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 .
DETAILED ACTION
1. This office action is in response to the filing of the application on 2/13/2023. Since the initial filing, no claims have been amended, added, or canceled. Thus, claims 1-13 are pending in the application.
Priority
2. Acknowledgement is made of applicant’s claim for foreign priority regarding 18/514,510 (filing date of 11/20/2023), PCT/US23/80538 (filing date of 11/20/2023), and 18/514,510 (filing date of 11/18/2022). However, 18/514,510 provides sufficient support for the subject matter of claims 1-12, 16-21, 22-29. Therefore, the current application will be assigned the effective filing date of 11/18/2022.
Election/Restrictions
3. Restriction to one of the following inventions is required under 35 U.S.C. 121:
I. Claims 1-12, 16-21, 22-29 drawn to Compression Garment Controller/Compliance Monitoring System, classified in A61H9/005.
II. Claims 13-15, drawn to Controller Mounting Attachment, classified in B60Q 1/006.
The inventions are independent or distinct, each from the other because:
Inventions 1 and 2 are directed to related compression therapy device subsystems. The related inventions are distinct if: (1) the inventions as claimed are either not capable of use together or can have a materially different design, mode of operation, function, or effect; (2) the inventions do not overlap in scope, i.e., are mutually exclusive; and (3) the inventions as claimed are not obvious variants. See MPEP § 806.05(j). In the instant case, the inventions as claimed are directed to materially different structures and functions, where invention 1 is directed to electronic control and compliance monitoring of a compression therapy system, while invention 2 is directed to mechanical mounting hardware for attaching the controller to a support structure. Furthermore, the inventions as claimed do not encompass overlapping subject matter and there is nothing of record to show them to be obvious variants.
Applicant elected Invention 1 (Claims 1-12, 16-21, 22-29) directed to the compression garment controller and compliance monitoring system without traverse during a telephone interview on 02/09/2026.
Claim Rejections - 35 USC § 102
4. 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 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)(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 1, 3, 4, 10, 16-20, 22, 23, and 28 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Newton et al (20240415728).
Regarding claim 1, Newton discloses a compression garment controller (FIG. 1) for monitoring compliance of a user with respect to wearing a compression garment in accordance with a compression therapy, the controller comprising:
a display screen configured to display a graphical user interface (FIG. 1, user interface 117 has a display screen);
at least one light emitting diode (LED) configured to selectively illuminate different colors ([0058] discloses that interface 117 has LED indicators. [0098 -0099] indicates that colors may be yellow or green);
at least one computer readable storage medium configured for storing one or more monitored parameters (FIG. 2, discloses microcontroller 210 having storage memory 250 [0061]. [0057] discloses the microcontroller monitoring compression);
one or more processors coupled to the at least one computer readable storage medium; and computer-executable instructions embodied on the at least one computer readable storage medium ([0061] discloses storage memory 250),
the computer-executable instructions including instructions for causing the one or more processors to:
direct a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate at least one inflatable bladder of the compression garment configured to be wrapped around a limb of a wearer of the garment ([0057] discloses the microcontroller monitoring compression feedback and reporting from the fluidic source 110 (e.g. an air compressor) can be used to detect the operating conditions and ensure consistent delivery of the compression. Flow chart in Fig. 5 discloses multiple compression cycles, which would include inflation and deflation);
receive pressure signals indicative of fluid pressure in the at least one inflatable bladder from a pressure sensor communicatively coupled thereto during at least one of inflation and deflation of the at least one inflatable bladder in a plurality of successive compression cycles; process the received pressure signals (FIG. 5 shows a flowchart detailing the invention that allows the determination of which display state to provide on the compression system. [0093] discloses analysis of multiple parameters and readings taken at different times during the inflation process);
cause the at least one LED to illuminate a first color in response to the received pressure signals indicating compliance with compression therapy ([0098] discloses a green LED indication);
and cause the at least one LED to illuminate a second color in response to the received pressure signals indicating an interruption of operation or non-compliance with compression therapy ([0099] discloses a yellow LED indication if the correct delivery of prophylaxis is not delivered).
Regarding claim 3, Newton discloses the compression garment controller further comprises a housing with an angled surface on each of vertical sides of the display screen with an LED located on each angled surface, whereby at least one LED is visible from the side of the compression garment controller.(FIG. 1 discloses controller with angled surface of the display screen with an LED located. FIGS. 3A-3B discloses at least one LED visible from the side of the controller).
Regarding claim 4, Newton discloses the at least one processor is further configured to display a graphical user interface (GUI) on the display screen with the GUI including a compliance meter indicating compliance with the compression therapy (FIGS. 3A-3B discloses a GUI including a compliance meter indicating compliance with the compression therapy).
Regarding claim 10, Newton discloses the at least one processor is further configured to display a graphical user interface (GUI) on the display screen with the GUI including a plurality of compliance meters indicating compliance with the compression therapy on a per day basis (FIGS. 3A-3B discloses a GUI including a compliance meter indicating compliance with the compression therapy. [0060] discloses tracking compliance data over multiple days).
Regarding claim 16, Newton discloses a compression garment system for monitoring compliance of a user wearing a compression garment wrapped around a limb of the user in accordance with a compression therapy (FIG. 1), the system comprising:
a compression garment (FIG. 1, compression garment 120);
and a controller (FIG. 1, controller 110),
wherein the controller includes: a display screen configured to display a graphical user interface (GUI) (FIG. 1, interface 117 is a GUI);
a plurality of light emitting diodes (LEDs) arranged at a visible angle on the controller (FIGS. 3A-3B depict a plurality of LEDs. FIG. 1, 117 discloses the angled display on the controller. [0058] discloses a user interface consisting of LED based visual indicators on display);
a memory; and a processor coupled to the memory and configured to: direct a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate an inflatable bladder of the compression garment configured to be wrapped around a limb of a wearer of the compression garment ([0057] discloses the microcontroller monitoring compression feedback and reporting from the fluidic source 110 (e.g. an air compressor. [0048] discloses control fluid flow to and from the inflatable/deflatable garment causing inflation and deflation and can be used to detect the operating conditions and ensure consistent delivery of the compression to a patient's limb or anatomical structure);
receive pressure signals indicative of fluid pressure in the inflatable bladder from a pressure sensor communicatively coupled thereto during at least one of inflation and deflation of the inflatable bladder in a plurality of successive compression cycles ([0057] discloses pressure measuring element 230 in FIG. 2 and described as the microcontroller monitoring compression feedback and reporting from the fluidic source 110 (e.g. an air compressor) can be used to detect the operating conditions and ensure consistent delivery of the compression to a patient's limb or anatomical structure);
process the received pressure signals to determine compliance or non-compliance with the compression therapy ([0103] discloses pressure sensor for measuring the pressure present on compliance or non-compliance);
cause the plurality of LEDs to illuminate in a first color in response to the received pressure signals indicating compliance with the compression therapy ([0098] discloses a flashing green LED indication of compliance with the compression therapy);
and cause the plurality of LEDS to illuminate in a second color in response to the received pressure signals indicating an interruption of operation or non-compliance with the compression therapy ([0099] discloses a yellow LED indication instead of a green LED signaling non-compliance).
Regarding claim 17, Newton discloses the compression garment is at least one of a leg sleeve, an ankle sleeve, a thigh sleeve, or a calf sleeve (FIG. 1, 120. [0112] discloses at least one type of compression garments for human body and limb which would include a leg of user).
Regarding claim 18, Newton discloses the compression garment includes a plurality of garments (FIG. 1, 120. [0054] discloses at a least one compression garment for mounting on a patient's limb, the compression garment being attachable to at least one connecting means via connector arrangements, comprising separable physical connector parts).
Regarding claim 19, Newton discloses the plurality of garments include a combination of different sleeves ([0054] discloses plurality of different sleeves).
Regarding claim 20, Newton discloses the plurality of garments include two of a same sleeve ([0071] discloses compression garment system operating same connected garment sleeves).
Regarding claim 22, Newton discloses a method for a compression garment controller for monitoring compliance of a user wearing a compression garment wrapped around a limb of the user in accordance with a compression therapy (FIG. 1), the method comprising:
directing a flow of fluid from a pressurized fluid flow source to cyclically inflate and deflate an inflatable bladder of the compression garment ([0048] discloses control fluid flow to and from the inflatable/deflatable garment causing inflation and deflation and can be used to detect the operating conditions and ensure consistent delivery of the compression to a patient's limb or anatomical structure);
receiving pressure signals indicative of fluid pressure in the inflatable bladder from a pressure sensor communicatively coupled thereto during at least one of inflation and deflation of the inflatable bladder in a plurality of successive compression cycles (FIG. 5 shows a flowchart detailing the invention that allows the determination of which display state to provide on the compression system. [0057] discloses the microcontroller monitoring compression feedback and reporting from the fluidic source 110 (e.g. an air compressor) can be used to detect the operating conditions and ensure consistent delivery of the compression and also disclose pressure measuring element 230 in FIG. 2);
processing the received pressure signals to determine compliance or non-compliance with the compression therapy ([0103] discloses pressure sensor for measuring the pressure present on compliance or non-compliance);
causing at least one light emitting diode (LED) to illuminate in a first color in response to the received pressure signals indicating compliance with the compression therapy ([0098] discloses a green LED indication);
and causing the at least one LED to illuminate in a second color in response to the received pressure signals indicating an interruption of operation or non-compliance with the compression therapy ([0098] discloses a yellow LED indication).
Regarding claim 23, Newton discloses a graphical user interface (GUI) of the controller, a compliance meter indicating compliance with the compression therapy (FIGS. 3A-3B discloses a GUI including a compliance meter indicating compliance with the compression therapy).
Regarding claim 28, Newton discloses a graphical user interface (GUI) of the controller, a plurality of compliance meters indicating compliance with the compression therapy on a per day basis (FIGS. 3A-3B discloses a GUI including a compliance meter indicating compliance with the compression therapy. [0060] discloses tracking compliance data over multiple days).
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Claim Rejections - 35 USC § 103
5. 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 of this title, 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.
6. Claims 2, 5, 6, 7, 9, 11, 24, 26, and 27 are rejected under 35 U.S.C. 103 as being unpatentable in view of Newton et al (20240415728).
Regarding claim 2, Newton does not explicitly disclose the compression garment controller of claim 1, wherein the at least one processor is further configured to cause the at least one LED to illuminate a third color in response to the received pressure signals indicating an error with the compression therapy.
However, Newton discloses a display screen of illuminating colored lights including green, yellow, and blinking green ([0099] discloses colored LED illumination occurring if there is an error, proper, or compliance in delivery of prophylaxis but not a third color).
Substituting one known color for another in an LED indicator would have been an obvious matter of design choice to one ordinary skill in the art, yielding predictable results without altering the operation of the device. Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to use blue in place of green.
Regarding claim 5, Newton does not explicitly disclose a compliance meter displayed as a twenty-four (24) hour circular bar with a first color indicating compliance and a second color indicating non-compliance.
However, Newton discloses a circular compliance (FIGS. 3A-3B 117B as a circular compliance meter. [0098] discloses a first color indicating compliance, and [0099] discloses a second color indicating non-compliance). Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to use a twenty-four (24) hour circular bar with a first color indicating compliance and a second color indicating non-compliance.
Regarding claim 6, Newton does not explicitly disclose the compression garment controller of claim 5, wherein the first color is blue.
However, Newton discloses a color ([0098] Newton discloses green as the compliance color, the particular selection of a specific color for indicating compliance constitutes a predictable design choice. It is well known in the art that various colors (e.g. blue, green, white) may be used to convey positive or normal operational states in visual indicators).
Substituting one known color for another in an LED indicator would have been an obvious matter of design choice to one ordinary skill in the art, yielding predictable results without altering the operation of the device. Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to use blue in place of green.
Regarding claim 7, Newton does not explicitly disclose the compression garment controller of claim 5, wherein the second color is orange.
However, Newton discloses a second color ([0099] discloses that non-compliance is indicated by a yellow LED). The use of color in LED indicators to represent warning or alarm conditions is well known in the art. Various colors (e.g. yellow, orange, red) are commonly used interchangeably to indicate cautionary or non-compliant states. Selecting orange instead of yellow constitutes a predictable substitution of one known warning color for another known warning color to convey substantially the same information.
Such substitution would have been an obvious design variation to one of ordinary skill in the art and would have yielded no unexpected results. Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to use orange as the second color.
Regarding claim 9, the modified controller of Newton does not explicitly disclose the displayed compliance meter includes a current time and date within the circular bar.
However, Newton discloses displaying real time information ([0040] discloses inclusion of a Real Time Clock (RTC) and date). Since the graphical interface already presents icons, time, and real time related information associated with device operation and therapy monitoring, it would have been obvious to one of ordinary skill in the art to incorporate the display of current time and date within the circular compliance meter. Such modification would merely involve a rearrangement of known display elements within the graphical user interface, yielding predictable results by presenting related information within the compliance indicator used to track therapy usage.
Therefore, modifying Newton to display current time and date within the circular compliance meter would have been obvious design choice and rearrangement of parts, consistent with the rationale set forth in MPEP § 2144.04.
Regarding claim 11, Newton does not explicitly disclose the GUI displays up to six compliance meters on the display screen.
However, Newton discloses a storage memory element that allows the system to store data and records configured to control the cycle time and pump subsystem and to provide a user interface and/or display (twelve prong indicator) ([0060] discloses data and records associated with both periods of system usage (i.e. that intended and prescribed) as well as periods of non-usage (i.e. contrary to that intended or prescribed) and includes timing information provided by the timing element lasting over hours and days as well as data associated with the usage of the pump with multiple patients over weeks and months.
Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to include a GUI displaying multiple compliance indicators in order to provide visual feedback to the user regarding treatment status and compliance.
Regarding claim 24, Newton discloses a compliance meter is displayed as a twenty-four (24) hour circular bar with a first color indicating compliance and a second color indicating non-compliance.
However, Newton discloses a circular compliance (FIGS. 3A-3B 117B as a circular compliance meter. [0098] discloses a first color indicating compliance, and [0099] discloses a second color indicating non-compliance). Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to use a twenty-four (24) hour circular bar with a first color indicating compliance and a second color indicating non-compliance.
Regarding claim 26, the modified controller of Newton does not explicitly display compliance meter including a current time and date within a circular bar.
However, Newton discloses real time information. ([0040] discloses inclusion of a Real Time Clock (RTC) and date). Since the graphical interface already presents icons, time, and real time related information associated with device operation and therapy monitoring, it would have been obvious to one of ordinary skill in the art to incorporate the display of current time and date within the circular compliance meter. Such modification represents a rearrangement of known display elements within the graphical user interface, which would yield predictable results by consolidating related information within the compliance display used to track therapy usage.
Therefore, modifying Newton to display current time and date within the circular compliance meter would have been obvious design choice and rearrangement of parts, consistent with the rationale set forth in MPEP § 2144.04.
Regarding claim 27, Newton does not explicitly disclose the method according to claim 22, further comprising causing the LED to illuminate in a third color in response to the received pressure signals indicating an error with the compression therapy.
However, Newton does not explicitly disclose that the LED is capable of illuminating in a third color ([0099] discloses yellow, green and flashing green). It would have been obvious to one of ordinary skill in the art to configure the LED to illuminate in an additional color to indicate another operational state of the device. Providing multiple color indicators for device status represents a predictable variation of known indicator systems, where different colors are used to communicate different operational states to the user.
Therefore, modifying Newton to include a third color indicator would have been obvious design choice and predictable variation, consistent with the rationale set forth in MPEP § 2144.04.
7. Claims 8, 25, and 29 are rejected under 35 U.S.C. 103 as being unpatentable over Newton et al (20240415728) in view of Parker (20200121545).
Regarding claim 8, Newton does not explicitly disclose the displayed compliance meter indicates an amount of time for the compression therapy in a twenty-four period.
However, Parker (US 20200121545) discloses such functionality (FIG. 7 discloses compliance meter indicating twenty-hour period. [0024] discloses subsystem may be configured to provide intermittent pressure over a clinically recommended daily duration (e.g., 18 - 24 hours per day) of a period).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to include a compliance meter indicating treatment duration within a 24-hour period as taught by Parker, in order to monitor patient compliance with therapy durations.
Regarding claim 25, Newton does not explicitly disclose the method according to claim 23, wherein the displayed compliance meter indicates an amount of time for the compression therapy in a twenty-four period.
However, Parker teaches a compliance meter configured to report user compliance for a current 24-hour period and over a sequence of 24-hour periods (FIG 7. discloses a compliance meter indicating amount of time for the compression therapy. [0032] discloses elapsed time that the prophylaxis is being successfully delivered to the patient).
Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to include a compliance meter indicating an amount of time within a 24-hour period as taught by Parker in order to monitor therapy usage over daily treatment intervals.
Regarding claim 29, Newton does not explicitly disclose the method according to claim 28, wherein the GUI displays up to six compliance meters. However, Parker teaches a compliance indicator including a twelve-prong indicator that displays treatment status (FIG. 7 shows a GUI display up twelve-prong compliance meters).
Since Parker demonstrates the use of multiple indicator segments to convey compliance and treatment information, it would have been obvious to one of ordinary skill in the art to modify Newton to include a GUI displaying multiple compliance meter, such as up to six compliance meters, in order to provide the user with clearer visual feedback regarding therapy usage and compliance over time.
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8. Claim 12 are rejected under 35 U.S.C. 103 as being unpatentable over Newton et al (20240415728) in view of Rathod (20220179665).
Regarding claim 12, Newton does not explicitly disclose at least one processor is further configured to: receive a selection of a system time icon from a displayed menu; display a map of a world along with a current time; display a current time in response to navigation commands; receive a selection of a highlighted current time zone; and save the selected current time zone.
However, Rathod teaches one or more processors (FIGS. 59-64 illustrates processing operations, flowchart, exemplary interfaces, etc. [0205] further disclosing a world map select country, state, city, area, place and point or search and user can further sort as per date & time or ranges of current date & time). Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to use a navigation command processor for selection of time and date for the system.
9. Claim 21 are rejected under 35 U.S.C. 103 as being unpatentable over Newton et al (20240415728) in view of Curry (20210240055).
Regarding claim 21, Newton does not explicitly disclose a pole attachment portion configured to secure the controller to a pole.
However, Curry teaches a mounting bracket to be attached to a supporting structure, such as a pole (FIGS. 2, 3, 8, 9, and 10 depicts mounting bracket by mounting hardware to be attached to a supporting structure, such as a pole, wall, or building). Therefore, it would have been obvious to one of ordinary skill in the art to modify Newton to configure the system to secure the controller to a pole.
Conclusion
4. Any inquiry concerning this communication or earlier communications from the examiner should be directed to LEROME PRATT whose telephone number is (571)272-8454. The examiner can normally be reached Mon - Fri 7am - 3pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, TIOMTHY STANIS can be reached at (571)272-5139. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.D.P./Examiner, Art Unit 3785
/TIMOTHY A STANIS/Supervisory Patent Examiner, Art Unit 3785
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