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 .
Information Disclosure Statement
The numerous references cited on the Information Disclosure Statements have been afforded a cursory review, similar to what would be expected of a classification search of the prior art. Should there be any references of particular relevance to the instant application claims, applicant is respectfully requested to identify such references for further review by the examiner.
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.
Claim 20 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 20 recites “a conductive ink” (line 2), which is unclear since claim 19, from which claim 20 depends, also recites “a conductive ink”. It appears the recitation of claim 20 should recite “the conductive ink”.
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 1-6 and 10-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hazan et al (WO 2018/229768).
Regarding claim 1, Hazan et al provide an end effector for a medical probe comprising an expandable distal end assembly (202 – Figure 2B) extending along a longitudinal axis, the distal assembly extending radially outward from the longitudinal axis (as seen in Figures 2B and 2C) and defining an outer diameter. A distal tip (generally 204, or the tube to which balloon 204 and tip 206 are connected) extending distally from the expandable distal end assembly along the longitudinal axis. The length of the distal tip may be greater than the outer diameter of the expandable member. See, for example, page 22 which recites a diameter for the balloon of 15-30mm and page 20, line 4 which states the length of the distal balloon (204) may be 30mm or longer (and the tip would extend even further). The distal tip is fixed longitudinally relative to the longitudinal axis (Figures 2A-2C) and is deflectable with respect to the longitudinal axis (i.e. must be flexible for advancement through the vasculature as required for use). The distal tip comprises an electrode (206) configured to deliver ablative energy or receive sensing signals from tissue (page 22, line 3, for example).
Regarding claims 2 and 3, the expandable distal end assembly also comprises a plurality of electrodes on the expandable distal end assembly to deliver energy or receive signals from tissue. See, for example, Figure 4D and page 32. Regarding claim 4, the tip is inherently capable of deflecting radially outward (i.e. must be flexible enough to advance through the vasculature). Regarding claim 5, see discussion of claim 1 and pages 20 and 22 above. Assuming a balloon length of 15mm, the tip length may be up to 30mm which would be twice the length of the balloon. Regarding claim 6, see page 20, lines 24-27 with discusses the use of impedance sensing with the electrodes to determine position (e.g. contact with tissue). Regarding claim 10, the distal end assembly is a balloon configured to be inflated/deflated (Figures 2A-2C). Regarding claims 11-13, the balloon may comprise a stretchable circuit material made with conductive ink (page 32, last paragraph to page 33, line 15. Regarding claim 14, the balloon comprises a flexible circuit as discussed with respect to claims 11-13. See, also, Figures 4C and 4D.
Regarding claim 15, Hazan et al provide a medical probe comprising an insertion tube (208) having proximal and distal ends, and an expandable distal end assembly (202) disposed at the end of the insertion tube, and a distal tip (tube on which balloon 204 and electrode 206 are located), the distal tip being fixed longitudinally to the expandable distal end assembly (Figures 2A-2C) and comprising an electrode (206) configured to deliver ablative energy to tissue. See discussion of claim 1 above.
Regarding claim 16, see discussion of claim 4 above. Regarding claim 17, see discussion of claim 5 above. Regarding claim 18, see pages 32-33 as discussed with regard to claims 11-14 above.
Regarding claim 19, Hazan et al provide an end effector comprising a balloon (202, for example) comprising a stretchable circuit material (pages 32-33 as addressed above), and a plurality of electrodes disposed on an outer surface of the balloon, the electrodes comprising a conductive ink. See Figure 4D and page 33 as addressed previously.
Regarding claim 20, see again the discussion at pages 32-33 as addressed previously, which discloses the use of flexible traces and conductive ink for securing electrodes to the balloon.
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.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Hazan et al (‘768) in view of the teaching of Racheli et al (10,976,148).
Hazan et al disclose the use of the electrodes to determine catheter position in tissue, but fail to expressly disclose an electromagnetic position sensor, in particular a triple axis sensor, as required by claims 7 and 8.
Racheli et al disclose another catheter device for treating cardiac tissue. In particular, Racheli et al teach that it is known to provide a position sensor comprising an electromagnetic sensor, and specifically a triple axis sensor, for determining the catheter position in a cardiac. See, for example, column 5, lines 17-26.
To have provided the Hazan et al device with an electromagnetic sensor to determine the catheter position within tissue would have been an obvious consideration for one of ordinary skill in the art at the time of the invention, particularly since Hazan et al disclose the use of position sensing technology and further since Racheli et al teach that it is known to use a triple axis electromagnetic sensor in cardiac catheters for determining the position of the catheter in tissue.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Hazan et al (‘768) in view of the teaching of Panescu et al (2021/0007796).
Hazan et al disclose the use of a fluid delivery system in the device but fail to expressly disclose the use of an irrigation fluid to irrigate the tip of the device.
Panescu et al disclose a similar catheter comprising a balloon end effector with a tip section extending beyond the balloon, the device including electrodes at the tip section. In particular, Panescu et al teach that it is known to provide an irrigation fluid to the tip member, the irrigation fluid exiting apertures (235) in the tip member.
To have provided the Hazan et al device with irrigation ports on the distal end of the catheter to irrigate tissue during treatment would have been an obvious modification for one of ordinary skill in the art at the time of the invention since Panescu et al fairly teach it is known to provide such an irrigation means in an analogous catheter device.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Salo et al (4,587,975) disclose another catheter device having a balloon end effector and a tip section extending beyond the balloon and including electrodes for sensing tissue. Chu et al (5,967,984) and Stewart et al (6,325,797) also have a balloon catheter having an electrode and a tip sections extending beyond the balloon having electrodes.
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/MICHAEL F PEFFLEY/Primary Examiner, Art Unit 3794
/M.F.P/June 20, 2026
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