloses a generally planar end effector with electrodes thereon, this reference fails to disclose the electrodes on each of the opposing first and second surfaces as well as the location sensing loops spaced apart from the framework as claimed. The Spector reference teaches a similar planar configuration with electrodes on both sides ([0013]) as well as “location sensing loops” as magnetic coils 123 within the insulative material, however Spector fails to disclose a location sensing center loop disposed over the longitudinal axis area and the pair of side loops being generally symmetrical about the longitudinal axis extending from a proximal portion to a distal portion of the insulative material as claimed. The Sterrett reference is similar to Spector as it discloses a similar planar configuration with planar electrodes on opposing sides (see Fig 19D) but similarly fails to explicitly teach the location sensing loops as claimed that are distinct from the electrodes. The Basu and Selkee references disclose similar configurations but fail to cure the above noted deficiencies such that there would be no reason or motivation by one of ordinary skill in the art to modify or combine any of the references of record to arrive at the claimed invention. Any such combination would necessarily rely on impermissible hindsight benefit using information solely gleaned from the applicant’s specification. No other pertinent prior art reference were found that would overcome the above deficiencies. Therefore, there is no motivation (either in these references or elsewhere in the art) for making such specific and significant modifications thereto to arrive at claim(s) 1-18
Conclusion
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/ADAM Z MINCHELLA/Primary Examiner, Art Unit 3794
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