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 Objections
Claim 8 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-6, 8-13 and 15-19 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 and 11-12 of U.S. Patent No. 12,220,221. Although the claims at issue are not identical, they are not patentably distinct from each other because the patent claims are more specific versions of the current claims.
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7, while a night is not specifically recited in the claims it is a routine period for monitoring sleep data.
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Claim 7 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,220,221 in view of Addison et al. US 2016/0045154. ‘221 discloses the ring monitoring device but does not claim using machine learning specifically. Addison discloses teaches a similar sleep monitoring system that determines apnea or breathing changes using machine learning architecture ([¶72-73]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing been obvious to one of ordinary skill in the art at the time of filing to combine the processing of Addison into the device of ‘221 in order to optimize prediction and detection ([¶72]).
Claim 14 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,220,221 in view of Pinhas et al. US 2007/0118054. ‘221 discloses the ring monitoring device but does not claim determining a deviation of the respiratory rate from the baseline rate as a metric. Pinhas teaches a similar sleep monitoring system that determines with the breathing is deviating from a baseline ([¶250]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing been obvious to one of ordinary skill in the art at the time of filing to combine the processing of Pinhas into the device of ‘221 in order to determine the onset or severity of the respiratory condition.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 2-19 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more. The claim recites the steps of determining a plurality of respiration rate values for the user, determining one or more respiration rate parameters associated with a change in the plurality of respiration rate values and determining one or more condition risk metrics associated with one or more medical conditions based at least in part on the one or more respiration rate parameters.
The limitation of determining a plurality of respiration rate values for the user, determining one or more respiration rate parameters associated with a change in the plurality of respiration rate values and determining one or more condition risk metrics associated with one or more medical conditions based at least in part on the one or more respiration rate parameters, as drafted, is a process that, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components. That is, other than reciting “one or more processor”, the claims are direct to concepts relating to organizing information in a way that can be performed mentally or analogous to human mental work and nothing in the claim element precludes the steps from practically being performed in the mind. For example, but for the processor, “determining” in the context of this claim encompasses the user manually visually assessing the PPG or respiration signal and either making calculations by hand or mentally determining changes. If a claim limitation, under its broadest reasonable interpretation, covers performance of the limitation in the mind but for the recitation of generic computer components, then it falls 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. In particular, the claim recites the additional elements of a housing and a plurality of optical components. These components involve mere data gathering and amount to insignificant extra-solutional activity, specifically pre-solutional activity. Additionally, the processor and the machine learning classifier recited in the dependent claims are recited at a high-level of generality such that it amounts no more than mere instructions to apply the exception using generic computer components. Accordingly, these additional elements do not integrate the abstract idea into a practical application because it does not impose any meaningful limits on practicing the abstract idea. The claim is directed to an abstract idea.
The claim does not include additional elements that are sufficient to amount to significantly more than the judicial exception. Similarly, the dependent claims do not include additional elements that amount to significantly more. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept and well-understood, routine and conventional activity is not sufficient to amount to significantly more than the abstract idea itself. The claim is not patent eligible.
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 and 8 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. The claims recite wherein the medical condition determined in claim 2 is “a virus”. This is very broad genus. The specification at ¶112 only seems to support determining respiratory viruses and not the broad category of “a virus” as recited in the claim. Applicant appears not to have been in possession of a device capable of determining a medical condition of a virus as recited.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 16 is 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. It is unclear what readiness score the claim is referring to as the only analysis is of the respiration parameter. It is unclear what readiness is being determined specifically.
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.
Claim(s) 1-8 and 12-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meger et al. US 2011/0112442 in view of Turcott US 2010/0152560.
Regarding claim 2, Meger discloses a device, comprising:
a housing comprising an external housing and an internal housing ([¶97] the device is packaged in a housing. External and internal housing are interpreted to be an internal and external face of the housing as they are not further defined);
a plurality of optical components disposed within the housing, the plurality of optical components comprising one or more light-transmitting components and one or more light-receiving components ([¶119,140] oximeter is used which inherently has an emitter and detector); and
one or more processors communicatively coupled with the plurality of optical components, the one or more processors configured to:
obtain one or more measurements of physiological data associated with the user via the plurality of optical components, the physiological data being continuously collected via the device ([¶122,254] measurements are continuous);
determine a plurality of respiration rate values for the user over a time interval based at least in part on the physiological data ([¶108,113] respiration rates and patterns are determined);
determine one or more respiration rate parameters associated with a change in the plurality of respiration rate values over the time interval ([¶208] average respiration rates and patterns are determined); and
determine one or more condition risk metrics associated with one or more medical conditions based at least in part on the one or more respiration rate parameters, the one or more condition risk metrics associated with a relative probability that the user experiences a respective medical condition of the one or more medical conditions ([¶208,293,294,393,424] the probability of disease or risk is determined based on the collected signals).
Meger does not disclose the device is a wearable ring device configured to be worn on a finger of a user. Turcott teaches a similar sleep and physiological monitoring sensor system that is in the form of a ring ([¶90,98]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Meger with the ring device of Turcott in order to create a more reliable and extended recording with a wearable device.
Regarding claim 3, Meger discloses the display device ([¶93]) displays an indication of the one or more condition risk metrics ([¶250,427] risk is displayed to the clinician) but does not disclose the one or more processors are further configured to: transmit, via a short-range transmitter of the wearable ring device, one or more signals causing a graphical user interface of a user device. Turcott teaches short range wireless transmission to a user device ([¶70] wireless transmission).
Regarding claim 4 and 5, Meger discloses the display device ([¶93]) to display a graph comprising one or more daily average respiration rate values ([¶108]). Meger does not specifically disclose the one or more processors are further configured to: transmit, via a short-range transmitter of the wearable ring device, one or more signals causing a graphical user interface of a user device. Turcott teaches short range wireless transmission to a user device ([¶70] wireless transmission).
Regarding claim 6 and 8, Meger discloses the one or more medical conditions comprise sleep deprivation, sleep apnea, asthma, allergies, chronic obstructive pulmonary disease, a respiratory infection, a virus, or any combination thereof ([¶103,284]).
Regarding claim 7, Meger discloses that to determine one or more condition risk metrics, the one or more processors are further configured to cause the device to: train a machine learning classifier to determine the one or more condition risk metrics; and input the one or more respiration rate parameters into the machine learning classifier, wherein the machine learning classifier is configured to determine the one or more condition risk metrics in accordance with the training ([¶107,379] the device uses cluster algorithms which are an form of machine learning classifier and various learning techniques and the training is the data provided prior to the clinical event).
Regarding claim 12, Meger discloses the one or more processors are further configured to cause the wearable ring device to: determine one or more additional parameters of the physiological data collected during the time interval, wherein determining the one or more condition risk metrics is based at least in part on the plurality of respiration rate values and the one or more additional parameters of the physiological data ([¶107-108] multiple other parameters are determined).
Regarding claim 13, Meger discloses the one or more processors are further configured to cause the wearable ring device to: obtain one or more measurement of additional physiological data associated with the user via the plurality of optical components, the additional physiological data being continuously collected via the wearable ring device over an additional time interval which precedes the time interval ([¶107-108,261] PTT is also determined form the optical sensors); and determine a baseline respiration rate data for the user based at least in part on the additional physiological data, wherein determining the plurality of respiration rate values, the one or more respiration rate parameters, the one or more condition risk metrics, or any combination thereof, is based at least in part on the baseline respiration rate data ([¶107-108] baselines are established for the various parameters).
Regarding claim 14, Meger discloses the one or more respiration rate parameters comprise a deviation of the plurality of respiration rate values from the baseline respiration rate data ([¶107] scores are determined based on deviation from baselines).
Regarding claim 15, Meger discloses the one or more processors are further configured to cause the wearable ring device to: determine one or more sleep periods for the user within the time interval based at least in part on the physiological data; and classify each sleep period of the one or more sleep periods into at least one of an awake sleep period, a light sleep period, a rapid-eye movement sleep period, or a deep sleep period ([¶361] the device can determine current sleep condition including REM), wherein determining the one or more condition risk metrics is based at least in part on the one or more respiration rate parameters and the one or more classified sleep periods ([¶101,108] risks are determined based on the physiological parameter and sleep).
Regarding claim 16, Meger discloses the one or more processors are further configured to cause the wearable ring device to: determine one or more scores for the user based at least in part on the plurality of respiration rate values, the one or more respiration rate parameters, or both, the one or more scores comprising a sleep score, a readiness score, or both ([¶399] a sleep score is determined).
Regarding claim 17, Meger discloses the time interval comprises a night of sleep for the user ([¶399] a sleep score is determined over a night for example).
Regarding claim 18, Meger discloses the one or more respiration rate parameters comprise a rate of change of the plurality of respiration rate values over the time interval ([¶107-108] changes in patterns and deviations in baselines for the parameters including respiration are determined)
Regarding claim 19, Turcott teaches the wearable ring device collects the physiological data from the user based on arterial blood flow ([¶56] the light sensors measure the blood flow and from that respiration is determined).
Claim(s) 9-10 is/are rejected under 35 U.S.C. 103 as being unpatentable over Meger in view of Turcott further in view of McDarby et al. US 2015/0230750.
Regarding claim 9, Meger does not specifically disclose determining fitting a line to the respiration rates and determining a slope. McDarby teaches a similar sleep monitoring device that teaches fitting a line to the plurality of respiration rate values for the user over the time interval ([¶306-310]); and determining a slope of the line, wherein the one or more respiration rate parameters comprise the slope, and wherein determining the one or more condition risk metrics is based at least in part on the slope ([¶306-310]). Therefore, it would have been obvious to one of ordinary skill in the art prior to the time of filing to combine the device of Weber with the teachings of McDarby in order evaluated short term and long-term correlations of the respiration rate ([¶304]).
Regarding claim 10, McDarby teaches the one or more processors are further configured to cause the wearable ring device to: determine a first condition risk metric for a medical condition of the one or more medical conditions based at least in part on the slope being greater than a threshold slope value; and determine a second condition risk metric for the medical condition based at least in part on the slope being less than the threshold slope value, the second condition risk metric different from the first condition risk metric ([¶307] the thresholds determine sleep conditions).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. He et al. US 2015/0164351 which discloses a wearable device that can determine sleep deprivation but does not specify it is from respiration rate data.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHAEL ANTHONY CATINA whose telephone number is (571)270-5951. The examiner can normally be reached 10-6pm.
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/MICHAEL A CATINA/Examiner, Art Unit 3791 /TSE CHEN/Supervisory Patent Examiner, Art Unit 3791
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