DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Response to Arguments
Applicant’s amendments filed 8/3/2026 merit new grounds for rejection under 35 U.S.C. § 112(d). Applicant's arguments filed 8/3/2026 have been fully considered but they are not persuasive.
On p. 5 of the remarks filed 8/3/2026, Applicant argues that the claims recite “using a fast Fourier transform to generate a frequency-transformed physiological signal comprising a plurality of frequency bins” and extracting energy “wherein extracting the energy comprises summing magnitudes of two or more of the plurality of frequency bins corresponding to the low frequency components” and therefore, the recitation of transforming a signal into a frequency domain is no longer generic and in the abstract. Instead, Applicant argues that the claims require a specific, named transform, a specific intermediate data structure, and a specific technique for deriving the claimed energy value from the data structure and states that, similar to Diamond v. Diehr, the claimed abstract idea is “integrated into a specific process,” analogous to “curing rubber”. Applicant goes on to say that the previous claims were “correctly identified as reciting (a) mathematical concept itself in the instant claims.”
Firstly, it’s noted that the abstract idea identified in the prior Office action is a mental process rather than a purely mathematical concept. While the instant claims do involve (now) a specific mathematical algorithm (Fast Fourier Transform/FFT), the Examiner contends as a whole, the claims are directed instead to a mental process that incorporates the FFT.
Secondly, the Examiner contends that the identified abstract idea is embodied by the following claim limitations:
transforming the physiological signal into a frequency domain using a fast Fourier transform to generate a frequency-transformed physiological signal comprising a plurality of frequency bins
extracting energy of low frequency components in the frequency transformed physiological signal, wherein the low frequency components comprise frequencies of 3Hz or lower, wherein extracting the energy comprises summing magnitudes of two or more of the plurality of frequency bins corresponding to the low frequency components
determining a likelihood of a good quality connection of the sensor only from the low frequency components, wherein the determination of the likelihood comprises determining that the extracted energy exceeds a threshold
in response to the determination that the extracted energy exceeds the threshold, detect(ing) that the sensor is properly attached to the patient
Therefore, in considering Applicant’s arguments that the identified abstract idea is “integrated into a specific process” this is not found persuasive. The elements Applicant identifies as integrating the steps into a specific process are part of the abstract idea and therefore not an additional element integrating the abstract idea into particular process. In Diamond v. Diehr, the mathematical formula was held to be integrated in a practical application, because courts held that the specific implementation of the mathematical formula in the claimed system improved the specific, existing technological process and specifically depended upon the constantly updating sensor information, the integration with a specific molding device, and constantly updating a calculated cure time in combination as elements that supported the integration. By contrast, Applicant’s claimed do not “constantly” obtain sensor data or provide said sensor data to a computer, nor do they “constantly” at any particularity of interval perform calculations with said sensor data, etc. Unlike Diamond v. Diehr, Applicant claims only one instance of “receiving a physiological signal from (a) sensor”, one iteration of a calculation sequence, and one generic output step that is not specifically computer implemented and certainly does not meet the specificity of “opening the press automatically when a said comparison indicates equivalence,” as found in Diamond v. Diehr.
On p. 6 of the remarks dated 8/3/2026, Applicant argues that the sensor “comprises one or more acoustic sensor elements configured to generate the physiological signal by mechanically deforming in response to acoustic energy emanating from the patient,” and states that claiming a “physical transduction mechanism” rather than a generic placeholder of “sensor” renders the activity of the sensor “integral to, rather than merely prefatory to, the claimed determination” and therefore is distinguished from the data-gathering step in CyberSource.
This is not found persuasive because all of the data gathering, despite the structural specificity of the sensor, is still performed “prefatory to” the claimed determination. The data is only received “from” the claimed sensor one time, prior to all of the steps identified as comprising the abstract idea, and no integral data gathering is performed. The sensor is further not claimed as actively sensing any data, but rather the data is received from the sensor- encompassing under BRI a scenario where the data is pre-existing as previously acquired from the claimed type of sensor, and received for performing the abstract idea.
On pp. 6-7 of the remarks dated 8/3/2026, Applicant argues that the claims tie the frequency-domain process to a “same physical signal path” because the claimed FFT is performed on “the physiological signal” and subsequent steps are derived from the “specific transform output” and therefore the claim is directed to a specific improvement in the field of patient physiological monitoring: “automatically evaluating whether an acoustic sensor is properly attached to a patient using only the low-frequency energy content of that sensor’s own signal without need of any second, independently placed sensor for cross-correlation,” characterizing this improvement as a meaningful, technology-specific application of recited signal processing rather than a generic “apply it” statement.
As noted above, the “physical signal path” claimed as “the physiological signal” is not an active or integrated step of constantly or repeatedly acquiring and providing data to a series of calculations. Therefore, even though the subsequent calculations use the claimed signal, the signal is only received once as a pre-solution activity. Next, with respect to the “improvement,” Applicant is reminded that courts have held that any specific components or steps of the invention providing the improvement described in the specification must be reflected in the claim and that the judicial exception alone cannot provide the improvement. In the instant claims, Applicant’s disclosed improvement is provided solely by the steps that have been identified as abstract, and as noted by the Examiner, are not integrated with any additional elements so that the additional elements provide the improvement in concert with the abstract idea.
On p. 7 of the remarks dated 8/3/2026, Applicant argues that the claims are directed to a “particular arrangement and use of sensors to achieve a specific technical result” and are not directed “merely to the underlying mathematics.” Applicant concedes that the claims do not recite a “particular sensor placement” but nevertheless likens the instant claims to those found in Thales Visionix stating the claims tie “a specific processing technique to a specific sensing structure to produce a specific, technologically useful output” for the purpose of avoiding presenting unreliable physiological readings to a caregiver.
This is not found persuasive, because as noted above, the instant “specific sensing structure” is not integrated with the identified abstract idea. Further, as noted by Applicant, the “specific sensing structure” does lack the claimed particular arrangement of sensors, which the Thales v. Visionix decision specifically references. Finally, the identified abstract idea is not merely mathematic algorithms or formulas, but instead to a mental process comprising all of identified elements a, b, and c. The Examiner does not contend that the claims are directed solely to mathematical concepts or formulas. Instead, the rejection acknowledges that the claims use mathematical concepts or formulas but are not directed to the mathematical concepts or formulas themselves. Instead the claims are identified as directed to a mental process that rely upon the mathematical concepts or formulas.
On p. 7 of the remarks dated 8/3/2026, Applicant argues that the claims are directed to a “specific, ordered combination” including (i) generating the physiological signal via mechanical deformation of an acoustic sensor element, (ii) transforming that specific signal via an FFT into a plurality of frequency bins, and (iii) summing the magnitudes of specific low-frequency bins to obtain the single energy value used for attachment determination. Applicant further contends that the Office is required to find that this specific combination of elements is “well-understood, routine, or conventional for the purpose of determining sensor-attachment quality from a single acoustic sensor’s output alone”.
This is not found persuasive because this argument again relies upon elements that are identified as part of the abstract idea. Under Step 2B, only the additional elements alone and in an ordered combination are evaluated for whether they do more than that which is considered well-understood, routine, or conventional. In the case of claim 1, the only additional elements are identified as (i) receiving a physiological signal from (a) sensor, wherein the sensor comprises one or more acoustic sensor elements configured to generate the physiological signal by mechanically deforming in response to acoustic energy emanating from the patient, and (ii) outputting an automated indication.
Therefore, as in the rejection below, the Examiner has found that not only are the combination of (i) and (ii) found to amount to pre/post-solution activity as held by the courts, that the ordered combination of (i) and (ii) is indeed known in the art as well-understood, routine, or conventional. Evidenced by U.S. Patent No. 2,777,903 to Turner, which teaches: “As is well known, the stethoscope commonly used by physicians in making physical examinations includes a diaphragm which is placed in contact with the body of the patient, as a result of which, the diaphragm is caused to vibrate by heart or lung sounds and such sounds are transmitted through a flexible tube of rubber or the like, to a pair of ear pieces which are placed in the ears of the physician,” in col. 1, lines 20-29.
Further, the Turner reference comprises an automated output from an acoustic sensor, which mechanically deforms to produce a sensor output (notably, both conventional stethoscopes and microphones function via this physical deformation, a diaphragm vibrates to pick up acoustic signals from the surrounding environment, which is then transmitted to a user via either electronic elements or the ear tubes of a stethoscope). Therefore, the Examiner considers that the claimed combination of additional elements does not contribute more than that which is already well understood, routine, or conventional.
Further evidenced by U.S. Patent No. 5,010,889 to Bredesen et al., which teaches a stethoscope comprising an output and a processor, stating specifically about incorporation of signal processing via a processor: “The digital waveform analysis performed by the software includes many techniques well known to those skilled in the digital arts to which the software portion of the present invention pertains,” in col. 11, lines 35-40. Bredesen goes on to state “Once all of the points along the energy curve have been interpolated and an energy envelope has been calculated, command is passed to command box where all of the sample points within the time interval are summed in a conventional fashion well known to those skilled in the art in order to integrate the area under the energy curve to determine the power envelope.” Showing that even if the energy determination had not already been found as part of the abstract idea, the combination of energy determination with the claimed sensor, processor, and output would nevertheless be considered well known in the art of acoustic sensing. Therefore, even for claim 32 which additionally requires a processor, the Examiner considers that the claimed combination of additional elements does not contribute more than that which is already well understood, routine, or conventional.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 31 and 37 rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 31 and 37 recite, optionally, a short-time Fourier transform. The Fourier transform is already recited in claims 26 and 32 more narrowly as a fast Fourier transform. Therefore, claims 31 and 37 provide nothing more than that which is already claimed. Applicant may further which to consider whether the other alternative transforms (chirplet, wavelet, Gabor) are disclosed in combination with the FFT or as an alternative, when considering any amendment. The Examiner recommends as a solution, cancelling claims 31 and 37.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 26-37 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
This analysis in view of 35 U.S.C. § 101 is based on MPEP § 2106, please see this section of the MPEP for additional information.
First, the broadest reasonable interpretation of the claim as a whole is established:
Claims 26 and 32 are directed to a method/system for automating detection of proper sensor attachment to a patient, including receiving sensor data, transforming the sensor data to a frequency domain, extracting the low frequency component energy, and determining that the sensor is likely to be attached properly if the low frequency component energy exceeds a threshold, and outputting an indication of proper attachment.
Claims 27-29, 31, 33-35, and 37 specify details of the transform, frequency band, and of interest.
Claims 30 and 36 limits the output to an alarm.
Step 1 of the analysis is the question: “Is the claim to a process, machine, manufacture, or composition of matter?” and the answer is determined to be yes, as the claims as a whole are directed to a system.
For Step 2, the preliminary question is whether the eligibility of the claim is self- evident. The answer is determined to be no, as the claim is not immediately self-evident as statutory.
Step 2A Prong One: Is the claim directed to a law of nature, a natural phenomenon (product of nature) or an abstract idea?
A claim is directed to a judicial exception when a law of nature, a natural phenomenon, or an abstract idea is recited (i.e., set forth or described) in the claim. While the terms “set forth” and “describe” are thus both equated with “recite”, their different language is intended to indicate that there are different ways in which an exception can be recited in a claim. For instance, the claims in Diehr set forth a mathematical equation in the repetitively calculating step, the claims in Mayo set forth laws of nature in the wherein clause, meaning that the claims in those cases contained discrete claim language that was identifiable as a judicial exception. The claims in Alice Corp., however, described the concept of intermediated settlement without ever explicitly using the words “intermediated” or “settlement.”
Claim 26 (and similarly in Claim 32) recites the following limitations:
transforming the physiological signal into a frequency domain using a fast Fourier transform to generate a frequency-transformed physiological signal comprising a plurality of frequency bins
extracting energy of low frequency components in the frequency transformed physiological signal, wherein the low frequency components comprise frequencies of 3Hz or lower, wherein extracting the energy comprises summing magnitudes of two or more of the plurality of frequency bins corresponding to the low frequency components
determining a likelihood of a good quality connection of the sensor only from the low frequency components, wherein the determination of the likelihood comprises determining that the extracted energy exceeds a threshold
in response to the determination that the extracted energy exceeds the threshold, detect(ing) that the sensor is properly attached to the patient
This claim language is identified as an abstract idea, because in MPEP § 2106.04(a)(2) III B. this language is similar to concepts relating to organizing or analyzing information in a way that can be performed mentally or are analogous to human mental work. For example, Synopsys, Inc. v. Mentor Graphics Corp., 839 F.3d 1138, 120 USPQ2d 1473 (Fed. Cir. 2016). In Synopsys, the patentee claimed methods of logic circuit design, comprising converting a functional description of a level sensitive latch into a hardware component description of the latch. 839 F.3d at 1140; 120 SPQ2d at 1475. Although the patentee argued that the claims were intended to be used in conjunction with computer-based design tools, the claims did not include any limitations requiring computer implementation of the methods and thus do not involve the use of a computer in any way. 839 F.3d at 1145; 120 USPQ2d at 1478-79. The court therefore concluded that the claims “read on an individual performing the claimed steps mentally or with pencil and paper,” and were directed to a mental process of “translating a functional description of a logic circuit into a hardware component description of the logic circuit.” 839 F.3d at 1149-50; 120 USPQ2d at 1482-83.
In the instant case, the identified abstract idea(s) is similar to Synopsys because the language reads on an individual performing the claimed sensor attachment evaluation mentally. They do not require any computer implementation beyond the recitation of a general purpose computer, or using the computer as a tool to perform the function and therefore are directed to a mental process and/or individual judgment of determining the quality of a sensor connection on a patient by determining a magnitude of component signal in the frequency domain, and comparing the magnitude to a threshold.
Yes. The claim is directed to an abstract idea.
Step 2A Prong Two: Does the claim recite additional elements that integrate the judicial exception into a practical application?
First, the additional elements are identified:
Claim 26 : sensor comprising one or more acoustic sensor elements configured to generate the physiological signal by mechanically deforming in response to acoustic energy emanating from the patient, receiving a physiological signal, outputting an indication
Claims 30 and 36: alarm
Claim 26 : processor, sensor comprising one or more acoustic sensor elements configured to generate the physiological signal by mechanically deforming in response to acoustic energy emanating from the patient, receiving a physiological signal, outputting an indication
In the case of the processor, receiving, and output, these elements appear to describe a general purpose computer, added post-hoc to an abstract idea rather than an improvement to computer functionality and does not qualify as a particular machine.
In the case of the claimed outputting of an indication and alarm, this appears to describe mere output or display as the feedback is only described at the highest level of generality and linked onto to a basic threshold comparison. The indication do not require the user to actually comply the with any instruction, recommendation, or adjustment and cannot be considered any particular positively recited treatment.
In the case of the sensor, the obtaining of signal is considered insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)). Because they are recited so broadly, they appear to only generally link the abstract idea to a particular field of use or device. The sensors are therefore not tied to any particular function or integrated into the abstract idea in any fashion to render the abstract idea an improvement to a technology or integrated into a practical application.
The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015).
Step 2B: Does the claim recite additional elements that amount to significantly
more than the judicial exception?
The additional elements are identified above in Step 2A, Prong 2.
In the case of the processor, receiving, and output, these elements appear to describe a general purpose computer, added post-hoc to an abstract idea rather than an improvement to computer functionality and does not qualify as a particular machine.
In the case of the claimed outputting of an indication and alarm, this appears to describe mere output or display as the feedback is only described at the highest level of generality and linked onto to a basic threshold comparison. The indication do not require the user to actually comply the with any instruction, recommendation, or adjustment and cannot be considered any particular positively recited treatment.
In the case of the sensor, the obtaining of signal is considered insignificant extra-solution activity to the judicial exception, e.g., mere data gathering in conjunction with a law of nature or abstract idea such as a step of obtaining information about credit card transactions so that the information can be analyzed by an abstract mental process, as discussed in CyberSource v. Retail Decisions, Inc., 654 F.3d 1366, 1375, 99 USPQ2d 1690, 1694 (Fed. Cir. 2011) (see MPEP § 2106.05(g)). Because they are recited so broadly, they appear to only generally link the abstract idea to a particular field of use or device. The sensors are therefore not tied to any particular function or integrated into the abstract idea in any fashion to render the abstract idea an improvement to a technology or integrated into a practical application.
The recitation of claim limitations that attempt to cover any solution to an identified problem with no restriction on how the result is accomplished and no description of the mechanism for accomplishing the result, does not integrate a judicial exception into a practical application or provide significantly more because this type of recitation is equivalent to the words “apply it”. See Electric Power Group, LLC v. Alstom, S.A., 830 F.3d 1350, 1356, 119 USPQ2d 1739, 1743-44 (Fed. Cir. 2016); Intellectual Ventures I v. Symantec, 838 F.3d 1307, 1327, 120 USPQ2d 1353, 1366 (Fed. Cir. 2016); Internet Patents Corp. v. Active Network, Inc., 790 F.3d 1343, 1348, 115 USPQ2d 1414, 1417 (Fed. Cir. 2015).
Further, in the case of the specific combination of a “sensor comprising one or more acoustic sensor elements configured to generate the physiological signal by mechanically deforming in response to acoustic energy emanating from the patient”, signal receiving, outputting an automated indication, and a processor, these elements are found to provide nothing more than that which is considered well understood, routine, or conventional in the art.
U.S. Patent No. 2,777,903 to Turner, which teaches: “As is well known, the stethoscope commonly used by physicians in making physical examinations includes a diaphragm which is placed in contact with the body of the patient, as a result of which, the diaphragm is caused to vibrate by heart or lung sounds and such sounds are transmitted through a flexible tube of rubber or the like, to a pair of ear pieces which are placed in the ears of the physician,” in col. 1, lines 20-29. Further, the Turner reference comprises an automated output from an acoustic sensor, which mechanically deforms to produce a sensor output (notably, both conventional stethoscopes and microphones function via this physical deformation, a diaphragm vibrates to pick up acoustic signals from the surrounding environment, which is then transmitted to a user via either electronic elements or the ear tubes of a stethoscope). Therefore, the Examiner considers that the claimed combination of additional elements does not contribute more than that which is already well understood, routine, or conventional.
U.S. Patent No. 5,010,889 to Bredesen et al., which teaches a stethoscope comprising an output and a processor, stating specifically about incorporation of signal processing via a processor: “The digital waveform analysis performed by the software includes many techniques well known to those skilled in the digital arts to which the software portion of the present invention pertains,” in col. 11, lines 35-40. Bredesen goes on to state “Once all of the points along the energy curve have been interpolated and an energy envelope has been calculated, command is passed to command box where all of the sample points within the time interval are summed in a conventional fashion well known to those skilled in the art in order to integrate the area under the energy curve to determine the power envelope.” Showing that even if the energy determination had not already been found as part of the abstract idea, the combination of energy determination with the claimed sensor, processor, and output would nevertheless be considered well known in the art of acoustic sensing. Therefore, even for claim 32 which additionally requires a processor, the Examiner considers that the claimed combination of additional elements does not contribute more than that which is already well understood, routine, or conventional.
Therefore, these additional elements do not amount to significantly more than the judicial exception and the claimed subject matter appears to be ineligible under 101.
Conclusion
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
