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 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 11, 13-21 and 23 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lui (US 2018/0360323 A1).
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With respect to claim 11, Lui discloses a wearable system configured to be coupled to a subject, comprising (see Figure 1 showing the watch #101 in the users wrist): a first sensor to detect cardiac electrical activity of a subject (see paragraph 0066 and see Figures 2 and 3 showing wearable watch as seen in Figure 2 having pressure monitor #101 including a ECG #103 considered as the claimed cardiac electrical activity sensor); a second sensor to detect cardiac photonic activity of the subject (see paragraph 0063 disclosing a PPG sensor as also seen in Figure 3 as #309 considered as the claimed photonic sensor for the second signal with light base technology in the wearable watch seen in Figure 2); a third sensor to detect cardiac
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mechanical activity of the subject (see paragraph 0075 disclosing a accelerometer #313 also seen on Figure 3 as the claimed mechanical activity sensor in the wearable watch in Figure 2); a processor device communicatively coupled to each of the first sensor, the second sensor, and the third sensor (see paragraph 0069); and a non-transitory computer-readable storage medium having computer-executable instructions stored thereon that are executable by the processor device to perform or control performance of operations to monitor blood pressure of a subject based on the cardiac electrical activity, cardiac photonic activity, and cardiac mechanical activity detected by the first, second, and third sensors (see micro-controller #301 in Figure 3); wherein the operations comprise: generating a first signal representing cardiac electrical activity of the subject using the first sensor (see paragraph 0066); generating a second signal representing cardiac photonic activity of the subject using the second sensor (see paragraph 0063); generating a third signal representing cardiac mechanical activity of the subject using the third sensor, the cardiac mechanical activity including closures of heart valve of the subject (see paragraphs 0064 disclosing the PPG sensor #309 and paragraph 0066 for ECG sensor #103 could be used for a signal relating to a heartbeat which inherently means opening and closing of a of heart valve causing the heartbeat cycle); determining from the third signal a time period during which the subject is stationary (see paragraph 0015); extracting one or more features from portions of two or more of the first, second, or third signals corresponding to the time period, the one or more extracted features comprising at least one of a pulse transit time (PTT), a pulse arrival time (PAT), or blood vessel elastics (BVE) features (see paragraph 0079 disclosing the extraction of PTT feature in the ECG and PPG signal sensors); and determining a current blood pressure of the subject based on the one or more extracted features (see paragraph 0079).
With respect to claim 13, Lui discloses calibrating the wearable system with a prior blood pressure measurement generated by a blood pressure monitor at a prior time (see paragraph 0089).
With respect to claim 14, Lui discloses calibrating the wearable system with the prior blood pressure measurement from the blood pressure monitor comprises: extracting a prior PTT, a prior PAT, or prior BVE features of the subject from portions of the first, second, and third signals corresponding to a prior time period that includes the prior time or that is within a threshold elapsed time of the prior time; and determining a relationship between the prior blood pressure measurement and the prior PTT, the prior PAT, or the prior BVE features; and determining the current blood pressure of the subject is further based on the determined relationship (see paragraphs 0089-0090 disclosing extracting a prior PTT to determine the relationship).
With respect to claim 15, Lui discloses determining the current blood pressure comprises determining at least one of a current mean arterial blood pressure (MAP), a current systolic blood pressure (SBP), or a current diastolic blood pressure (DBP) (see paragraph 0006-0014 disclosing the determination of SBP and DBP).
With respect to claim 16, Lui discloses extracting one or more additional features from portions of two or more of the first, second, or third signals corresponding to the time period during which the subject is stationary, wherein determining the current blood pressure of the subject is further based on the one or more additional extracted features (see Figure 6 and paragraph 0140 disclosing the ventricular contraction and relaxation at points R and T considered rise and decent times wherein said times are the extraction of additional features from the signal within the period #601).
With respect to claim 17, Lui discloses extracting the one or more additional features comprises extracting at least one of: a pressure constant k (PK) that is related to a total peripheral resistance (TPR) of a circulatory system of the subject; a photoplethysmography area (PA) that is associated with the TPR and changes in blood vessel tension of the subject; a rise time (RT) that is associated with contractile force and left ventricular function of the subject; a descent time (DT) that is associated with ventricular diastole of the subject; a pulsatile hetero height (PHH) that is associated with a magnitude of cardiac output of the subject; a pulse wave amplitude (peak); a systolic upstroke interval (Ts); or a diastolic interval (Td) (see Figure 6 and paragraph 0140 disclosing the ventricular contraction and relaxation at points R and T considered as the claimed rise and decent time).
With respect to claim 18, Lui discloses the one or more extracted features comprises the PTT or the PAT and correspond to a cardiac cycle of the subject; the method further comprises: determining one or more additional PTTs or one or more additional PATs corresponding to one or more additional cardiac cycles represented in portions of the first, second, and third signals corresponding to the time period during which the subject is stationary; and determining an average PTT from the PTT and the one or more additional PTTs or an average PAT from the PAT and the one or more additional PATs; and determining the current blood pressure is further based on the average PTT or the average PAT (see paragraph 0006 disclosing a plurality of PTT and averaging said values).
With respect to claim 19, Lui discloses at least one of: the first sensor comprises an electrocardiogram (ECG) sensor and generating the first signal comprises generating an ECG signal (see paragraph 0066 and see Figures 2 and 3 showing wearable watch as seen in Figure 2 having pressure monitor #101 including a ECG sensor #103); the second sensor comprises a pulse oximeter and generating the second signal comprises generating a photoplethysmography (PPG) signal (see paragraph 0063 disclosing a PPG sensor as also seen in Figure 3 as #309 as the claimed oximeter); or the third sensor comprises at least one of an accelerometer or an acoustic sensor and generating the third signal comprises generating at least one of an accelerometer signal or an audio signal (see paragraph 0075 disclosing a accelerometer #313 also seen on Figure 3).
With respect to claim 20, Lui discloses the third signal comprises an accelerometer signal and wherein determining from the third signal the time period during which the subject is stationary comprises determining from the third signal that the subject is stationary from a first time at or before a beginning of the time period to a second time at or after an end of the time period during which the subject is stationary (see paragraphs 0075 and 0015).
With respect to claim 21, Lui discloses the first sensor is incorporated in a first device of the wearable system that is configured to be coupled to a first location on the subject; the second sensor is incorporated in a second device of the wearable system that is configured to be coupled to a second location on the subject that is different than the first location; and the first and second devices are configured to wirelessly synchronize to each other (see Figure 2 disclosing sensors #203 and #205 in device #101 located in different locations; see paragraph 0079 disclosing the same heartbeat used for the data of both sensors implicitly teaching synchronized).
With respect to claim 23, Lui discloses a method to monitor blood pressure of a subject, comprising: generating an electrocardiogram (ECG) signal over a plurality of cardiac cycles of the subject using an ECG sensor of a wearable device coupled to the subject (see paragraph 0066 and see Figures 2 and 3 showing wearable watch as seen in Figure 2 having pressure monitor #101 including a ECG sensor #103); generating an optical signal over the plurality of cardiac cycles using an optical sensor of the wearable system (see paragraph 0063 disclosing a PPG sensor as also seen in Figure 3 as sensor #309), wherein the ECG sensor and the optical sensor are integrated into the same wearable device (as seen on Figure 2 and 3 having both sensor in the monitoring watch #101); generating an accelerometer signal or an audio signal over the plurality of cardiac cycles using an accelerometer or acoustic sensor of the wearable device (see paragraph 0075 disclosing a accelerometer #313 also seen on Figure 3), the accelerometer signal or audio signal capturing vibrations or sound energy from closures of the heart valves of the subject (see paragraphs 0064 disclosing the PPG sensor #309 and paragraph 0066 for ECG sensor #103 could be used for a signal relating to a heartbeat which inherently means opening and closing of a of heart valve causing the heartbeat cycle); determining from the accelerometer signal or the audio signal a time period during which the subject is stationary, the time period encompassing a subset of two or more of the plurality of cardiac cycles; extracting, for each cardiac cycle of the subset, one or more features from portions of two or more of the ECG, optical, or accelerometer or audio signals corresponding to the time period during which the subject is stationary (see paragraph 0015), the one or more extracted features for each cardiac cycle comprising at least one of a pulse transit time (PTT), a pulse arrival time (PAT), or blood vessel elastics (BVE) features; and one of: determining, for each cardiac cycle of the subset, instantaneous blood pressure of the subject based on the corresponding PTT, PAT, or BVE features extracted for the corresponding cardiac cycle (see paragraph 0079 disclosing the extraction of PTT feature in the ECG and PPG signal sensors); or determining average blood pressure of the subject based on an average of the PTTs, PATs, or BVE features across the subset of two or more of the plurality of cardiac cycles (see paragraph 0079).
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 (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 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-10 and 24-26 are rejected under 35 U.S.C. 103 as being unpatentable over Lui (US 2018/0360323 A1) in view of Raisanen et al (US 2020/0312453 A1).
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With respect to claim 1, Lui discloses a method to monitor blood pressure of a subject, the method comprising: generating a first signal representing cardiac electrical activity of the subject using a first sensor of a wearable system (see paragraph 0066 and see Figures 2 and 3 incorporated herein showing wearable watch as seen in Figure 2 having pressure monitor #101 including a ECG #103 considered as the claimed cardiac electrical activity sensor); generating a second signal representing cardiac photonic activity of the subject using a second sensor of the wearable system (see paragraph 0063 disclosing a PPG sensor as also seen in Figure 3 as #309 considered as the claimed photonic sensor for the second signal with light base technology in the wearable watch seen in Figure 2 to measure the PTT, or pulse transit time according to paragraphs 0064 and 0144, which is a cardiac activity); generating a third signal representing cardiac mechanical activity of the subject using a third sensor of the wearable system, the cardiac mechanical activity including closures of heart valve of the subject (see paragraphs 0064 disclosing the PPG sensor #309 and paragraph 0066 for ECG sensor #103 could be used for a signal relating to a heartbeat which inherently means opening and closing of a of heart valve causing the heartbeat cycle), wherein the first, second, and third sensors are coupled to the subject (see Figure 4 showing the person wearing the watch #101); determining from the third signal a time period during which the patient is stationary (see paragraph 0015); extracting one or more features from portions of two or more of the first, second, or third signals corresponding to the time period during which the subject is stationary, the one or more extracted features comprising at least one of a pulse transit time (PTT), a pulse arrival time (PAT), or blood vessel elastics (BVE) features (see paragraph 0079 disclosing the extraction of PTT feature in the ECG and PPG signal sensors); and determining a current blood pressure of the subject based on the one or more extracted features (see paragraph 0079).
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Furthermore, Lui discloses the monitor #101, as seen on Figure 1, can be worn in other parts of the body (see paragraph 0076), but does not specify the sensor is coupled to the torso. However, Raisanen discloses the wearable sensor #120 can be coupled to the torso as see on Figure 2 according to paragraph 0119). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the sensor coupled to the torso as taught by Raisanen in combination with Lui’s sensor device for the purpose of providing an alternative location for the sensor different than the extremities since at the extremities can be problematic, such as being prone to body movements, and, thus, create movement artifacts in measurement data in the form of data that actually measures decreased blood perfusion in the case of hypothermia or trauma, limiting blood circulation, and showing delay up to 15 seconds when compared to chest measurement. Thus, PPG sensor performs measurements at consist sensor location on the chest with minimal discomfort to patient and with minimal signal delay or adverse measurement sensitivity to movement from patient to obtain measurement data as taught by Raisanen (see paragraph 0152).
With respect to claim 2, Lui discloses calibrating the wearable system with a prior blood pressure measurement generated by a blood pressure monitor at a prior time (see paragraph 0089).
With respect to claim 3, Lui discloses calibrating the wearable system with the prior blood pressure measurement from the blood pressure monitor comprises: extracting a prior PTT, a prior PAT, or prior BVE features of the subject from portions of the first, second, and third signals corresponding to a prior time period that includes the prior time or that is within a threshold elapsed time of the prior time; and determining a relationship between the prior blood pressure measurement and the prior PTT, the prior PAT, or the prior BVE features; and determining the current blood pressure of the subject is further based on the determined relationship (see paragraphs 0089-0090 disclosing extracting a prior PTT to determine the relationship).
With respect to claim 4, Lui discloses determining the current blood pressure comprises determining at least one of a current mean arterial blood pressure (MAP), a current systolic blood pressure (SBP), or a current diastolic blood pressure (DBP) (see paragraph 0006-0014 disclosing the determination of SBP and DBP).
With respect to claim 5, Lui discloses extracting one or more additional features from portions of two or more of the first, second, or third signals corresponding to the time period during which the subject is stationary, wherein determining the current blood pressure of the subject is further based on the one or more additional extracted features (see Figure 6 and paragraph 0140 disclosing the ventricular contraction and relaxation at points R and T considered rise and decent times wherein said times are the extraction of additional features from the signal within the period #601).
With respect to claim 6, Lui discloses extracting the one or more additional features comprises extracting at least one of: a pressure constant k (PK) that is related to a total peripheral resistance (TPR) of a circulatory system of the subject; a photoplethysmography area (PA) that is associated with the TPR and changes in blood vessel tension of the subject; a rise time (RT) that is associated with contractile force and left ventricular function of the subject; a descent time (DT) that is associated with ventricular diastole of the subject; a pulsatile hetero height (PHH) that is associated with a magnitude of cardiac output of the subject; a pulse wave amplitude (peak); a systolic upstroke interval (Ts); or a diastolic interval (Td) (see Figure 6 and paragraph 0140 disclosing the ventricular contraction and relaxation at points R and T considered as the claimed rise and decent time).
With respect to claim 7, Lui discloses the one or more extracted features comprises the PTT or the PAT and correspond to a cardiac cycle of the subject; the method further comprises: determining one or more additional PTTs or one or more additional PATs corresponding to one or more additional cardiac cycles represented in portions of the first, second, and third signals corresponding to the time period during which the subject is stationary; and determining an average PTT from the PTT and the one or more additional PTTs or an average PAT from the PAT and the one or more additional PATs; and determining the current blood pressure is further based on the average PTT or the average PAT (see paragraph 0006 disclosing a plurality of PTT and averaging said values).
With respect to claim 8, Lui discloses at least one of: the first sensor comprises an electrocardiogram (ECG) sensor and generating the first signal comprises generating an ECG signal (see paragraph 0066 and see Figures 2 and 3 showing wearable watch as seen in Figure 2 having pressure monitor #101 including a ECG sensor #103); the second sensor comprises a pulse oximeter and generating the second signal comprises generating a photoplethysmography (PPG) signal (see paragraph 0063 disclosing a PPG sensor as also seen in Figure 3 as #309 as the claimed oximeter); or the third sensor comprises at least one of an accelerometer or an acoustic sensor and generating the third signal comprises generating at least one of an accelerometer signal or an audio signal (see paragraph 0075 disclosing a accelerometer #313 also seen on Figure 3).
With respect to claim 9, Lui discloses the third signal comprises an accelerometer signal and wherein determining from the third signal the time period during which the subject is stationary comprises determining from the third signal that the subject is stationary from a first time at or before a beginning of the time period to a second time at or after an end of the time period during which the subject is stationary (see paragraphs 0075 and 0015).
With respect to claim 10, Lui discloses a non-transitory computer-readable storage medium having computer-executable instructions stored thereon that are executable by a processor device to perform or control performance of the method of claim 1 (see Figure 3 showing a micro-controller to control the components as seen in the Figure).
With respect to claim 24, Lui discloses extracting one or more features from portions of two or more of the first, second, or third signals comprises extracting a PAT from portions of the second signal and the third signal (see paragraph 0080).
With respect to claim 25, Lui discloses extracting one or more additional features from portions of the third signal and one or both of the first and second signals, the portions corresponding to the time period during which the subject is stationary (see paragraph 0015), wherein determining the current blood pressure of the subject is further based on the one or more additional extracted features (see paragraph 0079).
With respect to claim 26, Lui discloses detecting an S1 feature and an S2 feature in the third signal representing cardiac mechanical activity of the subject, the S1 feature detected as a vibration or sound energy produced when atrioventricular valves of the subject close at the beginning of systole and the S2 feature detected as a vibration or sound energy produced when semilunar valves of the subject close at the end of systole (see paragraphs 0080-0087).
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lui (US 2018/0360323 A1) in view of Banet et al. (US 2010/0160798 A1).
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With respect to claim 22, Lui discloses the claimed inventio as stated above except for the first device is configured to be coupled to a torso of the subject; and the second device is configured to be coupled to an appendage of the subject. However, Banet discloses the first device is configured to be coupled to a torso of the subject (See Figure 24A provided herein showing a first device including an ECG electrodes 278a-278c on the patient’s torso); and the second device is configured to be coupled to an appendage of the subject (See Figure 24 A showing the pulse oximeter #292 on the patient’s finger). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have the first device configured to be coupled to a torso of the subject; and the second device is configured to be coupled to an appendage of the subject as taught by Banet in combination with Lui’s monitor for the purpose of having a choice of sensors located in any body location for performing the function of obtaining the blood pressure value as accurately as possible depending on the body placement and the accessibility of the patient as long as it is located in a place in contact with the patient’s vasculature to measure the pressure either by the subject itself or more accurately by a medical personnel according to the available equipment and setting.
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Lui (US 2018/0360323 A1) and Raisanen et al (US 2020/0312453 A1) in view of Stump (US 2021/0000347 A1).
With respect to claim 27, Lui and Raisanen disclose the claimed invention as stated above except for specifying that the one or more extracted features comprises at least one of the PAT or the BVE features. However, Stump discloses the one or more extracted features comprises at least one of the PAT or the BVE features (see paragraph 0163). Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was filed to have one or more extracted features comprising at least one of the PAT or the BVE features as taught by Stump in combination with Lui and Raisanen sensor device for the purpose of covering a wide range of physiological status from rest to exercise since changes in blood vessels inner diameter are expected to have change in the elasticity of the vessels or change the blood vessels inner diameter when blood pressure increases due to exercise or stress compared to static hence record any fluctuations in any status or due to a change in status as taught by (see paragraph 0163).
Response to Arguments
Applicant's arguments filed 10/23/25 have been fully considered but they are not persuasive.
Applicant argues that “claims 1 and 11 are herein amended to recite "generating a third signal representing cardiac mechanical activity ...including closures of heart valves of the subject". Support for this amendment to claim 1 is provided in at least paragraph 0055 of the instant application. Neither Lui nor Banet discloses "generating a third signal representing cardiac mechanical activity of the subject" generally, much less that "the cardia mechanical activity include[es] closures of heart valves of the subject" as now recited in amended claim 1.
To advance prosecution further still, claim 1 is herein amended to recite "wherein the first, second, and third sensors are coupled to a torso of the subject". Lui's wearable system is a wearable watch wearable on a user's wrist. Lui at, e.g., Figs. 1-2 and 4-5 and 0018 and 0062.
The examiner disagrees with applicant’s argument since Liu discloses the ECG sensor #103 is able to monitor the subject's heart beat (see paragraph 0066) wherein a heartbeat inherently means signals including opening and closing of a of heart valve causing the heartbeat composed of a pumping cycle of opening and closing the valves. Likewise, Liu discloses the optical sensor #203 is able to detect the heartbeat of the subject. In use, the PPG sensor is capable of sampling the subject's pulse and heart beat in real time (se paragraph 0064). Therefore, the heartbeat signal detected inherently includes the closing valve signal within the pumping cycle of opening and closing the valves.
Applicant argues regarding claim 1, that Banet's system includes a complicated series of sensors at various points on the body (e.g., torso, upper arm, wrist, and finger). Banet at, e.g., Figs. 22 and 24A-24B and 0127 and 0145-0146. Accordingly, Lui and Banet fail to disclose "wherein the first, second, and third sensors are coupled to a torso of the subject" as now recited in amended claim 1.
Applicant’s arguments with respect to claim 1 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Applicant argues that “in addition, the Office Action fails to present a prima facie case that dependent claims 6 and 17 are anticipated. In the rejection of claims 6 and 17, the Office Action alleges only that "Figure 6 and paragraph 0140 [of Lui disclose] the ventricular contraction and relaxation at points R and T considered as the claimed rise and decent time". Office Action at pp. 4-5. Paragraph 0140 and Fig. 6 of Lui simply label the well-know fiducial points of the ECG and their textbook definitions, including the R peak and the T point. However, extracting these particular points as allegedly done in Lui provides no indication as to or extraction of (1) the "rise time (RT) [e.g., a span between two points, not merely the location of a single point] that is associated with contractile force and left ventricular function of the subject" or (2) the "descent time (DT) [e.g., another span between two points, not merely the location of a single point] that is associated with ventricular diastole of the subject".
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., span between two points, not merely the location of a single point) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
For the reasons as stated above, the 35 U.S.C 102 and 35 U.S.C 103 rejections are maintained and considered proper.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The additional prior art cited in the PTO 892 not relied upon discloses blood pressure sensing devices directly measuring the heart valve closure or sensing PAT or BEV features.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DIXOMARA VARGAS whose telephone number is (571)272-2252. The examiner can normally be reached Monday-Friday 8am-5pm.
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/DIXOMARA VARGAS/Primary Examiner, Art Unit 3798