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 .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Notice of Amendment
In response to the amendment(s) filed on 6/24/26, amended claim(s) 1-14 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “at least one sensor device … configured to capture one or more analog micro-vibrations from at least one user and convert the micro-vibrations into at least one digital data signal,” in claim 1, which corresponds to “piezoelectric sensors” or “vibroacoustic sensors” (see para [073] of Applicant’s specification as originally filed);.
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 7-11 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
For claim 7, the claim language “amplify the derived physiological condition signals to a desired frequency by using a dynamic gain management module” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of amplify the derived physiological condition signals to a desired frequency by using a dynamic gain management module, but the specification never discloses the necessary steps and/or flowcharts of how to use the dynamic gain module to arrive at the desired frequency of the derived physiological condition signal. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
For claim 7, the claim language “determine desired audio file formats” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of determining desired audio file formats, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
For claim 11, the claim language “wherein the processing unit is configured to: determine at least one desired audio file format for the output physiological condition acoustic signals” does not appear to be described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. A claim may lack written description when the specification does not disclose the computer and the algorithm (i.e., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor invented the claimed subject matter. See MPEP 2161.01(I). Here, the claim recites the function of determining at least one desired audio file format for the output physiological condition acoustic signals, but the specification never discloses the necessary steps and/or flowcharts of how this occurs. It is not enough that a skilled artisan could devise a way to accomplish the function because this is not relevant to the issue of whether the inventor has shown possession of the claimed invention. See MPEP 2161.01(I). Therefore, adequate disclosure is needed.
Dependent claim(s) 8-11 fail to cure the deficiencies of claim 7, thus claim(s) 7-11 is/are rejected under 35 U.S.C. 112(a).
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.
Claim(s) 1-14 is/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.
For claim 1, the claim language “at least one sensor device positioned under a surface configured to capture” is ambiguous. Is it unclear whether the claimed “at least one sensor device” or the claimed “surface” is “configured to capture.” The claim is examined under the former interpretation.
For claim 1, the claim language “dynamically adjusting gain of the digital data signal in order to increase or decrease sensitivity of the signal, which enables capture of data across a range of uncontrollable factors, wherein the uncontrollable factors comprise user’s weight, position, and posture, as well as material, type and thickness of a surface of medium under which the at least one sensor device is positioned” is ambiguous. Specifically, the adjusting of the gain is defined in the claim language as a function of enabling capture of data across a range of uncontrollable factors. However, ambiguity may arise when claim language “only states a problem solved or a result obtained” without any “well-defined boundaries of the invention” (see MPEP 2173.05(g)) . Here, the examiner cannot ascertain what parameters of adjustment of the gain of the digital data signal that would lead to what increases or decreases of sensitivity of the signal that would result in capturing of data across a range of uncontrollable factors defined as user’s weight, position, and posture, as well as material, type and thickness of a surface of medium under which the at least one sensor device is positioned because the claim language is defined as a result to be obtained, and, consequentially, the metes and bounds of the claim to be indefinite. For example, would a +3 dB gain result in capture of data across a range of uncontrollable factors defined as user’s weight, position, and posture, as well as material, type and thickness of a surface of medium under which the at least one sensor device is positioned? What about a -7 dB gain? The examiner could not find any examples given in Applicant’s specification, weighing against any “well-defined boundaries” being established for the invention. The claim is examined as just meaning dynamically adjusting gain of the digital data signal in order to increase or decrease sensitivity of the signal.
Dependent claim(s) 2-14 fail to cure the ambiguity of independent claim 1, thus claim(s) 1-14 is/are rejected under 35 U.S.C. 112(b).
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.
Claim(s) 1-14 is/are rejected under 35 U.S.C. 101 because the claimed invention, considering all claim elements both individually and in combination as a whole, do not amount to significantly more than a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea).
Claim 1 is a claim to a process, machine, manufacture, or composition of matter and therefore meets one of the categorical limitations of 35 U.S.C. 101. However, claim 1 meets the first prong of the step 2A analysis because it is directed to a/an abstract idea, as evidenced by the claim language of “receive and process the at least one digital data signal from the at least one sensor device by dynamically adjusting gain of the digital data signal in order to increase or decrease sensitivity of the signal, which enables capture of data across a range of uncontrollable factors, wherein the uncontrollable factors comprise user’s weight, position and posture, as well as material, type and thickness of a surface of medium under which the at least one sensor device is positioned,” “convert the at least one processed digital data signal from the at least one data capturing device into one or more frequency-based physiological acoustic signals,” and “wherein the created frequency-based physiological acoustic signals are processed to determine one or more physiological conditions of the at least one user and generate one or more alerts based on the determined physiological condition acoustic signals.” This claim language, under the broadest, reasonable interpretation, encompasses subject matter that may be performed by a human using mental steps or with pen and paper that can involve basic critical thinking, which are types of activities that have been found by the courts to represents abstract ideas (i.e., the mental comparison in Ambry Genetics, or the diagnosing an abnormal condition by performing clinical tests and thinking about the results in Grams). The claim language also meets prong 2 of the step 2A analysis because the above-recited claim language does not integrate the abstract idea into a practical application. That is, there appears to be no tangible improvement in a technology, effect of a particular treatment or prophylaxis, a particular machine or manufacture that is integrated, or transformation/reduction of a particular article to a different state or thing as a result of this claimed subject matter. As a result, step 2A is satisfied and the second step, step 2B, must be considered.
With regard to the second step, the claim does not appear to recite additional elements that amount to significantly more. The additional elements are “at least one sensor device configured to capture one or more analog micro-vibrations from at least one user and convert the micro-vibrations into at least one digital data signal,” and “a processing unit configured to execute instructions stored in a memory unit.” However, these elements are not “significantly more” because they are well-known, routine, and/or conventional as evidenced by para [0023] of U.S. Patent Application Publication No. 2021/0140815 to Pretorious et al. (hereinafter “Pretorius”) and Alice and Mayo. Therefore, these elements do not add significantly more and thus the claim as a whole does not amount to significantly more than a judicial exception.
Additionally, the ordered combination of elements do not add anything significantly more to the claimed subject matter. Specifically, the ordered combination of elements do not have any function that is not already supplied by each element individually. That is, the whole is not greater than the sum of its parts.
In view of the above, independent claim 1 fails to recite patent-eligible subject matter under 35 U.S.C. 101. Dependent claim(s) 2 fails to cure the deficiencies of independent claim 1 by failing to recite significantly more in view of para [0023] of Pretorious. Dependent claim(s) 3 fails to cure the deficiencies of independent claim 1 by failing to recite significantly more in view of Figs. 1-2 and para [0005] of U.S. Patent Application Publication No. 2009/0195897 to Tsai et al. (hereinafter “Tsai”). Dependent claim(s) 4-14 fail to cure the deficiencies of independent claim 1 by merely reciting additional abstract ideas and/or further limitations on abstract ideas already recited. Thus, claim(s) 1-14 is/are rejected under 35 U.S.C. 101.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1, 4-5, and 12-14 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2014/0371632 to Al-Ali et al. (hereinafter “Al-Ali”) in view of U.S. Patent Application Publication No. 2024/0424207 to Yang.
For claim 1, Al-Ali discloses a system for non-intrusive monitoring of physiological conditions through created acoustic signals (Abstract), comprising:
at least one sensor device (see 110/120 in Fig. 1 and para [0029], but more specifically see 314 in Fig. 3b) positioned under a surface (see how 314 is under a surface pointed to by reference numeral “350” in Figs. 3A-B) configured to capture one or more analog micro-vibrations from at least one user (para [0035] and [0037]) and convert the micro-vibrations into at least one digital data signal (para [0008]-[0009]) (also see 120 in Fig. 1 and para [0030]);
a processing unit configured to execute instructions stored in a memory unit (130) (Fig. 1) (para [0029]) and configured to:
receive (see Fig. 1) and process the at least one digital data signal from the at least one sensor device (para [0029]-[0030]); and
convert the at least one processed digital data signal from the at least one data capturing device into one or more frequency-based physiological acoustic signals (para [0031] and [0037]) (also see para [0040]), wherein the created frequency-based physiological acoustic signals are processed to determine one or more physiological conditions of the at least one user (para [0032]) and generate one or more alerts based on the determined physiological condition acoustic signals (para [0010], [0032], and/or [0043]-[0044]).
Al-Ali does not expressly disclose that the processing unit is configured to dynamically adjusting gain of the digital data signal in order to increase or decrease sensitivity of the signal, which enables capture of data across a range of uncontrollable factors, wherein the uncontrollable factors comprise user’s weight, position and posture, as well as material, type and thickness of a surface of medium under which the at least one sensor device is positioned.
However, Yang teaches dynamically adjusting gain of the digital data signal in order to increase or decrease sensitivity of the signal, which enables capture of data across a range of uncontrollable factors, wherein the uncontrollable factors comprise user’s weight, position and posture, as well as material, type and thickness of a surface of medium under which the at least one sensor device is positioned (para [0325]).
It would have been obvious to a skilled artisan to modify Al-Ali such that the processing unit is configured to dynamically adjusting gain of the digital data signal in order to increase or decrease sensitivity of the signal, which enables capture of data across a range of uncontrollable factors, wherein the uncontrollable factors comprise user’s weight, position and posture, as well as material, type and thickness of a surface of medium under which the at least one sensor device is positioned, in view of the teachings of Yang, for the obvious advantage of individualizing the program to the user (see para [0325] of Yang).
For claim 4, Al-Ali further discloses wherein vibrations captured by the at least one sensor device comprises at least one of mechanical, and force-based signals comprising at least one of vibrations, microvibrations, macrovibrations, ballistocardiograph, seismo-cardiographs, and impedance signals associated with physiological parameters of the user's body (para [0035]).
For claim 5, Al-Ali further discloses wherein the processing unit is configured to receive the at least one digital data signal from the at least one sensor device (as can be seen in Fig. 1) (also see 132) and process the at least one digital data signal in order to derive amplified data signals (para [0031] and [0042]).
For claim 12, Al-Ali further discloses wherein processing unit is configured to: analyze and compare the created frequency-based physiological acoustic signals with stored physiological condition acoustic signals (para [0046]) (also see para [0031-[0032]), in order to predict health issues of the at least one user and to generate one or more alerts based on the health issues (para [0047]), and wherein the one or more alerts are received by using at least one user device that comprises a user application (para [0047]).
For claim 13, Al-Ali further discloses wherein the created frequency-based physiological condition acoustic signals comprise signals related to at least one of physiological conditions and biomarkers of the user's body (para [0050]), and wherein the physiological conditions comprise at least one of: low ejection fraction, high ejection fraction, heart murmurs, lung crackles, coughs, wheezing, and fluid in any organs (para [0050]).
For claim 14, Al-Ali further discloses wherein the stored physiological condition acoustic signals comprise previously gathered data of physiological conditions of previous users (para [0031]-[0032] and [0039]).
Claim(s) 2 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali in view of Yang, and further in view of Pretorious.
For claim 2, Al-Ali further discloses wherein the sensor comprises one or more of: piezoelectric sensors, and vibroacoustic sensors (para [0015]).
Al-Ali and Yang do not expressly disclose wherein the at least one sensor device comprises at least one sensor array.
However, Pretorious teaches a sensor array (para [0002]).
It would have been obvious to a skilled artisan to modify Al-Ali wherein the at least one sensor device comprises at least one sensor array, in view of the teachings of Pretorious, for the obvious advantage of adding a new dimension to the measurement.
Claim(s) 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Al-Ali in view of Yang, and further in view of U.S. Patent Application Publication No. 2021/0041287 to Rimminen et al. (hereinafter “Rimminen”).
For claim 3, Al-Ali does not expressly disclose wherein the at least one sensor device is configured to comprise at least one of: a strengthened outer cover for protecting and covering inner components of the at least one sensor device, wherein the strengthened outer cover comprises a durable material; and an electromagnetic shielding fabric that encases the sensor array, wherein the electromagnetic shielding fabric increases the signal to noise ratio of the detected signal and prevents any interference or digital noise, from any erroneous noise from an environment of the at least one sensor device.
However, Rimminen teaches wherein the at least one sensor device is configured to comprise at least one of: a strengthened outer cover for protecting and covering inner components of the at least one sensor device (514-1, 514-2) (Fig. 5) (para [0047]-[0049]), wherein the strengthened outer cover comprises a durable material (para [0047]-[0049]); and an electromagnetic shielding fabric (510-1, 510-2) (Fig. 5) (para [0045]-[0047]) that encases the sensor array (as can be seen in Fig. 5), wherein the electromagnetic shielding fabric increases the signal to noise ratio of the detected signal and prevents any interference or digital noise, from any erroneous noise from an environment of the at least one sensor device (para [0045]-[0047] and [0069]).
It would have been obvious to a skilled artisan to modify Al-Ali wherein the at least one sensor device is configured to comprise at least one of: a strengthened outer cover for protecting and covering inner components of the at least one sensor device, wherein the strengthened outer cover comprises a durable material; and an electromagnetic shielding fabric that encases the sensor array, wherein the electromagnetic shielding fabric increases the signal to noise ratio of the detected signal and prevents any interference or digital noise, from any erroneous noise from an environment of the at least one sensor device, in view of the teachings of Rimminen, for the obvious advantage of insulating the sensing components (see para [0049] of Rimminen) and also to mitigate noise interreference (see para [0069] of Rimminen).
Response to Arguments
Applicant's arguments filed 6/24/26 have been fully considered.
With respect to the 112 rejections, most of them are withdrawn in view of Applicant’s amendments and arguments. The ones that are maintained were not addressed in the amendments. Additionally, a new rejection has been necessitated by amendment.
With respect to the 101 rejection, Applicant’s amendments are not persuasive and will be treated in the order they were presented. With respect to step 2A, prong one, dynamically adjusting gain can be performed in the human mind. Adjusting a gain just adds a value to the entire signal based on whether the gain is increased or decreased. The human mind can take a signal and add or subtract a flat value to it. It’s not too complex for the human mind, especially since the claim language does not put a time constraint on this processing, thereby giving a human enough time, they can perform it in their mind. With respect to step 2B, prong two, this is not an improvement in technology, it’s an improvement in processing, which is an abstract idea. Wedding DJ’s do this, as well as any other audio engineer that is mic’ing up a speaker or presenter. The wedding DJ has to adjust the gain of the signal from the microphone to adjust for a person’s weight or the clothes that they are specifically wearing for the wedding. That is just one example, but in scenarios, an audio engineer would have to adjust the gain for a band that is performing at a concert or a singer at a sporting event, etc. It’s not an improvement in the technology, it’s just a process that different audio professionals have to go through. With respect to step 2B, the claims considered as a whole don’t result in a sum greater than its parts. That is, each element performs its respective function and when they are ordered together a new function is not created that is not collected already provided by group of elements. Additionally, the argument that Pretorius doesn’t teach the newly amended claim language is a red herring because the newly amended claim language falls under step 2A, not step 2B. As a result, the 101 rejection is maintained.
With respect to the 102/103 rejections, the first two arguments have been rendered moot by the new grounds of rejection necessitated by amendment. With respect to the third argument, this argument is not commensurate in scope with the claim language. Claim 1 does not recite a “sub-acoustic domain.”
Conclusion
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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Robertson can be reached at (571) 272-5001. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791
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