DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the enablement requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to enable one skilled in the art to which it pertains, or with which it is most nearly connected, to make and/or use the invention. The meaning of “a pressure to restrict or completely block the flow of blood during systole” is defined or described in a way to enable one of ordinary skill in the art to make or use the invention.
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. The meaning of “a pressure to restrict or completely block the flow of blood during systole” lacks definite meaning.
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1-20 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Orbach (US 2009/0216132 A1) in view of Asada et al. (US 2007/0055163 A1).
Regarding claim 1, Orbach (‘132) teach a system comprising: a processor (“processor 12” see [0063]; and Fig. 1); and a signal acquisition device for acquiring signals which can be used to derive a measurement of the blood pressure of a user (“The sensor unit 32 includes an ECG sensor 2 and a pulse sensor 4” see [0063]; and Fig. 1), wherein the signal acquisition device comprises: a blood flow occlusion device adapted to have one side only of a body part pressed against it such that a range of pressures are applied by the body part to the blood flow occlusion device, wherein the range of pressures includes a pressure sufficient to restrict or completely block the flow of blood during systole (“finger sensor may be attached to the finger using a strap 75, or the sensor module may be shaped so that a finger may be pressed onto it” see [0085]; and Fig. 5), and a blood flow detecting device configured to detect the flow of blood through the body part in contact with the blood flow occlusion device (“the electrode 45, the light source 36 and the light detector 41 may be in contact with the individual's left hand grasping the telephone 71 while the individual touches the electrode 44 with a finger of his right hand” see [0086]; and Fig. 6); wherein the processor is configured to determine a measurement of blood pressure from the pressures and the detected flow of blood (“processing includes calculation of a blood pressure of the individual in a calculation involving the processing results of the signals 7 and 9. The sensing unit 32 thus functions as a cuff-free blood pressure monitor” see [0064]); and communicate a trend in measured blood pressure to the user (“portable monitor 14 includes a display 16 for displaying in real time data transmitted to the monitor 14 from the CPU 6” see [0064]).
Orbach (‘132) fail to explicitly teach a pressure sensor configured to measure the range of pressures applied by the body part to the blood flow occlusion device and determine a measurement of blood pressure from the applied pressures. However, Asada et al. (‘163) from the same field of endeavor do teach a pressure sensor configured to measure the range of pressures applied by the body part to the blood flow occlusion device and determine a measurement of blood pressure from the applied pressures (“The focal pressure can be measured by a pressure sensor 1408 located on or under the protrusion, or predicted from the design of the sensor unit 1400” see [0124]). It would be obvious to one of ordinary skill in the art to combine the invention of Orbach with the features of Asada et al. for the benefit of a smaller and more comfortable patient device (see Asada et al. [0123]).
Regarding claim 2, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, wherein previous measurements of the user's blood pressure are stored and analyzed to obtain the trend in measured blood pressure (see Orbach [0132]).
Regarding claim 3, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 2, wherein the processor communicates with a data service that links the measurement of blood pressure and the trend in measured blood pressure to an alert service for changes in the data (see Orbach [0132]).
Regarding claim 4, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, wherein the processor is adapted to correlate the measurement of blood pressure with previous measurements of the user's blood pressure (see Orbach [0132]).
Regarding claim 5, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, wherein the processor is configured to store personal data selected from the group consisting of height, weight, waist circumference, finger diameter, age, sex, and previous measurements for the user (see Orbach [0132]).
Regarding claim 6, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 5, wherein the processor is configured to determine the measurement of blood pressure from the applied pressures, the detected flow of blood, and the personal data (see Orbach [0132]).
Regarding claim 7, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, wherein the processor is programmed to provide the user with a recommendation for action based on the measurement of blood pressure (see Orbach [0132]).
Regarding claim 8, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, wherein the processor is programmed to transmit the measurement of blood pressure to a remote clinician or health care provider for analysis and to receive the results for said analysis (see Orbach [0132]).
Regarding claim 9, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, wherein the pressure sensor is further configured to acquire signals that are processed by the processor to determine the time at which the user's heart beats (see Orbach [0072]).
Regarding claim 10, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, further comprising an acoustic sensor, wherein the processor is adapted to analyze signals acquired by the acoustic sensor to identify the initiation of systole (see Orbach [0085]-[0087]).
Regarding claim 11, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 10, wherein the acoustic sensor is selected from the group consisting of a microphone, a geophone, and a vibration sensor (see Orbach [0085]-[0087]).
Regarding claim 12, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, further comprising an electrical sensor, wherein the processor is adapted to process signals from the electrical sensor to indicate the time at which systole is initiated (see Orbach [0085]-[0087]).
Regarding claim 13, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 12, wherein the processor is adapted to amplify and filter the signals from the electrical sensor (see Orbach [0064]).
Regarding claim 14, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 12, wherein the electrical sensor comprises an electrode associated with the blood flow occlusion device (see Orbach [0074]).
Regarding claim 17, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, wherein the device is configured to encrypt the measurement of blood pressure and transmit the encrypted data to a data service for analysis (see Orbach [0132]).
Regarding claims 18-20, the claims are rejected mutatis mutandis in view of the rejection of Orbach (‘132) in view of Asada et al. (‘163) of claim 1 above, including the pressure applying device of Asada et al. (“The focal pressure can be measured by a pressure sensor 1408 located on or under the protrusion, or predicted from the design of the sensor unit 1400” see [0124]).
Claims 15-16 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Orbach (US 2009/0216132 A1) in view of Asada et al. (US 2007/0055163 A1), as applied to claim 1 above, and further in view of Ross et al. (US 2008/0318563 A1).
Regarding claims 15-16, Orbach (‘132) in view of Asada et al. (‘163) teach the system of claim 1, but fail to explicitly teach an identity sensor adapted to take a fingerprint of the user. However, Ross et al. (‘563) from the same field of endeavor do teach an identity sensor adapted to take a fingerprint of the user (see [0031]). It would be obvious to one of ordinary skill in the art to combine the invention of Orbach with the features of Ross et al. for the benefit of protecting patient medical data and medical data verification.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARK REMALY whose telephone number is (571)270-1491. The examiner can normally be reached Mon - Fri 9:00 - 6:00.
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, Christopher Koharski can be reached at (571) 272-7230. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARK D REMALY/Primary Examiner, Art Unit 3797