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 Status
Claims 1-32 are pending.
Claims 1-32 are rejected.
Claims 1, 28, and 29 are objected to.
Claims 1-3, 6-8, 10, and 12-32 are amended.
Claims 1 and 30 are independent.
No claims are canceled, new, or withdrawn.
Office Action Outline
Rejections applied
Abbreviations
x
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
102, 103
JE
Judicial Exception
x
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed in the 07/12/2022 filing receipt, this application is a 371 of PCT/EP2020/073826, filed 08/26/2020. This application claims priority to foreign application DE10 2019 006 866.1, filed 10/02/2019.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55. See paper entered 04/01/2022.
Reference to Claims and Specification
Reference to the Claims in this Office action is either:
(a) by plain claim number (e.g., claim 1), or
(b) by claim number and line number, where claim and line numbers are separated by a colon (e.g., claim 1:9-12 refers to claim 1 lines 9-12).
Reference to the Specification in this Office action refers to US Patent Publication
US 2022/0330837 A1, published 10/20/2022.
Overview of Withdrawal/Revision of Objections/Rejections/Interpretations
In view of the amendment and remarks received 06/12/2026:
• The objection to the title is withdrawn.
• One claim objection, previously to claim 1:3 (now to amended claim 1:2), is maintained with revision. All other previous claim objections are withdrawn. Additionally, a new claim objection is applied for claims 28 and 29 as being allowable except for depending on a rejected claim.
• The 112(f) interpretation is revised.
• The 112(b) rejections are withdrawn and new 112(b) rejections are applied.
• The 101 rejection is maintained for claims 1-27 and 30-32. However, claims 28 and 29 now recite eligible subject matter under 101 by reciting a particular therapy for patient ventilation dependent on the calculated estimated respiratory signal.
• The Nonstatutory Double Patenting rejections are withdrawn because Applicant's arguments are persuasive that the claims of reference U.S. Patent No.11,779,283 (from application 17/242,663), as well as the claims of reference Applications Nos. 17/707,476, 18/365,281, and 19/179,209, do not recite determining, with a signal processing unit, for a shape parameter, a shape parameter value which the shape parameter assumes during the heartbeat by analysis of the sum signal segment, wherein the shape parameter influences a time course of the cardiogenic signal and/or of the respiratory signal as in the present application. Additionally, no prior art has been found on at least this narrowing limitation.
Claim Objections
Claims 1, 28, and 29 are objected to because of the following informalities:
Maintained objection (asserted at ¶ 10, p.3-4, of the 03/16/2026 Office action; revised here to reflect the instant line number): Claim 1:2 recites "...with the use of a signal" which should be corrected to "...with [[the]] use of a signal." While it is clear how the recitation is interpreted, nonetheless there is no antecedent basis for "the use." Deleting "the" would resolve this objection.
New objection: Claims 28 and 29 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Appropriate correction is required.
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.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier.
Instant claim limitations interpreted as PROPERLY invoking 112(f)
The following claim limitation are interpreted as invoking 112(f):
• A "sum signal sensor device" recited in claims 1 and 30 recites means and function (an equivalent, nonce term, here a "sensor device", and function of sensing, here "measures a signal generated in the body") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at [0069, 0075, 0076], and as such, is definite under 112/b as properly invoking 112/f. MPEP 2181.III-IV pertain.
• A "body geometry sensor" recited in claim 10 and 11 recites means and function (in a "sensor") without reciting steps or structure to prevent invoking. The Specification does disclose sufficient structure, material, or acts and not just desired results, as exemplified at [0079-0080], and as such, is definite under 112/b as properly invoking 112/f. MPEP 2181.III-IV pertain.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Instant claim limitations interpreted as NOT invoking 112(f)
The following limitations are interpreted as not invoking 112(f):
• A "signal processing unit configured to process" recited in claim 30, and the "signal processing unit" recited in claims 1-8, 10, 13-14, 16-27, 29-32, recites means (or an equivalent, nonce term, here a "unit") and function and/or result (here "carry out, ...receive, ...generate, ...detect...process"), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure not to invoke. MPEP 2181.I.C pertains.
• A "signal estimating unit" recited in claims 1-3, 8, 13, 16, 19-21, 24-27, and 30, recites means (or an equivalent, nonce term, here a "unit") and function and/or result (here "yield a shape parameter", "calculating a shape parameter value," determining first transmission channel parameter values and value ranges, etc.), but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure (here for receiving, processing, generating values, etc.) not to invoke. MPEP 2181.I.C pertains.
• At least one "first sum signal sensor" and at least one "second sum signal sensor" recited in claim 19 recites means and function (in a "sensor") but the recitation does not invoke 112/f because the claim is interpreted as reciting sufficient structure (here, in measuring signals generated in the body of a patient) not to invoke. MPEP 2181.I.C pertains.
• A "breathing state sensor" recited in claim 11-13 recites means and function (in a "sensor") but the recitation does not invoke 112/f because the claims are interpreted as reciting sufficient structure (in this instance in the form of measuring current breathing state and/or ventilating state (claims 11-13); flow of gas into or out of the body, airway pressure (claim 12) ) not to invoke. MPEP 2181.I.C pertains.
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 13 and 17 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. Claims depending from rejected claims are rejected similarly, unless otherwise noted, and any amendments in response to the following rejections should be applied throughout the claims, as appropriate.
In claim 13:9-10, the two recited instances of "the measured values" require but lack clear antecedent in the recitation "the measured values of the breathing state sensor and of the measured values of the position sensor." Amending to recite "[[the ]]measured values of the breathing state sensor and of [[the ]]measured values of the position sensor" would likely overcome the rejection.
In claim 17:8-9, the recited "the measured values of the sum signal sensor located at a distance from the heart" require but lack clear antecedent. Amending to recite "[[the ]]measured values of the sum signal sensor located at a distance from the heart" would likely overcome the rejection.
Similarly, in claim 17:11-12, the recited "the measured values of the sum signal sensor located closer to the heart" require but lack clear antecedent. Amending to recite "[[the ]]measured values of the sum signal sensor located closer to the heart" would likely overcome the rejection.
Claim Rejections - 35 USC § 101
Note: Amended claims 28 and 29 recite eligible subject matter under 35 U.S.C. 101 by reciting a practical application at Step 2A Prong Two of a particular therapy, and of a transformation, for mechanical ventilation of a patient which is informed by the output of the judicial exception, i.e., the calculated estimated respiratory signal.
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 1-27 and 30-32 are rejected under 35 U.S.C. 101 because the claimed invention is directed to one or more judicial exceptions without significantly more.
MPEP 2106 details the following framework to analyze Subject Matter Eligibility:
• Step 1: Are the claims directed to a category of statutory subject matter (a process, machine, manufacture, or composition of matter)? (see MPEP § 2106.03)
• Step 2A, Prong One: Do the claims recite a judicially recognized exception, i.e. an abstract idea, a law of nature, or a natural phenomenon? (see MPEP § 2106.04(a), 2106.04(a)(2) & 2106.04(b))
• Step 2A, Prong Two: If the claims recite a judicial exception under Prong One, then is the judicial exception integrated into a practical application? (see MPEP § 2106.04(d))
• Step 2B: If the claims do not integrate the judicial exception, do the claims provide an inventive concept? (see MPEP § 2106.05)
Step 1:
Claims 1-27 and 31-32 are directed to 101 processes. Claim 30 is directed to a 101 machine or manufacture, here a signal processing unit. As such, claims 1-27 and 30-32 are directed to categories of statutory subject matter. (See MPEP § 2106.03). (Step 1: Yes.)
Step 1: YES, regarding claims 1-29 and 31-32: Claim 1 recites a 101 process, while claim 31 recites a 101 process, here a "process according to claim 1" comprising process steps such as "receiving..." (recited in claim 1) and "is provided" (recited in claim 31). Therefore, claims 1-29 and 31-32 are directed to 101 processes, which fall under the categories of statutory subject matter. (See MPEP § 2106.03).
Step 2A, Prong One:
The claims recite judicial exceptions in the form of abstract ideas as follows:
Independent claim 1 recites a process for performing mental processes and mathematical concepts for:
(a) calculating:
• an estimate for a cardiogenic signal and/or a respiratory signal (claim 1:1)
• the value of the first transmission channel parameter (claim 1:36-37)
• shape parameters (claim 1:68)
• an estimated cardiogenic signal segment and/or a respiratory signal segment (claim 1:72)
(b) detecting:
• heartbeat time or heartbeat time period of the heartbeat (claim 1:59-60)
(c) determining:
• a sum signal segment (claim 1:26)
• a shape parameter value for a shape parameter (claim 1:29-30)
• estimated respiratory signal or cardiogenic signals (claim 1:89)
(d) generating:
• a sum signal (claim 1:13-15)
• a sample and sample elements (claim 1:21-22)
• the sample element for the heartbeat (claim 1:44-45)
• a signal estimating unit (claim 1:49-50)
(e) combining signal segments (claim 1:82 and 85)
(f) compensating the influence of heartbeat on sum signal (claim 1:95)
Independent claim 30 recites similar mental processes and mathematical concepts as independent claim 1.
Dependent claims 2-7, and 31-32 further limit the abstract ideas recited in independent claim 1.
Product by Process Interpretations:
The recited claim 1 and 30 term "measured values" is interpreted as a product-by-process element, i.e. the recited "values" are limited according to any structure clearly required by the recited product-by-process limitation of having been "measured." The recited process or step of having been "measured" is not itself claimed and is limiting only to the extent that the structure of the "values" is clearly required to be limited by that process or step. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential). As claims 10, 13, 17-20, 22, and 31-32 each recites "measured values" and ultimately depend from claim 1, this interpretation applies to the "measured values" in claim 10, 13, 17-20, 22, and 31-32 as well. Possibly reciting an active step of measuring in the claims may result in withdrawal of the product-by-process interpretation.
The recited claim 10 "values have been measured" is interpreted as a product-by-process element, i.e. the recited "values" limited according to any structure clearly required by the recited product-by-process limitation of having been "measured." The recited process or step of having been "measured" is not itself claimed and is limiting only to the extent that the structure of the "values" is clearly required to be limited by that process or step. Regarding product-by-process limitations within a claim, MPEP 2113 pertains, as well as, for example, Biogen MA, Inc. v. EMD Serono, Inc. (Fed. Cir. 9-28-2020, precedential).
Step 2A Prong One Summary: The claims recite abstract ideas, characterized as mental processes and mathematical concepts. Considering the broadest reasonable interpretation (BRI) of the claims, the mental processes recited in independent claims 1 and 30 (e.g., in the steps for calculating, detecting, determining, combining, compensating, etc.) are directed to processes that may be performed in the human mind, or with pen and paper, because there are no limitations recited which would prevent the analysis and generating of results mentally. Additionally, the limitations of calculating shape parameters, estimates of cardiogenic/respiratory activity, and values of transmission channel parameters, etc., inherently recite mathematical concepts, such as those described throughout the Specification, and at [0148-0149, 0156-0166, 0177, 0195], etc. Such analysis performed mentally, or with paper and pencil, may take considerable time and effort, and although a general-purpose computer can perform these calculations at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea. Therefore, the claims recite elements that constitute judicial exceptions in the form of abstract ideas. (Step 2A, Prong One: Yes.)
Step 2A, Prong Two:
In Step 2A, Prong One above, claim steps and/or elements were identified as part of one or more judicial exceptions (JEs). Here at Step 2A, Prong Two, any remaining steps and/or elements not identified as JEs are therefore in addition to the identified JE(s), and are considered additional elements. Because the claims have been interpreted as being directed to judicial exceptions (abstract ideas in this instance) then Step 2A, Prong Two provides that the claims be examined further to determine whether the judicial exception is integrated into a practical application [see MPEP § 2106.04(d)]. A claim can be said to integrate a judicial exception into a practical application when it applies, relies on, or uses the judicial exception in a manner that imposes a meaningful limit on the judicial exception.
MPEP § 2106.04(d)(I) lists the following five example considerations for evaluating whether a judicial exception is integrated into a practical application:
(1) An improvement in the functioning of a computer or an improvement to other technology or another technical field, as discussed in MPEP §§ 2106.04(d)(1) and 2106.05(a).
(2) Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition, as discussed in MPEP § 2106.04(d)(2).
(3) Implementing a judicial exception with, or using a judicial exception in conjunction with, a particular machine or manufacture that is integral to the claim, as discussed in MPEP § 2106.05(b).
(4) Effecting a transformation or reduction of a particular article to a different state or thing, as discussed in MPEP § 2106.05(c).
(5) Applying or using the judicial exception in some other 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, as discussed in MPEP § 2106.05(e).
The claims recite additional elements as follows:
Additional elements of data gathering, inputting, and outputting steps: Claims 1, 4, 8, 10, 13, 19-21, and 30-32 recite additional elements of receiving data or detecting data from a sensor. Data gathering steps are additional elements which perform functions of inputting, collecting, and outputting the data needed to carry out the abstract idea. These steps, generally and unless persuasively demonstrated to the contrary, are considered insignificant extra-solution activity, and are insufficient to integrate an abstract idea into a practical application as they do not impose any meaningful limitation on the abstract idea or how it is performed [see MPEP § 2106.04(d)(I)].
Additional elements of computers, sensors, and ventilators: Claim 1 recites the additional element of a computer ("computer-implemented process") and a signal processing unit; claim 31 recites the additional element of a computer program; claims 1, 8-14, 17-20, 22, 25, and 30-32 recite the additional element of a sensor; claim 12 recites the additional element of a ventilator. The claims require only generic computer components, sensors, and ventilators. It is not yet clear that any one or combination of these elements improve computer technology, sensor technology, ventilator technology or other technology, nor that any integrate the recited judicial exceptions into a practical application (see MPEP § 2106.04(d)(1) and MPEP § 2106.05(f)).
Step 2A Prong Two summary: The claims have been further analyzed with respect to Step 2A, Prong Two, and no additional elements have been found, alone or in combination, that would integrate the judicial exception into a practical application. At this point in examination, it is not yet the case that any of the Step 2A Prong Two considerations enumerated above clearly demonstrates integration of the identified JE(s) into a practical application. Referring to the considerations above, none of 1. an improvement, 2. treatment, 3. a particular machine or 4. a transformation is clear in the record. For example, regarding the first consideration for improvement at MPEP 2106.04(d)(1), the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field. The claims do not yet clearly result in such an improvement. It is noted Specification [0018] discloses a basic object of the present invention is to provide a process and a signal processing unit, which determine an estimate or representation for a cardiogenic signal and/or for a respiratory signal from a sum signal...better than do prior-art processes and signal processing units, however, this is not yet enough to show an improvement. (Step 2A, Prong Two: No).
Step 2B analysis:
Because the additional claim elements do not integrate the judicial exceptions (i.e., the abstract ideas) into a practical application, the claims are further examined under Step 2B, which evaluates whether the additional elements, individually and in combination, amount to significantly more than the judicial exception itself by providing an inventive concept. An inventive concept is furnished by an element or combination of elements that is recited in the claim in addition to the judicial exception, and is sufficient to ensure that the claim, as a whole, amounts to significantly more than the judicial exception itself (see MPEP § 2106.05).
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the claims recite additional elements that are well-understood, routine, and conventional. Those additional elements are as follows:
Additional elements of data gathering, inputting, and outputting steps: The additional elements of receiving data from a sensor of claims 1, 4, 8, 10, 13, 19-21, and 30-32 do not cause the claims to rise to the level of significantly more than the judicial exception. The courts have recognized receiving or transmitting data over a network; storing and retrieving information in memory [see MPEP§2106.05(d)(II)], as well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as extra-solution activity. Additionally, the following reference shows receiving data from sensors to be well-understood, routine, and conventional:
Charlton, (IEEE reviews in biomedical engineering, vol. 11, pp.2-20 (2017); cited on the attached form PTO-892), shows sensor data (p.3-6).
Therefore, the additional elements of data gathering and outputting do not provide an inventive concept needed to amount to significantly more than the judicial exception.
Additional elements of computers, sensors, and ventilators: Claim 1 recites the additional element of a computer and a signal processing unit; claim 31 recites the additional element of a computer program; claims 1, 8-14, 17-20, 22, 25, and 30-32 recite the additional element of a sensor; claim 12 recites the additional element of a ventilator. These additional elements do not cause the claims to rise to the level of significantly more than the judicial exception; these are conventional computer components, sensors, and ventilators, and therefore, the additional elements of conventional computer components, sensors, and ventilators do not cause the claims to rise to the level of significantly more than the judicial exception as they do not provide an inventive concept. Additionally, the following reference shows the sensors and ventilators to be well-understood, routine, and conventional:
Charlton, (IEEE reviews in biomedical engineering, vol. 11, pp.2-20 (2017); cited on the attached form PTO-892), shows sensors (p.3; p.11).
Helfenbein, (Journal of electrocardiology, vol.47(6), pp.819-825 (2014; cited on the attached form PTO-892), shows ventilators (p.823-825).
Further regarding the conventionality of additional elements, the MPEP at 2106.05(b) and 2106.05(d) presents several points relevant to conventional computers and data gathering steps in regard to Step 2A Prong 2 and Step 2B, including:
• A general purpose computer that applies a judicial exception, such as an abstract idea, by use of conventional computer functions, does not qualify as a particular machine (see 2106.05(b)(I)), as in the case of claim 1 and 30, which recite conventional computer components.
• Integral use of a machine to achieve performance of a method may integrate the recited judicial exception into a practical application or provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not integrate the exception into a practical application or provide significantly more (see 2106.05(b)(II). In the instant claims, the recited computers and sensors are used in obtaining and analyzing data; as such, the computers and sensors act only as tools to perform the steps of data analysis and data obtaining, and do not integrate the exception into a practical application or provide significantly more.
• Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not integrate a judicial exception or provide significantly more (see 2106.05(b)(III). The computers and sensors of the claims used in data analysis and obtaining data do not impose meaningful limitations on the claims.
• The courts have recognized “receiving or transmitting data over a network”, “performing repetitive calculations”, and “storing and retrieving information in memory”, as well-understood, routine, and conventional functions when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity (see MPEP 2106.05(d)(II)). The acquiring, obtaining, and transmitting of data in claims 1 and 9 is recited in a generic manner.
Step 2B Summary: All limitations of claims 1-27 and 30-32 have been analyzed with respect to Step 2B, and none provides a specific inventive concept, as they all fail to rise to the level of significantly more than the identified judicial exception, and thus do not transform the judicial exception into a patent eligible application of the exceptions. (Step2B: NO.)
Therefore, claims 1-27 and 30-32, when the limitations are considered individually and as a whole, are rejected under 35 U.S.C. § 101 as being directed to non patent-eligible subject matter.
Response to Applicant Arguments - 35 USC § 101
Re: Claims 28 and 29:
No remarks were received regarding claims 28 and 29 and the 101 rejection. Nonetheless, regarding the second and fourth considerations at Step 2A Prong Two (see MPEP 2106.04(d), 2106.04(d)(2) and 2106.05(c)), amended claims 28 and 29 recite a practical application of a particular therapy and a particular transformation for mechanical ventilation of a patient which is informed by the output of the judicial exception, i.e., the calculated estimated respiratory signal. Note that claims 28 and 29 would be allowable but are objected to for depending on a rejected base claim (see claim objection section above).
Re: Claims 1-27 and 30-32:
Applicant's arguments filed 06/12/2026 have been fully considered but they are not yet persuasive regarding claims 1-27 and 30-32.
Applicant asserts at p.32-34 (regarding Step 2A Prong One):
• "The claims further include receiving measured values,...generating heartbeat-specific signal segments, determining a shape parameter value..., determining a transmission channel parameter..., and generating a signal estimating unit using a sample formed from the values. These features demonstrate that the claims are directed to a specific technological process for improving physiological signal processing, not to an abstract idea." (Remarks, p.33, ¶ 1.)
• "The characterization of the claims in the Office Action being directed to a mental process is improper. ...Such operations cannot practically be performed in the human mind and instead require specialized signal processing hardware and computation. Claims are not directed to a mental process where the claims require computer-based processing of complex data structures." (Remarks, bridging p.33-34.)
• "While the claims involve calculations, the claims do not merely recite a mathematical formula...The use of mathematical operations within a physical process does not render the claims abstract." (Remarks, p.34, ¶ 2.)
The arguments that the amended claims are not directed to an abstract idea are not persuasive. Regarding mental processes at Step 2A Prong One, the claims do not recite any level of complexity which would prevent the mental process of, from measured values, generating a sum signal, detecting a series of heartbeats, determining a sum signal segment, determining a shape parameter, etc. Although the method is computer implemented and requires a processor, a claim that requires a computer may still recite a mental process [see MPEP 2106.04(a)(2)(III)(C)]. Further, although a general-purpose computer can perform the analysis at a rate and accuracy that can far exceed the mental performance of a skilled artisan, the nature of the activity is essentially the same, and therefore constitutes an abstract idea.
Regarding mathematical concepts at Step 2A Prong One, at least the limitations of calculating shape parameters, estimates of cardiogenic/respiratory activity, and values of transmission channel parameters, etc., recite mathematical concepts in the claims, which are described throughout the Specification, especially at [0148-0149, 0156-0166, 0177, 0195], etc. Additionally, even if the limitations did not recite math, they still recite a mental process and so would recite an abstract idea.
Applicant asserts at p.33-35 (regarding Step 2A Prong Two and Step 2B):
• "Claims directed to a specific improvement in computer functionality or technology are not abstract. The present invention improves the functioning
of a signal processing system used in physiological monitoring." (Remarks, p.33, ¶ 1.)
• "The present invention advantageously improves the operation of a physiological monitoring system by enhancing signal separation accuracy, reducing interference between overlapping physiological signals, and adapting signal estimation based on patient-specific characteristics." (Remarks, p.34, ¶ 3.)
• "Even assuming the claims are directed to an abstract idea...the claims recite significantly more...Even if the elements of the claims are known (Applicant maintains such a position is untenable), the ordered ( sequenced) combination of the following features is not known"... (Remarks, p.35, ¶ 1.)
• "The claims do not merely implement an abstract idea on a generic computer. The claims include using event-driven processing based on physiological signals, accounting for patient-specific transmission characteristics, and enabling real-time estimation and compensation of physiological signals. These features provide a technical improvement in signal processing systems." (Remarks, p.35, ¶ 2.)
The arguments are not yet persuasive regarding the first consideration for improvement to technology or a technical field at MPEP 2106.04(d)(1), as it is not clear that the advantages stated by Applicant result from the claims as recited, e.g., the stated advantages for improving the functioning of a signal processing system, enhancing signal separation accuracy, providing a technical improvement in signal processing systems, etc., need strengthening to demonstrate a practical application of an improvement to technology over the previous state of the technology field. Further, the record, including the Specification, does not yet clearly disclose an explanation of improvement over the previous state of the technology field, and the claims do not yet clearly result in such an improvement.
Regarding showing an improvement to technology, a detailed explanation of a technical improvement may help to overcome a 101 rejection, (see MPEP 2106.04(d) and (d)(1), as well as MPEP 2106.05(a)). The explanation might include a concise statement of the improvement, including improvement over the previous state of the technology field; identification of the technology field; explanation of how the claims deliver the improvement and that reasonably all embodiments within the claim scope also will result in the asserted improvement, and extension of the explanation to persuasively demonstrate the nexus of integration of the judicial exceptions into a practical application. As further examples, argument may clearly and adequately explain cause and effect leading to improvement or, for example, when such cause and effect explanation is not possible, then may include evidence (e.g. experimental data) comparing a claimed result to conventional results. Also, arguments and evidence may be extrinsic to the original disclosure, including references available after the priority date, as long as it is clear that an argument applies to all embodiments of a properly supported claim. In the present invention, the 06/12/2026 arguments do not persuasively explain the improvement.
Conclusion
No claims are allowed.
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.
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/M.A.V./Examiner, Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner, Art Unit 1686
