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 .
Election/Restrictions
Claims 1-11, 21-34 withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/21/2026.
Applicant’s election without traverse of claims 12-20 in the reply filed on 5/21/2026 is acknowledged.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 12-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than
an abstract idea. A streamlined analysis of claim 12 follows.
Regarding claim 12, the claim recites a vascular monitoring method. Thus, the claim is directed to a machine/apparatus, which is one of the statutory categories of invention. The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
"providing a drive signal…measuring at least one of impedance and capacitance…wireless communication data…wireless transmitting data…determining vessel compatibility and deformity...".
These limitations describe a mathematical calculation. Furthermore, the limitations also describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application. For this part of the 101 analysis, the following additional limitations are considered:
"a vascular monitoring method, comprising: implanting a plurality of pairs of electrodes…providing a drive signal to the electrodes…a control system comprising a processor and memory…electrode pairs executed on the processor".
These additional limitations do not integrate the judicial exception into a practical
application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary to perform the identified judicial exception do not integrate the claims into a practical application. See MPEP 2106.05(g).
The additional limitations also do not add significantly more to the identified judicial exception because they are recited at a high level of generality. Moreover, Examiner takes official notice that "a pair of electrodes" is widely- understood, routine, and conventional.
Dependent claims 13-20 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 12-20 are not patent eligible under 35 USC 101.
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 12-20 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.
There is insufficient antecedent basis for these limitations in the following claims:
Claim 12 recites the limitation "the electrodes", “electrode pairs”.
Claim 13 recites “said electrodes”, “said electrode pairs”.
Claim 14 recites “plurality of electrode pairs”.
Claim 20 recites “each electrode pair”.
Claim Rejections - 35 USC § 103
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.
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.
Claim(s) 12-16, 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Corbucci (US 20090270729) in view of Varsavsky (US 20170181677)
Regarding claim 12, Corbucci discloses A vascular monitoring method (abstract), comprising:
implanting a plurality of pairs of electrodes (“pair of electrodes positioned in or on a vein…; 206, 208, 210) (paragraph 0025, 0045) within a vessel (18/100), on, in or adjacent a vessel wall (paragraph 0021-0022, 0025, 0045) (Fig 4);
providing a drive signal to the electrodes (paragraph 0025);
measuring at least one of impedance and capacitance between at least two of the plurality of pairs of electrodes (paragraph 0025-0026, 0028-0029, 0048-0051);
wirelessly communicating data from within the vessel (paragraph 0032, generally paragraphs 0025-0031);
wirelessly transmitting data representing measured impedance or capacitance to a control system comprising a processor (54) and memory (56) (paragraph 0031); and
determining vessel collapsibility or deformity over at least one respiratory cycle based on said measured impedance or capacitance between electrode pairs with steps executed on the processor (paragraph 0025-0026, 0029-0030).
Corbucci discloses all of the claimed limitations except using a wireless connection. Varsavsky teaches using a wireless connection (paragraph 0164). Therefore, it would have been obvious at the effective filing date of the invention to modify Corbucci to use a wireless connection to transmit data as taught by Varsavsky for the purpose of providing real-time, continuous, and highly localized physiological data without the encumbrance of physical wires and therefore, significantly reducing infection risk, minimizing tissue damage, and drastically improving patient comfort and mobility.
Regarding claim 13, Corbucci discloses The method of claim 12, further comprising calculating the distance between plural pairs of said electrodes based on the measured impedance or the measured capacitance between said electrode pairs (paragraph 0025, 0046-0051). .
Regarding claim 14, Corbucci discloses The method of claim 13, further comprising estimating at least one of cross-sectional area of the vessel lumen or vessel diameter based on measurements of impedance or capacitance between at least one of the plurality of electrode pairs (paragraph 0025-0026, 0029-0030, 0049-0051).
Regarding claim 15, Corbucci discloses The method of claim 12, further comprising: transmitting data representing measured impedance or capacitance to a control system comprising a processor and memory (paragraph 0025-0026, 0028-0029, 0048-0051). Corbucci discloses all of the claimed limitations except using a wireless connection and executing with the processor steps to correct the measurements for effects of fouling and/or endothelialisation on electrode surfaces. Varsavky teaches using a wireless connection (paragraph 0164) and executing with the processor steps to correct the measurements for effects of fouling and/or endothelialisation on electrode surfaces (paragraph 0255, 0273, 0292). Therefore, it would have been obvious at the effective filing date of the invention to modify Corbucci to use a wireless connection to transmit data and anti-fouling methods as taught by Varsavsky for the purpose of providing real-time, accurate, continuous, and highly localized physiological data without the encumbrance of physical wires and ensuring accurate in-body monitoring by reducing fouling and therefore, significantly reducing infection risk, minimizing tissue damage, and drastically improving patient comfort and mobility.
Regarding claim 16, Corbucci discloses The method of claim 15, wherein said executing steps to correct the measurements comprise one or more of the steps of: impedance-to-distance calibration based on resting dimensions (paragraph 0033); salinity recalibration with scales impedance measurements with reference change; geometric reconstruction with elliptical assumption; and fouling detection and rejection according to electrode geometry.
Regarding claim 20, Corbucci discloses all of the claimed limitations except The method of claim 12, further comprising delivering a sinusoidal waveform and cycling through each electrode pair taking impedance measurements or capacitive measurements. Varsavsky teaches delivering a sinusoidal waveform and cycling through each electrode pair taking impedance measurements or capacitive measurements (paragraph 0192, 0207, 0209). Therefore, it would have been obvious at the effective filing date of the invention to modify Corbucci by using sinusoidal waveforms as taught by Varsavsky for the purpose of preventing unintended stimulation by using smooth sine waves and minimizing tissue heating.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YASMEEN S WARSI whose telephone number is (571)272-9942. The examiner can normally be reached Monday-Friday 9 am to 5 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Alexander Valvis can be reached at 571-272-4233. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/YASMEEN S WARSI/Examiner, Art Unit 3791
/MAY A ABOUELELA/Primary Examiner, Art Unit 3791
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