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 amendment filed on August 4, 2026. As directed by the amendment: claim 21 has been amended, claim 8 has been canceled, and no new claims 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, and 20 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]).
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).
As to claim 7, 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.
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Ramanan (US 2020/0237607), in view of Dillon (US 4,590,925), Papadopoulou (US 2024/0009068), and Brosnan et al. (US 2017/0172838), as applied to claim 17 above, and further in view of Gonon (US 2021/0290477).
As to claim 21, modified Ramanan discloses the method of claim 17, but does not expressly disclose that the first pre-defined threshold is based at least in part on a real-time estimation of a maximum achievable limb volume reduction. However, Gonon teaches estimating a maximum achievable limb volume reduction (excess volume reduction target) used as a basis for evaluating progress of compression therapy (paragraph [0062]: the system can be used on the unaffected limb to measure a reference value integrated into the treatment objective as an excess volume reduction target to be reached). 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 include estimating a maximum achievable limb volume reduction to define the first threshold of the compression therapy, as taught by Gonon, in order to serve as a basis for determining the progress of therapy customized to the patient’s anatomy and degree of edema.
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 an 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 not persuasive.
Applicant argues on pages 6-7 of the remarks with respect to claims 1 and 11:
Dillon's canvas sheath cannot be combined with Ramanan's multi-chamber smart compression garment to supply the claimed outer layer material of claim 1 because the structural role of Dillon's canvas sheath is inseparable from Dillon's single-chamber architecture. Transplanting Dillon's canvas sheath into Ramanan's fundamentally different device would not achieve the stated purpose of the Office Action. In Dillon, the canvas sheath does not merely provide an outer fabric layer. It serves as the mounting surface for internal guide plates (wall-deforming plates 30 and 31) that engage the outer wall of the single inflatable legging to create internal flow channels for uniform gas distribution (see col. 3, In. 63-68 and col. 4, In. 1-45). The canvas sheath and the guide plates work together as an integrated system, and therefore the sheath's retaining function is inseparable from this guide-plate mechanism. Ramanan's garment, by contrast, has sixteen independently controllable pneumatic chambers, an outer layer of three-dimensional knitted fabric, and an integrated bioimpedance sensing system. None of these require or benefit from the guide-plate/canvas-sheath mechanism that defines Dillon's design. The stated motivation to provide a retaining means to confine and constrain the inflatable chambers in position surrounding and enclosing the patient's limb is already achieved by Ramanan's own multi-layer garment construction, which uses welded thermoplastic layers to define and retain the chambers. A skilled artisan would have no reason to replace Ramanan's functional three-dimensional knitted outer layer with Dillon's canvas sheath designed for a structurally incompatible single-chamber device.
However, the argument is not well taken because Dillon is only relied upon to teach canvas, which is a fairly common fabric worn on the body, as a suitable material choice for the outer fabric layer of Ramanan's compression sleeve. Ramanan already discloses that the outer layer of the compression device is a knitted fabric. One of ordinary skill in the art would be able to understand, upon seeing the Dillon reference, that canvas would be a suitable material choice for the outer layer of a Ramanan’s compression sleeve, without needing to adopt the guide plate feature along with it.
Applicant argues on pages 7-8 of the remarks with respect to claim 16:
Claim 16 requires that the recorded information indicates a treatment effectiveness, which is a functional characterization drawn from Applicant's model-based framework, in which the values of T (the time constant, related to lumped hydraulic resistance and hydraulic capacitance) and Q (related to maximum achievable limb volume change) are recorded at the end of each compression therapy session specifically to serve as indications of treatment effectiveness, and can be monitored by both the patient and the physician over the course of treatment for the chronic disease. Ramanan discloses no equivalent model-based framework, no recording of hydraulic resistance or capacitance parameters, and no characterization of any recorded quantity as a treatment-effectiveness indicator in this sense. The Office Action's inherency argument that a peak in a displayed graph inherently shows maximum limb volume does not establish that Ramanan teaches the deliberate recording of these specific model-based parameters as treatment-effectiveness indicators.
However, the argument is not well taken because the claim does not require the values be drawn from a model-based framework, as applicant asserts. Nor does the claim require that all of the values listed be recorded. Instead, the claim is written broadly, reciting "recording information related to a lumped hydraulic resistance, a hydraulic capacitance, a maximum achievable limb volume, or a combination of any thereof. It is also pointed out that while the specification lists a maximum achievable limb volume change or reduction (see paragraphs [0048],[0129]), the claim only recites "a maximum achievable limb volume" which reads as a maximum volume of the limb, rather than a reduction in the limb volume. Thus, Examiner interprets the limitation as a maximum volume of the limb (i.e., the volume of the limb at the maximum degree of swelling the patient experiences), which would be indicated on Ramanan's graph of the limb volume over time. Further, since viewing the patient's limb volume over time would indicate how effective the treatment was (the graph going down indicates it was effective in reducing limb volume/swelling), the limitation that the recorded information indicates treatment effectiveness is met.
Applicant argues on pages 8-9 of the remarks with respect to claim 17:
Claim 17 requires a specific, closed-loop feedback sequence: the pumps are stopped when swelling is reduced, and the chambers are reinflated when the body impedance returns to the first predefined threshold (indicating swelling has returned). Ramanan's paragraph [0224] describes using bioimpedance evaluations to increase or decrease compression therapy parameters in response to detected changes in fluid content or swelling. This is a general, open-ended description of therapy adjustment at the session or multi-session level. Ramanan does not describe a system that stops the pumps and then reinflates specifically when the bioimpedance returns to a first threshold. The "return to the first predefined threshold" language in claim 17 captures a precise re-triggering condition that is entirely absent from Ramanan's disclosure. Brosnan does not supply this missing teaching. Brosnan's pump activation and deactivation are governed entirely by pressure sensor readings. Further, Brosnan contains no bioimpedance sensing whatsoever, and its three-way valve system teaches only that a pump can be turned on to inflate and turned off to deflate a bladder based on pressure feedback. Grafting Brosnan's pressure-driven pump on/off mechanics onto Ramanan's general bioimpedance monitoring still leaves unanswered the question of what specific condition triggers reinflation. The Office Action has not identified any teaching in the combined references that discloses reinflating chambers upon bioimpedance returning to a named first predefined threshold
However, the argument is not well-taken. As applicant points out, Ramanan discloses that the bioimpedance values are used to evaluate when to increase or decrease compression therapy parameters (such as changing to a higher or lower pressure). Ramanan further discloses in paragraph [0008], that "sensors can be used in a control loop during therapy to dynamically adjust therapy parameters" and that the bioimpedance values can be evaluated periodically by the controller during a session (paragraphs [0225]-[0226]). Thus, Ramanan's system already discloses inflating/deflating the chambers in accordance with bioimpedance value thresholds.
What's essentially missing from Ramanan is that the decrease and increase in pressure based on the bioimpedance values reaching a threshold involves stopping and restarting the pump. In other words, it is not clear if lowering the pressure in the chambers involves stopping the pump motor, opening a release valve, reversing the pump, etc. Brosnan is simply relied upon to teach stopping the pump during deflation and starting the pump again during inflation, rather than having the pump run continuous and the flow from the pump be redirected when reducing pressure in the chamber. Thus, Brosnan teaches stopping the pump during deflation/pressure reduction and restarting it during inflation/pressure increase as one known technique that achieves the reduction/increase in pressure while conserving energy by shutting off the pump when not needed.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE L WOODWARD whose telephone number is (571)270-1479. The examiner can normally be reached Monday - Friday 8:30 am - 4:30 pm.
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/VALERIE L WOODWARD/Primary Examiner, Art Unit 3785
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