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 claims 1-17 in the reply filed on 21 March 2026 is acknowledged. Claims 18-20 have been withdrawn.
Claim Objections
Claim 17 is objected to because of the following informalities:
“the testing” in line 2 of claim 17 should read as “the testing sensor”
Appropriate correction is required.
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 1-17 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 10 follows.
STEP 1
Regarding claim 10, the claim recites a series of steps or acts, including compressing a superficial temporal artery (STA) using a tonometer. Thus, the claim is directed to a process, which is one of the statutory categories of invention.
STEP 2A, PRONG ONE
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of:
compressing a superficial temporal artery (STA) using a tonometer;
contacting tissue that includes the STA using the tonometer;
determining a compression distance from the compressing of the STA, the compression distance being defined as an axial distance the tonometer travels starting when the tonometer contacts tissue of the subject;
determining an elasticity of a tissue surrounding the STA based on the compression distance;
determining a blood pressure measurement based on the elasticity of the tissue surrounding the STA and the pressure measurement.
set forth a judicial exception. These steps describe 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. These steps also describe managing personal behavior or relationships or interactions between people (including social activities, teaching, and following rules or instructions). Thus, the claim is also drawn to Organizing Human Activity, which is also an Abstract Idea.
STEP 2A, PRONG TWO
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 10 recites generating a real-time communication based on the blood pressure measurement, which is merely adding insignificant extra-solution activity to the judicial exception (MPEP 2106.05(g)). The generating of the real-time communication 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 generated real-time communication, nor does the method use a particular machine to perform the Abstract Idea.
STEP 2B
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 additional step of: receiving, from the tonometer, a pressure measurement for the STA. The receiving step is a well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, 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 comparing 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 obtaining and comparing 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.
The same rationale applies to claim 1.
Regarding claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited wearable device is an additional element that is not significantly more and the tonometry device and electric control unit are configured to perform the Abstract Ideas. 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. Claims 2, 3, 5-7, 9, and 11-17 recite steps of pre-solution activity of data gathering and/or steps that add to the Abstract Idea. Claims 4 and 8 recite additional elements that are not significantly more. The steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Zhang et al. ‘695 (US Pub No. 2016/0262695).
Regarding claim 1, Zhang et al. ‘695 teaches a blood pressure measurement device (Title, Abstract) comprising:
a wearable device (Fig. 1 wearable device 12 and [0028]);
a tonometry device coupled to the wearable device (Fig. 1 tonometer 18 and [0030]) and configured to compress a tissue of a subject including a superficial temporal artery (STA) when the tonometry device is positioned on the subject ([0030]), the tonometry device including at least a first pressure sensor (Fig. 1 blood pressure sensor 16 and [0030]); and
an electric control unit (Fig. 1 electronic control unit 30 and [0039]) in communication with the tonometry device ([0054]), the electric control unit configured to:
determine a compression distance from the compressing of the STA (Fig. 3 compression distance 80 and [0037]), the compression distance being defined as an axial distance the tonometry device travels starting when the tonometry device contacts tissue of the subject (Fig. 3 compression distance 80 and [0037]);
determine an elasticity of a tissue surrounding the STA based on the compression distance ([0037]-[0038]; “elasticity”);
determine, based at least in part on a first signal from the first pressure sensor, a blood pressure signal ([0035]; “measuring waveforms of blood pressure signals using tonometry”);
determine a first arterial blood pressure measurement, based on the blood pressure signal ([0031]; “ABP”) and the elasticity of the tissue ([0038]; “ABP”); and
generate a real-time communication at least partially based on the first arterial blood pressure measurement (Fig. 4 process block 112 and [0041]).
Regarding claim 2, Zhang et al. ‘695 teaches an optical hemodynamic sensor in communication with the electric control unit, the optical hemodynamic sensor coupled to the wearable device and configured to illuminate a tissue of the subject and acquire a hemodynamic signal (Fig. 1 optical hemodynamic sensor 22 and [0033], [0046]),
wherein the electrical control unit is further configured to determine, based on the hemodynamic signal a second arterial blood pressure measurement (Fig. 7A and [0050]-[0051], [0053]).
Regarding claim 3, Zhang et al. ‘695 teaches wherein the electrical control unit is configured to calculate, based on the hemodynamic signal, a hemodynamic measurement comprising a change in hemoglobin concentration ([0033]), wherein the second arterial blood pressure measurement is based on the hemodynamic measurement ([0052]-[0053]).
Regarding claim 4, Zhang et al. ‘695 teaches wherein the second arterial blood pressure is determined based in part on a hydrostatic pressure reference ([0044], [0046]).
Regarding claim 5, Zhang et al. ‘695 teaches wherein the electric control unit is further configured to determine a multi-modal blood pressure measurement based on the first blood pressure measurement and the second blood pressure measurement, wherein the real-time alert is based on the multi-modal blood pressure measurement ([0047]).
Regarding claim 6, Zhang et al. ‘695 teaches wherein the electric control unit is further configured to determine a first signal quality index for the first arterial blood pressure measurement and a second signal quality index for the second arterial blood pressure measurement, wherein the multi-modal blood pressure measurement is based, at least in part, on the first signal quality index and the second signal quality index ([0047]; “SQI”).
Regarding claim 7, Zhang et al. ‘695 teaches at least one auxiliary sensor in communication with the electric control unit and coupled to the wearable device (Fig. 1 auxiliary sensor 24 and [0033]), the at least one auxiliary sensor configured to measure a potential error source for the second arterial blood pressure measurement ([0047]), wherein the electric control unit is further configured to:
receive, from the at least one auxiliary sensor, a first measurement ([0047]);
determine, based on the first measurement, the second signal quality index ([0047]).
Regarding claim 8, Zhang et al. ‘695 teaches wherein the at least one auxiliary sensor includes a temperature sensor (Fig. 1 auxiliary sensor 24 and [0033]).
Regarding claim 9, Zhang et al. ‘695 teaches an electrocardiograph (ECG) sensor in communication with the electric control unit ([0045]; “ECG”), wherein the electric control unit is further configured to:
determine, based on at least one ECG signal received from the ECG sensor, a pulse transit time ([0045]); and
determine, based at least in part on the pulse transit time, the first arterial blood pressure measurement ([0045]).
Regarding claim 10, Zhang et al. ‘695 teaches a method for monitoring blood pressure of a subject, the method comprising:
compressing a superficial temporal artery (STA) using a tonometer (Fig. 1 process block 100 and [0041]);
contacting tissue that includes the STA using the tonometer (Fig. 1 process block 100 and [0041]; One of ordinary skill would understand that in order to compress the STA, the tonometer would have to contact the tissue.);
receiving, from the tonometer, a pressure measurement for the STA (Fig. 1 process block 102 and [0041]);
determining a compression distance from the compressing of the STA, the compression distance being defined as an axial distance the tonometer travels starting when the tonometer contacts tissue of the subject (Fig. 3 compression distance 80 and [0037]);
determining an elasticity of a tissue surrounding the STA based on the compression distance (Fig. 4 process block 104 and [0037], [0041]);
determining a blood pressure measurement based on the elasticity of the tissue surrounding the STA and the pressure measurement (Fig. 4 process block 110 and [0038], [0041]); and
generating a real-time communication based on the blood pressure measurement (Fig. 1 process block 112 and [0041]).
Regarding claim 11, Zhang et al. ‘695 teaches recording an electrocardiograph (ECG) waveform with an ECG sensor ([0045]; “ECG”);
determining a pulse transit time from the ECG waveform ([0045]);
wherein the blood pressure measurement is further based on the ECG waveform ([0045]).
Regarding claim 12, Zhang et al. ‘695 teaches measuring a hemodynamic signal with a hemodynamic sensor, the hemodynamic sensor being configured to emit light, and receive optical data based on the emitted light (Fig. 1 optical hemodynamic sensor 22 and [0033], [0046]),
wherein the blood pressure measurement is further based on the optical data (Fig. 7A and [0050]-[0053]).
Regarding claim 13, Zhang et al. ‘695 teaches receiving, from an auxiliary sensor (Fig. 1 auxiliary sensor 24 and [0033]), an auxiliary measurement of a potential error source for the hemodynamic sensor ([0047]);
determining, based on the auxiliary measurement, a first signal quality index for the hemodynamic sensor ([0047]),
wherein the blood pressure measurement is further based on the first signal quality index ([0047]).
Regarding claim 14, Zhang et al. ‘695 teaches wherein the tonometer includes a sensor array having a testing sensor (Fig. 2 testing sensors 56 and [0036]) and a reference sensor (Fig. 2 reference sensors 58 and [0036]), the testing sensor being a pressure sensor ([0039]; “the sensor array [50] may consist of multiple piezoresistive or other type of pressure sensors”), and the reference sensor being a second pressure sensor ([0039]; “the sensor array [50] may consist of multiple piezoresistive or other type of pressure sensors”), when the sensor array contacts the tissue, the testing sensor is adjacent to the STA and the reference sensor is situated away from the STA, such that a surface of the reference sensor contacts tissue not including the STA; and
wherein receiving the pressure measurement comprises receiving first pressure data including cardiac pulses of the STA from the testing sensor (Figs. 2, 3 and [0036]; “Tissue 72 near an STA 74 is divided into a testing region 76 and a reference region 78. Correspondingly, the sensor array 50 of FIG. 2 is divided into a region of testing sensors 56 and a region of reference sensors 58.”); and
wherein the method further comprises receiving second pressure data from the reference sensor (0037]).
Regarding claim 15, Zhang et al. ‘695 teaches correcting the first pressure data using the second pressure data to produce a corrected pressure measurement, wherein the pressure measurement is based on the corrected pressure measurement ([0038]).
Regarding claim 16, Zhang et al. ‘695 teaches actuating an event button (Fig. 1 event button 28 and [0048]), wherein the cardiac pulses are sensed and the pressure data is received after actuation of the event button (Fig. 6 and [0048]-[0050]); and
wherein the even button is actuated prior to a subject performing at least one of a Valsalva maneuver ([0049], [0052]), and a micturition event ([0049]).
Regarding claim 17, Zhang et al. ‘695 teaches determining that a first sensor of the sensor array is the testing (Fig. 2 testing sensor 56 and [0036]), and
determining that a second sensor of the sensor array is the reference sensor (Fig. 2 reference sensor 58 and [0036]).
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 1, 10-12, 14, and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, 14, 16, 17, 19, 20, and 23 of U.S. Patent No. 11,850,066. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1, 13, 14, 16, 17, 19, 20, and 23 of the US Patent is narrower in scope than claims 1, 10-12, 14, and 16 of the current invention, and encompasses all of the subject matter of claims 1, 10-12, 14, and 16. Therefore, any reference meeting the limitations set forth in claims 1, 13, 14, 16, 17, 19, 20, and 23 of the US Patent would also meet the limitations set forth in claims 1, 10-12, 14, and 16 of the current invention. Therefore, any reference meeting the limitations set forth in claims 1, 13, 14, 16, 17, 19, 20, and 23 of the US Patent would also meet the limitations set forth in claims 1, 10-12, 14, and 16 of the current invention.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AURELIE H TU whose telephone number is (571)272-8465. The examiner can normally be reached [M-F] 7:30-3:30.
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/AURELIE H TU/ Primary Examiner, Art Unit 3791
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