DETAILED ACTION
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 (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.
Election/Restrictions
Applicant’s election without traverse of claims 1-17 in the reply filed on 27 March 2026 is acknowledged.
Claim 17 is directed to an allowable product. Pursuant to the procedures set forth in MPEP § 821.04(B), claims 18-20, directed to the process of making or using an allowable product, previously withdrawn from consideration as a result of a restriction requirement, are hereby rejoined and fully examined for patentability under 37 CFR 1.104.
Because all claims previously withdrawn from consideration under 37 CFR 1.142 have been rejoined, the restriction requirement as set forth in the Office action mailed on 28 January 2026 is hereby withdrawn. In view of the withdrawal of the restriction requirement as to the rejoined inventions, applicant(s) are advised that if any claim presented in a divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application. Once the restriction requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Claim Objections
Claim 18 is objected to because of the following informalities: “returns to the puncturing” in line 19 should be amended to --returns to the puncturing device--. Appropriate correction is required.
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.
Claims 18-20 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.
Claim 18 recites the limitations "the left atrium" and “the steps” in line 1; “the vasculature”, “the groin”, and “the femoral vein” in line 2; “the inferior vena cava”, “the right atrium”, and “the superior vena cava” in lines 4-5; and “the fossa ovalis” and “the septum” in line 11. There is insufficient antecedent basis for these limitations in the claim.
The term “slightly protruding” in claim 18 is a relative term which renders the claim indefinite. The term “slightly” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 20 recites the limitation "the step (x)" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Claim 19 is rejected by virtue of its dependency upon an indefinite base claim.
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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-16 are rejected under 35 U.S.C. 103 as being unpatentable over Highsmith et al. (US 2021/0401483) in view of Howard et al. (US 2022/0061911).
Regarding claim 1, Highsmith discloses a puncturing device (see Figs. 3A-3E) for use with a generator which is capable of supplying an energy for puncturing a tissue (see [0046]), the puncturing device comprising: an elongate member comprising a proximal portion and a distal portion (see distal end and proximal portions of transseptal needle 110, Fig. 1 and 3A-3E); the proximal portion is configured for being connected to the generator such that the energy for puncturing the tissue (see Fig. 1) is supplied to the elongate member; and the distal portion ending in a distal tip (see distal end 114, Fig. 3C), wherein the distal tip comprises an energy delivery device which is configured for delivering the energy for puncturing (see ablation electrode 128, Fig. 3C). However, Highsmith fails to teach the generator as capable of supplying an electrical current of known voltage, wherein the electrical current of known voltage can pass through the tissue without damaging the tissue; and wherein the distal tip comprises two electrodes which are configured for delivering the electrical current of known voltage through a material which is in contact with the distal tip, wherein a first of the two electrodes delivers the electrical current to the material and the electrical current returns to the puncturing device through a second of the two electrodes.
Howard teaches an electrosurgical device for treating the foramen ovale of the heart (see Figs. 11-13) wherein the generator is configured to supply an electrical current of known voltage (see [0061]-[0063]), and wherein the distal tip comprises two electrodes which are configured for delivering the electrical current of known voltage through a material which is in contact with the distal tip (see the needle 12 and additional electrodes in [0124] and/or electrodes 320-328 in [0132]-[0137] and Figs. 17A-19), wherein a first of the two electrodes delivers the electrical current to the material and the electrical current returns to the puncturing device through a second of the two electrodes (see [0085] and [0137]). Therefore, 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 the generator and distal tip as disclosed by Highsmith such that the generator as capable of supplying an electrical current of known voltage, wherein the electrical current of known voltage can pass through the tissue without damaging the tissue; and wherein the distal tip comprises two electrodes which are configured for delivering the electrical current of known voltage through a material which is in contact with the distal tip, wherein a first of the two electrodes delivers the electrical current to the material and the electrical current returns to the puncturing device through a second of the two electrodes in light of Howard, the motivation being to provide the additional advantage of enabling the device to determine when the electrode is in contact with target tissue and further determine (see [0081]-[0082]) as well as monitoring and controlling depth (see [0067]).
However, Highsmith in view of Howard fails to specifically teach wherein the electrical current of known voltage can pass through the tissue without damaging the tissue, it would have been further obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the power used by Highsmith in view Sato for at least initially determining contact with tissue to be low enough to pass through tissue without damaging the tissue, the motivation being to provide the additional advantage of inadvertently ablating non-target tissue before the distal tip of the device is in the correct position.
Regarding claim 2, Howard further teaches a sensor which is capable of detecting a value of the electrical current between the two electrodes associated with the electrical current traveling through the material in contact with the distal tip, and the puncturing device having means to communicate to the generator the value which is associated with the electrical current between the two electrodes (see [0067]).
Regarding claim 3, Howard further teaches a means to communicate a first electrode current parameter and a second electrode current parameter to the generator (see the wires in [0067]).
Regarding claim 4, Howard further teaches wherein the sensor is configured to detect impedance (see [0082]).
Regarding claim 5, Howard further teaches wherein the sensor is configured to detect dielectricity (see impedance as a measure of dielectricity, [0082]).
Regarding claim 6, Highsmith further discloses wherein the elongate member is a flexible wire or needle (see transseptal needle 110).
Regarding claim 7, Howard further teaches wherein the two electrodes are located on a distal face of the puncture device (see electrodes located on distal, outer face of the device as shown in Fig. 19).
Regarding claim 8, Howard further teaches an insulating material which electrically isolates the two electrodes from the energy delivery device (see insulative material of the dilator separating the electrodes as shown in Fig. 19).
Regarding claim 9, Howard further teaches wherein the two electrodes are located laterally opposite to each other on a side of the distal tip (see circumferentially segmented electrodes, [0070]).
Regarding claim 10, Highsmith further discloses wherein the proximal portion comprises a hub through which the proximal portion is connected to the generator (see 152 as a hub that the proximal portion passes into the connect to the generator as shown in Fig. 1).
Regarding claim 11, Highsmith in view of Howard further teaches the limitations of claim 11 under the same citations and rationale as that applied in the rejections of claims 1 and 2 above. Highsmith in view of Howard further teaches the generator comprising a generator switch for disabling the supplying of the energy for puncturing to the energy delivery device of the distal tip based on the value of the electric current detected by the sensor (see Howard [0081] and [0084]).
Regarding claims 12 and 13, Highsmith in view of Howard further teaches the limitations of claim under the same citations and rationale as applied in the rejection of claims 2 and 3 above.
Regarding claim 14, Howard further teaches wherein the generator switch is a hardware switch or a software algorithm (see [0081] and [0084], wherein software programming and a hardware switch to shut off power would be necessary).
Regarding claim 15, Howard further teaches wherein the generator switch disables the delivery of energy for puncturing when the value detected by the sensor is a value associated with blood (see [0082] and [0084]).
Regarding claim 16, Howard further teaches wherein the generator switch disables the delivery of energy for puncturing when the value detected by the sensor is less than a threshold value, and the threshold value is between a value associated with blood and a value associated with the tissue (see [0082] and [0084]).
Allowable Subject Matter
Claim 17 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 18-20 would be allowable if rewritten or amended to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art of record, Highsmith et al. (US 2021/0401483) and Howard et al. (US 2022/0061911), fails to reasonably teach or suggest wherein the generator delivers energy for puncturing the tissue in pulses and the electrical current of known voltage is delivered to the first of the two electrodes between pulses of energy for puncturing when considered in combination with the additional requirements of the claims. The closest prior art generally discloses providing measuring pulses and puncturing pulses, however fails to specifically teach or reasonably suggest providing pulses of known voltage between the puncturing pulses, with the pulses of known voltage occurring between the two electrodes or to the first of the two electrodes that are disposed on the distal tip as required.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SEAN W COLLINS whose telephone number is (408)918-7607. The examiner can normally be reached M-F 9:00 AM-5:00 PM ET.
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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.
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/SEAN W COLLINS/Primary Examiner, Art Unit 3794
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