DETAILED ACTION
This action is in response to applicant’s election of Species V in the communication received on 8/17/2026. It is noted that all of the originally filed claims 1-56 were canceled and new claims 57-82 added on 4/24/2026. Claims 70-71, 75 and 78-79 have been withdrawn from further consideration. A complete action on the merits of claims 57-69, 72-74, 76-77 and 80-52 follows below.
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.
Election/Restrictions
Claims 70-71, 75 and 78-79 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 08/17/2026.
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 57-63, 66-69, 72-74, 77 and 80-82 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Patel (US Pub. No. 2007/0287994).
Regarding Claim 57, Patel teaches an electrode assembly configured for a bipolar application of energy ([0036] and Fig. 10), the assembly comprising:
a first plurality of elongate interconnected electrodes 302/304, each of the first plurality of elongate interconnected electrodes 302 having a distal section, a distal end (Fig. 10), a proximal section and a proximal end (Fig. 10), the proximal end of each of the first plurality of elongate interconnected electrodes 302 terminates at a first hub region (Since a region can be reasonable interpreted to be a section that comprises something “any large, indefinite, and continuous part of a surface or space/ range, area, or scope” according to Dictionary.com; a distal region and a proximal region is interpreted to be the first and/or the second hub region);
a second plurality of elongate interconnected electrodes 304, each of the second plurality of elongate interconnected electrodes having a distal section, a distal end (Fig. 10), a proximal section and a proximal end, the proximal end of each of the second plurality of elongate interconnected electrodes terminates at a second hub region (Since a region can be reasonable interpreted to be a section that comprises something “any large, indefinite, and continuous part of a surface or space/ range, area, or scope” according to Dictionary.com; a distal region and a proximal region is interpreted to be the first and/or the second hub region);
wherein each of the first plurality of elongate interconnected electrodes 302 has a first polarity and each of the second plurality of elongate interconnected electrodes 304 has a second polarity ([0093]-[0094]), and wherein the first plurality of elongate interconnected electrodes 302 having the first polarity is configured to be affixed to, carried on or otherwise integrated with a first end of an expandable member (balloon 106, Fig. 10) and the second plurality of elongate interconnected electrodes 304 having the second polarity is configured to be affixed to, carried on or otherwise integrated with a second end of the expandable member (balloon 106, Fig. 10) such that the first and the second plurality of elongate interconnected electrodes each extend along a full length or substantially full length of the expandable member 106 (“electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon. The electrodes are of alternating positive and negative polarity to provide at least a bipolar treatment surface. The width of the electrodes 302 and 304 changes from narrow at the poles of the balloon to wide in the middle portion to allow for a constant ratio of the width of the electrode to the space between the electrodes” [0093] and Fig. 10).
Regarding Claim 58, Patel teaches wherein the first plurality of elongate interconnected electrodes 302 is configured to be centered around the first end of the expandable member 106 and the second plurality of elongate interconnected electrodes 304 is configured to be centered around the second end of the expandable member 106 (“electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon. The electrodes are of alternating positive and negative polarity to provide at least a bipolar treatment surface. The width of the electrodes 302 and 304 changes from narrow at the poles of the balloon to wide in the middle portion to allow for a constant ratio of the width of the electrode to the space between the electrodes” [0093] and Fig. 10).
Regarding Claim 59, Patel teaches wherein the first and/or the second hub region is continuous (Since a region can be reasonable interpreted to be a section that comprises something “any large, indefinite, and continuous part of a surface or space/ range, area, or scope” according to Dictionary.com; a distal region and a proximal region is interpreted to be the first and/or the second hub region, which are chosen to be continuous).
Regarding Claim 60, Patel teaches wherein the electrode assembly comprises an electrode portion with an enlarged end (the middle regions are enlarged, Fig. 10).
Regarding Claim 61, Patel teaches wherein the electrode assembly is manufactured from a flat pattern (please note that “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985); therefore, since this claim is directed to a product-by-process claim patentability is based on the product itself and does not depend on its method of production, based on the embodiment of Fig. 10, the final product appears to have a flat shape and thus configured to have been manufactured from a flat pattern or a similar method of manufacturing).
Regarding Claim 62, Patel teaches wherein at least a portion of one or more of the first and/or the second plurality of elongate interconnected electrodes is non-conductive or coated with an insulative material (electrodes 302 and 304 are conductive, [0072]-[0073]).
Regarding Claim 63, Patel teaches wherein the distal ends of at least some of the first plurality and/or the second plurality of elongate interconnected electrodes are conductive (electrodes 302 and 304 are conductive, [0072]-[0073]).
Regarding Claim 66, Patel teaches wherein an angle α between any of the plurality of elongate interconnected electrodes of the same polarity is defined by the formula: α=360
2
/
n
wherein n is the total number of elongate interconnected electrodes of the same polarity; and wherein an angle β between any of the plurality of elongate interconnected electrodes 302/304 of differing polarity is defined by the formula: β=360
/
n
(“The electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon” [0093]; therefore, an angle α between any of the plurality of elongate interconnected electrodes of the same polarity is defined by the formula: α=360
2
/
n
and wherein an angle β between any of the plurality of elongate interconnected electrodes 302/304 of differing polarity is defined by the formula: β=360
/
n
).
Regarding Claim 67, Patel teaches wherein the first plurality of elongate interconnected electrodes 302 and the second plurality of elongate interconnected electrodes 304 are rotated relative to each other (“electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon. The electrodes are of alternating positive and negative polarity to provide at least a bipolar treatment surface” [0093 therefore they are in a rotated configuration relative to one another).
Regarding Claim 68, Patel teaches further comprising: the expandable member 106 to which the first and the second plurality of elongate interconnected electrodes 302/304 are at least partially affixed to, carried on or otherwise integrated with, wherein the expandable member 106 is configured to expand from a collapsed configuration to an expanded configuration to place at least a portion of the electrode assembly in contact with tissue (Fig. 1 collapsed configuration to Fig. 10 expanded configuration, [0036], [0084]-[0085] and [0093]).
Regarding Claim 69, Patel teaches wherein the expandable member 106 comprises at least one of a mesh structure, a strut structure, a spline structure, a single neck balloon or a double neck balloon (balloon 106 Fig. 10).
Regarding Claim 72, Patel teaches wherein the electrode assembly is configured to apply energy selected from a group comprising: radio frequency energy, microsecond pulsed energy, nanosecond pulsed energy, picosecond pulsed energy, microwave energy and combinations thereof (RF energy, [0036]-[0038] and [0093]).
Regarding Claim 73, Patel teaches wherein the electrode assembly is a part of a catheter 104 ([0084], Figs. 1 and 10).
Regarding Claim 74, Patel teaches an electrode assembly configured for a bipolar application of energy in use ([0036] and Fig. 10), the assembly comprising:
a plurality of elongate interconnected electrodes 302, each of the plurality of elongate interconnected electrodes having a distal section, a distal end, a proximal section and a proximal end (Fig. 10), the proximal end of each of the plurality of elongate interconnected electrodes terminates at a hub region (Since a region can be reasonable interpreted to be a section that comprises something “any large, indefinite, and continuous part of a surface or space/ range, area, or scope” according to Dictionary.com; a distal region is interpreted to be the first hub region, see Fig. 10), wherein every other adjacent elongate interconnected electrode of the plurality of elongate interconnected electrodes has an alternating polarity (“electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon. The electrodes are of alternating positive and negative polarity to provide at least a bipolar treatment surface” [0093]), and wherein the electrode assembly is configured to be affixed to, carried on or otherwise integrated with an expandable member (balloon 106, Fig. 10) such that the plurality of elongate interconnected electrodes 302/304 extend along a full length or substantially full length of the expandable member (Fig. 10).
Regarding Claim 77, Patel teaches wherein an angle α between any of the plurality of elongate interconnected electrodes of the same polarity is defined by the formula: α=360
2
/
n
wherein n is the total number of elongate interconnected electrodes of the same polarity; and wherein an angle β between any of the plurality of elongate interconnected electrodes of differing polarities is defined by the formula: β=360
/
n
(“The electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon” [0093]; therefore, an angle α between any of the plurality of elongate interconnected electrodes of the same polarity is defined by the formula: α=360
2
/
n
and wherein an angle β between any of the plurality of elongate interconnected electrodes 302/304 of differing polarity is defined by the formula: β=360
/
n
).
Regarding Claim 80, Patel teaches further comprising a second electrode assembly 304 having a second plurality of elongate electrodes interconnected at a second hub region and having alternating polarities ([0093] and Fig. 10).
Regarding Claim 81, Patel teaches wherein the electrode assembly is a first electrode assembly, and wherein the first electrode assembly 302 and the second electrode assembly 304 are rotated relative to each other (“electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon. The electrodes are of alternating positive and negative polarity to provide at least a bipolar treatment surface” [0093 therefore they are in a rotated configuration relative to one another).
Regarding Claim 82, Patel teaches further comprising an expandable member (balloon 106), wherein the expandable member comprises a mesh structure, a strut structure, a spline structure, a single-neck balloon, or a double neck balloon (balloon 106 in Fig. 10).
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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied 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.
Claim 64 is rejected under 35 U.S.C. 103 as being unpatentable over Patel as applied above in view of Sugimoto (US Pub. No. 2013/0296853).
Regarding Claim 64, Patel teaches the assembly further comprising a conductive [band or sleeve configured to cover at least a portion of the conductive distal ends] when the electrode assembly is affixed to, carried on or otherwise integrated with the expandable member (“electrical conductors may be flexible metal strips, metal discs or conductive paint or conductive polymer. An external RF source is connected via two conductors that run the length of the shaft of the device to terminate in the electrical conductors on the surface of the expandable chamber” [0039]; thereby in the embodiment of Fig. 10 the electrical conductors/electricals that are flexible metal strips that are coupled to the external RF source via two conductors that run the length of the shaft of the device to terminate in the electrical conductors on the surface of the balloon. Although the two active/return conductors that run the length of the shaft are not shown, it is Examiner’s position that each are in an alternating arrangement coupled to the active electrodes 302/return electrodes 304 at one end of the electrodes); however, Patel does not show the connection part of the conductors to the electrodes are a band or sleeve configured to cover at least a portion of the conductive distal ends as claimed.
In the same field of invention, Sugimoto teaches two conductive bands each coupling distal ends of the plurality of active electrodes 22 and return electrodes 24 to conductors that run the length of the shaft to the generator “the energizing paths E1, E2 that are connected from the high-frequency power supply 30 to the electrodes 22, 24 comprise first wires E1a, E2a connected by connectors to the high-frequency power supply 30 and extending up to a position near the opening 36 in the shaft 14, and second wires E1b, E2b connected to the distal ends of the energizing cables E1a, E2a and extending from the position near the opening 36 to the electrodes 22, 24” [0046] and “a second wire E1b which provides the one energizing path E1 is indicated by the solid lines, and a second wire E2b which provides the other energizing path E2 is indicated by the broken lines” [0037] shown in Fig. 2.
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to couple to distal ends of each of the plurality of electrode sets 302/304 to a conductive band that couples the electrodes to the generator in different paths in order to supply the active energy to the plurality of active electrodes and return the energy from the plurality of return electrodes without the conductive regions touching and/or shoring in view of the teachings of Sugimoto.
Claim 65 is rejected under 35 U.S.C. 103 as being unpatentable over Patel as applied above in view of Govari (US Pub. No. 2022/0087734).
Regarding Claim 65, Patel teaches wherein at least one of the first and/or the second plurality of elongate interconnected electrodes 302/304 but does not teach comprises an additional electrode portion that is connected to and configured to be disposed at least partially within an area of a ring defined, respectively, by the first hub region or the second hub region.
In the same field of invention, Govari teaches “electrode 99C, coupled to surface 89 of apex 88” [0051] in order for “a bipolar signal may be sensed between electrode 99C that is coupled to surface 89, and electrode 99D that is coupled to section 77D of spline 56D” [0054].
It would have been obvious to one having ordinary skill in the art prior to the effective filing date of the current invention to add a ring such as cap 89 at the first hub region of the invention of Patel including a sensing electrode in order to be able to sense a bipolar signal between the tip electrode and at least one other electrode on a spline as disclosed by Govari.
Claim 76 is rejected under 35 U.S.C. 103 as being unpatentable over Patel.
Regarding Claim 76, Patel teaches “conductors 302 and 304 are made of copper and are covered with plastic insulation” [0087] and “electrodes 302 and 304 are uniformly disposed longitudinally in alternating arrangement on the balloon. The electrodes are of alternating positive and negative polarity to provide at least a bipolar treatment surface” [0093]; however, does not specifically teach at least a portion of the distal section of every other elongate electrode is non-conductive and every other adjacent elongate electrode comprises conductive distal sections so that conductive and non-conductive distal ends of each interconnected elongate electrode alternate as claimed. Examiner takes the position that since the distal ends are shown in Fig. 10 to extend to the same length at the distal end, it would have been obvious to add insulations in a manner to prevent the active and return electrodes from touching one another at the distal end thereby providing at least a portion of the distal section of every other elongate electrode with a non-conductive cover and every other adjacent elongate electrode comprises conductive distal sections so that conductive and non-conductive distal ends of each interconnected elongate electrode alternate as claimed in order to prevent shoring and/or touching of the active/return electrodes at the distal section.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KHADIJEH A VAHDAT whose telephone number is (571)270-7631. The examiner can normally be reached M-F 9-6 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KHADIJEH A VAHDAT/Primary Examiner, Art Unit 3794
Prosecution Insights