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 Reply to Office Action filed April 11, 2025. The Examiner acknowledges the amendments to claims 1-2, 4-6, and 8-11. Claims 1-14 are currently pending.
Response to Arguments
Applicant’s arguments, see remarks, filed April 11, 2025, with respect to the previous rejection of claims 10 & 11 under 35 USC 112(b) have been fully considered and are persuasive. The previous rejection of claims 10 & 11 under 35 USC 112(b) has been withdrawn.
Regarding the rejection of claims 1-14 under 35 USC 101, Applicant argues that the method recited in claim 1 cannot be completed merely by a mental process, as the transmitting and receiving of the synchronous periodic AC voltage signals with different frequencies cannot be performed by the mental process of a human being without the help of electronic devices. Moreover, Applicant states that claim 1 has been amended to recite specific apparatuses required for each of the steps to avoid being interpreted that the steps could be processed merely by mental processes. Additionally, Applicant argues that the capacitance used in the present application is different from the capacitance used in well-understood, routine and conventional methods. Further, Applicant argues the recitation of using capacitances measured under multiple frequencies yields a claim as a whole that is significantly more than the judicial exception itself.
The Examiner respectfully disagrees with these arguments. The Examiner would like to note that the abstract idea found in the claims is the recitation of estimating, by at least one processor, motion characteristics of myocardial tissue according to resistances and capacitances. The step of estimating, by at least one processor, motion characteristics of myocardial tissue according to resistances and capacitances sets forth a judicial exception because this step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion), which draws the claim to a Mental Process, which is an Abstract Idea. Though the claim has been amended to recite specific apparatuses required in the method, those specific apparatuses fail to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception (i.e., the step of estimating) in a manner that imposes a meaningful limitation on the judicial exception. Therefore, the claim does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change, nor does the method use a particular machine to perform the Abstract Idea.
Moreover, the specific apparatuses pertain to the steps of transmitting, by a plurality of transmitting electrodes of one or more sensors, a plurality of generated alternating currents with different frequencies into an organism, receiving, by a plurality of receiving electrodes of the one or more sensors, periodic AC voltage signals modulated by changes within the organism’s heart so as to obtain the organism’s frequency responses, and calculating, by at least one processor, resistances and capacitances of the heart tissue according to the frequency responses. The transmitting, receiving, and calculating steps that are effected by the specific apparatuses are each 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. As such, 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)).
Further, regarding Applicant’s arguments that the capacitance used in the present application is different from the capacitance used in well-understood, routine and conventional methods, and that the recitation of using capacitances measured under multiple frequencies yields a claim as a whole that is significantly more than the judicial exception itself, as those limitations have been found in the prior art (see 35 USC 102/103 rejections), those limitations are indistinguishable from well-understood, routine and conventional methods. For these reasons, the claims are still rejected under 35 USC 101. Moreover, the Examiner would like to note that as claim 1 is not patent eligible under 35 USC 101, though claims 2-5 and 7-9 contain allowable subject matter, they are not patent eligible either. See 35 USC 101 rejection below.
Regarding the rejection of claims 1 and 10-12 under 35 USC 102 as being anticipated by “Min”, Applicant argues that Min does not describe the calculating step as recited in the claims. Further, Applicant argues that Min describes a method based on invasive estimation, while the claims of the instant application recite a non-invasive method, which leads to a different technical solution. Additionally, Applicant argues that Min does not recite generating synchronous periodic AC voltage signals with different frequencies, that Min can only measure the biological impedance of tissue channels from the perspective of extracellular fluid, and that capacitance is measured only under a specific frequency, rather than multiple frequencies.
Regarding the rejection of claims 6, 13 and 14 under 35 USC 103, Applicant argues that as there are deficiencies with the 102 rejection of claims 1 and 10-12 over Min, the analysis used in the 103 rejections do not make up for those deficiencies, and therefore claims 6, 13 and 14 distinguish over the applied references.
The Examiner respectfully disagrees with Applicant’s arguments regarding the rejection of the claims under 35 USC 102 and 103. Regarding Applicant’s argument that that Min does not describe the calculating step as recited in the claims, the Examiner disagrees because Min discloses calculating the impedance of tissue according to frequency responses of the tissue (see Min, par 0004-0005, 0062-0066, 0069-0073, fig. 14), as required by claim 1. Further, Min does not describe that the method is based on invasive estimation, and instead discloses that the method for conducting bioimpedance measurements can be done non-invasively, as in fig. 1, or invasively using a multielectrode device, as in fig. 2 (see Min, , figs. 1-3). Also, Min discloses that the method is used in applications such as impedance cardiography, which is a non-invasive technology (see Min, par 0051). Additionally, Min does recite generating synchronous periodic AC voltage signals with different frequencies, as Min discloses sending signals with 8 different frequencies to 1-4 excitation electrodes, wherein the response voltages are measured by up to 4 measurement electrodes (see Min, par 0049, 0053-0056, figs. 10-13). Applicant alleges that Min can only measure the biological impedance of tissue channels from the perspective of extracellular fluid but did not provide sufficient evidence to support that claim. As such, the claims are still rejected under 35 USC 102 and 103 using the Min reference. See 102 and 103 rejections below.
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 1-14 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, by at least one processor, motion characteristics of myocardial tissue according to resistances and capacitances. 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, by at least one processor, motion characteristics of myocardial tissue according to resistances and capacitances 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. Therefore, the claim does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change, 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 transmitting, by a plurality of transmitting electrodes of one or more sensors, a plurality of generated alternating currents with different frequencies into an organism, receiving, by a plurality of receiving electrodes of the one or more sensors, periodic AC voltage signals modulated by changes within the organism’s heart so as to obtain the organism’s frequency responses, and calculating, by at least one processor, resistances and capacitances of the heart tissue according to the frequency responses. The transmitting, receiving, and calculating steps are each 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 10, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited sensor 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 transmitting, receiving, and calculating 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 & 10-12 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by US Patent Application Publication 20100225303 --as cited by applicant--, hereinafter referenced as "Min".
With respect to claim 1, Min teaches a non-invasive method for measuring the motion characteristics of a myocardial tissue (i.e., heart tissue) (see Min, abstract, par 0051 discussing the impedance cardiography applications of the method) wherein the method comprises:
transmitting, by a plurality of transmitting electrodes of one or more sensors, a plurality of generated synchronous orthogonal, phase controllable and adjustable alternating currents with different frequencies into an organism so as to generate a plurality of synchronous periodic AC voltage signals with different frequencies (see Min, par 0049, 0053-0056, figs. 10-13);
receiving, by a plurality of receiving electrodes of the one or more sensors, the periodic AC voltage signals modulated by changes in the organism's heart tissue to obtain the organism's frequency responses (see Min, par 0049, 0056-0058, 0066, figs. 14 & 16-18, claim 33);
calculating, by a least one processor, resistances and capacitances of the heart tissue according to the frequency responses (i.e., calculating the impedance of the tissue according to the frequency responses) (see Min, par 0004-0005, 0062-0066, 0069-0073, figs. 9 & 14);
and estimating, by the at least one processor, the motion characteristics of the myocardial tissue according to the resistances and the capacitances (i.e., a variation of the bioimpedance due to heartbeats and breathing) (see Min, par 0023, 0066).
With respect to claim 10, Min teaches a system for implementing a non-invasive method for measuring the motion characteristics of a myocardial tissue (i.e., heart tissue) (see Min, abstract, par 0014-0017), wherein the system comprises a terminal and at least one processor (see Min, fig. 9), wherein the terminal comprises:
a generator for generating a plurality of synchronous orthogonal, phase controllable and adjustable, and periodic alternating currents with different frequencies (see Min, par 0049, 0053-0056, figs. 9-13);
and one or more sensors for transmitting the periodic alternating currents into an organism to generate a plurality of periodic AC voltage signals with different frequencies, and receiving the periodic AC voltage signals modulated by changes in the heart tissue of the organism to obtain the organism's frequency responses (see Min, par 0053-0058, 0064-0066, figs. 14 & 16-18, claim 33);
wherein the processor is configured to calculate resistances and capacitances of the heart tissue according to the frequency responses, and to estimate the motion characteristics of the myocardial tissue according to the resistances and the capacitances (i.e., a variation of the bioimpedance due to heartbeats and breathing) (see Min, par 0023, 0062-0066).
With respect to claim 11, Min further teaches the one or more sensors (i.e., electrode) of claim 10 are configured to collect single or multiple pieces of data from different parts (see Min, par 0053-0054).
With respect to claim 12, Min further teaches the system of claim 10 further comprises a database for storing processing results and data of the processor or processors, and the processor or processors can retrieve the database (i.e., a field programmable gate array, FGPA, stores the digitized signals) (see Min, par 0045, 0048, 0060, 0062).
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.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Min as applied to claim 1 above in paragraph 6.
With respect to claim 6, Min fails to teach that obtaining the organism’s frequency responses comprises calculating a frequency response estimation values of a specific frequency every 0.25 to 5 milliseconds.
Nonetheless, 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 Min such that frequency response estimation values of a specific frequency are calculated every 0.25 to 5 milliseconds because Min teaches that a sampling rate of 10 MHz can be used to detect response signals in the frequency range of 30 kHz – 100 kHz (see Min, par 0055). Therefore, it would merely be a matter of routine optimization to arrive at a sampling rate of 0.25 to 5 milliseconds that is used to calculate frequency response estimation values, since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine optimization.” See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1995). See MPEP 2144.05 II. Routine Optimization A. Optimization within Prior Art Conditions or Through Routine Experimentation.
Claim(s) 13 & 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Min as applied to claim 10 above, and further in view of US Patent Application Publication 20140249441 --as previously cited--, hereinafter referenced as "Banet".
With respect to claim 13, Min teaches the system according to claim 10, but fails to teach the processor or processors can be remote, and can be used for remote observation of the system's work in a real-time mode.
Banet teaches a body-worn system for continuous noninvasive measurement of cardiac output, stroke volume, cardiac power, and blood pressure wherein the aforementioned values are transmitted wirelessly to remote processing upon completion of measurements (see Banet, par 0085).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Min such that the processor(s) are remote and can be used for remote observation of the system’s work in a real-time mode because this permits data to be processed in a hospital-based wireless network that can be interfaced with a medical records system, such that medical professionals can evaluate physiological values for a patient to make a diagnosis (see Banet, par 0085).
With respect to claim 14, Min teaches the system according to claim 10, but fails to teach the terminal further comprises a man-machine interface for controlling the system and/or displaying results.
Banet teaches the body-worn system comprises a display device that displays physiological values of cardiac output, stroke volume, cardiac power, and blood pressure after processing (see Banet, par 0024-0025, 0106, 0117-0118, 0162-0163).
It would have been obvious to one of ordinary skill before the effective filing date of the claimed invention to modify the system of Min such that the terminal further comprises a man-machine interface for controlling the system and/or displaying results because that enables physiological data of a patient to be clearly displayed to a patient or a medical professional that is caring for the patient (see Banet, par 0024-0025, 0106, 0117-0118, 0162-0163).
Examiner’s Note
Claims 2-5 & 7-9 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 101 set forth in this Office action and to include all of the limitations of the base claim and any intervening claims.
Regarding claims 2 & 9, none of the prior art teaches or suggests, either alone or in combination, performing multi-chamber modeling to separate heart tissue and peripheral tissues in order to calculate resistances and capacitances of heart tissue according to frequency responses, in combination with the other claimed elements or steps.
Regarding claims 3-5 & 7-8, none of the prior art teaches or suggests, either alone or in combination, calculating average longitudinal length of myocardial cells, and obtaining a longitudinal elastic state of the heart according to the average longitudinal length of the myocardial cells, in order to estimate the motion characteristics/health and working states of myocardial tissue according to resistances and capacitances, in combination with the other claimed elements or steps.
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 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
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