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 § 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.
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 10 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).
Claim 10 recites “sensor is attached to said user’s chest” in line 2. Specifically, the claiming of structures being in contact with the body amounts to an inferential recitation of the body, which renders these claims non-statutory. The examiner recommends changing “is attached to” to --is configured to be attached--.
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 and 8-20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Trapero et al. (US 11,116,448 B1).
As to claim 1, Trapero et al. discloses a wearable physiological signal sensing system (Abstract; Figures 1, 5 and 7) comprising: a circuit board (printed circuit board, PCB; depicted in Figure 2; col. 10, lines 20-40) having an upper surface and a lower surface (Figure 2; col. 10, lines 20-40); a stethoscope (col. 10, lines 12-19; “electronics module 102 as an auscultation device in a fashion similar to that of a stethoscope”) formed on said lower surface and electrically connected to said circuit board for sensing a user's heart, lung or intestinal sound signal (col. 11, line 29- col. 12, line 12); and a plurality of ECG electrodes (depicted as 230 in Figure 2; col. 10, lines 41-58) disposed on said lower surface for sensing an ECG signal of said user (Figure 2; col. 10, line 41- col. 11, line 2).
As to claim 8, Trapero et al. discloses said stethoscope includes a diaphragm (sensor window, depicted as 112 in Figure 1; diaphragm is a partition. As such, under the broadest reasonable interpretation, the sensor window is a diaphragm) disposed on said lower surface of said circuit board (Figure 1 and 5).
As to claim 9, Trapero et al. discloses a sound isolation ring (bottom portion, depicted as 106 in Figure 1 and 406 in Figure 4) surrounds said diaphragm, thereby forming a resonance cavity with said circuit board (Figures 1 and 4).
As to claim 10, Trapero et al. discloses a piezoelectric sensor (col. 34, lines 21-34). The piezoelectric sensor is an audio signaling device (e.g., a buzzer) that that provides output feedback to alert the wearer of events or alerts (col. 34, lines 21-34). Therefore, under a broadest reasonable interpretation, the piezoelectric signaling device is a piezoelectric sensor that by notifying the patient of “medical alerts” effectively “monitors physiological signals” of the patient. Furthermore, Trapero et al. disclose placing the device on the users chest (Figure 7), thus the examiner considers the piezoelectric sensor is attached to the user’s chest.
As to claim 11, Trapero et al. discloses said wearable physiological signal sensing system is connected to an external mobile device to transmit said physiological signal (Figure 19A-19B).
As to claim 12, Trapero et al. discloses said wearable physiological signal sensing system is connected to a cloud server (col. 32, line 16- col. 33, line 3) or an edge computing device to process and analyze said physiological signal (col. 32, line 16- col. 33, line 46).
As to claim 13, Trapero et al. discloses an e-SIM formed on said circuit board (col. 32, lines 16-41).
As to claim 14, Trapero et al. discloses said wearable physiological signal sensing system is connected to an external mobile device through said e-SIM to transmit said physiological signal (col. 32, lines 16-57).
As to claim 15, Trapero et al. discloses said wearable physiological signal sensing system is connected to a cloud server through said e-SIM to transmit said physiological signal (col. 32, line 16- col. 33, line 3).
As to claim 16, Trapero et al. discloses said wearable physiological signal sensing system is connected to an edge computing device through said e-SIM to transmit said physiological signal (col. 32, line 16- col. 33, line 46).
As to claim 17, Trapero et al. discloses said stethoscope collects biometrics identity (col. 31, lines 8-60; col. 42, lines 41-45; microphone for sensing voice signals and thus collects biometrics identity data).
As to claim 18, Trapero et al. discloses said stethoscope performs heart rate analysis to determine whether it is an emergency (col. 11, lines 29-48; “Determining the origin location of an auscultatory signal can be useful in diagnosing a user”. Therefore, based on a broadest reasonable interpretation, “diagnosing a user”, would “determine whether it is an emergency”; also see col. 37, lines 27-34).
As to claim 19, Trapero et al. discloses wireless charging coils (col. 9, lines 28-47).
As to claim 20, Trapero et al. discloses said stethoscope includes a plurality of through holes to allow sound to be received by a resonance cavity (col.7, line 64- col.8, line 4; col. 8, line 41-col. 9, line 18).
Claim Rejections - 35 USC § 103
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.
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 2-7 are rejected under 35 U.S.C. 103 as being unpatentable over Trapero et al. (US 11,116,448 B1).
As to claim 2, Trapero et al. discloses an oximeter for sensing a blood oxygen level and a pulse wave signal of said user (col. 37, lines 35-54). However, Trapero et al. disclose the oximeter is arranged on the lower surface of the circuit board (col. 8, line 41-col. 9, line 6). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the location of the oximeter, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70 (see MPEP 2144.04). Furthermore, such a modification to the PCB to modify the location of the components would provide the predictable results of providing “a space saving design” by using both the upper and lower surfaces of the PCB (col. 8, line 41-col. 9, line 6).
As to claim 3, Trapero et al., and thus the modified Trapero et al., discloses comprising steps of comparing said ECG signal with said pulse wave signal, or comparing a heart sound signal with said pulse wave signal, for obtaining a pulse wave transit time of said user, and followed by calculating a continuous blood pressure of said user (col. 11, lines 29-36).
As to claim 4, Trapero et al., and thus the modified Trapero et al., discloses said continuous blood pressure is used to predict a blood pressure (col. 5, line 64- col. 6, line 19) by an artificial intelligence (AI) algorithm (col. 40, line 30- col. 41, line 26).
As to claim 5, Trapero et al., and thus the modified Trapero et al., discloses a multivariate linear model is established by said artificial intelligence algorithm using a time domain characteristics of said pulse wave signal (col. 40, line 30- col. 41, line 26) and pulse wave transit time and “Health Record (EHR) 19122 within a database system. The user's EHR 19122 may contain other health and personal information not acquired from the smart patch 1900 (e.g., physician notes from clinic visits, information about prescribed medications and doses, vaccination records, lab reports, diagnostic imaging records, family medical history, genetic information, gut microbiome analysis, etc)” (col. 40, line 30- col. 41, line 26). The modified Trapaero et al. disclose the invention substantially as claimed with user health and personal information but does not explicitly disclose collecting or utilizing the height of said user. It would have been obvious to one having ordinary skill in the art at the time the invention was made to collect and utilize the users physical data, such as height, in order to provide the predictable results of optimizing treatment to meet specific patient therapeutic needs and requirements.
As to claim 6, Trapero et al., and thus the modified Trapero et al., discloses oximeter includes an infrared light source, a red-light source and a photoreceptor (col. 12, line 13 – col. 13, line 67). Additionally, the functional language and introductory statement of intended use has been carefully considered but are not considered to impart any further structural limitations over the prior art. Since Trapero et al. (and the modified Trapero et al.) utilize oximeter includes an infrared light source, a red-light source and a photoreceptor as claimed by the Applicant, Trapero et al. (and the modified Trapero et al.) are therefore capable of being used for sensing a fingertip pulse wave of said user. In addition nothing prevents Trapero et al. (and the modified Trapero et al.) from being used for sensing a fingertip pulse wave of said user. Therefore, the oximeter of Trapero et al. (and the modified Trapero et al.) is capable of being used for sensing a fingertip pulse wave of said user.
As to claim 7, Trapero et al., and thus the modified Trapero et al., discloses oximeter that is pressed into contact with the skin of the user (col. 53, lines 52-65). Therefore, Trapero et al. and thus the modified Trapero et al. disclose “user presses said oximeter to obtain said blood oxygen saturation level and said pulse wave signal” by pressing the oximeter against the skin of the user.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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