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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 8 April 2025 has been entered.
Claim Interpretation
The Examiner notes that a “comparison unit” and an “evaluation unit” were interpreted under 112f in the Office Action of 31 January 2024, and as they no longer recite sufficient structure with their functional language this interpretation still stands.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 recites “a comparison unit, with which as a comparison a difference between a phase of a signal and a phase of the AC voltage can be calculated as a function of time” – it appears that this phrase requires at least additional commas to clearly set forth the various clauses “with which, as a comparison, a difference”, but also it is not clear why “as a comparison” has been recited unless Applicant believes there is some way of finding a difference between two values that does not involve comparing those values?
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 27, 29-37, 39-46, 48, 49 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 27 defines a unit configured to calculate “a difference between a phase of a signal supplied from the receiving structure and a phase of the AC voltage” as a function of time. The receiving structure is not defined as being configured to supply anything, particularly not supply a signal. At best the transmitting structure might transmit the AC voltage which is applied to it, but it is not clear if this might be considered “a signal” that is supplied “from” this structure. The claim later also refers to “the signal supplied by the receiving structure”; there is no clear definition that the transmitting structure actively transmits sort of signal, only that a voltage is “applied” to it, but further there is no clear definition of what signal might be “supplied” by the receiving structure or why a “receiving structure” appears to be doing only the opposite of receiving. Claim 36 also refers to “a signal supplied from the at least one receiving structure” – what is this signal that the receiving structure supplies? Where is it supplied to? In this particular claim, the method also calls for the receiving structure to receive an irradiated electromagnetic field, but it does not indicate what other signal the structure “supplies” or where it is supplied to. Clarification is required.
Claim 27 recites use of a determining unit “with which computing and/or correction steps can be carried out to determine at least one respiratory parameter” – as presented, the unit is configured to potentially use only “correction steps” to determine a parameter? How can performing a “correction” result in finding a parameter? The same is found in claim 36; clarification is required.
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 27, 29-35 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) determining any one of several “respiratory parameters” by comparing data, which falls into the grouping of mental processes. This judicial exception is not integrated into a practical application because the mental process of determining a “respiratory parameter”:
does not present any improvement to the functioning of a computer or to any other technology, as it is merely a nonspecific calculation which involves the collected data and somehow using it to find one of a number of standard respiratory-related parameters
does not apply or use a judicial exception to effect a particular treatment or as a prophylaxis for a disease or medical condition, as the result of the determination is not used as part of any particular treatment or prophylaxis
does not apply the judicial exception with, or by use of, a particular machine, as the determination is performed by a “determining unit” (see MPEP 2106.05(d), Bancorp Services v. Sun Life, 687 F.3d 1266, 1278, 103 USPQ2d 1425, 1433 (Fed. Cir. 2012) ("The computer required by some of Bancorp’s claims is employed only for its most basic function, the performance of repetitive calculations, and as such does not impose meaningful limits on the scope of those claims."), showing that these computer functions are well-understood, routine, and conventional functions)
does not effect a transformation or reduction of a particular article to a different state or thing, as it is merely an unspecified method of performing some sort of determination of a parameter from gathered data
does not apply or use the judicial exception in some other meaningful way, as the result of the determination itself is not applied or used in any way the beyond finding of the parameter and is not output in any manner
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only other elements are a “transmitting structure”, “receiving structure”, and “signal generator” used in combination for the insignificant extrasolution activity of data gathering (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional), a “comparison unit” used for the first stage of collating the gathered data, which is also part of the data gathering. As such, considered individually and as a whole, the claim limitations do not amount to significantly more than the abstract idea itself.
The dependent claims also fail to provide anything significantly more, as claims 29-35 are directed to the insignificant extrasolution activity of data gathering.
Claims 36, 37, 39-46, 48, and 49 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim(s) recite(s) determining a “respiratory parameter” by comparing data, which falls into the grouping of mental processes. This judicial exception is not integrated into a practical application because the mental process of determining a “respiratory parameter”:
does not present any improvement to the functioning of a computer or to any other technology, as it is merely a nonspecific calculation which involves the collected data and somehow using a comparison of data to find a parameter
does not apply or use a judicial exception to effect a particular treatment or as a prophylaxis for a disease or medical condition, as the result of the determination is not used as part of any particular treatment or prophylaxis
does not apply the judicial exception with, or by use of, a particular machine, as the determination is not performed by any particular element such that it is inherently a mental process as recited
does not effect a transformation or reduction of a particular article to a different state or thing, as it is merely an unspecified method of performing some sort of determination of a parameter from gathered data
does not apply or use the judicial exception in some other meaningful way, as the determination itself is not applied or used in any way the beyond finding of the unspecified parameter
The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because the only other elements are a “transmitting structure”, “receiving structure”, “electrode or antenna”, and “signal generator” used in combination for the insignificant extrasolution activity of data gathering (See MPEP 2106.05(d), where determining the level of a biomarker by any means, Mayo, 566 U.S. at 79, 101 USPQ2d at 1968; Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1362, 123 USPQ2d 1081, 1088 (Fed. Cir. 2017) is held to be well-understood, routine, and conventional); the “output” of the result is entirely disembodied, and even if performed by any particular device is still the generic insignificant postsolution activity of outputting a result (see MPEP 2106.05 - Presenting data, OIP Techs., 788 F.3d at 1362-63, 115 USPQ2d at 1092-93 - another type of activity that the courts have found to be well-understood, routine, conventional activity when they are claimed in a merely generic manner (e.g., at a high level of generality) or as insignificant extra-solution activity). As such, considered individually and as a whole, the claim limitations do not amount to significantly more than the abstract idea itself.
The dependent claims also fail to provide anything significantly more, as claims 37, 41-45 are directed to aspects of the abstract idea’s “determining”, claims 39, 40, 43, 44, 46, 48 are directed to the insignificant extrasolution activity of data gathering, and claim 49 merely describes what is not included in the claims.
Response to Arguments
Applicant's arguments filed 8 April 2025 have been fully considered but they are not persuasive.
Regarding the rejections under 112, the Examiner notes that though previous issues have been resolved, the amendments have resulted in new rejections as set forth above.
Regarding the rejections under 101, Applicant first argues that the claims should not be treated as falling into the group of mental processes because the claims include “specific hardware components” that are used to obtain the data that is processed. As is set forth in the rejection above, these are not part of the judicial exception itself, which has been clearly identified as the determination of the respiratory parameter, but are instead additional elements also recited in the claim – and these elements, recited at a high level of generality, are used only for the insignificant extrasolution activity of data gathering. The actual identified judicial exception of determining a respiratory parameter is indeed a mental process recited as having a generic computing element (comparison unit and determining unit) for its execution.
Still further, Applicant asserts that these finding these respiratory parameters requires “complex mathematical transformations that go beyond mental processes” – no particular “complex mathematical transformations” are recited as part of the claimed invention that might limit the performance to beyond what can be performed in the human mind. Applicant’s mere assertion that “computing and/or correction steps” are far too complex, without any description of what these steps might involve or what algorithms or tasks are involved in the “computing and/or correction” that are “complex” or even “transformations” of any sort is entirely lacking in evidence. Rather, a step of “comparison” as claimed is entirely capable of being performed purely mentally, and the disclosure of the instant invention clearly describes “suitable computing or correction steps for this purpose, such as averaging, differentiation, determination of minima and maxima, adaptive filtering, correlation filtering, frequency filtering, and the like.” (p. 17 as filed), where none of these are “complex mathematical transformations” and at least averaging and determination of maxima and minima are capable of easily being performed mentally.
Applicant continues by addressing whether a human mind can “perceive electrical voltages”; again, being embodied on a computer for its performance does not make the comparison of two pieces of data, such as the phase of a signal over time, any less a comparison of two pieces of data which could be performed mentally. “Claims can recite a mental process even if they are claimed as being performed on a computer. The Supreme Court recognized this in Benson, determining that a mathematical algorithm for converting binary coded decimal to pure binary within a computer’s shift register was an abstract idea. The Court concluded that the algorithm could be performed purely mentally even though the claimed procedures “can be carried out in existing computers long in use, no new machinery being necessary.” 409 U.S at 67, 175 USPQ at 675.” See MPEP 2106.04(a)III.C.
Applicant concludes this section by again referring to “specialized equipment and signal processing techniques”; again, the equipment used for the extrasolution data gathering is not specialized, nor are the “units” used for execution of unidentified “computing and/or correction steps”, such that this conclusory statement is also unpersuasive.
Applicant next asserts that the recited determination of a respiratory parameter provides a practical application pointing to “paragraphs [0002]-[0006]” as evidence – it should be noted that the specification of the instant invention as filed does not include page numbers, such that it is not clear what document Applicant is referring to to provide this evidence of “a multitude of practical applications”. Applicant appears to assert that the general performance of monitoring that does not involve “a cardiac model and does not require elastic straps” is an improvement, apparently over these other types of monitoring? It is not clear what is considered to be the improvement – the process of monitoring itself? The data acquired by the monitoring? What specific part of the invention as claimed overcomes these unidentified “disadvantages”?
Applicant continues by asserting that the claimed invention enables “more accurate and reliable determination of various respiratory parameters” – as presented there is no specificity as to how these “various” parameters are determined. What aspect of the “determination” provides the improvement? Is this improvement realized in determination of every single one of the recited parameters or only in some of them? How is this “accuracy” and “reliability” evaluated? Applicant next refers to the “real-time continuous monitoring” performed by the invention – this has not been claimed, such that this argument is entirely moot.
Applicant then generally asserts that the various determined parameters themselves “have important practical applications” – as has been previously noted, “the judicial exception alone cannot provide the improvement” (MPEP 2106.05(a)). The mere existence of these parameters is not an improvement, and determination of these parameters is the judicial exception such that it cannot provide the improvement. This argument remains unpersuasive.
Applicant then argues that the claims recite “a specific, unconventional combination of physical components” “and signal processing techniques”; Applicant’s remarks in this section appear to misinterpret how data gathering is separate from the judicial exception. Applicant argues that “the additional elements” are used for “much more than mere data gathering and output” because they recite “specific techniques for processing the gathered data” – processing gathered data is wholly separate from data gathering itself, such that it is unclear why Applicant is attempting to argue that gathering data so that it can be processed is not data gathering. It should also be noted that no part of the invention as claimed includes any “specific techniques for processing the gathered data”, as has been discussed above.
Applicant continues by generally asserting that “the specific combination of elements recited in the claims” “provides a novel and non-obvious approach” to respiratory monitoring; again, as has been noted in previous Office Actions, MPEP 2106.05(I) clearly states:
As made clear by the courts, the "‘novelty’ of any element or steps in a process, or even of the process itself, is of no relevance in determining whether the subject matter of a claim falls within the § 101 categories of possibly patentable subject matter." Intellectual Ventures I v. Symantec Corp., 838 F.3d 1307, 1315, 120 USPQ2d 1353, 1358 (Fed. Cir. 2016) (quoting Diamond v. Diehr, 450 U.S. at 188–89, 209 USPQ at 9). See also Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 1151, 120 USPQ2d 1473, 1483 (Fed. Cir. 2016) ("a claim for a new abstract idea is still an abstract idea. The search for a § 101 inventive concept is thus distinct from demonstrating § 102 novelty.").
The claims remain rejected.
Regarding the art rejections, as no art is currently applied against the claims, Applicant’s remarks are noted but will not be further addressed at this time, but will be revisited if still applicable upon future amendments to the claims.
Conclusion
No art has been applied against the claims at this time; however, as the claims are all rejected under 112 and 101 above they are not presently allowable and the question of prior art will be revisited upon resolution of the above issues.
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/KAREN E TOTH/ Examiner, Art Unit 3791