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 December 15, 2025, have been fully considered by the examiner. The following is a complete response to the November 21, 2024 communication.
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 negatived by the manner in which the invention was made.
Claims 1-5 and 7-21 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sachs et al (‘798) in view of the teaching of Gelbart et al (2009/0131930).
Regarding claim 1, Sachs et al provide a device for treating a disorder in a hollow bodily organ comprising a shaft (151) advanceable through a body channel to reach a cavity of an organ (Figure 21, for example). The device includes an ablation member (153) that may be collapsed for advancement into the body then expanded (Figure 23) to create a predetermined pattern of lesions in the wall of the body organ. The device may be moved/repositioned to create as many lesions as desired/necessary, and the device is inherently capable of creating electrically isolated regions being no larger than half of a total inner surface of the organ. Sachs et al fail to expressly disclose the device may create a predetermined pattern of tissue regions from a single deployed position, the isolated regions being no larger than half of a total inner surface area of the body organ. It is noted that Figure 23 shows multiple ablation regions, but only shows a portion of the device.
Gelbart et al disclose another device that has an expandable member including ablation members for creating linear lesions in a hollow body organ. Gelbart et al disclose embodiments having expanding splines, as well as embodiments having expanding balloons, for locating the ablation elements in contact with tissue. Sachs et al also has a similar disclosure of using expandable splines and expandable balloons to place ablation elements into contact with tissue. Gelbart et al specifically teach that the ablation elements may run in longitudinal and latitudinal directions to provide ablation lesions in any desired direction/orientation to treat tissue. See, for example, Figure 1 and Figures 17A-18B which show various different embodiments of ablation members extending in transverse directions relative to each other. The electrodes are independently controllable such that any desired pattern of lesions may be created. See, for example, paragraphs [0076] and [0086]. Given that the Gelbart et al device, as well as the Sachs device, is generally inflated/expanded to contact the entire surface of the body organ, and given that Gelbart et al provide an entire three-dimensional array of electrodes, the combination of the Gelbart et al teaching (i.e. with the electrodes extending across the entire surface of the expandable member) with the Sachs et al device would yield a device capable of creating isolated regions with each region being no larger than half a total inner surface area of the organ. It is noted that applicant’s specification fails to provide any criticality for the specific size and/or shape of the lesions and makes no specific reference to creating isolated regions no larger than half a total inner surface area of the organ except in the claims.
To have provided the Sachs et al device with ablation members extending in longitudinal and transverse directions around then entirety of the expandable member in order to create a desired lesion pattern in tissue would have been an obvious modification for one of ordinary skill in the art in view of the teaching of Gelbart et al.
Regarding claim 2, an expandable member (152) is coupled to a distal end of the shaft (Figure 23) having a collapsed configuration and an expanded configuration. See, also, paragraph [0129]. Regarding claim 3, the ablation member (i.e. electrodes 153) is disposed over the expandable member (Figure 23 of Sachs). Regarding claim 4, the expandable member of Sachs is a balloon (152). Regarding claim 5, the balloon may be inflated with a liquid or a gas (para. [0119], for example). Regarding claim 7, the balloon is configured to conform to the inner wall of the bodily organ (para. [0120], for example). Regarding claims 8-10, the ablation member comprises one or more longitudinal elongate members (153 – Figure 23) that is disposed parallel to the longitudinal axis of the shaft and/or body organ. Regarding claims 11-13, Gelbart et al provide longitudinal and latitudinal electrode members (Figure 1, for example) to create a desired lesion pattern in tissue. Regarding claim 14, Sachs et al clearly provide multiple elongate members that may have portions that are transverse to others (Figure 23). Regarding claim 15, the ablation member is configured to conform to an inner wall of the organ (para. [0120], for example). Regarding claims 16-18, the Sachs et al ablation element is capable of providing each of the recited ablation lines. Regarding claim 19, Sachs et al disclose various different ablation modalities, including RF microwave, ultrasound and others (para. [0119], for example). Regarding claim 20, the device may be used in a hollow body organ such as the bladder (para. [0028], for example). Regarding claim 21, the Sachs device, as modified by Gelbart et al to have the electrode pattern across the entirety of the balloon, would be inherently capable of creating an ablation pattern in a single application (e.g. AR1 in Figure 13).
Claim 6 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Sachs et al (‘798) in view of the teaching Gelbart et al (‘930) and further in view of the teaching of Wallsten (7,156,860).
Sachs et al provide an expandable balloon supporting elongate ablation elements, but fails to disclose the balloon is mounted to a distal end of a telescopic shaft to extend the length of the expandable member as required by claim 6.
Wallsten provides another expandable device used to treat the cavity of a body organ with heat. In particular, Wallsten specifically disclose a balloon connected to a telescoping member such that the length of the balloon may be adjusted as necessary/desired to fit tissue (col. 5, lines 60-64, for example).
To have provided the Sachs et al device, as modified by the teaching of Gelbart et al, with a balloon connected to a telescopic shaft to enable control of the length of the balloon to fit a desired treatment area would have been an obvious modification for one of ordinary skill in the art in view of the teaching of Wallsten.
Response to Arguments
Applicant's arguments filed December 15, 2025 have been fully considered but they are not persuasive.
The examiner has now applied the Gelbart et al teaching to the newly amended claim 1. The examiner maintains that Gelbart et al fairly teach it is known to provide an expandable member with electrodes extending in longitudinal and latitudinal directions around the entirety of the expandable surface to create a desired pattern of lesions in tissue. The examiner maintains it would have been an obvious consideration for one of ordinary skill in the art at the time of the invention to have employed the electrode pattern taught by Gelbart et al on the expandable balloon of Sachs et al (Figure 23, which already has a plurality of electrical patterns on the surface) to enable the device to create a desired lesion pattern on any portion of the hollow body organ from a single deployed position of the energy delivery device. It is again noted that applicant’s specification fails to specifically address the need to create lesions to create isolated regions no larger than half the total inner surface area of the organ. It is also noted that applicant failed to specifically address the combination of the Gelbart et al teaching with the Sachs et al device as applied to claims 11-13 in the previous Office action.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/January 2, 2026