DETAILED ACTION
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.
Claim(s) 9, 14-16 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claim(s) currently recite(s) a product.
Step 2A, Prong 1
Claim(s) 9 recite(s) “determine, via the at least one external processor, a clinically significant event based on a determined pathology”. The element is directed to the judicial exception of an abstract idea of a mental process of evaluation, judgement, or opinion that can be executed without the use of the claimed structure. A professional can perform the mental process of determining a clinically significant event based on vital sign data.
Step 2A, Prong 2
Claim(s) 9 recite(s) the additional elements of : “provide an indication when the clinically significant event is detected”.
This additional element is recited at such a high level of generality to simply amount to generic computer implementation of the abstract idea.
Step 2B
As noted in Step 2A, Prong 2, The claims recite the additional elements of: “provide an indication when the clinically significant event is detected”.
The additional elements are recited at such a high level of generality to simply amount to generic computer implementation of the abstract idea.
Elements from dependent claims
The additional elements of the dependent claims do not relate to the determination process and therefore constitute insignificant extra solution activity.
Claim Rejections - 35 USC § 112
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 1-3,7-10,and 14-16 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.
Claims 1 and 9 recite the limitation “package data to be transmitted, via the transmitter, to an external device based on a criteria”. However, the required criteria are not clearly listed in the claims or the specification and without clearly stating the criteria, it is unclear when the package data should be transmitted.
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.
Claim(s) 1-3,7,9,10,14, and 16 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Marriott et al (US20210059586A1); hereinafter Marriott.
Regarding claim 1, Marriott teaches a wireless vital sign patch ([0003] medical monitoring devices) apparatus comprising:
a printed circuit board ("PCB") ([0045] printed circuit board) comprising:
a transmitter ([0177] after collection, the data can be transmitted from its storage on device 100 back to the desired computing resource (FIGS. 3A and/or 4, e.g.));
a plurality of sensors comprising a heartrate monitor ([0181] the wearable device including one or more sensors for gathering health data of one or more of: heart rate), a gyroscope, and an accelerometer ([0181] the wearable device including one or more sensors for gathering health data of one or more of: motion or exertion);
at least one processor ([0181] processor), at least one memory comprising computer-executable instructions which, when executed by the at least one processor, cause the at least one processor to:
package data to be transmitted, via the transmitter, to an external device based on a criteria ([0177] after collection, the data can be transmitted from its storage on device 100 back to the desired computing resource (FIGS. 3A and/or 4, e.g.));
and a housing encapsulating the PCB, the housing composed a flexible material ([0050] an exterior housing 530 is shown in FIGS. 1H, 1H1, and 1I as it might be disposed over and contain the other parts. This might be made of a pliable or flexible silicone), the housing comprising an interfacing surface configured to reversibly interface with a patient ([0027] anisotropic conductive adhesive electrode interface that may permit electrical communication only between an electrode and a patient's skin immediately beneath the electrode).
Regarding claim 9, Marriott teaches a wireless vital sign detection system ([0003] medical monitoring devices) comprising:
a patch ([0197] a patch device such as a device 100) comprising:
a printed circuit board ("PCB") ([0045] printed circuit board) comprising:
a transmitter ([0177] after collection, the data can be transmitted from its storage on device 100 back to the desired computing resource (FIGS. 3A and/or 4, e.g.));
a plurality of sensors comprising a heartrate monitor ([0181] the wearable device including one or more sensors for gathering health data of one or more of: heart rate), a gyroscope, and an accelerometer ([0181] the wearable device including one or more sensors for gathering health data of one or more of: motion or exertion);
at least one patch processor ([0181] processor), at least one patch memory comprising computer-executable patch instructions which, when executed by the at least one patch processor, cause the at least one patch processor to:
package data to be transmitted, via the transmitter, to an external device based on a criteria ([0177] after collection, the data can be transmitted from its storage on device 100 back to the desired computing resource (FIGS. 3A and/or 4, e.g.));
a housing encapsulating the PCB, the housing composed a flexible material ([0050] an exterior housing 530 is shown in FIGS. 1H, 1H1, and 1I as it might be disposed over and contain the other parts. This might be made of a pliable or flexible silicone), the housing comprising an interfacing surface configured to reversibly interface with a patient ([0027] anisotropic conductive adhesive electrode interface that may permit electrical communication only between an electrode and a patient's skin immediately beneath the electrode);
and an external device ([0024] external device) comprising:
a receiver in wireless communication with the transmitter ([0076] emitters and receivers);
at least one external processor, at least one external memory comprising computer-executable external instructions which, when executed by the at least one external processor, cause the at least one external processor to:
receive, via the receiver, the packaged data ([0231] The signal is then digitized and transmitted wirelessly to a receiver);
determine, via the at least one external processor, a clinically significant event based on a determined pathology; and provide an indication when the clinically significant event is detected ([0025] automated event capture and/or allow immediate or delayed, local data interpretation).
Regarding claims 2 and 16, Marriott teaches the apparatuses of claim 1 and claim 9. Marriott further teaches the flexible material is transparent ([0046] substantially transparent or translucent device together with some other elements that may be used herewith).
Regarding claims 3 and 10, Marriott teaches the apparatuses of claim 1 and claim 9. Marriott further teaches the flexible material is silicone ([0050] An exterior housing 530 is shown in FIGS. 1H, 1H1, and 1I as it might be disposed over and contain the other parts. This might be made of a pliable or flexible silicone).
Regarding claims 7 and 14, Marriott teaches the apparatuses of claim 1 and claim 9. Marriott further teaches the housing further comprising an adhesive disposed on the interfacing surface ([0024] a conductive adhesive removably attached to the bottom surface of the flat elastic or resilient substrate, the conductive adhesive capable of adhering to skin of the patient or other user, fig. 1h part 513).
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.
Claim(s) 8 and 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marriott et al (US20210059586A1); hereinafter Marriott.
Marriott teaches the apparatuses of claims 1 and 9. Marriot does not anticipate a material that has an acoustic impedance similar to that of human tissue, however this limitation is obvious over the teachings of Marriott. Marriott teaches a “low electrical impedance path in between the layers of the device” ([0125]). If there is low electrical impedance between layers of the device and high impedance between the electrodes to prevent cross-talk, then it would be obvious that the impedance between the device and skin should be as continuous as possible.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dhrasti SNEHAL Dalal whose telephone number is (571)272-0780. The examiner can normally be reached Monday - Thursday 8:30 am - 6:00 pm, Alternate Friday off, 8:30 am - 5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Carl Layno can be reached at (571) 272-4949. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/D.S.D./Examiner, Art Unit 3796
/CARL H LAYNO/Supervisory Patent Examiner, Art Unit 3796