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 .
This Office Action is responsive to the claims filed June 29, 2022. The Examiner acknowledges the amendments to claims 1, 3-7, 10-15, 17-25 and 27, and the cancellation of claims 2, 8-9, 26, and 29-37. Claims 1, 3-7, 10-25 and 27-28 are currently pending.
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 27 & 28 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 27 recites “wherein the processor is configured to classify the electrical measurements to obtain the estimated state of occlusion according to a time duration beginning upon receiving the predetermined signal, and ending upon returning of the electrical measurements to their values pre-injection”. Claim 27 is recited to be dependent upon claim 20, however there is no recitation of an injection or a predetermined signal in claim 20. Therefore, there is a lack of antecedent basis in claim 27 for “the predetermined signal” and a “pre-injection” state, and as such, it is unclear as to what predetermined signal or injection the claim is referring. The Examiner suggests amending claim 27 to be dependent upon claim 23 to have the proper antecedence for the predetermined signal and the injection.
Dependent claims are similarly rejected as their base claim.
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 1, 3-7, 10-25 and 27-28 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 1 follows.
Regarding claim 1, the claim recites a series of steps or acts, including estimating a state of occlusion based on accessed electrical measurements. Thus, the claim is directed to a process, 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 step of estimating a state of occlusion based on accessed electrical measurements sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites providing an indication of the estimated state of occlusion, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The provision of the indication of the estimated state of occlusion does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the provided indication of the estimated state of occlusion, nor does the method use a particular machine to perform the Abstract Idea.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites additional steps of accessing electrical measurements measured using an electrode portion of an occlusive implant. The accessing step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 20, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited electrode portion of the occlusive implant is a generic sensor configured to perform pre-solutional data gathering activity, and the processor is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering and data processing. The accessing steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 3-7, 10-15, 17-20, 22-25 & 27-28 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication 2016/0157914 --as cited by applicant--, hereinafter referenced as "Avitall".
With respect to claim 1, Avitall teaches a method of providing an estimated state of occlusion resulting from an occlusive implant positioned between two compartments of a lumenal space of a body of a patient (i.e., assessing pulmonary vein occlusion quality in a patient using a cryotreatment catheter device and a saline/contrast mixture) (see Avitall, par 0009-0010, 0018-0019, 0025-0026, 0028-0032, figs. 1-3, 4A-4D), the method comprising:
accessing electrical measurements measured using an electrode portion 30 of the occlusive implant 26 (i.e., an electrode of a cryotreatment catheter comprising a cryoballoon that functions as an occlusion element is configured to deliver energy to a treatment area, wherein temperature measurements from the electrode are obtained and used to determine the state of pulmonary vein occlusion) (see Avitall, par 0010, 0019, 0022, 0024, 0025-0031, figs. 1-3);
estimating the state of occlusion based on the accessed electrical measurements (see Avitall, par 0025-0031, figs. 1-3, 4A-4D);
and providing an indication of the estimated state of occlusion (i.e., displays or alerts are generated to notify a user of system criteria or determinations) (see Avitall, par 0022).
With respect to claim 3, Avitall teaches the method of claim 1, and Avitall further teaches the accessed electrical measurements comprise measurements made during a period following an injection of a dielectric contrast agent within at least one of the two compartments (i.e., the cyroballoon including the electrode is positioned at a pulmonary vein ostium and saline, a biocompatible contrast medium, or a combination of both is injected into the pulmonary vein, wherein temperature measurements are taken by the electrode to determine the occlusion of the pulmonary vein after injection of the saline/contrast medium) (see Avitall, par 0020, 0025-0029).
With respect to claim 4, Avitall teaches the method of claim 3, and Avitall further teaches the occlusive implant has a proximal side attached to a delivery device, and a distal side;
and the dielectric contrast agent is injected to the compartment on the distal side of the occlusive implant (see Avitall, par 0018-0020, 0022, 0024, 0025-0031, figs. 1-3).
With respect to claim 5, Avitall teaches the method of claim 4, and Avitall further teaches the dielectric contrast agent is pressed across a membrane of the occlusive implant into the compartment on the distal side of the occlusive implant (see Avitall, par 0026, figs. 1-3).
With respect to claim 6, Avitall teaches the method of claim 1, and Avitall further teaches the state of occlusion is estimated based on a variation of the electrical measurements over time.
With respect to claim 7, Avitall teaches the method of claim 3, wherein the estimating comprises identifying, by a computer processor 56 (see Avitall, par 0022, 0027, 0031, fig. 1), a rate at which the electrical measurements return toward a baseline value after the injection (see Avitall, abstract, par 0010-0012, 0020, 0025-0028);
and estimating the state of occlusion based on comparison of said rate to a predetermined threshold (see Avitall, abstract, par 0010-0012, 0020, 0025-0028, table 1).
With respect to claim 10, Avitall teaches the method of claim 7, and Avitall further teaches the state of occlusion is estimated to be a satisfactory state of occlusion when the identified rate is slower than the predetermined threshold (i.e., the pulmonary vein occlusion is assessed to be a good occlusion the longer it takes the saline/contrast mixture to dissipate from the area proximate the cryotreatment catheter) (see Avitall, par 0028, table 1, figs, 4A-4D).
With respect to claim 11, Avitall teaches the method of claim 1, and Avitall further teaches the lumenal space comprises lumenal portions of a heart, and the state of occlusion is estimated based on changes in the electrical measurements driven at least in part by beating of the heart (i.e., the treatment area includes pulmonary vein tissue, tissue of the pulmonary vein ostium, the pulmonary vein antrum, left atrium wall tissue, and/or tissue at the junction between the left atrium and pulmonary vein, and the state of occlusion is based on changes in the electrical measurements of the temperature change of the electrode that is caused by blood flow in the treatment area as a result of the heart beating) (see Avitall, par 0025-0027, fig. 3).
With respect to claim 12, Avitall teaches the method of claim 1, and Avitall further teaches the occlusive implant occludes an opening between a left atrial appendage and a remaining lumen of a heart left atrium (i.e., the treatment area includes pulmonary vein tissue, tissue of the pulmonary vein ostium, the pulmonary vein antrum, left atrium wall tissue, and/or tissue at the junction between the left atrium and pulmonary vein) (see Avitall, par 0025-0027, fig. 3).
With respect to claim 13, Avitall teaches the method of claim 1, and Avitall further teaches the occlusive implant occludes an opening between a left atrium and a right atrium of a heart (i.e., the treatment area includes pulmonary vein tissue, tissue of the pulmonary vein ostium, the pulmonary vein antrum, left atrium wall tissue, and/or tissue at the junction between the left atrium and pulmonary vein) (see Avitall, par 0025-0027, fig. 3).
With respect to claim 14, Avitall teaches the method of claim 1, and Avitall further teaches the occlusive implant occludes an opening between a left ventricle and right ventricle of a heart (i.e., the treatment area includes pulmonary vein tissue, tissue of the pulmonary vein ostium, the pulmonary vein antrum, left atrium wall tissue, and/or tissue at the junction between the left atrium and pulmonary vein) (see Avitall, par 0025-0027, fig. 3).
With respect to claim 15, Avitall teaches the method of claim 1, and Avitall further teaches the electrical measurements include measurements of voltage between the electrode portion 30 of the occlusive implant, and a reference electrode 34 (i.e., the electrode is configured to record impedance data and electrogram data, and the cryotreatment catheter comprising the electrode also comprises a reference electrode) (see Avitall, par 0018-0019, 0021, 0024, figs. 1-3).
With respect to claim 17, Avitall teaches the method of claim 1, and Avitall further teaches the electrical measurements include measurements of electrical current injected to the electrode portion 30 of the occlusive implant (i.e., the electrode is configured to deliver energy) (see Avitall, par 0019-0020, 0022, 0027).
With respect to claim 18, Avitall teaches the method of claim 1, and Avitall further teaches the electrical measurements include impedance measurements (i.e., the electrode is configured to record impedance data) (see Avitall, par 0019).
With respect to claim 19, Avitall teaches the method of claim 18, and Avitall further teaches the impedance is a ratio between a voltage and current, wherein the voltage is a voltage measured between the electrode portion of the occlusive implant and a reference electrode; and the current is an electrical current injected to the electrode portion of the occlusive implant (i.e., the electrode is configured to record impedance data, which is a ratio between voltage and current, and the electrode is configured to deliver electrical energy which is current) (see Avitall, par 0019-0020, 0022, 0027).
With respect to claim 20, Avitall teaches an apparatus 10 for presenting an indication of a state of occlusion resulting from an occlusive implant 26 positioned between two compartments of a lumenal space of a body of a patient (i.e., assessing pulmonary vein occlusion quality in a patient using a cryotreatment catheter device and a saline/contrast mixture) (see Avitall, par 0009-0010, 0018-0019, 0025-0026, 0028-0032, figs. 1-3, 4A-4D), the apparatus comprising a processor 56 (see Avitall, par 0022, 0027, 0031, fig. 1) configured to:
access electrical measurements measured using an electrode portion 30 of the occlusive implant 26 (i.e., an electrode of a cryotreatment catheter comprising a cryoballoon that functions as an occlusion element is configured to deliver energy to a treatment area, wherein temperature measurements from the electrode are obtained and used to determine the state of pulmonary vein occlusion) (see Avitall, par 0010, 0019, 0022, 0024, 0025-0031, figs. 1-3);
estimate a state of occlusion based on the accessed electrical measurements (see Avitall, par 0025-0031, figs. 1-3, 4A-4D);
and present an indication of the estimated state of occlusion (i.e., displays or alerts are generated to notify a user of system criteria or determinations) (see Avitall, par 0022).
With respect to claim 22, Avitall teaches the apparatus of claim 20, and Avitall further teaches a display 54 controlled by the processor to present the indication of the estimated state of occlusion (i.e., displays or alerts are generated to notify a user of system criteria or determinations) (see Avitall, par 0022, 0031, fig. 1).
With respect to claim 23, Avitall teaches the apparatus of claim 20, and Avitall further teaches the apparatus further comprises an interface configured to provide the processor with a predetermined signal when a dielectric contrast agent is being injected on at least one side of the occlusive implant, and the processor is configured to use said predetermined signal in estimating the state of occlusion (i.e., the saline/contrast mixture is expelled with an initial temperature of 2-3 degrees Celsius, and the temperature is continuously measured after the initial expulsion of the saline/contrast mixture to determine whether the pulmonary vein is completely occluded) (see Avitall, par 0022, 0026-0028, 0030-0031).
With respect to claim 24, Avitall teaches the apparatus of claim 20, and Avitall further teaches the processor is configured to estimate the state of occlusion based on a change of the electrical measurements over time (see Avitall, par 0026-0028, 0030-0031, figs. 4A-4D, table 1).
With respect to claim 25, Avitall teaches the apparatus of claim 23, and Avitall further teaches the processor is configured to estimate the state of occlusion based on a change of the electrical measurements over time beginning upon receipt of the predetermined signal (i.e., after the saline/contrast mixture is expelled with a temperature of 2-3 degrees Celsius, the temperature is continuously measured after the initial expulsion of the saline/contrast mixture to determine whether the pulmonary vein is completely occluded) (see Avitall, par 0026-0028).
With respect to claim 27, Avitall teaches the apparatus of claim 20, and Avitall further teaches the processor is configured to classify the electrical measurements to obtain the estimated state of occlusion according to a time duration beginning upon receiving the predetermined signal, and ending upon returning of the electrical measurements to their values pre-injection (i.e., the saline/contrast mixture is expelled with an initial temperature of 2-3 degrees Celsius, whereas the occluded site is initially 38 degrees Celsius (i.e., body temperature) and the temperature is continuously measured after the initial expulsion of the saline/contrast mixture to see how long it takes the occluded site to return to 38 degrees Celsius, to determine whether the occluded site has good occlusion, fair occlusion, or poor/bad occlusion) (see Avitall, par 0022, 0026-0028, 0030-0031, figs. 4A-4D, table 1).
With respect to claim 28, Avitall teaches the apparatus of claim 27, and Avitall further teaches the processor is configured to compare the time duration to a predetermined threshold, and classify the electrical measurements based on the comparison (i.e., the saline/contrast mixture is expelled with an initial temperature of 2-3 degrees Celsius, whereas the occluded site is initially 38 degrees Celsius (i.e., body temperature) and the temperature is continuously measured after the initial expulsion of the saline/contrast mixture to see how long it takes the occluded site to return to 38 degrees Celsius, to determine whether the occluded site has good occlusion, fair occlusion, or poor/bad occlusion) (see Avitall, par 0022, 0026-0028, 0030-0031, figs. 4A-4D, table 1).
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.
Claim(s) 16 & 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Avitall as applied to claims 15 & 20 above, in view of US Patent Application Publication 2019/0298220, hereinafter referenced as "Sakaue".
With respect to claim 16, Avitall teaches the method of claim 15, but Avitall fails to teach the reference electrode is attached to a body surface of the patient.
Sakaue teaches an in vivo potential measurement device configured to measure electrical potentials at desired sites that comprises an electrode 10 that is in contact with a desired site, and a reference ground electrode 40 that is affixed to the surface of a living body 60 (see Sakaue, par 0025, 0028, 0048, fig. 1 & 3). An amplifier 80 is disposed outside of the living body, and amplifies the voltage between the ground electrode 40 and the electrode 10 in contact with the desired site (see Sakaue, par 0025, 0028, 0048, fig. 1 & 3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Avitall such that the reference electrode is attached to a body surface of the patient because a reference electrode that is attached to a body surface of the patient permits amplification of the voltage difference between the ground electrode and the electrode placed at a desired site (see Sakaue, par 0025, 0028, 0048, fig. 1 & 3), thereby resulting in accurate electrical potential measurements in real-time (see Sakaue, par 0014, 0025, 0028, 0048, figs. 1 & 3).
With respect to claim 21, Avitall teaches the apparatus of claim 20, but Avitall fails to further teach the apparatus further comprises: an electrical current source, configured to inject electrical current to the electrode portion of the occlusive implant; a voltmeter configured to measure alternating voltage between the electrode portion of the occlusive implant and a reference electrode attached to an outer surface of the patient; and wherein the electrical measurements include measurements of voltage, alternating at a frequency, made when current of said frequency is injected from the electrical current source to the electrode portion of the occlusive implant.
Sakaue teaches an in vivo potential measurement device configured to measure electrical potentials at desired sites that comprises an electrode 10 that is in contact with a desired site, and a reference ground electrode 40 that is affixed to the surface of a living body 60 (see Sakaue, par 0025, 0028, 0048, fig. 1 & 3). An amplifier 80 is disposed outside of the living body, and amplifies the voltage between the ground electrode 40 and the electrode 10 in contact with the desired site (see Sakaue, par 0025, 0028, 0048, fig. 1 & 3). The in vivo potential measurement device further comprises an alternating voltage source (see Sakaue, figs. 1-3) and a high-frequency current that passes through electrode 10 configured to cauterize tissue, wherein voltages are measured after the current is passed through the tissue to evaluate the contact/occlusion state of the tissue with an insulating member (i.e., a balloon) of the electrode 10 after cauterization (see Sakaue, par 0022, 0025-0026, 0042, 0044-0045, 0058, figs. 1-3).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the system of Avitall such that it further comprises an electrical current source, configured to inject electrical current to the electrode portion of the occlusive implant; a voltmeter configured to measure alternating voltage between the electrode portion of the occlusive implant and a reference electrode attached to an outer surface of the patient; and wherein the electrical measurements include measurements of voltage, alternating at a frequency, made when current of said frequency is injected from the electrical current source to the electrode portion of the occlusive implant because this would improve the apparatus of Avitall by permitting the apparatus of Avitall to cauterize tissues in a desired site and evaluate the contact/occlusion state of the tissue with the occlusive implant after cauterization (see Sakaue, par 0022, 0025-0026, 0042, 0044-0045, 0058, figs. 1-3). Furthermore, a reference electrode that is attached to a body surface of the patient permits amplification of the voltage difference between the ground electrode and the electrode placed at a desired site (see Sakaue, par 0025, 0028, 0048, fig. 1 & 3), thereby resulting in accurate electrical potential measurements in real-time (see Sakaue, par 0014, 0025, 0028, 0048, figs. 1 & 3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Destiny J Cruickshank whose telephone number is (571)270-0187. The examiner can normally be reached M-F, 9am-6pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Charles Marmor II can be reached at (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/D.J.C./Examiner, Art Unit 3791