DETAILED ACTION
Applicant’s response, filed December 8, 2025, is fully acknowledged by the Examiner. Currently, claims 1-20 are pending. The following is a complete response to the December 8, 2025 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 .
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 (i.e., changing from AIA to pre-AIA ) 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.
Election/Restrictions
Applicant’s election without traverse of Group II, Claims 6-16 in the reply filed on December 8, 2025 is acknowledged. Claims 1-5 and 17-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a respective one of nonelected groups I and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on December 8, 2025.
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.
Claim 10 is 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.
Regarding claim 10, the claim recites the limitation "the discrete spine member" therein. There is insufficient antecedent basis for this limitation in the claim. Specifically, each of parent claims 6 and 7 only provide for “the plurality of discrete spine members” and “the discrete spine members”. As such, the lack of antecedent basis renders the scope of claim 10 as indefinite because it is unclear which of the plurality of discrete spine members the at-issue limitation in claim 10 is referring to. Appropriate correction is required.
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.
Claims 6, 7 and 9-11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Basu et al. (US Pat. Pub. 2021/0121231 A1).
Regarding claim 6, Basu provides for a medical probe (see the probe as in figure 2B) comprising 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) 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 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), and 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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Regarding claim 7, Basu provides that the discrete spine members further comprising a straight portion between the distal bend and a second spine end of the respective discrete spine member, the straight portion positioned in the substantially cylindrical structure (see figure 10 and the annotated version of figure 10 where each element 310 has 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).
Regarding claim 9, Basu provides that the substantially cylindrical structure formed from the plurality of discrete spine members aligning each straight portion of a respective spine member proximate the straight portion of a neighboring spine member (see figures 10 and 11 with each straight portion as defined in the rejection of claim 7 above to be 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).
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) as applied to claim 7 above, and further in view of Whayne et al. (US Pat. No. 6,120,496).
Regarding claim 8, Basu, while providing for the straight portion as in the rejection of claim 7 above that extends to a degree within the cylindrical structure, fails to specifically provide that the first spine end of each spine member meets the second spine end of the spine member when the substantially cylindrical structure is in an expanded configuration. 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 for a discrete spine member to meet a second spine end of the spine member when its structure is in an expanded configured (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). 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).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Basu et al. (US Pat. Pub. 2021/0121231 A1) 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. Govari disclose a similar probe as that of Basu that includes a plurality of discrete spine members (splines 52) wherein one ore 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 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 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).
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