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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 12/19/2025 has been entered.
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 1-2, 8-9, 11-16, and 20-23 are rejected under 35 U.S.C. 103 as being unpatentable over Zeutzius et al. 2014/0303533, in view of Varga et al. 2014/0276254.
Regarding claim 1, Zeutzius discloses a therapeutic compression system for applying pressure to at least one limb of the human body (abstract) while reducing slippage and increasing alignment of the therapeutic compression system on the limb when self-applied and in use (0006 states that “The system allows true portability while improving patient discomfort, reducing fall risks, and providing the desired therapeutic and prophylactic compression”, 0047 further states that “The wrap 200 is securely releasably fastened around the limb 300”), comprising: at least one therapeutic compression apparatus (Figure 10) including and at least one wrap configured to be worn on a limb of a user (Wraps 600 and 605, figure 10) the at least one wrap including at least one bladder (Bladder sections 655 and 660) connected to a single universal port (Inflation/deflation port 615) configured to be capable of connection to a pneumatic static or intermittent inflation means (figure 5, pump 590), wherein the single universal port is configured to both inflate the at least one bladder and deflate the at least one bladder such that the at least one bladder releases out of the at least one wrap through the single universal port (0058 states “inflation/deflation port 615, for pumping air into the bladder of the wrap and then evacuating the air from the inflated bladder.” The air releases out of the bladder through port 615 and into module 100), a pneumatic static or intermittent inflation means connected to the at least one bladder via the single universal port (0010 states that “The fill port supplies pressurized air to the bladder. During a fill cycle, compressed air flows from the pump, through the solenoid and through the fill port 150 into the inflatable bladder. During a ventilation cycle, compressed air from an inflated bladder flows from the bladder through the fill port 150 through the solenoid valve and through the ventilation port 145.”) wherein the pneumatic inflation means includes a check valve (check valve 580); and wherein the single universal port includes a sealing means configured to include an open position and a closed position (Solenoid vale 575 is connected to the inflation/deflation port by way of port 565, 0053) wherein the closed position maintains the at least one bladder in an inflated or deflated state (0048 states that the pump is deactivated and the solenoid is closed to maintain a state once a limit is reached on either end) and is in the open position when coupled to the pneumatic inflation means so that the at least one bladder is the same inflation state as the inflation means (0047 discusses the opening of the solenoid to allow for air flow through from the pump, and 0049 discusses the flow back through the solenoid, depending on what action is taking place, the bladder would be in the same state as said action).
Zeutzius fails to teach at least one elastic sleeve and a connecting means configured to connect the at least one elastic sleeve to the at least one wrap to reduce slippage and increase alignment of the therapeutic compression system on the limb when in use and self-applied by the user.
Varga discloses an analogous patient warming wrap that does teach at least one elastic sleeve (0084, figure 10 depicts elastic inner layer 502) and a connecting means configured to connect the at least one elastic sleeve to the at least one wrap (connection means 506) to reduce slippage and increase alignment of the therapeutic compression system on the limb when in use and self-applied by the user (0036 states that “The inner garment may be an elastic inner layer that conforms snugly to the shape of an appendage, or body portion, of the patient so that the inner layer wraps around and substantially contacts most of an underlying surface area of the appendage”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify Zeutzius with the teachings of Varga and include at least one elastic sleeve to the at least one wrap to reduce slippage and increase alignment of the therapeutic compression system on the limb when in use and self-applied by the user as the use of the elastic inner layer applies a compressive force to the surrounded appendage to compress surface veins, arteries and muscles (0079).
Regarding claim 2 modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the connecting means is selected from the group consisting of buttons, stud buttons, snaps, straps, adhesives, welds, zippers, hooks, buckles, hook and loop, or a combination thereof. Varga does further disclose wherein the connecting means is selected from the group consisting of buttons, stud buttons, snaps, straps, adhesives, welds, zippers, hooks, buckles, hook and loop, or a combination thereof (Paragraph 0084 of Varga states “The connection 506 may include, for example, hook and loop fasteners, adhesive tabs, buttons, snaps, or press and seal fasteners.”).
Regarding claim 8, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the at least one wrap is configured to be placed on a thigh of a user and includes an elastic portion configured to be placed on a groin area of a user (Paragraph 0047 of Varga states that “the central portion 112 may be sized to fit an upper arm (such as around biceps and/or triceps), a hand, a lower leg (such as a calf and/or shin), an upper leg (such as a thigh) of a patient” One of ordinary skill in the art would have the ability to slightly modify the elastic sleeve to allow for placement on the groin area.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Zeutzius to include wherein the at least one wrap is configured to be placed on a thigh of a user and includes an elastic portion configured to be placed on the groin area of a user as doing so allows for the overall compression apparatus to apply a strong compressive force on a groin area, so as to compress surface veins, arteries, and muscles, increasing venous blood flow velocity and valve effectiveness.
Regarding claim 9, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the inflation means is selected from the group consisting of manual pumps, static pumps, intermittent pumps, electrical inflation pumps, battery inflation pumps, gas powered inflation pumps, static pneumatic compression pumps, intermittent pneumatic pressure pumps, and the combination thereof (0047 of Zeutzius describes the pump) and the inflation means for the at least one bladder is selected from the group consisting of air, gas, fluid or combinations thereof (0047 discusses the use of pressurized air).
Regarding claim 11, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the inflation means includes a powered pump configured to provide static and/or intermittent inflation (Paragraph 0045 of Zeutzius discusses intermittent inflation.).
Regarding claim 12, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the inflation means is connected to a securing means configured to be worn on a body of the user ( Figure 7 of Zeutzius depicts module 100, which contains pump 460, worn on the body of the user.).
Regarding claim 13, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the sealing means is selected from the group consisting of valves, caps, levers, switches, screws, stop taps, stopcocks, or combinations thereof (Paragraphs 0047 and 0048 discusses the solenoid valve involving a method of closing or opening.).
Regarding claim 14, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the single universal port is a self-sealing port configured to prevent deflation of the at least one bladder unless a deflation status is activated (Paragraph 0048 of Zeutzius states “When the sensed pressure reaches a determined fill limit, a pressure switch 405 is activated. The pressure switch signals the microcontroller 415 that the fill pressure (e.g., 50 mmHg) has been reached. The microcontroller ceases filling by deactivating the pump 460 via the relay 455 and causing the solenoid 440 to close both outlets.” 0049 discusses the opening of the valve once deflation is activated.) and includes a check valve (435).
Regarding claim 15, modified Zeutzius teaches the therapeutic compression system of claim 1, further comprising a pressure sensor (Paragraph 0048 states that “A pressure sensor 400 is in fluid communication with the sensor port 140. The sensor 400 produces an output signal corresponding to sensed pressure”) operatively connected to the inflation means to protect from over inflation (0048 states “When the sensed pressure reaches a determined fill limit, a pressure switch 405 is activated. The pressure switch signals the microcontroller 415 that the fill pressure (e.g., 50 mmHg) has been reached. The microcontroller ceases filling by deactivating the pump 460 via the relay 455 and causing the solenoid 440 to close”) and wherein the check valve is set to open at a predetermined pressure or a user selectable pressure (0047 states “One or more check valves may be provided to vent pressure to the atmosphere if pressure increases above a determined limit”.).
Regarding claim 16, modified Zeutzius the therapeutic compression system of claim 1, further comprising a second wrap wherein the first wrap and the second wrap may each be configured to wrap around the at least one limb of the user wherein the limb is selected from the group consisting of the foot, ankle, calf, lower leg, knee, thigh, upper leg, whole leg, waist, torso, chest, arm, shoulder, elbow, wrist, hand, neck or any combinations thereof (Figure 11b depicts an additional wrap to be used for both legs of the user).
Regarding claim 20, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the at least one bladder is an air bladder configured to have at least one chamber (inflation/deflation port 615) capable of sequential gradient pressure when connected to the inflation means (Paragraph 0046 of Zeutzius discusses the progressive inflation of the bladder.).
Regarding claim 21, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the at least one bladder is configured to provide gradient compression profile when inflated by the inflation means (Paragraph 0046 of Zeutzius).
Regarding claim 22, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the inflation means includes a three-way switch (0053, three-way solenoid valve 575) configured to be capable of holding a pressure created by the inflation means within the at least one bladder creating an inflated state of the bladder (0053, “The solenoid valve 575 may be selectively set to allow pressurized air to flow from the pump 590 into a first port of the solenoid valve 575 and out of a second port of the solenoid valve 575 and into the bladder 240 of the wrap 200 through a first port of the bladder 240 and, then, to maintain the bladder 240 in an inflated state”), capable of releasing a set amount of pressure within the at least one bladder creating a partially deflated state of the bladder and capable of releasing all the pressure within the at least one bladder so as to create a fully deflated state of the bladder (0053, “and then to allow flow of pressurized air from the inflated bladder 240 via the first port of the bladder 240 through the second port of the solenoid valve 575 to a third port of the solenoid valve 575 to a ventilation port 565..”).
Regarding claim 23, modified Zeutzius teaches the therapeutic compression system of claim 1, wherein the inflation means includes a real-time pressure measurement mechanism (Paragraph 0048 of Zeutzius teaches a pressure sensor in communication with the pump).
Claims 3-7, 10, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over modified Zeutzius, in view of Ravikumar WO 2018052676
Regarding claim 3, modified Zeutzius teaches the therapeutic compression system of claim 1, but fails to teach further comprising a compression strap configured for a foot and wherein the at least one elastic sleeve is configured to be placed on a lower leg including a closed foot portion of the elastic sleeve. Ravikumar teaches an analogous therapeutic compression apparatus that does teach further comprising a compression strap configured for a foot and wherein the at least one elastic sleeve is configured to be placed on a lower leg including a closed foot portion of the elastic sleeve (Paragraph 0037 states “The secondary wrap may be configured to envelope a limb such as the toes of the foot and/or configured to envelope a heel of the foot. The secondary wrap may also be configured as an adjustable strap around the foot.” One of ordinary skill in the art would have the ability to modify the elastic sleeve 502a of Varga and make it suitable for one’s foot.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Zeutzius with the teachings of Ravikumar to include comprising a compression strap configured for a foot and wherein the at least one elastic sleeve is configured to be placed on a lower leg including a closed foot portion of the elastic sleeve as doing so allows for the overall compression apparatus to apply a strong compressive force on the leg, so as to compress surface veins, arteries, and muscles, increasing venous blood flow velocity and valve effectiveness.
Regarding claim 4, modified Zeutzius in view of Ravikumar teaches the therapeutic compression system of claim 3, wherein the foot compression strap is configured to be placed around an arch and sole area of the foot over the elastic sleeve (Figure 17 of Ravikumar illustrates the strap placed over the arch and sole area of the foot of the individual).
Regarding claim 5, modified Zeutzius in view of Ravikumar teaches the therapeutic compression system of claim 3, wherein the at least one wrap includes an elastic portion configured to be placed on an ankle portion of a user. (Paragraph 0092 of Varga states that “the wrap 602 of a patient warming and DVT preventions system may be worn around a patient's lower leg and foot.” One of ordinary skill in the art would be able to modify the elastic sleeve to fully fit over the ankle.).
Regarding claim 6, modified Zeutzius the therapeutic compression system of claim 1, but fails to teach wherein the at least one wrap is configured to be placed on an arm of a user and includes an aperture configured to encircle a portion of an elbow portion of a user. Ravikumar, in a separate embodiment, further discloses wherein the at least one wrap is configured to be placed on an arm of a user and includes an aperture configured to encircle a portion of an elbow portion of a user (0202 states “The compression apparatus 1300 may include a portion 1 30 for use around the patient's elbow as shown in FIG. 37 and may include an aperture.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Zeutzius with the teachings of Ravikumar to include wherein the at least one wrap is configured to be placed on an arm of a user and includes an aperture configured to encircle a portion of an elbow portion of a user as doing so provides a way to design the compression device around the elbow and tightly compress both the lower and upper arm around the elbow.
Regarding claim 7, modified Zeutzius in view of Ravikumar teaches the therapeutic compression system of claim 6, wherein the at least one elastic sleeve is configured to be placed on the arm of a user. A separate embodiment of Ravikumar does disclose and includes an aperture on a distal end of the elastic sleeve configured for insertion of a thumb of a user (Figure 37 depicts an aperture for the thumb.). It would have bene prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Zeutzius in view of Ravikumar to include wherein the at least one elastic sleeve is configured to be placed on the arm of a user and includes an aperture on a distal end of the elastic sleeve configured for insertion of a thumb of a user as doing so provides a way to design the compression device around the thumb to allow for tight compression of the hand.
Regarding claim 10, modified Zeutzius teaches the therapeutic compression system of claim 1, but fails to teach wherein the inflation means includes a manual pump configured to provide static inflation. Ravikumar does teach wherein the inflation means includes a manual pump configured to provide static inflation (Paragraph 0118 states “The pump 30 may be a manual pump or an electronic pump for providing air to the bladder 22.” By design a manual pump will provide static inflation as described in paragraph 0208.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention and further modify modified Zeutzius with the teachings of Ravikumar and include wherein the inflation means includes a manual pump configured to provide static inflation as this provides the user with a way of manually controlling the inflation of the device.
Regarding claim 18, modified Zeutzius teaches the therapeutic compression system of claim 1, but fails to teach wherein the at least one wrap includes at least two bladders configured to be either separate or joined. Ravikumar further teaches wherein the at least one wrap includes at least two bladders configured to be either separate or joined (Paragraph 0123 states that “However, it is envisioned that secondary wrap 104 can have an independent bladder cither separately inflatable or inflatable through a one-way valve or other desired inflation/deflation configuration.”). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Zeutzius with the teachings of Ravikumar and include wherein the at least one wrap includes at least two bladders configured to be either separate or joined as this would allow for an additional therapy point to be applied to a different location of the user.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over modified Zeutzius in view of Eddy et al. 2010/0137764.
Regarding claim 17, modified Zeutzius teaches the therapeutic compression system of claim 16, but fails to teach wherein the first wrap and second wrap are not connected to each other while connected to the same inflation means and wherein the second wrap has a different inflation pressure than the inflation pressure of the first wrap when both the first wrap and second wrap are inflated from the same inflation means. Eddy discloses an analogous compression device that does teach wherein the first wrap and second wrap are not connected to each other while connected to the same inflation means (Fig. 1 depicts both cuffs 52 connected to the compression device 10) and wherein the second wrap has a different inflation pressure than the inflation pressure of the first wrap when both the first wrap and second wrap are inflated from the same inflation means (Paragraph 0044 discloses the use of differing pressures in s sequential manner to inflate both wrap.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify modified Zeutzius with the teachings of Eddy and include wherein the first wrap and second wrap are not connected to each other while connected to the same inflation means and wherein the second wrap has a different inflation pressure than the inflation pressure of the first wrap when both the first wrap and second wrap are inflated from the same inflation means as this allows for sequential control of the inflation/deflation of both wraps (0039).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over modified Zeutzius in view of Ravikumar, further in view of Eddy
Regarding claim 19, modified Zeutzius in view of Ravikumar teaches the therapeutic compression system of claim 18, but fails to teach wherein the second bladder has a different inflation pressure than the inflation pressure of the first bladder when both the first wrap and second wrap are inflated from the same inflation means. Eddy does teach wherein a second bladder has a different inflation pressure than the inflation pressure of the first bladder when both the first wrap and second wrap are inflated from the same inflation means (Paragraph 0019 discloses the use of differing pressures in a sequential manner to inflate both wraps.). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to further modify modified Zeutzius in view of Ravikumar with the teachings of Eddy and include wherein the second bladder has a different inflation pressure than the inflation pressure of the first bladder when both the first wrap and second wrap are inflated from the same inflation means as this allows for sequential control of the inflation/deflation of both wraps (0039).
Claim 24 is rejected under 35 U.S.C. 103 as being unpatentable over Zeutzius, in view of Varga and Ravikumar
Regarding claim 24, Zeutzius teaches a method for applying compression pressure to a portion of a human body (abstract) while reducing slippage and increasing alignment of the therapeutic compression system on the limb when self-applied and in use (0006 states that “The system allows true portability while improving patient discomfort, reducing fall risks, and providing the desired therapeutic and prophylactic compression”, 0047 further states that “The wrap 200 is securely releasably fastened around the limb 300”), comprising:
activating an at least one therapeutic compression apparatus (Figure 10) wherein the at least one wrap includes (a) at least one air bladder (Bladder sections 655 and 660) connected to a pneumatic inflation means (figure 5, pump 590), and (b) a single universal port (Inflation/deflation port 615) having a sealing means configured to include an open position and a closed position (Solenoid vale 575 is connected to the inflation/deflation port by way of port 565, 0053) wherein the closed position maintains the at least one air bladder in an inflated or deflated state (0048 states that the pump is deactivated and the solenoid is closed to maintain a state once a limit is reached on either end) and is in the open position when coupled to the pneumatic inflation means so that the at least one air bladder is the same inflation state as the inflation means (0047 discusses the opening of the solenoid to allow for air flow through from the pump, and 0049 discusses the flow back through the solenoid, depending on what action is taking place, the bladder would be in the same state as said action); a check valve and a valve cap (Check valve 580 would inherently have a valve cap that is able to prevent excessive inflation) wherein the valve cap is capable of releasing a pressure created by the pneumatic inflation means within the at least one air bladder by deactivating and opening the sealing means (0055 states “A manifold 585 fluidly couples the outlet of the pump 590 to a port (i.e., the inlet port) of the solenoid valve 575 and to a check valve 580. The check valve 580 is a pressure relief valve that prevents excessive inflation.”) securing the inflation means to the same or different body part of the user (Figure 11a); inflating the at least one air bladder (through pump 590); the user moving such that the at least one wrap is secure and stable on the body part (Figure 11a); removing the inflation means from the single universal port activating the sealing means on the single universal port (The closing of solenoid valve 575); and deflating the inflated at least one air bladder by opening the sealing means of the single universal port and releasing a pressure within the at least one bladder through the single universal port out of the at least one wrap (0058 states “inflation/deflation port 615, for pumping air into the bladder of the wrap and then evacuating the air from the inflated bladder.” The air releases out of the bladder through port 615 and into module 100).
Zeutzius does not disclose activating an at least one therapeutic compression apparatus by connecting at least one elastic sleeve to at least one wrap by a connecting means; a user affixing the at least one elastic sleeve on the body part of the user; securing the inflation means to the same or different body part of a user; and the single universal port further including an elbow connector
Varga does disclose at least one therapeutic compression apparatus with at least one elastic sleeve connected to at least one wrap by a connecting means (Fig. 11 illustrates an elastic inner layer 502a that includes a compression sleeve (0084), this elastic inner layer is attached to the intermediate layer through connections 506a.); Ravikumar does disclose affixing the wrap to a body part of the user (Paragraph 0208 states that “may be placed by the patient, practioner or care-giver on the chosen limb, such as for instance the lower leg on the calf and foot and the secondary wrap, or the foot wrap is fastened around the foot of the patient.”) It would be prima facie obvious to one of ordinary skill in the art to modify the teachings of Ravikumar with the teachings of Varga and include at least one therapeutic compression apparatus with at least one elastic sleeve connected to at least one wrap by a connecting means as the connection of the inner elastic sleeve allows the overall compression apparatus to apply a strong compressive force on the body portion, so as to compress surface veins, arteries, and muscles, increasing venous blood flow velocity and valve effectiveness (0079).
Therefore, a method of use of modified Ravikumar now including the inner elastic sleeve of Varga would include activating an at least one therapeutic compression apparatus by connecting at least one elastic sleeve to at least one wrap by a connecting means and a user affixing the at least one elastic sleeve on a body part of the user.
The combination still fails to teach wherein the single universal port further includes an elbow connector. Ravikumar teaches an analogous therapeutic compression apparatus that does teach wherein the inflation port further includes an elbow connector (Figure 30A, elbow connector 510). It would have been prima facie obvious for one of ordinary skill in the art before the effective filing date of the claimed invention to modify the universal port of modified Zeutzius with the teachings of Ravikumar and include wherein the inflation port further includes an elbow connector as this allows for a connection of a check valve connection to occur (0194).
Conclusion
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/ROHAN PATEL/Examiner, Art Unit 3785
/BRANDY S LEE/Supervisory Patent Examiner, Art Unit 3785
