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 .
Election/Restrictions
Claims 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected Group I, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on May 4th, 2026.
Applicant's election with traverse of Group II (Claims 8-16) in the reply filed on May 4th, 2026 is acknowledged. The traversal is on the ground(s) that “the apparatus as claimed is not used to practice another materially different process”. This is not found persuasive because although Groups I and II have similar limitations, Groups I and II are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case, the apparatus as claimed can be used to practice another materially different process such as a method for early detection of heart disease.
Applicant may amend the withdrawn claims concurrently during prosecution and would likely be able to rejoin them if any found allowable subject matter is inputted into those claims. The requirement is still deemed proper and is therefore made FINAL.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claims 8-10 and 12-16 are objected to because of the following informalities:
Claim 8 recites “the patient’s own breathing activity” in line 9, but should read “a breathing activity of the patient”
Claim 9 recites “sequence,” in line 3, but should read “sequence:”
Claim 10 recites “the patient’s own breathing activity” in lines 9-10, but should read “a breathing activity of the patient”
Claim 12 recites “wherein the processing unit” in lines 1-2, but should read “wherein the signal processing unit”
Claim 13 recites “wherein the processing unit” in lines 1-2, but should read “wherein the signal processing unit”
Claim 14 recites “wherein with the processing unit” in lines 1-2, but should read “wherein within the signal processing unit”
Claim 14 recites “where N > 1 is a predetermined number” in lines 3-4, but should read “wherein N is a predetermined number and is greater than 1”
Claim 15 recites “wherein with the processing unit” in lines 1-2, but should read “wherein within the signal processing unit”
Claim 16 recites “sequence,” in line 2, but should read “sequence:”
Appropriate correction is required.
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 8-16 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.
Claim 8 recites the limitation "the cardiac activity" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the course" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the related heartbeat" in line 14. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "a cardiogenic reference signal segment" in lines 17-18. It is unclear as to whether this limitation is referring to the previously introduced “cardiogenic reference signal segment” from lines 1-2 of Claim 8, or a separate element.
Claim 8 recites “at least one of” in lines 25-26. Further in line 30, Claim 8 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 8 recites the limitation "the following quality measures" in line 26. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites the limitation "the generated cardiogenic reference signal segment" in line 32. It is unclear as to whether this limitation is referring to the previously introduced “a cardiogenic reference signal segment” from lines 1-2 of Claim 8, "a cardiogenic reference signal segment" from lines 17-18 of Claim 8, or a separate element. Examiner further notes that in lines 17-18 of Claim 8, the “cardiogenic reference signal segment” is determined, not generated.
Claim 8 recites the limitation "the greater" in line 33. There is insufficient antecedent basis for this limitation in the claim.
Claim 8 recites "wherein the weight factor is the greater, the greater the quality measure used or the greater each quality measured used is" in lines 33-34. It is unclear as to what this limitation entails, as there seem to be grammatical issues present. Clarification is requested.
Claim 9 recites the limitation "a measured value" in line 4. It is unclear as to whether this limitation is referring to one of the previously introduced “measured values” from line 4 of Claim 8, or a separate element.
Claim 9 recites "wherein an anthropological parameter assumes for the patient the measured value in the course of the heartbeat of the sample sequence" in lines 4-6. It is unclear as to what this limitation entails, as there seem to be grammatical issues present. Clarification is requested.
Claim 9 recites the limitation "the value" in line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the cardiac activity" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the course" in line 5. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "determining the cardiogenic reference signal segment" in lines 16-17. However, Claim 10 previously recited “generating a cardiogenic reference signal segment” in line 4. It is unclear as to whether the cardiogenic reference signal segment is determined or generated. Clarification is requested.
Claim 10 recites “at least one of” in lines 22-23. Further in line 27, Claim 10 recites “and”. These two terms conflict one another. Examiner cannot definitively ascertain whether this is an alternative limitation or if all limitations are required. The Examiner will interpret the claim as in the alternative.
Claim 10 recites the limitation "the following quality measures" in line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the related heartbeat" in line 25. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites the limitation "the generated cardiogenic reference signal segment" in line 29. It is unclear as to whether this limitation is referring to the previously introduced “a cardiogenic reference signal segment” from line 4 of Claim 10, "cardiogenic reference signal segment" from lines 16-17 of Claim 10, or a separate element. Examiner further notes that in lines 16-17 of Claim 10, the “cardiogenic reference signal segment” is determined, not generated.
Claim 10 recites the limitation "the greater" in line 30. There is insufficient antecedent basis for this limitation in the claim.
Claim 10 recites "wherein the weight factor is the greater, the greater the quality measure used or the greater each quality measured used is" in lines 30-31. It is unclear as to what this limitation entails, as there seem to be grammatical issues present. Clarification is requested.
Claim 11 recites the limitation "the contribution" in line 3. There is insufficient antecedent basis for this limitation in the claim.
Claim 12 recites “a heartbeat sequence of heartbeats” in lines 3-4. It is unclear as to whether this limitation is referring to the previously introduced “a sequence of heartbeats” from Claim 10, or a separate element.
Claim 12 recites the limitation "the duplicates" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Claim 13 recites the limitation "the determined characteristic heartbeat time points" in line 4. There is insufficient antecedent basis for this limitation in the claim. Examiner notes that although the “characteristic heartbeat time points” was previously introduced in Claim 10, it was never recited that they were “determined”.
Claim 14 recites the limitation "the respective most recent N heartbeats" in lines 6-7. There is insufficient antecedent basis for this limitation in the claim.
Claim 15 recites the limitation "the previous determination" in line 7. There is insufficient antecedent basis for this limitation in the claim.
Claim 16 recites the limitation "a measured value" in line 3. It is unclear as to whether this limitation is referring to one of the previously introduced “measured values” from line 7 of Claim 10, or a separate element.
Claim 16 recites "an anthropological parameter assuming the measured value for the patient in the course of the heartbeat of the sample sequence" in lines 3-4. It is unclear as to what this limitation entails, as there seem to be grammatical issues present. Clarification is requested.
Claim 16 recites the limitation "the value" in line 6. There is insufficient antecedent basis for this limitation in the claim.
Regarding independent claims 8 and 10 and their dependent claims 9 and 11-16,
… where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims. MPEP 2173.06 II.
The application of prior art to independent claims 8 and 10 and their dependent claims 9 and 11-16 would require considerable speculation/assumptions about the meaning of the claim limitations.
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 8-16 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.
Each of Claims 8-16 has been analyzed to determine whether it is directed to any judicial exceptions.
Step 1
Claims 8-16 recite a signal processing unit and a system. Thus, the claims are directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong 1
Each of Claims 8-16 recites at least one step or instruction for generating a cardiogenic reference signal segment, which is grouped as a mental process under the 2019 PEG.
Both Claims 8 and 10 recite abstract ideas in the form of mental processes, as consistent with Mayo Collaborative Servs. v. Prometheus Labs., Inc., 566 U.S. 66 (2012). If a claim, under its broadest reasonable interpretation, covers performance in the mind but for the recitation of generic computer components, then it is still in the mental processes category unless the claim cannot practically be performed in the mind, see Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1318 (Fed. Cir. 2016). Generating a cardiogenic reference signal segment may be performed by a human. This applies for all claims dependent on claims 8 and 10.
Accordingly, each of Claims 8-16 recites an abstract idea.
Specifically, independent claim 8 recites the abstract idea of (as best understood, in view of the 112(b) rejections above): “wherein the signal processing unit is configured to generate a sum signal by pre-processing measured values of the sensor arrangement, wherein the sum signal comprises a superposition of a respiratory signal, describing the patient's own breathing activity, with a cardiogenic signal, describing the patient's cardiac activity, wherein the signal processing unit is configured to generate a sample, wherein the generated sample comprises, for each heartbeat of a sample sequence of heartbeats, a respective sum signal segment, wherein the sum signal segment for a heartbeat of the sample sequence describes a course of the sum signal in the course of the related heartbeat of the sample sequence, wherein the signal processing unit is configured to detect a respective characteristic heartbeat time point for each heartbeat of the sample sequence and to determine a cardiogenic reference signal segment using the characteristic heartbeat time points of the sample sequence and an aggregation of the sum signal segments of the generated sample, wherein the signal processing unit is configured to perform the aggregation using a respective weight factor for each sum signal segment and the characteristic heartbeat time points of the sample sequence, wherein the signal processing unit is configured to determine the respective weight factor for the sum signal segment of a heartbeat of the heartbeat sample depending on at least one of the following quality measures: a quality measure for a quality with which the sum signal and/or the sum signal segment for the related heartbeat have been generated by the measured value pre-processing; a quality measure for a reliability with which the characteristic heartbeat time point of the related heartbeat has been detected; and a quality measure that assesses a shape of the sum signal segment or that assesses a shape of the generated cardiogenic reference signal segment, and wherein the weight factor is the greater, the greater the quality measure used or the greater each quality measure used is”.
Specifically, independent claim 10 recites the abstract idea of (as best understood, in view of the 112(b) rejections above): “a signal processing unit for generating a cardiogenic reference signal segment, the segment describing the cardiac activity of a patient in the course of a heartbeat, the signal processing unit comprising: a sum signal generator configured to generate a sum signal from the measured values of the sensor arrangement by pre-processing measured values, the generated sum signal comprising a superposition of a respiratory signal, describing the patient's own breathing activity, with a cardiogenic signal, describing the patient's cardiac activity; a sum signal segment generator generating a sum signal segment for each heartbeat of a sequence of heartbeats where the respective sum signal segment for a heartbeat of the sequence describes a course of the sum signal in the course of the respective heartbeat; a characteristic heartbeat time point functional unit for detecting for each heartbeat of the sequence of heartbeats a respective characteristic heartbeat time point; a cardiogenic reference signal segment functional unit for determining the cardiogenic reference signal segment using the characteristic heartbeat time points of the sequence of heartbeats and an aggregation of the sum signal segments, wherein the aggregation is determined using for each sum signal segment a respective weight factor; and a weight factor determination means configured to determine the respective weight factor for the sum signal segment of a heartbeat of the heartbeat sample depending on at least one of the following quality measures: a quality measure for a quality with which the sum signal and/or the sum signal segment for the related heartbeat have been generated by the measured value pre-processing; a quality measure for a reliability with which the characteristic heartbeat time points of the heartbeats have been detected; and a quality measure that assesses a shape of the sum signal segment or that assesses a shape of the generated cardiogenic reference signal segment, and wherein the weight factor is the greater, the greater the quality measure used or the greater each quality measure used is”.
Further, dependent Claims 9 and 11-16 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 process steps are performed.
Accordingly, as indicated above, each of the above-identified claims recites an abstract idea.
Step 2A, Prong 2
The above-identified abstract idea in each of independent Claims 8 and 10 (and their respective dependent Claims 9 and 11-16) is not integrated into a practical application under 2019 PEG because the additional elements (identified above in independent Claims 8 and 10), either alone or in combination, generally link the use of the above-identified abstract idea to a particular technological environment or field of use. More specifically, the additional elements of: “signal processing unit” and “sensor arrangement” are generically recited computer elements in independent Claims 8 and 10 (and their respective dependent claims) which do not improve the functioning of a computer, or any other technology or technical field. Nor do these above-identified additional elements 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 elements do not add a meaningful limitation to the abstract idea because they amount to simply implementing the abstract idea on a computer. For at least these reasons, the abstract idea identified above in independent Claims 8 and 10 (and their respective dependent claims) is not integrated into a practical application under 2019 PEG.
Moreover, the above-identified abstract idea is not integrated into a practical application under 2019 PEG because the claimed system merely implements the above-identified abstract idea (e.g., mental process) using rules (e.g., computer instructions) executed by a computer (e.g., “signal processing unit” 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. Additionally, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. That is, like Affinity Labs of Tex. v. DirecTV, LLC, the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution. Thus, for these additional reasons, the abstract idea identified above in independent Claims 8 and 10 (and their respective dependent claims) is not integrated into a practical application under the 2019 PEG.
Accordingly, independent Claims 8 and 10 (and their respective dependent claims) are each directed to an abstract idea under 2019 PEG.
Step 2B
None of Claims 8-16 include additional elements that are sufficient to amount to significantly more than the abstract idea for at least the following reasons.
These claims require the additional elements of: “signal processing unit” and “sensor arrangement”. The above-identified additional elements are generically claimed computer components which enable the above-identified abstract idea(s) to be conducted by performing the basic functions of automating mental tasks or categorized as data-gathering. The courts have recognized such computer functions as well understood, routine, and conventional functions when claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity. See, Versata Dev. Group, Inc. v. SAP Am., Inc. , 793 F.3d 1306, 1334, 115 USPQ2d 1681, 1701 (Fed. Cir. 2015); and OIP Techs., 788 F.3d at 1363, 115 USPQ2d at 1092-93.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by the Applicant’s specification which discloses that the processor(s) comprise generic computer components that are configured to perform the generic computer functions (e.g. receiving, generating, detecting, performing, determining) that are well-understood, routine, and conventional activities previously known to the pertinent industry; the Applicant’s Background in the specification; and the non-patent literature of record in the application.
Accordingly, in light of Applicant’s specification, the claimed term “signal processing unit” is reasonably construed as a generic computing device. Like SAP America vs Investpic, LLC (Federal Circuit 2018), it is clear, from the claims themselves and the specification, that these limitations require no improved computer resources, just already available computers, with their already available basic functions, to use as tools in executing the claimed process.
Furthermore, Applicant’s specification does not describe any special programming or algorithms required for the “signal processing unit”. This lack of disclosure is acceptable under 35 U.S.C. §112(a) since this hardware performs non-specialized functions known by those of ordinary skill in the computer arts. By omitting any specialized programming or algorithms, Applicant's specification essentially admits that this hardware is conventional and performs well understood, routine and conventional activities in the computer industry or arts. In other words, Applicant’s specification demonstrates the well-understood, routine, conventional nature of the above-identified additional elements because it describes these additional elements in a manner that indicates that the additional elements are sufficiently well-known that the specification does not need to describe the particulars of such additional elements to satisfy 35 U.S.C. § 112(a) (see Berkheimer memo from April 19, 2018, (III)(A)(1) on page 3). Adding hardware that performs “‘well understood, routine, conventional activit[ies]’ previously known to the industry” will not make claims patent-eligible (TLI Communications).
The recitation of the above-identified additional limitations in Claims 8-16 amounts to mere instructions to implement the abstract idea on a computer. Simply using a computer or other machinery in its ordinary capacity for economic or other tasks (e.g., to receive, store, or transmit data) or simply adding a general purpose computer or computer components after the fact to an abstract idea (e.g., a fundamental economic practice or mathematical equation) does not provide significantly more. See Affinity Labs v. DirecTV, 838 F.3d 1253, 1262, 120 USPQ2d 1201, 1207 (Fed. Cir. 2016) (cellular telephone); and TLI Communications LLC v. AV Auto, LLC, 823 F.3d 607, 613, 118 USPQ2d 1744, 1748 (Fed. Cir. 2016) (computer server and telephone unit). Moreover, implementing an abstract idea on a generic computer, does not add significantly more, similar to how the recitation of the computer in the claim in Alice amounted to mere instructions to apply the abstract idea of intermediated settlement on a generic computer.
A claim that purports to improve computer capabilities or to improve an existing technology may provide significantly more. McRO, Inc. v. Bandai Namco Games Am. Inc., 837 F.3d 1299, 1314-15, 120 USPQ2d 1091, 1101-02 (Fed. Cir. 2016); and Enfish, LLC v. Microsoft Corp., 822 F.3d 1327, 1335-36, 118 USPQ2d 1684, 1688-89 (Fed. Cir. 2016). However, a technical explanation as to how to implement the invention should be present in the specification for any assertion that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes. That is, the disclosure must provide sufficient details such that one of ordinary skill in the art would recognize the claimed invention as providing an improvement. Here, Applicant’s specification does not include any discussion of how the claimed invention provides a technical improvement realized by these claims over the prior art or any explanation of a technical problem having an unconventional technical solution that is expressed in these claims. Instead, as in Affinity Labs of Tex. v. DirecTV, LLC 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016), the specification fails to provide sufficient details regarding the manner in which the claimed invention accomplishes any technical improvement or solution.
For at least the above reasons, the systems of Claims 8-16 are directed to applying an abstract idea as identified above on a general purpose computer without (i) improving the performance of the computer itself, or (ii) providing a technical solution to a problem in a technical field. None of Claims 8-16 provides meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that these claims amount to significantly more than the abstract idea itself.
Taking the additional elements individually and in combination, the additional elements do not provide significantly more. Specifically, when viewed individually, the above-identified additional elements in independent Claims 8 and 10 (and their dependent claims) do not add significantly more because they are simply an attempt to limit the abstract idea to a particular technological environment. That is, neither the general computer elements nor any other additional element adds meaningful limitations to the abstract idea because these additional elements represent insignificant extra-solution activity. When viewed as a combination, these above-identified additional elements simply implement the claimed functions with well-understood, routine and conventional activity specified at a high level of generality in a particular technological environment. As such, there is no inventive concept sufficient to transform the claimed subject matter into a patent-eligible application. When viewed as whole, the above-identified additional elements do not provide meaningful limitations to transform the abstract idea into a patent eligible application of the abstract idea such that the claims amount to significantly more than the abstract idea itself. Thus, Claims 8-16 merely apply an abstract idea to a computer and do not (i) improve the performance of the computer itself (as in Bascom and Enfish), or (ii) provide a technical solution to a problem in a technical field (as in DDR).
Therefore, none of the Claims 8-16 amounts to significantly more than the abstract idea itself. Accordingly, Claims 8-16 are not patent eligible and rejected under 35 U.S.C. 101.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Kahl (U.S. Publication No. 2021/0338176; cited by Applicant) discloses a process and signal processing unit for determining a cardiogenic signal, wherein measured values are received, and a sum signal is generated, which is a superimposition of the respiratory signal to a cardiogenic signal. The unit detects heartbeats, and a respective heartbeat time period for each. An intermediate signal is calculated by compensating the influence of the cardiac activity on the sum signal. The unit determines an attenuation signal, which is an indicator of the average time curve of the contribution of the cardiogenic signal to the intermediate signal in a predefined reference heartbeat time period. An intermediate signal section is generated as a section of the intermediate signal in a heartbeat time period and intermediate signal sections are mapped to the reference heartbeat time period. The estimated respiratory signal is calculated with the use of the mapped intermediate signal sections and of the attenuation signal.
Yesha (U.S. Publication No. 2007/0149883 A1) discloses an apparatus and system for non-invasively detecting and determining the heart rate and respiration rate of a patient, while the patient is within their sleep environment, suitable for both home and hospital monitoring, which includes an array of at least two pressure-sensitive sensors, positioned under the mattress, which gathers data from the patient corresponding to the vertical and horizontal movements of the body, and wherein the data from each sensor is collected, filtered, and analyzed and finally, the difference between the results gathered from each sensor detects and determines heart and respiration rates.
Robinson et al (U.S. Publication No. 2023/0148876 A1) discloses methods and apparatuses for assessment and management of hemodynamic status by using systematic perturbations of venous return or trend observation over time, wherein information is processed and aggregated together to improve signal quality of overall measurement improvement.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CHANEL J YOON whose telephone number is (571) 272-2695. The examiner can normally be reached on Monday-Friday 9:00AM-5:00PM.
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/CHANEL J YOON/Examiner, Art Unit 3791
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