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 1-2, 4-21 are pending.
This action is Final.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the features of claim 6 including that the wearable apparatus includes embedded audio sensors and “at least one of the plurality of the audio sensors comprises a diaphragm, a chest piece, and a sound meter” must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference characters "100" and "101" have both been used to designate device. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “100” has been used to designate both system and device. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
The disclosure is objected to because of the following informalities: the disagreement for drawing elements as set forth in the drawing objections above.
Appropriate correction is required.
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.
Claims 6, 20-21 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.
Regarding claim 6, the limitations “the device of claim 1, wherein at least one of the plurality of audio sensors comprises a diaphragm, a chest piece, and a sound meter” are rejected for lack of adequate written description. While the limitations find explicit recitation in the description for the claim 6, that being a further of the wearable device embodiment is not a feature present that can be reasonably discerned. It is not clear that the embodiment of claim 1 can contain such features. Plainly, what is the sound meter for the embodiment of the wearable device? Based on the detailed description, the sound meter is involved in an experimental embodiment measuring flow by a pump, and not by the required structures of claim 1 including:
“a wearable apparatus positionable proximate to a lung; a plurality of audio sensors embedded in the wearable apparatus configured to record lung sounds, wherein the plurality of audio sensors are positioned at locations of the wearable apparatus corresponding to lung auscultation points, wherein the lung auscultation points include at least one of an apex of a lung, an upper lobe of the lung, a middle lobe of the lung, and a lower lobe of the lung;” (emphasis added)
The only reference to sound meter is not in relationship to the wearable device. Applicant admission is that stethoscopes are known to contain a diaphragm and chest piece, but the discussion in relation to these elements lacks any mention of a sound meter, let alone a stethoscope embedded into a wearable apparatus as set forth in the claim:
“A stethoscope comprises a tube connected to a round metal piece, known as the chest piece, with a surrounding diaphragm, or plastic piece. When a physician places a stethoscope on a patient's chest, the sound of the airflow will cause the diaphragm to vibrate, and the sound eventually travels through the connected tube to the physician's ears. By listening to a patient's chest, a physician can identify whether the respiratory sound is normal or abnormal, then diagnose them with a respiratory condition or disease based on the sound and their symptoms.
It is not clear how the wearable apparatus of Figure 3B includes the sound meter of Figures 7/18. As such, one of skill in the art would not have recognized applicant was in possession of the claimed invention at the time the application was filed. Applicant is invited to explain where the embodiment of the wearable device discusses relationship to the sound meter or cancel claim 6.
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Regarding claim 20, the limitations “wherein the change in a patient's lung sounds over time is identified via a machine learning algorithm” is rejected for lack of adequate written description. Machine learning is a field of study in artificial intelligence concerned with the development and study of statistical algorithms that can learn from data and generalize to unseen data, there is no implicit/inherent meaning to “machine learning algorithm” to allow for the establishment as to how applicant achieved the claimed results. It is not clear if the aspects needed to provide the written description for the scope claimed are provided by an incorporated by reference document. If such is the argued case, such is improper under rule 1.57 if this is from a NPL document. Applicant is invited to explain where the basis to support such scope may be found in the disclosure as filed. For these reasons explained, one of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed.
Regarding claim 21, the limitation of “wherein the device is configured to activate a subset of the plurality of audio sensors at a point corresponding to a breathing period, wherein the breathing period comprises an inhalation period or an exhalation period” is rejected for lack of adequate written description. The claim amounts to a functional limitation of the device, but the disclosure as filed contains no description of how such functions are achieved by any structure, but merely repeats the claim features that such functions are achieved. This amounts to unlimited functional limitation. How are the positively recited structures of the device structured to allow for such functions? Which elements are configured for such result? Unlimited functional claim limitations that extend to all means or methods of resolving a problem may not be adequately supported by the written description or may not be commensurate in scope with the enabling disclosure, both of which are required by 35 U.S.C. 112(a) and pre-AIA 35 U.S.C. 112, first paragraph. In re Hyatt, 708 F.2d 712, 714, 218 USPQ 195, 197 (Fed. Cir. 1983); Ariad, 598 F.3d at 1340, 94 USPQ2d at 1167. As such, one of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed. See MPEP 2173.05(g).
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 1-2, 4-21 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.
Regarding claims 1 and 10, the limitation of “a lung…a lung…the lung…the lung…the lung” renders the claim indefinite. It is unclear if the two “a lung” are the same or different, and unclear which is being further referenced in “the lung”. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Regarding claim 6, the limitations “the device of claim 1, wherein at least one of the plurality of audio sensors comprises a diaphragm, a chest piece, and a sound meter” is rendered indefinite in view of the requirements of claim 1 and the detailed description as filed. While the limitations find explicit recitation in the description for the claim 6, that being a further of the wearable device embodiment is not a feature present that can be reasonably discerned. It is not clear that the embodiment of claim 1 can contain such features as illustrated by the drawings referenced above. Plainly, what is the sound meter for the embodiment of the wearable device? Based on the detailed description, the sound meter is involved in an experimental embodiment measuring flow by a pump, and not by the required structures of claim 1 including:
“a wearable apparatus positionable proximate to a lung; a plurality of audio sensors embedded in the wearable apparatus configured to record lung sounds, wherein the plurality of audio sensors are positioned at locations of the wearable apparatus corresponding to lung auscultation points;”
The only reference to sound meter is not in relationship to the wearable device. Now applicant admission is that stethoscopes are known to contain a diaphragm and chest piece, but the discussion in relation to these elements lacks any mention of a sound meter:
“A stethoscope comprises a tube connected to a round metal piece, known as the chest piece, with a surrounding diaphragm, or plastic piece. When a physician places a stethoscope on a patient's chest, the sound of the airflow will cause the diaphragm to vibrate, and the sound eventually travels through the connected tube to the physician's ears. By listening to a patient's chest, a physician can identify whether the respiratory sound is normal or abnormal, then diagnose them with a respiratory condition or disease based on the sound and their symptoms.
It is not clear how the wearable apparatus of Figure 3B includes the sound meter of Figures 7/18. This makes the metes and bounds of the claim unclear which renders the claim indefinite. As such, considerable uncertainty, assumptions, and speculation exists for claim 6 and it would be improper to speculatively apply prior art to claim 6, In re Steele. See MPEP 2173.06
“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.
Regarding claim 20, the limitations “a patient’s lung sounds” renders the claim indefinite. It is not clear whether these are the same or different from like terms previously set forth which renders the claim indefinite. This makes the metes and bounds of the claim unclear which renders the claim indefinite.
Regarding claim 21, “wherein the device is configured to activate a subset of the plurality of audio sensors at a point corresponding to a breathing period, wherein the breathing period comprises an inhalation period or an exhalation period” renders the claim indefinite. The claim amounts to a functional limitation of the device, but the disclosure as filed contains no description of how such functions are achieved but merely repeats the claim functional result. This amounts to unlimited functional limitation, however, there is no clear-cut indication of how such functions are achieved. How are the positively recited structures of the device structured to allow for such functions? Which elements are configured for such result? See MPEP 2173.05(g) Notwithstanding the permissible instances, the use of functional language in a claim may fail “to provide a clear-cut indication of the scope of the subject matter embraced by the claim” and thus be indefinite. In re Swinehart, 439 F.2d 210, 213 (CCPA 1971). For example, when claims merely recite a description of a problem to be solved or a function or result achieved by the invention, the boundaries of the claim scope may be unclear. Halliburton Energy Servs., Inc. v. M-I LLC, 514 F.3d 1244, 1255, 85 USPQ2d 1654, 1663 (Fed. Cir. 2008) (noting that the Supreme Court explained that a vice of functional claiming occurs “when the inventor is painstaking when he recites what has already been seen, and then uses conveniently functional language at the exact point of novelty”) (quoting General Elec. Co. v. Wabash Appliance Corp., 304 U.S. 364, 371 (1938)); see also United Carbon Co. v. Binney & Smith Co., 317 U.S. 228, 234 (1942) (holding indefinite claims that recited substantially pure carbon black “in the form of commercially uniform, comparatively small, rounded smooth aggregates having a spongy or porous exterior”). Further, without reciting the particular structure, materials or steps that accomplish the function or achieve the result, all means or methods of resolving the problem may be encompassed by the claim. Ariad Pharmaceuticals., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1353, 94 USPQ2d 1161, 1173 (Fed. Cir. 2010) (en banc). See also Datamize LLC v. Plumtree Software Inc., 75 USPQ2d 1801 (Fed. Cir. 2005) where a claim directed to a software based system for creating a customized computer interface screen recited that the screen be "aesthetically pleasing," which is an intended result and does not provide a clear cut indication of scope because it imposed no structural limits on the screen. As such, the metes and bounds of the claim are not clear which renders the claim indefinite.
The dependent claims are rejected for depending on a rejected claim.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2, 4-5, 8, 21 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Farhoud (US 2016/0306940).
Regarding claim 1, Farhoud teaches an auscultation device, comprising:
a wearable apparatus positionable proximate to a lung (see entire document, especially Figures 1-3);
a plurality of audio sensors embedded in the wearable apparatus configured to record lung sounds, wherein the plurality of audio sensors are positioned at locations of the wearable apparatus corresponding to lung auscultation points (see entire document, especially Figures 2-4 element 16, [0022], meets the intended use), wherein the lung auscultation points include at least one of an apex of a lung, an upper lobe of the lung, a middle lobe of the lung, and a lower lobe of the lung (see entire document, especially Figures 2-3, [0022] “The back six positions correspond to the lung apex, mid-lung fields, and lung bases, respectively…It will be understood that different types and any number of microphones may be embedded in or positioned at different locations on the wearable garment 12 for obtaining similar readings.”, meets the intended use);
a microcontroller embedded in the wearable apparatus configured to control operation of the plurality of audio sensors (see entire document, especially Figure 4, processor 18, [0004]);
a transceiver embedded in the wearable apparatus (see entire document, especially Figure 4 element 22); and
a power source embedded in the wearable apparatus (see entire document, especially Figure 4 element 24).
Regarding claim 2, Farhoud teaches wherein the wearable apparatus comprises a vest, a strap, a jacket, or a shirt (see entire document, especially Figures 1-3, [0004]).
Regarding claim 4, Farhoud teaches wherein the wearable apparatus is configured to accommodate variations in body weight or size (see Figures 1-3, [0035], meets the intended use).
Regarding claim 5, Farhoud teaches wherein the wearable apparatus is configured to accommodate male and female patients (see Figures 1-3, [0035], meets the intended use).
Regarding claim 8, Farhoud teaches wherein the power source comprises a battery (see entire document, especially [0027]).
Regarding claim 21, Farhoud teaches wherein the device is configured to activate a subset of the plurality of audio sensors at a point corresponding to a breathing period, wherein the breathing period comprises an inhalation period or an exhalation period (intended use of the device, met by the teachings in Figure 5 and [0038] to activate a portion of microphones or sensors via user interface).
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.
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.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Farhoud (US 2016/0306940) as applied to claim 1 above, and further in view of Nasry (US 2019/0231262).
Regarding claim 7, the limitations are met by Farhoud where it is taught different types of microphones can be used (see [0022]), except the limitations of wherein at least one of the plurality of audio sensors comprises a stethoscope is not directly taught.
Nasry teaches a related system where a wearable unit includes sensors, wherein microphones and stethoscopes are taught to be alternatives (see entire document, especially title, abstract, Figures 1, 8, [0009]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention as an obvious substitution of one known element for another to obtain predictable results to replace the microphones of Farhoud with the stethoscopes taught by Nasry in order to measure lung/heart sounds on a worn unit.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Farhoud (US 2016/0306940) as applied to claim 1 above, and further in view of Freeman et al. (Freeman, US 10,702,166).
Regarding claim 9, Farhoud teaches the wearable apparatus can contain any desirable number of acoustic sensors and directly teaches an embodiment of ten microphones with four on the front and 6 on the back (see entire document, especially [0022]), where positioning includes at least one of an apex of a lung, an upper lobe of the lung, a middle lobe of the lung, and a lower lobe of the lung (see [0022]), but does not directly teach wherein the plurality of audio sensors include eight posterior sensors. Freeman teaches at least eight posterior sensors (see Figure 23). It would have been obvious to one of ordinary skill to use any desired number of sensors as taught and suggested in the art to measure signals as desired.
Claims 10-20 are rejected under 35 U.S.C. 103 as being unpatentable over Farhoud (US 2016/0306940) in view of Papadopoulos et al. (Papadopoulos, US 2014/0155705)
Regarding claim 10, Farhoud teaches an auscultation system, comprising:
an auscultation device (see Figures 1-3), comprising:
a wearable apparatus positionable proximate to a lung (see entire document, especially Figures 1-3);
a plurality of audio sensors embedded in the wearable apparatus configured to record lung sounds, wherein the plurality of audio sensors are positioned at locations of the wearable apparatus corresponding to lung auscultation points (see entire document, especially Figures 2-4 element 16, [0022], meets the intended use), wherein the lung auscultation points include at least one of an apex of a lung, an upper lobe of the lung, a middle lobe of the lung, and a lower lobe of the lung (see entire document, especially Figures 2-3, [0022] “The back six positions correspond to the lung apex, mid-lung fields, and lung bases, respectively…It will be understood that different types and any number of microphones may be embedded in or positioned at different locations on the wearable garment 12 for obtaining similar readings.”, meets the intended use);
a microcontroller embedded in the wearable apparatus configured to control operation of the plurality of audio sensors (see entire document, especially Figure 4, processor 18, [0004]);
a transceiver embedded in the wearable apparatus (see entire document, especially Figure 4 element 22); and
a power source embedded in the wearable apparatus (see entire document, especially Figure 4 element 24).
a computing system communicatively connected to the auscultation device (see entire document, especially Figure 1 any of the elements connected to 12 by network), comprising a processor and a non-transitory computer-readable medium with instructions stored thereon, which when executed by a processor (see entire document, especially Figure 1 any of the elements connected to 12 by network);
however, the limitations of the computer system performs steps establishing a baseline lung sound spectrum via data received from the auscultation device; recording a lung sound spectrum via data received from the auscultation device; and identifying a change in a patient's lung sounds over time via comparing the recorded lung sound spectrum to the baseline lung sound spectrum are not directly taught.
Papadopoulos teaches a related system which monitors heath on a computer system (see entire document, especially title and abstract), and teaches processes of establishing baseline data, comparing future data to the baseline data for diagnostic purposes, which such steps would suggest to use the data of Farhoud to establish respiration acoustic data baseline and identify changes in future measurements and thus reasonably teaches the claimed features establishing a baseline lung sound spectrum via data received from the auscultation device, recording a lung sound spectrum via data received from the auscultation device, and identifying a change in a patient's lung sounds over time via comparing the recorded lung sound spectrum to the baseline lung sound spectrum (see entire document, especially [0016] “data from the monitor worn by a patient, combined with data from external sensors in the environment, may be trended over time to provide a continuous yet nonintrusive automated monitoring of an individual patient's wellness between regular clinical checkups, and by detecting deviations from the individual's personal trended values, or baseline, provide inferences of changes in behavior that correlates with a change in health and wellness status). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way in order to track a user’s respiration profile change over time in order to allow for identifying clinical changes.
Regarding claim 11, the limitations are met by Farhoud in view of Papadopoulos, where Farhoud teaches wherein the auscultation device is wirelessly communicatively connected to the computing system via a wireless communication protocol comprising 3G, 4G/LTE, 5G, Bluetooth®, Bluetooth® Low Energy (BLE), Zigbee, near-field communication (NFC), or infrared (see entire document, especially [0025]).
Regarding claim 12, the limitations are met by Farhoud in view of Papadopoulos, where Farhoud teaches further comprising a network communicatively connected to the auscultation device and computing system (see entire document, especially Figure 1, [0025]).
Regarding claim 13, the limitations are met by Farhoud in view of Papadopoulos, where Farhoud teaches wherein the auscultation device and computing system are wirelessly communicatively connected to the network via a wireless communication protocol comprising 3G, 4G/LTE, 5G, Bluetooth®, Bluetooth® Low Energy (BLE), Zigbee, near-field communication (NFC), or infrared (see entire document, especially Figure 1, [0025]).
Regarding claim 14, the limitations are met by Farhoud in view of Papadopoulos, where the combination teaches a method for monitoring a patient's change in lung sounds over time, comprising: providing the system of claim 10 proximate to the patient's lung (see Farhoud Figures 1-4); establishing the baseline lung sound spectrum via the auscultation device; recording the lung sound spectrum via the auscultation device; and identifying the change in the patient's lung sounds over time via comparing the recorded lung sound spectrum to the baseline lung sound spectrum as Papadopoulos teaches a related system which monitors heath on a computer system (see entire document, especially title and abstract), and teaches processes of establishing baseline data, comparing future data to the baseline data for diagnostic purposes, which such steps would suggest to use the data of Farhoud to establish respiration acoustic data baseline and identify changes in future measurements and thus reasonably teaches the claimed features (see entire document, especially [0016]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way in order to track a user’s respiration profile change over time in order to allow for identifying clinical changes.
Regarding claim 15, the limitations are met by Farhoud in view of Papadopoulos, where Papadopoulos teaches further comprising: establishing a background noise spectrum; calculating a background subtracted lung sound spectrum and baseline lung sound spectrum by subtracting the background noise spectrum from each respective lung sound spectrum as Papadopoulos suggests using sensors to gather ambient data and removing the ambient data from the desired data prior to analysis (see entire document, especially [0016], [0089]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way in order to identify ambient data, and remove ambient data from the desired data in order to reduce errors in diagnostic determinations.
Regarding claim 16, the limitations are met by Farhoud in view of Papadopoulos, where Papadopoulos teaches wherein recording the lung sound spectrum is performed continuously or periodically (see entire document, especially [0016]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of recording data in a continuous or periodic manner over time in order to allow for data trended to occur.
Regarding claim 17, the limitations are met by Farhoud in view of Papadopoulos, where the combination teaches further comprising: administering a treatment (see Farhoud [0046]) recording, after the treatment is administered, a subsequent lung sound spectrum via the auscultation device (see Farhoud [0046] continue monitoring); comparing the subsequent lung sound spectrum to the baseline lung sound spectrum to identify a change in the patient's lung sounds over time (see [0078] compare data to stored data); determining, based on the identified change, at least one of a treatment effectiveness, a disease state, and a disease progression based on the change in a patient's lung sounds over time; and providing at least one of the treatment effectiveness, the disease state, and the disease progression to a practitioner (see entire document, especially [0016] health and wellness status equates to disease state). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to use a known technique to improve similar devices in the same way in order to track a user’s respiration profile change over time in order to allow for identifying clinical changes.
Regarding claim 18, the limitations are met by Farhoud in view of Papadopoulos, where Papadopoulos teaches further comprising transmitting, to a remote practitioner, data indicative of the at least one of the treatment effectiveness, the disease state, and the disease (see entire document, especially [0049]-[0050]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of alerting a doctor of a patient’s health changes in order to give care.
Regarding claim 19, the limitations are met by Farhoud in view of Papadopoulos, where Papadopoulos teaches wherein the at least one of the treatment effectiveness, the disease state, and the disease progression is provided to the practitioner in real time. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of alerting a doctor of a patient’s health changes in order to give care.
Regarding claim 20, the limitations are met by Farhoud in view of Papadopoulos, where Papadopoulos teaches wherein the change in a patient's lung sounds over time is identified via a machine learning algorithm (see entire document, especially [0075]). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine prior art elements according to known methods to yield predictable results of using machine learning software to aid in determining differences in data patterns to aid in health status determinations.
Response to Arguments
The examiner acknowledges applicant’s submission of amendments to the claims and specification filed 12/12/2025; and IDS filed 10/15/2025.
Applicant’s arguments regarding the IDS have been fully considered; the IDS has been considered.
Applicant’s arguments regarding the drawing objections have been fully considered but are not persuasive. Applicant argues the examiner is mistaken and cites to paragraph 69; the examiner respectfully disagrees as it is the disclosure itself that is mischaracterizing the features as clearly evident from paragraph 71. The objections are respectfully maintained
Applicant’s arguments regarding the specification objections have been fully considered and are partially persuasive due to the amendments to the specification; the objections remain as presented above.
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. 112(a) have been fully considered.
Regarding claim 6, applicant has amended the claims, stated that such support is in paragraph 71 of the specification and states “The Specification does not limit the sound meter to pump-based experiments in FIGs. 7 and 18, as suggested by the Examiner. Under MPEP $2164.01 (a), the Specification need not describe every embodiment in exhaustive detail, so long as persons in the art would understand that an acoustic sensor system (diaphragm, chest piece and sound meter) can be integrated into a wearable housing. Integrating the audio sensors into the wearable housing does not require undue experimentation for a person of ordinary skill in the art.” However, the drawings and the description do not bridge the concepts. As explained in the rejection, the like terminologies is present in both. The disclosure is very clear that like features are the same “The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:”. There is nothing in the disclosure that states that the sound meter implied for use in 104 is different than the sound meter which is only explained in detail for Figures 7 and 18, which is exemplified as ennoLogic eS528L Sound Level Meter. It is not clear how applicant is embedding such a structure into a wearable apparatus in view of what such handheld sound meter is known to be. To summarize, it is the like terms where the terms have an explanation already which is the issue for 112a, not that one of skill could put any sound sensor with a diaphragm and plate into the wearable apparatus, but that the explained structures do not appear to be possible. Perhaps using a different term in the claims for “sound meter” with the prior presented arguments could be more compelling. The rejection is respectfully maintained.
Regarding claim 17, the amendments and arguments including citations are persuasive. The rejections are withdrawn.
Regarding claim 20, the arguments are not persuasive. Applicant argues that the disclosure as filed is sufficient by citing to passages which describe the desired inputs and results of a machine learning algorithm. However, the rejection is not on the basis that the disclosure as filed does not repeat the claimed features, but is on the basis of no description of any machine learning algorithm, but merely a genus of all machine learning, or what subjectively could be considered “machine learning”. As explained in the rejection, Machine learning is a field of study in artificial intelligence concerned with the development and study of statistical algorithms that can learn from data and generalize to unseen data, there is no implicit/inherent meaning to “machine learning algorithm” to allow for the establishment as to how applicant achieved the claimed results. For these reasons explained, one of skill in the art would not have recognized applicant had possession of the claimed invention at the time the application was filed. The rejections are respectfully maintained.
Applicant’s arguments regarding the rejections of the claims under 35 U.S.C. 112(b) have been fully considered and are partially persuasive due to the amendments to the claims and arguments, but not all issues have been overcome and the amendments have necessitated new grounds of rejections and are maintained as presented above.
Regarding claim 6, the arguments mirror those for 112(a). However, the drawings and the description do not bridge the concepts. As explained in the rejection, the like terminologies is present in both. The disclosure is very clear that like features are the same “The foregoing purposes and features, as well as other purposes and features, will become apparent with reference to the description and accompanying figures below, which are included to provide an understanding of the invention and constitute a part of the specification, in which like numerals represent like elements, and in which:”. There is nothing in the disclosure that states that the sound meter implied for use in 104 is different than the sound meter which is only explained in detail for Figures 7 and 18, which is exemplified as ennoLogic eS528L Sound Level Meter. It is not clear how applicant is embedding such a structure into a wearable apparatus in view of what such handheld sound meter is known to be. To summarize, it is the like terms where the terms have an explanation already which is the issue for 112b for definiteness, correct claim interpretations, and unnecessary speculation into the claimed features, not that one of skill could put any sound sensor with a diaphragm and plate into the wearable apparatus, but that the explained structures do not appear to be possible between embodiments. Perhaps using a different term in the claims for “sound meter” with the prior presented arguments could be more compelling. The rejection is respectfully maintained.
Regarding claim 20, applicant forgot to make the amendment they stated was made; the rejections are respectfully maintained.
Applicant’s arguments regarding the rejections of the claims in view of prior art have been fully considered but are not persuasive. Applicant argues:
“Applicants respectfully submit that the Examiner has mistakenly misinterpreted Farhoud, and that Farhoud fails to teach, expressly or inherently, all the elements of claim 1. The Applicants note that claim 1 requires that the audio sensors be positioned at locations of the wearable apparatus corresponding to lung auscultation points. The limitations of which Farhoud fails to disclose. Farhoud places sensors arbitrarily in four quadrants of the garment (right/left, upper/lower) and not at clinical auscultation points. Lung auscultation points are well-defined, anatomically distinct clinical landmarks used in medical examination, which is a structural arrangement of the device and cannot be interpreted as "intended use" as the Examiner alleges in the rejection of claim 3 (now canceled). To clearly highlight the use of auscultation points and enhance this structural distinction, Applicants have amended claim 1 to include subject matter of claim 3 to recite that "wherein the plurality of audio sensors are positioned at clinical lung auscultation points including at least an apex, upper lobe, middle lobe, and lower lobe of the lung." Thus, Farhoud fails to teach each and every element at least as set forth in amended claim 1. Applicants therefore respectfully submit that amended claim 1, and claims 2, 4-5 and 8 dependent therefrom, are patentable over Farhoud. Applicants respectfully request reconsideration and allowance.”
These arguments are not persuasive for the following reasons. First, no mistakes have been made in interpretation of the reference by the Examiner, but applicant may want to more carefully review the form of the claims and the teaching of the applied reference. Contrary to the applicant position the reference is quite clear the sensors are intended for measuring lung auscultations and the intended locations (see Farhoud paragraph 22, with emphasis added).
[0022] “The microphones 16 detect lung and heart auscultations and other vibrations. The microphones 16 may be positioned in the upper left back area, upper right back area, middle left back area, middle right back area, lower left back area, lower right back area, upper right front area near the midline, upper left front area near the midline, middle left side near the midline, and middle of the left side. The back six positions correspond to the lung apex, mid-lung fields, and lung bases, respectively. The front four positions correspond to the second right intercostal space/aortic valve area, the second left intercostal space/pulmonic valve area, the fourth left intercostal space/tricuspid valve area, and fifth intercostal space/mitral valve area. In one embodiment, the microphones 16 include ten microphones spaced along the wearable garment 12. It will be understood that different types and any number of microphones may be embedded in or positioned at different locations on the wearable garment 12 for obtaining similar readings.”
In regards to the argument of intended use, if the system/device was directed to or encompassed human organisms, then the claims could not be patentable under 101, as such, the intended orientation with lung relations is indeed an intended use of the claimed system/device as the human organism relations are intended based on the arrangements of the sensors in the apparatus itself. Again, applicant insistence on the arbitrarily in four quadrants of placement for sensors in the reference is misplaced. As already highlighted, the reference teaches such placement is for the purpose of lung auscultation sounds, suggests explicitly the location claimed, and suggests any position that can obtain the equivalent signals desired, and hence naturally teaches such positions. Lastly, the scope argued and the scope claimed are not in agreement. The rejections are based on the form presented in the claims which include at least one position, and not applicant arguments which are more narrowed. The rejections are respectfully maintained as presented above to account for the amendments to the claims.
Conclusion
No prior art rejections have been applied to claim 6 due to the 112(b) issues and uncertainty in correct interpretation and considerable speculation, In re Steele. See MPEP 2173.06
“Second, where there is a great deal of confusion and uncertainty as to the proper interpretation of the limitations of a claim, it would not be proper to reject such a claim on the basis of prior art. As stated in In re Steele, 305 F.2d 859, 134 USPQ 292 (CCPA 1962), a rejection under 35 U.S.C. 103 should not be based on considerable speculation about the meaning of terms employed in a claim or assumptions that must be made as to the scope of the claims.
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 MICHAEL R BLOCH whose telephone number is (571)270-3252. The examiner can normally be reached M-F 11-8 EST.
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/MICHAEL R BLOCH/Primary Examiner, Art Unit 3791