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.
Response to Amendment
Acknowledgment is made to the amendment received 1/29/2026.
Applicant's request for reconsideration of the finality of the rejection of the last Office action is persuasive and, therefore, the finality of that action is withdrawn in view of the typographical errors relating the Salahieh et al. reference.
Response to Arguments
Applicant’s arguments with respect to the Salahieh et al. reference and Pars. [0151], [0179] & [0184] are persuasive. The following office action corrects the some of the Par. Citations for the Salahieh et al. prior art reference.
Applicant's arguments have been fully considered, but are moot in view of the new ground(s) of rejection as the cited Salahieh et al. discloses the plurality of pressure sensors located along the axial length of the balloon: “sensors located at or near the electrodes can be incorporated to detect tissue contact with the electrodes or the amount of pressure exerted on the tissue during a procedure” ([0231]). Since the sensors that detect pressure are located “at…the electrodes” and at least Figs. 18, 20, 23, 28 teach electrodes located at different locations along an axial length of the balloon (34), the pressure sensors are thus also located at “different locations along an axial length of the compliant balloon”.
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 1, 4-6, 8-9, 12-16, 18 & 20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salahieh et al. (2012/0071870, previously cited) in view of Friedman et al. (2010/0198040, previously cited).
Concerning claim 1, as illustrated at least Fig. 1A-D, 3A, 7, 8, 18A-M, Salahieh et al. disclose a method for treating target tissue (method of ablating tissue; [0100]), comprising:
advancing a treatment device through a body lumen to a target tissue (distal end of membrane 34 can be manipulated with a guidewire 40 for proper placement at or near target tissue 80 such as into a vessel; [0148]), the treatment device comprising:
a catheter shaft having a distal region (shaft 57; [0116]),
an expandable member having an outer surface coupled to the distal region, the expandable member comprising a compliant balloon (membrane 34 can have a closed expandable structure, such as a compliant balloon; [0155], [0173]), and
a flexible circuit assembly disposed on the outer surface of the expandable member, the flexible circuit assembly comprising one or more bipolar electrode pairs, (electrode assembly 105 comprises one or more flexible circuits 89 that comprise one or more electrodes 6 and are coupled to membrane 34, where electrodes 6 can be individually activated to form bipolar pairs, where for bipolar, electrodes 6 can be individually or simultaneously activated by switches 37; [0101], [0140]) and a plurality of pressure sensors disposed at different locations along an axial length of the compliant balloon (pressure sensors can be placed on the flex circuits near or at the electrodes 6 which are located on the outer surface of and along the axial length of membrane 34 and detect tissue contact with the electrodes or the amount of pressure exerted on the tissue during a procedure; [0231], [0236]);
expanding the expandable member to contact the target tissue (electrode assembly 105 and deployable flexible membrane 34 can be deployed to deliver energy to target tissue; [0103-0104], [0147]);
sensing contact between the outer surface of the expandable member and the target tissue with the plurality of pressure sensors (pressure sensitive mechanism provides feedback to user about tissue contact; [0231], [0236-0237]);
activating at least one of the bipolar electrode pairs in contact with the target tissue to deliver energy to the target tissue (deliver energy to target tissue to ablate when tissue is in contact with electrodes 6; [0147], [0236-0237], [0272]).
Salahieh et al. fail to disclose automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of the expandable member and the target tissue based on feedback from the plurality of pressure sensors that a portion of the expandable member is not in contact with the target tissue. However, Friedman et al. disclose a medical device for heating (10) comprising a plurality of pressure sensors (502a-d) mounted on an expandable member (28) and automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of the expandable member (28) and the target tissue based on feedback from the plurality of pressure sensors (502a-d) that a portion of the expandable member (28) is not in contact with the target tissue. 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 Salahieh et al. such that the method comprises automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of the expandable member and the target tissue based on feedback from the plurality of pressure sensors that a portion of the expandable member is not in contact with the target tissue in order to provide the benefit of ensuring contact as taught by Friedman et al. ([0222-0228], [0232-0234]; Fig. 50-55)
Concerning claim 4, Salahieh et al. disclose the flexible circuit assembly includes one or more temperature sensors (90) disposed on the flexible circuit assembly (89) between each of the bipolar electrode pairs (6) ([0115]; Fig. 1D).
Concerning claim 5, Salahieh et al. disclose the catheter shaft (57) has a longitudinal axis and wherein at least a portion of the flexible circuit assembly (89) is disposed at an angle relative to the longitudinal axis ([0131], [0164]; Fig. 18S).
Concerning claim 6, Salahieh et al. disclose the catheter shaft (57) has a longitudinal axis and wherein at least a portion of the flexible circuit assembly (89) is helically disposed about the longitudinal axis ([0131], [0164]; Fig. 18S).
Concerning claim 8, Salahieh et al. disclose at least one of the one or more pressure sensors is disposed adjacent to a proximal end region of the expandable member (34), a distal end region of the expandable member (34), or both ([0184]; Fig. 18A-M), where “adjacent” can be defined as: “not distant : NEARBY” (www.m-w.com).
Concerning claim 9, as illustrated at least Fig. 1A-D, 3A, 7, 8, 18A-M, Salahieh et al. disclose a method for treating target tissue (method of ablating tissue; [0100]), comprising:
advancing a treatment device through a body lumen to a target tissue (distal end of membrane 34 can be manipulated with a guidewire 40 for proper placement at or near target tissue 80 such as into a vessel; [0148]), the treatment device comprising:
a catheter shaft having a distal region (shaft 57; [0116]),
an expandable member having an outer surface coupled to the distal region, the expandable member comprising a compliant balloon (membrane 34 can have a closed expandable structure, such as a compliant balloon; [0155], [0173]),
a flexible circuit assembly disposed on the outer surface of the expandable member, the flexible circuit assembly comprising one or more bipolar electrode pairs (electrode assembly 105 comprises one or more flexible circuits 89 that comprise one or more electrodes 6 and are coupled to membrane 34, where electrodes 6 can be individually activated to form bipolar pairs, where for bipolar, electrodes 6 can be individually or simultaneously activated by switches 37; [0101], [0140]) and a plurality of pressure sensors disposed at different locations along an axial length of the compliant balloon (pressure sensors can be placed on the flex circuits near or at the electrodes 6 which are located on the outer surface of and along the axial length of membrane 34 and detect tissue contact with the electrodes or the amount of pressure exerted on the tissue during a procedure; [0231], [0236]);
expanding the expandable member to contact the target tissue (electrode assembly 105 and deployable flexible membrane 34 can be deployed to deliver energy to target tissue; [0103-0104], [0147]);
sensing contact between the outer surface of the expandable member and the target tissue with the one or more pressure sensors (pressure sensitive mechanism provides feedback to user about tissue contact; [0231], [0236-0237]);
activating at least one of the bipolar electrode pairs in contact with the target tissue to deliver energy to the target tissue (deliver energy to target tissue to ablate when tissue is in contact with electrodes 6; [0147], [0236-0237], [0272]); and
adjusting power to the activated bipolar electrode pairs based on feedback from the one or more pressure sensors (pressure sensitive mechanism provides feedback to user about tissue contact prior to activation and deactivates electrodes 6 not in contact with tissue via respective microswitches associated with each electrode 6; [0231], [0236-0237]).
Salahieh et al. fail to disclose automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of the expandable member and the target tissue based on feedback from the plurality of pressure sensors that a portion of the expandable member is not in contact with the target tissue. However, Friedman et al. disclose a medical device for heating (10) comprising a plurality of pressure sensors (502a-d) mounted on an expandable member (28) and automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of the expandable member (28) and the target tissue based on feedback from the plurality of pressure sensors (502a-d) that a portion of the expandable member (28) is not in contact with the target tissue. 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 Salahieh et al. such that the method comprises automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of the expandable member and the target tissue based on feedback from the plurality of pressure sensors that a portion of the expandable member is not in contact with the target tissue in order to provide the benefit of ensuring contact as taught by Friedman et al. ([0222-0228], [0232-0234]; Fig. 50-55)
Claim 12 is rejected upon the same rationale as applied to claim 4.
Claim 13 is rejected upon the same rationale as applied to claim 5.
Claim 14 is rejected upon the same rationale as applied to claim 6.
Claim 15 is rejected upon the same rationale as applied to claim 8.
Concerning claim 16, as illustrated at least Fig. 1A-D, 3A, 7, 8, 18A-M, Salahieh et al. disclose a method for treating renal nerves (method of ablating tissue; [0100], [0267]), the method comprising:
advancing a renal nerve treatment device through a blood vessel to target tissue within a renal artery (distal end of membrane 34 can be manipulated with a guidewire 40 for proper placement at or near target tissue 80 such as into a pulmonary or renal vessel; [0148], [0267]), the treatment device comprising:
a catheter shaft having a distal region (shaft 57; [0116]),
a compliant balloon coupled to the distal region (membrane 34 can have a closed expandable structure, such as a compliant balloon; [0155], [0173]),
one or more pairs of bipolar electrodes coupled to the compliant balloon (electrode assembly 105 comprises one or more flexible circuits 89 that comprise one or more electrodes 6 and are coupled to membrane 34, where electrodes 6 can be individually activated to form bipolar pairs, where for bipolar, electrodes 6 can be individually or simultaneously activated by switches 37; [0101], [0140]), and
one or more pressure sensors disposed at different locations along an axial length of the compliant balloon (pressure sensors can be placed on the flex circuits near or at the electrodes 6 which are located on the outer surface of and along the axial length of membrane 34 and detect tissue contact with the electrodes or the amount of pressure exerted on the tissue during a procedure; [0231], [0236]);
expanding the compliant balloon (electrode assembly 105 and deployable flexible membrane 34 can be deployed to deliver energy to target tissue; [0103-0104], [0147]);
sensing contact between the compliant balloon and the target tissue of the renal artery with the one or more pressure sensors (pressure sensitive mechanism provides feedback to user about tissue contact; [0231], [0236-0237]); and
activating at least one of the one or more pairs of bipolar electrodes in contact with the target tissue to deliver energy to the target tissue (deliver energy to target tissue to ablate when tissue is in contact with electrodes 6; [0147], [0236-0237], [0272]).
Salahieh et al. fail to disclose automatically increasing a pressure level within the compliant balloon to maintain the contact between the outer surface of the compliant balloon and the target tissue based on feedback from the plurality of pressure sensors that a portion of the compliant balloon is not in contact with the target tissue. However, Friedman et al. disclose a medical device for heating (10) comprising a plurality of pressure sensors (502a-d) mounted on an expandable member (28) and automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of a balloon (28) and the target tissue based on feedback from the plurality of pressure sensors (502a-d) that a portion of the balloon (28) is not in contact with the target tissue. 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 Salahieh et al. such that the method comprises automatically increasing a pressure level within the compliant balloon to maintain the contact between the outer surface of the compliant balloon and the target tissue based on feedback from the plurality of pressure sensors that a portion of the expandable member is not in contact with the target tissue in order to provide the benefit of ensuring contact as taught by Friedman et al. ([0222-0228], [0232-0234]; Fig. 50-55)
Claim 18 is rejected upon the same rationale as applied to claim 4.
Claim 20 is rejected upon the same rationale as applied to claim 8.
Claims 3, 11 & 17 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salahieh et al. (2012/0071870, previously cited) in view of Friedman et al. (2010/0198040, previously cited), as applied to claims 1, 9 & 16, in further view of Edwards (2006/0009758, previously cited).
Concerning claims 3, 11 & 17, Salahieh et al. in view of Freidman et al. fail to disclose the compliant balloon includes one of a polyether block amide and a polyurethane. However, Edwards discloses a medical device (10) comprising a flexible circuit assembly (64) coupled to an expandable member (16), the expandable member being a compliant balloon (40) including a polyether block amide or a polyurethane. 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 Salahieh et al. in view of Freidman et al. such that the compliant balloon includes a polyether block amide or a polyurethane in order to provide the benefit of a suitable material as taught by Edwards ([0061], [0079]; Fig. 17) and 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.
Claims 7 & 19 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Salahieh et al. (2012/0071870, previously cited) in view of Friedman et al. (2010/0198040, previously cited), as applied to claims 1 & 16, in further view of Chabach (2009/0038930, previously cited).
Concerning claims 7 & 19, Salahieh et al. in view of Freidman et al. fail to disclose the pressure sensors to include a polyethylene terephthalate (PET) foil pressure sensor. However, Chabach discloses a pressure sensor that includes a polyethylene terephthalate foil pressure sensor. 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 Salahieh et al. in view of Freidman et al. such that the pressure sensor includes a polyethylene terephthalate (PET) foil pressure sensor in order to provide the benefit of improving the mechanical strength of the sensor and to guarantee the same sensor response over an automotive range by using a material with a constant elasticity modulus over the temperature range, and a material that has very good mechanical robustness, high chemical resistance, and high resistance against humidity quick relaxation and low price as taught by Chabach ([0015], [0035])
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3-9 & 11-20 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 11,246,654 in view of Friedman et al. (2010/0198040). Although the claims at issue are not identical, they are not patentably distinct from each other because they both recite treating target tissue with a catheter having a catheter shaft, expandable membrane, flex circuit electrodes, and pressure sensors disposed along a length of the expandable membrane, by expanding the membrane, sensing contact, activating electrodes, and/or adjusting power or pressure. The Patent fails to specifically disclose automatically increasing a pressure level within the compliant balloon to maintain the contact between the outer surface of the compliant balloon/expandable member and the target tissue based on feedback from the plurality of pressure sensors that a portion of the compliant balloon/expandable member is not in contact with the target tissue. However, Friedman et al. disclose a medical device for heating (10) comprising a plurality of pressure sensors (502a-d) mounted on an expandable member (28) and automatically increasing a pressure level within the expandable member to maintain the contact between the outer surface of a balloon (28) and the target tissue based on feedback from the plurality of pressure sensors (502a-d) that a portion of the balloon (28) is not in contact with the target tissue. 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 patent such that the method comprises automatically increasing a pressure level within the compliant balloon to maintain the contact between the outer surface of the compliant balloon and the target tissue based on feedback from the plurality of pressure sensors that a portion of the expandable member is not in contact with the target tissue in order to provide the benefit of ensuring contact as taught by Friedman et al. ([0222-0228], [0232-0234]; Fig. 50-55)
Conclusion
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/JAYMI E DELLA/Primary Examiner, Art Unit 3794
JAYMI E. DELLA
Primary Examiner
Art Unit 3794