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 .
Applicant’s amendments and comments, received June 17, 2026, have been fully considered by the examiner. The amendments have obviated the 35 USC 112 issues, and the Terminal Disclaimer has obviated the double patenting rejection. The following is a complete response to the June 17, 2026 communication.
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 21-26, 28, 30-36, 38 and 40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Danek et al (8,51,070).
Regarding claim 21, Danek et al provide a computer-moderated method for treating tissue (col. 9, lines 63-67, for example) comprising displaying on a user interface an anatomical map of the body to be treated (Figure 5 and discussion at col. 17). The system receives information about a selection on different treatable segments (i.e. treatment sites) as discussed at column 17. See, also, column 13, lines 60-67. The system is set to determine treatment parameters and automatically deliver a pre-determined dose of energy based on the treatment (col. 15, lines 1-5 and col. 10, lines 13-26 which discloses a set energy dosage). The automatic delivery includes initiating the treatment and stopping the treatment dose when the metered does is reached (col. 10, lines 13-26, for example).
Regarding claim 22, the energy is thermal energy (col. 9, lines 1-5). Regarding claim 23, the energy is delivered by a catheter (100) that is advanced to the anatomical site. Regarding claim 24, the anatomical map is a map of the airways (Figure 5). Regarding claim 25, Danek et al teach of updating various different parameters (i.e. dose indicator, see col. 10, lines 1-10). Regarding claim 26, Danek et al perform a safety check prior to energy delivery (col. 11, lines 63-67, for example). Regarding claim 28, Danek et al provide patient type information to determine the dosing for the procedure (col. 14, lines 54-67, for example). Regarding claims 30 and 31, Danek et al disclose the use of temperature, including a rate of change of temperature, to determine when an appropriate dose has been administered (col. 19, lines 7-30, for example). Regarding claim 32, Danek et al disclose providing visual indicators including updating information relating to energy delivery (col. 9, line 63 to col. 10, lines 12, for example).
Regarding claim 33, Danek et al provide a system for treating tissue by applying energy, the system comprising an energy delivery device (100) configured to apply energy to tissue, and a computer console (116) comprising a processor and a display. The display may include an anatomical map (Figure 5 and associated discussion) of a body area to be treated, wherein the map is divided into different treatable segments (i.e. stages). See, column 13, lines 60-67, and column 17, for example. The controller (i.e. computer 116) receives information on the different treatable segments and automatically delivers a predetermined dose of energy to the tissue, including stopping the energy delivery when the dose has been delivered. See column 15, lines 1-5 and col. 10, lines 13-26 which discloses a set energy dosage, and stopping the treatment dose when the metered dose is reached (col. 10, lines 13-26, for example).
Regarding claim 34, the device comprises a catheter (100) for delivery to the treatable segments. Regarding claim 35, see discussion of claim 25 above. Regarding claim 36, see discussion of claim 26 above. Regarding claim 38, see discussion of claim of claim 28 above. Regarding claim 40, see discussion of claim 30 above.
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.
Claims 27 and 37 are rejected under 35 U.S.C. 103 as being unpatentable over Danek et al (8,251,070) in view of the teaching of Kudaravalli et al (6,471,694).
Danek et al disclose the use of a cryogen for treating tissue (col. 9, line 2, for example), but fails to disclose doing a safety check of the cryogen delivery system before the procedure.
Kudaravalli et al disclose a cryosurgical catheter system for treating tissue, and specifically provide the teaching that it is known to provide a safety check of the cryogen delivery mechanism before using the system. See, for example, Figure 7A which shows various checks of the cryogen and electrical systems before using the device.
To have provided the Danek et al system with a safety check to ensure the cryo-energy delivery device was properly functioning before performing the procedure would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Kudaravalli et al fairly teach it is known to check a cryo-surgical catheter before performing a procedure.
Claims 29 and 39 are rejected under 35 U.S.C. 103 as being unpatentable over Danek et al (8,251,070) in view of the teaching of Narayan et al (2013/0006131).
Danek et al consider various criteria of a patient before setting operation criteria, but fail to expressly disclose data such as gender, age and weight. The examiner maintains it is generally known that all surgical procedures consider such patient data before performing any procedure. Narayan et al teach that it is known to input such personal data into a computer system in preparation for an automated ablation procedure. See, for example, paragraph [0184].
To have provided the Danek et al system with an input for patient gender, age or weight as a consideration for the surgical procedure would have been an obvious consideration for one of ordinary skill in the art at the time of the invention since Narayan et al specifically teach it is known to input such data for a computer controlled surgical procedure.
Response to Arguments
Applicant's arguments filed June 17, 2026 have been fully considered but they are not persuasive.
Applicant asserts that Danek does not disclose displaying an anatomical map of a body area wherein the map is divided into different treatable segments and automatically delivering a pre-determined metered dose of energy based on the selected treatable region. In particular, applicant asserts that the map of Danek does not provide automated delivery of a segment-specific dose of energy, whereby the selected treatable segment is automatically treated with the appropriate dose. The examiner disagrees. Danek makes clear from the disclosure that an anatomical map (Figure 5 and associated discussion) is provided, from which map sites may be selected for specific treatment (e.g. “different treatable segments”). Danek further specifically discloses that “Dividing of the treating step may be accomplished by treating different regions of the lung at different times (col. 13, lines 65-66) further elucidating that different treatment segments are clearly considered by Danek. As to the “segment specific dose”, or the automatic delivery of a pre-determined metered dose of energy based on a selected treatment site, Danek teach throughout the specification of the different means to interrogate and/or sense tissue to determine the appropriate amount of energy to be delivered to a selected treatment site. For example, column 12, line 47 through column 13, line 3 specifically addresses deriving treatment parameters for multiple sites based on evaluation of the tissue to a stimulation protocol. Danek discloses the steps of evaluating tissue to a stimulation, and then selecting at least one treatment parameter based upon the results of the evaluating step. Column 16, lines 36-67 specifically addresses identification of multiple treatment sites, and assigning a specific treatment to multiple sites that are tailored to each individual site. As addressed in the above rejections, Danek clearly provides a map of tissue showing multiple possible sites and means to display treatment sites (col. 17), and Danek clearly also discloses providing site specific parameters for each site (col. 16, lines 59-65). Additionally, as addressed previously, Danek et al disclose the step of automatically stopping a treatment when a metered dose of energy has been delivered (col. 10, lines 15-26). While Danek et al may not delineate the claimed steps in a concise manner, it is clear that all the elements of the claimed invention are clearly present in the Danek disclosure.
Applicant’s arguments that Danek fails to disclose “automatically stopping the treatment does when the metered dose of energy has been delivered” (pages 8 and 9) are also not persuasive. Applicant discusses the disclosure of Danek at column 19 which discloses the use of temperature to control energy delivery. The examiner maintains that stopping the delivery of energy based on temperature remains a relative teaching of a “treatment dose”, particularly since the fluctuation in temperature is an indication of the amount of energy, or heat, delivered to the tissue. That notwithstanding, the examiner maintains that the disclosure of Danek at column 10 which recites specific doses that are contemplated, coupled with the disclosure at column 16 which specifically addresses different doses for different sized airways is sufficient to read on the claimed limitations.
Applicant has not substantively argued any of the dependent claims, and the examiner maintains the rejections of those claims, including those rejected as being obvious, remain tenable.
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.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/August 5, 2026
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