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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 5/13/2026 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 5/13/2026.
Applicant’s amendments to the claims are sufficient to overcome the claim objections set forth in the previous office action.
Applicant’s amendments to the claims are sufficient to overcome the 35 USC § 112(b) rejections set forth in the previous office action.
Response to Arguments
Applicant’s arguments with respect to claims 1 and 93 have been considered but are moot because the new grounds 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. Previously, claims 1 and 93 were rejected under 35 U.S.C. 103 as being unpatentable over Townley in view of Chou. Now, based on amendments to the claim language, claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Townley in view of Woloszko and Chou.
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 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.
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, 3, 7, 13-15, 18-19, and 93-103 are rejected under 35 U.S.C. 103 as being unpatentable over Townley et al., US 20160331459, herein referred to as “Townley”, in view of Woloszko et al., US 20050251134, herein referred to as “Woloszko”, further in view of Chou et al., US 20150366508, herein referred to as “Chou”.
Regarding claim 1, Townley discloses a device for treating a condition within a sino-nasal cavity of a patient (Figures 2-4), the device comprising: an end effector (Figure 4) comprising a retractable and expandable segment (Figure 4: basket 442) arranged at a distal portion of a shaft (Figure 4: shaft 408) of the device, the retractable and expandable segment comprising: a framework of a plurality of loop-shaped support structures (Figure 4: branches 446) transformable between a low-profile delivery state and an expanded state ([0066]: “The therapeutic assembly 412 includes a plurality of struts 440 that are spaced apart from each other to form a frame or basket 442 when the therapeutic assembly 412 is in the expanded state.”), wherein, when in the expanded state, the plurality of loop-shaped support structures cooperatively form an open-ended circumferential shape ([0067]: “For example, when in the expanded state, the struts 440 can form an ovoid shape, a hemispherical shape, a cylindrical structure, a pyramid structure, and/or other suitable shapes.”), wherein each loop-shaped support structure is defined by a pair of immediately adjacent flexible struts joined to one another (Figure 4: struts 440 and [0067]: “each of the branches 446 includes two struts 440 positioned adjacent to each other”); and a plurality of members coupled to the plurality of loop-shaped support structures (Figure 4: electrodes 444), wherein each flexible strut of a pair of flexible struts of a loop-shaped support structure comprises a respective one of the plurality of members fixedly coupled thereto (Figure 4: each strut 440 has an electrode 444 coupled to it), wherein each member is configured for delivering energy to one or more target sites within the sino-nasal cavity of the patient ([0066]: “In the expanded state, the struts 440 can position at least two of the electrodes 444 against tissue at a target site within the nasal region (e.g., proximate to the palatine bone inferior to the SPF). The electrodes 444 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site”), wherein each member comprises one or more pairs of bipolar electrodes (Figure 4: each strut 440 has at least one pair of electrodes 444) positioned along a length thereof and configured to deliver energy to tissue at the one or more target sites ([0066]: “In the expanded state, the struts 440 can position at least two of the electrodes 444 against tissue at a target site within the nasal region (e.g., proximate to the palatine bone inferior to the SPF). The electrodes 444 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site”). Townley does not explicitly disclose a device wherein each loop-shaped support structure is defined by a pair of immediately adjacent flexible struts joined to one another via a respective polymer tubing placed over respective distal ends of each flexible strut; or wherein the member is a flexible printed circuit board (PCB) that comprises a PCB substrate.
However, Woloszko teaches a device (Figures 23A-E) wherein each loop-shaped support structure (Figures 23A-E: resecting loop assembly 12’) is defined by a pair of immediately adjacent flexible struts (Figures 23A-E: electrodes 560 and 562) joined to one another via a respective polymer tubing placed over respective distal ends of each flexible strut (Figure 23A: insulating spacer 564 and [0082]: “The washers may be separated by thin concentric insulating spacers (e.g., anodized aluminum, silicone rubber, ceramic, glass, glass ceramic, plastic, etc.)”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Townley so that each loop-shaped support structure is defined by a pair of immediately adjacent flexible struts joined to one another via a respective polymer tubing placed over respective distal ends of each flexible strut as taught by Woloszko so that each loop can be connected to both poles of the output of the power supply to deliver a current which affects tissue cutting, ablation, shrinkage and/or coagulation (Woloszko [0122]).
Further, Chou teaches a device (Figure 9A) wherein the member is a flexible printed circuit board (PCB) that comprises a PCB substrate (Figure 2A: flex-PCB substrate 200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed by Townley so that the member is a flexible printed circuit board (PCB) that comprises a PCB substrate as taught by Chou for enhanced flexibility and reduced cost (Chou [0141]).
Regarding claim 3, Townley in view of Woloszko and Chou discloses the device of claim 1, and Chou further discloses a device wherein each flexible PCB member comprises one or more electrical communication paths positioned at least on or within the PCB substrate ([0080]) and selectively coupling the one or more pairs of bipolar electrodes to a corresponding one or more electrical contacts ([0086]) configured to electrically couple the one or more pairs of bipolar electrodes to a controller (Figure 1: electronic module 360 and [0075] and [0078]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Townley so that each flexible PCB member comprises one or more electrical communication paths positioned at least on or within the PCB substrate and selectively coupling the one or more pairs of bipolar electrodes to a corresponding one or more electrical contacts as taught by Chou for enhanced flexibility and reduced cost (Chou [0141]).
Regarding claim 7, Townley in view of Woloszko and Chou discloses the device of claim 1, and Chou further discloses a device wherein PCB substrate of each flexible PCB members comprises a flexible material (Figure 2A: flex-PCB substrate 200) configured to correspondingly transition from a collapsed configuration to a deployed configuration upon movement of the segment to an expanded configuration (Figure 9A).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Townley so that each PCB substrate of each flexible PCB members comprises a flexible material configured to correspondingly transition from a collapsed configuration to a deployed configuration upon movement of the segment to an expanded configuration as taught by Chou for enhanced flexibility and reduced cost (Chou [0141]).
Regarding claim 13, Townley in view of Woloszko and Chou discloses the device of claim 1, and Townley further discloses a device wherein each flexible strut comprises a deformable wire ([0073]: “When each of the electrodes 444 is independently controlled, each electrode 444 couples to a corresponding wire that extends through the shaft 408.” And [0123]).
Regarding claim 14, Townley in view of Woloszko and Chou discloses the device of claim 13, and Townley further teaches a device (Figure 4) wherein the deformable wire comprises a shape memory material ([0070]: “The individual struts 440 can be made from a resilient material, such as a shape-memory material (e.g., Nitinol) that allows the struts 440 to self-expand into the desired shape of the basket 442 when in the expanded state.”).
Regarding claim 15, Townley in view of Woloszko and Chou discloses the device of claim 14, and Chou further discloses a device wherein each flexible PCB member is fixedly coupled to a respective flexible strut via an adhesive (Claim 44).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Townley so that each flexible PCB member is fixedly coupled to a respective flexible strut via an adhesive as taught by Chou for enhanced flexibility and reduced cost (Chou [0141]).
Regarding claim 18, Townley in view of Woloszko and Chou discloses the device of claim 1, and Townley further discloses a device wherein the one or more pairs of bipolar electrodes are configured to deliver radiofrequency (RF) energy (Claim 2).
Regarding claim 19, Townley in view of Woloszko and Chou discloses the device of claim 1, and Chou further discloses a device wherein at least one flexible PCB members comprise: a first subset of a plurality of elements provided on the PCB substrate and configured to deliver non-therapeutic stimulating energy to tissue at the one or more target sites at a frequency for locating target tissue and non-target tissue ([0151]); and a second subset of a plurality of elements provided on the PCB substrate and configured to sense properties of at least one of the target tissue and non-target tissue in response to the non-therapeutic stimulating energy ([0084]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the device disclosed by Townley so that a first subset of a plurality of elements provided on the PCB substrate are configured to deliver non-therapeutic stimulating energy to tissue at the one or more target sites at a frequency for locating target tissue and non-target tissue and a second subset of a plurality of elements provided on the PCB substrate are configured to sense properties of at least one of the target tissue and non-target tissue in response to the non-therapeutic stimulating energy as taught by Chou to create a three-dimensional display of the anatomical location of the tissue (Chou [0151]).
Regarding claim 93, Townley discloses a system for treating a condition within a sino-nasal cavity of a patient (Figures 2-4), the system comprising: a treatment device comprising an end effector (Figure 4) dimensioned for insertion into a sino-nasal cavity of the patient, the end effector comprising a retractable and expandable segment (Figure 4: basket 442) arranged at a distal portion of a shaft (Figure 4: shaft 408) of the treatment device, the retractable and expandable segment comprising: a framework of a plurality of loop-shaped support structures (Figure 4: branches 446) transformable between a low-profile delivery state and an expanded state ([0066]: “The therapeutic assembly 412 includes a plurality of struts 440 that are spaced apart from each other to form a frame or basket 442 when the therapeutic assembly 412 is in the expanded state.”), wherein, when in the expanded state, the plurality of loop-shaped support structures cooperatively form an open-ended circumferential shape ([0067]: “For example, when in the expanded state, the struts 440 can form an ovoid shape, a hemispherical shape, a cylindrical structure, a pyramid structure, and/or other suitable shapes.”), wherein each loop-shaped support structure is defined by a pair of immediately adjacent flexible struts joined to one another (Figure 4: struts 440 and [0067]: “each of the branches 446 includes two struts 440 positioned adjacent to each other”); and a plurality of members coupled to the plurality of loop-shaped support structures (Figure 4: electrodes 444), wherein each flexible strut of a pair of flexible struts of a loop-shaped support structure comprises a respective one of the plurality of members fixedly coupled thereto (Figure 4: each strut 440 has an electrode 444 coupled to it), wherein each member comprises one or more pairs of bipolar electrodes (Figure 4: each strut 440 has at least one pair of electrodes 444) positioned along a length thereof for delivering energy to one or more target sites within the sino-nasal cavity of the patient ([0066]: “In the expanded state, the struts 440 can position at least two of the electrodes 444 against tissue at a target site within the nasal region (e.g., proximate to the palatine bone inferior to the SPF). The electrodes 444 can apply bipolar or multi-polar radiofrequency (RF) energy to the target site to therapeutically modulate postganglionic parasympathetic nerves that innervate the nasal mucosa proximate to the target site”); and a controller operably coupled to the treatment device and configured to control operation thereof (Figure 2: controller 218 [0046]). Townley does not explicitly disclose a system wherein each loop-shaped support structure is defined by a pair of immediately adjacent flexible struts joined to one another via a respective polymer tubing placed over respective distal ends of each flexible strut; or wherein the member is a flexible printed circuit board (PCB) that comprises a PCB substrate.
However, Woloszko teaches a system (Figures 23A-E) wherein each loop-shaped support structure (Figures 23A-E: resecting loop assembly 12’) is defined by a pair of immediately adjacent flexible struts (Figures 23A-E: electrodes 560 and 562) joined to one another via a respective polymer tubing placed over respective distal ends of each flexible strut (Figure 23A: insulating spacer 564 and [0082]: “The washers may be separated by thin concentric insulating spacers (e.g., anodized aluminum, silicone rubber, ceramic, glass, glass ceramic, plastic, etc.)”).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Townley so that each loop-shaped support structure is defined by a pair of immediately adjacent flexible struts joined to one another via a respective polymer tubing placed over respective distal ends of each flexible strut as taught by Woloszko so that each loop can be connected to both poles of the output of the power supply to deliver a current which affects tissue cutting, ablation, shrinkage and/or coagulation (Woloszko [0122]).
Further, Chou teaches a system (Figure 9A) wherein the member is a flexible printed circuit board (PCB) that comprises a PCB substrate (Figure 2A: flex-PCB substrate 200).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to modify the system disclosed by Townley so that the member is a flexible printed circuit board (PCB) that comprises a PCB substrate as taught by Chou for enhanced flexibility and reduced cost (Chou [0141]).
Regarding claim 94, Townley in view of Woloszko and Chou discloses the system of claim 93, and Chou further discloses a system wherein each flexible PCB member comprises one or more electrical communication paths positioned at least on or within the PCB substrate ([0080]) and selectively coupling the one or more pairs of bipolar electrodes to a corresponding one or more electrical contacts ([0086]) configured to electrically couple the one or more pairs of bipolar electrodes to the controller (Figure 1: electronic module 360 and [0075] and [0078]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Townley so that each flexible PCB member comprises one or more electrical communication paths positioned at least on or within the PCB substrate and selectively coupling the one or more pairs of bipolar electrodes to a corresponding one or more electrical contacts as taught by Chou for enhanced flexibility and reduced cost (Chou [0141]).
Regarding claim 95, Townley in view of Woloszko and Chou discloses the system of claim 93, and Chou further discloses a system wherein the PCB substrate comprises a flexible material (Figure 2A: flex-PCB substrate 200) configured to correspondingly transition from a collapsed configuration to a deployed configuration upon movement of the segment to an expanded configuration (Figure 9A).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Townley so that each PCB substrate of each flexible PCB members comprises a flexible material configured to correspondingly transition from a collapsed configuration to a deployed configuration upon movement of the segment to an expanded configuration as taught by Chou for enhanced flexibility and reduced cost (Chou [0141]).
Regarding claim 96, Townley in view of Woloszko and Chou discloses the system of claim 93, and Townley further discloses a system wherein the treatment device further comprises a handle (Figure 2: handle 210) with which an operator can manipulate the end effector ([0069]) and control emission of RF energy therefrom ([0046]: “the controller 218 can be carried by the handle 210 of the therapeutic neuromodulation device 202”).
Regarding claim 97, Townley in view of Woloszko and Chou discloses the system of claim 93, and Townley further discloses a system wherein the retractable and expandable segment comprises at least four loop-shaped support structures ([0067]).
Regarding claim 98, Townley in view of Woloszko and Chou discloses the system of claim 93, and Chou further discloses a system wherein at least one flexible PCB member comprises a first subset of a plurality of elements provided on the PCB substrate and configured to deliver non- therapeutic stimulating energy to tissue at the one or more target sites at a frequency for locating target tissue and non-target tissue ([0151]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Townley so that a first subset of a plurality of elements provided on the PCB substrate are configured to deliver non-therapeutic stimulating energy to tissue at the one or more target sites at a frequency for locating target tissue and non-target tissue as taught by Chou to create a three-dimensional display of the anatomical location of the tissue (Chou [0151]).
Regarding claim 99, Townley in view of Woloszko and Chou discloses the system of claim 98, and Chou further discloses a system wherein the at least one flexible PCB member comprises a second subset of a plurality of elements provided on the PCB substrate and configured to sense properties of at least one of the target tissue and non-target tissue in response to the non- therapeutic stimulating energy ([0084]).
It would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to modify the system disclosed by Townley so that a second subset of a plurality of elements provided on the PCB substrate are configured to sense properties of at least one of the target tissue and non-target tissue in response to the non- therapeutic stimulating energy as taught by Chou to create a three-dimensional display of the anatomical location of the tissue (Chou [0151]).
Regarding claim 100, Townley in view of Woloszko and Chou discloses the system of claim 93, and Townley further discloses a system wherein the controller is configured to: control emission of RF energy from at least one pair of bipolar electrodes for the detection of one or more properties of tissue at the target site; and control delivery of a plurality of treatment applications comprising emission of RF energy from at least one pair of bipolar electrodes for altering transmission of signals through the target tissue at the one or more target sites ([0046]-[0047] and [0072]).
Regarding claim 101, Townley in view of Woloszko and Chou discloses the system of claim 93, and Townley further discloses a system further comprising a console unit operably coupled to the treatment device via the controller (Figure 2: console 204).
Regarding claim 102, Townley in view of Woloszko and Chou discloses the system of claim 93, and Townley further discloses a system wherein the console unit comprises an energy generator configured to generate RF energy to be delivered by at least one pair of bipolar electrodes (Figure 2: energy generator 216).
Regarding claim 103, Townley in view of Woloszko and Chou discloses the system of claim 93, and Townley further discloses a system wherein the console unit comprises a user interface to control, monitor, and regulate RF energy delivery to tissue by the treatment device (Figure 2: display 222 and [0047]).
Conclusion
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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