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 .
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 1-6, specifically independent claims 1 and 5, are rejected under 35 U.S.C 101 because the invention is directed to a judicial exemption without significantly more. Please see the below 2 Prong Analysis:
Step One:
Claim 1 is directed to a system, which is a product. Therefore, the claim falls within a statutory category of invention.
Claim 5 is directed to a method. Therefore, the claim falls within a statutory category of invention.
Step 2A, Prong One:
Each of claims 1 and 5 recites the method steps of:
“…acquiring time-series biological information regarding pulsation of a heart…”
“…acquiring distribution candidate information…information indicating candidates for channel activity timing distribution…”
“…acquiring information indicating a state of an activity of an ion channel in the heart…”
Under the broadest reasonable interpretation, the claims recite a method comprising mental processes and/or method of organizing human activity (i.e. acquiring), which is an act of evaluating information, i.e. biological information, that can be practically performed in the human mind. Thus, since claims 1 and 5 recite a limitation that falls within the mental processes grouping of abstract idea.
Step 2A, Prong Two:Claim 1, as whole, fails to integrate the abstract idea into a practical application.
Claim 1 recites the following additional elements, which for the reasons set forth below, do not integrate the abstract idea into a practical application because they are insignificant extra-solution activity:
“a processor;” which is directed to data gathering, see MPEP 2106.05(g).
“a storage medium having computer program instructions stored thereon…” which is directed to data gathering, see MPEP 2106.05(g).
“…a display device…” which is directed to data output, see MPEP 2106.05(f).
Thus, the claims fail to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1 & 5 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The above claims are silent to providing any treatment at all to a patient.
Step 2B:
The claims as a whole fails to recite an inventive concept. The additional elements, when considered individually and in combination, do not recite significantly more than the abstract idea for the same reason as set forth above in Step 2A, Prong Two.
Upon re-evaluating the limitation that was previously identified as insignificant extra-solution activity in Step 2A, Prong 2, the following evidence to show that the limitation is well-understood, routine and conventional:
producing at said computer processor a human-readable output (i.e. processor) of the analysis of the gathered data, this is also WURC, as evidenced by Electric Power Group, LLC v. Alstom S.A., 830F.3d 1350, 119 USPQ2d 1739 (Fed.Cir. 2016), which discusses “conventional computer, network, and display technology” and states that “nothing in the patent contains any suggestion that the displays needed for that purpose are anything but readily available. We have repeatedly held that such invocations of computers and networks that are not even arguably inventive are “insufficient to pass the test of an inventive concept in the application” of an abstract idea”.” Similarly, there is nothing in Applicant’s specification that indicates that the device that is “producing at said computer processor a human-readable output indicating” the findings of the analysis is anything but readily available.
The examiner also notes that the limitations of the dependent claims, claims 2-4 & 6, define the distribution candidate information and the stored program that causes a computer to function etc. which further limit claim limitations already indicated above as being directed to an abstract idea. Therefore, the above dependent claims are directed to patient-ineligible subject matter.
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)(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) 1-6 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Pak et al. (US 2018/0271453).
1.
A signal analysis device comprising:
E.G. via the disclosed antiarrhythmic agent effect evaluation system 100 {[0044]-[0045] & (Fig 1)}.
a processor;
E.G. via the disclosed antiarrhythmic agent effect simulative evaluation unit 30 {[0048] & (Fig. 1)}
and a storage medium having computer program instructions stored thereon, wherein the computer program instructions, when executed by the processor, perform processing of: acquiring time-series biological information regarding pulsation of a heart that is an analysis target;
E.G. via the disclosed ion channel value storage unit 21 and the action potential measurement unit 10 {[0049], [0052] & (Fig 7)}.
acquiring distribution candidate information including, using the distribution candidate information, information indicating candidates for channel activity timing distribution which is distribution of timings of the activity of an ion channel in the heart.
E.G. via the disclosed ion channel characteristic determination unit 20 that determines ion channel characteristics ([0049]-[0050]).
Note: The examiner is interpreting the ion channel characteristics as being the claimed distribution candidate information. The examiner also notes that the claim language “…indicating candidates for channel activity timing distribution…” is intended use language and as long as the cited prior art is capable of providing the claim limitation then the limitation is met, in which the disclosed ion channel characteristic is capable of providing the claimed indicated information.
Acquiring information indicating a state of an activity of the ion channel in the heart on the basis of the biological information and the distribution candidate information
E.G. via the disclosed ion channel characteristic deriving unit 27 which extracts specific ion channel values further used to determine antiarrhythmic effect evaluation ([0066]-[0068]).
and displaying the information indicating the state of the activity of the ion channel in the heart on a display device.
E.G. via the disclosed ion channel characteristics determination unit 20 including a graph generation unit 25, which generates a pacing interval relation graph showing the timing relationship between said ion characteristic ([0051] & [0055]).
2.
The signal analysis device according to claim 1, wherein the distribution candidate information is expressed by a cumulative distribution function using a function representing candidates for channel activity timing distribution as a probability density function.
E.G. via the disclosed parameter set unit that utilizes maximum values of n ion channels with ion channel modeling that are uniformly distributed are set by k times, with a distribution range of the parameters ([0057] & [0063]-[0065])
3.
The signal analysis device according to claim 2, wherein the information indicating a state of the activity of the ion channel is acquired on the basis of a result of fitting one or a plurality of the cumulative distribution functions to the biological information.
E.G. via the disclosed parameter set obtain via the parameter extraction unit 22 that extracts physiological conductance maximum values of the n ion channel with ion channel modeling from physiological conductance maximum values stored [0063].
4.
The signal analysis device according to claim 3, wherein the fitting is fitting that minimizes a difference between the biological information and a linear sum of the plurality of cumulative distribution functions which includes overlapping domains of definition and satisfies predetermined conditions regarding weights including at least a condition that at least one of the weights has a sign that is different from that of other weights.
E.G. via the disclosed parameter set extraction unit that may determine the difference between each action potential to produce squares of said difference, total the squares and calculate a square root of the sum of the squares, wherein the parameters extracted have a uniform distribution and ([0012]-[0013]).
5.
A signal analysis method comprising:
E.G. [0006].
acquiring time-series biological information regarding pulsation of a heart that is an analysis target;
E.G. via the disclosed action potential measurement unit 10 [0032].
acquiring distribution candidate information including, using the distribution candidate information, information indicating candidates for channel activity timing distribution which is distribution of timings of the activity of an ion channel in the heart.
E.G. via the disclosed ion channel characteristic determination unit 20 that determines ion channel characteristics ([0049]-[0050]).
Note: The examiner is interpreting the ion channel characteristics as being the claimed distribution candidate information.
acquiring information indicating a state of an activity of the ion channel on the basis of the biological information and distribution candidate information
E.G. via the disclosed ion channel characteristic deriving unit 27 which extracts specific ion channel values further used to determine antiarrhythmic effect evaluation ([0066]-[0068]).
and displaying the information indicating the state of the activity of the ion channel in the heart on a display device.
E.G. via the disclosed ion channel characteristics determination unit 20 including a graph generation unit 25, which generates a pacing interval relation graph showing the timing relationship between said ion characteristic ([0051] & [0055]).
6.
A non-transitory computer readable medium which stores a program that causes a computer to function as the signal analysis device according to claim 1.
E.G. via the disclosed evaluation method being embodied in the form of a computer program recorded on a computer-readable recording medium [0068].
Response to Arguments
Applicant's arguments filed October 22, 2025 have been fully considered but they are not persuasive. The applicant argues the following point(s) in which the examiner provides a reason(s) as to why the arguments are not persuasive:
In regards to the 35 U.S.C 101 rejection, the applicant states that the amended claims are not directed to an abstract idea, since the claim include significantly more than any alleged abstract idea and are integrated into a practical application.
Based on the broadest reasonable interpretation of the claims the examiner disagrees. The amended claim limitation adds the following:
“…acquiring distribution candidate information including, using the distribution candidate information, information indicating candidates for channel activity timing distribution which is distribution of timings of the activity of an ion channel in the heart;”
And
“…displaying the information indicating the state of the activity of the ion channel in the heart on a display device.”
According to Step 2A, Prong 1, the claims recite a method comprising mental processes and/or method of organizing human activity (i.e. acquiring distribution candidate information), which is an act of evaluating information, i.e. biological information, that can be practically performed in the human mind.
In addition, Step 2A, Prong Two illustrates how the claim limitation explicitly fail to integrate the abstract idea into a practical application. The amended claim limitation of “…displaying the information…on a display device…” is merely directed to data output (MPEP 2106.05(f)), therefore failing to integrate the abstract idea into a practical application. The examiner also notes that the additional elements recited in claims 1 & 5 do not apply or use the judicial exception to affect a particular treatment or prophylaxis for a disease or medical condition. The above claims are silent to providing any treatment at all to a patient.
In conclusion, the claims do not include significantly more than abstract ideas and are not integrated into a practical application. Please see the above rejection.
The applicant argues that the primary reference, Pak, does not teach the following limitations:
acquiring distribution candidate information including, using the distribution candidate information, information indicating candidates for channel activity timing distribution which is distribution of timings of the activity of an ion channel in the heart:
acquiring information indicating a state of an activity of the ion channel in the heart on the basis of the biological information and the distribution candidate information
The applicant further argues that the claimed distribution candidate information does not correspond to the disclosed cardiac action potential as alleged by the examiner.
Based on the broadest reasonable interpretation of the claims the examiner disagrees and further points out that Pak discloses an ion channel characteristic determination unit 20 that determines ion channel characteristics ([0049]-[0050]), which reads on the claimed distribution candidate information. The examiner also notes that the claim language “…indicating candidates for channel activity timing distribution…” is intended use language and as long as the cited prior art is capable of providing the claim limitation then the limitation is met, in which the disclosed ion channel characteristic is capable of providing the claimed indicated information. The disclosed ion channel characteristic deriving unit 27, which extracts specific ion channel values further used to determine antiarrhythmic effect evaluation ([0066]-[0068]), provides the claimed acquired data indicating the state of an activity of the ion channel in the heart on the basis of the biological information.
Applicant’s arguments, filed October 22, 2025, with respect to the specification objection and the 35 U.S.C. 112, second paragraph claim rejections have been fully considered and are persuasive and have been withdrawn.
Conclusion
THIS ACTION IS MADE FINAL. 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 NICOLE F JOHNSON whose telephone number is (571)270-5040. The examiner can normally be reached Monday-Friday 8:00am-5:00pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at 571-270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NICOLE F JOHNSON/Primary Examiner, Art Unit 3796