DETAILED ACTION
Note: The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1, 4-11, 15-17, 23-26, 28, 30, 32, and 33 are pending and currently under consideration for patentability under 37 CFR 1.104
Information Disclosure Statement
The information disclosure statement (IDS) submitted on January 4, 2024 has been considered by the examiner.
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.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
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 limitations are:
Claim 24:
“the communication unit” in line 2
“a remote computing device” in line 3
Claim 25:
“the notification unit” in line 2
Because these claim limitations are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, they are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof:
[0073] In some embodiments, device 100 may include a communication unit 136. Communication unit 136 may be connected to support 110. In some embodiments, communication unit 136 may be a wireless communication unit. Wireless communication unit 136 may be, for example, near-field communication (NFC)-based unit, Bluetooth-based unit, radiofrequency identification (RFID)-based unit, etc.
[0076] In some embodiments, communication unit 136 may transmit to a remote computing device a notification indicative of the detection of the abnormal/pathological sound pattern(s) and/or the detection of abnormal/pathological biomarker(s) that require immediate attention. For example, the remote computing device may be a smartphone of the subject, appointed physician's smartphone, healthcare center's server, etc.
If applicant does not intend to have these limitations interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitations to avoid 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 limitations recite sufficient structure to perform the claimed function so as to avoid them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
Claim Rejections - 35 USC § 112B
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 1, 4-11, 15-17, 23-26, 28, 30, 32, and 33 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 1, and all dependent claims thereof, recites:
“a subject’s body” in line 3, which is indefinite. Does this refer to the same “a subject’s body” previously recited in lines 1-2?
“a subject’s clothing” in lines 3-4, which is indefinite. Does this refer to the same “a subject” previously recited?
Claim 17 recites “the time schedule” in lines 1-2, which lacks antecedent basis.
Claim 24 recites “the communication unit” in line 2, which lacks antecedent basis.
Claim 25 recites “the notification unit” in line 2, which lacks antecedent basis.
Claim 28 recites “the electronic components” in lines 2-3, which lacks antecedent basis.
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, 4-11, 15-17, 23-26, 28, 30, 32, and 33 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Regarding claim 1, the claim recites a device for recording, detecting and analyzing sounds from a subject’s body. Thus, the claim is directed to a machine/apparatus, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The following limitations set forth a judicial exception:
“…at least one of: save at least a portion of the output signal in the digital storage unit, preprocess the output signal by detecting one or more subsets of data values in the output signal indicative of one or more abnormal/pathological sound patterns and save only the detected one or more subsets of data value in the digital storage unit, and analyze the output signal to detect one or more abnormal/pathological biomarkers indicative of at least one of: a health, physical, fitness-related, or wellness-related condition of the subject and save information related to the detected abnormal/pathological biomarkers in the digital storage unit.”
These limitations describe a mental process as the skilled artisan is capable of performing the recited limitations and making a mental assessment thereafter. Examiner also notes that nothing from the claims suggest that the limitations cannot be practically performed by a human, or using simple pen/paper.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, integrates the identified judicial exception into a practical application.
For this part of the 101 analysis, the following additional limitations are considered:
“…a device for recording, detecting and analyzing sounds from a subject's body, the device comprising: a support configured to be removably attached to a subject's body or a subject's clothing; an acoustic sensor connected to the support and configured to detect sounds from within the subject's body and generate an output signal; an acoustic waveguide connected to the support and configured to guide the sounds from within the subject's body to the acoustic sensor, wherein the acoustic sensor comprises a piezo electric element within a housing having the acoustic waveguide as one of the surfaces of the housing; a digital storage unit connected to the support; and a processor connected to the support and configured to: receive the output signal…”
These additional limitations do not integrate the judicial exception into a practical application. Rather, the additional limitations are each recited at a high level of generality such that it amounts to insignificant extra-solution activity, e.g., mere data gathering steps necessary from generically recited structural limitations, sensors, etc. to perform the identified judicial exception.
The additional limitations also do not add significantly more to the identified judicial exception because they pertain to widely-understood, routine, and conventional components in the art. For instance, Examiner takes official notice that it is widely known to utilize “an acoustic sensor” to obtain sound data from a subject.
Dependent claims 4-11, 15-17, 23-26, 28, 30, 32, and 33 also fail to add something more to the abstract independent claims as they merely further limit the abstract idea, recite limitations that do not integrate the claims into a practical application for substantially similar reasons as set forth above, and/or do not recite significantly more than the identified abstract idea for substantially similar reasons as set forth above.
Therefore, claims 1, 4-11, 15-17, 23-26, 28, 30, 32, and 33 are not patent eligible under 35 USC 101.
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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.
Claims 1, 4-11, 15-17, 28, 30, 32, and 33 are rejected under 35 U.S.C. 103 as being unpatentable over Telfort et al. (US PG Pub. No. 2011/0213272 A1) (hereinafter “Telfort”).
With respect to claim 1, Telfort teaches a device for recording, detecting and analyzing sounds from a subject's body (par.0016 “acoustic sensing element configured to be acoustically coupled to the body of a patient”), the device comprising: a support Note: instant application similarly discloses/depicts an acoustic waveguide in the form of a hole/channel that addresses ambient sources, see instant drawings, Fig. 1B; par.0050), wherein the acoustic sensor comprises a piezo electric element within a housing having the acoustic waveguide as one of the surfaces of the housing (par.0105 “piezoelectric membranes including through holes or vias”; par.0282); a digital storage unit connected to the support (par.0339 “wide variety of memory devices known to an artisan… including a flash memory”, which equates to digital storage unit; see also par.0347); and a processor connected to the support and configured to: receive the output signal (par.0249 “the sensor includes circuitry to transmit the voltage generated by the sensing element to a processor for processing”) and at least one of (Note: when applying broadest reasonable interpretation, “at least one of” only requires one of the subsequent limitations recited): save at least a portion of the output signal in the digital storage unit, preprocess the output signal by detecting one or more subsets of data values in the output signal indicative of one or more abnormal/pathological sound patterns and save only the detected one or more subsets of data value in the digital storage unit, and analyze the output signal to detect one or more abnormal/pathological biomarkers indicative of at least one of: a health, physical, fitness-related, or wellness-related condition of the subject and save information related to the detected abnormal/pathological biomarkers in the digital storage unit (par.0066 “acoustic signal processing system monitors other physiological sounds… change in heart sounds such as normal to murmur or split heart sounds indicating fluid overload”).
Although Telfort does not explicitly teach a support configured to be removably attached to a subject's body or a subject's clothing, such a modification would have been prima facie obvious to person having ordinary skill in the art (“PHOSITA”) when the invention was filed for the following reasons. First, Telfort discloses an attachment sub-assembly can be secured to a subject’s body by various means including “tape, glue, a suction device”, etc. (par.0082); and “a wearable sensor package” (par.0164). Moreover, removable wearable devices, garments, etc. are widely known in prior physiological monitoring systems. Therefore, PHOSITA would have had predictable success modifying Telfort’s attachment sub-assembly to allow for removable attachment of the acoustic sensor for the purpose of allowing replaceability of the sensor/monitor as needed.
With respect to claim 4, Telfort teaches wherein the acoustic sensor is configured to detect sounds associated with subject's speech or sounds being byproducts of subject's speech (par.0078 “listening to a patient bodily or speech sounds”).
With respect to claim 5, Telfort teaches comprising two or more acoustic sensors and two or more acoustic waveguides, each of the two or more acoustic waveguides for one of the two or more acoustic sensors (abstract “multiple acoustic sensing elements).
With respect to claim 6, Telfort teaches wherein the two or more acoustic sensors are configured to detect sounds of the same frequency range (par.0006, 0168, 0277).
With respect to claim 7, Telfort teaches wherein each of the two or more acoustic sensors is configured to detect sounds of a different frequency range as compared to the other acoustic sensors of the two or more acoustic sensors (par.0006, 0168, 0277).
With respect to claim 8, Telfort teaches wherein frequency ranges of the two or more acoustic sensors partly overlap with each other (par.0006, 0168, 0277).
With respect to claim 9, Telfort teaches wherein the two or more acoustic sensors are configured to detect sounds arriving from a same at least one direction, or location from within the subject's body (par.0015).
With respect to claim 10, Telfort teaches wherein each of two or more acoustic sensors is configured to detect sounds arriving from a different at least one direction, or location from within the subject's body as compared to other acoustic sensors of the two or more acoustic sensors (par.0016).
With respect to claim 11, Telfort teaches wherein the processor is configured to detect at least one of the one or more abnormal/pathological sound patterns and the one or more abnormal/pathological biomarkers based on normal sound patterns and normal biomarkers, respectively; and wherein the normal sound patterns and the normal biomarkers (i) are subject-specific and are predefined based on accumulated sound data collected from the subject or (ii) are specific to a population or subpopulation to which the subject being monitored belongs and are predefined based on accumulated sound data collected from a plurality of individuals belonging to the population or subpopulation (par.0066).
With respect to claim 15, Telfort teaches wherein the acoustic sensor is configured to continuously detect sounds from within the subject's body (par.0078).
With respect to claim 16, Telfort does not explicitly teach wherein the processor is configured to control the acoustic sensor to detect sounds from within the subject's body during predetermined time intervals according to a predetermined time schedule. However, further modifying Telfort such that sounds are detected during predetermined time intervals (e.g. sleep) would only require routine skill in the art. Examiner also takes official notice that detecting bodily sounds during predetermined time intervals (exercise, sleep, etc.) is widely known in the art.
With respect to claim 17, Telfort does not explicitly teach wherein the processor is configured to update the time schedule based on at least one of occurrence and duration of at least one of the one or more abnormal/pathological sound patterns and the one or more abnormal/pathological biomarkers in the output signal. However, further modifying Telfort such that the time schedule is updated based on occurrence of abnormal sound patterns (e.g. sleep apnea) would only require routine skill in the art. Examiner also takes official notice that updating the time schedule of physiological monitoring based on various expected physiological abnormalities is widely known in the art.
With respect to claim 28, Telfort teaches a frame connected to electronic components of the device and configured to removably connect the electronic components of the device to the support (par.0076, 0246).
With respect to claim 30, Telfort teaches a clip connected to the support and configured, when actuated, to push the acoustic sensor and the acoustic waveguide towards the support (par.0261).
With respect to claim 32, Telfort teaches at least one gel pad acoustically coupling the piezo electric element and the waveguide (par.0312).
With respect to claim 33, Telfort teaches wherein acoustic sensor comprises a microphone or within a housing having the waveguide as one of the surfaces of the housing (par.0049, 0163, 0225).
Claims 23-26 are rejected under 35 U.S.C. 103 as being unpatentable over Telfort, as applied to claim 1 above, in further view of Reaser (WO 2013/059529 A1).
With respect to claims 23-26, Telfort teaches a device for recording, detecting and analyzing sounds from a subject's body.
However, Telfort does not teach the limitations further recited in claims 23-26.
Regarding claim 23, Reaser teaches teaches wherein the processor is configured to perform a sound detection test upon attachment of the device to the subject's body or the subject's clothing and initiation thereof, the sound detection test comprises: analyzing the output signal from the acoustic sensor, and determining whether or not the sounds from within the subject's body are being properly detected by the acoustic sensor (par.00050).
Regarding claim 23, Reaser teaches wherein upon determination of improper detection of the sounds, the communication unit is configured to transmit a respective notification to a remote computing device, wherein the respective notification comprises instructions describing how to change a location of the device on the subject's body so as to cause the device to properly detect the sounds from within the subject's body (par.00050).
Regarding claim 25, Reaser teaches wherein upon determination of improper detection of the sounds, the notification unit is configured to generate respective at least one of one or more visual notifications, one or more sound notifications and one or more mechanical notifications (par.00050).
Therefore, it would have been prima facie obvious to PHOSITA when the invention was filed to modify Telfort to incorporate a sound detection test in the manner recited in order to inform the user of an error suggesting improper sensor placement with regards to acoustic data collection, as evidence by Reaser (par.00050).
With respect to claim 26, Telfort teaches comprising one or more additional sensors connected to the support and configured to generate one or more additional sensor output signals (par.0067-68).
Conclusion
No claim is allowed.
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/PUYA AGAHI/Primary Examiner, Art Unit 3791