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 .
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 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.
Status of Claims
Claims 1-20 are pending and under consideration for patentability.
Claim Rejections - 35 USC § 102
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5, 11, 13-15, and 20 are rejected under 35 U.S.C. 102(a)(1) and 35 U.S.C. 102(a)(2) as being anticipated by Telfort et al. (US 2009/0093687 A1).
Regarding claim 1, Telfort describes an integrated sensing device for heart sounds ([0156]: “in some cases the acoustic signal processing system monitors other physiological sounds, such as…heart sounds (S1, S2, S3, S4, and murmurs), and change in heart sounds such as normal to murmur or split heart sounds indicating fluid overload”) and ECG signals ([0157]: “in certain embodiments, the physiological monitoring system comprises or includes an electrocardiograph (ECG) that measures and/or determines electrical signals generated by the cardiac system of a patient”), comprising
sensing units configured to capture multiple heart sounds and ECG signals at multiple different positions ([0014]: “each device typically has its own sensor and processing system, and is often connected to multiple tissue sites on the patient”)
each sensing unit including a flexible substrate having an upper surface and a lower surface ([0391], [0393], piezoelectric film and flexible substrate 3108 as embodied in figure 31), and a bottom electrode on said lower surface of said flexible substrate ([0425] - [0426])
a piezoelectric layer arranged on said upper surface of said flexible substrate ([0391], [0393])
a piezoelectric electrode disposed on said piezoelectric layer ([0425] - [0426])
a buckle passing through said flexible substrate and said piezoelectric layer (figure 31, cap 3110; [0071], contact bump)
Regarding claim 2, Telfort describes wherein said bottom electrode is employed for sensing electrocardiogram signals ([0165], figure 2C, conventional ECG electrode), and said bottom electrode and said piezoelectric electrode being used for sensing heart sound signals ([0391] - [0392]).
Regarding claim 3, Telfort describes a system circuit board electrically connected to said sensing units for pre-processing collected heart sounds and ECG signals ([0020], [0243]: “the electronic components include filters, amplifiers, etc. for pre-processing…”).
Regarding claim 4, Telfort describes wherein said system circuit board includes a signal pre-processing module for filtering, amplifying and digitizing said heart sound and ECG signals to generate preprocessing signals ([0243]), and a microprocessor electrically connected to said signal pre-processing module to receive said pre-processing signal ([0243], processor, central processing unit; [0316], multi-purpose microprocessor) to obtain noise free signals ([0318]: “the filter 2202 may include a low pass filter that attenuates high frequency signals…because such signals often include noise”), and to store said noise free signals in a storage unit ([0160]).
Regarding claim 5, Telfort describes transmitting said noise free signals to an external computing device ([0231]: “the primary microcontroller 521 also includes a communication interface to support communication with a data collection host 533 or other external component”).
Regarding claim 11, Telfort describes wherein said system circuit board is arranged on said flexible substrate ([0020]).
Regarding claim 13, Telfort describes wherein said piezoelectric layer includes polyvinylidene fluoride ([0389]).
Regarding claim 14, Telfort describes an integrated sensing device for heart sounds ([0156]: “in some cases the acoustic signal processing system monitors other physiological sounds, such as…heart sounds (S1, S2, S3, S4, and murmurs), and change in heart sounds such as normal to murmur or split heart sounds indicating fluid overload”) and ECG signals ([0157]: “in certain embodiments, the physiological monitoring system comprises or includes an electrocardiograph (ECG) that measures and/or determines electrical signals generated by the cardiac system of a patient”), comprising
sensing units configured to capture multiple heart sounds and ECG signals at multiple different positions ([0014]: “each device typically has its own sensor and processing system, and is often connected to multiple tissue sites on the patient”)
each sensing unit including a flexible substrate having an upper surface and a lower surface ([0391], [0393], piezoelectric film and flexible substrate 3108 as embodied in figure 31), and a bottom electrode arranged on said lower surface of said flexible substrate ([0425] - [0426]) for sensing electrocardiogram signals ([0165]), said bottom electrode and said piezoelectric electrode are used for sensing heart sound signals ([0391] - [0392])
a piezoelectric layer arranged on said upper surface of said flexible substrate ([0391], [0393])
a piezoelectric electrode disposed on said piezoelectric layer ([0425] - [0426])
a buckle passing through said flexible substrate and said piezoelectric layer (figure 31, cap 3110; [0071], contact bump)
a system circuit board electrically connected to said sensing units for pre-processing collected heart sounds and ECG signals ([0020], [0243]: “the electronic components include filters, amplifiers, etc. for pre-processing…”).
Regarding claim 15, Telfort describes wherein said system circuit board includes a signal pre-processing module for filtering, amplifying and digitizing said heart sound and ECG signals to generate preprocessing signals ([0243]), and a microprocessor electrically connected to said signal pre-processing module to receive said pre-processing signal ([0243], processor, central processing unit; [0316], multi-purpose microprocessor) to obtain noise free signals ([0318]: “the filter 2202 may include a low pass filter that attenuates high frequency signals…because such signals often include noise”), and to store said noise free signals in a storage unit ([0160]).
Regarding claim 20, Telfort describes wherein said piezoelectric layer includes polyvinylidene fluoride ([0389]).
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.
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 6-10 and 16-19 are rejected under 35 U.S.C. 103 as being unpatentable over Teflort in view of Darbari et al. (US 2018/0116626 A1).
Regarding claims 6, 7, and 16, Teflort describes the device of claim 5 and claim 14 but does not explicitly disclose wherein said external computing device analyzes and cross-compares said noise free signals. However, Darbari also describes an integrated sensing device for heart sounds and ECG signals ([0032]), including an external computing device for analyzing and cross-comparing noise free signals ([0039], external device or processor; [0041] - [0042]). As Darbari is also directed towards sensing heart sounds and ECG signals and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate an external component for analysis and cross-comparison, similar to that described by Darbari, when using the device described by Telfort, as doing so advantageously allows a portion of the processing components to be located away from the patient, thereby minimizing the weight and number of components placed upon the patient’s body.
Regarding claims 8 and 17, Darbari describes wherein steps of said analysis and cross-comparison include signal processing, feature extraction, feature point comparison and classification (figure 5).
Regarding claims 9 and 18, Darbari describes wherein said classification is to classify normal and abnormal heart sounds and ECG signals by AI algorithms ([0034], [0049]).
Regarding claims 10 and 19, Darbari describes wherein said AI algorithms perform following steps by an electronic computing equipment (figure 5)
pre-filtering and normalizing input heart sounds and ECG signals ([0042])
extracting time-domain and frequency-domain features from said pre-filtered and normalized heart sounds and electrocardiograms ([0042], [0049])
outputting classification results for said time domain and frequency domain features by convolutional neural network model ([0049])
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Telfort in view of Guo et al. (US 2016/0324487 A1).
Regarding claim 12, Telfort describes the device of claim 1 but does not explicitly disclose wherein said flexible substrate includes a fabric, polysiamine or polyethylene terephthalate. However, Guo also describes an integrated sensing device for heart sounds and ECG signals ([0117], [0119]), including a flexible substrate made of polyethylene terephthalate ([0059], figure 1). As Guo is also directed towards sensing heart sounds and ECG signals and is in a similar field of endeavor, it would have been obvious to a person having ordinary skill in the art at the time the invention was filed to incorporate a polyethylene terephthalate substrate similar to that described by Guo when using the device described by Telfort, as doing so advantageously allows the resulting device to flex in order to accommodate various positions on the patient’s body while maintaining proper contact between the sensors and the patient.
Statement on Communication via Internet
Communications via Internet e-mail are at the discretion of the applicant. Without a written authorization by applicant in place, the USPTO will not respond via Internet e-mail to any Internet correspondence which contains information subject to the confidentiality requirement as set forth in 35 U.S.C. 122. Where a written authorization is given by the applicant, communications via Internet e-mail, other than those under 35 U.S.C. 132 or which otherwise require a signature, may be used. USPTO employees are NOT permitted to initiate communications with applicants via Internet e-mail unless there is a written authorization of record in the patent application by the applicant. The following is a sample authorization form which may be used by applicant:
“Recognizing that Internet communications are not secure, I hereby authorize the USPTO to communicate with the undersigned and practitioners in accordance with 37 CFR 1.33 and 37 CFR 1.34 concerning any subject matter of this application by video conferencing, instant messaging, or electronic mail. I understand that a copy of these communications will be made of record in the application file.”
Please refer to MPEP 502.03 for guidance on Communications via Internet.
Conclusion
Any inquiry concerning this communication or earlier communications from the Examiner should be directed to Ankit D. Tejani, whose telephone number is 571-272-5140. The Examiner may normally be reached on Monday through Friday, 8:30AM through 5:00PM EST. 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, Carl Layno, can be reached by telephone at 571-272-4949. 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 at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative or access to the automated information system, call 800-786-9199 (in USA or Canada) or 571-272-1000.
/Ankit D Tejani/
Primary Examiner, Art Unit 3796