DETAILED ACTION
The following is a Non-Final Office Action on the merits.
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 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.
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 4/29/2025 has been entered.
Response to Amendment
Acknowledgment is made to the amendment received 4/29/2025.
Applicant’s amendments are sufficient to overcome the claim objections set forth in the previous office action.
Claim Interpretation
Claims 4, 6, 8, 12, 14 & 16 recite limitations directed to the structure of the claimed “tissue”, and specifically where the structure is an artery. Since claims 1 & 9 are directed to a product, claims 4, 6, 8, 12. 14 & 16 are considered to further limit claims 1 & 9 since arteries fall within a range of dimensions, and the specific dimensions claimed in the dependent claims, and thus, the product of claims 1 & 9 must be configured to curl around the tissue having those cited dimensions. The Examiner notes that the “tissue” is recited as functional language only in claims 1 & 9.
Claims 5, 7, 13 & 15 recite limitations directed to a size of the thermal boundary. Since claims 1 & 9 are directed to a product, claims 5, 7, 13 & 15 are considered to further limit claims 1 & 9 since specific energy delivery parameters correspond to the claimed sizes.
Claim 9 recites the limitation “arranged in parallel to each other with a predetermined distance”. The phrase “predetermined distance” is interpreted as the distance between the electrodes arranged in parallel.
Claim Objections
Claim 1 is objected to because of the following informalities: amend “the tissue and a substrate” to -the tissue; and a substrate- in ll. 11. Appropriate correction is required.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim(s) 1-16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Toth et al. (2015/0224326, previously cited) in view of Mrva et al. (2006/0030919, previously cited) and Cao et al. (2015/0119882, previously cited).
Concerning claim 1, as illustrated in Fig. 8a-9b, Toth et al. disclose a catheter apparatus for perivascular nerve denervation (self-wrapping tool 810/910; [0180], [0275-0276]), comprising:
a loop disposed near the distal end and configured to curl around a tissue and receive, via the shaft, energy for the perivascular nerve denervation to denervate at least a portion of the tissue, wherein the loop includes: a body capable of bending to curl around an outer circumference of the tissue; a plurality of electrodes disposed on the body; a substrate embedded in the body and separated from the plurality of electrodes, and wherein the loop is configured to perform the perivascular nerve denervation at a temperature of 480 C to 650 C for 70 to 150 seconds to denervate while preventing thermal damage to tunica intima or a lumen of the tissue (self-wrapping surgical tool 810 curls around to capture vessel 7 and comprises parallelly spaced electrodes 830 that directly contact tissue and are separated by insulating regions 835 and disposed on thin, flexible actuator layers 840, 845, where thermal energy is localized between any two of the plurality of electrodes 830 when activated in a bipolar manner, or self-wrapping surgical tool 910 curls around to capture vessel 7 and comprises parallelly spaced electrodes 930 that directly contact tissue and also comprises a soft backing material 915 and a central member (film, filament, etc.); [0196], [0274-0276]).
Toth et al. fail to specifically disclose a shaft having a distal end in the embodiment of Fig. 8A-B. However, in the embodiment of Fig. 16, Toth et al. disclose a catheter tool (1640) delivered to a location by emerging from a delivery catheter shaft (1655). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the embodiment of Fig. 8A-C of Toth et al. to further comprise a shaft having a distal end in order to provide the benefit delivering the tool to a desired location as taught by Toth et al. ([0293]; Fig. 16).
Toth et al. fail to disclose the loop body capable of bending to curl onto itself. However, Mrva et al. disclose a catheter apparatus for perivascular nerve denervation comprising a body loop capable of bending to curl around an outer circumference of a tissue (N) and onto itself. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Toth et al. such that the loop body is capable of bending to curl onto itself in order to provide the benefit of snugly wrapping the body around the targeted tissue without causing damage or trauma so the electrodes make and sustain circumferential contact substantially about the entire periphery of the tissue for a complete motor block as taught by Mrva et al. ([0007], [0036], [0038], [0040]; Fig. 1 & 3A])
Toth et al. in view of Mrva et al. fail to disclose a sensor disposed on the body at a position corresponding to between the plurality of electrodes, the sensor configured to sense at least one of impedance of the plurality of electrodes or the temperature of the tissue from outside the tissue. However, Cao et al. disclose a catheter apparatus for nerve denervation comprising a plurality of electrodes (322) disposed on a first film (306) and arranged parallel to each other and a temperature sensor (326) disposed at a position corresponding to a position between the plurality of electrodes (322). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Toth et al. in view of Mrva et al. to further comprise a sensor disposed at a position corresponding to a position between the plurality of electrodes in order to provide the benefit of measuring temperature representative of the plurality of electrodes and/or tissue adjacent to and/or in contact with the plurality of electrodes as taught by Cao et al. ([0057], [0059-0060]; Fig. 7).
Concerning claim 2, Toth et al. disclose the nerve denervation can be performed at the loop temperature of 48 C to 50 C for 120 to 150 seconds when catheter (810) can be connected to an appropriate power source to achieve the desired temperature for the desired duration ([0199]).
Concerning claim 3, Toth et al. disclose the nerve denervation is performed at the loop temperature of 60 C to 65 C for 70 to 120 seconds when catheter (810) can be connected to an appropriate power source to achieve the desired temperature for the desired duration ([0199]).
Concerning claim 4, Toth et al. disclose the catheter (810) capable of being used with tissue that is an artery including a lumen, a tunica media and a tunica adventitia ([0024]).
Concerning claim 5, Toth et al. disclose a thermal lesion boundary between the tunica media and the tunica adventitia is 1.3 mm to 1.5 mm when catheter (810) can be connected to an appropriate power source to achieve the desired temperature for the desired duration ([0199]).
Concerning claim 6, Toth et al. disclose the catheter (810) capable of being used with a lumen has a diameter of 2 mm, a tunica media has a thickness of 0.5 mm and a tunica adventitia has a thickness of 1 mm ([0024]).
Concerning claim 7, Toth et al. disclose a thermal lesion boundary between the tunica media and the tunica adventitia is 1.1 mm to 1.3 mm when catheter (810) can be connected to an appropriate power source to achieve the desired temperature for the desired duration ([0199]).
Concerning claim , Toth et al. disclose the catheter (810) capable of being used with the lumen has a diameter of 1.4 mm, a tunica media has a thickness of 0.6 mm and a tunica adventitia has a thickness of 1.2 mm ([0024]).
Concerning claim 9, as illustrated in Fig. 8a-9b, Toth et al. disclose a catheter apparatus for perivascular nerve denervation (self-wrapping tool 810/910; [0180], [0275-0276]), comprising:
a loop disposed near the distal end and configured to curl around an outer circumference of a tissue and receive, via the shaft, energy to denervate at least a portion of the tissue, wherein the loop includes: a first film capable of bending to curl around the tissue; a plurality of electrodes disposed on the first film and arranged in parallel to each other with a predetermined distance; and wherein the loop is configured to perform the perivascular nerve denervation at a temperature of 480 C to 650 C for 70 to 150 seconds to denervate while preventing thermal damage to tunica intima or a lumen of the tissue (self-wrapping surgical tool 810 curls around to capture vessel 7 and comprises parallelly spaced electrodes 830 that directly contact tissue and are separated by insulating regions 835 and disposed on thin, flexible actuator layers 840, 845, where thermal energy is localized between any two of the plurality of electrodes 830 when activated in a bipolar manner, or self-wrapping surgical tool 910 curls around to capture vessel 7 and comprises parallelly spaced electrodes 930 that directly contact tissue and also comprises a soft backing material 915 and a central member (film, filament, etc.); [0196]; [0274-0276]).
Toth et al. fail to specifically disclose a shaft having a distal end in the embodiment of Fig. 8A-B. However, in the embodiment of Fig. 16, Toth et al. disclose a catheter tool (1640) delivered to a location by emerging from a delivery catheter shaft (1655). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of the embodiment of Fig. 8A-C of Toth et al. to further comprise a shaft having a distal end in order to provide the benefit delivering the tool to a desired location as taught by Toth et al. ([0293]; Fig. 16).
Toth et al. fail to disclose the loop body capable of bending to curl onto itself. However, Mrva et al. disclose a catheter apparatus for perivascular nerve denervation comprising a body loop capable of bending to curl around an outer circumferent of a tissue (N) and onto itself. At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Toth et al. such that the loop body is capable of bending to curl onto itself in order to provide the benefit of snugly wrapping the body around the targeted tissue without causing damage or trauma so the electrodes make and sustain circumferential contact substantially about the entire periphery of the tissue for a complete motor block as taught by Mrva et al. ([0007], [0036], [0038], [0040]; Fig. 1 & 3A])
Toth et al. in view of Mrva et al. fail to disclose a sensor disposed at a position corresponding to a position between the plurality of electrodes, the sensor configured to sense at least one of impedance of the plurality of electrodes or the temperature of the tissue from outside the tissue. However, Cao et al. disclose a catheter apparatus for nerve denervation comprising a plurality of electrodes (322) disposed on a first film (306) and arranged parallel to each other and a temperature sensor (326) disposed at a position corresponding to a position between the plurality of electrodes (322). At the time the invention was effectively filed, it would have been obvious to one of ordinary skill in the art to modify the invention of Toth et al. in view of Mrva et al. to further comprise a sensor disposed at a position corresponding to a position between the plurality of electrodes in order to provide the benefit of measuring temperature representative of the plurality of electrodes and/or tissue adjacent to and/or in contact with the plurality of electrodes as taught by Cao et al. ([0057], [0059-0060]; Fig. 7).
Claim 10 is rejected upon the same rationale as provided for claim 2.
Claim 11 is rejected upon the same rationale as provided for claim 3.
Claim 12 is rejected upon the same rationale as provided for claim 4.
Claim 13 is rejected upon the same rationale as provided for claim 5.
Claim 14 is rejected upon the same rationale as provided for claim 6.
Claim 15 is rejected upon the same rationale as provided for claim 7.
Claim 16 is rejected upon the same rationale as provided for claim 8.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-16 have 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.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Ng et al. (2018/0318578) and Schuettler et al. (2019/0059820) both disclose overlapping nerve cuffs.
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794