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
Claim 120 is objected to because of the following informalities: “the preferred orientation” lacks proper antecedent basis. The term was only previously recited in claims 117 and 119, neither of which is in the chain of dependency for claim 120. Appropriate correction is required.
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 111 and 112 rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claims 111 recites “preventing the signal leakage using an electrically insulating material” and claim 112 recites “preventing the signal leakage using a shock absorbing material configured to absorb or redirect external forces.” These limitations are not supported by the originally filed disclosure. The originally filed disclosure teaches that a spacer may be used, and that “In some embodiments, the spacer comprises an electrically insulating material. In some embodiments, the spacer prevents signal leakage between the electrodes. In some embodiments, the spacer comprises a shock absorbing material configured to absorb or redirect external forces.” (see e.g. Specification Para. 6). Notably, there is no disclosure that the insulating material or the shock absorbing material is related to preventing signal leakage. In other words, using claim 112 as an example, while there is disclosure of using a shock absorbing material, there isn’t disclosure that the shock absorbing material prevents signal leakage. As such, claims 111 and 112 are rejected for containing new matter.
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 102-104, 106-107 and 113-115 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by US 2010/0317958 A1 to Beck et al. (hereinafter “Beck”).
Regarding Claim 102, Beck teaches a method of amplifying a differential signal between two input signal voltages (see e.g. claim 23: “wherein the amplifier detects differential signals from opposite pairs of electrodes”) comprising:
contacting a skin surface of a user's body with a patch (see e.g. Para. 32: “the embodiments of the present invention described herein refer to patches placed on the skin surface”), wherein the patch comprises:
a base comprising two or more electrodes configured to measure a voltage (see e.g. 405 in FIG. 4);
a cover coupled to the base (see e.g. Para. 30: “Protective covering to withstand environmental hazards”), wherein the cover comprises one or more indicators associated with a preferred placement of the patch (see FIG. 7 and Para. 86: “… FIG. 7 shows an example of a graphic aid--a heart--imprinted on the top of the patch to help the patient orient the patch on their body”);
a radio configured to wirelessly transmit or receive data (see e.g. 406+407 in FIG. 8 and Para. 63; see e.g. claim 23: “a radio for wirelessly transmitting the digital signals”); and
an electronic module (see generally Paras. 39-46; also see e.g. 403 in FIG. 4) comprising:
an ASIC housed between the base and the cover (see e.g. Para. 39: “The functions shown in the figures may be instantiated with discrete circuits, one or more ASICs (Application Specific Integrated Circuits) or any combination of them.”); and
one or more instrument amplifiers configured to amplify a difference between voltages measured from two different electrodes (see e.g. claim 23: “wherein the amplifier detects differential signals from opposite pairs of electrodes”);
measuring a voltage from the two or more electrodes (see e.g. Para. 38: “the measurement of differential voltages across multiple pairs of electrodes”); and
amplifying a difference between the measured voltages (see e.g. claim 23: “wherein the amplifier detects differential signals from opposite pairs of electrodes”).
Regarding Claim 103, Beck teaches contacting the skin surface of the user at the preferred placement associated with the one or more indicators (see FIG. 7 and Para. 86: “… FIG. 7 shows an example of a graphic aid--a heart--imprinted on the top of the patch to help the patient orient the patch on their body”).
Regarding Claim 104, Beck teaches wherein the one or more indicators comprise a symbol, marking, sign, or shape (see FIG. 7 and Para. 86: “… FIG. 7 shows an example of a graphic aid--a heart--imprinted on the top of the patch to help the patient orient the patch on their body”).
Regarding Claims 106-107, Beck teaches communicating, using the patch, with one or more external devices via radio signals; wherein the one or more external devices comprise one or more of: cell phones, tablet, PDAs, or fitness trackers, or any combination thereof (see e.g. Para. 27: “Radio for transmission to a nearby mobile device or any other device” and Para. 2: “a mobile device such as a cell phone or a personal digital assistant”)
Regarding Claim 113, Beck teaches analyzing or processing gathered information using one or more processors of the patch (see e.g. Para. 2: “In some cases, the wireless sensors 12a-12n can have on-board processors to perform clinical analysis”).
Regarding Claims 114-115, Beck teaches generating and transmitting an alert to the user based on the analyzed or processed gathered information; generating, using the patch, a visual alert, an auditory alert, or a haptic alert to the user based on the analyzed or processed gathered information (see e.g. Para. 37: “The patch 100 could include in an embodiment output devices such as LEDs, displays or an audible tone that may function as warning signals or may signify other conditions to the patient.”).
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.
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 105 and 116-120 are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of US 8,150,502 to Kumar et al. (hereinafter “Kumar”).
Regarding Claim 105, Beck further teaches indicators comprising LEDs (see e.g. Paras. 37, 45) but fails to teach that the LEDs are used as indicators associated with a preferred placement of the patch. Another reference, Kumar, teaches an analogous cardiac monitoring patch including LEDs for this purpose (see e.g. Col. 20 lines 32-65). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Beck to utilize the LED(s) to convey information related to a preferred placement of the patch, as seen in Kumar, because it would advantageously help ensure that the patch is used in the preferred placement and therefore yields the most diagnostically accurate data.
Regarding Claims 116-117, Beck teaches generating instructions for the preferred placement of the patch; wherein the preferred placement of the patch comprises a preferred orientation of the patch. However, Beck fails to teach that this is done “based at least in part on one or more physiological signals.” Another reference, Kumar, teaches an analogous cardiac monitoring patch including generating instructions for the preferred placement of the patch based on sensed physiological signals (see e.g. Col. 20 lines 32-65 along with FIG. 9 and Col. 22 lines 28-31). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Beck to generate instructions based on one or more physiological signals, as seen in Kumar, because it would advantageously help ensure that the patch is making proper skin contact in the desired placement/orientation.
Regarding Claims 118-120, Beck further teaches wherein the preferred placement of the patch comprises at least two different locations on the skin surface of the user's body; wherein the preferred orientation of the patch is determined based at least in part on the preferred placement of the patch; wherein the preferred orientation of the patch is different for each of the at least two different locations on the skin surface of the user's body (see e.g. Para. 83: “additional patches may be added to different locations on the body”; each location on the body constitutes both a different “placement” and a different “orientation”).
Claims 108-109 are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of US 2011/0019595 A1 to Magar et al. (hereinafter “Magar”).
Regarding Claims 108-109, Beck teaches a radio as noted above, but fails to specifically teach “using the radio signals to communicate with a triple mode hybrid radio; communicating with the triple mode hybrid radio using Wi-Fi, Medical band, or ultra-wideband bandwidth signals, or any combination thereof.” Another reference, Magar, teaches these limitations in an analogous context of communicating between wearable patches and a base station (see e.g. Paras. 6, 19, 25 and claim 14; e.g. in Para. 25: “Additionally, the base can communicate with the micropatches using at least one radio. The base can be designed to work with any suitable radio scheme including, but not limited to WiFi, Bluetooth, ZigBee, ultrawideband (UWB), medical implant communications service (MICS), wireless medical telemetry service (WMTS), any suitable narrowband radio, any other suitable standard or proprietary based radio, or combination thereof.). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Beck to include using the radio signals to communicate with a triple mode hybrid radio; communicating with the triple mode hybrid radio using Wi-Fi, Medical band, or ultra-wideband bandwidth signals, or any combination thereof, as seen in Magar, because it would predictably and advantageously increase the redundancy and versatility of the wireless transmissions.
Claims 110-111 are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of US 2012/0143034 A1 to Gaw et al. (hereinafter “Gaw”).
Regarding Claims 110-111, Beck fails to specifically teach “preventing signal leakage between the two or more electrodes; preventing the signal leakage using an electrically insulating material.” Another reference, Gaw, teaches an analogous electrode patch including this feature (see e.g. Para. 71: “The substrate material is also typically electrically insulative to prevent leakage between the electrodes.”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Beck to use insulative material to prevent leakage between the electrodes, as seen in Gaw, because it would advantageously and predictably help ensure a more accurate diagnostic reading.
Claims 110 and 112 are rejected under 35 U.S.C. 103 as being unpatentable over Beck in view of US 4,040,412 A to Sato (hereinafter “Sato”).
Regarding Claims 110 and 112, Beck fails to specifically teach preventing signal leakage between the two or more electrodes; preventing the signal leakage using a shock absorbing material configured to absorb or redirect external forces. Another reference, Sato, teaches this limitation in the analogous context of a bioelectrode (see e.g. Col. 8 lines 43-46: “In this manner, the flexible sponge 66, which serves as a shock absorber isolating the electrode 22 from mechanical disturbances emanating from body parts …”). It would have been obvious to one of ordinary skill in the art as of Applicant's effective filing date to modify Beck to incorporate shock absorbing material for the electrodes, as seen in Sato, because this would predictably and advantageously help isolate the electrodes from mechanical disturbances emanating from body parts as taught by Sato.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN R DOWNEY whose telephone number is (571)270-7247. The examiner can normally be reached Monday-Friday 8:30am-5:00pm ET.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, NIKETA PATEL can be reached at (571)-272-4156. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JOHN R DOWNEY/Primary Examiner, Art Unit 3792
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