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 Objections
Claims1, 10, 6 and 17 are objected to because of the following informalities:
In claims 1 and 10 line 6, insert “is” between “monitor” and accessible”.
In claim 6 line 1, insert “is” between “storage” and accessible”.
In claim 17 line 10, insert “is” between “monitor” and accessible”.
Appropriate correction is required.
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 1-9 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stanczak et al (U.S. Patent Application Publication Number: US 2006/0167367 A1, hereinafter “Stanczak”).
Regarding claim 1, Stanczak teaches a wireless ECG system (e.g. Fig.1,3) for recording electrocardiograms (ECGs) of a patient, the wireless ECG system comprising:
a wireless portable ECG device having a plurality of wireless electrodes (i.e. ambulatory medical recording device (AMRD) e.g. 30 Fig.3, [0012], [0026] [0012],[0026]: recording device may be an ambulatory medical recording device (AMRD) and has sensors in communication with the recording device via a wireless connection),
a monitor for displaying an ECG recording (e.g. 33 Fig. 3, [0027]), and
a wireless communication channel for transmitting said ECG recording to a remote device; wherein said monitor accessible for further analysis and inspection at said remote device (e.g. 20 Figs.1, 2,[0024], [0032], [0037], [0038]: The data recorded by the AMRD may be transmitted to the computer 15, 21 using wireless transfer); and
further wherein said displaying said ECG recording is real time (e.g. 20 Figs.1, 2, [0027], [0036], claim 13: each discrete recording device is configured to continuously receive, store, display, analyze and transmit physiological data gathered from its associated patient).
Regarding claim 2, Stanczak teaches said wireless communication channel is connected to the group consisting of at least one of an encrypted cloud storage (e.g. [0010]-[0012]:central computer, third party computers for storage and analysis), a hospital medical record system (e.g. [0010]-[0011]), and a printer (e.g. [0012]).
Regarding claim 3, Stanczak teaches said plurality of wireless electrodes are wireless suction electrodes (e.g. [0012],[0026]).
Regarding claim 4, Stanczak teaches said wireless communication channel is connected to a plurality of third-party devices (e.g. [0010], [0011]: management system, [0012]: printer).
Regarding claims 5-6, Stanczak teaches that said wireless communication channel connected to a plurality of computers including third party computers and storage for transmitted ECG data in real time for transmission, analysis and storage and can be observed at any time (e.g. [0010]-[0012]) and that the data is also encrypted accessible only by authorized individuals (e.g. [0011]: unique serial numbers, security options). Therefore they teach that the wireless communication channel is connected to cloud storage, and further wherein said encrypted cloud storage is selected from the group consisting of a central storage and a distributed storage accessible only by authorized individuals.
Regarding claims 7 and 8, Stanczak teaches that said wireless communication channel is connected to a hospital medical record system and a plurality of hospital medical record systems for directly transmitting said ECG recording for said real time monitoring and analysis by healthcare professionals (e.g. 151-15M Fig. 1[0010]-[0012], [0024], claim 13: each discrete recording device is configured to continuously receive, store, display, analyze and transmit physiological data gathered from its associated patient).
Regarding claim 9, Stanczak teaches said wherein said wireless communication channel is connected to one or more printers for generation of physical copies of said ECG recordings (e.g. [0012]).
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 10-16 are rejected under 35 U.S.C. 103 as being unpatentable over Stanczak et al (U.S. Patent Application Publication Number: US 2006/0167367 A1, hereinafter “Stanczak”) in view of Schwibner et al (U.S. Patent Application Publication Number: US 2011/0046688 A1, hereinafter “Schwibner”) OR Holman et al (U.S. Design Patent Number: US D1041661, hereinafter “Holman”) and further in view of Kheraj (U.S. Patent Application Publication Number: US 2021/0250708 A1, hereinafter “Kheraj”).
Regarding claim 10, Stanczak teaches wireless ECG system (e.g. Fig.1,3) for recording electrocardiograms (ECGs) of a patient, the wireless ECG system comprising:
a wireless portable ECG device having a plurality of wireless electrodes (i.e. ambulatory medical recording device (AMRD) e.g. 30 Fig.3, [0012], [0026] [0012],[0026]: recording device may be an ambulatory medical recording device (AMRD) and has sensors in communication with the recording device via a wireless connection),
a monitor for displaying an ECG recording (e.g. 33 Fig. 3, [0027]),
a wireless communication channel for transmitting said ECG recording to a remote device and wherein said monitor accessible for further analysis and inspection at said remote device (e.g. 20 Figs.1, 2, [0024], [0032], [0037], [0038]: The data recorded by the AMRD may be transmitted to the computer 15, 21 using wireless transfer); and
a housing (i.e. housing of the AMRD 30 as seen in Fig 3);
Stanczak does not specifically teach that the said housing has a drawer for housing said plurality of wireless electrodes and a UV light for disinfecting said plurality of wireless electrodes stored in said drawer.
In a similar field of endeavor, Schwibner teaches a portable handheld device comprising a compartment for storing electrodes (e.g. [0053],[0054], Figs. 1-5). Holman is another teaching of a portable electrocardiographic device with a touch screen display comprising a compartment (e.g. Fig. 9). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the housing of the AMRD in the teachings of Stanczak with a compartment for storage of electrodes as taught by Schwibner OR Holman in order to provide the predictable results of ease of use and a more user-friendly device.
Further Kheraj teaches that it is well known to include UV lights for sterilization in a storage container (e.g. 135 Fig 1). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the drawer in the housing of the AMRD as taught by Stanczak in view of Schwibner OR Holman with UV lights for disinfection of the stored material as taught by Kheraj in order to provide the predictable results of reducing cross contamination and improved safety and extending electrode life.
Regarding claim 11, Stanczak in view of Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches said displaying said ECG recording is real time (e.g. 20 Figs.1, 2, [0027], [0036], claim 63: each discrete recording device is configured to continuously receive, store, display, analyze and transmit physiological data gathered from its associated patient).
Regarding claim 12, Stanczak in view of Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches said wireless communication channel is connected to the group consisting of at least one of an encrypted cloud storage (e.g. [0010]-[0012]:central computer, third party computers for storage and analysis), a hospital medical record system (e.g. [0010]-[0011]), and a printer (e.g. [0012]).
Regarding claim 13, Stanczak in view of Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches said plurality of wireless electrodes are wireless suction electrodes (e.g. [0012],[0026]).
Regarding claim 14, Stanczak teaches that said wireless communication channel connected to a plurality of computers including third party computers and storage for transmitted ECG data in real time for transmission, analysis and storage and can be observed at any time (e.g. [0010]-[0012]) and that the data is also encrypted accessible only by authorized individuals (e.g. [0011]: unique serial numbers, security options). Therefore they teach that the wireless communication channel is connected to cloud storage, and further wherein said encrypted cloud storage is selected from the group consisting of a central storage and a distributed storage accessible only by authorized individuals.
Regarding claim 15, Stanczak in view of Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches that said wireless communication channel is connected to at least one hospital medical record systems for directly transmitting said ECG recording for said real time monitoring and analysis by healthcare professionals (e.g. 151-15M Fig. 1[0010]-[0012], [0024], claim 13: each discrete recording device is configured to continuously receive, store, display, analyze and transmit physiological data gathered from its associated patient).
Regarding claim 16, Stanczak in view of Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches said wherein said wireless communication channel is connected to one or more printers for generation of physical copies of said ECG recordings (e.g. [0012]).
Claims 17-20 are rejected under 35 U.S.C. 103 as being unpatentable over Stanczak et al (U.S. Patent Application Publication Number: US 2006/0167367 A1, hereinafter “Stanczak”) in view of Peterson et al (U.S. Patent Application Publication Number : US 2008/0281163 A1, hereinafter “ Peterson”) in view of Schwibner et al (U.S. Patent Application Publication Number: US 2011/0046688 A1, hereinafter “Schwibner”) OR Holman et al (U.S. Design Patent Number: US D1041661, hereinafter “Holman”) and further in view of Kheraj (U.S. Patent Application Publication Number: US 2021/0250708 A1, hereinafter “Kheraj”).
Regarding claim 17, Stanczak, teaches a wireless ECG system (e.g. Fig.1,3) for recording electrocardiograms (ECGs) of a patient, the wireless ECG system comprising:
a wireless portable ECG device having a plurality of wireless electrodes (i.e. ambulatory medical recording device (AMRD) e.g. 30 Fig.3, [0012], [0026] [0012],[0026]: recording device may be an ambulatory medical recording device (AMRD) and has sensors in communication with the recording device via a wireless connection),
a monitor for displaying an ECG recording (e.g. 33 Fig. 3, [0027]),
a wireless communication channel for transmitting said ECG recording to a remote device and wherein said monitor accessible for further analysis and inspection at said remote device (e.g. 20 Figs.1, 2,[0024], [0032], [0037], [0038]: The data recorded by the AMRD may be transmitted to the computer 15, 21 using wireless transfer); and
a housing (i.e. housing of the AMRD 30 as seen in Fig 3);
Stanczak does not specifically teach that said plurality of wireless electrodes integrated with a low power near-field communication (NFC) for transmitting said ECG recording to said remote device; wherein said NFC amplified by an amplifier for increasing strength of the transmitting of said ECG recording and further wherein said housing having a drawer for housing said plurality of wireless electrodes and a UV light for disinfecting said plurality of wireless electrodes stored in said drawer.
Peterson teaches an ECG collection device that comprises an NFC integrated circuit and an amplifier to amplify weak ECG signals (e.g. [0020], Fig. 1). Therefore it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the each of the electrodes of Stanczak to have an NFC integrated circuit and an amplifier as taught by Peterson in order to provide the predictable results of facilitating the process of interpreting resultant data.
Schwibner teaches a portable handheld device comprising a compartment for storing electrodes (e.g. [0053],[0054], Figs. 1-5). Holman is another teaching of a portable electrocardiographic device with a touch screen display comprising a compartment (e.g. Fig. 9). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to modify the housing of the AMRD in the teachings of Stanczak in view of Peterson with a compartment for storage of electrodes as taught by Schwibner OR Holman in order to provide the predictable results of ease of use and a more user-friendly device.
Further Kheraj teaches that it is well known to include UV lights for sterilization in a storage container (e.g. 135 Fig 1). Therefore, it would have been obvious to a person having ordinary skill in the art before the effective filing date of the invention to further modify the drawer in the housing of the AMRD as taught by Stanczak in view of Peterson and Schwibner OR Holman with UV lights for disinfection of the stored material as taught by Kheraj in order to provide the predictable results of reducing cross contamination and improved safety and extending electrode life.
Regarding claim 18, Stanczak in view of Peterson and Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches said displaying said ECG recording is real time (e.g. 20 Figs.1, 2, [0027], [0036], claim 63: each discrete recording device is configured to continuously receive, store, display, analyze and transmit physiological data gathered from its associated patient).
Regarding claim 19, Stanczak in view of Peterson and Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches said wireless communication channel is connected to the group consisting of at least one of an encrypted cloud storage (e.g. [0010]-[0012]:central computer, third party computers for storage and analysis), a hospital medical record system (e.g. [0010]-[0011]), and a printer (e.g. [0012]).
Regarding claim 20, Stanczak in view of Peterson and Schwibner OR Holman and Kheraj teaches the claimed invention as discussed above and Stanczak further teaches said plurality of wireless electrodes are wireless suction electrodes (e.g. [0012],[0026]).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Evans et al (U.S. Patent Application Publication Number: US 2015/0005608 A1, hereinafter “Evans”) teaches a wireless ECG recording system comprising a plurality of wireless electrodes and a wireless communication channel to an ECG monitor which is accessible at a remote device (e.g. Fig. 4D, [0043], [0059])
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/MALLIKA D FAIRCHILD/Primary Examiner, Art Unit 3792