DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
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.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claims 12-19 are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
In lines 7-8 and 9-10 of claim 12, the limitations “receive first physiological data associated with a user from a first wearable device worn at a first position on the user” and “receive second physiological data associated with the user from a second wearable device worn at a second position on the user” are directed to non-statutory subject matter. Specifically, the phrase “worn at a first/second position on the user” implies that the user is part of the claimed invention. As stated in MPEP 2105(III), claims directed to or encompassing a human organism are excluded from patentability. For the purposes of examination, the limitation will be interpreted to mean “receive first physiological data associated with a user from a first wearable device worn configured to be worn at a first position on the user” and “receive second physiological data associated with the user from a second wearable device configured to be worn at a second position on the user”, and further applicant is recommended to amend the claim in this way.
Claims 1-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to the mental process of “determining one or more physiological characteristics” without significantly more.
Step 1
Claims recite a device, and therefore, it is a product and falls within the statutory category.
Step 2A, Prong 1
Claims 1, 12, and 20 recite a limitation of determining one or more physiological characteristics of a user by using physiological data collected from a wearable device. The physiological characteristic determination limitation as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind. That is, other than reciting the “determining one or more physiological characteristics”, nothing in the claim precludes the determination of physiological characteristics step from practically being performed in the human mind. For example, but for the “determining one or more physiological characteristics” language, the claim encompasses the user visually inspecting the physiological data to identify a variety of physiological characteristics. This limitation is a mental process.
Step 2A, Prong 2
Claims 1, 12, and 20 recite additional elements: “receiving data” used to receive physiological data from a wearable device, “causing a GUI of a user device to display…” that displays the physiological characteristics associated with the user, and, specifically in claim 12, “a processor” and “a memory coupled with the processor” that are a part of the apparatus for collecting physiological data.
The “receiving data” step, is recited at a high level of generality, and it amounts to no more than pre-solution activity of data gathering to determine physiological characteristics.
The “causing a GUI of a user device to display…” step is recited at a high level of generality, and it amounts to no more than post-solution activity of displaying physiological data and characteristics.
The “processor” and “memory coupled with the processor”, are recited at a high level of generality, i.e., as generic computer components, performing a generic computer function of retrieving, storing, and executing a set of instructions to collect physiological data.
Step 2B
As discussed with respect to Step 2A Prong Two, the additional elements in the claim amount to no more than mere instructions to apply the exception using a generic computer component. The same analysis applies here in 2B, i.e., mere instructions to apply an exception on a generic computer cannot integrate a judicial except into a practical application at Step 2A or provide an inventive concept in Step 2B.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in paragraphs [0090] do not provide any indication that the processor and memory are anything other than generic, off-the-shelf computer components. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than a mental process (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement a mental process, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement a mental process is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
As discussed with respect to Step 2A Prong Two, the “receiving data” step is recited at a high level of generality and it amounts to no more than pre-solution activity of data gathering by the apparatus. This pre-solution activity of data gathering is well-understood, routine, and conventional in the field of physiological monitoring. All uses of the recited mental process require the pre-solution of data gathering.
The “causing a GUI of a user device to display…” step is recited at a high level of generality and it amounts to no more than post-solution activity of data output by the apparatus. This post-solution activity of data output is well-understood, routine, and conventional in the field of physiological monitoring. All uses of the recited mental process require the post-solution of data output.
Under 2019 PEG, a conclusion that an additional element is insignificant extra-solution activity in Step 2A should be re-evaluated in Step 2B to determine if it is more than what is well-understood, routine, conventional activity in the field. The specification in paragraphs [0090] do not provide any indication that the processor and memory are anything other than generic, off-the-shelf computer components. Court decisions cited in MPEP 2106.05(d)(II) indicate that computer‐implemented processes not to be significantly more than a mental process (and thus ineligible) where the claim as a whole amounts to nothing more than generic computer functions merely used to implement a mental process, such as an idea that could be done by a human analog (i.e., by hand or by merely thinking). Accordingly, a conclusion that the generic computer functions merely being used to implement a mental process is well-understood, routine, conventional activity is supported under Berkheimer Option 2.
Dependent claims 2-11 and 13-19 further limit the process of receiving and displaying data using a processor and a memory. Therefore, these claims further limit the mental process already indicated in independent claims 1, 12, and 20, and they are ineligible for the same reasons provided for claims 1, 12, and 20 above.
For these reasons, there is no inventive concept in the claims and thus they are ineligible.
Claim Rejections - 35 USC § 102
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 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, 3-5, 8-9, 11-12, 14-16, and 19-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Burton (US 20210169417 A1, published 06/10/2021).
Regarding claim 1, Burton discloses a method for collecting physiological data (“physiological parameter data-acquisition-linked system” [0164]) from a plurality of wearable devices (“one or more wearable devices” [0105]), comprising:
receiving first physiological data associated with a user from a first wearable device worn at a first position on the user (“the deployment of a subject applied forehead-sensor capable of monitoring principle sleep-parameters…” [0128]);
receiving second physiological data associated with the user from a second wearable device worn at a second position on the user different from the first position (“…combined with interconnectivity with a secondary wearable communication/indicator device enables a range of sleep and wake events or disorders to be tracked and managed” second wearable device as shown in Fig. 1, reference number 5, [0128]);
determining one or more physiological characteristics associated with the user based at least in part on a comparison of the first physiological data and the second physiological data (“the subject with a wearable device (such as but not limited to headband; wristband; ankle-band; armband…other attachable device or watch) can be used to measure and enable rhythm, synchrony, fluidity, motion, degree of various motions, and also interrelationship with other limbs such as wrist or arm motion characteristics” [0217]); and
causing a graphical user interface of a user device to display an indication of the one or more physiological characteristics (“forehead applied sensor system incorporating a wrist-forehead interchangeable or exchangeable active electronic module with option of display capabilities” [0107]).
Regarding claims 12 and 20, Burton discloses the method for collecting physiological data as described above, and further discloses a processor (“incorporating one or more microprocessor system(s) capable of tracking physiological processes, events, or health conditions or interest” [1195]); memory coupled with the processor; and instructions stored in the memory (“shared resources across devices, methods, systems and networks or interconnectivity arrangements (i.e. memory storage, buffering, etc.)” [0164]), and executable by the processor (“one of more computer programs including instructions or applications [3216]”).
Regarding claims 3 and 14, Burton discloses selectively modifying the one or more operational parameters comprises: selectively transitioning the second wearable device from an active state to an inactive state, selectively modifying a current provided to one or more sensors of the second wearable device, or both (“option of the present invention's GSR approach includes switching or alternating the direction of the small constant current between the electrodes in order to minimize electrode polarization effects” [0151]).
Regarding claims 4 and 15, Burton discloses receiving the first physiological data and second physiological data comprises:
receiving, at the user device from the first wearable device, one or more signals comprising the first physiological data; and receiving, at the user device from the second wearable device, one or more additional signals comprising the second physiological data (“full disclosure includes means of displaying any of or any combination of primary monitored raw data (i.e. physiological waveform data) and/or secondary monitored data” [0237]).
Regarding claims 5 and 16, Burton discloses receiving the first physiological data and second physiological data comprises:
receiving, at the user device from one of the first wearable device or the second wearable device, one or more signals comprising the first physiological data and the second physiological data (“a first wearable device which has means of attachment or interconnectivity with a second wearable device, the said ‘means of enabling information access applicable to sleep health as well as general health’ can include combining, sharing, exchanging indications, displays, data storage, data processing, deriving indices, or associated measurements” [0279-0280]).
Regarding claim 8, Burton discloses the one or more physiological characteristics comprise a metric associated with blood circulation of the user (“means of measuring arterial blood pressure (pulse) via pressure sensor which can be incorporated as part of watch or watchband” [1510]), one or more risk metrics associated with one or more medical conditions, or both, and wherein the one or more medical conditions comprise Parkinson's, Alzheimer's, stroke, or any combination thereof (“capable of inputting to automatic incorporating means of computing gait, walking characteristics (including Parkinson's onset)” [0146]).
Regarding claims 9 and 19, Burton discloses the first physiological data comprises a first set of physiological parameters, and wherein the second physiological data comprises a second set of physiological parameters different from the first set of physiological parameters (“’measures or associated indices’ can include any of or any combination of this for fitness, health and/or sleep-parameters…full disclosure includes means of displaying any of or any combination of primary monitored raw data (i.e. physiological waveform data) and/or secondary monitored data” [0130] & [0237]).
Regarding claim 11, Burton discloses the first wearable device, the second wearable device, or both, collects the first physiological data and the second physiological data, respectively, based on arterial blood flow (“present invention can further computes the pulse wave analysis (PWA) comprising recording a period of arterial pressure in order to derive the associated ascending aortic pressure wave, from which a number cardiovascular measurements can be derived, and/or other cardiac functional measures” [0177]).
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 text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
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.
Claims 2, 6-7, 13, and 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Capodilupo et. al, (US 20190110755 A1, published 04/18/2019, hereinafter known as Capodilupo).
Regarding claims 2 and 13, Burton discloses selectively modifying one or more operational parameters associated with the second wearable device (“where required continually modify and improve the interpreter rules…time relationship between the said two or more waveforms can be adjusted or varied” [0460] & [3231]).
However Burton does not disclose identifying that a first quality metric associated with the first physiological data is greater than a second quality metric associated with the second physiological data; and modifying one or more operational parameters at least in part on the first quality metric being greater than the second quality metric.
Capodilupo teaches physiological monitoring with a wearable device by comparing data from the wearable device to concurrent data acquisition from a ground truth device such as a chest strap or electrocardiography (EKG) heart rate monitor (Abstract). The analytics system may determine if the recovery is greater than…a first predetermined threshold (e.g., about 60% to about 80% in some examples) that indicates that the user is recovered and is ready for exercise [0106].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to include the verification if the first quality metric is greater than a predetermined quality threshold of Capodilupo with the method and system for collecting physiological data of Burton because it allows the system to deliver information to the user regarding their current readiness and quality of health.
Regarding claims 6 and 17, Burton discloses the first physiological data comprises first motion data (“an electronic monitoring transfer electronic module from (with applied forehead EEG, EOG, EMG monitoring part)” [0136]) and the second physiological data comprises second motion data (“wearable wrist device wrist augment conventional daytime wrist pedometer or motion-based fitness devices with sleep measures” [0136]).
However Burton does not disclose the method further comprising: identifying that the user is engaged in a physical activity based at least in part on the first motion data, the second motion data, or both; and
classifying the physical activity into a physical activity type selected from a plurality of candidate physical activity types based at least in part on a comparison of the first motion data and the second motion data.
Capodilupo teaches the sensors may include one or more sensors for activity measurement [0045]. Activity sensors may be used to classify or categorize activity, such as walking, running, performing another sport, standing, sitting or lying down…in some embodiments, one or more of collected physiological data may be aggregated to generate an aggregate activity level [0045]. The aggregate level may be compared with or evaluated relative to previous recordings of the user's aggregate activity level, as well as the aggregate activity levels of other users [0045].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the recognition and classification of physical activity of Capodilupo with the method and system for collecting physiological data of Burton because this allows the user to receive a more in depth, representative dataset of their activity information.
Regarding claims 7 and 18, Burton does not disclose calculating one or more scores for the user based at least in part on the first physiological data and the second physiological data, the one or more scores comprising a sleep score, a readiness score, an activity score, or any combination thereof.
Capodilupo teaches the recovery score is a weighted combination of the user's heart rate variability (HRV), resting heart rate, sleep quality indicated by a sleep score, and recent strain (indicated, in one example, by the intensity score of the user)…the sleep score combined with performance readiness measures (such as, morning heart rate and morning heart rate variability) provides a complete overview of recovery to the user [0096].
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the calculation of a user’s recovery score and sleep score of Capodilupo with the method and system for collecting physiological data of Burton because these indicators or scores may be stored and displayed in a meaningful format to assist a user in managing his health and exercise regimen (Capodilupo, [0030]).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Burton in view of Wasson et. al, (US 10918289 B1, published 02/16/2021, hereinafter known as Wasson).
Regarding claim 10, Burton does not disclose the first wearable device, the second wearable device, or both, comprise a wearable ring device.
However, Wasson discloses a ring-shaped wearable device for detecting biometrics with a light source and a photodetector directed towards a digit wearing the ring-shaped device (Abstract). A user can wear a ring on a finger of the user’s hand…then the ring can collect biometric data (Col. 2, lines 59-64).
Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to combine the structure of a wearable ring device of Wasson with the method and system for collecting physiological data of Burton because the ring can provide more accurate biometric information that a smart watch or similar device because the ring abuts the users skin more completely and reliably (Wasson, Col. 3-4, lines 67-3).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to FIONA M KOWALKOWSKI whose telephone number is (571)272-2790. The examiner can normally be reached Monday-Friday 7:30am-5:00pm.
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/F.M.K./Patent Examiner, Art Unit 3792
/ALLEN PORTER/Primary Examiner, Art Unit 3796
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