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 .
Election/Restrictions
Claims 3-5, 8, 10-11, and 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention and species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 07/17/26.
Response to Amendment
This office action is in response to the amendment filed 07/17/26. No claims have been amended, new claims 21-26 have been added, and claims 3-5, 8, 10-11,and 15-20 have been withdrawn. Thus, claims 1-2, 6-7, 9, 12-14, and 21-26 are presently pending in this application.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 9, 13, and 23-26 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hyde (2016/0220808).
With respect to claim 9, Hyde discloses a treatment providing garment (102, fig 3B), comprising a shirt (not drawn; see [0033]) including an inner layer of fabric (302, fig 3B); and an outer layer of fabric (304, fig 3B) extending along and coupled to the inner layer of fabric (the fabrics are layered with one another as seen in fig 3B); actuators (306, fig 3B) disposed between the inner layer of fabric and the outer layer of fabric (see fig 3B and [0115]), wherein the actuators are configured to be arranged over an affected area (see [0117]), and wherein the actuators are selectively operable between a deployed state and a non-deployed state (see [0117]); and a control assembly (112, fig 3B) coupled to the shirt (operatively coupled via wire or wireless; see [0037]), wherein the control assembly includes a controller (114, fig 3B) communicatively coupled to the actuators (see [0043]), wherein the controller is configured to selectively adjust the actuators between the deployed state and the non-deployed state to provide a directional pattern of pressure on the affected area (see [0044]).
With respect to claim 13, Hyde discloses each actuator is an electro-activated actuation assembly (see [0115] of Hyde) having a dielectric polymer disposed between conductive layers (see layers 304/306/302 in fig 3B of Hyde), and wherein each electro-activated actuation assembly is configured to compress to the deployed state in response to a predefined voltage (see [0115] ‘actuation stimulus’ and [0086] ‘electroactive polymer actuators can increase or decrease in length, diameter, or other dimension depending on the polarity of the applied voltage to cause the flexible compression garment 102 to selectively constrict or dilate’).
With respect to claim 23, Hyde discloses in the non-deployed state, the electro-activated actuation assemblies define a first distance between the conductive layers to blend with the inner and outer layers of fabric, and wherein, in the deployed state, the actuation assemblies compress to define a second distance between the conductive layers in response to the predefined voltage, the second distance being less than the first distance (see ‘constrict or dilate’ [0086] of Hyde where the change in voltage changes the length of the actuator dependent on dilation or constriction).
With respect to claim 24, Hyde discloses the electro-activated actuator assemblies (see in fig 3B where actuator 306 is between layer 302 and 304 of Hyde) are disposed in an array disposed between the inner layer of fabric (302, fig 3B of Hyde) and the outer layer of fabric (304, fig 3B of Hyde).
With respect to claim 25, Hyde discloses a power source (116, fig 3B of Hyde) electrically coupled with the electro-activated actuator assemblies (see [0037] of Hyde), wherein the predefined voltage from the power source is applied to the electro-activated actuator assemblies to adjust the electro-activated actuator assemblies to the deployed state which is a compressed condition, and wherein the predefined voltage is removed from the electro-activated actuator assemblies to adjust the electro-activated actuator assemblies to the non-deployed state which is a relaxed condition (see [0086] of Hyde).
With respect to claim 26, Hyde discloses the actuators each include a dielectric polymer (see [0086] of Hyde) disposed between conductive layers configured to compress to the deployed state (see [0115] of Hyde) to apply a selected pressure to the affected area in response to a voltage (see [0086] of Hyde).
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.
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.
Claim(s) 1-2, 6, and 22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyde (2016/0220808) in view of Pamplin (2018/0177677).
With respect to claim 1, Hyde discloses a wearable health management system (100, fig 2A), comprising a flexible member (102, fig 2A) configured to be worn on an affected area by a patient (see fig 2A and [0030]); actuators (110, fig 2A) operably coupled to the flexible member (see fig 2A and [0030]), wherein the actuators are configured to be selectively adjusted between a deployed state and a non-deployed state (see [0036]), and wherein the actuators are spaced apart from one another along the flexible member to be arranged from a distal portion of the affected area to a proximal portion of the affected area (see multiple 110 in fig 2A), the proximal portion configured to be proximate to a trunk of a body of the patient (see fig 2A where the garment is proximate the trunk as applied to the leg of the user); a sensor (see [0116]) coupled to the flexible member (see fig 3B and [0116]) and configured to obtain one or more health metrics from the patient (see [0052]); and a control assembly (112, fig 3B) in communication with the actuators and the sensor (see [0031]), includes a power source (116, fig 3B); and a controller (114, fig 3B0 configured to sequentially adjust the actuators to the deployed state to provide a selected pressure in a directional pattern to the affected area (see [0044] where the actuators are constricted at a gradient), but is silent regarding the control assembly includes a housing coupled to the flexible member.
However, Pamplin teaches a garment system (100, fig 2) comprising a control assembly (control module; 150, fig 2) includes a housing (see module 150 and [0092]) coupled to the garment (see [0092]) and control circuitry housed in the module (see [0093]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the control assembly of Hyde to be housed and coupled to the garment as taught by Pamplin so as to keep all components in one convenient location.
With respect to claim 2, the modified Hyde shows the directional pattern is from a distal end of the flexible member proximate the distal portion to a proximal end of the flexible member proximate the proximal portion (note the compression is adjustable and can be applied in a gradient allowing for a pattern from the distal to proximal ends).
With respect to claim 6, the modified Hyde shows the actuators each include a dielectric polymer and a conductive layer configured to compress to the deployed state (see [0115] “electroactive polymer/shape memory alloy” and [0086] dielectric elastomers of Hyde).
With respect to claim 22, the modified Hyde shows the power source is configured to supply a predefined voltage to the actuators (see [0086] of Hyde) via an electrical connection (wired or wireless; [0037] of Hyde) in response to a signal from the controller (see [0037] of Hyde), and wherein the actuators are configured to contract to the deployed state in response to the predefined voltage to apply to a selected pressure to the affected area, and further wherein the actuators are configured to expand to the non- deployed state in response to removal of the predefined voltage (see [0086] of Hyde).
Claim(s) 7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyde in view of Pamplin as applied to claim 1 above, and further in view of Ramanan (WO2020/077008).
With respect to claim 7, the modified Hyde shows the sensor (see claim 1 above) but lacks the sensor is a bioimpedance sensor having a drive electrode configured to be in contact with the distal portion of the affected area and a sense electrode configured to be in contact with the proximal portion of the affected area.
However, Ramanan teaches a garment system (1000, fig 1) comprising a sensor (electrodes; 4273, fig 5), wherein the sensor is a bioimpedance sensor (see [000161]) having a drive electrode configured to be in contact with a distal portion of the affected area and a sense electrode configured to be in contact with a proximal portion of the affected area (see [000161] and [000227]) where a set of electrodes measures the bioimpedance in one or more zones and thus work together at different locations to sense).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the sensor of the modified Hyde to include a bioimpedance sensor of electrodes as taught by Ramanan so as to determine conditions such as tissue fibrosis, hardening and fluid retention or lymphedema (see [000227] of Ramanan).
Claim(s) 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyde as applied to claim 9 above, further in view of Barker (WO2014/114925).
With respect to claim 12, Hyde discloses the shirt (not drawn; see [0033]) and a sleeve (100, fig 2C) wherein the actuators are arranged along the sleeve (see fig 2C the actuators 110 are along the sleeve), and further wherein the controller is configured to adjust the actuators to the deployed state in a directional pattern (see [0044] where the actuators are constricted at a gradient and adjustable), but is silent regarding the shirt includes a torso portion and at least one sleeve.
However, Barker teaches a compression garment (long sleeve top; fig 1) of a shirt comprising a torso portion and a sleeve (see fig 1 where the shirt is to be worn on the torso and arms see pg. 7 last paragraph).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shirt of Hyde to include a torso portion and sleeve as taught by Barker so as to provide a top that extends the entire upper body for compression of the chest and arms.
Claim(s) 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hyde as applied to claim 9 above, further in view of Salamon (2018/0098707) and Ramanan (2020/0237607).
With respect to claim 14, Hyde shows the sensor (see claim 9 above) but is silent regarding a photoplethysmogram sensor coupled to the shirt to obtain photoplethysmogram data; and a bioimpedance sensor coupled to the shirt to obtain impedance data.
However, Salamon discloses a system and method for synchronizing external compression for a limb for increased blood flow return to the heart from a limb (Abstract) and teaches a photoplethysmogram sensor ([0048], [0063]: second sensor 130/130B may be a non-invasive peripheral blood flow sensor such as, but not limited to, a pulse photoplethysmography sensor) coupled to the flexible member ([0063], [0075]: sensor 130b is integrated into the garment 115; second sensor 130 may be attached to the limb from or through the apparatus) to obtain one or more health metrics from the patient ([0076]: to measure local arterial blood flow).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the wearable health management system of Hyde to have a photoplethysmogram sensor coupled to the flexible member to obtain one or more health metrics from the patient, as taught by Salamon, for the benefit of better synchronizing the compression when the diastolic phase of the local blood flow in the limb takes place ([0051]).
Further, the modified Hyde lacks a bioimpedance sensor coupled to the shirt to obtain impedance data.
However, Ramanan teaches a compression garment system (1000, fig 1) comprising a bioimpedance sensor (4273, fig 5) coupled to the garment (see [0157 and 224]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the shirt of the modified Hyde to include a bioimpedance sensor as taught by Ramanan so as to monitor for indications of swelling while using the device (see [0224] of Ramanan).
Allowable Subject Matter
Claim 21 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Morris (2002/0022791), Larson (2008/0195018), Cheatham (2016/0058644), Fleury (WO2021/108922), and Doraiswamy (2021/0386614) are cited to show additional compression garments.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KELSEY E BALLER whose telephone number is (571)272-8153. The examiner can normally be reached Monday - Friday 8 AM - 4 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Timothy 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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/KELSEY E BALLER/ Examiner, Art Unit 3785
/TU A VO/ Primary Examiner, Art Unit 3785
