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 § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1 and 3-8 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
As noted in MPEP §2163, II, A, 3, a, ii, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021)… A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus.").”
Claim 1 currently claims the genus of first, second, third and fourth cumulative distribution functions that are distribution functions of first, second, third and fourth unimodal distribution functions. However, the specification only provides examples of normal distribution functions, i.e. Gaussian distribution functions. The term “unimodal distribution function” encompasses significantly more functions that just a normal Gaussian distribution, such as Poisson distributions, exponential distributions, log-normal distributions, Chi-square distributions, etc. that have different, non-shared features than those of normal distributions, see “Unimodal Distribution: A Comprehensive Guide with Interactive Tools” (APPLICANT CITED). There is a substantial variation in the types of unimodal distribution functions, each of which could have infinite permutations within the function type. Applicant has not provided a representative number of species in the specification to account for the variations in the broad genus “unimodal distribution function”.
To overcome the current rejection, the Examiner suggest amending “unimodal distribution function” to either a “normal unimodal distribution function” or a “Gaussian unimodal distribution function”.
Claims 3-8 contain the same issue above and likewise need to be addressed for the same reasons as set forth with respect to Claim 1.
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 and 3-8 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Each of Claims 1 and 3-8 have been analyzed to determine whether it is directed to any judicial exceptions.
Claims 1, 7 and 8 recite a device and methods comprising obtaining R wave and T wave from a cardiac cycle, inverting the T wave time axis, determining a myocardial activity parameter set by, for the R wave, fitting two cumulative distribution functions to the waveform and using their shapes, weights, and a level value to reconstruct the signal and for the T wave, fit the inverted time-axis version of the waveform or use inverse cumulative functions directly, obtaining synthesized R wave and T waves and connecting the synthesized waveform in the time section of the R wave and the synthesized waveform in the time section of the T wave together to obtain a synthesized signal for a waveform indicating the cardiac cycle of the target heart.
To determine whether a claim satisfies the criteria for subject matter eligibility, the claim is evaluated according to a stepwise process as described in MPEP 2106(III) and 2106.03-2106.05. The instant claims are evaluated according to such analysis.
Step 1: Is the claim to a process, machine, manufacture or composition of matter?
Claim 1 is directed to a device, claims 7 and 8 is directed to methods and thus meet the requirements for step 1.
Step 2A (Prong 1): Does the claim recite an abstract idea, law of nature, or natural phenomenon?
Claims 1, 7 and 8 recite a device and methods comprising the steps that include steps that comprise steps performed by a waveform synthesizer that:
sets a set as a myocardial activity parameter set, the set including
a value of a parameter specifying a first unimodal distribution or a value of a parameter specifying a first cumulative distribution function,
a value of a parameter specifying a second unimodal distribution or a value of a parameter specifying a second cumulative distribution function,
a value of a first weight parameter,
a value of a second weight parameter, and
a value of a first level parameter when the first target time waveform is approximated by a first approximate time waveform that is a time waveform represented by a function obtained by subtracting, from a function obtained by multiplying the first cumulative distribution function that is a cumulative distribution function of the first unimodal distribution by the value of the first weight parameter,
a function obtained by multiplying the second cumulative distribution function that is a cumulative distribution function of the second unimodal distribution by the value of the second weight parameter, and adding the value of the first level parameter; and
a value of a parameter specifying a third unimodal distribution or a value of a parameter specifying a third cumulative distribution function,
a value of a parameter specifying a fourth unimodal distribution or a value of a parameter specifying a fourth cumulative distribution function,
a value of a third weight parameter,
a value of a fourth weight parameter, and
a value of a second level parameter when the second target inverse time waveform is approximated by a second approximate inverse time waveform that is a waveform represented by a function obtained by subtracting, from a function obtained by multiplying the third cumulative distribution function that is a cumulative distribution function of the third unimodal distribution by the value of the third weight parameter,
a function obtained by multiplying the fourth cumulative distribution function that is a cumulative distribution function of the fourth unimodal distribution by the value of the fourth weight parameter, and adding the value of the second level parameter;
sets each of element values included in the myocardial activity parameter set as a myocardial activity parameter value;
uses each of myocardial activity parameter values included in the myocardial activity parameter set of a heart to be a target (Hereinafter, the heart is referred to as a "target heart".);
obtains, as a synthesized waveform in the time section of the R wave, a time waveform represented by a function obtained by subtracting, from a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the first unimodal distribution or the first cumulative distribution function by the myocardial activity parameter value of the first weight parameter, a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the second unimodal distribution or the second cumulative distribution function by the myocardial activity parameter value of the second weight parameter, and adding the myocardial activity parameter value of the first level parameter;
obtains, as a synthesized waveform in the time section of the T wave, a waveform obtained by inverting a time axis of a waveform represented by a function obtained by subtracting, from a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the third unimodal distribution or the third cumulative distribution function by the myocardial activity parameter value of the third weight parameter, a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the fourth unimodal distribution or the fourth cumulative distribution function by the myocardial activity parameter value of the fourth weight parameter, and adding the myocardial activity parameter value of the second level parameter; and
connects the synthesized waveform in the time section of the R wave and the synthesized waveform in the time section of the T wave together to obtain a synthesized signal for a waveform indicating the cardiac cycle of the target heart.
Therefore, claims 1, 7 and 8 recite mathematical concepts (as described by the steps claimed and the equations in the current application) that can be performed manually by a human or a generic processor (i.e. a waveform synthesizer).
Further, dependent Claims 3-6 merely include limitations that either further define the abstract idea (and thus don’t make the abstract idea any less abstract) or amount to no more than generally linking the use of the abstract idea to a particular technological environment or field of use because they’re merely incidental or token additions to the claims that do not alter or affect how the steps are performed.
Step 2A (Prong 2): Does the claim recite additional elements that integrate the judicial exception into a practical application?
Claims 1, 7 and 8 recite the additional elements of a “waveform synthesizer which is being interpreted as a processor as described in the originally filed specifications as a central processing unit (CPU) as shown in 91 Fig. 1. However, the processor is recited at a high level of generality performing the function of generic data processing such that it amounts to no more than mere instructions to simply implement the abstract idea using generic computer components. See MPEP 2106.05(b) and (f).
Claims 1, 7 and 8 (and their respective dependent claims) do not improve the functioning of a computer, or any other technology or technical field. Nor do this above-identified additional element serve to apply the above-identified abstract idea with, or by use of, a particular machine, effect a transformation or apply or use the above-identified abstract idea in some other meaningful way beyond generally linking the use thereof to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. Furthermore, the above-identified additional element does not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. Moreover, the above-identified abstract idea is not integrated into a practical application because the claimed method and device merely implements the above-identified abstract idea using instruction executed by a computer (i.e. waveform synthesizer) as claimed. In other words, these claims are merely directed to an abstract idea with additional generic computer elements which do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer.
Accordingly, the additional element does not integrate the abstract idea into a practical application.
Step 2B: Does the claim recite additional elements that amount to significantly more than the judicial exception
The additional elements when considered individually and in combination are not enough to qualify as significantly more than the abstract idea. As discussed above with respect to integration of the abstract idea into a practical application, “waveform synthesizer” which is being interpreted as a generic processor as recited to perform the claimed steps. The above-identified additional element is generically claimed computer components which enable the above-identified abstract idea to be conducted by performing the steps as claimed. Mere instructions to apply an exception using generic components cannot provide an inventive concept. These additional elements are well‐understood, routine (For example Zhang et al (U.S. Patent Application Publication Number: US 2012/0302903 A1, hereinafter “Zhang”- APPLICANT CITED) teaches a device and method to identify wave components of the cardiac cycle and analyze the data using a generic processor (e.g. 15 Fig.1).
In short, the claims do not recite any additional elements that:(1) improve the functioning of a computer or other technology, (2) are applied with any particular machine, (3) effect a transformation of a particular article to a different state, and (4) are applied in any meaningful way beyond generally linking the use of the judicial exception to a particular technological environment, such that the claim as a whole is more than a drafting effort designed to monopolize the exception. See MPEP § 2106.05(a){c), (e)-(h).
Therefore, these additional elements are well‐understood, routine and conventional limitations that do not amount to significantly more.
No prior art was found teaching individually, or suggesting in combination, all of the features of the applicants' invention, specifically a waveform synthesizer that "sets a set as a myocardial activity parameter set, the set including a value of a parameter specifying a first unimodal distribution or a value of a parameter specifying a first cumulative distribution function, a value of a parameter specifying a second unimodal distribution or a value of a parameter specifying a second cumulative distribution function, a value of a first weight parameter, a value of a second weight parameter, and a value of a first level parameter when the first target time waveform is approximated by a first approximate time waveform that is a time waveform represented by a function obtained by subtracting, from a function obtained by multiplying the first cumulative distribution function that is a cumulative distribution function of the first unimodal distribution by the value of the first weight parameter, a function obtained by multiplying the second cumulative distribution function that is a cumulative distribution function of the second unimodal distribution by the value of the second weight parameter, and adding the value of the first level parameter; and
a value of a parameter specifying a third unimodal distribution or a value of a parameter specifying a third cumulative distribution function, a value of a parameter specifying a fourth unimodal distribution or a value of a parameter specifying a fourth cumulative distribution function, a value of a third weight parameter, a value of a fourth weight parameter, and a value of a second level parameter when the second target inverse time waveform is approximated by a second approximate inverse time waveform that is a waveform represented by a function obtained by subtracting, from a function obtained by multiplying the third cumulative distribution function that is a cumulative distribution function of the third unimodal distribution by the value of the third weight parameter, a function obtained by multiplying the fourth cumulative distribution function that is a cumulative distribution function of the fourth unimodal distribution by the value of the fourth weight parameter, and adding the value of the second level parameter;
sets each of element values included in the myocardial activity parameter set as a myocardial activity parameter value;
uses each of myocardial activity parameter values included in the myocardial activity parameter set of a heart to be a target (Hereinafter, the heart is referred to as a "target heart".);
obtains, as a synthesized waveform in the time section of the R wave, a time waveform represented by a function obtained by subtracting, from a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the first unimodal distribution or the first cumulative distribution function by the myocardial activity parameter value of the first weight parameter, a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the second unimodal distribution or the second cumulative distribution function by the myocardial activity parameter value of the second weight parameter, and adding the myocardial activity parameter value of the first level parameter;
obtains, as a synthesized waveform in the time section of the T wave, a waveform obtained by inverting a time axis of a waveform represented by a function obtained by subtracting, from a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the third unimodal distribution or the third cumulative distribution function by the myocardial activity parameter value of the third weight parameter, a function obtained by multiplying a cumulative distribution function specified by the myocardial activity parameter value of the parameter specifying the fourth unimodal distribution or the fourth cumulative distribution function by the myocardial activity parameter value of the fourth weight parameter, and adding the myocardial activity parameter value of the second level parameter; and
connects the synthesized waveform in the time section of the R wave and the synthesized waveform in the time section of the T wave together to obtain a synthesized signal for a waveform indicating the cardiac cycle of the target heart” as claimed in independent claims 1, 7 and 8 in combination with the recited limitations of the claimed invention.
While no prior art rejection has been provided the claims cannot be indicated as allowable due to the rejections discussed above.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Burton et al (U.S. Patent Application Publication Number: US 2015/0216426 A1, hereinafter “Burton”) teaches a device and method of obtaining single channel biological data for the heart; and processing solely the single channel biological data to detect cardiac dysfunction.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MALLIKA DIPAYAN FAIRCHILD whose telephone number is (571)270-7043. The examiner can normally be reached Monday- Friday 8 am-5pm EST.
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792
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