DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 42 and 44 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 42 and 44 recite “wherein a longitudinal length of the band electrode is 2 mm or less” in lines 1-2, however this is not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Paragraph 0048 of the specification as originally filed teaches that the band electrode is typically about 0.25 to about 0.5 mm in length and therefore there is no support for the length being 2mm or less.
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.
Claim 28 is 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 28 has been amended to recite “a lumen extension member extending from the at least one lumen, at least partially through the first and second electrode segments” which is vague and indefinite. As currently written it is not clear if it is the lumen extension member or the at least one lumen which is required to at least partially through the first and second flexible electrode segments. Furthermore, there seems to be a grammatical error that is further confusing what is recited in the claim.
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.
Claims 22, 24-26, 29, 30, 32-37, 39, 40 and 42-45 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huy D. Phan (2003/0078644) in view of Bowe (7,013,169).
Referring to claims 22 and 34, Phan teaches a catheter apparatus comprising: an elongated catheter body (302) having a distal portion, a proximal end, and at least one fluid lumen 316/318) extending longitudinally therein (paragraphs 0069 and 0070; Figures 13-16); a first flexible electrode segment (one of 306) on the distal portion of the catheter body (paragraphs 0069, 0087, 0088, 0095 and 0096), the first flexible electrode segment energizable to form a first ablation zone; a second flexible electrode segment (one of 306) spaced apart longitudinally from the first flexible electrode segment on the distal portion of the catheter body, the second flexible electrode segment energizable to form a second ablation zone that overlaps with the first ablation zone to form a continuous lesion (paragraphs 0069, 0087, 0088, 0095 and 0096; Figures 13-16), wherein each of the first and second flexible electrode segments comprises a sidewall provided with one or more elongated stiffness reductions extending through the sidewall (paragraph 0095; Figure 16); and a third electrode (one of 306) positioned longitudinally between and spaced apart from the first and second flexible electrode segments (paragraphs 0069, 0087, 0088, 0095 and 0096; Figures 13-16).
Phan fails to teach that the third electrode comprises a band electrode for diagnostic purposes. Bowe teaches an analogous catheter comprising multiple electrodes comprising a third electrode (one of 106) positioned longitudinally between and spaced apart from the first and second electrode segments (other 106) wherein the third electrode comprises a band electrode for diagnostic purposes (Col. 4, lines 3-13 and Col. 5, lines 45-50; Figure 1). It would be obvious to one of ordinary skill in the art at the time that the invention was made to modify the third electrode, as taught by Phan, to be a band electrode for diagnostic purposes, as taught by Bowe, in order to ensure lesions are effective formed by the electrodes (Col. 4, lines 9-13). Additionally, one of ordinary skill in the art at the time that the invention was made would know to modify the shape of the third electrode to modify the ablation pattern and flexibility of the device (see MPEP 2144.04).
Referring to claims 24 and 35, Phan teaches comprising an electrically nonconductive segment (portion of shaft 303a) positioned between the first and second flexible electrode segments (paragraphs 0069-0070; Figure 13).
Referring to claims 25 and 36, Phan teaches wherein the corresponding electrically nonconductive segment (portion of shaft 303a) is not as flexible as the neighboring flexible electrode segments (paragraphs 0069-0070; Figure 13).
Referring to claims 26 and 37, Phan teaches wherein the electrically nonconductive segment is sufficiently small in length to provide substantially continuous flexibility across the flexible electrode segments and the corresponding electrically nonconductive segment (paragraphs 0069, 0070, 0087, 0088, 0095 and 0096; Figures 13-16).
Referring to claim 32, Phan is silent regarding whether a ratio between a length of each of the corresponding pair of neighboring flexible electrode segments and a diameter of the distal portion is less than 1.7. Due to a lack of disclosed criticality or unexpected results it would be obvious to one of ordinary skill in the art at the time that the invention was made modify the ratio, as taught by Phan, such that a ratio between a length of each of the corresponding pair of neighboring flexible electrode segments and a diameter of the distal portion is less than 1.7 because this is a change in size/proportion that is not sufficient to patentable distinguish over the prior art (See MPEP 2144.04). One of ordinary skill in the art at the time that the invention was made would know to modify a ratio between a length of each of the corresponding pair of neighboring flexible electrode segments and a diameter of the distal portion is less than 1.7 to modify the ablation pattern and flexibility of the device.
Referring to claim 33, Phan is silent regarding whether the electrically nonconductive segment is less than 1.09 times of a diameter of the distal portion. Due to a lack of disclosed criticality or unexpected results it would be obvious to one of ordinary skill in the art at the time that the invention was made modify the diameter ratio, as taught by Phan, such that the electrically nonconductive segment is less than about 1.09 times of a diameter of the distal portion because this is a change in size/proportion that is not sufficient to patentable distinguish over the prior art (See MPEP 2144.04). One of ordinary skill in the art at the time that the invention was made would know to modify the diameter of the electrically nonconductive segment and/or the diameter of the distal portion such that the electrically nonconductive segment is less than about 1.09 times of a diameter of the distal portion to modify the ablation pattern and flexibility of the device.
Referring to claims 29, 30, 39 and 40, Phan teaches a first and second flexible electrode segment however fails to teach a measurement circuit coupled with the electrodes. Bowe teaches a measurement circuit (thermal sensor) coupled with multiple band electrodes (106) (Col. 4, lines 3-13; Figure 1). It would be obvious to one of ordinary skill in the art at the time that the invention was made modify the three electrodes, as taught by Phan, to comprise a measurement circuit, as taught by Bowe, in order to ensure lesions are effectively formed by the electrodes (Col. 4, lines 9-13) and in order to position the catheter and ensure improved tissue contact before ablation more quickly.
Referring to claims 42-45, the modified Phan reference fails to teach a longitudinal length of the band electrode. Due to a lack of disclosed criticality or unexpected result it would have been an obvious matter of design choice to modify the longitudinal length of the band electrode, as taught by the modified Phan reference, to be 2 mm to less or 0.25 mm to 0.5 mm 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).
Claim 27 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huy D. Phan (2003/0078644) in view of Bowe (7,013,169) as applied to the claims above, and further in view of Pappone et al (2008/0294158) (hereinafter referred to as Pappone2).
Referring to claim 27, Phan fails to teach wherein the first and second flexible electrode segments are biased to stretch lengthwise. Pappone2 teaches that the electrode is biased to stretch lengthwise (paragraphs 0023 and 0084; Figures 14A and 14B). It would have been obvious to one of ordinary skill in the art at the time that the invention was made to modify the first and second electrode segments, as taught by Phan, to be biased to stretch lengthwise, as taught by Pappone2, in order to provide structural integrity to the electrode and resiliently keep the electrode in a pre-determined configuration at rest (paragraph 0084).
Claim 28 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Huy D. Phan (2003/0078644) in view of Bowe (7,013,169) as applied to the claims above, and further in view of Pappone et al (2008/0249463).
Referring to claim 28, Phan teaches a first and second flexible electrode segments with a fluid lumen however fails to teach a lumen extension member extending at least partially through the first and second flexible electrode segments, the lumen extension member having a plurality of openings configured and arranged to produce a predetermined fluid flow from the lumen extension member through the first and second flexible electrode segments. Pappone et al teaches an analogous catheter comprising a first and second electrode (22 or 222) with at least one fluid lumen which includes a lumen extension member from the at least one lumen, extending at least partially through the first and second flexible electrode segments, the lumen extension member having a plurality of openings configured and arranged to produce a predetermined fluid flow from the lumen extension member through the first and second flexible electrode segments (paragraphs 0044, 0048, 0051-0054; claims 1 and 3; Figures 2, 5-14). It would have been obvious to one of ordinary skill in the art at the time that the invention was made to modify the first and second electrode segments with a fluid lumen, as taught by Phan, include a lumen extension member extending at least partially through the first and second flexible electrode segments, the lumen extension member having a plurality of openings configured and arranged to produce a predetermined fluid flow from the lumen extension member through the first and second flexible electrode segments, as taught by Pappone et al, in order to control the fluid flow rate as desired (abstract). Pappone et al specifically teaches that a flow constrictor is used to allow for balanced outflow and that various factors can be adjusted to fit the functional needs of the particular application (paragraph 0049).
Response to Arguments
Applicant’s arguments with respect to the pending claims have been considered but are moot due to the new grounds of rejection. No specific arguments were made in the submitted arguments of December 29, 2025 with regard to the previously applied Bowe reference.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SAMANTHA M GOOD whose telephone number is (571)270-7480. The examiner can normally be reached Mon to Wed, 7am to 3pm.
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/SAMANTHA M GOOD/Examiner, Art Unit 3794
/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
