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 .
Response to Arguments
Applicant’s arguments, see Remarks, filed 7/28/2026, with respect to the rejections of claims 1-20 under 35 U.S.C. 112(d), 35 U.S.C. 102(a)(1) and 35 U.S.C. 103, have been fully considered and are persuasive in view of the amendments to the claims. Therefore, the rejections have been withdrawn. However, upon further consideration, a new grounds of rejection is made.
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.
Claims 1-10, 13-16 and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yang et al. (hereafter Yang)(US PgPub 2020/0317210) and in view of Bennett (US PgPub 2014/0300458).
Regarding claim 1, Yang discloses regarding claim 1, Yang discloses a medical device (Figures 10-12), comprising: a first monitoring interface having a first housing (Figures 10, 12, Element 2110 and Paragraphs 0045-0048 where a user places their left palm on at least one of a plurality of sensing modules); a second monitoring interface having a second housing (Figures 10, 12, Elements 2110 and Paragraphs 0045-0048 where a user places their right palm on at least one of a plurality of sensing modules); the first monitoring interface and the second monitoring interface being operatively linked (Figure 10, Element 2100 and Paragraphs 0045-0046 where the sensing modules are operatively linked in the information sensing system 2100); the first housing and the second housing being configured to be biased against a steering wheel of a vehicle (Figure 12, Elements 2110 and Paragraphs 0048 where the sensing modules are biased against an interior of the steering wheel); and wherein the biased first housing and the biased second housing expose the first monitoring interface and the second monitoring interface against a palm of a subject to maintain effective skin contact with the palm (Figure 12 and Paragraphs 0045-0048 where the sensing modules detect physiological information from the palms of the user). Yang does not specifically disclose where each housing comprises a bias component composed of a resilient material such that the biasing components urge the first housing and the second housing against the steering wheel to create a nominal contact force. Yang is silent with respect sensing module materials and effective biasing against the steering wheel using biasing components as claimed. In the same field of endeavor, Bennet discloses a steering wheel cover driver safety system which includes an innermost layer made of rubber or another highly resilient material that facilitates maximum grip with the steering wheel (Figure 2 and Paragraph 0023).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the rubber or highly resilient steering wheel cover material of Bennett to the driving assistance system of Yang, thereby composing the sensing modules with rubber or a highly resilient material, motivation being to ensure maximum grip with the steering wheel which facilitates more accurate readings by the sensing modules. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to compose the sensing modules with rubber or a highly resilient material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Regarding claim 2, Yang discloses wherein the first monitoring interface and the second
monitoring interface are operatively linked by a subsidiary module (Figure 10, Elements 2120, 2130 and
Paragraphs 0046-0047 where the sensing modules are operatively linked to a switching circuit and microcontroller).
Regarding claim 3, Yang discloses wherein the subsidiary module is coupled to the vehicle
(Figures 10-12 where the physiological information sensing system is provided in a vehicle).
Regarding claim 4, Yang discloses wherein operatively associated with the first monitoring
interface and the second monitoring interface, and contained in the first housing and the second
housing and the subsidiary module are at least two or more physiological monitor units (Figure 10,
Elements 2112, 2114 and Paragraphs 0047-0048 where the sensing modules include an ECG sensor and
a PPG sensor).
Regarding claim 5, Yang discloses wherein the two or more operatively associated physiological
monitor units include sensors, biomarkers, or the like, that when the first monitoring interface and the
second monitoring interface have effective skin contact with the palm of a subject, the two or more
physiological monitor devices sense or monitor physiological parameters (Figures 10-12 and Paragraphs
0045-0048 where physiological parameters of the user are monitored when skin contact with the
palm(s) of the user is detected).
Regarding claim 6, Yang discloses wherein the two or more operatively associated physiological
monitor units include sensors, biomarkers, or the like, that when the first monitoring interface and the
second monitoring interfaces have effective skin contact with the palm of a subject, the two or more
physiological monitor devices sense, monitor or determine a disease or disorder (Paragraphs 0033-0034
and 0045-0048 where disease and/or physiological disorders are monitored and determined).
Regarding claim 7, Yang discloses wherein the two or more operatively associated physiological monitor units include sensors, biomarkers, or the like, that when the first monitoring interface and the second monitoring interfaces have effective skin contact with the palm of a subject, the two or more physiological monitor devices sense, monitor or determine a disease or disorder, and forecast the disease or disorder (Paragraphs 0033-0034 and 0045-0048 where disease and/or physiological disorders are monitored, determined and predicted).
Regarding claim 8, Yang discloses wherein the two or more operatively associated physiological
monitor units include sensors, biomarkers, or the like, that when the first monitoring interface and the
second monitoring interfaces have effective skin contact with the palm of a subject, the two or more
physiological monitor devices sense, monitor or determine a disease or disorder continuously and/or in
real-time (Paragraphs 0026, 0033-0034 and 0045-0048 where disease and/or physiological disorders are
monitored and determined in real time).
Regarding claim 9, Yang discloses wherein the two or more operatively associated physiological
monitor units include sensors, biomarkers, or the like, that when the first monitoring interface and the
second monitoring interface have effective skin contact with the palm of a subject, the two or more
physiological monitor devices sense, monitor or determine the attention span, alertness, fitness and
general wellness of the subject (Paragraphs 0026, 0029, 0033-0034 and 0045-0048 where alertness and
general wellness of the user are monitored).
Regarding claim 10, Yang discloses wherein the biomarker is one or more of the group consisting
of electrocardiogram (ECG); respiration rate (RR); cardiac rhythm (CR), photoplethysmography (PPG);
body mass index (BMI); alkaline phosphatase (ALP); alanine transaminase (ALT); aspartate
aminotransferase (AST); arterial pH (Art pH); partial pressure of oxygen (PaO.sub.2); oxygen saturation
(SpO.sub.2%); partial pressure of carbon dioxide (PaCO.sub.2); red blood cell count (RBC); mean
corpuscular haemoglobin concentration (MCHC); mean corpuscular haemoglobin (MCH); mean platelet
volume (MPV); platelet distribution width (PDW); red cell distribution width (RDW); white blood cells (WBC); absolute neutrophil count (ANC); activated partial thromboplastin time (aPTT); partial
thromboplastin time; hypoxanthine; pulse transit time (PTT); pulse; blood pressure; capillary pulse
wave; arterial pulse wave and C-reactive protein (CRP) (Figure 10, Elements 2112, 2114 and Paragraphs
0047-0048 where the sensing modules include an ECG sensor and a PPG sensor).
Regarding claim 13, Yang discloses wherein the biomarker is cardiac rhythm (Paragraphs 0028,
0030 and 0031 where cardiac rhythm is determined).
Regarding claim 14, Yang discloses wherein the biomarker is pulse transit time (PTT) (Paragraph
0044 where PTT is determined).
Regarding claim 15, Yang discloses wherein the biomarker is pulse rate (Paragraph 0028 where
pulse rate is determined).
Regarding claim 16, Yang discloses wherein the biomarker is blood pressure (Paragraph 0028
where blood pressure is determined).
Regarding claim 19, Yang discloses wherein a subject is monitored continuously (Paragraphs
0026, 0033-0034 and 0045-0048 where disease and/or physiological disorders are monitored and
determined continuously in real time).
Regarding claim 20, Yang discloses a medical device (Figures 10-12), comprising: a monitoring
interface having a housing (Figures 10, 12, Elements 2110 and Paragraphs 0045-0048 where a user
places their left palm and right palms on at least one of a plurality of sensing modules); the housing
being configured to be biased against a steering wheel of a vehicle (Figure 12, Elements 2110 and
Paragraphs 0048 where the sensing modules are biased against an interior of the steering wheel); and
wherein the biased housing exposes the monitoring interface against a palm of a subject to maintain effective skin contact with the palm (Figure 12 and Paragraphs 0045-0048 where the sensing modules detect physiological information from the palms of the user). Yang does not specifically disclose a biasing component composed of a resilient material such that the biasing component urges the housing against the steering wheel to create a nominal contact force. Yang is silent with respect to sensing module materials and effective biasing against the steering wheel using a biasing component as claimed. In the same field of endeavor, Bennet discloses a steering wheel cover driver safety system which includes an innermost layer made of rubber or another highly resilient material that facilitates maximum grip with the steering wheel (Figure 2 and Paragraph 0023).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to provide the rubber or highly resilient steering wheel cover material of Bennett to the driving assistance system of Yang, thereby composing the sensing modules with rubber or a highly resilient material, motivation being to ensure maximum grip with the steering wheel which facilitates more accurate readings by the sensing modules. Furthermore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to compose the sensing modules with rubber or a highly resilient material since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice. In re Leshin, 125 USPQ 416.
Claims 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Bennett, as applied to claims 1-10, 13-16 and 19-20 above, and further in view of Ravishankar et al. (hereafter Ravishankar) PgPub 2023/0031328).
Regarding claims 11-12, Yang and Bennett do not specifically disclose wherein the biomarker is a partial pressure oxygen or an oxygen saturation. In the same field of endeavor, Ravishankar discloses a system for monitoring and alerting short-term oxygen support needs for patients where physiological data is tracked using partial pressure oxygen and an oxygen saturation (Paragraph 0048).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to provide the physiological data tracking using partial pressure oxygen and
oxygen saturation of Ravishankar to the physiological determination system of Yang and Bennett, motivation being to accurately detect and monitor oxygen related biomarkers which increases user and vehicle system security. Furthermore, the biomarkers were well known before the effective filing date of the claimed invention, such a modification involves routine skill in the art and would have been obvious absent of unexpected results.
Claims 17-18 are rejected under 35 U.S.C. 103 as being unpatentable over Yang in view of Bennett, as applied to claims 1-10, 13-16 and 19-20 above, and further in view of Park et al. (hereafter Park)(US PgPub 2020/0000353).
Regarding claims 17-18, Yang and Bennett do not specifically disclose wherein the first monitoring interface and the second monitoring interface sense, monitor or determine the capillary pulse wave and the arterial pulse wave, wherein the capillary pulse wave and the arterial pulse wave are determined simultaneously, sequentially or concomitantly. In the same field of endeavor, Park discloses an apparatus for measuring bioinformation where first and second sensors detect a capillary pulse wave
and an arterial pulse wave sequentially (Figure 2, Elements 110, 120 and Paragraphs 0059-0063 and
0070).
It would have been obvious to one of ordinary skill in the art before the effective filing date of
the claimed invention to provide the physiological data tracking using capillary pulse wave and arterial
pulse wave data sequentially of Park to the physiological determination system of Yang and Bennett, motivation being to accurately detect and monitor blood related biomarkers which increases user and vehicle system security. Furthermore, the biomarkers were well known before the effective filing date of the claimed invention, such a modification involves routine skill in the art and would have been obvious absent of unexpected results.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THOMAS D ALUNKAL whose telephone number is (571)270-1127. The examiner can normally be reached M-F 9AM-5PM.
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/THOMAS D ALUNKAL/Primary Examiner, Art Unit 2686
