DETAILED ACTION
Notice of Pre-AIA or AIA Status
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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.
Response to Arguments
3. Applicant's arguments filed 11/7/2025 have been fully considered but they are not persuasive. For purposes of the explanation below, it is noted that previous Claims 2 and 4 have been cancelled, and their limitations have been incorporated into the newly amended Claim 1, at present.
4. The applicant argues that Ben-Ezra (U.S. 2015/0157391) as modified by Weinkam (U.S. 2013/0066220) fails to teach that the “longitudinal electrodes comprise a flexible printed circuit material” (language now recited in Claim 1, but previously recited in Claim 4). They reason that Ben-Ezra fails to teach anything that is not a wire to deliver energy to the tissue, therefore lacking motivation to distinguish one subset of electrodes from another by structure or material. The applicant further argues that Weinkam teaches various embodiments of ablative transducer elements, but fails to teach that these different embodiments be combined into a single device. However, the examiner disagrees.
5. Ben-Ezra teaches longitudinal electrodes (Ben-Ezra, Fig. 42, ref num 330) and circumferential electrodes (Ben-Ezra, Fig. 42, ref num 4212). This is presented in the Non-Final Rejection (filed 5/7/25, see paragraph 7). Ben-Ezra also goes on to explain that the circumferential electrodes comprise of a wire (Ben-Ezra, para 0305, “each of the wires 330 described is comprised of several wires, bundled together (e.g., four wires braided together into one cable)…”). These electrodes are further explained to have a plurality of configurations, such as several wires bundled together, a flat strip of wires, and a configuration of gaps between wires (Ben-Ezra, para 0305). It is also contemplated that the wires (ref num 330) may be electrodes printed onto struts, like tat of “flexible printed circuitry” (see Ben-Ezra, para 0334). Therefore, Ben-Ezra does discuss various structures of electrodes. However, as previously stated by the examiner, Ben-Ezra does fails to explicitly teach that the “longitudinal electrodes comprise [the] flexible printed circuit material”.
6. The examiner then relies upon Weinkam to teach such limitation. Weinkam teaches a plurality of different forms of electrodes (see Weinkam, Figs. 4A-4H) which comprise both circumferential and longitudinal electrodes, further that these electrodes may be formed of wires or flexible printed circuit material (Weinkam, para 0081, 0097, 0100). Weinkam goes on to discuss that the system comprises a plurality of electrodes (Weinkam, see Fig. 7, ref nums 702a-702d) which may include printed circuit material or wires (Weinkam, para 0104, “transducer elements 702a-702d (collectively 702) may be resistive elements, for example formed from copper traces on a flexible printed circuit board substrate, or resistive wires mounted on a structure”; para 0114, “each transducer element 802 includes a respective resistive member 809 (three called out in FIG. 8A), for example formed from copper traces on a flexible printed circuit board substrate, or resistive elements provided on a structure”). It is also discussed that the electrode elements may be constructed from multiple parts, such as discrete components or components integrally formed therein (Weinkam, para 0066). Therefore, Weinkam does contemplate different kinds of electrodes within the same device.
7. So, while Ben-Ezra fails to teach that the longitudinal electrodes comprise a flexible printed circuit material, they do consider this form for one set of electrodes, while the other form does not have this material. Weinkam discusses various forms of electrodes, including flexible printed circuit material and wires. Therefore, one would be motivated to modify Ben-Ezra with the teachings of Weinkam in order to modify the longitudinal electrodes to comprise a flexible printed circuit material.
8. It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electrodes made of different materials, such as wires and/or flexible printed circuit material, 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. It is readily apparent to anyone skilled in the art that these different forms/materials produce the same expected result of conducting and delivering energy to the target tissue, and therefore, may be formed of any material that would produce this result.
9. Therefore, the previous rejections of these limitations stand.
Claim Objections
10. Claim 7 was objected to for minor informalities. Claim 7 has been amended to overcome these objections.
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.
11. Claims 17, 23, and 28, as well as Claims 18-22 and 24-27 based on their dependencies to the previous claims, 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.
12. Claim 17 recites the limitation "at least one electrode" in lines 24 and 28-29. There is insufficient antecedent basis for this limitation in the claim. Previously in Claim 17, the limitation “at least one set of electrodes” is recited (see line 10). This language is carried throughout except for in lines 24 and 28-29. It is unclear whether the first recitation of “the at least one electrode” in line 24 is the same electrode recited in lines 28-29, or rather if this recitation is part of the “at least one set of electrodes” recited throughout. For examination purposes, line 24 will be interpreted as “the at least one set of electrodes” and lines 28-29 will be recited as an alternative electrode to the “at least one set of electrodes”. Proper correction is required.
13. Claim 23 recites the limitation “the electrodes” in line 1. There is insufficient antecedent basis for this limitation in the claim. It is unclear what electrode(s) this refers to when considering Claim 17, rendering the claim indefinite. Therefore, for examination purposes, any previously claimed electrode recited in Claim 17 may be considered as the “electrodes” recited in Claim 23. Proper correction is required.
14. Claim 28 recites “the at least one set of bipolar electrodes” in lines 1-2. There is insufficient antecedent basis for this limitation in the claim. There is no previous recitation of such electrodes in Claim 17. Therefore, for examination purposes, any previously claimed electrode recited in Claim 17 may be considered as the “bipolar electrodes” recited in Claim 28. Proper correction is required.
Claim Rejections - 35 USC § 103
15. The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
16. Claims 1, 3, 6, 8-21, and 22-28 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra U.S. 2015/0157391 (herein referred to as “Ben-Ezra”), and in view of Weinkam U.S. 2013/0066220 (herein referred to as “Weinkam”).
17. Regarding Claim 1, Ben-Ezra teaches a device for treating a disorder in a hollow body organ (Fig. 42, ref num 100), said device comprising:
a. a shaft (Fig. 42, ref num 4208) having a distal tip (Fig. 42, ref num 4207);
b. at least one set of bipolar electrodes (Fig. 42, ref num 330; para 0293); and
c. an expandable member configured to radially expand the at least one set of bipolar electrodes from a folded or compressed position to a deployed position (Fig. 42, ref num 110; para 0292)
d. wherein each set of bipolar electrodes comprises at least one first polarity electrode and at least one second polarity electrode (para 0223),
e. wherein a total tissue contact area of the at least one first polarity electrode of each set of bipolar electrodes is substantially equal to a total surface area of the at least one second polarity electrode of the same set of bipolar electrodes (para 0019, 0233, 0293)
f. wherein the device is configured for creating a predetermined pattern of electrically isolated tissue regions having reduced electrical propagation in an inner wall of the hollow body organ such that electrical propagation through the hollow body organ as a whole is reduced (para 0009, 0019);
g. wherein each electrode comprises an elongate conductor (Fig. 42, ref num 330 has wires, ref nums 4212; para 0304, 0306, 0327; also see para 0150 and 0320); and
h. wherein the at least one set of bipolar electrodes (ref num 330) comprises at least one set of longitudinal electrodes which are configured to be substantially parallel to the longitudinal axis of the shaft in the deployed position (Fig. 42, ref num 330, para 0098) and at least one set of circumferential electrodes which are configured to be substantially transverse to the longitudinal axis of the shaft in the deployed position (Fig. 42, ref num 4212, para 0099);
j. the circumferential electrodes comprise a wire or braid (Fig. 42, ref num 4212; para 0304).
Ben-Ezra also teaches the at least one set of electrodes comprising a printed circuit material (para 0334).
Ben-Ezra fails to teach but fails to teach the longitudinal electrodes comprise a printed circuit material.
Weinkam teaches a device of analogous art (Fig. 2), wherein the device comprises electrodes (Fig. 2, ref nums 206). These electrodes comprise of longitudinal electrodes and circumferential electrodes (see Figs. 2 and 4F). Both the longitudinal and circumferential electrodes comprise a flexible printed circuit material (Fig. 4F, ref num 400f; para 0081, 0097). This material produces the same expected result of conducting and delivering energy to the target tissue via the electrodes as taught by the electrodes in Ben-Ezra (Weinkam, para 0081, 0097; Ben-Ezra, para 0305, 0320-0321, 0336). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electrodes comprise of a flexible printed circuit material, 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.
18. Regarding Claim 3, Ben-Ezra teaches the at least one set of longitudinal electrodes are structured as eight spines from the device tip to the equator of the expandable element (Fig. 42, ref num 330; para 0326, “may have 8 longitudinal wire electrodes”), and the at least one set of circumferential electrodes is structured as one line around the equator of the expandable element (Fig. 42, ref num 4212; para 0335, “circumferential electrodes 4212 may assume a circumferential position and collective create a circumferential line”).
19. Regarding Claim 6, Ben-Ezra fails to teach all first polarity electrode segments of each set and all second polarity electrode segments of each set are connected to each other but not to any other electrode segments via a printed circuit board located at the distal tip of the shaft.
Weinkam teaches a device of analogous art (Fig. 2), wherein the device comprises electrodes (Fig. 2, ref nums 206). It is understood that these electrodes have a first polarity segment and a second polarity segment, such that they are connected to each other via a printed circuit board at the distal end of the device (Fig. 2 and Fig. 4f, ref num 400f; para 0081, 0097). This configuration allows the electrodes to stay connected when undergoing deformation, such as being disposed on a balloon that is expanding (para 0097; 0081-0082). Since Ben-Ezra already teaches an expandable member that expands a set of electrodes (Ben-Ezra, ref num 110, 330, para 0292), then 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 Ben-Ezra to have the electrodes connected via a printed circuit board, as this produces the same expected result of connecting the electrodes while being radially expanded.
20. Regarding Claim 8, Ben-Ezra teaches the device further comprising one or more wires configured to deliver power to a PCB pass via the shaft (Fig. 42C, ref num 4224; para 0303).
21. Regarding Claim 9, Ben-Ezra teaches an atraumatic cap at the distal tip of the shaft (Fig. 42, ref num 4207).
22. Regarding Claim 10, Ben-Ezra teaches the expandable member comprises a balloon or bladder made of a non-compliant material (Fig. 42, ref num 110; para 0292).
23. Regarding Claim 11, Ben-Ezra teaches the at least one set of bipolar electrodes is printed on the expandable member (para 0334).
24. Regarding Claim 12, Ben-Ezra teaches the expandable member is made of a compliant material (para 0199).
25. Regarding Claim 13, Ben-Ezra teaches the electrodes create a pattern that is asymmetrical (para 0013 describes use of predetermined pattern of any configuration).
26. Regarding Claim 14, Ben-Ezra teaches the pattern is configured to spare an area of the hollow organ (para 0013, 0109, 0124).
27. Regarding Claim 15, Ben-Ezra teaches the hollow organ is any of a urinary bladder, uterus, rectum, large or small bowel, stomach, pulmonary artery, cardiac atrium, cardiac ventricle, and the disorder is any of overactive bladder, Detrusor-sphincter dyssynergia, irritable uterus, menorrhagia, irritable bowel, obesity, asthma, atrial fibrillation, ventricular tachycardia (para 0025).
28. Regarding Claim 16, Ben-Ezra teaches the at least one set of bipolar electrodes comprises a conductive flexible or gelatinous material layer on surfaces thereof (para 0353).
29. Regarding Claim 17, Ben-Ezra teaches a device for treating a disorder in a hollow body organ (Fig. 42, ref num 100), the device comprising:
a. a handle (Fig. 42, ref num 4215) having a distal end, a proximal end, and a slot (see Figs. 42 and 42C, ref num 4215 has a proximal and distal end and the slot is defined within ref num 4218; para 0317);
b. an inner shaft (Fig. 42E, ref num 4204) having a distal tip (Fig. 42E, ref num 4206), a proximal end (see Fig. 42E, ref num 4204 has a proximal end), a stopper (Fig. 42E, ref num 4205) and at least one opening (Fig. 42E, ref num 4201; para 0323);
c. an outer shaft (Figs. 42C and 42E, ref num 4202) slidably positioned over the inner shaft (par 0323, “telescopic balloon tube 4204 [i.e., the inner shaft] may be slidably situated inside distal end of balloon inflation tube 4202 [i.e., the outer shaft]…”) and having a distal tip (see Fig. 42E, ref num 4202 has a distal tip), a proximal end (see Fig. 42C, ref num 4202 has a proximal end), a seal (Fig. 42C, ref num 4210), and an outer shaft base (Fig. 42C, ref num 4217);
d. an outer sheath (Figs. 42 and 42C, ref num 4208) slidably position over the outer shaft (para 0316, 0320,) and having a distal end, a proximal end (see Figs. 42 and 42C, ref num 4208 has a distal and proximal end), and a valve (Fig. 42C, ref num 4209);
e. at least one set of bipolar electrodes (Fig. 42, ref num 330; para 0293) each having a distal end and a proximal end (see Figs. 42 and 42E, ref nums 330 have distal and proximal ends) and comprising at least one electrode segment (Fig. 42, ref num 4212; para 0111, 0326); and
f. a balloon having a distal leg and a proximal leg (Fig. 42, ref num 110 has distal and proximal legs);
g. wherein the proximal end of the inner shaft is connected to the handle (inner shaft = ref num 4204, handle = 4215; Figs. 42 and 42E, ref num 4204 is connected to ref num 4215 via ref num 4202; para 0323-0324, 0335);
h. wherein the outer shaft base (ref num 4217) further comprises a retraction knob (Fig. 42C, ref num 4216) which slideably protrudes through the slot of the handle (Fig. 42C, slot defined in ref num 4218, which has ref num 4216 protruding through it; para 0294);
i. wherein an inflation tube (Fig. 42C, ref num 4203) and wires (Fig. 42C, ref num 4224) enter the handle and are sealed to the inner shaft (see Figs. 42 and 42C for ref nums 4203 and 4224 to enter handle, ref num 4215; see para 0303, 0316, 0319 for description of seal);
j.1 wherein the distal leg of the balloon is connected to the inner shaft (see Fig. 42E, distal end of ref num 110 is connected to inner shaft, ref num 4204) proximate the distal tip of the inner shaft (balloon, ref num 110, connected to ref num 4204 proximal to tip, ref num 4206) and
j.2 the proximal leg of the balloon is connected to the outer shaft (see Fig. 42E, proximal end of ref num 110 is connected to ref num 4202) proximal the distal tip of the outer shaft (distal tip of ref num 4202 is found more distal than where ref num 110 and 4202 are connected);
k. wherein the wires pass through the inner shaft and out of the distal tip of the shaft and connect to the at least one set of electrodes (Figs. 42C, 42D, 42E; para 0320, 0323);
l. wherein the proximal end of the at least one set of electrodes is connected as a ring slideably position over the outer shaft proximal to the proximal leg of the balloon (Fig. 42D, ref num 4221; para 0321).
h. wherein the at least one set of bipolar electrodes (ref num 330) comprises at least one set of longitudinal electrodes which are configured to be substantially parallel to the longitudinal axis of the shaft in the deployed position (Fig. 42, ref num 330, para 0098) and at least one set of circumferential electrodes which are configured to be substantially transverse to the longitudinal axis of the shaft in the deployed position (Fig. 42, ref num 4212, para 0099);
m. at least one electrode comprising a wire or braid (Fig. 42, ref num 4212; para 0304).
Ben-Ezra also teaches the at least one electrode comprising a printed circuit material (para 0334).
Ben-Ezra fails to teach but fails to teach the at least one set of electrodes comprises a printed circuit material.
Weinkam teaches a device of analogous art (Fig. 2), wherein the device comprises electrodes (Fig. 2, ref nums 206). These electrodes comprise of various configurations, such as a set of electrodes and an electrode (see Figs. 2 and 4F). Both types of electrodes may comprise a flexible printed circuit material (Fig. 4F, ref num 400f; para 0081, 0097). This material produces the same expected result of conducting and delivering energy to the target tissue via the electrodes as taught by the electrodes in Ben-Ezra (Weinkam, para 0081, 0097; Ben-Ezra, para 0305, 0320-0321, 0336). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electrodes comprise of a flexible printed circuit material, 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.
30. Regarding Claim 18, Ben-Ezra teaches:
i. the device has a folded or compressed position and a deployed position (para 0292, 0306) and further comprises an atraumatic cap connected to the inner shaft distal tip (Fig. 42E, ref num 4207 connected to distal tip of ref num 4204),
ii. wherein the atraumatic cap is configured to either partially and completely cover the outer sheath distal end when in the folded or compressed position (para 0309, 0325),
iii. wherein the outer sheath is configured to expose the electrodes when pulled proximally (para 0294, 0301-0302, 0306),
iv. wherein the balloon is configured to radially expand the electrodes when inflated (para 0306, 0335),
v. wherein the electrodes are configured to deliver energy to the hollow organ (para 0301, 0335), and
vi. wherein the outer shaft is configured to stretch the balloon and collapse the electrodes when pulled proximally by the retraction knob (0337).
31. Regarding Claim 19, Ben-Ezra teaches the at least one set of electrodes comprises longitudinal and circumferential electrodes (Fig. 42, ref nums 330 and 4212; para 0098 describes longitudinal and para 0099 describes circumferential).
32. Regarding Claims 20 and 21, Ben-Ezra fails to teach the longitudinal electrodes comprise a flexible printed circuit material, as well as fails to teach the circumferential electrodes comprise a flexible printed circuit material.
Weinkam teaches a device of analogous art (Fig. 2), wherein the device comprises electrodes (Fig. 2, ref nums 206). These electrodes comprise of longitudinal electrodes and circumferential electrodes (see Figs. 2 and 4F). Both the longitudinal and circumferential electrodes comprise a flexible printed circuit material (Fig. 4F, ref num 400f; para 0081, 0097). This material produces the same expected result of conducting and delivering energy to the target tissue via the electrodes as taught by the electrodes in Ben-Ezra (Weinkam, para 0081, 0097; Ben-Ezra, para 0305, 0320-0321, 0336). It would have been obvious to one having ordinary skill in the art at the time the invention was made to have the electrodes comprise of a flexible printed circuit material, 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.
33. Regarding Claim 22, Ben-Ezra teaches the circumferential electrodes are foldable (ref num 4212; para 0337).
34. Regarding Claim 23, Ben-Ezra teaches the electrodes create a pattern that is asymmetrical (para 0013 describes use of predetermined pattern of any configuration).
35. Regarding Claim 24, Ben-Ezra teaches the pattern is configured to spare an area of the hollow organ (para 0013, 0109, 0124).
36. Regarding Claim 25, Ben-Ezra teaches the balloon is made of a compliant material (Fig. 42, ref num 110; para 0199).
37. Regarding Claim 26, Ben-Ezra teaches the balloon is made of a non-compliant material (Fig. 42, ref num 110; para 0292).
38. Regarding Claim 27, Ben-Ezra teaches the hollow organ is any of a urinary bladder, uterus, rectum, large or small bowel, stomach, pulmonary artery, cardiac atrium, cardiac ventricle, and the disorder is any of overactive bladder, Detrusor-sphincter dyssynergia, irritable uterus, menorrhagia, irritable bowel, obesity, asthma, atrial fibrillation, ventricular tachycardia (para 0025).
39. Regarding Claim 28, Ben-Ezra teaches the at least one set of bipolar electrodes comprises a conductive flexible or gelatinous material layer on surfaces thereof (para 0353).
40. Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Ezra.
41. Regarding Claim 7, Ben-Ezra teaches the tissue contact area of each electrode set is between 1 mm2 and 50 mm2 (para 0205, describes there length to be between 0.5-2mm; therefore, it is assumed that the tissue contact area would be similar to the area of the electrode). It would have been an obvious matter of design choice to have the tissue contact area of each electrode set be in the desired range, since such a modification would have involved a mere change in the size of a component. A change in size is generally recognized as being within the level of ordinary skill in the art. In re Rose, 105 USPQ 237 (CCPA 1955).
Conclusion
42. THIS ACTION IS MADE FINAL. 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.
43. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ANNIE L SHOULDERS whose telephone number is (571)272-3846. The examiner can normally be reached Monday-Friday (alternate Fridays) 8AM-5PM 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, Joseph Stoklosa can be reached at 571-272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ANNIE L SHOULDERS/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794