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 Amendment
This office action is responsive to the Request for Continue Examination and the claims filed on February 6, 2026. As directed by the amendment: claims 1, 6, 10, and 11 have been amended, claim 8 has been canceled, and new claims 18-21 have been added. Thus, claims 1-7 and 9-21 are presently pending in the application.
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) states, "the list may not be incorporated into the specification but must be submitted in a separate paper." Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
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 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.
Claims 1-6, 9-16, 18, 20, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Ramanan (US 2020/0237607), in view of Dillon (US 4,590,925), and further in view of Papadopoulou (US 2024/0009068).
As to claim 1, Ramanan discloses a compression device 1000 (Fig. 1) comprising: a sleeve (garment 1004) comprising a plurality of inflatable chambers (7304-1 to 7304-16, Fig. 7); at least one pneumatic pump (4245 blower of compression pressure generator (CPG) device 1002, Fig. 5, paragraph [0118]) coupled to at least one inflatable chamber (CPG 1002 is connected to the chambers 7304-1 to 7304-16 via pneumatic valves 1008/7008, see Fig. 1, Fig. 7); a portable bio impedance analyzer 4230 (part of central controller 4230 that receives signals from electrodes 4273 evaluates them to determine bioimpedance, paragraphs [0140],[0216]); a microcontroller 4230/4240 (therapy device controller 4240 and/or part of the central controller that determines control parameters for the therapy device based on the sensor data, paragraphs [0216], [0142]-[0143]; see also paragraph [0362] describing that a controller can mean one or more microcontrollers); and a battery 4210 (Fig. 5, paragraph [0118]); wherein the battery 4210 powers the microcontroller 4240 and the at least one pneumatic pump 4245 and wherein the microcontroller 20 controls the portable bio impedance analyzer 4230 and the at least one pneumatic pump 4240 (paragraph [0216],[0142]-[0143]), and wherein the sleeve 1004 is configured to be activated to maintain a predetermined level of swelling of a patient, and wherein the at least one pneumatic pump is configured to activate or deactivate based on a level of swelling (paragraph [0224]-[0226]: an increase/decrease in swelling indicated and serves as a basis for the controller to decrease/increase or change a compression therapy parameter; process may be performed before, during or after during a session to assess whether further therapy is needed or if the therapy should be discontinued).
While Ramanan discloses that the sleeve comprises an outer layer comprising a fabric (outer layer is a three-dimensional knitted fabric, paragraph [0184]), they do not expressly disclose that the outer fabric layer comprises canvas, fleece, polyester, or a combination of any thereof. However, Dillon teaches a compression sleeve 10 having an outer layer (outer retaining garment 25, Fig. 1, Fig. 2) comprising canvas (leg-shaped canvas sheath, col. 3, ln. 31-43]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the compression device so that the outer fabric layer is a canvas sheath employed over the inflatable chambers, as taught by Dillon, in order to provide a retaining means to confine and constrain the inflatable chambers in position surrounding and enclosing the patient's limb so that the inflation and deflation of the chambers properly compresses and decompresses the limb during treatment (see Dillon, col. 3, ln. 30-41).
Ramanan further discloses that one or more layers of the garment (e.g., the skin contacting layer) comprises nylon (paragraph [0183]: one or more layers of the garment includes polyester, elastane, nylon, and thermoplastic polyurethane (TPU), but does not explicitly disclose that each of the plurality of inflatable chambers comprises a polymer-coated fabric, wherein the polymer coated fabric comprises nylon, latex, or a combination of any thereof. However, Papadopoulou teaches a pneumatic sleeve 1500 (see Fig. 15, Fig. 19A, paragraph [0004]) having inflatable chambers (inflatable subdivisions 1010,1011,1012, Figs. 10-12, paragraphs [0038]-[0040], shown as subdivisions 1301 in Figs 13-15, paragraphs [0045]-[0046]) comprising a polymer coated fabric (fabric coated with thermoplastic material (TPU coated), see paragraphs [0037],[0047]); wherein the polymer coated fabric comprises nylon, latex, or a combination of any thereof (nylon fabric coated with TPU, paragraphs [0037],[0052]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Ramanan so that the plurality of chambers are formed from a polymer coated nylon, as taught by Papadopoulou, in order to provide a suitable material that is air tight and flexible to inflate with pressurization.
As to claim 2, modified Ramanan discloses the compression device of claim 1, wherein the portable bio impedance analyzer comprises at least one sensor (electrodes 4273, 23500, Fig. 5, Fig. 23D of Ramanan) and a bio impedance circuit, wherein the bio impedance circuit is configured to send signals to and receive signals from a user's skin (paragraph [0157], [0224]-0226] of Ramanan).
As to claim 3, modified Ramanan discloses the compression device of claim 1, wherein the at least one pneumatic pump 4142 (Fig. 4 of Ramanan), the portable bio impedance analyzer 4230 (Fig. 5), the microcontroller 4240, and the battery 4210 are contained within the sleeve CPG external housing 1002 is held in pocket 17886 of garment 17004, see Fig. 17 of Ramanan, see also Fig. 3, paragraph [0115],[0118] describing the CPG housing and its components).
As to claim 4, modified Ramanan discloses the compression device of claim 1, further comprising at least one pressure sensor 4272 that senses the pressure inside at least one of the inflatable chambers (pressure transducer 4272, Figs. 4-5, paragraph [0116], [0153]-[0154] of Ramanan).
As to claim 5, modified Ramanan discloses the compression device of claim 1, wherein the inflatable chambers are inflated sequentially (paragraphs [0037],[0044] of Ramanan), and wherein the pressure and the duration of the inflation is controlled in response to data received from the portable bio impedance analyzer (a control module of the controller estimates bioimpedance of the body part via the current and voltage signals sent/received from the electrodes 23500, Fig. 23D, paragraphs [0223]-[0224] of Ramanan), and controls the pressure and duration of inflation of chambers in the garment in response to such data (Paragraph [0225]-[0226]: controller changes pressure and/or duration in response to bio-impedance measurement indicating an increased or decreased swelling, see also paragraph [0245] of Ramanan).
As to claim 6, modified Ramanan discloses the compression device of claim 1, wherein the pressure in each inflatable chamber is the same as or different from one another (see Ramanan Fig. 63A, paragraph [0329]: macro-chambers 6340a-6340f), and wherein the maximum pressure in each inflatable chamber is configured to be within a range of about 53 to about 60 mm Hg (see Ramadan, paragraph [0321]: pressures entering the macro chambers can range from 15 mm Hg to about 120 mm Hg; and in some implementations between about 15 mm Hg to 100 mm Hg; and in other implementations between about 25 mm Hg to about 65 mm Hg; and in yet other implementations between about 35 mm Hg to about 55 mm Hg).
As to claim 9, modified Ramanan discloses the compression device of claim 2, wherein the signals are measurements of one or more of total body water, extra-cellular fluid, intra-cellular fluid, fat mass, and fat free mass of the user (Ramanan, paragraph [0224]: bioimpedance is used to evaluate increased fluid content or swelling; paragraph [0216]: controller can determine skin/body composition (e.g., fluid vs. fat).
As to claim 10, modified Ramanan discloses the compression device of claim 1, wherein the outer layer consists of canvas, fleece, or both (as taught by Dillon’s outer retaining garment 25, which is a canvas sheath, Fig. 1, Fig. 2, col. 3, ln. 31-43]).
As to claim 11, Ramanan discloses a method of treating a patient with a compression device 1000, comprising: attaching to a patient's limb a plurality of sensors 4273 and a sleeve (garment 1004) comprising a plurality of inflatable chambers 7304-1 through 7304-16, Fig. 7, paragraph [0171]); receiving body impedance values from the sensors 4273 by a bio impedance circuit connected to a microcontroller 4230 (paragraph [0157]); sending instructions from the microcontroller 4230 to a plurality of pumps (see paragraph [0211] describes micropumps embedded in the chambers instead of a single pump/blower connected to the individual chambers by tubing and valves) based on the values received by the bio impedance circuit (paragraph [0024]); inflating the inflatable chambers based on the instructions from the microcontroller 4230 when the body impedance values meet a first predefined threshold, when a swelling of the patient is detected by the microcontroller, or both (when bioimpedance value reaches threshold indicating increased swelling, the controller increases pressure, paragraph [0224]); and stopping the plurality of pumps when the swelling is reduced (paragraph [0226]: controller may discontinue therapy if the evaluation of the determined bioimpedance suggests that no further therapy is needed).
While Ramanan discloses that the sleeve comprises an outer layer comprising a fabric (outer layer is a three-dimensional knitted fabric, paragraph [0184]), they do not expressly disclose that the outer fabric layer comprises canvas, fleece, polyester, or a combination of any thereof. However, Dillon teaches a compression sleeve 10 having an outer layer (outer retaining garment 25, Fig. 1, Fig. 2) comprising canvas (leg-shaped canvas sheath, col. 3, ln. 31-43]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the compression device so that the outer fabric layer is a canvas sheath employed over the inflatable chambers, as taught by Dillon, in order to provide a retaining means to confine and constrain the inflatable chambers in position surrounding and enclosing the patient's limb so that the inflation and deflation of the chambers properly compresses and decompresses the limb during treatment (see Dillon, col. 3, ln. 30-41).
Ramanan further discloses that one or more layers of the garment (e.g., the skin contacting layer) comprises nylon (paragraph [0183]: one or more layers of the garment includes polyester, elastane, nylon, and thermoplastic polyurethane (TPU), but does not explicitly disclose that each of the plurality of inflatable chambers comprises a polymer-coated fabric, wherein the polymer coated fabric comprises nylon, latex, or a combination of any thereof. However, Papadopoulou teaches a pneumatic sleeve 1500 (see Fig. 15, Fig. 19A, paragraph [0004]) having inflatable chambers (inflatable subdivisions 1010,1011,1012, Figs. 10-12, paragraphs [0038]-[0040], shown as subdivisions 1301 in Figs 13-15, paragraphs [0045]-[0046]) comprising a polymer coated fabric (fabric coated with thermoplastic material (TPU coated), see paragraphs [0037],[0047]); wherein the polymer coated fabric comprises nylon, latex, or a combination of any thereof (nylon fabric coated with TPU, paragraphs [0037],[0052]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Ramanan so that the plurality of chambers are formed from a polymer coated nylon, as taught by Papadopoulou, in order to provide a suitable material that is air tight and flexible to inflate with pressurization.
As to claim 12, Ramanan discloses the method according to claim 11, wherein a duration, pressure, and sequence of the inflating is adjusted according to the body impedance values received from the sensors (paragraph [0224]-[0226] - bioimpedance value indicating increased fluid content/swelling = higher pressure, different therapy protocol, and/or longer therapy session; bioimpedance value indicating decreased fluid content/swelling = lower pressure, different therapy protocol, and/or shorter therapy session; see also paragraph [0245] describing adjusting the sequencing of Unload Phase and Clearance Phase in response to the sensors).
As to claim 13, Ramanan discloses the method according to claim 11, wherein the patient is ambulatory during treatment (paragraph [0326], allows user to be mobile while wearing the compression garment).
As to claim 14, Ramanan discloses the method according to claim 11, wherein the device 1000 is wearable (see Figs. 21-22, paragraph [0206]).
As to claim 15, Ramanan discloses the method according to claim 11, wherein the inflating moves lymph fluid away from an affected area of the patient (Fig. 56A, paragraph [0243] – each section advances in a direction away from the heart).
As to claim 16, modified Ramanan discloses the method of claim 11, further comprising recording information related to a lumped hydraulic resistance, a hydraulic capacitance, a maximum achievable limb volume, or a combination of any thereof, wherein the information indicates a treatment effectiveness (the graph of limb volume vs time 31100-D, which is part of a daily display presented by the controller, inherently shows the maximum limb volume of that day (the peak of the graph), see Fig. 31, paragraph [0263]).
As to claim 18, modified Ramanan discloses the method of claim 11, wherein the pressure in each inflatable chamber is the same as or different from one another (see Ramanan Fig. 63A, paragraph [0329]: macro-chambers 6340a-6340f), and wherein the maximum pressure in each inflatable chamber is configured to be within a range of about 53 to about 60 mm Hg (see Ramadan, paragraph [0321]: pressures entering the macro chambers can range from 15 mm Hg to about 120 mm Hg; and in some implementations between about 15 mm Hg to 100 mm Hg; and in other implementations between about 25 mm Hg to about 65 mm Hg; and in yet other implementations between about 35 mm Hg to about 55 mm Hg).
As to claim 20, modified Ramanan discloses the compression device of claim 1, wherein the outer layer consists of canvas, polyester, or both (as taught by Dillon’s outer retaining garment 25, which is a canvas sheath, Fig. 1, Fig. 2, col. 3, ln. 31-43]).
As to claim 21, modified Ramanan discloses the compression device of claim 1, wherein the polymer-coated fabric consists of nylon, latex, or both (as taught by Papadopoulou’s nylon fabric coated with TPU, paragraphs [0037],[0052]).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Ramanan (US 2020/0237607), in view of Dillon (US 4,590,925), and Papadopoulou (US 2024/0009068), as applied to claim 1 above, and further in view of Ren et al. (2022/0331195).
Ramanan discloses the compression device of claim 1, but does not expressly disclose that the at least one pneumatic pump is a 4.5 V DC-motor-driven gas diaphragm pump. However, Ren teaches a pump (mini air pump) 101 for a compression device which is a 4.5 V DC-motor-driven gas diaphragm pump 101 (Fig. 1, Fig. 29, paragraph [0223]: "22K series miniature diaphragm pump from BOXER", see also Applicant’s paragraph [0060] disclosing the 22K series pumps from Boxer GmbH).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Ramanan so that the pump is a 4.5 V DC-motor-driven gas diaphragm pump, as taught by Ren, in order to provide a suitable known type of air pump which is compatible with compression therapy devices and small enough to be carried on the user’s body.
Claim 17 is rejected under 35 U.S.C. 103 as being unpatentable over Ramanan (US 2020/0237607), in view of Dillon (US 4,590,925), and Papadopoulou (US 2024/0009068), as applied to claim 11 above, and further in view of Brosnan et al. (US 2017/0172838).
As to claim 17, modified Ramanan discloses the method of claim 16, but does not expressly disclose reinflating the inflatable chambers when the body impedance values return to the first predefined threshold after the pumps have been stopped due to body impedance levels reaching the second threshold.
However, Ramanan does disclose that pressure is decreased in response to the body impedance values reaching a first threshold (indicating decreased swelling) and is increased in response to body impedance values reaching a second threshold (indicating increased swelling, paragraphs [0224]). Further, Brosnan teaches a compression therapy device (inflatable garment 200, Fig. 3) in which a decrease in pressure within an inflatable bladder is achieved by turning off a pump 220 and allowing air within a bladder to be released to atmosphere to thus deflate the bladder, and an increase in pressure within the bladder is achieved by turning on the pump 220 to allow more air into the bladder and inflate it (Fig. 3, paragraphs [0069]-[0070]).
Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the method of Ramanan so that the decrease in pressure at the first impedance value threshold is achieved by turning off the pump(s) and allowing air to escape the chamber(s) and an increase in pressure is achieved by turning the pump(s) back on to reinflate the chamber(s), as taught by Brosnan, in order to provide a simple means of creating the change in pressure within the chambers without the need for more expensive variable speed pumps.
Claims 1 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Ramanan (US 2020/0237607), in view of Arkans (US 4,198,961), and further in view of Papadopoulou (US 2024/0009068).
As to claim 1, Ramanan discloses a compression device 1000 (Fig. 1) comprising: a sleeve (garment 1004) comprising a plurality of inflatable chambers (7304-1 to 7304-16, Fig. 7); at least one pneumatic pump (4245 blower of compression pressure generator (CPG) device 1002, Fig. 5, paragraph [0118]) coupled to at least one inflatable chamber (CPG 1002 is connected to the chambers 7304-1 to 7304-16 via pneumatic valves 1008/7008, see Fig. 1, Fig. 7); a portable bio impedance analyzer 4230 (part of central controller 4230 that receives signals from electrodes 4273 evaluates them to determine bioimpedance, paragraphs [0140],[0216]); a microcontroller 4230/4240 (therapy device controller 4240 and/or part of the central controller that determines control parameters for the therapy device based on the sensor data, paragraphs [0216], [0142]-[0143]; see also paragraph [0362] describing that a controller can mean one or more microcontrollers); and a battery 4210 (Fig. 5, paragraph [0118]); wherein the battery 4210 powers the microcontroller 4240 and the at least one pneumatic pump 4245 and wherein the microcontroller 20 controls the portable bio impedance analyzer 4230 and the at least one pneumatic pump 4240 (paragraph [0216],[0142]-[0143]), and wherein the sleeve 1004 is configured to be activated to maintain a predetermined level of swelling of a patient, and wherein the at least one pneumatic pump is configured to activate or deactivate based on a level of swelling (paragraph [0224]-[0226]: an increase/decrease in swelling indicated and serves as a basis for the controller to decrease/increase or change a compression therapy parameter; process may be performed before, during or after during a session to assess whether further therapy is needed or if the therapy should be discontinued).
While Ramanan discloses that the sleeve comprises an outer layer comprising a fabric (outer layer is a three-dimensional knitted fabric, paragraph [0184]), they do not expressly disclose that the outer fabric layer comprises canvas, fleece, polyester, or a combination of any thereof. However, Arkans teaches a compression sleeve 26 (Fig. 1) having an outer layer (outer cover sheet 36, Fig. 1, Fig. 2) comprising polyester (col. 2, ln. 55-67). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the compression device so that the outer fabric layer is an outer over sheet comprising polyester, as taught by Arkans, in order to provide a n attractive outer surface of the device (col. 2, ln. 55-60).
Ramanan further discloses that one or more layers of the garment (e.g., the skin contacting layer) comprises nylon (paragraph [0183]: one or more layers of the garment includes polyester, elastane, nylon, and thermoplastic polyurethane (TPU), but does not explicitly disclose that each of the plurality of inflatable chambers comprises a polymer-coated fabric, wherein the polymer coated fabric comprises nylon, latex, or a combination of any thereof. However, Papadopoulou teaches a pneumatic sleeve 1500 (see Fig. 15, Fig. 19A, paragraph [0004]) having inflatable chambers (inflatable subdivisions 1010,1011,1012, Figs. 10-12, paragraphs [0038]-[0040], shown as subdivisions 1301 in Figs 13-15, paragraphs [0045]-[0046]) comprising a polymer coated fabric (fabric coated with thermoplastic material (TPU coated), see paragraphs [0037],[0047]); wherein the polymer coated fabric comprises nylon, latex, or a combination of any thereof (nylon fabric coated with TPU, paragraphs [0037],[0052]). Therefore, it would have been obvious to one of ordinary skill in the art as of the effective filing date of the invention to modify the device of Ramanan so that the plurality of chambers are formed from a polymer coated nylon, as taught by Papadopoulou, in order to provide a suitable material that is air tight and flexible to inflate with pressurization.
As to claim 19, modified Ramanan discloses the compression device of claim 1, wherein the outer layer consists of fleece, polyester, or both (the fabric of the sheet 36 may be warp knit from polyester yarns on a tricot machine, after which the fabric is dyed to a suitable color, and the fabric is brushed or napped on a suitable machine to raise loops from the fabric).
Response to Arguments
Applicant’s arguments with respect to claims 1-7 and 9-17 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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