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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07/21/2026 has been entered.
Response to Amendment
This Office Action is responsive to the amendment filed on 07/13/2026. As directed by the amendment: Claims 1-3, 8, 11-14, and 19-20 have been amended, no claims have been cancelled, and no claims have been added. Claims 4-7 and 9 were previously withdrawn due to a Restriction Requirement. Thus, claims 1-3, 8, and 10-20 are presently under consideration in this application.
Response to Arguments
Applicant’s arguments, see page 10, filed 07/13/2026, with respect to 35 U.S.C. 112(a) and 112(b) have been fully considered and are not persuasive. Applicant argues on page 10 that the claims are fully supported by the spec and figures and are clear and definite.
Examiner disagrees because Applicant has failed to address how the specification fails to disclose all of the written description rejections written in the previous office action, as Applicant has not argued against them. The rejection of the claims has been maintained.
Applicant’s arguments, see pages 10-12, filed 07/13/2026, with respect to 35 U.S.C. 101 have been fully considered. Applicant asserts on pages 10-11 that the claims are not directed to an abstract idea, but for arguments purpose, integrates the abstract idea into practical application. Applicant then cites the Memo in August of 2025 to remind Examiners to not expand on the mental process grouping and argues on page 12 that “previously-presented independent claims include recitations of particular processing operations including obtaining physiologic data from sensors associated with a wearable device of a subject including a photoplethysmogram (PPG) waveform, ultrasound waveforms and sonic waveform energy and using such physiologic data to detect a timing of carotid changes of a heart of a subject relative to heart sounds of the subject, to determine physiologic metrics of the subject, to detect anomalous physiologic events indicative of hypovolemic shock of the subject, and to generate and delivery notifications in response thereto. Such recitations of particular processing operations are clearly not mental processes as alleged, as the human mind is not equipped to perform these claim limitations, i.e., such processing operations cannot practically be performed in the human mind.”
Examiner disagrees because the claims fail to claim structure related to the wearable structure and any of the sensors. Nevertheless, Applicant is asserting the abstract idea itself as the improvement. However, the abstract idea cannot be an “additional element” that shows integration into a practical application. The order of calculations and the particular calculations claimed do not make the abstract idea any less abstract. The claims are currently structured as simply using a generic computer to implement the abstract idea (mental process), which is not enough to show a practical application.
Applicant then argues on page 12 that “the previously-presented independent claims clearly recite arrangements providing improvements to physiologic monitoring systems. As described in the
specification at, for example, paragraphs [00174]-[00183], describes how early hemorrhage and
shock, among other health conditions, is not easily detected using noninvasive technology.
Illustrative embodiments of the claimed arrangements provide approaches to obtaining and
processing signals from the vasculature of a subject (e.g., via sensors of wearable devices attached
to skin of a subject) that enable such early detection of health conditions. Accordingly, even if
one assumes for purposes of argument only that previously-presented independent claims could
somehow be construed as reciting an abstract idea, these claims are not directed to an abstract idea
as the previously-presented independent claims clearly integrate any such abstract idea into
practical applications that provide improvements in computer technology.”
Examiner disagrees since the processing of data on a microcontroller unit is merely performing this process on a generic computer structure. The transmitting of signals is simply a generic computer function performed by a generic computer structure, wherein implementing the abstract idea with a generic computer is not enough to show integration into a practical application or significantly more than the abstract idea itself. The transmission of data to and from the sensor systems is merely data gathering, which is insignificant extra-solution activity.
The rejection of the claims has been maintained.
Applicant’s arguments, see pages 13-14, filed 07/13/2026, with respect to the rejection(s) of the claim(s) under 35 U.S.C. 102 and 103 have been fully considered and are persuasive. Amendments obviate the rejection of record. Specifically, the use of arterial blood flow, and sonic waveform energy used to determine heart sounds used to detect timing of carotid changes, in which the obtained physiologic data and baseline physiologic metrics to determine differences used to detect a likelihood of an anomalous physiologic event indicative of hypovolemic shock and generating notifications and activating stimuli based on the likelihood of occurrence are not conventionally relied upon in the detection of hypovolemic shock is free from prior art. Therefore, the rejection has been withdrawn.
Claim Objections
Claim 1, 19, and 20 are objected to because of the following informalities: the phrase “one or more oxygen saturation ones” and “one or more ultrasound transducer ones”, and “one or more ultrasonic transducer ones” should be amended to clarify the sensor, and to remove the term “ones”. Appropriate correction is required.
Claim 3 is objected to because of the following informalities: Examiner suggests clarifying if the phrase “a given likelihood of occurrence of a given one of the one or more anomalous physiologic events indicative of hypovolemic shock” is the same or different than the “likelihood of occurrence of one or more anomalous physiologic events indicative of hypovolemic shock” of claim 1. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 1-3, 8, and 10-20 is 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.
Similarly, original claims may lack written description when the claims define the invention in functional language specifying a desired result but the specification does not sufficiently describe how the function is performed or the result is achieved. For software, this can occur when the algorithm or steps/procedure for performing the computer function are not explained at all or are not explained in sufficient detail (simply restating the function recited in the claim is not necessarily sufficient). In other words, the algorithm or steps/procedure taken to perform the function must be described with sufficient detail so that one of ordinary skill in the art would understand how the inventor intended the function to be performed. See MPEP §§ 2163.02 and 2181, subsection IV.
When examining computer-implemented functional claims, examiners should determine whether the specification discloses the computer and the algorithm (e.g., the necessary steps and/or flowcharts) that perform the claimed function in sufficient detail such that one of ordinary skill in the art can reasonably conclude that the inventor possessed the claimed subject matter at the time of filing. An algorithm is defined, for example, as "a finite sequence of steps for solving a logical or mathematical problem or performing a task." Microsoft Computer Dictionary (5th ed., 2002). Applicant may “express that algorithm in any understandable terms including as a mathematical formula, in prose, or as a flow chart, or in any other manner that provides sufficient structure." Finisar Corp. v. DirecTV Grp., Inc., 523 F.3d 1323, 1340 (Fed. Cir. 2008) (internal citation omitted).It is not enough that one skilled in the art could write a program to achieve the claimed function because the specification must explain how the inventor intends to achieve the claimed function to satisfy the written description requirement. See, e.g., Vasudevan Software, Inc. v. MicroStrategy, Inc., 782 F.3d 671, 681-683, 114 USPQ2d 1349, 1356, 1357 (Fed. Cir. 2015).
Applicant’s measurement of vascular structures via processing of sensor signals (claim 1) lacks written description support. The mere statement and recitation of “ultrasound waveform signals to determine arterial blood flow of the subject combined with changes in arterial compliance of the subject” (claim 1 and 19-20 and [00183] of the instant specification), provides insufficient disclosure of the detail of how the: Ultrasound waveform signals are processed to determine arterial blood flow of the subject combined with changes in arterial compliance. Specifically, the instant specification nominally recites the function of obtaining these measurements without showing the processing steps required to obtain each determination. Ultimately, the specification is written generically such that it only defines the invention in functional language specifying a desired result but does not sufficiently identify how the function is performed, thereby lacking written description (see MPEP §2161.01).
Applicant’s measurement of vascular structures via processing of sensor signals (claim 1) lacks written description support. The mere statement and recitation of “to detect a timing of carotid changes of the heart of the subject relative to the heart sounds of the heart of the subject” (claim 1 and 19-20 and [00175] of the instant specification), provides insufficient disclosure of the detail of how the sonic waveform energy is used to detect timing of carotid changes. Specifically, the instant specification nominally recites the function of obtaining these measurements without showing the processing steps required to obtain each determination. It is unknown how the differences are determined/calculated for the timing of carotid change and how it is used to detect an anomalous event indicative of hypovolemic shock. Ultimately, the specification is written generically such that it only defines the invention in functional language specifying a desired result but does not sufficiently identify how the function is performed, thereby lacking written description (see MPEP §2161.01).
Applicant’s measurement of vascular structures via processing of sensor signals (claim 1) lacks written description support. The mere statement and recitation of “to determine one or more measured physiologic metrics utilizing the obtained physiologic data, at least one of the one or more measured physiologic metrics characterizing arterial blood flow of the subject” (claim 1 and 19-20, [0014], and [00183] of the instant specification), provides insufficient disclosure of the detail of how the combination of PPG, sonic waveform energy, and ultrasound waveform can be used to determine arterial blood flow. Specifically, the instant specification nominally recites the function of obtaining these measurements without showing the processing steps required to obtain the determination of arterial blood flow. Applicant fails to disclose what within the PPG, sonic waveform energy, and ultrasound waveform is used to any type pf physiologic metric, and more specifically, arterial blood flow and how to combine both PPG, sonic waveform energy, and ultrasound waveform to make this determination. It is further unknown how the differences are determined/calculated for the arterial blood flow and how it is used to detect an anomalous event indicative of hypovolemic shock. Ultimately, the specification is written generically such that it only defines the invention in functional language specifying a desired result but does not sufficiently identify how the function is performed, thereby lacking written description (see MPEP §2161.01).
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 8 and 10 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 8, it is unclear how each of the plurality of sensors can “independently measure” each of the signals listed. The limitation means that each sensor can measure each signal, which is unclear how this is possible.
Claim 10 recites the limitation "the one or more measured physiologic parameters" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections - 35 USC § 101
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.
Claim 2 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).
Regarding claim 2, the phrase “the plurality of sensors are attached to the skin” is claiming the skin, as the sensors are attached to the skin. Examiner suggests to amend the claim to recite “the plurality of sensor are adapted to be attached to the skin”.
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, 8, and 10-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
MPEP 2106(III) outlines steps for determining whether a claim is directed to statutory subject
matter. The stepwise analysis for the instant claim is provided here.
Step 1 – Statutory categories
Claim 1 is directed to a system (i.e. machine) and thus meets the step 1 requirements.
Claim 20 is directed to a method and thus meets the step 1 requirements.
Claim 19 is directed to a tangible non-transitory computer-readable medium (i.e. a product), and
thus, meets the step 1 requirements.
Step 2A – Prong 1 – Judicial exception (j.e.)
Regarding claims 1, 19, and 20, the following step is an abstract idea:
“to process the PPG waveforms to determine changes in pulsatile arterial blood flow of the subject;
to process the ultrasound waveforms to determine arterial blood flow of the subject combined with changes in arterial compliance of the subject;
to process the sonic waveform energy characterizing to determine heart sounds of a heart of the subject;
to detect a timing of carotid changes of the heart of the subject relative to the heart sounds of the heart of the subject;
to determine one or more measured physiologic metrics utilizing the obtained physiologic data, at least one of the one or more measured physiologic metrics characterizing arterial blood flow of the subject;
to determine differences between the one or more measured physiologic metrics in the obtained physiologic data and one or more baseline physiologic metrics;
to detect a likelihood of occurrence of one or more anomalous physiologic events indicative of hypovolemic shock of the subject based at least in part on the determined differences between the one or more measured physiologic metrics and the one or more baseline physiologic metrics”, which is a mental process when given its broadest reasonable interpretation. As discussed in MPEP 2106.04(a)(2)(II), the mental process grouping includes observations, evaluations, judgements, and opinions. In this case, a human could analyze the differences between the physiologic metrics from obtained physiologic data and one or more baseline and detecting a hypovolemic event based on the differences. Further, detecting timing carotid changes from heart sounds and determining metrics from PPG and ultrasound waves can be done by evaluating the signals. Further, the determining of pulsatile arterial blood flow from PPG, arterial blood flow from the ultrasound waveform, and the heart sounds from sonic waveform energy can be evaluated by a user using pen and paper.
Step 2A – Prong 2 – additional elements to integrate j.e. into a practical application
Regarding claims 1, 19, and 20, the abstract idea is not integrated into a practical application.
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a wearable device”, “a memory”, “indictor devices”, and “a processing device” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “plurality of sensors”, and “ultrasonic transducer” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “physiological data”, “oxygen saturation signals”, “echoed signals”, “difference”, “physiologic metrics”, “PPG”, “ultrasound waveforms”, “sonic waveform energy”, “changes in pulsatile arterial blood flow”, “changes in arterial compliance”, “heart sounds”, “timing of carotid changes”, “baseline physiologic metrics”, “one or more anomalous physiologic events (hypovolemic shock)”, “likelihood”, “stimuli”, and “notifications (settings)” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
Step 2B – significantly more/inventive concept
The following claim elements do not add any meaningful limitation to the abstract idea:
- “a wearable device”, “a memory”, “indictor devices”, and “a processing device” are recited at a high level of generality amounting to generic computer components for implementing abstract idea [MPEP 2106.05(b)];
- “plurality of sensors”, and “ultrasonic transducer” are data gathering structures for the insignificant extra-solution activity of data gathering [MPEP 2106.05(b)];
- “physiological data”, “oxygen saturation signals”, “echoed signals”, “difference”, “physiologic metrics”, “PPG”, “ultrasound waveforms”, “sonic waveform energy”, “changes in pulsatile arterial blood flow”, “changes in arterial compliance”, “heart sounds”, “timing of carotid changes”, “baseline physiologic metrics”, “one or more anomalous physiologic events (hypovolemic shock)”, “likelihood”, “stimuli”, and “notifications (settings)” are data (gathering, selecting, and displaying) that is necessary to implement the abstract idea on a computer amounting to insignificant extra-solution activity [MPEP 2106.05(g)].
The additional elements of claims 1, 19, and 20, when considered separately and in combination, do not add significantly more (ie. an inventive concept) to the abstract idea. As discussed above with respect to the integration of the abstract idea into a practical application, the wearable device, processing device, and memory, along with their associated functions, are recited at a high level of generality and simply amount to implementing the abstract idea on a computer. The sensors are claimed very generically and are used only to gather the data they are designed for. These are well-understood, routine and conventional structure since the diagnostic art in Brumfield et al. (US 20140364750) teaches the use of pulse oximetry PPG for obtaining PPG ([0018]), Kim et al. (US 20160120416) shows that the heart sounds are collected from microphones ([0040]), and Kimball et al. (US 6258046) shows that the doppler blood flow sensor senses blood flow (Col. 3 lines 20-21).
Dependent claims 2-3, 8, and 10-18 do not integrate the abstract idea into a practical application and do not add significantly more to the abstract idea of claim 1 and 10. The dependent claim limitations are directed to the data gathering (extra-solution activity) by a generic acquisition device (claims 2-3, 8, and 17-18) and to extra-solution activity of displaying (claims 10-16), which are insignificant extra-solution activity and do not amount to more than what is well-understood, routine, and conventional.
In summary, claims 1-3, 8, and 10-20 are directed to an abstract idea without significantly more and, therefore, are patent ineligible.
Conclusion
Claims 1-3, 8, and 10-20 overcome the prior art but are still rejected under 35 U.S.C. 101 and 35 U.S.C. 112(a).
The following is a statement of reasons for the indication of the claims overcoming the prior art:
The obtained physiologic data comprising PPG used to determine pulsatile arterial blood flow, ultrasound waveforms used to determine arterial blood flow, and sonic waveform energy used to determine heart sounds used to detect timing of carotid changes, in which the obtained physiologic data and baseline physiologic metrics to determine differences used to detect a likelihood of an anomalous physiologic event indicative of hypovolemic shock and generating notifications and activating stimuli based on the likelihood of occurrence are not conventionally relied upon in the detection of hypovolemic shock and are therefore allowable over the prior art.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MOUSSA M HADDAD whose telephone number is (571)272-6341. The examiner can normally be reached M-TH 8:00-6:00.
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/MOUSSA HADDAD/Examiner, Art Unit 3796
