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 .
Response and Amendment Filed
Applicant’s response and amendment, filed January 27, 2026, has been entered and made of record.
Previously Set Forth Rejections
The status of the rejections set forth in the previous non-final Office action (mailed 10/29/2025) is as follows:
The 35 USC 101 rejection of claims 1-19 is hereby withdrawn.
The 35 USC 112(b) rejection of claims 4, 5, 7, 15 and 17 is hereby withdrawn.
The 35 USC 103 rejection of claims 1-19 as being unpatentable over Townley et al. (U.S. Patent Application Publication No. 2022/0104870) in view of Hayashida et al. (U.S. Patent Application Publication No. 2019/0046262) is hereby withdrawn.
The following new grounds of rejection are set forth:
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 13 and 14 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.
In claim 13, the phrase “wherein a target” appears to be a sentence fragment and it cannot be determined what applicant is intending to claim. As claim 14 depends from claim 13, it is likewise rejected.
Claim Rejections - 35 USC § 103
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.
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.
Claims 1-23 is/are rejected under 35 U.S.C. 103 as being obvious over Townley et al. (U.S. Patent Application Publication No. 2022/0104870) in view of Sverdlik et al. (U.S. Patent Application Publication No. 2012/0095372).
In regard to claims 1, 8, 9, 11-15, 18 and 19, Townley et al. teach a therapeutic system 100 comprised of a handheld device 102 and a console 104 where the handheld device 102 has an end effector 114 for performing a procedure (see Figs. 1A and 1B). The console 104 is configured to determine a specific treatment pattern for controlling delivery of energy from the end effector 114 at a target site at a specific level for a specific time sufficient to ensure successful ablation/modulation of the target tissue while minimizing/preventing collateral damage to surrounding or adjacent non-targeted tissue (see para. 0088). The end effector 114 may include at least one energy delivery element, such as an electrode and may include other energy delivery elements such as ultrasound energy (see para. 0089). The console 104 includes a controller 107 that is configured to initiate, terminate and/or adjust operation of the end effector 114 directly and/or via the console 104 (see para. 0092). The controller 107 can include a computer-readable medium carrying instructions which, when executed by the controller 107, causes the device to perform certain functions (see para. 0092). Townley et al. teach an embodiment where the end effector 214 delivers a non-therapeutic stimulating energy to respective positions so that various properties of the tissue at the target site can be detected (acquiring monitor information) (see Fig. 14A and para. 0188). This information is transmitted to the controller 107 to determine the anatomy at the target site, locate a tissue of interest, differentiate between different types of tissue, map the anatomical an/or neural structures at the target site, detect resistance, electrical impedance, dielectric properties and temperature (see para. 0188). The system 100 provides resistance measurements with a high degree of accuracy and precision and the information can be analyzed by evaluation/feedback algorithms and/or the controller 107 and communicated to the operator via a high resolution spatial grid (on the display 112) and/or any other type of display (see para. 0189). Townley et al. discuss that this information is used to produce a spectral profile or anatomical map that can be visualized in 2D or 3D on the display 112 (see para. 0197). Figure 14B then demonstrates the communication of sensor data from the handheld device 102 to the controller 107 and the subsequent determination, via the controller 107, of a treatment pattern for controlling delivery of energy at a specific level for a specific period of time sufficient to ensure successful ablation/modulation of the targeted tissue while minimizing collateral damage to surrounding tissues (see paras. 0198-0199). Townley et al. are silent as to acquiring image information and performing an estimation to determine an estimated thermal invasion. However, Sverdlik et al. teach an ultrasound treatment catheter 1222 having a transducer 300 where target tissue 1216 is treated by an ultrasound beam 1228 from transducer 300 (see Fig. 1 and para. 0096). At 1504, one or more variables are measured and/or estimated as part of treatment feedback, such as distances 1218 and 1232 and variables measured at 1504 are used to calibrate and/or adjust parameters at 1506, for example, by a look-up table or correlated values (thresholds) (see para. 0098). Optionally ay 1516, the transducer 300 is used in an imaging mode to obtain feedback about a target tissue 1216, such as the distance 1232 between the target tissue and the inner surface of wall 1226 (see para. 0102). Sverdlik et al. teach that the ultrasound imaging methods can be used to estimate the extent of thermal damage in the target tissue and/or the surrounding tissue using a variety of methods (see para. 0102). Sverdlik et al. thus demonstrate that the use of imaging to acquire image information and using that information to perform and estimation of thermal invasion into the tissue is well known in the art and that using look-up tables (thresholds) to make such estimations and then control the output of the transducer are also well known in the art, for the purpose of limiting damage to tissues (either the target tissues or the surrounding tissues). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide the device of Townsley et al. with imaging abilities and the ability to estimate the extent of thermal damage, as disclosed by Sverdlik et al., in order to limit damage to tissues.
In regard to claims 2 and 16, since the device of Townley et al. in view of Sverdlik et al. is applying ultrasound energy and is measuring impedance at the tissue site, it follows that the impedance measurement would reflect a change in frequency of the ultrasound being applied. In regard to claims 3 and 17, since the device of Townley et al. in view of Sverdlik et al. is applying RF energy via the electrodes and is measuring impedance at the tissue site, it follows that the impedance measurement would reflect a change in frequency of the RF energy being applied. In regard to claim 4, Sverdlik et al. are silent as to the type of light being used by the transducer 300 but it would have been obvious to one of ordinary skill in the art at the effective filing date of the invention that at least white light would be used to irradiate the tissue, otherwise correct and accurate images could not be acquired. In regard to claims 5-7, see para. 0102 of Sverdlik et al. In regard to claims 10 and 20-23, see paras. 0162-0164 of Townley et al.
Response to Arguments
Applicant’s arguments, filed January 27, 2026, with respect to the rejection(s) of claim(s) 1-19 under 35 USC 103 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Sverdlik et al. Accordingly, applicant’s arguments with respect to claim(s) 1-19 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794