DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Withdrawal of finality
This is a 2nd non-final Office action superseding the 11/19/2025 final action and withdrawing finality. A shortened statutory period for reply is set to expire THREE MONTHS from the mailing date of this action.
In the 02/12/2025 non-final Office action, in the 103 rejection, the present action corrects the legal statement at the top of the non-final rejection to cite to Tierney 2001 (instead of 2000). Page citations, etc. within the body of the rejection already were and remain to Tierney 2001.
A Form PTO-892 is provided here citing both Tierney references with copies newly provided. Nonetheless, the 103 rejection relies only on Tierney 2001.
Office Action Overview
Claim Status
Canceled:
1-47, 50, 51, 61, and 64
Pending:
48, 49, 52-60, 62, 63, and 65-67
Withdrawn:
none
Examined:
48, 49, 52-60, 62, 63, and 65-67
Independent:
48, 58, 67
Amended:
48, 52, 53, 55, 57, 58
New:
none
Allowable:
none
Objected to:
none
Rejections applied
Abbreviations
112/b Indefiniteness
PHOSITA
"a Person Having Ordinary Skill In The Art before the effective filing date of the claimed invention"
112/b "Means for"
BRI
Broadest Reasonable Interpretation
112/a Enablement,
Written description
CRM
"Computer-Readable Media" and equivalent language
112 Other
IDS
Information Disclosure Statement
X
102, 103
JE
Judicial Exception
101 JE(s)
112/a
35 USC 112(a) and similarly for 112/b, etc.
101 Other
N:N
page:line
X
Double Patenting
MM/DD/YYYY
date format
Priority
As detailed on the 09/19/2023 filing receipt, this application claims priority to as early as 08/27/2008. At this point in examination, all claims have been interpreted as being accorded this priority date.
Specification citations are to US PGPUB
Citations to the instant Specification refer to US PGPUB 2023/0414102 Al.
Withdrawal/Revision of Objections/Rejections
In view of the 08/12/2025 amendment and remarks:
• The 112(a) rejection is withdrawn.
• The 103 rejection is revised.
• The Non-Statutory Double Patenting rejection is revised.
Claim language interpretations regarding 112(f)
Withdrawal of previous interpretations
The previous 112(f) interpretations of claims 53 and 65 as invoking 112(f) (pp. 2-6 of previous action) are withdrawn, and the relevant recitations of those claims are no longer interpreted as invoking, as further discussed below.
New interpretations as not invoking 112(f)
The recited "circuitry…configured to perform a comparison," in claims 53 and 65, recites means (or an equivalent, nonce term, here, "circuitry") and function and/or result (here, "to perform a comparison"), but the recitations are interpreted as not invoking 112(f) because each is interpreted as also reciting sufficient structure in the claim in the form of the further recited comparing a physiological constituent level to a threshold value so as not to invoke. As such these recitations are not interpreted under 112(f) as invoking. (MPEP 2181.I and 2181.I.C pertain.)
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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter 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 under pre-AIA 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 48, 49, 52-60, 62, 63, and 65-67 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Magar (U.S. Patent Pub 2009/0054737; as cited on the 12/10/2024 IDS) in view of Tierney 2001 (Biosensors and Bioelectronics, vol. 16:9-12, pages 621-629, 2001; as cited on the attached Form PTO-892; as also cited on the 12/10/2024 IDS) and Stafford (U.S. Patent Pub 2008/0119707; as cited on the 12/10/2024 IDS).
Independent claim 48 recites a device comprising a positioning structure, an adhesive backing to secure positioning structure to skin of a subject, a transceiver supported by the positioning structure to wirelessly communicate with a remote device comprising a sensor configured to measure a level of a physiological constituent in the subject, and a display supported by the positioning structure to present information, comprising the level of the physiological constituent, received wirelessly from the remote device .
Dependent claim 49 further recites the display is a light-emitting diode (LED). Dependent claim 52 further recites the physiological constituent comprises potassium, sodium, calcium, blood glucose, neurotransmitter release, and/or blood oxygen. Dependent claim 53 further recites device circuitry coupled to transceiver compares the level of the physiological constituent with a threshold. Dependent claim 54 further recites information representative of the comparison is presented via the display. Dependent claim 55 further recites the level of the physiological constituent comprises a subject’s blood glucose level. Dependent claim 56 further recites the remote device is an electrochemical sensor for measuring blood glucose. Dependent claim 57 further recites the received data is a status update, and information representative of the status update is presented via the display in response to receipt of the status update.
Independent claim 58 recites a first device worn on a subject, comprising a positioning structure; an adhesive backing attached to the positioning structure to secure the positioning structure to a skin surface of a subject; a sensor supported by the positioning structure to monitor a level of a physiological component in the subject; and a transmitter supported by the positioning structure to wirelessly transmit data comprising the level of the physiological component; and a second device worn on the subject, comprising: a positioning structure; an adhesive backing attached to the positioning structure to secure the positioning structure to a skin surface of a subject; a receiver supported by the positioning structure to receive the wirelessly transmitted data from the first device; and a display supported by the positioning structure and configured to present information representative of the level of the physiological component.
Dependent claim 59 further recites the physiological component is glucose. Dependent claim 60 further recites the second device display is a light emitting diode. Dependent claim 62 further recites an array of sensors. Dependent claim 63 further recites an electrochemical sensor. Dependent claim 65 further recites first device circuitry compares the level of the physiological component with a threshold. Dependent claim 66 further recites the received data is a status update from the first device, and the second device presents information representative of the status update via the display.
Independent claim 67 recites a device, similar to a combination of claims 48, 49, and 55, comprising an adhesive patch, a transceiver to wirelessly receive blood glucose data from a remote device, and an LED display, to display blood glucose level information in response to the data received by the transceiver.
Magar shows a wearable patch(es) held onto the skin with an adhesive [0110, fig.1A, fig.1B]; the patch comprises sensors for taking physiological measurements [0108]; which are positioned on a body [0111, fig.1A, fig.1B]; and are incorporated with a wearable adhesive patch [0109]; see also [0027, 0035]. Magar shows in some embodiments the patch comprises an alert (i.e., status update) which can be a visual display [0036, 0056]. Magar shows the patch-ASIC chip comprises transmitters and receivers [0007, 0008]; and therefore wireless transmission. Additionally, Magar shows the remote sensor of claim 48 and 58 as Magar's u-patch, as described in embodiments of Magar at [0184] and Fig.3A), which discusses the u-patch {which comprise the actual sensor(s), and transmits to the patch}, and the patch-ASIC (which receives and transmits data, has an adhesive patch and display of the “device” of claim 48). This is discussed at Magar [0184]: the wireless patch 102 comprises a patch-ASIC 120 which receives signals from either external analog sensors 220 (i.e., the remote devices) or built in sensors 221 via a sensor interface 204 which has an analog to digital converter (ADC), such that the patch receives {first or second device} wireless signals from remote device {second or first device}) [0010, 0041, 0045]. Magar shows the patch has two main parts: sensor circuits, and a radio core for the transmission of sensor data to other devices [0181]. Magar shows the sensor patch is capable of measuring ECG, EEG, EMG, SpO2 , tissue impedance, heart rate, accelerometer, blood glucose, etc.[0035, 0039, 0114]. Magar shows a plurality of electrical, optical, electromechanical and biochemical sensors (i.e., an array), including blood glucose, (fig.2; [0056]) Magar shows the patch comprises an alert (i.e., information representative of a status update) which can inform the user of a particular health condition or of a recommended action to take due to the measured physiological signals; e.g., the alert can be used to recommend that the patient take a medication and/or to contact medical professionals; a visual alert can be, for example, a flashing or constant light such as an LED, or can comprise a display that displays signals to the user, such as a liquid crystal display capable of displaying alpha-numeric characters [0118]. Magar shows light emitting diodes [0114], and transceivers (combined transmitter/ receivers) [0161]. (Showing the adhesive patch(es), transceiver, wireless communication, remote device and sensor data from remote device, LED display of data, sensor(s) and sensor array, first and second device, of claims 48-49, 55, 58, 60, 62, 66, and 67; the blood glucose constituent and blood glucose sensor of claims 52, 55, 56, 59, 63, and 67; displaying representative status updates via the display of claim 57; transmitter and receiver of claim 58.
Regarding claims 53, 54, and 65, Magar shows, as stated above, an alert which can inform the user of a particular health condition (due to the measured physiological signals) which can be a flashing or constant light such as an LED [0118]. This would inherently teach the comparing of sensor data (of physiological levels of a constituent like blood glucose) to a threshold by the device or system circuitry in order to cause an alert to be display by the LED. As such, Magar shows the circuitry to compare physiological levels to a threshold, and the display of results of the comparison, of claims 53, 54, and 65.
Magar does not explicitly show a positioning structure of claim 48 and 58.
While Magar does show a plurality of electrical, optical, electromechanical and biochemical sensors, including blood glucose, (fig.2; [0056]), Magar does not explicitly state the term "electrochemical" as in the limitation: "an electrochemical blood glucose sensor" and "an electrochemical sensor", of claims 56/57, and claim 63, respectively.
Tierney 2001 shows the GlucoWatch® biographer, a wrist-watch device which includes a microprocessor to convert the sensor signal into glucose readings (p.622, col.1). Tierney 2001 shows the GlucoWatch® biographer displaying the glucose level, attached to a wrist, with an outer housing (i.e., positioning structure) (p.623, fig.1). (Showing the device with positioning structure of claim 48 and 58.)
Stafford shows a wearable adhesive patch and method for monitoring body analytes, the patch comprising a plurality of transcutaneous analyte sensors (fig. 1, sensor sites 34) and [0002, 0023]. The sensors are electrochemical sensors ([0002], and see documents incorporated by reference in paragraph 24) configured to measure a level of lactate, acetyl choline, amylase, bilirubin, cholesterol, chorionic gonadotropin, creatine kinase, creatine, DNA, fructosamine, glucose, etc., in samples of body fluid [Abstract, 0001, 0002, 0006, 0011, 0023, and 0024]; (Figure 1). ( Also showing the adhesive patch of claims 48 and 58, and the electrochemical sensors of claims 56, 57, and 63).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the adhesive patch(es) device system including sensors, transmitters, and receivers, and measuring of physiological constituents of Magar, with the electrochemical sensors as taught by Stafford, and with the positioning structure comprising wearable device to determine a physiological constituent of Tierney 2001, to come to a wearable, adhesive patch(es) device with electrochemical sensors in a system for sensor data gathering, processing, determining of physiological constituents, and receiving & transmission of data, as Magar shows their invention supports a variety of sensors for various physiologic parameters (Magar at [0074]), and at discusses [0183-0203] embodiments in which patches can dynamically alter the performance of their various functional blocks to choose trade off among high reliability, high security, low power, and low cost for given applications of health monitoring, in analyzing and displaying sensor data (i.e., processing data), [while Stafford shows that patches for monitoring analytes can be modified to include a plurality of electrochemical sensors (Stafford at [0023] and Figure 1), and Tierney 2001 shows their device provides frequent, non-invasive measurements of glucose with high accuracy and precision (p.628, col.2). Additionally, Stafford discloses the further advantages that the components that may be integrated with the flexible patch include temperature and other sensors, etc. (Stafford at [0007]); and the multiple sensors which can be used simultaneously to acquire redundant analyte readings(Stafford at [0023]). One would have a reasonable expectation of success as Magar, Stafford, and Tierney 2001 are generally drawn to related teaching of wearable physiological sensor devices and systems, and as such, the modification would have been obvious.
Response to Applicant Arguments - 35 USC § 103
The Applicant's arguments filed 08/12/2025 have been fully and respectfully considered but they are not persuasive.
The Applicant asserts (p.7, para.2), regarding claims 48 and 58, that Magar, Tierney 2001, and Stafford, alone or in combination, fail to teach or suggest a device comprising a positioning structure and an adhesive backing that is configured to (1) receive data comprising a level of a physiological constituent from a remote (claim 48) or first (claim 58) device, and (2) present information based on the data received from the remote or first device, where the data comprises the level of a physiological constituent. (Emphasis by Applicant).
• The argument is not persuasive because Magar teaches external analog sensors 220 communicating with the Patch-ASIC and shows a display alert (Magar, [0184]). Additionally, Tierny was relied upon for showing a device (the GlucoWatch® biographer) that displays the glucose level (Tierney 2001, p.622, col.1 and Fig. 1).
The Applicant asserts (middle of p.8), (re: Magar ):…first, the base-ASIC device does not comprise a sensor, and therefore cannot provide support for the remote device of claim 48 or first device of claim 58. Second, Magar' s patch-ASIC chip does not receive data comprising a level of a physiological constituent from the base-ASIC chip. Instead, the patch-ASIC chip transmits signals corresponding to physiological measurements to the base-ASIC chip (and not vice versa) for processing (See Magar, para. [0041])...
• The argument is not persuasive because Magar teaches the remote sensor of claim as Magar's u-patch, as described in embodiments of Magar at [0184] and Fig.3A), which discusses the u-patch {which comprise the actual sensor(s), and transmits to the patch}, and the patch-ASIC (which receives and transmits data, has an adhesive patch and display of the “device” of claim 48). This is because Magar discusses at [0184]: the wireless patch 102 comprises a patch-ASIC 120 which receives signals from either external analog sensors 220 (i.e., a u-patch as the remote device) or built in sensors 221 via a sensor interface 204 which has an analog to digital converter (ADC)… As such, Magar's external analog sensors show the remote device comprising a sensor configured to measure a level of a physiological constituent in the subject of claim 48, 58, and 67.
The Applicant asserts (near end of p.8) that Magar's base device lacks both a positioning structure and adhesive backing and a display configured to present health related information based on the claimed data. Thus, Magar fails to teach or suggest Applicant's claimed device for presenting health related information or second device that receives a level of a physiological constituent from a remote device or first device respectively. Necessarily, Magar also fails to teach or suggest that the patch-ASIC chip displays information based on the received data, which comprises the level of the physiological constituent.
• The argument is not persuasive because Magar’s base device isn’t relied upon in the instant rejection to show the remote device, but Magar’s u-patch/external analog sensors do [0184]. Additionally, Magar is not relied upon for teaching the positioning structure and display of blood glucose, but Tierney 2001 is used to teach positioning structure and display of level of physiological constituent and glucose (p.623, text and fig.1).
The Applicant asserts (p.9) that Magar, Tierney 2001, and Stafford, alone or in combination, fail to teach or suggest a device comprising an adhesive patch that is configured to (1) receive data corresponding to a blood glucose level from a remote device and (2) present information representative of the blood glucose level.
• The argument is not persuasive because Magar was used to show physiological measurements blood glucose as Magar shows the sensor patch is capable of measuring ECG, EEG, EMG, SpO2 , tissue impedance, heart rate, accelerometer, blood glucose, etc.[0035, 0039, 0114]. Magar shows a plurality of electrical, optical, electromechanical and biochemical sensors (i.e., an array), including blood glucose, (fig.2; [0056])”.
• Further, Tierney 2001 is relied upon for teaching a display supported by a positioning structure (of claim 48, 58, and 67) in teaching the GlucoWatch® biographer device, which is shown displaying the glucose level (p.623, text and fig.1).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 48, 49, 56-58, 60, 62, and 63 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48, 49, 56, 83, and 87 of copending Application No. 16/827,366 in view of Magar (U.S. Patent Pub 2009/0054737; as cited on the 12/10/2024 IDS), Tierney 2001 (Biosensors and Bioelectronics, vol. 16:9-12, pages 621-629, 2001; as cited on the attached Form PTO-892; as also cited on the 12/10/2024 IDS) and Stafford (U.S. Patent Pub 2008/0119707; as cited on the 12/10/2024 IDS). Although the claims at issue are not identical, they are not patentably distinct from each other as follows:
Pending
Claims
18/243,623
Limitations
Copending
Claims
16/827,366
Limitations
Pending 48
A device for presenting health-related information, comprising a positioning structure ;
Copending 48
A wearable device comprising:
a positioning structure
an adhesive backing attached to the positioning structure and configured to secure the positioning structure to a skin surface of a subject;
Copending 48
an adhesive attached to the positioning structure and configured to secure the positioning structure to a subject;
a transceiver supported by the positioning structure and configured to wirelessly communicate with a remote device
comprising a sensor configured to measure a level of a physiological constituent in the subject; and
a receiver supported by the positioning structure and configured to receive wireless signals
from one or more remote devices; and
a transmitter supported by the positioning structure and configured to wirelessly transmit to a first remote device of the one or more remote devices, responsive to a request from the first
remote device, health-related information including the level of the physiological constituent.
Pending 48
Pending 49
a display supported by the positioning structure and configured to present information based on data received wirelessly from the remote device.
the display comprises a light-emitting diode
Copending 48
at least one light-emitting diode supported by the positioning structure and configured to
provide an output indicating the level of the physiological constituent;
Pending 48
the remote device comprises a sensor configured to
measure a level of a physiological constituent in the subject.
Copending 48
a processing device supported by the positioning structure and configured to receive sensor data from the plurality of electrochemical sensors and process the sensor data to determine the
level of the physiological constituent of the subject;
Pending 56
the remote device comprises an electrochemical
sensor configured to measure the blood glucose level.
Copending 48
a plurality of electrochemical sensors configured to measure a level of a physiological
constituent of the subject, wherein the adhesive is configured to position the plurality of electrochemical sensors on a body of the subject;
Copending 49
one of the plurality
of electrochemical sensors is configured to measure blood glucose.
Pending 57
the data received comprises a status update from the
electrochemical sensor and the device is configured to present, in response to receipt of the
status update, information representative of the status update via the display
Copending 87
The wearable device of claim 48, wherein the transmitter is further configured to
wirelessly transmit the health-related information to the first remote device in response to one or more status updates related to a patient wearing the wearable device
Pending claim 58
-a first device configured to be worn on a subject, the first device comprising:
a sensor configured to monitor a level of a physiological component in the
subject; and
-the first device further comprises a first adhesive
backing to secure the first device to a skin surface of the subject.
Copending 56
A wearable adhesive patch comprising: a plurality of electrochemical sensors configured to measure a level of a physiological constituent of a subject, wherein the wearable adhesive backing is configured
to position the plurality of electrochemical sensors on a body of the subject;
Pending claim 58
Pending claim 60
-a display configured to present information representative of the level of the physiological component.
-display of the second device comprises a light emitting diode.
Copending 56
at least one light-emitting diode configured to provide an output indicating the level of the physiological constituent;
Pending claim 58
a second device configured to be worn on the subject, the second device comprising a receiver configured to receive the wirelessly transmitted data from the first
device;
Copending 56
a first receiver configured to receive wireless signals; and
Pending claim 58
a transmitter configured to wirelessly transmit data comprising the level of the
physiological component;
a first transmitter configured to transmit, responsive to a request received by the
first receiver, health-related information including the level of the physiological
constituent; and
Pending claim 58
a second device configured to be worn on the subject, (the second device comprising a receiver and a display)
Copending 83
the local module comprises:
a second receiver configured to receive the health-related information transmitted
from the first transmitter of the wearable adhesive patch; and
a second transmitter configured to transmit information to at least one of the first
receiver of the wearable adhesive patch, a network, and a remote device.
Pending Claim 62
the sensor comprises an array of sensor elements.
Copending 56
a plurality of electrochemical sensors configured to measure a level of a
physiological constituent of a subject, wherein the wearable adhesive patch is configured
to position the plurality of electrochemical sensors on a body of the subject;
Pending Claim 63
the array of sensor elements is configured as an
electrochemical sensor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claim is allowed.
This Office action is a Non-Final action. A shortened statutory period for reply to this action is set to expire THREE MONTHS from the mailing date of this action.
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/M.A.V./Examiner
Art Unit 1687
/G. STEVEN VANNI/Primary patents examiner
Art Unit 1686