DETAILED ACTION
The amendment filed January 28, 2026, has been entered and fully considered. Claims 1-14 and 23-32 are pending in this application. Claims 1 and 14 have been amended. Claim 32 has been newly added.
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.
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 14 and 29 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Perfler (U.S. PGPub. No. 2017/0151014).
Regarding claim 14, Perfler (Figs. 1-5) discloses an apparatus comprising: an elongate body (4a) extending proximally to distally (Fig. 2); and an applicator region (ablation head 3) at a distal end region of the elongate body (4a), the applicator region (3) comprising: a first wire electrode (3a) formed from a first small profile wire having a first electrically active region (3b) extending between two insulated regions (3c) of the first wire electrode (3a), the two insulated regions (3c) comprising a first one or more arms within or through which at least a portion of the first wire electrode extends (see abstract, “each of the ablation elements or petals (3a) comprises: a continuous ablation electrode (3b) which extends without interruption over a circumferential peripheral portion of each petal (3a) . . . the side portions (3c) and the ablation electrode (3b) being integral with each other.” Also see [0113], “This effect is obtained, for example, by coating the side portions 3c with a layer of electrically insulating material, preferably a paint (not illustrated in the figures).”); and a second wire electrode (3a) formed from a second small profile wire extending distally from the first wire in a delivery configuration (see Fig. 5, as broadly claimed, second wire electrode extends distally from the first wire electrode within the plane perpendicular to the elongate body 4a), the second wire having a second electrically active region (3b) extending between two insulated regions (3c) of the second wire electrode, the two insulated regions (3c) comprising a second one or more arms within or through which at least a portion of the second wire electrode extends (see abstract, “each of the ablation elements or petals (3a) comprises: a continuous ablation electrode (3b) which extends without interruption over a circumferential peripheral portion of each petal (3a) . . . the side portions (3c) and the ablation electrode (3b) being integral with each other.” Also see [0113], “This effect is obtained, for example, by coating the side portions 3c with a layer of electrically insulating material, preferably a paint (not illustrated in the figures).”); wherein the first electrically active region is radially outward of the second electrically active region relative to the elongate body in a deployed configuration (Fig. 5; as broadly claimed, the various active regions extend radially outward relative to each other and to the elongate body in a deployed configuration), further wherein the first and the second one or more arms are shape-set (see [0116]-[0117], for ablation petals made of Nitinol wire that are set into a shape) and configured to maintain the first active region (3b) separated from the second active region (3b) by a minimum distance, d, that is approximately the same along a length of the first electrically active region, to apply a uniform energy density to tissue to be ablated (Fig. 5; As broadly claimed, in the “use” state, the first active region (3b) is separated from the second active region (3b) by a minimum distance, d, that is substantially constant along a length of the first electrically active region), and further wherein the first electrically active region is configured to have a first polarity and the second electrically active region is configured to have a second polarity ((0114], “Each ablation petal 3a is separate and distinct from another ablation petal of the ablation head and all the ablation petals 3 a of the head are connected separately to a separate electric energy generator to cause a radiofrequency ablation under a powered condition of the ablation electrode 3 b.”) and wherein the first electrically active region and the second electrically active region are configured to flexibly conform to a body lumen (see [0116]-[0117], for ablation petals made of Nitinol wire).
Regarding claim 29, Perfler (Figs. 1-5) discloses wherein the first and the second electrically active regions (3b) are curved (see Fig. 5).
Claims 1-7, 10-11, 23, 28, 30 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Townley et al., (‘Townley,” U.S. PGPub. No. 2021/0316137).
Regarding claim 1, Townley (Figs. 1 and 5) discloses an apparatus comprising: an elongate body extending proximally to distally (116); and an applicator region (114, 122) at a distal end region of the elongate body (116), the applicator region comprising :a first wire electrode (136) formed from a first small profile wire (130) having a first elongate uninsulated electrically active length and an adjacent first insulated length ([0094], “In some embodiments, such as illustrated in FIG. 6, a strut may include an outer jacket surrounding a conductive wire, wherein portions of the outer jacket are selectively absent along a length of the strut, thereby exposing the underlying conductive wire so as to act as an energy delivering element (i.e., an electrode)...”), and a second wire electrode (136) formed from a second small profile wire (132) having a second elongate uninsulated electrically active length and an adjacent second insulated length (see [0094]); wherein the first elongate uninsulated electrically active length is adjacent to and distal to the second elongate uninsulated electrically active length in a delivery configuration (Fig. 5D), further wherein the first elongate uninsulated electrically active length (136, 130) is separated from the second elongate uninsulated electrically active length (136, 132) by a minimum distance, d, that is approximately the same along the length of the first uninsulated electrically active length, to apply a uniform energy density to tissue to be ablated, and further wherein the first elongate uninsulated electrically active length is configured to have a first polarity and the second elongate uninsulated electrically active length is configured to have a second polarity. ([0093], “The electrodes 136 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. In various embodiments, the electrodes 136 can be configured to apply pulsed RF energy with a desired duty cycle (e.g., 1 second on/0.5 seconds off) to regulate the temperature increase in the target tissue.” Also see [0095]-[0096]).
Regarding claim 2, Townley discloses wherein the first wire electrode comprises a first loop (130) and the second wire electrode comprises a second loop (132) (Fig. 5D).
Regarding claim 3, Townley discloses wherein the second loop (132) is positioned concentrically within the first loop (130) (Fig. 5D).
Regarding claim 4, Townley discloses the first and second elongate uninsulated electrically active lengths are configured to flexibly conform to a body lumen ([0094], “The first and second segments 122, 124 and the associated struts 130, 132, and 134 can have sufficient rigidity to support the electrodes 136 and position or press the electrodes 136 against tissue at the target site. In addition, 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…”).
Regarding claim 5, Townley (Figs. 5) discloses wherein the first wire electrode (130) and the second wire electrode (132) extend from the elongate body (116) in a plane (Figs. 5).
Regarding claim 6, Townley (Figs. 5) discloses wherein the first wire electrode (130) and the second wire electrode (132) form a flat, paddle shape (Figs. 5).
Regarding claim 7, Townley discloses wherein the first insulated length and/or the elongate body comprises a bend so that the first and second wires extend at an angle to the long axis of the elongate body (see Figs. 5 for wires 130, 132 (void of electrodes 136) at a bend, thereby meeting the limitations of the claim).
Regarding claim 10, Townley discloses wherein the separation between the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length is adjustable ([0094], “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 In addition, the expansion and conformability of the struts 130, 132, 134 can facilitate placing the electrodes 136 in contact with the surrounding tissue at the target site.”).
Regarding claim 11, Townley discloses further comprising one or more mapping electrodes on the applicator region and/or on the elongate body (see [0093] for any number of electrodes 136; [0155], “The mapping/evaluation/feedback algorithms 110 can determine resistance of the tissue by detecting the actual power and current of the load (e.g., via the electrodes 136).”).
Regarding claim 23, Townley discloses wherein the applicator region is configured to deliver non-thermal pulses ([0128], “Desired non-thermal neuromodulation effects may include altering the electrical signals transmitted in a nerve.” As broadly claimed, the generator is capable of providing non-thermal pulses).
Regarding claim 28, Townley discloses wherein the first elongate uninsulated electrically active length (136) and the second elongate uninsulated electrically active length (136) extend approximately transverse to a long axis of the elongate body (116).
Regarding claim 30, Townley discloses wherein the first elongate uninsulated electrically active length (136) and the second elongate uninsulated electrically active length (136) extend between one or more pairs of arms (130, 132) and wherein the one or more pairs of arms are shape-set (Fig. 5D) and configured to maintain the first elongate uninsulated electrically active length (136, 130) separated from the second elongate uninsulated electrically active length (136, 132) by the minimum distance, d (Fig. 5D).
Regarding claim 31, Townley discloses wherein the separation is maintained by at least one of: a shape-set of the applicator region, an extension region, a strut, a spacer, a guide or a channel at a distal end of the elongate body, and/or a bounding by insulated region (As broadly claimed, see distal end of shaft 116 in Fig. 1 and also Fig. 5D for expanded view of guide or channel at a distal end of the elongate body that maintains the desired shape and configuration).
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.
Claims 8-9, 13, 26 and 27 are rejected under 35 U.S.C. 103 as being unpatentable over Townley in view of Townley.
Regarding claim 8, Townley discloses all of the limitations of the apparatus according to claim 1, but is silent regarding wherein the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length have a thickness that is 0.38 mm or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the thickness of the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length as taught by Townley such that each have a thickness that is 0.38 mm or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Townley discloses all of the limitations of the apparatus according to claim 1, but is silent regarding wherein the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length have a thickness that is 0.2 mm or less.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the thickness of the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length as taught by Townley such that each have a thickness that is 0.2 mm or less, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 13, Townley discloses all of the limitations of the apparatus according to claim 1. Townley further discloses “the first and second segments 122, 124 have shapes and sizes when in the expanded configuration that are specifically designed [for the associated tissue site]” ([0097]), but is silent regarding wherein the minimum distance, d, is between 0.5 and 40 mm.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the minimum distance, d, as taught by Townley such that the minimum distance, d, is between 0.5 and 40 mm, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 26, Townley discloses all of the limitations of the apparatus according to claim 1, but is silent regarding wherein the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length are between about 5 mm and 3 cm long.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the elongate uninsulated electrically active lengths as taught by Townley such that the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length are between about 5 mm and 3 cm long, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 27, Townley discloses all of the limitations of the apparatus according to claim 1. Townley further discloses “the first and second segments 122, 124 have shapes and sizes when in the expanded configuration that are specifically designed [for the associated tissue site]” ([0097]), but is silent regarding wherein the first wire electrode and the second wire electrode are 5 cm or longer.
However, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the wire electrode lengths as taught by Townley such that the first wire electrode and the second wire electrode are 5 cm or longer, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Claims 12 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Townley in view of Byrd et al., (hereinafter ‘Byrd,’ U.S. PGPub. No. 2021/0161582).
Regarding claims 12 and 24, Townley discloses wherein the apparatus is configured to couple to a pulse generator (generator 106) configured to provide electrical pulses (see [0072], for pulsed electrical energy; [0093], “…the electrodes 136 can be configured to apply pulsed RF energy with a desired duty cycle (e.g., 1 second on/0.5 seconds off) to regulate the temperature increase in the target tissue.”). Townley further teaches “each electrode can be individually activated and the polarity and amplitude of each electrode can be selected by an operator or a control algorithm (e.g., executed by the controller 107 previously described herein.” ([0095]; also see [0195], “the system 100 can vary pulse-width or amplitude to vary the energy…”).
Townley, however, is silent regarding configured to provide electrical pulses having an amplitude of greater than 0.1 kV and a duration in microsecond or sub-microsecond range, wherein the applicator region is configured to deliver pulses of microsecond, nanosecond and/or picosecond duration.
However, in the same field of endeavor, Byrd (Fig. 1) teaches a similar apparatus wherein the apparatus is configured to couple to a pulse generator (electroporation generator 26) configured to provide electrical pulses having an amplitude of greater than 0.1 kV and a duration in microsecond or sub-microsecond range ([0051], “generator 26 may be configured to produce an electric current that is delivered via electrode assembly 12 as a pulsed electric field in the form of short-duration DC pulses transmitted between closely spaced electrodes (e.g., electrode pairs of electrode assembly 12) and capable of delivering an electric field strength of about 0.1 to 1.0 kV/cm (e.g., at the tissue site).” Also see [0056], “Each of the first phase and second phase has a voltage amplitude of at least 500 volts and a pulse duration of less than 20 microseconds.”). It is well known in the art (as can be seen in Byrd) to provide generators capable of providing electrical pulses within the claimed range in order to provide electroporation to the targeted tissue, “to directly cause an irreversible loss of plasma membrane (cell wall) integrity leading to its breakdown and cell necrosis” and thereby “avoid some possible thermal effects that may occur when using RF energy.” ([0023]-[0024], resulting in improved safety and control).
Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the generator as taught by Townley such that it can provide electrical pulses having an amplitude of greater than 0.1 kV and a duration in microsecond or sub-microsecond range, as taught by Byrd in order to provide electroporation to the targeted tissue, “to directly cause an irreversible loss of plasma membrane (cell wall) integrity leading to its breakdown and cell necrosis” and thereby “avoid some possible thermal effects that may occur when using RF energy.” ([0023]-[0024], resulting in improved safety and control).
Claim 25 is rejected under 35 U.S.C. 103 as being unpatentable over Townley in view Perfler.
Regarding claim 25, Townley discloses all of the limitations of the apparatus according to claim 1, but is silent regarding the first elongate uninsulated electrically active length of the first small profile wire is at least several times longer than a thickness or diameter of the first small profile wire.
However, in the same field of endeavor, Perfler (Figs. 1-5) teaches a similar apparatus comprising a plurality of wires, wherein the first elongate uninsulated electrically active length of the first small profile wire is at least several times longer than a thickness or diameter of the first small profile wire ([0061]-[0064], length L of the active part (circumferential part of the petal, i.e. electrode) ranges from 10 to 25 mm and the relative optimum diameter preferably ranges from 0.20 mm to 0.50 mm, preferably 0.30 mm). Perfler teaches, “[t]his particular ratio linked to the material with which the petal is produced (Nitinol) ensures that optimal electric characteristics are obtained together with an optimum adhesion of the petal on the surface to be treated, so that it is possible to obtain perfectly straight lesions, without necrotized areas.” ([0063]). Therefore, it would have been obvious to one having ordinary skill in the art before the effective filing date to have modified the apparatus as taught by Townley to include the first elongate uninsulated electrically active length of the first small profile wire is at least several times longer than a thickness or diameter of the first small profile wire, as taught by Perfler, in order to provide “optimal electric characteristics . . . together with an optimum adhesion of the petal on the surface to be treated, so that it is possible to obtain perfectly straight lesions, without necrotized areas.” ([0063]), thereby improving accuracy, safety and control.
Allowable Subject Matter
Claim 32 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
The following is a statement of reasons for the indication of allowable subject matter: although Townley teaches a similar apparatus comprising a first elongate uninsulated electrically active length and a second elongate uninsulated electrically active length, the prior art fails to disclose, teach or suggest, in part the specifically claimed configuration “wherein the first elongate uninsulated electrically active length and the second elongate uninsulated electrically active length are substantially parallel within +/- 5 degrees along the length of their respective electrically active regions.”
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-14 and 23-31 have been considered but are moot because the amendment has necessitated a new ground of rejection.
In view of the amendment, Applicant’s arguments that Perfler does not teach independent claim 14 and dependent claim 29 are not found persuasive.
Applicant argues (p. 10-11) Perfler does not “suggest all of the features of claims 14 and 29. Specifically, Perfler does not suggest a least an apparatus including a second wire electrode formed from a second small profile wire extending distally from the first wire in a delivery configuration.” This argument is not found persuasive. Further, Applicant argues that the wire electrodes are located in the same plane so they cannot be distal or proximal to one another. However, it is the Examiner’s position that, as broadly claimed, the distal and proximal points are relative, thus one wire electrode extends from the other. In particular, Perfler provides a second wire electrode (3a) formed from a second small profile wire extending distally from the first wire (3a) in a delivery configuration. As illustrated in Fig. 5, the second wire electrode extends distally from the first wire electrode within the plane perpendicular to the elongate body (4a).
Applicant notes (p. 11), “[i]n Perfler, the distal structure (e.g., positioning head, including arms 2a) are not electrodes.” Examiner does not rely on this portion of the apparatus to meet the claims.
Applicant’s remarks regarding Byrd are moot in view of the rejection. At most, Byrd is relied upon to teach the specifications of the generator in dependent claims 12 and 24.
No further arguments have been set forth regarding the dependent claims.
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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/C.A.D./Examiner, Art Unit 3794
/LINDA C DVORAK/Primary Examiner, Art Unit 3794