DETAILED ACTION
Acknowledgements
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-11, 16-17, 19, 21-26 are pending.
This action is Final.
Terminal Disclaimer
The terminal disclaimer filed on 2/16/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Patent No. 11793423 has been reviewed and is accepted. The terminal disclaimer has been recorded.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-11, 16-17, 19, 21-26 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more. The claim(s) recite(s):
Claim 1
identify the cough using morphological features of the accelerometer signal comprising a smooth increase from a baseline, then a sharp decrease after the smooth increase, a peak within the sharp decrease wherein the peak occurs in the accelerometer signal at a sample between a dropoff point and a valley point of a long-term average signal determined from the accelerometer signal, and a gradual return to the baseline after the sharp decrease (mental process recognizing the claimed pattern, mathematical processes in recognizing the claimed pattern in view of the disclosure as filed)
Claim 11
identifying the cough using morphological features of the accelerometer signal comprising a smooth increase from a baseline, a sharp decrease after the smooth increase, a peak within the sharp decrease wherein the peak occurs in the accelerometer signal at a sample between a dropoff point and a valley point of a long-term average signals determined from the accelerometer signal, and a gradual return to the baseline after the sharp decrease (mental process recognizing the claimed pattern, mathematical processes in recognizing the claimed pattern in view of the disclosure as filed)
These claim limitations fall within the identified groupings of abstract ideas:
Mathematical Concepts:
mathematical relationships
mathematical formulas or equations
mathematical calculations
Mental Processes
concepts performed in the human mind (including an observation, evaluation, judgment, opinion)
This judicial exception is not integrated into a practical application because:
Under the step 2A, analysis is conducted on the additional features of the claim. Under this analysis, the additional features beyond the judicial exception are:
Claim 1
a medical device (generic structure/field of use) comprising:
an accelerometer configured to generate an accelerometer signal, wherein the accelerometer signal is indicative of one or more patient movements that occur during a cough (insignificant pre-solution details related to data gathering); and
processing circuitry configured to (computer structures implemented as a tool to perform the claimed exception(s):
Claim 11
collecting, using an accelerometer of a medical device, an accelerometer signal, wherein the accelerometer signal is indicative of one or more patient movements that occur during a cough (insignificant pre-solution details related to data gathering);
These features in the claim do not integrate the exception into a practical application of the exception as the additional elements in the claim do not apply, rely on, or use the judicial exception in a manner that imposes a meaningful limit on the judicial exception, such that the claim is no more than a drafting effort designed to monopolize the exception.
Limitation concepts that are indicative of integration into a practical application:
Improvements to the functioning of a computer, or to any other technology or technical field - see MPEP 2106.05(a)
Applying or using a judicial exception to effect a particular treatment or prophylaxis for a disease or medical condition – see Vanda Memo
Applying the judicial exception with, or by use of, a particular machine - see MPEP 2106.05(b)
Effecting a transformation or reduction of a particular article to a different state or thing - see MPEP 2106.05(c)
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 - see MPEP 2106.05(e) and Vanda Memo
Limitation concepts that are not indicative of integration into a practical application:
Adding the words “apply it” (or an equivalent) with the judicial exception, or mere instructions to implement an abstract idea on a computer, or merely uses a computer as a tool to perform an abstract idea - see MPEP 2106.05(f)
Adding insignificant extra-solution activity to the judicial exception - see MPEP 2106.05(g)
Generally linking the use of the judicial exception to a particular technological environment or field of use – see MPEP 2106.05(h)
Under Step 2B, the claim limitations are evaluated for an inventive concept. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because, when considered separately and in combination, they do not add significantly more to the exception. Analyzing the additional claim limitations individually, the additional limitation that is not directed to the abstract idea are the same as those identified above in relations to the instant step 2A section. Such limitations related to the acceleration sensors/accelerometers, are recognized by the courts as routine data gathering in order to input data to the mathematical algorithm/mental processes, and thus, do not add a meaningful limitation to the system/method as it would be routinely used by those of ordinary skill in the art in order to apply the mathematical algorithm/mental processes. In addition, these sensor structures are known from US 2003/0023184 ([0077]), US 2011/0066042 ([0205]), US 2015/0094544 ([0031]) US 2018/0035924 ([0106]), US 2021/0106253 (0005) that accelerometers can generate/collect/measure coughs. The method does not contain any computing structure, such that the steps can all be analog/mental processing of data patterns. The computer structures cited above are claimed as performing generic computer functions routinely used in computer applications. Generic computer components recited as performing generic computer functions that are well-understood, routine and conventional activities amount to no more than implementing the abstract idea with a computerized system. The additional limitations recited in the dependent claims are merely directed to further mental processes, mathematical concepts in processing the data to identify cough from the gathered data (A more specific abstraction is still an abstraction). Looking at the limitations as an ordered combination adds nothing that is not already present when looking at the elements taken individually. Therefore, analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims filed 2/16/2026; and terminal disclaimer filed 2/16/2026.
Applicant’s arguments regarding the claim objections have been fully considered and are persuasive due to the amendments to the claims; the objections are withdrawn.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 101 have been fully considered but are not persuasive.
Applicant argues the claims are not directed to an abstract idea and recite significantly more. The examiner respectfully disagrees as addressed in the rejection through the Mayo/Alice analysis.
Applicant argues the claim should be analyzed by streamlined with conclusory rationale and thus should be allowed. The examiner respectfully disagrees as questions rise to the claimed features reciting judicial exception(s), thus the full analysis is proper.
Applicant argues that the claimed features are not mathematical concepts and not mental processes. The examiner respectfully disagrees and will address each as follows.
Applicant’s position is that the claim recites morphological features of a signal and not any mathematical concepts. The examiner respectfully disagrees. The step in question is not merely defining a signal, but is to set forth a process to identify the cough either by a processor or completing the process in general using morphological features. It is clear from the disclosure as filed ([0048]-[0052]) that the series of features used to identify the presence are each individual steps in an algorithm for achieving such identification of the particular morphological features. MPEP 2106 “It is important to note that a mathematical concept need not be expressed in mathematical symbols, because “[w]ords used in a claim operating on data to solve a problem can serve the same purpose as a formula.” In re Grams, 888 F.2d 835, 837 and n.1, 12 USPQ2d 1824, 1826 and n.1 (Fed. Cir. 1989). See, e.g., SAP America, Inc. v. InvestPic, LLC, 898 F.3d 1161, 1163, 127 USPQ2d 1597, 1599 (Fed. Cir. 2018) (holding that claims to a ‘‘series of mathematical calculations based on selected information’’ are directed to abstract ideas); Digitech Image Techs., LLC v. Elecs. for Imaging, Inc., 758 F.3d 1344, 1350, 111 USPQ2d 1717, 1721 (Fed. Cir. 2014) (holding that claims to a ‘‘process of organizing information through mathematical correlations’’ are directed to an abstract idea); and Bancorp Servs., LLC v. Sun Life Assurance Co. of Can. (U.S.), 687 F.3d 1266, 1280, 103 USPQ2d 1425, 1434 (Fed. Cir. 2012) (identifying the concept of ‘‘managing a stable value protected life insurance policy by performing calculations and manipulating the results’’ as an abstract idea).” Thus, the claims do indeed recite mathematical concepts, as further agreed to by applicant as identified in the next section.
Applicant argues that the claims do not recite a mental process as the identifying step claimed using morphological features cannot be performed in a human mind because the signals are sampled at 100Hz and human mind cannot process data so quickly. Applicant further argues against mental process by arguing for a mathematical algorithm to check and analyze features present in the signal to identify a cough; and applicant appears to argue that novelty should be given weight to mental process not being performed in the human mind. The examiner respectfully disagrees. First, where in the claims is speed a limiting factor for either identifying or sensor sampling rate? This aspect appears to be wholly lacking from the claims and is thus not persuasive. In addition, generally, mental processes do not have a time requirement for achieving such claimed feature and is in general inclusive of the use of pen and paper, as recognized by the courts, and the examiner is not persuaded that the concepts of the morphological signal identification, even considering steps of algorithmic checks, cannot be achieved through such combination of mental process and pen and paper. There is no processor in the method claims to support the argument of “specialized hardware”, and which further supports such identifying cough using morphological features can indeed be performed by a human mind, otherwise the method claim would necessarily require a processor. Is applicant stating that such structures are essential matter not presently claimed? Lastly, novelty does not equate to patentability for a claim reciting a judicial exception without the claim including a practical application of such exception or significantly more than the exception, which will be addressed in the next sections.
Applicant argues that the claims as a whole amount to a practical application. The examiner respectfully disagrees. Applicant cites Diehr, this is not found persuasive as the claimed concepts are not so similar. The claims are to data gathering from a sensor and identifying a pattern in the signal, there is no feedback for rubber mold press as present in Diehr. Applicant cites CardioNet and concludes the invention is similarly an improvement to technology. This is not found persuasive as the claims are not so similar, while both sets identify features, which the court in CardioNet identified as abstract ideas, it was the further features of an event generator that that analysis moved those specific facts to patent eligibility. Those similar features are wholly lacking from the instant disclosure and thus are not so similarly alike. In addition, other CardioNet decisions of patent ineligibility are more closely aligned with the instant facts of this application. Applicant argues that the examiner should consult the specification for improvement and cites to two passages. However, where in the claims are these improvements represented? The claims appear significantly broader than any of the argued passages in the specification seeking to establish an improvement. Noteworthy, the judicial exception alone cannot provide the improvement. Novelty and improvement are not one in the same. Based on these facts, the argument for improvement is not persuasive. MPEP 2106.05(a)
If it is asserted that the invention improves upon conventional functioning of a computer, or upon conventional technology or technological processes, a technical explanation as to how to implement the invention should be present in the specification. 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. The specification need not explicitly set forth the improvement, but it must describe the invention such that the improvement would be apparent to one of ordinary skill in the art. Conversely, if the specification explicitly sets forth an improvement but in a conclusory manner (i.e., a bare assertion of an improvement without the detail necessary to be apparent to a person of ordinary skill in the art), the examiner should not determine the claim improves technology. An indication that the claimed invention provides an improvement can include a discussion in the specification that identifies a technical problem and explains the details of an unconventional technical solution expressed in the claim, or identifies technical improvements realized by the claim over the prior art. For example, in McRO, the court relied on the specification’s explanation of how the particular rules recited in the claim enabled the automation of specific animation tasks that previously could only be performed subjectively by humans, when determining that the claims were directed to improvements in computer animation instead of an abstract idea. McRO, 837 F.3d at 1313-14, 120 USPQ2d at 1100-01. In contrast, the court in Affinity Labs of Tex. v. DirecTV, LLC relied on the specification’s failure to provide details regarding the manner in which the invention accomplished the alleged improvement when holding the claimed methods of delivering broadcast content to cellphones ineligible. 838 F.3d 1253, 1263-64, 120 USPQ2d 1201, 1207-08 (Fed. Cir. 2016).
After the examiner has consulted the specification and determined that the disclosed invention improves technology, the claim must be evaluated to ensure the claim itself reflects the disclosed improvement in technology. Intellectual Ventures I LLC v. Symantec Corp., 838 F.3d 1307, 1316, 120 USPQ2d 1353, 1359 (Fed. Cir. 2016) (patent owner argued that the claimed email filtering system improved technology by shrinking the protection gap and mooting the volume problem, but the court disagreed because the claims themselves did not have any limitations that addressed these issues). That is, the claim must include the components or steps of the invention that provide the improvement described in the specification. However, the claim itself does not need to explicitly recite the improvement described in the specification (e.g., “thereby increasing the bandwidth of the channel”). The full scope of the claim under the BRI should be considered to determine if the claim reflects an improvement in technology (e.g., the improvement described in the specification). In making this determination, it is critical that examiners look at the claim “as a whole,” in other words, the claim should be evaluated “as an ordered combination, without ignoring the requirements of the individual steps.” When performing this evaluation, examiners should be “careful to avoid oversimplifying the claims” by looking at them generally and failing to account for the specific requirements of the claims. McRO, 837 F.3d at 1313, 120 USPQ2d at 1100.
An important consideration in determining whether a claim improves technology is the extent to which the claim covers a particular solution to a problem or a particular way to achieve a desired outcome, as opposed to merely claiming the idea of a solution or outcome. McRO, 837 F.3d at 1314-15, 120 USPQ2d at 1102-03; DDR Holdings, 773 F.3d at 1259, 113 USPQ2d at 1107. In this respect, the improvement consideration overlaps with other considerations, specifically the particular machine consideration (see MPEP § 2106.05(b)), and the mere instructions to apply an exception consideration (see MPEP § 2106.05(f)). Thus, evaluation of those other considerations may assist examiners in making a determination of whether a claim satisfies the improvement consideration.
It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements. See the discussion of Diamond v. Diehr, 450 U.S. 175, 187 and 191-92, 209 USPQ 1, 10 (1981)) in subsection II, below. In addition, the improvement can be provided by the additional element(s) in combination with the recited judicial exception. See MPEP § 2106.04(d) (discussing Finjan, Inc. v. Blue Coat Sys., Inc., 879 F.3d 1299, 1303-04, 125 USPQ2d 1282, 1285-87 (Fed. Cir. 2018)). Thus, it is important for examiners to analyze the claim as a whole when determining whether the claim provides an improvement to the functioning of computers or an improvement to other technology or technical field.
During examination, the examiner should analyze the “improvements” consideration by evaluating the specification and the claims to ensure that a technical explanation of the asserted improvement is present in the specification, and that the claim reflects the asserted improvement. Generally, examiners are not expected to make a qualitative judgement on the merits of the asserted improvement. If the examiner concludes the disclosed invention does not improve technology, the burden shifts to applicant to provide persuasive arguments supported by any necessary evidence to demonstrate that one of ordinary skill in the art would understand that the disclosed invention improves technology. Any such evidence submitted under 37 CFR 1.132 must establish what the specification would convey to one of ordinary skill in the art and cannot be used to supplement the specification. See, e.g.MPEP § 716.09 on 37 CFR 1.132 practice with respect to rejections under 35 U.S.C. 112(a). For example, in response to a rejection under 35 U.S.C. 101, an applicant could submit a declaration under § 1.132 providing testimony on how one of ordinary skill in the art would interpret the disclosed invention as improving technology and the underlying factual basis for that conclusion.
Applicant argues that the claims amount to significantly more than the recited judicial exception because the claims include a medical device with an accelerometer and processing circuitry. The examiner respectfully disagrees. As discussed prior, the method contains no processing structures. As set forth in the rejection, such devices with accelerometers and processors for detecting coughs are well-known, conventional, and routine. The examiner is unpersuaded that the analysis of significantly more is in error and the arguments appear more conclusory based on the prior discussion of practical application. The claim is to data gathering and identification of pattern in the signal using known sensors for measuring such data and where claimed, using processor as a tool to implement such exception. Analyzing the claims as an ordered combination under the Mayo/Alice analysis the features claimed are directed to patent ineligible limitations. The rejections are respectfully maintained.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112 have been fully considered and are persuasive due to the amendments to the claims; the rejections are withdrawn.
Applicant’s arguments regarding the double patenting rejections have been fully considered and are persuasive due to the terminal disclaimer; the rejections are withdrawn.
Conclusion
No prior art rejections have been applied to the claims due to the presence of features similar to those allowed in the parent application US 17/306,372 where the pattern used is different than the pattern of the prior art documents, specifically, in the combination of features considered as a whole: identifying cough with a particular morphology characteristic including identifying the cough using morphological features of the accelerometer signal comprising a smooth increase from a baseline, a sharp decrease after the smooth increase, a peak within the sharp decrease wherein the peak occurs in the accelerometer signal at a sample between a dropoff point and a valley point of a long-term average signals determined from the accelerometer signal, and a gradual return to the baseline after the sharp decrease. However, the claims are not allowable due to the 101 rejections.
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. US 2003/0023184 ([0077]), US 2011/0066042 ([0205]), US 2015/0094544 ([0031]) US 2018/0035924 ([0106]), US 2021/0106253 ([0005], [0098], Figure 12) teach acceleration used to determine cough, but does not directly teach the claimed identification pattern as claimed.
THIS ACTION IS MADE FINAL. 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 MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert (Tse) Chen can be reached at (571)272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791