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 .
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 Objections
Claim 24 is objected to because of the following informalities: “receive a user unput” in line 2 should be amended to –receive a user input--. Appropriate correction is required.
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 2-4 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 2 recites the limitation "the targeted tissue". There is insufficient antecedent basis for this limitation in the claim.
Claims 3 and 4 are rejected by virtue of their dependency on an indefinite base claim.
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.
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 1-4, 7 and 15-22 are rejected under 35 U.S.C. 103 as being unpatentable over Fox et al. (US 2018/0103994) in view of Arena et al. (US 2012/0109122).
Regarding claim 1, Fox discloses a pulsed field electroporation (PFE) system configured to deliver PFE pulses to nasal tissue (see Figs. 1-3), comprising: a handheld PFE tool having a handle (see handle 110, Fig. 3), an elongated shaft extending distally from the handle toward a bendable distal shaft portion (see proximal end of cannula 102 extending distally towards a bendable distal cannula portion as shown in Figs. 1 and 2), and a bulbous treatment tip extending distally from the bendable distal shaft portion (see bulbous portion that electrodes 104 are disposed on, Fig. 2) and having a PFE electrode configured to deliver PFE pulses to nasal tissue adjacent to the bulbous treatment tip (see nerve stimulating electrodes 104 configured to deliver pulses to adjacent nasal tissue, [0018], [0063], and [0084]); and a PFE control console configured to receive a connector of the handheld PFE tool (see 304; [0063], Fig. 3), the PFE control console including a user interface display (see Fig. 14) and a PFE generator (see outputting of the pulsed field according to the predefined pattern of pulses via electrical source circuitry of the electrical source 304 in Fox) configured to output from the PFE electrode a pulsed field according to a predefined pattern of pulses (see preselected voltage, pulse rate, and current, [0084]). However, Fox fails to specifically disclose the bulbous treatment tip having a maximum lateral width of less than 5 mm and the pulses as having a voltage within a range from 850 V to 10,000 V and a pulse duration of 0.05 microseconds (µs) to 3 µs to induce irreversible electroporation in the nasal tissue.
Arena teaches a method of inducing irreversible electroporation in tissue using a predefined pattern of pulses having a voltage of 2600 V (see [0093]) and a pulse duration in the range of about 2 MHz (250 ns) to about 500 kHz (1 µs) (see [0023] and [0028]) administered in pulse bursts having a duration of less than 10 milliseconds (see [0021], see also Fig. 2). Therefore, it would have been obvious to one having ordinary skill in the art before the time of filing to modify the electrodes as taught by Fox to perform the ablation via a predefined pattern of pulses, the pulses as having a voltage within a range from 850 V to 10,000 V and a pulse duration of 0.05 microseconds (µs) to 3 µs to apply the proper field strength such that they induce irreversible electroporation in the nasal tissue as a matter of simple substitution of one ablation type for another with the added benefit of non-thermal ablation without causing nerve excitation or muscle contraction (see Arena [0015]), and further 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. See MPEP 2144.05.
Fox fails to specifically teach the bulbous treatment tip having a maximum lateral width of less than 5 mm, however it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to cause the bulbous treatment tip of Fox to have a maximum lateral width of less than 5 mm since it has been held that “where the only difference between the prior art and the claims was a recitation of relative dimensions of the claimed device and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device” Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 SPQ 232 (1984). In the instant case, the device of Fox would not operate differently with the claimed diameter and since the bulbous treatment tip is designed to be placed in the nasal passageway and sizing the treatment tip to be the appropriate size to reach the desired treatment site would only result in the treatment tip functioning appropriately when having the claimed diameter. Further, applicant places no particular criticality on the range claimed, indicating simply that the diameter “can” be within the claimed range (specification as filed [0077]).
Regarding claim 2, Fox in view of Arena further teaches wherein the PFE generator is configured to output from the PFE electrode the pulsed field to induce apoptosis in the nasal tissue without changing a targeted tissue treatment temperature of the nasal tissue more than 5 degrees C (see Arena: “non-thermal”, [0015]).
Regarding claim 3, Fox further discloses wherein the PFE control console is connectable to an endoscope system to receive medical image data from the endoscope system such that endoscopic images of the treatment tip of the handheld PFE tool are displayed at the user interface display of the PFE control console (see verification of contact of the electrodes with the tissue using endoscope 200, [0061]-[0062], Fig. 2).
Regarding claim 4, Fox further discloses wherein the bulbous treatment tip has a rigid shape (see predetermined spacing between electrode, therefore the shape must be rigid to set this spacing, [0070]) with a single PFE electrode exposed along an exterior of the bulbous treatment tip (see single electrode 604A exposed along an exterior of the tip, Fig. 6), the maximum width of the bulbous treatment tip being 2 mm to 4 mm (this is considered obvious under the same rationale as that applied to the range of the diameter as set in the rejection of claim 1 above).
Regarding claim 7, Fox in view of Arena further teaches outputting the pulsed field so that the predefined pattern of pulses comprises a sequence of bursts of electrical pulses, and wherein each burst of electrical pulses comprises a high-frequency pulse train (see Arena: frequency window of 250 kHz to 2 MHz, [0079]).
Regarding claim 15, Fox in view of Arena further teaches wherein each electrical pulse of the high-frequency pulse train comprises a monophasic waveform (see Fig. 15C).
Regarding claims 16-19, Fox in view of Arena further teaches wherein each electrical pulse of the predefined pattern of pulses comprises a biphasic waveform, wherein the electrical pulses of the high-frequency pulse train alternate between having a positive amplitude and having a negative amplitude, wherein the pulsed field comprises a sequence of bursts of electrical pulses, and wherein each burst of electrical pulses of the sequence of bursts of electrical pulses comprises a plurality of pulse groups, and wherein each pulse group of the plurality of pulse groups comprises first pulse having a positive polarity followed by a second pulse having a negative polarity (see alternating pulse polarities in Arena [0028] comprising a biphasic waveform, see also pulses and groups of pulses in Arena Figs. 2 and 15B-C).
Regarding claims 20 and 21, Fox in view of Arena further teaches wherein each pulse group of the plurality of pulse groups comprises first pulse having a positive polarity, followed by a second pulse having a negative polarity, followed by a third pulse having a positive polarity, and wherein each pulse group of the plurality of pulse groups comprises first pulse having a negative polarity, followed by a second pulse having a positive polarity, followed by a third pulse having a negative polarity (since the positive and following negative, or negative followed by positive pulses can be chosen within the alternating waveforms taught by Arena in Fig. 15C).
Regarding claim 22, Fox further discloses wherein an angle of the bendable distal shaft portion is adjustable (see angle of the bendable shaft being bendable to be more transverse in Fig. 2 relative to the central axis of the straight configuration in Fig. 3 in order to insert the bulbous treatment tip is insertable into the nasal passageway as shown in Fig. 2).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Fox in view of Arena and in further view of Deem et al. (US 2006/0041277).
Regarding claim 5, Fox in view of Arena teaches the limitations of claim 1, however fails to teach wherein the PFE control console is connectable to a return electrode pad configured to adhere to a skin of a patient, and wherein the PFE generator is configured to output the pulsed field from the PFE electrode to induce irreversible electroporation in the nasal tissue of the patient so that the pulsed field returns to the PFE control console via the return electrode pad on the skin of the patient.
Deem teaches a method of delivering pulsed electrical therapy including inducing irreversible electroporation (see [0082] and [0090]-[0092]) wherein the method includes connecting a return electrode pad configured to be attached to the patient to a control console in order to return the pulsed field to the control console via the return pad (see [0090]-[0092], Fig. 2). 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 the method as taught by Fox in view of Arena to have further included connecting the PFE control console to a return electrode pad configured to adhere to a skin of the patient; and outputting the pulsed field according to the predefined pattern of pulses from the PFE electrode to induce irreversible electroporation in the nasal tissue of the patient so that the pulsed field returns to the PFE control console via the return electrode pad on the skin of the patient in light of Deem, the motivation being to provide the additional functionality of operating the device in a bipolar or monopolar mode as desired (see Deem [0090]).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fox in view of Arena and in further view of Deem and Mayer et al. (US 2019/0247680).
Regarding claim 6, Fox in view of Arena, and Deem teaches the limitations of claim 5, however fails to teach wherein the PFE control console is connectable to a footswitch, and wherein the PFE control console is configured to activate the PFE generator for outputting the pulsed field in response to receiving a user input via the footswitch.
Mayer teaches a therapeutic therapy device (see Fig. 7) which is controlled by a footswitch connected to the control console which controls the RF generator to output RF power (see user input device as a footswitch; [0113], [0333], Fig. 7). 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 the method as taught by Fox in view of Arena, and Deem to have included activating, based on receiving a user input to the footswitch connected to the PFE console, the PFE generator for outputting the pulsed field according to the predefined pattern of pulses via the PFE electrode in light of Mayer since one of ordinary skill in the art could have combined the prior art elements according to known methods for the predictable result of providing a suitable user input device to trigger treatment to commence.
Claims 23-25 are rejected under 35 U.S.C. 103 as being unpatentable over Fox in view of Arena and in further view of Avitall (US 5,327,905).
Regarding claim 23, Fox in view of Arena further teaches the bendable shaft portion maintaining a non-parallel position relative to the proximal portion of the elongated shaft extending from the handle (see Fox: Figs. 2-3). However, Fox in view of Arena fails to specifically teach wherein the angle of the bendable distal shaft portion is adjustable in response to pressure applied to the bendable distal shaft portion.
Avitall teaches a surgical device having a shaft (see Fig. 1) that has its angle adjusted via user-applied bending force through sliding a handle member (see handle member 18, Fig. 1) relative to the handle longitudinally (see col. 6, lines 24-34, Fig. 1). 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 the method as taught by Fox in view of Arena to have included adjusting the angle of the bendable distal shaft portion in response to a user-applied bending force as claimed in light of Avitall since one of ordinary skill in the art could have combined the prior art elements according to known methods for the predictable result of providing a suitable mechanism for bending control of the treatment tip portion of the device.
Regarding claims 24 and 25, the claims are rejected under the same rationale and teachings as those relied upon in the rejection of claim 23 above.
Allowable Subject Matter
Claims 8-14 are 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: The closest prior art of record, Fox et al. (US 2018/0103994), Arena et al. (US 2012/0109122), Long et al. (US 2011/0160514), and Palushi et al. (US 2022/0087739), fails to reasonably teach or suggest wherein the bursts of electrical pulses occur at a first frequency, and wherein the electrical pulses of each high-frequency pulse train occur at a second frequency greater than the first frequency, or wherein outputting the sequence of bursts of electrical pulses comprises: defining a predefined gap within the sequence between consecutive high-frequency pulse trains, and defining a pulse gap between consecutive PFE pulses within each the high-frequency pulse train, the pulse gap being shorter than the predefined gap that occurs between consecutive high-frequency pulse trains when considered in combination with the cumulative requirements of the claims, respectively.
Conclusion
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794