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 .
Response to Arguments
Applicant’s arguments with respect to claims 1, 13-15, 24, 28, 34, 49-50, 53, 57, 73 and 83-85 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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, 13-15, 24, 28, 34, 49-50, 53 and 83-84 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.
Claims 1 and 34 recite the limitation "the sensors" in lines 13 and 15 respectively. There is insufficient antecedent basis for this limitation in the claim.
NOTE: in claims 1, line 16 and claim 34, line 18, the sensors are properly recited. Examiner recommends amending claims 1 and 34 to recite the limitation of “the sensors” similarly to how it is recited in claim 57.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 13 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. Claim 13 recites “wherein the physiological inputs are recorded by the biodata collection element”. However, claim 1 already recites “a biodata collection element for sensing the physiological characteristics” and “wherein the biodata collection element includes two or more sensors responsive to different physiological inputs”. Therefore, the limitations of claim 13 fail to further limit the subject matter of claim 1. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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 1, 13-15, 24, 28, 34, 49-50, 53, 57 and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Flomerfelt et al. (US 2013/0281861 A1) in view of Jeutter et al. (US 5,314,457).
As to claims 1, 34 and 57, Flomerfelt et al. discloses a device for monitoring a plurality of physiological characteristics of a patient (Abstract) including: a first biosensor layer ([0031]; Figure 1 and Figure 7) including a biodata collection element (sensors or sensor array, depicted as 102 in Figure 7 ) for sensing the physiological characteristics (Figures 1 and 7); an adhesive layer (adhesive material, depicted as 5 in Figure 1 and 106 in Figure 7) for maintaining contact between the biosensor layer and a skin surface of the patient ([0052]; Figure 1); wherein the biodata collection element includes two or more sensors (sensors or sensor array, depicted as 102 in Figure 7) responsive to different physiological inputs and wherein the physiological inputs include heart rate (maternal heart rate and fetal heart rate [0029-0033, 0080], which are two different physiological inputs that include heart rate), electrical activity of a heart (ECG), measurement of wound recovery factors (uterine integrity; [0029, 0031]); wherein the sensors are activated and deactivated remotely and the device includes a receiver for receiving a signal for controlling a circuit to activate and/or deactivate the sensors at a command of a remote server ([0054-0056]).
Additionally, Flomerfelt et al. discloses “In accordance with an embodiment of the present invention, use of a rechargable battery for the patch is contemplated. A hydrogen peroxide sterilization procedure, used increasingly in hospitals, can be employed to disinfect/sterilize the cell phone sized, for example, battery pack the patient can wear while she is being monitored. The patch can have a metal coil around its perimeter that will power the unit in concert with the battery pack” ([0036]). Therefore, Flomerfelt et al. discloses coil or antenna receiver that is disposed around the patch to receive transmission of power signals. Flomerfelt et al. discloses the device substantially as claimed but does not explicitly disclose a circuit that extracts power from receiving electromagnetic radiation to power the device, wherein the electromagnetic radiation transmission received from a Wi-Fi, Bluetooth, cellular or low-power wide-area network power source. Extracting power from a radiofrequency (RF) signals and/or electromagnetic radiation for devices, including external and implantable medical devices, is well known in the medical device art as well as the electrical art. Jeutter et al. discloses antennas, or receivers, to derive power for a rechargable battery of a medical device by extracting power from an electromagnetic radiation signal (col. 3, lines 23-36). It would have been obvious to one having ordinary skill in the art at the time the invention was made to provide power for the dermal patch of Flomerfelt et al. with a circuit for extracting power for the device from the received electromagnetic radiation; and wherein the device is powered remotely by extracting of power for the device from electromagnetic radiation transmission received from a Wi-Fi, Bluetooth, cellular or low-power wide-area network power source to extract power from received electromagnetic radiation as disclosed by Jeutter et al. in order to provide the predictable results of remotely recharging a medical device.
As to claim 13, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose the physiological inputs are recorded by the biodata collection element ([0029-0033, 0080]; Abstract).
As to claim 14, the modified Flomerfelt et al. discloses the device includes a radio frequency transmitter (Jeutter et al., col. 3, lines 23-36, claim 1 in cols. 10-11).
As to claim 15, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose the recorded physiological inputs are transferred to a database, wherein the database is on a remote server (claim 21 on page 8; [0038, 0052-0055, 0074-0077]).
As to claim 24, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose the device is formed from flexible materials ([0031-0032]).
As to claim 28, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose the adhesive adheres to the patient, and thus maintains contact with the skin surface for at least 1 day ([0052, 0056]). Therefore, the dermal patch of Flomerfelt et al. necessarily maintains the adhesive layer maintains contact with the skin surface of the user for between 1 to 30 days.
As to claim 49, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose the notifying a secondary device of the recorded physiological inputs (claim 21 on page 8; [0038, 0052-0055, 0074-0077]).
As to claim 50, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose the determining whether a change in the recorded physiological input(s) reaches a predefined threshold ([0073, 0080]; claim 22 on page 8).
As to claim 53, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose the secondary device includes a data module configured to receive, monitor and/or analyse the physiological inputs recorded by the first biosensor layer (claim 21 on page 8; [0038, 0052-0055, 0074-0077]).
As to claim 73, Flomerfelt et al., and thus the modified Flomerfelt et al., disclose a means (via wireless transmission; [0055, 0077]) for notifying a secondary device of the recorded physiological inputs (claim 21 on page 8; [0038, 0052-0055, 0074-0077]).
Claims 83-85 are rejected under 35 U.S.C. 103 as being unpatentable over the modified Flomerfelt et al. as applied to claims 1, 13-15, 24, 28, 34, 49-50, 53, 57 and 73 above, in further view of Chan et al. (2015/0020571 A1).
The modified Flomerfelt et al. discloses the device substantially as claimed but does not explicitly include that one of the physiological inputs comprise a fall detection sensor. Chan et al. discloses a wireless sensing device for fall detection. It would have been obvious to one having ordinary skill in the art at the time the invention was made to incorporate an accelerometer sensor in the sensor array of the dermal patch of the modified Flomerfelt et al. for monitoring if a patient has fallen as disclosed by Chan et al. in order to provide the predictable results of meeting specific patient therapeutic needs and requirements. Furthermore, fall detection in a hospital environment can be helpful in ensuring the safety and well-being of the patient.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ALYSSA M ALTER whose telephone number is (571)272-4939. The examiner can normally be reached M-F 8am-4pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David E Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ALYSSA M ALTER/Primary Examiner, Art Unit 3796
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