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 with traverse of Species V in the reply filed on 13 October 2025 is acknowledged.
Applicant has argued that Species I-IV, directed to “different means of measuring blood flow or diagnosis”, are not mutually exclusive from Species V-VII which are “directed to adaptation for attachment to different body parts.” The Office respectfully disagrees. Each of Species I-IV are directed to various types {i.e. species} of biometric data {e.g. diffuse correlation spectroscopy measurements, transcranial Doppler ultrasound measurements, ultrasound measurements of arteries, } and not generalized as “different means of measuring blood flow or diagnosis.” Whereas the Species V-VII are directed to various “target locations” or anchor locations.
According to MPEP § 806.04(f), “[C]laims to different species are mutually exclusive if one claim recites limitations disclosed for a first species but not a second, while a second claim recites limitations disclosed only for the second species and not the first. This may also be expressed by saying that to require restriction between claims limited to species, the claims must not overlap in scope.” Applicant argues that Species I can be combined with any of Species V-VII; however, the standard is not whether they can be useable together, bur rather whether the species can anticipate/obviate one another. Since there is no overlap in scope regarding the various types of biometric data and the various target locations/anchor points, the species do not overlap in scope. Therefore, the election of species is proper and Applicant’s arguments are unpersuasive.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 17 October 2024, 7 January 2025, 19 August 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 1 is objected to because of lack of antecedent basis for the recited limitation " the sample ear biometric data" in line 24. Appropriate correction is required.
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(4) because reference character “106” has been used to designate both microcontroller and attachment mechanism. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 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.
Claim(s) 1-2, 7-12, 16 and 18-19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lee et al. (WO2022056241A1; hereinafter "Lee"). It should be appreciated that corresponding US PGPUB 20230355187 will act as a proxy for the WO2022056241A1 reference.
With regards to Claim 1, a system for non-invasively measuring blood flow to a brain (device 100 includes a biometric sensor 101 is configured to monitor at least one biometric parameter of the subject such as cerebral blood flow; see Lee ¶ [0058]; wherein the sensor is an optical PPG sensor; see Lee ¶ [0012]), the system comprising:
a biometric sensor configured to be removably retained against an external surface of a skin portion of a target location at a head of a user (the device 100 is adapted to attach to the auricle of the subject at the cymba concha, scapha, triangular fossa, anti-helix, or inner surface of the helix of the subject; see Lee ¶ [0066-0067]; attachment mechanism 106 includes any one of elastomeric wings, suction cups, rough surface, or a mold; see Lee ¶ [0068]; i.e. the attachment mechanism amounts to a removable mechanism according to the various examples); and
a processor (microcontroller to aggregate and process sensor data; see Lee ¶ [0060]) and a memory storing computer instructions (the microcontroller analyzes the data to detect or predict one or more of: poor cerebral blood flow, poor blood pressure, presyncope, syncope, and a fall event; se Lee ¶ [0060]; it is well known in the art that microcontrollers contain memory with instructions to perform actions such as analyzing the sensor data), wherein the system is configured to:
obtain, using the biometric sensor, biometric data relating to a blood flow waveform of one or more arteries near the target location (the biometric sensors herein targets branches of the posterior auricular artery for improved PPG sensing, i.e. acquiring biometric sensor data associated with cerebral blood flow ; see Lee ¶ [0058 & 0067]);
determine, based on the biometric data relating to the biometric data and/or blood flow waveform of the one or more arteries near the target location, a parameter indicative of a blood flow to a brain of the user ((the biometric sensors herein targets branches of the posterior auricular artery for improved PPG sensing, i.e. acquiring biometric sensor data associated with cerebral blood flow ; see Lee ¶ [0058 & 0067])); and
display or transmit the parameter indicative of the blood flow to the brain of the user (displaying via GUI cerebral blood flow changes; see Lee ¶ [0054]);
wherein determining the parameter indicative of the blood flow to the brain of the user comprises performing one or more computations using the biometric data and/or the blood flow waveform of the one or more arteries at the target location (a hand-crafted heuristic model can comprise comparing a current blood pressure to a predetermined blood pressure graph based on clustering of known previously human annotated labels; see Lee ¶ [0077]), the one or more computations being statistically determined by:
obtaining sample target location biometric data relating to sample blood flow waveforms of one or more sample arteries within ears of a plurality of sample subjects (identifying trends pertaining to cerebral blood flow for the subject; see Lee ¶ [0074]; it should be appreciated that trends indicates to one of ordinary skill in the art that previous data is compared to current data, i.e. a plurality of sample blood waveforms of a plurality of subjects);
obtaining sample brain biometric data relating to one or more brains of the plurality of sample subjects (identifying trends pertaining to actual/predicted presyncope or syncope events, i.e. brain biometric data; see Lee ¶ [0074]);
for each of at least a subgroup of the plurality of sample subjects, pairing the sample ear biometric data to the sample brain biometric data obtained for a respective sample subject to create a plurality of sample data pairs (the analysis is based on the analysis comprises one or more of identifying trends pertaining to cerebral blood flow for the subject AND identifying trends pertaining to actual/predicted presyncope or syncope events; see Lee ¶ [0074]; wherein the analysis is based on both cerebral blood flow trends and presyncope/syncope trends amounts to a pair of sample data pairs); and
based on the sample data pairs, determine one or more relationships between the sample ear biometric data and the sample brain biometric data (provide resulting biometric feedback and behavioral coaching recommendations {i.e. one or more relationships} based on the analysis; see Lee ¶ [0074]).
Claim 19 recite similar limitations and are rejected under the same rationale as Claim 1.
With regards to Claim 21, wherein the one or more computations are performed by a machine learning model that has been trained based on the plurality of sample data pairs to identify the one or more relationships between the sample biometric data and the sample brain biometric data (analysis is based on machine learning; see Lee ¶ [0076]).
With regards to Claim 71, wherein the target location is an ear of the user to target a posterior auricular artery of the user (the biometric sensors herein targets branches of the posterior auricular artery for improved PPG sensing, i.e. acquiring biometric sensor data associated with cerebral blood flow ; see Lee ¶ [0058 & 0067]).
With regards to Claim 81, wherein the biometric sensor is configured to be anchored to an ear of the user (attachment mechanism 106 includes any one of elastomeric wings, suction cups, rough surface, or a mold; see Lee ¶ [0068]; i.e. the attachment mechanism amounts to a removable mechanism which anchors the device to the ear).
With regards to Claim 98, wherein the biometric sensor is configured to be anchored at a cymba concha of the user (the biometric sensors herein targets branches of the posterior auricular artery at the cymba concha for improved PPG sensing, i.e. acquiring biometric sensor data associated with cerebral blood flow ; see Lee ¶ [0058 & 0067]).
With regards to Claim 101, wherein the target location is within the ear of the user, and the biometric sensor is attached to a polymeric insert comprising an aperture through which the biometric sensor emits light, wherein, when the polymeric insert is positioned within the ear of the user (FIGS. 1 & 4A clearly illustrate an opening {i.e. aperture} in the attachment mechanism 106 & 106A from which sensor 101 transceives PPG signals), the aperture is less than five (5) millimeters from a branch of the posterior auricular artery (according to the longest dimension of 12-15mm, as illustrated in FIG. 1 of Lee, the distance from the sensor 101 and the outer surface of the attachment mechanism 106, one of ordinary skill in the art would recognize that said distance would be much less than 5mm according to scale; FIGS. 2-3 of Lee clearly illustrate the device disposed in the concha cymba which is adjacent to the posterior auricular artery).
With regards to Claim 1110, wherein the branch emerges at an anterior face of the user's ear within seven (7) millimeters of a helical root of the user's ear (as illustrated in FIGS. 2 & 3 of Lee, the device 100 abuts against the cymba concha which is well known to be directly adjacent to branches of the posterior auricular artery), and the polymeric insert is at least partially disposed at the base of the helical root (FIG. 3 of Lee clearly illustrate the attachment mechanism adjacent to the helical root).
With regards to Claim 121, wherein the parameter indicative of the blood flow to the brain of the user is cerebral blood flow, blood flow to a head of the user, carotid blood flow, stroke volume (SV), and/or cardiac output (CO) (device 100 includes a biometric sensor 101 is configured to monitor at least one biometric parameter of the subject such as cerebral blood flow; see Lee ¶ [0058]).
With regards to Claim 161, wherein determining the parameter indicative of the blood flow to the brain of the user is performed by an integrated hardware device that includes the biometric sensor and is configured to be disposed at the target location of the user (the microcontroller is housed withing a housing also comprising the sensor 101; see Lee ¶ [0055]).
With regards to Claim 181, wherein the sample brain biometric data relates to one of: (i) sample blood flow wave forms within the one or more brains of the plurality of sample subjects, or (ii) cognitive function data relating to the plurality of sample subjects (identifying trends pertaining to actual/predicted presyncope or syncope events, i.e. brain biometric data; see Lee ¶ [0074]).
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 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 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.
Claim 17 & 20 are rejected under 35 U.S.C. 103 as being unpatentable over Lee et al. (WO2022056241A1; hereinafter "Lee") in further view of Melker et al. (US PGPUB 20100192952; hereinafter "Melker") . It should be appreciated that corresponding US PGPUB 20230355187 will act as a proxy for the WO2022056241A1 reference.
With regards to Claim 171, while Lee discloses all of the limitations of intervening claim 1 as shown above, it appears that Lee may be silent to wherein the one or more computations comprise one or more of: (1) analyzing a fullness of the blood flow waveform of the one or more arteries near the target location; (2) determining an area under a systolic period of a cardiac pulse in the blood flow waveform of the one or more arteries near the target location; and (3) determining an assessment of a time period from a start of systole to a dichrotic notch of a cardiac pulse in a carotid artery of the user.
However, Melker teaches of a PPG probe for measuring blood flow at a pre- or post-auricular site to correlate blood flow to the brain (see Melker ¶ [0029] & FIGS. 7-8). In particular, Melker teaches of:
wherein the one or more computations comprise one or more of: (1) analyzing a fullness of the blood flow waveform of the one or more arteries near the target location (Quantification of the PAC and VIC changes can include peak or trough counting, peak-peak timing, peak-trough height, area under the curve {i.e. fullness of the blood flow waveform}}, shape of the curves, frequency characteristics of the curves, entropy of the curves, changes in the positions of the peaks, troughs, or midpoints from heart beat to heart beat or breath to breath; see Melker ¶ [0081]; wherein PAC is a measure of region blood flow which is then correlated to blood flow to the brain; see Melker ¶ [0079 & 0029] ); (claimed in the alternative).
Lee and Melker are both considered to be analogous to the claimed invention because they are in the same field of PPG cerebral blood flow determination. Therefore, it would have been obvious to someone of ordinary skill in the art before the effective filing date of the claimed invention to have modified Lee to incorporate the above teachings of Melker to provide at least analyzing a fullness of the blood flow waveform of the one or more arteries near the target location. Doing so would aid in quantifying region blood flow to correlate to brain blood flow (see Melker ¶ [0029 & 0029]).
Claim 20 recites similar limitations and are rejected under the same rationale as Claim 17.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ASHISH S. JASANI whose telephone number is (571) 272-6402. The examiner can normally be reached M-F 9:00 am - 5:00 pm (CST).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Keith Raymond can be reached on (571) 270-1790. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ASHISH S. JASANI/Examiner, Art Unit 3798
/KEITH M RAYMOND/ Supervisory Patent Examiner, Art Unit 3798