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 .
Response to Amendment
This office action is in response to the amendment filed on 5/20/2026. Currently claims 1-20 are pending.
Response to Arguments
Applicant’s arguments, see pgs. 9-15, filed 5/20/2026, with respect to the previous rejection(s) of:
claim(s) 1-11 and 13-17 rejected under 35 USC 103 as being unpatentable over Ghosh
claim(s) 12 rejected under 35 USC 103 as being unpatentable over Ghosh in view of Bonner
have been fully considered and are persuasive. The previous prior art rejections of claims 1-20 has been withdrawn.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
Claim 14 recites the limitation “a means of measuring the signal of each channel”
Best support seems to come from pg. 27-28 of applicant’s specification received on 9/14/2023 which states the following:
“The device comprises a means of measuring the signal of each channel Vi. More precisely, the measurement means is configured to measure an electrical potential of each of the channels Vi. For example, the measurement means maybe an acquisition card. The acquisition card may comprise an input to collect an electrical signal, and an analog digital converter to digitize the acquired signal. The digitized signal is then transmitted to a calculator. For example, the digitized signal may be transmitted to a computer that performs the processing steps on the signal”.
Based on this section a “means of measuring the signal of each channel” appears to be a digital converter and its functional equivalents.
Claim 14 recites the limitation “a calculation means configured to:
select a subset of descriptors from a set of predefined descriptors according to an input parameter defining a measurement context, each electrophysiological descriptor of the subset being associated with at least one channel, a signal type, a signal marker and a statistical modality for calculation; at least one descriptor of the subset being associated with a statistical modality different to that of a second descriptor of the subset and a signal marker different to that of the second descriptor;
record a plurality of cardiac electrical activities defining said channels, each channel being obtained by the recordings of at least two electrodes;
estimate the set of electrophysiological descriptors of the subset, each electrophysiological descriptor being calculated from the statistical modality that is applied to the signal marker of the acquired signal according to the signal type on a selected channel associated with said electrophysiological descriptor;
compare the value of the set of electrophysiological descriptors with at least one threshold value specific to the set of electrophysiological descriptors, said at least one threshold value being defined by a statistical distribution of said descriptors of a set of patients;
calculate a score defining an electrophysiological parameter as a function of the
exceeding of the at least one threshold value defined by the statistical distribution”
Best support seems to come from pg. 4 of applicant’s specification which states the following:
“The different steps of the method according to the invention may be implemented by calculation means such as calculators. The latter may be those of an electronic board of dedicated equipment or those of a remote computer or data server.”
And pg. 9-10 of applicant’s specification which states the following:
“According to one aspect, the invention relates to a device or a system comprising means for implementing the method of the invention. The means may comprise calculators, memories, electronic boards, electrodes and electrode holders. The device or the system of the invention may comprise computers or servers when calculation resources are required.”
Based on these sections, a calculation means is interpreted to be a processor and its functional equivalents.
Claim 16 recites the limitation “said device comprising means configured to implement the method of claim 1”
Best support seems to come from pg. 4 of applicant’s specification which states the following:
“The different steps of the method according to the invention may be implemented by calculation means such as calculators. The latter may be those of an electronic board of dedicated equipment or those of a remote computer or data server.”
And pg. 9-10 of applicant’s specification which states the following:
“According to one aspect, the invention relates to a device or a system comprising means for implementing the method of the invention. The means may comprise calculators, memories, electronic boards, electrodes and electrode holders. The device or the system of the invention may comprise computers or servers when calculation resources are required.”
Based on these sections, a means configured to implement the method of claim 1 is interpreted to be a processor and its functional equivalents.
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 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to abstract idea (i.e. specifically a mental process) without significantly more.
Regarding claim 1:
The claim(s) recite(s):
“selecting a subset of first electrophysiological descriptors from a set of first predefined electrophysiological descriptors, according to an input parameter defining a measurement context, each first electrophysiological descriptor of the subset being associated with at least one channel, a signal type, a signal marker and a statistical modality for calculation; at least one first descriptor of the subset being associated with a statistical modality different to that of another first descriptor of the subset and a signal marker different to that of the other first descriptor”, “estimating the set of electrophysiological descriptors of the subset, each electrophysiological descriptor being calculated from the statistical modality that is applied to the signal marker of the acquired signal according to the signal type on a selected channel associated with said electrophysiological descriptor”, “comparing the value of the set of electrophysiological descriptors with at least one threshold value specific to the set of electrophysiological descriptors, said at least one threshold value being defined by a statistical distribution of said descriptors of a set of patients of a reference group” and “calculating a score defining an electrophysiological parameter as a function of the
exceeding of the at least one threshold value” which recite an abstract idea in the form of a mental process. This judicial exception is not integrated into a practical application because the only additional steps are “arranging a plurality of surface electrodes on a patient's body” and “recording of a plurality of cardiac electrical activities defining said channels, each channel being obtained by the recordings of at least two electrodes” which are directed to mere data collection which is a form of insignificant pre-solution activity . And as ruled in Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) outlined in MPEP 2106.05(g) such insignificant pre-solution activity does not integrate the judicial exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims merely recite the use of two generic electrodes. The element(s) are well known and convention the field of electrophysiology as demonstrated by Ghosh et al (US 20200352470) hereafter known as Ghosh [see Fig. 2 elements 112 and para 46] and Ives et al (US 20100059274) hereafter known as Ives [see paras 3-5]. Thus, because the additional structures are well known and convention these structures don’t amount to significantly more than the judicial exception. Therefore, the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 1 is rejected under 35 USC 101.
Regarding dependent claims 2-13, 16 and 18-20, these claims only further describe the mental process (i.e. abstract idea) and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 2-13, 16 and 18-20 are rejected under 35 USC 101 for similar reasons as claim 1.
Regarding claim 14:
The claim(s) recite(s):
“select a subset of descriptors from a set of predefined descriptors according to an
input parameter defining a measurement context, each electrophysiological
descriptor of the subset being associated with at least one channel, a signal type,
a signal marker and a statistical modality for calculation; at least one descriptor of
the subset being associated with a statistical modality different to that of a second
descriptor of the subset and a signal marker different to that of the second
descriptor”, “estimate the set of electrophysiological descriptors of the subset, each
electrophysiological descriptor being calculated from the statistical modality that
is applied to the signal marker of the acquired signal according to the signal type
on a selected channel associated with said electrophysiological descriptor”, “compare the value of the set of electrophysiological descriptors with at least one threshold value specific to the set of electrophysiological descriptors, said at least one threshold value being defined by a statistical distribution of said descriptors of a set of patients” and “calculate a score defining an electrophysiological parameter as a function of the
exceeding of the at least one threshold value defined by the statistical distribution”. This judicial exception is not integrated into a practical application because the only additional steps is that of “record a plurality of cardiac electrical activities defining said channels, each channel being obtained by the recordings of at least two electrodes” which are directed to mere data collection which is a form of insignificant pre-solution activity . And, as ruled in Mayo, 566 U.S. at 79, 101 USPQ2d at 1968. See also PerkinElmer, Inc. v. Intema Ltd., 496 Fed. App'x 65, 73, 105 USPQ2d 1960, 1966 (Fed. Cir. 2012) outlined in MPEP 2106.05(g) such insignificant pre-solution activity does not integrate the judicial exception into a practical application.
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims merely recite a plurality of generic surface electrodes, a means for measuring (i.e. a generic digital converter) and a calculation means (i.e. a generic processor). The element(s) are well known and convention the field of electrophysiology as demonstrated by Ghosh [see Fig. 2 elements 112 and para 46 for the electrodes, see Fig. 2 element 116 and para 46 for means for measuring, see Fig. 2 element 140 and para 37 for calculation means] and Ives [see paras 3-5 for electrodes, see para 49 for means for measuring and see Fig. 1 element 15 and para 38 for calculation means]. Thus, because the additional structures are well known and conventional these structures don’t amount to significantly more than the judicial exception. Therefore, the mental process (i.e. the judicial exception) is not integrated into a practical application and the additional structures do not amount to significantly more than the judicial exception. Thus, claim 14 is rejected under 35 USC 101.
Regarding dependent claims 15 and 17, these claims only further describe the mental process (i.e. abstract idea) and do not further integrate the judicial exception into a practical application or amount to significantly more than the judicial exception. Thus, claims 15 and 17 are rejected under 35 USC 101 for similar reasons as claim 14.
Examiner’s Note
No prior art was found to anticipate and/or obviate the combination of limitations recited in claims 1-20. Therefore, claims 1-20 are only rejected under 35 USC 101 for the reasons outlined above.
Conclusion
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SEBASTIAN X LUKJAN
/SXL/Examiner, Art Unit 3792
/NIKETA PATEL/Supervisory Patent Examiner, Art Unit 3792
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