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 .
Election/Restrictions
Applicant’s election without traverse of Species I and Subspecies A in the reply filed on 01 June 2026 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species (that is, Species II having unilateral geometry), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 01 June 2026.
Drawings
The drawings are objected to because the drawings contain deficient line quality. All drawings must be made by a process which will give them satisfactory reproduction characteristics. Every line, number, and letter must be durable, clean, black (except for color drawings), sufficiently dense and dark, and uniformly thick and well-defined. Refer to 37 CFR 1.84(l). See Figure(s) 12B-12C, 18-19, 26A-26B, 27A-27B, 28-29, 31-32, and 33A-33B. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 5-6 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.
Claim 5 recites the limitation “the segment” in line 3. There is insufficient antecedent basis for this limitation in the claim. Examiner recommends amending this limitation to read --the at least one segment-- as recited earlier in claim 1. Dependent claim 6 is necessarily rejected as depending upon a rejected base claim.
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 1-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley et al. (WO 2022/043757, published 03 March 2022, more than one year prior to the effective filing date of the claimed invention), hereinafter Townley.
Regarding claim 1, Townley discloses a device for treating a condition within a sino-nasal cavity of a patient (Figs. 2 and 4: device 102), the device comprising:
an end effector comprising at least one retractable and expandable segment (page 32, lines 8-9: “a multi-segment end effector 114 transformable between a retracted configuration and an expanded deployed configuration”) comprising a micro-electrode array arranged about a plurality of struts having a bilateral geometry (Fig. 4 and page 34, lines 9-10: “The first and second segments 122, 124, specifically struts 130, 132, and 134 include one or more energy delivery elements, such as a plurality of electrodes 136”)
and configured to conform to and accommodate an anatomical structure within the nasal cavity when the at least one segment is in an expanded state (page 34, lines 12-13: “In the expanded state, the struts 130, 132, and 134 can position any number of electrodes 136 against tissue at a target site within the sino-nasal region”),
wherein the plurality of struts comprises: a first set of struts extending outwardly in a first direction from a central axis of the at least one segment (Figs. 4-5C: first set of struts 130(a), 132(a), 134(1), 134(2)) and configured to conform to and accommodate a first anatomical structure within a first nasal cavity (page 34, lines 22-25: “each of the expanded first and second segments 122, 124 can press against surrounding anatomical structures proximate to the target site (e g., the turbinates, the palatine bone, etc.) and the individual struts 130, 132, 134 can at least partially conform to the shape of the adjacent anatomical structures to anchor the end effector 114”);
and a second set of struts extending outwardly in a second direction from the central axis of the at least one segment (Figs. 4-5C: second set of struts 130(b), 132(b), 134(n)) and configured to conform to and accommodate a second anatomical structure within a second nasal cavity (page 37, lines 15-22: “struts 130a, 132a conform to and complement a shape of a lateral attachment and posterior-inferior edge of the middle turbinate when the first segment 122 is in the deployed configuration, thereby allowing for both sides of the anatomical structure to receive energy from the electrodes. By having this independence between first and second side (i.e., right and left side) configurations, the first segment 122 is a true bilateral device. By providing a bilateral geometry, the multi-segment end effector 114 does not require a repeat use configuration to treat the other side of the anatomical structure, as both sides of the structure are accounted at the same time due to the bilateral geometry”).
Regarding claim 2, Townley discloses the device of claim 1 as described previously. Townley further discloses wherein the micro-electrode array is provided via one or more flexible printed circuit board (PCB) members positioned on one or more of the plurality of struts (page 2, lines 4-10: “Each retractable and expandable segment further includes one or more flexible printed circuit board (PCB) members provided thereon [...] Each flexible PCB member further includes one or more energy delivering elements (e.g., electrodes) provided thereon”).
Regarding claim 3, Townley discloses the device of claim 2 as described previously. Townley further discloses wherein the one or more flexible PCB members comprises a PCB substrate and one or more electrodes configured to deliver energy to tissue at the one or more target sites (Fig. 13: flexible substrate 402, electrodes 404 and 406).
Regarding claim 4, Townley discloses the device of claim 3 as described previously. Townley further discloses wherein each of the one or more flexible PCB members comprises one or more electrical communication paths positioned at least on or within the PCB substrate (Fig. 13: electrical communication paths 405, 407) and selectively coupling the one or more electrodes to a corresponding one or more electrical contacts configured to electrically couple the one or more electrodes to a controller (Fig. 16B and page 45, line 31 - page 46, line 2: “FIG. 16B illustrates a standard connector at the proximal end of the PCB assembly, which includes multiple electrical contacts coupled to the electrodes 404, 406 via the communication pathways 405, 407”).
Regarding claim 5, Townley discloses the device of claim 3 as described previously. Townley further discloses wherein the PCB substrate of the one or more flexible PCB members comprises a flexible material configured to correspondingly transition from a collapsed configuration to a deployed configuration upon movement of the at least one segment to the expanded state (page 43, lines 5-8: “as a result of a flexible substrate material, each of the flexible PCB members 200 is capable of moving (e.g, bending, twisting, folding, etc.) between various positions in correspondence with movement of the underlying retractable and expandable leaflet 134 to which it is attached”).
Regarding claim 6, Townley discloses the device of claim 5 as described previously. Townley further discloses wherein each of the plurality of struts includes at least a portion of one or more flexible PCB members fixedly coupled thereto (page 42, lines 26-28: “the struts or support structures 134 may also be referred to herein as leaflets. Each leaflet 134 includes a pair of flexible PCB members 200 affixed to a portion thereof”).
Regarding claim 7, Townley discloses the device of claim 1 as described previously. Townley further discloses wherein at least one of the plurality of struts is configured in a loop-like or leaflet-like shape when the first segment is in an expanded state (Figs. 5A-5E and page 42, line 25: “each of the struts or support elements 134(1)- 134(6) of the second (distal) segment 134 includes loop-like or leaflet-like shape”).
Regarding claim 8, Townley discloses the device of claim 1 as described previously. Townley further discloses wherein at least one of the plurality of struts has a distal-most end that is independent and separate from the other plurality of struts (Fig. 5A: strut 134(1) having a distal-most end independent and separate from 134(2) and 134(n)).
Regarding claim 9, Townley discloses the device of claim 1 as described previously. Townley further discloses wherein each of the plurality of struts comprises a deformable material selected from the group consisting of a polymer and a shape memory material (page 33, lines 7-12: “the first segment 122 includes at least a first set of flexible support elements, generally in the form of wires, arranged in a first configuration, and the second segment 124 includes a second set of flexible support elements, also in the form of wires, arranged in a second configuration. The first and second sets of flexible support elements include composite wires having conductive and elastic properties. For example, in some embodiments, the composite wires include a shape memory material, such as nitinol”).
Regarding claim 10, Townley discloses the device of claim 1 as described previously. Townley further discloses wherein the least one segment is a unitary single piece of material (page 14, lines 24-27: “The proximal and distal segments are constructed from single, unitary work pieces having elastic properties. More specifically, a single piece of shape memory material, such as nitinol, may be used to construct one or more portions of the proximal segment and further construct the distal segment in its entirety”).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Lakshmi (US PGPub No. 2023/0054079) teaches a device with bilateral geometry for treating a nasal nerve tissue or nasal blood vessel within bilateral nasal cavities.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M RODDEN can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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