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 Preliminary Amendment
In the preliminary amendment filed on April 29, 2025, the following has occurred: claim(s) 28-47 have been added and claim(s) 1-27 have been cancelled. Now, claim(s) 28-47 are pending.
Claim Objections
Claim 28 objected to because of the following informalities: “the patient’s ECG” in p. 3, ll. 9. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “the patient’s electrocardiogram (ECG)”.
Claim 41 objected to because of the following informalities: “the recorded one or more patient response” in p. 5, ll. 7-8. This appears to be a typographical error. Appropriate correction is required. For examination purposes, the Examiner will interpret the claimed portion as “the recorded one or more patient responses”.
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) 28-47 is/are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Claim 28: Step 2A Prong One
Claim 28 recite(s):
receive one or more custom prompts from a health care professional for a physical activity test, wherein the one or more custom prompts are configured to perform at least one of guiding the patient through the physical activity test, ascertaining patient conditions prior to the physical activity test, ascertaining patient conditions during the physical activity test, ascertaining patient conditions after the physical activity test, or providing warnings for emergency conditions during the physical activity test,
administer the physical activity test to the patient, and
communicate the one or more custom prompts to the patient during the physical activity test
These limitations, as drafted, given the broadest reasonable interpretation, but for the recitation of generic computer components, encompass managing interactions between people
(including following rules or instructions), which is a subgrouping of Certain Methods of
Organizing Human Activity. For example, but for the “an external medical device controller electrically connected to the plurality of sensing electrodes and the plurality of therapy electrodes, the external medical device controller comprising a data storage and at least one processor configured to perform a series of instructions that, when executed by the at least one processor, cause the at least one processor to” language, the “receive” function in the context of this claim encompasses a user following instructions to receive a message to perform at least one of guiding the patient through the physical activity test, ascertaining patient conditions prior to the physical activity test, ascertaining patient conditions during the physical activity test, ascertaining patient conditions after the physical activity test, or providing warnings for emergency conditions during the physical activity test. Similarly, but for the “an external medical device controller electrically connected to the plurality of sensing electrodes and the plurality of therapy electrodes, the external medical device controller comprising a data storage and at least one processor configured to perform a series of instructions that, when executed by the at least one processor, cause the at least one processor to” language, the “administer” function in the context of this claim encompasses a user following instructions to administer the physical activity test to the patient. Finally, but for the “an external medical device controller electrically connected to the plurality of sensing electrodes and the plurality of therapy electrodes, the external medical device controller comprising a data storage and at least one processor configured to perform a series of instructions that, when executed by the at least one processor, cause the at least one processor to” language, the “communicate” function in the context of this claim encompasses a user following instructions to communicate the message to the patient during the physical activity test. These steps could be accomplished by a person following instructions to monitor a patient, and therefore encompass Certain Methods of Organizing Human Activity.
Claim 28: Step 2A Prong Two
This judicial exception is not integrated into a practical application because the remaining elements amount to no more than general purpose computer components programmed to perform the abstract idea, and generally linking the abstract idea to a particular technical environment.
Claim 28, directly or in directly, recite the following generic computer components, “an external medical device controller electrically connected to the plurality of sensing electrodes and the plurality of therapy electrodes, the external medical device controller comprising a data storage and at least one processor configured to perform a series of instructions that, when executed by the at least one processor, cause the at least one processor to” ” configured to implement the abstract idea. As set forth in the MPEP 2106.04(d) “merely including instructions to implement an abstract idea on a computer” is an example of when an abstract idea has not been integrated into a practical application.
Additionally, claim 28 recites “a garment comprising a pair of shoulder straps and a belt that are configured to be worn about a torso of a patient;”, “a plurality of sensing electrodes configured to sense the patient's electrocardiogram (ECG), the plurality of sensing electrodes attached to the garment;”, “a plurality of therapy electrodes configured to deliver one or more therapeutic defibrillating shocks to the patient;” at a high degree of generality, amount no more than generally linking the abstract idea to a particular technical environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an example of when an abstract idea has not been integrated into a practical application.
Claim 28: Step 2B
The claim(s) does/do not include additional elements that are sufficient to amount to
significantly more than the judicial exception. As discussed above with respect to integration of
the abstract idea into a practical application, the additional elements of using a computer configured to perform above identified functions amounts to no more than mere instructions to apply the exception using generic computer components. Mere instructions to apply an exception using a generic computer component cannot provide an inventive concept. See Alice 573 U.S. at 223 (“mere recitation of a generic computer cannot transform a patent-ineligible abstract idea
into a patent-eligible invention.”)
Additionally, generally linking the abstract idea to a particular technological environment does not amount to significantly more than the abstract idea (See MPEP 2016.05(h) and Affinity Labs of Texas v. DirectTV, LLC, 838 F.3d 1253, 120 USP12d 1201 (Fed. Cir. 2016)).
Dependent claims 29-47 incorporate the abstract idea of claim 28 as identified above and recite additional limitations that expand on the abstract idea. Claim 29 further describes the physical activity test. Similarly, claims 30, 32-37, 39-40, 46-47 further describe the series of instructions. Similarly, claim 31 further describes the one or more custom prompts. Similarly, claim 38 further describes the generic computer components. Finally, claims 41-45 describes the generic computer component of “a computer system associated with a health care professional”. Therefore, these claims recite limitations that fall into the Certain Methods of Organizing Human Activity grouping of abstract ideas.
Dependent claims 29-47 recite additional subject matter which amounts to limitations
consisted with the additional elements in independent claim 28 (such as claim 41 at a high degree
of generality, amount no more than generally linking the abstract idea to a particular technical
environment. The recitation is also similar to adding the words “apply it” to the abstract idea. As
set forth in MPEP 2106.05(f), merely reciting the words “apply it” or an equivalent, is an
example of when an abstract idea has not been integrated into a practical application.)
Looking at the limitations as an ordered combination adds nothing that is not already
present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional computer implementation and do not impose a meaningful limit to integrate the abstract idea into a practical application.
The claims are not patent eligible.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 28, 31, 38-47 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being unpatentable over Cowan et al. (U.S. Patent Pre-Grant Publication No. 2014/0046391).
As per independent claim 28, Cowan discloses a wearable defibrillator configured to be ambulatory and move with a patient and further configured to receive and provide custom prompts, comprising:
a garment comprising a pair of shoulder straps and a belt that are configured to be worn about a torso of a patient (See Fig. 2, [0041]: The support structure can be any structure suitable for wearing, such as a harness, a vest, another garment, and so on);
a plurality of sensing electrodes configured to sense the patient's electrocardiogram (ECG), the plurality of sensing electrodes attached to the garment (See Figs. 2-3, [0051]-[0052]: It is also possible that ECG electrodes can be connected continuously to ECG port 319, instead, ECG electrodes 309 can help sense an ECG signal, e.g. a 12-lead signal, or a signal from a different number of leads, as long as they make good electrical contact with the body of the patient, which the Examiner is interpreting the ECG electrodes to encompass a plurality of sensing electrodes);
a plurality of therapy electrodes configured to deliver one or more therapeutic defibrillating shocks to the patient (See Fig. 2, [0041]: A support structure may have a top component resting on the shoulders, for ensuring that the defibrillation electrodes will be in the right place for defibrillating, and a bottom component resting on the hips, for carrying the bulk of the weight of the defibrillator, which the Examiner is interpreting the defibrillation electrodes to encompass a plurality of therapy electrodes); and
an external medical device controller electrically connected to the plurality of sensing electrodes and the plurality of therapy electrodes, the external medical device controller comprising a data storage and at least one processor configured to perform a series of instructions that, when executed by the at least one processor (See [0134]-[0135]: Mobile communication device 1110 additionally includes a controller, the controller can be one or more processors, implemented as a Central Processing Unit (CPU), a digital signal processor, a microprocessor, a microcontroller, an application-specific Integrated circuit (ASIC), a programmable logic device (PLD) or other implementation, and can be combined with a single chip with a memory controller and a peripherals interface), cause the at least one processor to
receive one or more custom prompts from a health care professional for a physical activity test (See [0143], [0156]-p0157[: The remote access request is a request by a wearable defibrillation system that the remote comlink be established with a device in the network, so that the wearable defibrillation system can ultimately forward data to it, or request data from it, which the Examiner is interpreting request to encompass one or more custom prompts from a health care professional for a physical test ([0157]: Other Entity), wherein the one or more custom prompts are configured to perform at least one of guiding the patient through the physical activity test, ascertaining patient conditions prior to the physical activity test, ascertaining patient conditions during the physical activity test, ascertaining patient conditions after the physical activity test (See [0080]-[0081]: A physician monitoring the progress of patient 182 will know about a condition that is not improving or deteriorating, a trend can be reported as part of the data exchanged over via one of the comlinks, along perhaps with a warning, which the Examiner is interpreting patient parameters to encompass patient conditions after the physical test), or providing warnings for emergency conditions during the physical activity test,
administer the physical activity test to the patient (See [0080]: A physician can tailor more accurately the prescribed medical therapy (medication) and exercise regimen (prescribed physical activity program), which the Examiner is interpreting the exercise regimen to encompass the physical activity test), and
communicate the one or more custom prompts to the patient during the physical activity test (See [0130], [0144]-[147]: Human-perceptible indications are emitted per the guidance data, which the Examiner is interpreting the guidance data to encompass the one or more custom prompts to the patient during the physical activity test as the guidance data could ultimately be sourcing from other entity 130, such as an intervening doctor, and arriving either via remote comlink 172, or via bypass comlink 476 and local comlink 171.)
As per claim 31, Cowan discloses the apparatus of claim 28 as described above. Cowan further teaches wherein the one or more custom prompts comprise an instruction to cease the physical activity test (See [0069]: Communication can be a voice conversation, email messaging, texting, and so on, which the Examiner is interpreting the communication between the user and remote person to encompass an instruction to cease the physical activity test when combined with Hogle's disclosure of instructions for performing a test or task in Paragraph [0066].)
As per claim 38, Cowan discloses the apparatus of claim 28 as described above. Cowan further teaches wherein the external medical device controller is in networked communication with a computer system configured to provide a custom prompt interface to the health care professional (See Fig. 4, [0077]: Reported data 422 can further include anything that user 382 reports live in a communication 412 with remote person 492, which the Examiner is interpreting element 492 in Fig. 4 to encompass a custom prompt interface.)
As per claim 39, Cowan discloses the apparatus of claims 28 and 38 as described above. Cowan further teaches wherein the series of instructions is configured to cause the at least one processor to receive the one or more custom prompts from the health care professional for the physical activity test via the computer system providing the custom prompt interface to the health care professional (See [0130], [0144]-[147]: Human-perceptible indications are emitted per the guidance data, which the Examiner is interpreting the guidance data to encompass the one or more custom prompts from the health care professional as the guidance data could ultimately be sourcing from other entity 130, such as an intervening doctor, and arriving either via remote comlink 172, or via bypass comlink 476 and local comlink 171.)
As per claim 40, Cowan discloses the apparatus of claim 28 as described above. Cowan further teaches wherein the series of instructions are further configured to cause the at least one processor to record one or more patient responses to the one or more custom prompts (See [0071]: The answers can then be reported to the doctor later by the system, which the Examiner is interpreting the answers to encompass the patient responses.)
As per claim 41, Cowan discloses the apparatus of claims 28 and 40 as described above. Cowan further teaches wherein the series of instructions are further configured to cause the at least one processor to communicate the recorded one or more patient responses to a computer system associated with a health care professional (See [0071]: The answers can then be reported to the doctor later by the system, which the Examiner is interpreting the answers can then be reported to the doctor to encompass the claimed portion.)
As per claim 42, Cowan discloses the apparatus of claims 28 and 40-41 as described above. Cowan further teaches wherein the computer system associated with the health care professional is configured to provide a display of the one or more patient responses to the one or more custom prompts (See Fig. 14, [0035]: Other Entity 190 can be a person or institution, equipped with any one of a cellular telephone, a desktop computer, a server, a mainframe computer, and so on, which the Examiner is interpreting a desktop computer to encompass provide a display of the one or more patient responses to the one or more custom prompts.)
As per claim 43, Cowan discloses the apparatus of claims 28 and 40-42 as described above. Cowan further teaches wherein the display comprises a date identifier for each of the one or more patient responses (See [0082]-[0083]: System parameters of wearable defibrillation system 101 can include system identification, battery status, system date and time, reports of self-testing, records of data entered, records of episodes and intervention, which the Examiner is interpreting system date and time, and records of data entered to encompass a date identifier for each of the one or more patient responses.)
As per claim 44, Cowan discloses the apparatus of claims 28 and 40-41 as described above. Cowan further teaches wherein the computer system associated with the health care professional is configured to provide a display of a trend of patient responses comprising the one or more patient responses to the one or more custom prompts (See [0080]: Once a trend is detected, it can be reported as part of the data exchanged over via one of the comlinks, along perhaps with a warning, from the report, a physician monitoring the progress of patient 182 will know about a condition that is not improving or deteriorating, which the Examiner is interpreting the detected trend to encompass a trend of patient responses, and interpreting the physician monitoring the progress of patient 182 to encompass the health care professional is configured to provide a display.)
As per claim 45, Cowan discloses the apparatus of claims 28 and 40-41, 44 as described above. Cowan further teaches wherein the display of the trend of patient responses comprises at least one of a graph, chart, or figure (See [0080]: Once a trend is detected, it can be reported as part of the data exchanged over via one of the comlinks, along perhaps with a warning, which the Examiner is interpreting the report to encompass a figure.)
As per claim 46, Cowan discloses the apparatus of claim 28 as described above. Cowan further teaches wherein the series of instructions are further configured to cause the at least one processor to prompt the patient, via a natural language prompt, to call an emergency service (See [0073], [0156]-[0157]: Other feedback can be that patient 182 should consult with a professional caregiver within so much time, like immediately or the next 24 hours, and the remote comlink can be with an emergency telephone number, which the Examiner is interpreting the feedback to encompass to call an emergency service.)
As per claim 47, Cowan discloses the apparatus of claim 28 as described above. Cowan further teaches wherein the series of instructions are further configured to cause the at least one processor to prompt the patient to change a battery of the wearable defibrillator (See [0059], [0073], [0083]: System parameters of wearable defibrillation system 101 can include system identification, battery status, system date and time, reports of self-testing, records of data entered, records of episodes and intervention, which the Examiner is interpreting battery status to encompass prompt the patient to change a battery of the wearable defibrillator as the system may remind patient 182 of the physician's orders, and encourage compliance, which the Examiner is interpreting the physician's orders could include scheduled changing of the wearable defibrillator’s battery.)
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.
Claims 29-30 are rejected under 35 U.S.C. 103 as being unpatentable over Cowan et al. (U.S. Patent Pre-Grant Publication No. 2014/0046391) in view of Hogle et al (U.S. Patent Pre-Grant Publication No. 2008/0281550).
As per claim 29, Cowan discloses the apparatus of claim 28 as described above. Cowan may not explicitly teach wherein the physical activity test comprises a six minute walk test.
Hogle teaches an apparatus wherein the physical activity test comprises a six minute walk test (See [0063], [0313]-[0326]: The Timed Up and Go is a functional measure of basic balance and mobility in the elderly, which the Examiner is interpreting the Timed Up and Go to encompass a six minute walk test ([0326]).)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the apparatus of Cowan to include the physical activity test comprises a six minute walk test as taught by Hogle. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cowan with Hogle with the motivation of providing better systems and methods for characterizing balance function in a subject (See Background of Invention of Hogle in Paragraph [0005]).
As per claim 30, Cowan discloses the apparatus of claim 28 as described above. Cowan may not explicitly teach wherein the series of instructions are further configured to cause the at least one processor to monitor a gait of the patient during the physical activity test.
Hogle teaches an apparatus wherein the series of instructions are further configured to cause the at least one processor to monitor a gait of the patient during the physical activity test (See [0039], [0044]: Systems and methods of the present invention are utilized to monitor a subject's proficiency (e.g., balance control and/or function) in one or more physical tests (e.g., dynamic gait index test, functional gait assessment test, Berg balance test, timed up and go test, and the dynamic task test) and/or to compare a subject's results to a database of "normal"/"healthy" and "non-normal"/"non-healthy" results (e.g., to provide an objective score and/or assessment of the subject being tested), which the Examiner is interpreting the dynamic gait index test to encompass monitor a gait of the patient during the physical activity test ([0044]: sensors monitor and processors generate an objective assessment/characterization of a subject.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the apparatus of Cowan to include monitor a gait of the patient during the physical activity test as taught by Hogle. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cowan with Hogle with the motivation of providing better systems and methods for characterizing balance function in a subject (See Background of Invention of Hogle in Paragraph [0005]).
Claims 32-37 are rejected under 35 U.S.C. 103 as being unpatentable over Cowan et al. (U.S. Patent Pre-Grant Publication No. 2014/0046391) in view of MacInnis et al. (U.S. Patent Pre-Grant Publication No. 2009/0023422).
As per claim 32, Cowan discloses the apparatus of claim 28 as described above. Cowan may not explicitly teach wherein the series of instructions are further configured to cause the at least one processor to detect one or more speech patterns of the patient during the physical activity test.
MacInnis teaches an apparatus wherein the series of instructions are further configured to cause the at least one processor to detect one or more speech patterns of the patient during the physical activity test (See [0041]-[0042]: The biometric event data BD2 may be from audio speech pattern, speech content, voice pitch for user recognition or for mood condition, mental state, and character or behavior analysis, which the Examiner is interpreting the biometric event data to encompass during the physical activity test.)
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed to modify the apparatus of Cowan to include detect one or more speech patterns of the patient during the physical activity test as taught by MacInnis. One of ordinary skill in the art before the effective filing date of the claimed invention would have been motivated to modify Cowan with MacInnis with the motivation of providing identify captured events or stored data for future retrieval (See Detailed Description of the Invention of MacInnis in Paragraph [0025]).
As per claim 33, Cowan discloses the apparatus of claim 28 and Cowan/MacInnis discloses the apparatus of claim 32 as described above. Cowan further teaches wherein the series of instructions are further configured to cause the at least one processor to provide one or more suggestions to the patient based on the detected one or more speech patterns (See [0073]: One of the triggered functions can be that system 101 gives feedback to patient 182, for example via local comlink 171 as human perceptible indications, the feedback can be for patient 182 to manage his condition following physician orders, which the Examiner is interpreting feedback to encompass provide one or more suggestions to the patient.)
As per claim 34, Cowan discloses the apparatus of claim 28 and Cowan/MacInnis discloses the apparatus of claims 32-33 as described above. Cowan further teaches wherein the detected one or more speech patterns comprise labored breathing (See [0073]: The system may consider the patient status data, and evaluate a set of parameters against baseline values, parameters to evaluate include b) changes in breathing pattern, which the Examiner is interpreting changes in breathing pattern to encompass labored breathing.)
As per claim 35, Cowan discloses the apparatus of claim 28 and Cowan/MacInnis discloses the apparatus of claims 32-33 as described above. Cowan further teaches wherein the one or more suggestions comprise suggesting that the patient slow down or stop the physical activity test (See [0073]: The feedback can be for patient to manage his condition following physician orders, and can include further questions such as "Are you keeping your physical activity within range Y?", which the Examiner is interpreting "Are you keeping your physical activity within range Y?" to encompass suggesting that the patient slow down or stop the physical activity test.)
As per claim 36, Cowan discloses the apparatus of claim 28 and Cowan/MacInnis discloses the apparatus of claims 32-33 as described above. Cowan further teaches wherein the series of instructions are further configured to cause the at least one processor to provide one or more suggestions to the patient based on the detected one or more speech patterns and based further on additional correlating information (See [0073]: The parameters to evaluate can include changes in heart rate variability, and functions can be triggered that may be stratified based on severity, which the Examiner is interpreting the heart rate variability to encompass additional correlating information.)
As per claim 37, Cowan discloses the apparatus of claim 28 and Cowan/MacInnis discloses the apparatus of claims 32-33, 37 as described above. Cowan further teaches wherein the additional correlating information comprises a heart rate of the patient (See [0073]: The parameters to evaluate can include changes in heart rate variability.)
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Tyler et al. (U.S. Patent Pre-Grant Publication No. 2007/0250119), describes systems and methods for management of brain and body functions and sensory perception.
Serdiuk (U.S. Patent Pre-Grant Publication No. 2012/0254907), describes a system also includes a sensor data processing module configured to process the sensor data to determine a probable activity type for the user, and a controller coupled to the sensor data processing module.
Pantelopoulos et al. (“A Survey on Wearable Sensor-Based Systems for Health Monitoring and Prognosis”), describes a variety of system implementations are compared in an approach to identify the technological shortcomings of the current state-of-the-art in wearable biosensor solutions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Bennett S Erickson whose telephone number is (571)270-3690. The examiner can normally be reached Monday - Friday: 9:00am - 5:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Morgan can be reached at (571) 272-6773. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Bennett Stephen Erickson/Primary Examiner, Art Unit 3683