DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after 16 March 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Amendment
The amendment to the claims filed 31 March 2026 has been entered. Claim(s) 1, 14-15 and 19 is/are currently amended. Claim(s) 18 has/have been canceled. New claim(s) 20 has/have been added. Claim(s) 1-17 and 19-20 is/are pending.
Rejections Withdrawn
Rejections under 35 U.S.C. 101, rejections under 35 U.S.C. 112(a) (pre-AIA 35 U.S.C. 112, first paragraph) and/or rejections under 35 U.S.C. 112(b) (pre-AIA 35 U.S.C. 112, second paragraph) not reproduced below has/have been withdrawn in view of Applicant's amendments to the claims and/or submitted remarks.
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 pre-AIA 35 U.S.C. 112, first paragraph:
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) 19 and claims dependent thereon is/are rejected under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding claim 19 and claims dependent thereon, Applicant discloses, "Likewise, the instructions sent by healthcare server 130 can direct the user (patient) to follow a therapy regimen for the disease condition when the analysis by healthcare server 130 shows (a) a satisfactory therapy for the condition (e.g., confidence interval of therapy improving the patient's condition is greater than 50%, 60%, 75%, 85%, 95%, or 98%), (b) a disease condition level that requires immediate attention (e.g., condition related attack pending, patient undergoing condition attack, patient's life is at risk), (c) the condition level requires pre-therapy conditioning (e.g., fasting, liquid diet, administration of drugs, etc. required before treatment), or (d) otherwise indicates the patient should follow a therapy regimen for the disease condition" (¶ [0047]). Accordingly, Applicant discloses a healthcare server can instruct a therapy regimen when an analysis shows a satisfactory therapy (e.g., confidence of improving the condition is greater than 50%) or instruct a therapy regimen when the analysis shows a disease condition level that requires immediate attention, but does not disclose the combination of features required by claim 19. Specifically, Applicant does not disclose the same therapy regimen is determined to be satisfactory (i.e., greater than 50% chance the therapy regimen improves the health-related condition) and is instructed "because the characterization of the health-related condition indicates immediate action is required." Rather, as noted above, Applicant appears to disclose these are alternative instructions (e.g., ¶ [0047] a, b, c, or d) that may be determined by a server and/or provided to a person.
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) 1-17 and 19-20 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception without significantly more.
Claims 1-17 and 19-20 recite the steps of deriving a characterization of a health-related condition of a person based on a first set of respiratory data, including a characterization indicating immediate action is required (e.g., an emergency); identifying the characterization of the health-related condition as a false positive based on patient demographics or environmental characteristics; identifying a therapy regimen that has a greater than 50% chance to improve the health-related condition; and verifying an identity of the person based on a respiratory sound.
These limitations, as drafted, are a process that, under its broadest reasonable interpretation (BRI), covers performance of the limitations in the mind but for the recitation of generic computer components (e.g., processor). That is, nothing in the claim element precludes the steps from practically being performed in the mind. For example, the above-noted steps encompass a user (e.g., physician) considering respiratory data (e.g., spirometer readings, pulse oximeter data, respiratory sounds, etc.) in any manner he/she chooses to mentally verify an identity of a patient and mentally assess the patient's condition, considering patient demographics and/or environment to confirm his/her assessment is valid, and identifying a therapy regimen that is more likely than not to be effective for said assessed condition. Indeed, the steps are consistent with steps routinely performed by doctors (see, e.g., US 2012/0284298 A1, ¶ [0003]). If claim limitations, under a BRI thereof, cover performance of the limitation in the mind but for the recitation of generic computer components, then they fall within the "mental processes" grouping of abstract ideas. Accordingly, the claim recites an abstract idea.
This judicial exception is not integrated into a practical application. The claims recite the additional element of using a monitoring device to obtain or derive the respiratory data on which the characterization is based, wherein using the monitoring device comprises reconfiguring, such as sliding open, said device to provide the patient functional access to a oximeter or spirometer, using a processor to derive the characterization, and a user interface to instruct a person to perform the identified therapy regimen. The monitoring device is recited at a high level of generality and used only for gathering data necessary to perform the abstract idea. This is similar to concepts identified by the courts as insignificant extra-solution activity, or mere data gathering (MPEP 2106.05(g), "performing clinical tests on individuals to obtain input for an equation"). The steps of using a processor to derive the characterization and a user interface to inform the person of the identified therapy regimen amounts to no more than using a computer as a tool to perform an existing process (e.g., like those routinely performed by doctors, as noted above), which is comparable to concepts identified by the courts as mere instructions to apply an exception (MPEP 2106.05(f), "requiring the use of software to tailor information and provide it to the user on a generic computer"). Accordingly, these additional elements do not integrate the abstract idea into a practical application because they do not impose any meaningful limits on practicing the abstract idea. Therefore, the claims are directed to an abstract idea.
The claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception. As discussed above with respect to integration of the abstract idea into a practical application, the additional elements of using a generic processor to the derive the characterization and a generic user interface to notify a person of an identified therapy regimen amounts to no more than mere instructions to apply the exception using a generic computer component(s). Additionally, Applicant acknowledges at least spirometry and pulse oximetry data may be acquired/derived from a commercially available device (e.g., ¶ [0007]). Similarly, Hassan discloses a commercially available device, such a as smartphone or microphone thereof, may be used as a monitoring device for obtaining respiratory data such as respiratory sounds or sound pattern (e.g., ¶ [0080]). Further, "reconfiguring" a monitoring device, such as a spirometer, or sliding open the device/spirometer, to provide functional access thereto is well-understood, routine and/or conventional in the field. Specifically, the claim limitations are written broadly enough to encompass merely sliding/removing a cover/cap to access a mouthpiece, or sliding/otherwise moving a mouthpiece portion of the device for access thereto, which is well-known in the art, particularly for portable spirometers. See, for example, US 2017/0007159 A1 (Dieffenderfer, discussed further below); US 2017/0135605 A1 (Sandholt, Figs. 2-3); US 5,224,487 A (Bellofatto, Figs. 1-3); US 5,277,195 A (Williams, slidable door 21); US 5,518,002 A (Wolf, removable cover 170); US 5,613,497 A (DeBush, Figs. 3-4); etc. Accordingly, reconfiguring/sliding open a monitoring device and using said monitoring device to derive respiratory data as claimed is well-understood, routine and/or conventional in the field.
Even when viewed in combination, the additional elements amount to no more than using a well-understood, routine and/or conventional device to acquire or derive respiratory data, and using a computer as a tool to characterize a condition or disease based on the derived respiratory data and to identify and notify a person of a therapy regimen more likely than not to improve said condition. Mere instructions to apply an exception using a generic computer component(s), adding insignificant extra-solution activity to the judicial exception, and/or simply appending well-understood, routine, conventional activities previously known to the industry, specified at a high level of generality, to the judicial exception cannot provide an inventive concept. Accordingly, claims 1-17 and 19-20 are not patent eligible.
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:
Determining the scope and contents of the prior art.
Ascertaining the differences between the prior art and the claims at issue.
Resolving the level of ordinary skill in the pertinent art.
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(s) 1-4, 7-10, 12-15 and 19-20 is/are rejected under 35 U.S.C. 103 as obvious over WO 2017/068581 A1 (previously cited, Hassan) in view of US 2017/0007159 A1 (Dieffenderfer) and US 2017/0270260 A1 (previously cited, Shetty); or alternatively, over Hassan in view of Dieffenderfer, Shetty and "Management of COPD Exacerbations" (previously cited, Evensen).
Regarding claims 1, 9 and 19-20, Hassan discloses and/or suggests a method of facilitating delivery of healthcare to a person, the method comprising:
using a monitoring device (Fig. 1A, input devices 135 operatively connected to computing device 100) to derive a first set of respiratory data from the person (¶ [0050] input devices 135 may include a microphone and/or any number of systems and/or devices adapted to capture, obtain or measure signals related to a medical state of a user, such as a pulse oximetry sensing device, a spirometer; etc.; ¶ [0080] microphone capturing breathing sounds) (Fig. 6, block 615, receiving patient data, such as physiological data as described in ¶ [0056], and/or block 602, recoding breathing sounds);
using a processor (Fig. 1A, controller 105 of computing device 100) to autonomously derive from the first set of respiratory data a characterization of a health-related condition of the person (Figs. 6, blocks 635 and 640, performing data analysis and determining a condition, state, trend, progress, improvement and/or deterioration of the user's medical condition; ¶ [0048]; ¶ [0096]; etc.) and deliver the characterization to the person (e.g., ¶ [0055] providing feedback regarding a patient's condition and/or any development, state, status, deterioration or progress in the patient's physical and medical status to the patient); and
using a user interface (Fig. 1A, output devices 140 operatively connected to computing device 100; ¶ [0051]) to instruct the person to perform a therapy regimen related to the characterization of the health-related condition (Fig. 6, block 660, interacting with a patient, e.g., using the computing device to instruct the patient to lie down and rest, call an ambulance, or perform any other operation),
wherein each of the monitoring device, the processor, and the user interface cooperate as components of a mobile system local to the person (¶ [0043] computing device 100 may be, or may be included in, a cellular telephone (e.g., smartphone or mobile phone); ¶ [0096]; ¶ [0098]; etc.).
While Hassan discloses the monitoring device may include a spirometer and/or pulse oximeter sensor, as noted above, Hassan does not disclose using the monitoring device comprises reconfiguring the monitoring device to provide the person functional access to at least one of a pulse oximeter or a spirometer to provide the first set of respiratory data, wherein reconfiguring the monitoring device comprises sliding open the monitoring device to provide functional access to a pulse oximeter sensor or a breathing tube of a spirometer.
Dieffenderfer discloses and/or suggests a method of using a monitoring device, such as a spirometer (portable spirometry device), comprising reconfiguring the monitoring device by sliding open the monitoring device to provide the person functional access to a breathing tube (mouthpiece 18) of the device/spirometer (e.g., Fig. 5 to Fig. 6, removing cover 20; ¶ [0037] user utilizes outer ring 56 to move mouthpiece 18 between a recessed position, in which mouthpiece 18 is retracted (e.g., hidden) inside housing 16, and an exposed position, in which mouthpiece 18 is extended outside of housing 16; etc.).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with using the monitoring device comprising reconfiguring the monitoring device to provide the person functional access to a spirometer to provide the first set of respiratory data, wherein reconfiguring the monitoring device comprises sliding open the monitoring device to provide functional access to a breathing tube of a spirometer, as taught/suggested by Dieffenderfer in order to facilitate using a monitoring device in which components of the monitoring device are protected from dust, damage, etc. when said device is not in use (Dieffenderfer, ¶ [0037]).
Hassan as modified further discloses the processor may additionally be informationally coupled with a server (e.g., cloud platform or server 250) for providing the person with instructions, e.g., therapy instructions (e.g., Fig. 6). However, Hassan as modified does not expressly disclose the method comprises instructing the person to perform a therapy regimen for the health-related condition if there is a greater than 50% chance the therapy regimen improves the health-related condition. However, Hassan does disclose at least providing the person with instructions designed to best handle a detected medical emergency, which one of ordinary skill in the art would readily appreciate requires immediate attention, and discloses the instructions provided may comprise instructing the person to seek emergency health services (e.g., ¶ [0098] call an ambulance).
Additionally, Shetty discloses/suggests a method comprising using a monitoring device (¶ [0138], ¶ [0149], etc., measurement device) to derive a first set of respiratory data from the person (¶ [0138] pressure and/or cardiopulmonary biomarker measurements; ¶ [0141], ¶ [0149], etc. spirometry measures and/or reading; etc.); using a processor (¶ [0149] remote computing device, or processor thereof, as described in, e.g., ¶ [0016]) to autonomously derive from the first set of respiratory data a characterization of a health-related condition of the person (¶ [0144] comparing recording levels to stored threshold values or historical patient-specific values; ¶ [0149] identifying an appropriate zone, e.g., green or healthy, yellow or cautious, red or dangerous, for the obtained the spirometry reading) and deliver the characterization to the person (¶¶ [0143]-[0144] presenting a warning, or symbol indicating patient status (e.g., well, worse, critical); ¶ [0149] providing feedback to the patient in the form of easy-to-interpret results, e.g., a portion of an output GUI may be color-coded in accordance with the identified zone); and using a user interface to instruct the person to perform a therapy regimen related to the characterization of the health-related condition (Fig. 11A, contact doctor; ¶ [0143] alert to emergency contact or emergency responders; ¶ [0149] providing feedback to the patient in the form of treatment and/or monitoring recommendations, e.g., Figs. 22F-H), wherein each of the monitoring device, the processor, and the user interface cooperate as components of a mobile system local to the person (e.g., ¶ [0016] remote computing device may be a mobile computing device such as a smart-watch, smartphone, or tablet, a laptop computer, or a desktop computer).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with instructing the person, e.g., via a server informationally coupled with the processor, to perform a therapy regimen for the health-related condition because the characterization of the health-related condition indicates immediate action is required because a condition-related attack is pending, the person is undergoing a condition-related attack, or the person's life is at risk, as taught and/or suggested by Shetty (e.g., instructing the person how to appropriately use rescue medication, adjust his/her control medications, monitor his/her lung function and symptoms, and/or to seek emergency health services) in order to facilitate notifying the person of the medical alert/emergency and instructing him/her as to how to best handle said medical emergency and/or improve his/her current lung performance (Shetty, ¶ [0149]).
Shetty (or Hassan as modified thereby) does not expressly disclose instructing the person to perform the therapy regimen "if there is a greater than 50% chance the therapy regimen improves the health condition." However, Shetty discloses the therapy regimen instructions associated with each zone are recommendations to maintain a healthy state or improve an unhealthy and/or potentially dangerous state (e.g., ¶ [0149]). Shetty further discloses a physician may make modifications to a patient's treatment plan (e.g., ¶ [0155]). One of ordinary skill in the art would readily recognize a physician-recommended medication dosage as a therapy considered by said physician to be at least more likely than not to work, i.e., improve the person's condition, particularly as the goal(s) of the method disclosed by Shetty include reducing frequency/severity of condition-related attacks, better controlling said condition, etc. (¶¶ [0002]-[0006]). Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with instructing the person, e.g., via a server informationally coupled with the processor, to perform a therapy regimen for the health-related condition if there is a greater than 50% chance the therapy regimen improves the health-related condition (e.g., recommending a medication/dosage/regimen that a physician determines is more likely than not to improve the patient's current condition) as taught and/or suggested by Shetty in order to facilitate balancing improving the health-related condition and preventing overuse of, e.g., fast-acting, medications that have dangerous side effects (e.g., ¶¶ [0002]-[0006]).
Alternatively/Additionally, Evensen discloses randomized clinical trials can demonstrate the effectiveness of multiple interventions for a health-related condition or exacerbation thereof (e.g., COPD) (pg. 607), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with instructing the person, e.g., via a server informationally coupled with the processor, to perform a therapy regimen for the health-related condition if there is a greater than 50% chance the therapy regimen improves the health-related condition (e.g., recommending a medication/dosage/regimen proven effective by clinical trial) as taught/suggested by Evensen in order to facilitate instructing the user to follow an evidence-based action plan that is more likely than not to improve his/her condition.
Regarding claim 2, Hassan as modified discloses/suggests the monitoring device comprises a spirometer (e.g., Hassan ¶ [0050], ¶ [0079], etc., input device may include a spirometer, and spirometry data may be used to determine the condition, state, trend or progress, etc. related to the medical condition of the user; Dieffenderfer, throughout document, portable spirometry device; etc.).
Regarding claim 3, Hassan as modified discloses/suggests the first set of respiratory data comprises a breathing pattern (e.g., ¶ [0056] respiration sound patterns).
Regarding claim 4, Hassan as modified discloses/suggests the method further comprises the processor autonomously deriving a second characterization of the health-related condition of the person, subsequent to the person performing the therapy regimen (Hassan, ¶ [0100] continuously or periodically monitoring and/or determining the user's medical condition, state, trend and/or progress; Hassan, ¶ [0124] reevaluating the user's medical condition after the user has rested; Shetty, Fig. 22G, spirometer readings 1 hour after treatment; Shetty, Fig. 22H, spirometer readings 15 minutes after treatment; Shetty, ¶ [0142] following every forced expiration, spirometry measures are calculated and the data is compared to stored baseline data or threshold values; etc.).
Regarding claim 7, Hassan as modified discloses/suggests the method further comprises using the user interface to instruct the person that the first set of respiratory data is within a healthy range (Hassan, ¶ [0055] providing feedback regarding a patient's condition and/or any development, state, status, deterioration or progress in the patient's physical and medical status to the patient). Alternatively/Additionally, Shetty discloses/suggests using the user interface to instruct the person that the first set of respiratory data is within a healthy range (e.g., Fig. 22F), such that it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan to further comprise using the user interface to instruct the person that the first set of respiratory data is within a healthy range as taught/suggested by Shetty in order to encourage the patient to maintain success (Shetty, ¶ [0149]), such as compliance with an instructed therapy regimen.
Regarding claim 8, Hassan as modified discloses/suggests the health-related condition comprises a disease (e.g., ¶ [0006]; ¶ [0026]; etc.).
Regarding claim 10, Hassan as modified discloses/suggests the method further comprises wirelessly conveying the first set of respiratory data to a healthcare professional (e.g., ¶¶ [0096]-[0097] data recorded may be sent to a cloud platform, e.g., to server 250, to be provided to, and reviewed by, a healthcare provider, e.g., a physician; ¶ [0078] network enabling communications to/from server 250 may be wireless).
Regarding claim 12, Hassan as modified discloses/suggests the method further comprises identifying the characterization of the health-related condition as a false positive based on a demographic of the person (¶ [0133] characterizing the health-related condition of the user based on demographic data). Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Hassan with identifying the characterization of the health-related condition as a false positive based on a demographic of the person (e.g., comparing respiratory data to universal threshold, then later considering the demographic data in judging how to characterize the health-related condition and/or whether to generate an alarm) because Applicant has not disclosed that any particular method of using or considering the demographic data of the person in characterizing the health-related condition provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the characterization of the health-related condition being derived based on demographic data in the manner disclosed by Hassan because either method/arrangement takes demographic data of the person into account when characterizing his/her health-related condition.
Regarding claim 13, Hassan as modified discloses/suggests the method further comprises identifying the characterization of the health-related condition as a false positive based on an environmental characteristic of the person (¶ [0120] characterizing the health-related condition of the user may be based on environmental data, e.g., location, altitude, pollution, weather, etc.). Alternatively/Additionally, at the time the invention was effectively filed, it would have been an obvious matter of design choice to a person of ordinary skill in the art to modify the method of Hassan with identifying the characterization of the health-related condition as a false positive based on an environmental characteristic of the person (e.g., comparing respiratory data to universal threshold, then later considering environmental data in determining how to characterize the health-related condition and/or whether to generate an alarm) because Applicant has not disclosed that any particular method of using or considering the environmental data of the person in characterizing the health-related condition provides an advantage, is used for a particular purpose, or solves a stated problem. As no evidence has been provided to the contrary, one of ordinary skill in the art, furthermore, would have expected Applicant's invention to perform equally well with the characterization of the health-related condition being derived based on environmental data in the manner disclosed by Hassan because either method/arrangement takes environmental data of the person into account when characterizing his/her health-related condition.
Regarding claim 14, Hassan as modified discloses/suggests the server informationally coupled to the processor uses data from a pulse oximeter to derive the therapy regimen (Fig. 6, patient data received in block 615, such as physiological data as described in ¶ [0057], is provided to cloud platform/server 645; [0050], ¶ [0079], etc., input device may include a pulse oximetry sensing device, and pulse oximetry data may be used to determine the condition, state, trend or progress, etc. related to the medical condition of the user, on which therapy instructions are based).
Regarding claim 15, Hassan as modified discloses/suggests the server informationally coupled to the processor uses data from a respiratory sound of the person to derive the therapy regimen (Fig. 6, breathing sounds recorded in 620 is provided to cloud platform/server 645 to determine the condition, state, trend or progress, etc. related to the medical condition of the user, on which therapy instructions are based).
Claim(s) 5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassan, Dieffenderfer in view of Shetty (or Hassan in view of Dieffenderfer, Shetty and Evensen) as applied to claim(s) 1 above, and further in view of US 2013/0184540 A1 (previously cited, Boschetti Sacco).
Regarding claim 5, Hassan as modified discloses/suggests the limitations of claim 1, as discussed above, and discloses/suggests the method further comprises the processor autonomously deriving a second characterization of the health-related condition of the person (e.g., Hassan, ¶ [0100] continuously or periodically monitoring and/or determining the user's medical condition, state, trend and/or progress; Shetty, ¶ [0142]; etc.). Hassan as modified does not expressly disclose the second characterization is derived subsequent to the person performing an exercise test.
Boschetti Sacco discloses a method comprising deriving a characterization of a health-related condition of a person subsequent to the person performing an exercise test (¶¶ [0072]-[0080] Desaturation Area/Movement index/parameter measured during an exercise test enables the comparison of two measurement sessions in order to measure the variation in the state of health of the patient through their own performance and exercise capacity).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with the second characterization being derived subsequent to the person performing an exercise test in order to enable basing said characterization on additional data, such as a Desaturation Area/Movement index disclosed by Boschetti Sacco as useful in determining a condition, state, trend, progress, etc. of the medical condition (Boschetti Sacco, ¶ [0080]). Alternatively stated, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with the received patient data including data obtained during an exercise test, and any subsequent characterization(s) being based on said test data, as Boschetti Sacco discloses such test data is useful in assessing the state of the medical condition of the person.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassan, Dieffenderfer in view of Shetty (or Hassan in view of Dieffenderfer, Shetty and Evensen) as applied to claim(s) 1 above; or alternatively, over Hassan, Dieffenderfer in view of Shetty (or Hassan in view of Dieffenderfer, Shetty and Evensen) as applied to claim(s) 1 above, and further in view of US 2016/0029970 A1 (previously cited, Park).
Regarding claim 6, Hassan as modified discloses/suggests the method further comprises the processor triggering an instruction to the person to retake a reading based upon a validity error (¶ [0083] an embodiment may analyze or determine the quality of the recording, and if the recording is of bad quality, said embodiment may notify the user and request, or instruct, the user to preform another recording). Alternatively/Additionally, Park discloses and/or suggests a method comprising using a monitoring device to derive a first set of physiological data from a person (Fig. 7, S705, acquiring first biological data); and triggering an instruction to the person to retake a reading based upon a validity error (Fig. 7, S720, outputting a message requesting re-measurement of the biological data when the first biological data is not within a valid range). It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with the processor alternatively or additionally triggering an instruction to the person to retake a reading based upon a validity error as taught/suggested by Park to enhance/further enhance the validity of the respiratory data (Park, ¶ [0006]) used in deriving the characterization of a health-related condition of the person, thereby increasing the accuracy and/or reliability of said characterization.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassan, Dieffenderfer in view of Shetty (or Hassan in view of Dieffenderfer, Shetty and Evensen) as applied to claim(s) 1 above, and further in view of US 2016/0103966 A1 (previously cited, Mirza).
Regarding claim 11, Hassan as modified discloses/suggests the limitations of claim 1 and further discloses/suggests the method further comprises wirelessly conveying the first set of respiratory data to a healthcare professional (¶¶ [0096]-[0097] data recorded may be sent to a cloud platform, e.g., to server 250, to be provided to and/or reviewed by a healthcare provider, e.g., a physician; ¶ [0078] where network enabling communications to/from server 250 may be wireless), but does not expressly disclose said data is conveyed in accordance with provisions of the Health Insurance Portability and Accountability Act (HIPAA).
Mirza teaches/suggests a method comprising using a monitoring device to derive a first set of respiratory data from a person and wirelessly conveying the first set of respiratory data in accordance with HIPAA (¶ [0078] wirelessly communicating sensor data via cellular phone to a cloud/web-based server for analysis and distribution to all nodes identified; ¶ [0090], ¶ [0093], etc. where sensor data may be encrypted, which may include conditioning the data to comply with patient privacy requirements (e.g., HIPAA) and conveyed).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with the first set of respiratory data being wirelessly conveyed the to a healthcare professional in accordance with HIPAA as taught and/or suggested by Mirza in order to comply with patient privacy requirements (Mirza, ¶ [0093]).
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassan, Dieffenderfer in view of Shetty (or Hassan in view of Dieffenderfer, Shetty and Evensen) as applied to claim(s) 1 above, and further in view of US 2019/0000350 A1 (previously cited, Narayan).
Regarding claim 16, Hassan as modified discloses/suggests the limitations of claim 1, as discussed above, and discloses the processor additionally uses data from a respiratory sound of the person (Fig. 6, recorded breathing sounds are analyzed to determine the condition, state, trend or progress, etc. related to the medical condition of the user), but does not expressly disclose the method further comprises the processor using the respiratory sound data to verify the identity of the person.
Narayan discloses/suggests a method comprising deriving a first set of respiratory data from the person, including data from a respiratory sound of the person (¶ [0230] recording breath sounds with a smartphone), and using a processor to verify the identity of the person based on the respiratory sound data (e.g., ¶ [0232] to monitor breathing health, sound files are analyzed after confirming that biometric data matches that from the individual in question, wherein the biometric data may comprise breath sounds that are compared to known signals from that individual).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan to further comprise the processor using the respiratory sound data to verify the identity of the person as taught/suggested by Narayan in order to ensure a baseline value(s) from which the characterization is derived is being applied to the correct person (e.g., ensuring the correct user-specific or tailored baseline is being utilized for a given characterization), thereby increasing the accuracy and/or reliability of the characterization (Narayan, ¶ [0121], ¶ [0232], etc.; Hassan, ¶ [0094]).
Claim(s) 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hassan, Dieffenderfer in view of Shetty (or Hassan in view of Dieffenderfer, Shetty and Evensen) as applied to claim(s) 1 above, and further in view of US 2019/0254534 A1 (Koltowski).
Regarding claim 17, Hassan as modified discloses/suggests the limitations of claim 1, as discussed above, and further discloses additional data can be received via user input and/or sensors (e.g., ¶ [0050]), but does not expressly disclose the monitoring device collects a humidity parameter local to the person.
As discussed above with respect to claim 13, Hassan discloses using an environmental characteristic of the person in order to identify false positive characterizations. Further, Koltowski discloses/suggests a patient monitoring device comprising a spirometer; a pulse oximeter; and a humidity sensor for determining a humidity parameter (¶ [0111] spirometer 1, pulse oximetry sensor 17, and humidity sensor 20).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method of Hassan with the monitoring device collecting a humidity parameter from the person as taught/suggested by Koltowski in order to further facilitate identifying false positives (Hassan, ¶ [0120]) and/or to facilitate comparison/correlation of environmental data and measured physiological data (respiratory, oxygen saturation, etc.) for obtaining a deeper insight into e.g., the pathogenesis of respiratory diseases (Koltowski, ¶ [0178]).
Response to Arguments
Applicant's arguments with respect the prior art rejections have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant's remaining arguments have been fully considered but they are not persuasive.
With respect to rejections under 35 U.S.C. 112(a), Applicant contends, "The Office rejected claim 19 on the basis the Specification teaches a server provides the recited instruction, rather than a processor local to the person. Claim 19 is amended to require the instruction is provided by a server informationally coupled with the processor, with support at para [004 7] and Figure 1. Applicant respectfully requests the rejection be withdrawn" (Remarks, pg. 5).
The examiner respectfully disagrees. Claim 19 was not rejection on the basis alleged by Applicant. Rather, as reproduced above, claim 19 is rejected under 35 U.S.C. 112(a) because the application as filed fails to a therapy regimen is instructed to be performed that is determined to be satisfactory (i.e., greater than 50% chance the therapy regimen improves the health-related condition) and is instructed "because the characterization of the health-related condition indicates immediate action is required."
With respect to eligibility under 35 U.S.C. 101, Applicant contends, "[The] claims as amended require more than just mental processes, and respectfully requests the claims be allowed" (Remarks, pg. 5-6). That the claims "require more than just mental processes" is not the test for subject matter eligibility. For at the reasons noted in the rejections of record above, the additional elements of the pending claims fail to practically apply, and/or amount to significantly more than, the mental process (judicial exception) recited therein.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Meredith Weare whose telephone number is 571-270-3957. The examiner can normally be reached Monday - Friday, 9 AM - 5 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. Applicant is encouraged to use the USPTO Automated Interview Request at http://www.uspto.gov/interviewpractice to schedule an interview.
If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Tse Chen, can be reached on 571-272-3672. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/Meredith Weare/Primary Examiner, Art Unit 3791
Prosecution Insights