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 .
Response to Amendment
Acknowledgment is made to the amendment received 9/17/2025.
Response to Arguments
Applicant’s arguments with respect to claim 1 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. Previously, claim 1 was rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley. 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 Chou.
Claim Objections
Claim 1 is objected to because of the following informalities: Line 14: “each flexible PCB member for delivering” should read –wherein each flexible PCB member is configured for delivering--. Appropriate correction is required.
The numbering of claims is not in accordance with 37 CFR 1.126 which requires the original numbering of the claims to be preserved throughout the prosecution. When claims are canceled, the remaining claims must not be renumbered. When new claims are presented, they must be numbered consecutively beginning with the number next following the highest numbered claims previously presented (whether entered or not). Currently, there are two claims numbered as “102”. For examination purposes, the second claim labeled “102” will be considered claim 103.
Misnumbered claim 102 been renumbered 103.
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 1, 3, 7, 13-15, 18-19, and 93-103 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.
Regarding claim 1, the claim recites the limitation “each flexible PCB member" in lines 14 and 15-16. However, line 12 of the claim recites “a flexible PCB member”. The word “each” indicates that there are multiple flexible PCB members, but only one flexible PCB member is claimed in line 12. Additionally, lines 1-2 of claim 3, lines 1-2 of claim 7, and lines 1-2 of claim 15 also use the language “each flexible PCB member”. Clarity is needed.
Regarding dependent claims 3, 7, 13-15, and 18-19, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Regarding claim 93, the claim recites the limitation “each flexible PCB member" in lines 14-15. However, line 13 of the claim recites “a flexible PCB member”. The word “each” indicates that there are multiple flexible PCB members, but only one flexible PCB member is claimed in line 13. Additionally, line 1 of claim 94 also uses the language “each flexible PCB member”. Clarity is needed.
Regarding dependent claims 94-103, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
Claims 19 and 98 recite the limitation "at least one flexible PCB member" in lines 1-2 and line 1, respectively. It is unclear if this the same flexible PCB member claimed in line 12 of claim 1 or line 13 of claim 93, respectively. Clarity is needed.
Regarding dependent claim 99, dependent claims inherit the deficiencies from the claims from which they depend and are similarly rejected over 35 U.S.C. 112(b).
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 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 (Figure 4: struts 440) joined to one another via a tubing placed over respective distal ends of each flexible strut (Figure 4: support member 448 is placed over the distal ends of each strut 440); and a member fixedly coupled to each flexible strut of a pair of flexible struts of a loop-shaped support structure (Figure 4: electrodes 444), 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 the tubing is a polymer tubing or wherein the member is a flexible printed circuit board (PCB) that comprises a PCB substrate.
However, Chou teaches a device (Figure 9A) wherein the tubing is a polymer tubing (Figure 9A: flexible shaft 114 and [0147]) or 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 tubing of Townley so that it is specifically polymer tubing, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331. It would have also 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 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 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 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 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 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 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 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 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 (Figure 4: struts 440) joined to one another via a tubing placed over respective distal ends of each flexible strut (Figure 4: support member 448 is placed over the distal ends of each strut 440); ; and a member fixedly coupled to each flexible strut of a pair of flexible struts of a loop-shaped support structure (Figure 4: electrodes 444), 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”) 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 the tubing is a polymer tubing or wherein the member is a flexible printed circuit board (PCB) that comprises a PCB substrate.
However, Chou teaches a system (Figures 1 and 9A) wherein the tubing is a polymer tubing (Figure 9A: flexible shaft 114 and [0147]) or 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 tubing of Townley so that it is specifically polymer tubing, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416. See also Ballas Liquidating Co. v. Allied industries of Kansas, Inc. (DC Kans) 205 USPQ 331. It would have also 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 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 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 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 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 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 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 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 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 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 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 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
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.
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/N.W.R./Examiner, Art Unit 3794
/SEAN W COLLINS/Primary Examiner, Art Unit 3794