DETAILED ACTION
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.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. The instant application was filed on 09/18/2024, co-pending as a continuation (CON) of 18/411,460, now U.S. Patent No. 12,108,979, granted 09/18/2024. Application number 18/411,460 was filed on 01/12/2024, co-pending as a CON of 17/225,560, now U.S. Patent No. 11,883,091, granted 10/08/2024. Application number 17/225,560 cites a provisional patent application filed 04/09/2020 with an original filing date of 04/08/2021. The contents of the instant application exist within the provisional application filed 04/08/2021. Therefore, the instant application is granted an effective filing date of 04/09/2021.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 01/14/2025 and 02/02/2026 was filed after the mailing date of the application on 09/18/2024. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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.
Claims 1-4, 14-15, and 19-20 are rejected under 35 U.S.C. 103 as being obvious over Wolf (US Patent No. 11,241,271 B2).
Regarding claim 1, Wolf teaches
“A method for treating at least one of rhinitis, congestion, and rhinorrhea within a sino-nasal cavity of the patient (Abstract, col. 1, lines 36-42), the method comprising: advancing a multi-electrode end effector into the sino-nasal cavity of the patient (abstract) , (Fig. 27) wherein the multi-electrode end effector is operably associated with a shaft of a treatment device (652, 648) and comprises at least a first electrode (644) that is spaced apart from a second electrode (657) along a length of the multi-electrode end effector such that each of the first and second electrodes comprises a respective location on the multi-electrode end effector (Fig. 27),”
“and wherein the first electrode (644) is exposed from a surface of the multi-electrode end effector and is positioned at a discrete portion thereon (646), the first electrode extending in a first outward direction relative to a longitudinal axis of the shaft to interact with anatomy at a first location within the sino-nasal cavity (col.14, lines 35-47, when any location can be picked due to selectively treat tissue)”,
“the second electrode (657) is exposed from the surface of the multi-electrode end effector and is positioned at a discrete portion thereon (654), the second electrode extending in a second outward direction relative to a longitudinal axis of the shaft to interact with anatomy at a second location within the sino-nasal cavity (col.14, lines 35-47, when any second location can be picked due to selectively treat tissue)”,
“delivering radiofrequency (RF) energy, via the first and second electrodes, to one or more target sites within a sino-nasal cavity of the patient to disrupt multiple neural signals to mucus producing and/or mucosal engorgement elements, thereby reducing production of mucus and/or mucosal engorgement within a nose of the patient and reducing or eliminating one or more symptoms associated with at least one of rhinitis, congestion, and rhinorrhea to improve nasal breathability of the patient (col. 5, lines 56-67, col. 6 lines 1-27 and col. 48, lines 1-8)”.
Wolf teaches in the embodiment of Figure 27 all the structure of the claimed limitations, but does not explicitly teach the delivery of RF energy to the first and second electrodes of Figure 27 to reduce production of mucus, mucosal engorgement within a node of the patient and reducing or eliminating one or more symptoms associated with rhinitis, congestion, and rhinorrhea to improve nasal breathing of the patient. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use embodiment of Figure 27 with the application of RF energy to reduce production of mucus and mucosal engorgement as described in one embodiment of Col. 5, lines 55-67, Col. 6, lines 1-27, and Col. 48, lines 1-8 described arrive at the claimed invention. Indeed, Wolf states “Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above" (col. 48, lines 8-18) and the modifications of Wolf produce predictable results of reducing mucosal engorgement through the application of RF energy.
Regarding claim 2, the limitations of claim 1 are taught as described above. Wolf teaches “wherein RF energy delivered from the first and second electrodes is controlled via a console unit operably associated with the treatment device and multi-electrode end effector (col. 5, lines 35-40)”.
Regarding claims 3-4, the limitations of claim 2 are taught as described above. Wolf teaches “wherein the console unit is configured to receive feedback from a temperature sensor arranged relative to the first and second electrodes and configured to sense temperature at an interface between tissue and the first and second electrodes, wherein the console unit is configured to control energy output from the first and second electrodes based, at least in part, on the feedback in order to maintain a predetermined temperature of tissue at the one or more target sites” and “wherein the console unit is configured to receive one or more temperature readings from the at least one temperature sensor and process the readings to determine a level of RF energy to be delivered by the first and second electrodes that is sufficient to maintain a temperature of tissue at the one or more target sites below a predetermined threshold” in Col. 44, lines 50-67 and col. 45, lines 1-5 which states "Such sensors may be used to sense any of a number of relevant tissue properties, such as temperature, impedance and the like. The sensors may be located on a treatment device in some embodiments, or alternatively they may be separate from the treatment device and positioned at or near the device during treatment. In some embodiments, the sensor(s) may provide feedback directly to the treatment device. For example if a particular tissue temperature threshold is reached, a sensor (or sensors) may send a signal to a power generator to shut down or decrease power delivered to a treatment device. In alternative embodiment, the sensor(s) may instead provide feedback to a physician or other user, so that the physician or other user can make treatment adjustments. For example, sensors may provide a warning signal when a particular tissue temperature or impedance is reached, which will help a physician know when to turn off or decrease power delivery to a treatment device".
Regarding claim 14, the limitations of claim 1 are taught as described above. Wolf teaches “wherein the end effector is operably coupled to an energy generator configured to generate RF energy to be delivered by the first and second electrodes (col. 33, lines 49-61).”
Regarding claim 15, the limitations of claim 14 are taught as described above. Wolf teaches “wherein the RF energy comprises at least bipolar RF energy (col. 22, lines 26-30).”, but this passage is not specific to the embodiment of Figure 27, though Wolf states that this passage is not limited to any specific embodiment and instead can be applied to any embodiment within the disclosure. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use modifications of embodiments described in Wolf to arrive at the claimed invention. Indeed, Wolf states "Although this invention has been disclosed in the context of certain preferred embodiments and examples, it will be understood by those skilled in the art that the present invention extends beyond the specifically disclosed embodiments to other alternative embodiments and/or uses of the invention and obvious modifications and equivalents thereof. Thus, it is intended that the scope of the present invention herein disclosed should not be limited by the particular disclosed embodiments described above" (col. 48, lines 8-18) and the modifications of Wolf’s embodiment of Figure 27 to include bipolar RF energy produce predictable results of reduce mucosal engorgement.
Regarding claim 19, the limitations of claim 1 are taught as described above. Wolf teaches “wherein the one or more target sites comprises an inferior turbinate within the sino-nasal cavity and the tissue comprises submucosal tissue associated with the inferior turbinate (Fig. 36, col. 47 lines 45-67).”
Regarding claim 20, the limitations of claim 1 are taught as described above. Wolf teaches “wherein the one or more target sites comprises a posterior nasal nerve within the sino-nasal cavity and the tissue comprises submucosal tissue around a region of the posterior nasal nerve (Fig. 36, col. 47 lines 45-67).”
Claims 5-9 and 21-23 are rejected under 35 U.S.C. 103 as being obvious over Wolf (US Patent No. 11,241,271 B2) in view of Vrba (US 2017/0348049).
Regarding claim 5, the limitations of claim 4 are taught as described above. First, note that Wolf does teach the use of a controller or console unit 43 in Fig. 3, Fig. 22G, and the ability of the control unit to use temperature measurements to control energy being delivered to the electrode and tissue in col. 30, lines 7-30. However, Wolf does not explicitly teach the use of "a hardware processor coupled to a computer readable memory containing the hardware processor coupled to non-transitory, computer-readable memory containing instructions executable by the processor to cause the console unit to automatically control and adjust RF energy output from the first and second electrodes based, at least in part, on a predetermined elapsed time period and a predetermined threshold maximum temperature during delivery of RF energy to ensure that application of said RF energy results in the desired effect of reduced engorgement of the tissue at the target site for a given treatment application", but Vrba does in an analogous tissue modulation device. Vrba explicitly teaches the use of a general-purpose processor (a hardwire processor couped to non-transitory, computer-readable memory) (p.[0461-0462]) to automatically control and adjust energy output based on both predetermined elapsed time (p.[0396]) and predetermined maximum temperature (p.[0392]), therefore teaching the claimed invention.
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use Vrba in Wolf's system as taught in Vrba, by monitoring the elapsed time and temperature of the tissue during treatment, the user can avoid unwanted tissue damage to surrounding tissues that are not the target of treatment (p.[0396]) and such a system produces predictable results of refined application of energy during treatment.
Regarding claims 6-7, the limitations of claim 5 are taught as described above. Wolf teaches the limitation of claim 6 “the predetermined elapsed time period is from about 1 second to about 20 seconds” and the limitation of claim 7 which states “wherein the predetermined elapsed time period is from about 10 seconds to about 12 seconds” in Col. 6, lines 39-41 which states "For example, RF energy or other energy may be delivered to the one or more electrodes for about 15 seconds to about 1 minute". It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the time period of Wolf in Wolf/Vrba. As stated in MPEP 2144.05, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” Further, note that MPEP 2144.05 states “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. Therefore, the disclosure of Wolf teaches both limitations as described.
Regarding claims 8-9, the limitations of claim 5 are taught as described above. Wolf teaches the limitation of claims 8 and 9, “wherein the predetermined threshold maximum temperature is less than 90°C. “ and “wherein the predetermined threshold maximum temperature is greater than 37°C and less than 90°C” in Col. 6, lines 41-43 "RF energy or other energy may be delivered to heat an area of tissue to a temperature of about 50 degrees Celsius to about 70 degrees Celsius." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the time period of Wolf in Wolf/Vrba. As stated in MPEP 2144.05, “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists.” Further, note that MPEP 2144.05 states “Similarly, a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close”. Therefore, the disclosure of Wolf teaches both limitations as described.
Regarding claim 21, the limitations of claim 2 are taught as described above. Wolf does not teach monitoring impedance during delivery of RF energy via at least two electrodes, but Vrba does in an analogous neuromodulation device. Vrba teaches measuring impedance in p.[0037, 0372], which describes how the inner and outer electrodes can measure impedance of the electrodes during use. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to measure impedance as taught in Vrba in Wolf. As stated in Vrba, measuring impedance "may also be used as feedback to trigger other changes in an energy delivery protocol, such as decreasing power or increasing cooling" (p.[0374]) to thereby confirm lesion development or formation to denervate the target nerves (p.[0373]).
Regarding claim 22, the limitations of claim 21 are taught as described above. Wolf does not teach that the impedance measurements are used to determine contact between the electrodes and target sites via the processing device, but Vrba does in an analogous neuromodulation device. Vrba teaches in p.[0036-0037] that the processing device may use bipolar contact impedance measurements to determine the tissue contact sensing measurements to determine whether the tissue is in contact with the inner and outer electrodes. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to determine contact between the electrodes via impedance measurements as taught in Vrba. As stated in Vrba (p.[0380]), maintaining contact conditions is ideal for successful ablations and produces predictable results.
Regarding claim 23, the limitations of claim 21 are taught as described above. Wolf does not teach the use of impedance measurements to control energy output for the electrodes, but Vrba does. Vrba teaches in p.[0374] that "The decoupling of temperature and impedance may be used as an indication of lesion formation to confirm denervation. If impedance begins to increase without a corresponding decrease in tip temperature, this may be used as an end point or as confirmation of lesion formation. The time of decoupling of temperature and impedance may also be used as feedback to trigger other changes in an energy delivery protocol, such as decreasing power or increasing cooling." It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use impedance measurements to control energy outputs, as stated in Vrba, in Wolf. As stated in Vrba, monitoring impedance during ablation assists with monitoring and confirming lesion development and produces predictable results (p.[0373-0374]).
Claims 10-12 and 16-18 are rejected under 35 U.S.C. 103 as being obvious over Wolf (US Patent No. 11,241,271 B2) in view of Townley (US 2019/0239957).
Regarding claim 10, the limitations of claim 4 are taught as described above. Wolf partially teaches “wherein the console unit is configured to monitor temperature of tissue at the one or more target sites during delivery of RF energy thereto based on temperature readings from the at least one temperature sensor and further monitor an elapsed time during delivery of RF energy to tissue at the one or more target sites” in Col. 30, lines 7-14 which states "The thermocouple can also be configured to measure a temperature of the treatment element 532 itself. The temperature measurements taken by the thermocouple can be routed as feedback signals to a control unit (e.g., the control unit 42 described with respect to FIG. 3) and the control unit can use the temperature measurements to adjust the intensity of energy being delivered through the electrode." but does not describe monitoring the elapsed time of RF delivery to tissue. However, Townley does teach this missing limitation in an analogous neuromodulation device. Townley teaches in p.[0047] that "In other embodiments, the evaluation/feedback algorithm 220, in conjunction with the controller 218, can be configured to automatically terminate treatment after a predetermined maximum time, a predetermined maximum impedance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement), a predetermined maximum impedance of the targeted tissue), and/or other threshold values for biomarkers associated with autonomic function. This and other information associated with the operation of the system 200 can be communicated to the operator via a display 222 (e.g., a monitor or touchscreen) on the console 204 and/or a separate display (not shown) communicatively coupled to the console 204." The elapsed time of during delivery of the RF energy would be the predetermined maximum time for clarity on the record. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Townley in Wolf. As stated in Townley, the use of this feedback algorithm can include features to improve efficacy of the treatment or enhance the desired performance of the system (p.[0047]) and produces predictable results.
Regarding claims 11-12, the limitations of claim 4 are taught as described above. Wolf does not teach “wherein the console unit is configured to provide, via a display, feedback information to an operator, wherein said feedback information comprises at least an elapsed time during delivery of RF energy to tissue at the one or more target sites” or use of a display with a touchscreen monitor specifically, but Townley does in an analogous therapeutic nasal modulation device. Townley teaches in p.[0047] that " In other embodiments, the evaluation/feedback algorithm 220, in conjunction with the controller 218, can be configured to automatically terminate treatment after a predetermined maximum time, a predetermined maximum impedance rise of the targeted tissue (i.e., in comparison to a baseline impedance measurement), a predetermined maximum impedance of the targeted tissue), and/or other threshold values for biomarkers associated with autonomic function. This and other information associated with the operation of the system 200 can be communicated to the operator via a display 222 (e.g., a monitor or touchscreen) on the console 204 and/or a separate display (not shown) communicatively coupled to the console 204." The elapsed time of during delivery of the RF energy would be the predetermined maximum time for clarity on the record. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use the system of Townley in Wolf. As stated in Townley, the use of this feedback algorithm can include features to improve efficacy of the treatment or enhance the desired performance of the system (p.[0047]) and produces predictable results.
Regarding claims 16-18, the limitations of claim 1 are taught as described above. Wolf does not explicitly teach the use of at least four, six, or eight electrodes, nor does Townley. However, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use four, six, or eight electrodes in the system of Wolf/Townley. It has been held that mere duplication of the essential working parts of a device involves only routine skill in the art, and the use of more electrodes (pending a statement of criticality) does not provide any patentable distinction, novelty, or nonobvious results. St. Regis Paper Co. v. Bemis Co., 193 USPQ 8.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 13 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of U.S. Patent No. 12,102,379 in view of Wolf (US Patent 11,241,271 B2).
Regarding claim 13, the limitations of claim 2 are taught as described above. Wolf teaches the limitations of claim 2, however, the limitations of claim 13 are nearly identical to the limitations of claim 2 of U.S. Patent No. 12,102,379. Claim 2 of U.S. Patent No. 12,102,379 states “wherein the shaft is a substantially rigid shaft with a hollow cavity, wherein the shaft comprises an outer sheath and hypotube, wherein the first electrode and second electrode is operably coupled to a console unit via wires disposed in the hollow cavity of the substantially rigid shaft, and wherein RF energy is delivered from the first and second electrodes to tissue at the one or more target sites and is controlled via the console unit operably associated with the treatment device and multi-electrode end effector”, describing the same limitation as claim 13 of the instant application, as follows: “wherein the shaft is a substantially rigid shaft with a hollow cavity and comprises an outer sheath and hypotube, and wherein the first electrode and second electrode are operably coupled to the console unit via wires disposed in the hollow cavity of the substantially rigid shaft”. Here, the more specific patent claims encompass the broader application claims. Following the rationale in In re Goodman cited in the preceding paragraph, where applicant has once been granted a patent containing a claim for the specific narrow invention, applicant may not obtain a second patent with a claim for the generic or broader invention without first submitting an appropriate terminal disclaimer.
Conclusion
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/ABIGAIL BOCK/Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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