DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Claim Rejections - 35 USC § 102
3. 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.
4. Claims 1-6, 9-12, and 14-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hakimimehr U.S. 2024/0138895 (earliest filing date 10/28/2022; herein referred to as “Hakimimehr”).
5. Regarding Claim 1, Hakimimehr teaches a method for treating a nasal airway to ameliorate one or more symptoms of rhinitis in a patient (para 0085), the method comprising:
a. advancing a treatment tip of a treatment device into a nostril of the patient (para 0116; Fig. 1E, ref num 113 advanced into nostril);
b. contacting nasal mucosa with the treatment tip at a first location (Fig. 1E, ref num 113 contacts ref num 100A; para 0116, “Distal end 113 is placed against the mucosal tissue of the nasal septum 100A so that it is in contact with at least a portion of AEN 101”) overlying an anterior ethmoidal nerve (para 0116, “it is in contact with at least a portion of AEN 101”; AEN = anterior ethmoidal nerve, para 0054, “Anterior ethmoid nerve (AEN)”);
c. delivering energy from the treatment tip, to change a property of the anterior ethmoidal nerve (para 0116, “An ablation mechanism is triggered and at least a portion of AEN 101 is ablated”; para 0055, “ablation of AEN with or without simultaneous ablation of PEN is intended to treat nasal hyperreactivity such as that seen in rhinitis and rhinosinusitis”) ; and
d. removing the treatment tip from the nostril (para 0072, “Upon completion of the ablation procedure the distal end may be collapsed before the device is removed from the nasal cavity”).
6. Regarding Claim 2, Hakimimehr teaches moving the treatment tip to a second location overlying additional nerve tissue (para 0119, “the device repositioned and then triggered again at an adjacent location as needed until the desired portion of NPN 102 is ablated”) selected from the group consisting of the anterior ethmoidal nerve, a branch of the anterior ethmoidal nerve, and a posterior nasal nerve; and delivering energy from the treatment tip at the second location (para 0120, “ distal end 113 is navigated to PEN (not shown). An ablation mechanism is triggered, e.g., on the handle of the device 112, to activate the distal end 113 to ablate at least a portion of PEN”; para 0085).
7. Regarding Claim 3, Hakimimehr teaches moving the treatment tip to a third location (para 0126, “mucosa overlaying both Little's area 206 and nasal swell body 304 are ablated”; para 0123); and delivering energy from the treatment tip at the third location (para 0123), wherein the energy is delivered in a pulsed or sinusoidal modality (para 0128, “device 100C uses radiofrequency, pulsed radiofrequency”).
8. Regarding Claim 4, Hakimimehr teaches the third location is selected from the group consisting of a turbinate, a swell body, and a nasal septum (para 0126, “mucosa overlaying both Little's area 206 and nasal swell body 304 are ablated”).
9. Regarding Claim 5, Hakimimehr teaches changing the property of the anterior ethmoidal nerve comprises ablating the anterior ethmoidal nerve (para 0116, “An ablation mechanism is triggered and at least a portion of AEN 101 is ablated”).
10. Regarding Claim 6, Hakimimehr teaches the energy comprises delivering an energy type selected from the group consisting of radiofrequency, DC current, microwave, heat, cryotherapy, ultrasound, and chemical energy (para 0128, “device 100C uses radiofrequency, pulsed radiofrequency”).
11. Regarding Claim 9, Hakimimehr teaches bending a shaft of the treatment device before advancing the treatment tip into the nostril (para 0135, “all or part of shaft 403 is malleable allowing for adjusting the angle between distal end 402 and shaft 403”).
12. Regarding Claim 10, Hakimimehr teaches treating the nasal airway in conjunction with treatment of one or more of: asthma; chronic rhino sinusitis (CRS); chronic cough; sneezing; eustachian tube dysfunction; emphysema; and chronic obstructive pulmonary disease (COPD) (para 0010).
13. Regarding Claim 11, Hakimimehr teaches a device for treating an anterior ethmoidal nerve to ameliorate one or more symptoms of rhinitis (Fig. 1C, ref num 100C; Fig. 4A), the device comprising:
a. a handle (Fig. 1C, ref num 112; para 0110, “ proximal end 112 (e.g., having a handle)…”);
b. a shaft extending from the handle (Fig. 1C, ref num 114); and
c. an energy delivery treatment tip extending from a distal end of the shaft (Fig. 1C, ref num 113).
14. Regarding Claim 12, Hakimimehr teaches the shaft is malleable (Fig. 4A, ref num 403; para 0135, “shaft 403 is malleable”) and has a width of 4 millimeters to 5 millimeters (para 0134, “a shaft with a length ranging from, e.g., 4 cm to 12 cm and a diameter ranging from, e.g., 0.5 mm to 5 mm”).
15. Regarding Claim 14, Hakimimehr teaches the energy comprises delivering an energy type selected from the group consisting of radiofrequency, DC current, microwave, heat, cryotherapy, ultrasound, and chemical energy (para 0128, “device 100C uses radiofrequency, pulsed radiofrequency”).
16. Regarding Claim 15, another embodiment of Hakimimehr teaches the energy delivery treatment tip comprises an expandable cryotherapy balloon (para 0141, “expandable component of distal end 602 is a balloon”; para 0073, “the ablation device is a cryogenic device”). Hakimimehr teaches the embodiments may be combined in order to effect the treatment (para 0172). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have combined one embodiment of Hakimimehr with another in order to effect the treatment.
17. Regarding Claim 16, Hakimimehr teaches a length of the shaft is selected to extend from a first end that is attached to the handle, located just outside a nostril of a patient, to a second end, attached to the energy delivery treatment tip located at the anterior ethmoidal nerve in a nasal cavity of the patient (Figs. 1C, 1D, 1E; para 0116).
18. Regarding Claim 17, Hakimimehr teaches treatment of the anterior ethmoidal nerve is performed in conjunction with treatment of one or more of: asthma; chronic rhino sinusitis (CRS); chronic cough; sneezing; eustachian tube dysfunction; emphysema; and chronic obstructive pulmonary disease (COPD) (para 0010).
19. Regarding Claim 18, Hakimimehr teaches the energy delivery treatment tip is configured to deliver energy in a pulsed or sinusoidal modality (para 0128, “device 100C uses radiofrequency, pulsed radiofrequency”).
Claim Rejections - 35 USC § 103
20. 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.
21. Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hakimimehr and in view of Townley U.S. 2023/0133359 (herein referred to as “Townley”).
22. Regarding Claim 7, Hakimimehr fails to teach sensing at least one of temperature or impedance of the treatment device.
Townley teaches a method of analogous art (para 0003, Fig. 6), wherein the method comprises sensing at least one of temperature or impedance with a sensor of the treatment device (Fig. 3, ref num 114; para 0041, “the end effector 114 may include one or more sensors (not shown)… impedance sensors”). This data is used as feedback to identify properties of the neural tissue for treatment (para 0046). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hakimimehr to sense impedance of the treatment device in order to provide feedback about the nerve tissue for treatment.
23. Regarding Claim 8, Hakimimehr fails to teach automatically shutting off delivery of energy from the treatment device if the temperature or the impedance exceeds a preset maximum.
Townley teaches a method of analogous art (para 0003), wherein the method comprises automatically shutting off delivery of energy from the treatment device if the temperature or the impedance exceeds a preset maximum (para 0044, “the evaluation/feedback algorithm 110, in conjunction with the controller 107, 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”). By shutting off delivery of the energy, this achieves the desired treatment outcome and confirms efficacy of the treatment (para 0044). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified Hakimimehr and automatically shut off delivery of energy when the impedance exceeds a preset maximum, as this achieves the desired treatment to the target site.
24. Claim 13 is rejected under 35 U.S.C. 103 as being unpatentable over Hakimimehr and in view of Wolf U.S. 10,456,185 (herein referred to as “Wolf”).
25. Regarding Claim 13, Hakimimehr fails to teach the energy delivery treatment tip comprises at least two radiofrequency electrodes, and wherein the device further comprises a power cord connected at one end of the handle and including a connector at an opposite end for connecting to an outlet of a radiofrequency console.
Wolf teaches a device of analogous art (Fig. 3) wherein the device comprises an energy delivery treatment tip with at least two radiofrequency electrodes (Col. 5, lines 9-19, “electrodes may comprise one or more monopolar needles, one or more monopolar plates, or one or more bipolar electrode pairs (which may also comprise one or more needles or plates). These electrodes may may be located in various locations, for example, inside the nasal passageway, external to the nose or both. For example, when using bipolar electrode pairs, a first electrode surface may be positioned internal to the nose and a second electrode surface may be positioned external to the nose, so that the two electrode surfaces are positioned on opposite sides of nasal tissue”; Col. 3, lines 6-11, “a radiofrequency member is attached to an outer surface of the inflatable balloon. For example, the radiofrequency member may be a single monopolar electrode, multiple monopolar electrodes, or multiple bipolar electrodes. In some embodiments, delivering the energy involves delivering radiofrequency energy via the radiofrequency member”). The device further comprises a power cord connected at one end of a handle and including a connector at an opposite end for connecting to an outlet of a radiofrequency console (Fig. 3, ref num 40, 44, 34; Col. 4, lines 28-32, “the controller and/or the power source may be located in the handle or may be separate from the handle, for example in a separate box or, in the case of the power source, the system may include a cord for plugging into a wall socket”; Col. 11, lines 37-39; Col. 11, lines 59-67 – Col. 12, lines 1-15).
Conclusion
26. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM EST.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794