Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Applicant’s amendments and comments, received January 12, 2026, have been fully considered by the examiner. It is noted that claims 26-28 remain withdrawn from consideration. The following is a complete response to the January 12, 2026 communication.
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 30 and 32 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 30 lacks proper antecedent basis for “the ablation pattern” and for “the longitudinal axis of the bladder”. Claim 30 depends from claim 22 which fails to recite an “ablation pattern”. It is noted that claim 24 recites “a predetermined pattern of one or more ablation lines”.
Newly filed claim 32 also lacks proper antecedent basis for “the longitudinal axis of the bladder”. Further, it is noted that referencing a body part (i.e. the bladder) in relation to a device is generally unclear as the body cannot be part of a claimed invention. It is suggested language such as “the ablation pattern is configured to be tilted with respect to a longitudinal axis of the bladder” be used to avoid the positive recitation of the body.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
Claim 22-25 and 29-32 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Ingle et al (2010/0049186) in view of the teaching of Gelbart et al (2008/0004534).
Regarding claim 22, Ingle et al provide a device for treating the urinary bladder (Abstract, for example) comprising a catheter shaft (44 – Figure 6) and a treatment element comprising at least one elongate longitudinal conductor and at least one latitudinal conductor (Figure 7). Ingle et al provide an expandable member (balloon 56) with electrodes thereon in one embodiment, but don’t expressly provide a balloon for the expandable member (58) of Figure 7. Ingle et al also fail to expressly disclose that the latitudinal conductors, when collapsed, are substantially parallel to the longitudinal conductors. The examiner maintains that based on applicant’s response of May 12, 2025 at page 3 which states “this transition in conductor orientation is a natural and necessary geometric consequence of mounting a flexible latitudinal conductor on an expandable member designed to change from a collapsed, shaft-aligned configuration to an expanded, dome-like configuration”, that the Ingle et al expandable conductor device would exhibit the same geometric consequence.
Regarding the use of an expandable member, the examiner maintains that one of ordinary skill in the art would recognize the expandable member of Figure 7 of Ingle et al could be deployed using a balloon. To further support such an assertion, attention is directed to the Gelbart et al device which provides a similar expandable device having longitudinal and latitudinal members (Figure 3B, for example). Gelbart et al show in Figure 3A that the latitudinal and longitudinal members are substantially parallel in the collapsed condition (Figure 3A), and Gelbart et al specifically state the device may be self-expanding (i.e. similar to the Ingle et al Figure 7 embodiment), or may be expanded with the assistance of a balloon (para. [0036], for example).
To have provided the Ingle et al device, as shown in the embodiment of Figure 7, with an expandable balloon to assist in expanding the conductors to the deployed state to treat tissue would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Gelbart et al fairly teach it is known to provide such a structure either as self-expanding, or as being expandable with a balloon. The parallel orientation of the latitudinal and longitudinal members is deemed to be an obvious, natural occurrence upon collapsing the device given the reasoning of applicant’s arguments as addressed above, and the depiction shown by Gelbart et al.
Regarding claim 23, the longitudinal conductors of both Ingle et al (Figure 7) and Gelbart et al (Figure 3) are substantially parallel to the longitudinal axis of the catheter shaft. Regarding claims 24 and 25, both Ingle et al and Gelbart et al disclose creating a predetermined pattern of ablation lines to treat tissue which would have the same claimed effects. Regarding claim 29, the elongate conductor of Ingle et al is configured to ablate the inner wall of the urinary bladder as claimed, and the Gelbart et al conductors would also be capable of such an intended use (although it is disclosed as being used to treat cardiac tissue). Regarding claim 30, see Figure 7 which shows part of the ablation conductors having a tilt angle (i.e. proximal portion of the conductors). Also, the examiner maintains the basket structure of Ingle et al may create lesions on a variety of surfaces, including the back wall of the bladder. Creation of lesions on the back wall of the bladder would create an ablation pattern that is tilted approximately 90 degrees relative to the bladder. As addressed in the above 35 USC 112, 2nd paragraph rejection, defining the ablation pattern relative to the bladder (i.e. the human body) is unclear since the human body cannot directly form a claim limitation and must be inferentially recited.
Regarding claim 31, Ingle et al provide a catheter shaft, and an elongate conductor structure having latitudinal and longitudinal conductors as addressed previously with respect to claim 22. Gelbart et al provides the teaching of providing an expandable member to expand the conductors as addressed above. The same rationale for combining these teachings remains. The examiner maintains the curved nature of the Ingle et al expanded conductors (Figure 7) would enable the ablation device to avoid certain areas. Moreover, Ingle et al specifically teach that certain areas of the conductors may be provided with a shield (i.e. masked off) to avoid heating certain areas (para. [0128]). Further, Gelbart et al provide a teaching of activating select conductors to create a desired ablation pattern in tissue.
Regarding claim 32, the examiner again maintains the basket structure of Ingle et al may create lesions on a variety of surfaces, including the back wall of the bladder. Creation of lesions on the back wall of the bladder would create an ablation pattern that is tilted approximately 90 degrees relative to the bladder. As addressed in the above 35 USC 112, 2nd paragraph rejection, defining the ablation pattern relative to the bladder (i.e. the human body) is unclear since the human body cannot directly form a claim limitation and must be inferentially recited.
Response to Arguments
Applicant's arguments filed January 12, 2026 have been fully considered but they are not persuasive.
Applicant asserts there is no reason to combine the two structurally different embodiments of Figures 6 and 7 of the Ingle et al reference. The examiner maintains no such combination was ever suggested (and is not suggested) in the rejection. The examiner merely indicated that Ingle et al provided an embodiment that included a balloon, but made no statements that it would have been obvious to combine those embodiments. That mention of Figure 6 was simply to show that Ingle et al contemplated the use of balloons. The Gelbart et al reference was specifically recited for its teaching of an expandable structure that could either be self expanding (as the Figure 7 embodiment of Ingle et al is self-expanding), or may utilize a balloon to assist in expanding the mesh structure that has the electrodes.
Regarding the Gelbart et al reference, applicant asserts that the examiner’s rationale is incomplete. The examiner disagrees. There is no requirement that the references used in a rejection must somehow point out “deficiencies” in the prior art. Rather, the examiner must provide proper motivation to combine the teachings of the reference. Ingle et al provides a self-expanding structure having electrodes to treat tissue. Gelbart et al also provides an expandable device whereby the expandable structure has electrodes to treat tissue. In particular, Gelbart et al teach the expandable structure may be self-expanding through the use of shape-memory material, which is similar to the structure provided by Ingle et al. Additionally, Gelbart et al teach that as an alternative to a self-expanding mesh, the device may be provided with a balloon structure to assist in expanding the mesh structure when deployed into tissue. Hence, Gelbart et al provide the relevant teaching that it is known to provide an expandable structure that is self-expanding (or “unfurling”), or expandable with the assistance of a balloon. As such, the examiner maintains that Gelbart et al clearly teach it is known to provide expandable structures either as “self-expanding” (or unfurling), or expanded with a balloon. There are numerous catheters in the prior art that expand a basket or mesh structure with a balloon, and the examiner maintains that the Gelbart et al teaching is sufficient to suggest to one of ordinary skill in the art that the Ingle et al device of Figure 7 may be modified to be expanded with a balloon.
Regarding claims 30 and 32, these claims are deemed to have 35 USC 112, 2nd paragraph issues as addressed above. Reciting that the ablation pattern may be tilted is merely suggestive of the location of the ablation pattern, and is not limited by any structural limitations associated with the claimed invention. The examiner maintains the Ingle et al device may clearly be used to create patterned ablation lesions on, for example, the back wall of the bladder which would incur an angle with respect to the longitudinal axis of the bladder. Moreover, there is no clear definition of what constitutes “the longitudinal axis of the bladder”, and given that the bladder is somewhat spherical, that phrase is not specifically clear.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL PEFFLEY whose telephone number is (571)272-4770. The examiner can normally be reached Mon-Fri 8 am-5 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Linda Dvorak can be reached at (571) 272-4764. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/March 13, 2026