DETAILED ACTION
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 September 15, 2026 has been entered.
Currently, claims 6, 9-16, 21 and 22 are pending with clams 21 and 22 newly added, claims 1-5, 7, 8 and 17-20 cancelled, and claims 6 and 9 amended. Applicant’s amendments claim 6 have obviated the previously-filed Drawing objections as well as the prior rejection under 35 U.S.C. 112(a). The following is a complete response to the September 15, 2026 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 .
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 6, 9-11, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) further in view of Whayne et al. (US Pat. No. 6,120,496).
Regarding claim 6, Basu provides for a medical probe (see the probe as in figure 2B) comprising:
a tubular member (body 12), and
a substantially cylindrical structure (see the structure of end effector 200 as in figures 10-11 with figure 11 showing the plurality of elements 310 to define a substantially cylindrical shape) further comprising a plurality of discrete spine members (each of 310) comprising: a distal bend, a middle portion, and a first spine end (see the annotated figure 10 below indicating the location of each feature on each element 310).
Basu further provides that the plurality of discrete spine members are arranged together at a distal end of the substantially cylindrical structure at each respective distal bend (see figure 10 with the element 310 arranged together at the distal end of the structure at the indicated distal end locations) and at a proximal end of the substantially cylindrical structure at each respective first spine end (see figure 10 with the element 310 arranged together at the proximal end of the structure at the indicated first spine end locations), the discrete spine members further comprising a substantially straight portion between the distal bend and a second spine end of the respective discrete spine member, the substantially straight portion positioned in the substantially cylindrical structure (see figure 10 where each element 310 having an extension extending proximally from the distal bend and within the cylindrical structure; similar structure can also be seen in the element 210 in figure 5 at 214),
each respective middle portion curving axially from a longitudinal axis to form an outer surface of the substantially cylindrical structure (via the axial curving of each 310 as shown in figures 10 and 11 away from the axis defined through the catheter 120).
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Basu further provides for a first section extending distally from the first spine end (in view of the annotated figure 10 above, a first section is taken as the portion extending from the proximal most portion of the element 310 to the location of 310 noted as the distal bend) and a proximal portion of the substantially straight portion extending distally from the second spine end of each spine member (the portion of the identified straight portion extending distally from its end to the location at the noted distal bend), the first section and the proximal portion of each spine member overlapping with one another along the longitudinal axis when the substantially cylindrical structure is in an expanded configuration (as shown in figure 10 with the overlap between the two).
While Basu provides for the structures of the first section and the proximal portion, Basu fails to specifically provide that each respective first spine end and second spine end are physically connected to a distal end of the tubular member at a proximal end of the substantially cylindrical structure given that the second spine end would be spaced distally from the tubular member. Whayne discloses a similar probe structure as that of Basu including a plurality of differing arrangements for the discrete spine members (see, for example, individual spines at 20(1) as in figure 9, bifurcated spines as in figure 39A, and individual spines in figure 55). Whayne further provides for a first spine end and a second spine end to be physically connected to the distal end of a tubular member (see figure 55 with each spine L1/2/3/4 having a first spine end formed by the outer portion of the looped spine at its proximal end near 26 and having a second spine end formed by the inner portion of the looped spine at its proximal end near 26 with such being physically connected the body 12).
Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized the alternative construction for the straight portion of each discrete spine member of Basu in view of the teaching of Whayne to provide for an alternative manner for attaching each spine member to the distal end of the shaft of the device. Whayne provides that such an arrangement allows for each spine member to be individually controllable thereby allowing the use to provide for a desired shape of the structure in the expanded shape (see col. 26; 21-31).
Regarding claim 9, in view of the combination of Basu and Whayne above, the combined arrangement further provides that the substantially cylindrical structure formed from the plurality of discrete spine members aligning each substantially straight portion of a respective spine member proximate the substantially straight portion of a neighboring spine member (see figures 10 and 11 of Basu with each straight portion being aligned near one another by virtue of each of 310 being near one another when forming the cylindrical structure).
Regarding claim 10, Basu provides that the discrete spine member further comprises a bifurcated portion between the first spine end and the second spine end (see figures 10 and 11 with each of 310 having a point where the arms form a fork of two sub spine members).
Regarding claim 11, Basu provides that the first spine end of each respective discrete spine member converging into a proximal ring at the proximal end of the substantially cylindrical structure (see the first spine ends as defined in the annotated version of figure 10 above converging into a ring shaped structure at 340 as in figure 10).
Regarding claim 21, in view of the combination with Whayne above, the Examiner is of the position that the resultant structure would provide for the proximal portion of each spine member per the arrangement with Whayne would be generally parallel to the first section of the spine member (given that the straight proximal portion would extend generally parallel to at least the portion of the first section extending from the first spine end to the bend near the reference character 321).
Regarding claim 22, in view of the combination with Whayne above, the Examiner is of the position that the first spine end of each discrete spine member would meet the second spine end of the discrete spine member when the substantially cylindrical structure is in an expanded configuration (via the first and second spine ends above meeting at the point of the physical connection when the structure of the end effector 200 is in an expanded configuration).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) in view of Whayne et al. (US Pat. No. 6,120,496) as applied to claim 6 above, and further in view of Govari et al. (US Pat. Pub. 2018/0160936 A1).
Regarding claim 12, Basu provides for one or more location coils (see [0045] with the position sensor 127) but fails to provide that such is location on one or more the plurality of discrete spine member. Whayne fails to cure this deficiency. Govari disclose a similar probe as that of Basu that includes a plurality of discrete spine members (splines 52) wherein one or more location coils are included one at least one of the spine members (see at least one coil 62 on each spline 52). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized at least one location coil on at least one of the spine members 310 of Basu in view of the teaching of Govari. Govari readily provides that the use of the location coils on the spine members provides the user the ability to actually determine the location of each spine relative to the tissue such that mapping and treatment locations can be accurately determined and tracked during a procedure (See at least [0035] of Govari).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) in view of Whayne et al. (US Pat. No. 6,120,496) and Govari et al. (US Pat. Pub. 2018/0160936 A1) as applied to claim 12 above, and further in view of Willard et al. (US Pat. Pub. 2015/0018818 A1).
Regarding claim 13, neither Basu nor Whayne nor Govari provides that the substantially cylindrical structure further comprising a membrane positioned over the plurality of discrete spine members, the membrane comprising one or more electrodes coupled to an external surface of the membrane. Willard discloses a similar probe structure as that of Basu and specifically contemplates a substantially cylindrical structure (structure at 100, see figures 2A-2D) wherein the cylindrical structure further comprises a membrane positioned over the plurality of discrete spine members (130 as in figures 2C and 2D), the membrane comprising one or more electrodes coupled to an external surface of the membrane (see [0036] providing for “one or more electrode assemblies 124a, 124b may be positioned on a surface of an outer cover 130” as in figure 2C). Therefore, it is the Examiner’s position that it would have been obvious to one of ordinary skill in the art at the time of filing to have utilized a membrane over the cylindrical member of Basu in view of the teaching of Willard to provide for a combined probe with a membrane-mounted electrodes covering the cylindrical structure. Willard provides that such a membrane provides for the control of fluid perfusion past/through the cylindrical structure when treatment is being performed (see [0053] of Willard) thereby providing for a desired control over the energy application to tissue as well as the cooling of the tissue at the tissue site.
Regarding claim 14, in view of the combination with Willard above, the membrane per Willard further comprises one or more apertures to allow fluid communication from an internal volume to ambient environment (see [0053] with the plurality of holes contemplated in 130).
Regarding claim 15, in view of the combination with Willard above, the membrane further comprises one or more conductive traces disposed on a surface of the membrane each electrical trace being connected to a respective electrode of the one or more electrodes (see [0037] providing for the traces to traced inside … the outer cover 130”, see also [0051] disclosing that the traces are sandwiched between 122 and 130). The combination with Willard fails to explicitly recite that the traces extend between the one or more apertures. However, the Examiner is of the position that the location which the traces run from the proximal end of the membrane to the electrodes would be a mere matter of design choice where the location of the conductive traces would have a known number of options, each with a reasonable expectation of success when utilized. Further, the Examiner notes that the locating of the traces between the holes would have further been a matter of design choice by one of ordinary skill since it has been held that rearranging parts of an invention involves only routine skill in the art. see In re Japikse, 86 USPQ 70.
Regarding claim 16, in view of the combination with Willard above, the membrane of the combination further comprises one or more reference electrodes coupled to an internal surface of the membrane (another of 124a/b coupled to an internal surface of 130).
Response to Arguments
Applicant’s arguments, see pages 5-8 of the Remarks filed September 15, 2026 with respect to the prior rejection of claim 6 under 35 U.S.C. 112(a) for failing to comply with the written description requirement have been fully considered and are persuasive. Specifically, Applicant’s arguments with respect to the amended claim language set forth in claim 6 has addressed the prior issues noted by the Examiner in the June 18, 2026 Final Office Action Therefore, the rejection has been withdrawn. The Examiner notes that substantially the same rationale is equally applicable to the prior filed objection to the drawings
The Examiner notes that the following new grounds of rejection have been set forth in the action above:
Claims 6, 9-11, 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) further in view of Whayne et al. (US Pat. No. 6,120,496).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) in view of Whayne et al. (US Pat. No. 6,120,496) as applied to claim 6 above, and further in view of Govari et al. (US Pat. Pub. 2018/0160936 A1).
Claims 13-16 are rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) in view of Whayne et al. (US Pat. No. 6,120,496) and Govari et al. (US Pat. Pub. 2018/0160936 A1) as applied to claim 12 above, and further in view of Willard et al. (US Pat. Pub. 2015/0018818 A1).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RONALD HUPCZEY, JR whose telephone number is (571)270-5534. The examiner can normally be reached Monday - Friday; 8 am - 4 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Ronald Hupczey, Jr./Primary Examiner, Art Unit 3794
