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 .
Election/Restrictions
Applicant’s election without traverse of Species B, Claims 1-3, 5, and 8-20, in the reply filed on 31 October 2025 is acknowledged.
Claim Rejections - 35 USC § 112
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 1-3, 5, and 8-20 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 claim 1, the phrase “a computer-system comprising a process” renders the claim indefinite. It is unclear what it means for a computer system to comprise a process. For the purpose of examination, the phrase is being interpreted as “a computer-system comprising a processor”. Regarding claim 3, a pressure transducer is a pressure sensor. It is therefore unclear what further limitation is provided by reciting that the pressure sensor is a pressure transducer. While not an indefiniteness issue, it is noted that the terms “providing” and “receiving” in claim 8 should be amended to read “provide” and “receive”, respectively. Regarding claim 9, it is unclear what further limitation the claim provides as there is no positive recitation that an element of the system itself trains the BP classifier. The BP classifier could be trained in an external system and then transmitted to the claimed system. Further regarding claim 9, it is unclear what is meant by “using the training-PTT values a feature vectors” in option iv). Clarification is requested. Regarding claim 14, the phrase “the low-BP value” lacks proper antecedent basis. For the purpose of examination, the claim is being interpreted as being dependent on claim 12, as claim 12 recites a low-BP value. Regarding claim 15, the phrase “the BP-dip value” lacks proper antecedent basis. For the purpose of examination, the phrase is being interpreted as “a BP-dip value”. Regarding claim 17, the phrase “the BP value” in lines 2 and 3 renders the claim indefinite in that claim 1 recites determining one or more BP values. For the purpose of examination, the phrase is being interpreted as “the one or more BP values”. Regarding claim 18, it is unclear what further limitation the claim provides to the claimed system. Claim 18 recites a method step without tying it to any structural or functional element of the claimed system. Further regarding claim 18, the phrase “small calibration dataset” renders the claim indefinite in that the term “small” is a relative term that is not defined by the specification or by the claim itself.
Claims not explicitly rejected above are rejected due to their dependence on a rejected base claim.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-3, 5, and 8-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 20 follows.
Regarding claim 20, the claim recites a series of steps or acts, including receiving first and second BCG data, and determining one or more blood pressure values. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
The claim is then analyzed to determine whether it is directed to any judicial exception. The step of determining one ore more blood pressure values sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 20 fails to recite any application of the determined one or more blood pressure values. The determination of the one or more blood pressure values does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on the determined one or more blood pressure values, nor does the method use a particular machine to perform the Abstract Idea. It is noted that no machine is recited as being used in the claimed method.
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Idea, the claim recites the additional step of receiving first and second BCG data from first and second BCG sensors, respectively. The receiving step is recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and determining activity engaged in by medical professionals prior to Applicant's invention. Furthermore, it is well established that the mere physical or tangible nature of additional elements such as the receiving and determining steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-statutory subject matter.
Regarding claim 1, the system recited in the claim is a generic device comprising generic components configured to perform the Abstract Idea. The recited BCG sensors are generic sensors configured to perform pre-solutional data gathering activity, and the computer system is configured to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The same rationale applies to claim 19. The system recited in the claim is a generic system comprising generic components configured to perform the Abstract Idea. The recited one or more processors and computer memory make up a computer system that is configured to perform pre-solutional data gathering activity and to perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an abstract idea does not integrate the Abstract Idea into a practical application.
The dependent claims also fail to add something more to the abstract independent claims as they generally define the type of BCG sensor used (generic pressure sensor/load cell), state where a sensor is placed, or pertain to data gathering and processing steps that are capable of being performed mentally and/or by hand. The receiving and determining steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Further regarding claim 5, the claim is 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). Claim 5 improperly recites human tissue as part of the claimed invention. It is suggested that Applicant amend the claim to recite that the second BCG sensor is a device configured to be worn by the user in order to remove the recitation of human tissue.
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 1-3, 5, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Raisanen’741 (WO 2018/191741).
Regarding claim 1, Figure 1 of Raisanen’741 discloses a system comprising: a bed 80 having a mattress to support a user laying on the bed; a first ballistocardiograph (BCG) sensor 100a/102a configured to collect first BCG data from a first location of the user laying on the bed due to pressure applied to the bed by the user (page 11, lines 18-23; page 16, lines 7-11; page 18, lines 1-5); a second BCG sensor 100b/102b configured to collect second BCG data from a second location of a user (page 15, lines 32-34; page 16, lines 7-11; page 17, lines 1-3); and a computer system comprising a processor and memory, the computer system configured to: receive the first BCG data and the second BCG data (page 27, line 25 – page 28, line 25); and determine one or more blood pressure (BP) values for the user (page 15, lines 3-13).
Regarding claim 2, the first BCG sensor is a pressure sensor configured to sense pressure readings applied to the bed by the user due to weight and motion of the user (page 11, lines 18-23; page 16, lines 7-11; page 18, lines 1-5).
Regarding claim 3, the first BCG sensor is one of the group consisting of a pressure transducer and a load cell (page 11, lines 18-23; page 16, lines 7-11; page 18, lines 1-5).
Regarding claim 5, the second BCG sensor is a device worn by the user on a specified location of the user’s body (Figure 1 shows the second BCG sensor being worn by the user around their chest; and page 15, lines 32-34 and page 17, lines 1-3).
Regarding claim 19, the sections of Raisanen’741 cited above disclose a system comprising the elements recited in the claim.
Regarding claim 20, the sections of Raisanen’741 cited above disclose a method comprising the steps recited in the claim.
Claims 1-3, 8, 19, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lu et al.’982 (WO 2020/210982).
Regarding claim 1, Figure 3 of Lu et al.’982 discloses a system comprising: a bed 4 having a mattress to support a user laying on the bed; a first ballistocardiograph (BCG) sensor 11 configured to collect first BCG data from a first location of the user laying on the bed due to pressure applied to the bed by the user (sections [0028-0033], [0040], [0042], [0049-0050]); a second BCG sensor 12 configured to collect second BCG data from a second location of a user (sections [0028-0033], [0040], [0042], [0049-0050]); and a computer system comprising a processor and memory, the computer system configured to: receive the first BCG data and the second BCG data (sections [0007-0009], [0013-0018], [0028-0033], [0042-0045]); and determine one or more blood pressure (BP) values for the user (sections [0001], [0004], [0007-0009], [0013-0018], [0028-0033], [0039], [0048]).
Regarding claim 2, the first BCG sensor is a pressure sensor configured to sense pressure readings applied to the bed by the user due to weight and motion of the user (section [0010]).
Regarding claim 3, the first BCG sensor is one of the group consisting of a pressure transducer and a load cell (section [0010]).
Regarding claim 8, in order to determine one or more BP values for the user, the computer system is configured to: determine a pulse transit time (PTT) for the user identifying a length of time between a pulse event in the first BCG data and the second BCG data representing the length of time between when a pulse of the user’s blood reaches the first location and the second location (sections [0012], [0038], [0047]); provide, as input, the PTT to a BP classifier (sections [0013], [0039], [0048]); and receive, as output, the one or more blood pressure values for the user (sections [0012-0013], [0048]).
Regarding claim 19, the sections of Lu et al.’982 cited above disclose a system comprising the elements recited in the claim.
Regarding claim 20, the sections of Lu et al.’982 cited above disclose a method comprising the steps recited in the claim.
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.
Claims 9 and 10 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al.’982, as applied to claim 8, in view of Arand et al.’164 (US Pub No. 2004/0158164).
Regarding claim 9, Lu et al.’982 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the BP classifier being trained using at least one model of the group consisting of: i) a linear model finding a fit between training PTT values and training BP values; ii) a polynomial model finding coefficients describing a function that relates the training PTT values with the training BP value; iii) a machine learning model that creates a data structure created by a machine learning process; and iv) a boosted decision tree regression model.
Arand et al.’164 teaches that a physiological classifier (an equation) can be trained using a linear model finding a fit between training values and training final values or using a polynomial model finding coefficients describing a function that relates two sets of values (sections [0035-0036]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the BP classifier of Lu et al.’982 (the equation shown in section [0039]) such that it is trained using either a linear model finding a fit between training PTT values and training BP values or a polynomial model finding coefficients describing a function that relates the training PTT values with the training BP value, as Arand et al.’164 teaches that a classifier can be trained using a linear model finding a fit between two sets of values or a polynomial model finding coefficients describing a function that relates two values. The modification to Lu et al.’982 would merely be combining prior art elements according to known methods to yield predictable results.
Regarding claim 10, as Lu et al.’982 in view of Arand et al.’164 teaches using either model i) or model ii) to train its classifier, it need not teach the recitation in claim 10 further limiting model iii). Claim 10 provides a further limitation to an option of claim 9; when another option of claim 9 is used, claim 10 fails to provide a further limitation to the claimed invention.
Claims 11-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Raisanen’741, as applied to claim 1, in view of Burton’733 (US Pub No. 2007/0032733).
Regarding claim 11, Raisanen’741 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for the computer system being configured to: identify a time window of a particular sleep stage of a sleep session of the user sleeping on the bed, and identify a representative BP for the sleep stage based on the one or more BP values for the user which are within the time window.
Burton’733 teaches a computer system configured to identify a time window of a particular sleep stage of a sleep session of a sleeping user, and identify a representative blood pressure value for the sleep stage based on one or more of blood pressure values which are within the time window (sections [0433-0435]; “blood pressure changes during one or more stages of sleep state” requires identifying representative blood pressure values for each sleep stage). Burton’733 teaches determining the representative BP for a determined sleep stage in order to alert a healthcare worker if a patient’s blood pressure is outside of safe limits of bounds during one or more stages of sleep, or to modify administration of therapeutic treatment based on an abnormal blood pressure in one or more stages of sleep (section [0436-0437]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the computer system of Raisanen’741 to be configured to identify a time window of a particular sleep stage of a sleep session of the user sleeping on the bed, and identify a representative BP for the sleep stage based on the one or more BP values for the user which are within the time window, as this would allow a healthcare worker to be alerted if safe limits or bounds of blood pressure are violated in one or more of the sleep stages, and it would also allow the modification of therapeutic intervention based on the identified blood pressure.
Regarding claim 12, the representative blood pressure for each sleep stage can be considered an Nth lowest BP value within the time window to represent a low BP value for the sleep stage (“N” can be any number as it is not defined by the claim).
Regarding claim 13, the representative blood pressure can be considered the Nth lowest percentile BP value (“N” can be any number as it is not defined by the claim).
Regarding claim 16, different sleep stages are capable of being identified within a time window of between 0 and 4 hours after sleep onset. The identification of a particular sleep stage depends entirely on when the user enters the sleep stage.
Claims 11-13 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al.’982, as applied to claim 1, in view of Burton’733.
Regarding claim 11, Lu et al.’982 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for the computer system being configured to: identify a time window of a particular sleep stage of a sleep session of the user sleeping on the bed, and identify a representative BP for the sleep stage based on the one or more BP values for the user which are within the time window.
Burton’733 teaches a computer system configured to identify a time window of a particular sleep stage of a sleep session of a sleeping user, and identify a representative blood pressure value for the sleep stage based on one or more of blood pressure values which are within the time window (sections [0433-0435]; “blood pressure changes during one or more stages of sleep state” requires identifying representative blood pressure values for each sleep stage). Burton’733 teaches determining the representative BP for a determined sleep stage in order to alert a healthcare worker if a patient’s blood pressure is outside of safe limits of bounds during one or more stages of sleep, or to modify administration of therapeutic treatment based on an abnormal blood pressure in one or more stages of sleep (section [0436-0437]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the computer system of Lu et al.’982 to be configured to identify a time window of a particular sleep stage of a sleep session of the user sleeping on the bed, and identify a representative BP for the sleep stage based on the one or more BP values for the user which are within the time window, as this would allow a healthcare worker to be alerted if safe limits or bounds of blood pressure are violated in one or more of the sleep stages, and it would also allow the modification of therapeutic intervention based on the identified blood pressure.
Regarding claim 12, the representative blood pressure for each sleep stage can be considered an Nth lowest BP value within the time window to represent a low BP value for the sleep stage (“N” can be any number as it is not defined by the claim).
Regarding claim 13, the representative blood pressure can be considered the Nth lowest percentile BP value (“N” can be any number as it is not defined by the claim).
Regarding claim 16, different sleep stages are capable of being identified within a time window of between 0 and 4 hours after sleep onset. The identification of a particular sleep stage depends entirely on when the user enters the sleep stage.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Raisanen’741 in view of Burton’733, as applied to claims 11 and 13, further in view of Nakajima et al.’910 (US Pub No. 2019/0320910).
Regarding claim 14, Raisanen’741 in view of Burton’733 discloses all of the elements of the current invention, as discussed in paragraph 12 above, except for the computer system being configured to: receive an instant BP value for the user taken after the sleep session; and compare a low BP value for a sleep stage with the instant BP value to determine a BP dip value for the user.
Nakajima et al.’910 teaches receiving an instant BP value for a user taken after a sleep session, and comparing the instant BP value to a BP value taken during a previous sleep stage. Nakajima et al.’910 teaches performing these steps in order to diagnose early morning hypertension (section [0047]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the computer system of Raisanen’741 in view of Burton’733 to be configured to compare an instant BP value of the user taken after a sleep session with a low BP value of the user during a sleep stage, as this would help in diagnosing early morning hypertension.
Regarding claim 15, Raisanen’741 in view of Burton’733 further in view of Nakajima et al.’910 discloses all of the elements of the current invention, as discussed above, except for explicitly stating that the computer system is configured to store a BP dip value to the memory or generate an alert for output to a user output device. Official notice is being taken that it is well known in the art to store determined physiological values such as BP changes. Official notice is also being taken that it is well known in the art for a medical device to generate an alert for output to a user output device if a determined parameter (e.g., blood pressure, change in blood pressure) is outside of a predetermined range.
Claims 14 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Lu et al.’982 in view of Burton’733, as applied to claims 11 and 13, further in view of Nakajima et al.’910.
Regarding claim 14, Lu et al.’982 in view of Burton’733 discloses all of the elements of the current invention, as discussed in paragraph 13 above, except for the computer system being configured to: receive an instant BP value for the user taken after the sleep session; and compare a low BP value for a sleep stage with the instant BP value to determine a BP dip value for the user.
Nakajima et al.’910 teaches receiving an instant BP value for a user taken after a sleep session, and comparing the instant BP value to a BP value taken during a previous sleep stage. Nakajima et al.’910 teaches performing these steps in order to diagnose early morning hypertension (section [0047]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the computer system of Lu et al.’982 in view of Burton’733 to be configured to compare an instant BP value of the user taken after a sleep session with a low BP value of the user during a sleep stage, as this would help in diagnosing early morning hypertension.
Regarding claim 15, Lu et al.’982 in view of Burton’733 further in view of Nakajima et al.’910 discloses all of the elements of the current invention, as discussed above, except for explicitly stating that the computer system is configured to store a BP dip value to the memory or generate an alert for output to a user output device. Official notice is being taken that it is well known in the art to store determined physiological values such as BP changes. Official notice is also being taken that it is well known in the art for a medical device to generate an alert for output to a user output device if a determined parameter (e.g., blood pressure, change in blood pressure) is outside of a predetermined range.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Raisanen’741, as applied to claim 1.
Raisanen’741 discloses all of the elements of the current invention, as discussed in paragraph 8 above, except for explicitly stating that the computer system is configured to store the BP value to the memory or generate an alert for output to a user output device. Official notice is being taken that it is well known in the art to store determined physiological values such as BP. Official notice is also being taken that it is well known in the art for a medical device to generate an alert for output to a user output device if a determined parameter (e.g., blood pressure, change in blood pressure) is outside of a predetermined range.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Lu et al.’982, as applied to claim 1.
Lu et al.’982 discloses all of the elements of the current invention, as discussed in paragraph 9 above, except for explicitly stating that the computer system is configured to store the BP value to the memory or generate an alert for output to a user output device. Official notice is being taken that it is well known in the art to store determined physiological values such as BP. Official notice is also being taken that it is well known in the art for a medical device to generate an alert for output to a user output device if a determined parameter (e.g., blood pressure, change in blood pressure) is outside of a predetermined range.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant’s disclosure. Watson et al.’353 (US Pub No. 2009/0326353) teaches determining a blood pressure dip value during sleep stages in order to detect one or more types of sleep events. Inan et al.’847 (US Pub No. 2017/0238847) discloses a system and method that determines blood pressure values from BCG signals.
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/ETSUB D BERHANU/Primary Examiner, Art Unit 3791