DETAILED ACTION
This action is responsive to the RCE filed 5/15/26.
Claims 1-9 and 11-22 are rejected.
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.
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 .
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9, 11-22 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1 and 13, the claims recite the limitation that the compressive element ‘curves towards the bottom layer’. This limitation is ambiguous and susceptible to multiple competing interpretations. For instance, it is unclear whether ‘curves towards’ requires that the compressive layer structurally flexes or bends its overall geometric profile to conform to the curvature of the bottom layer, or whether it requires a wall of the compressive element to expand/bulge outwardly in the direction of the bottom layer upon pressure activation. Therefore, POSITA would be unable to determine the true scope of the claim, considering the multiple competing interpretations of the limitation.
Regarding claim 11, the claim recites the limitation “a plurality of stays configured based on usage parameters […] wherein the usage parameters are associated with one or more of a desired curvature, a body part, a body shape, or a body size.” The term ‘usage parameter’ is an open-ended, ill-defined term that renders the claim indefinite. For instance, POSITA would not be apprised to determine whether a given parameter would or would not be considered a ‘usage parameter.’
Further, the innate ambiguity of the term ‘usage parameter’ renders the functional limitation related to the ‘plurality of stays’ indefinite. POSITA would be unable to determine whether a structure falls within the metes and bounds of ‘a plurality of stays configured based on usage parameters […]’.
Finally, regarding claim 11, the claim recites “a pattern that facilitates the compressive element curving to more closely conform to the bottom layer”. The claim is indefinite, since it is unclear how to parse the limitation of ‘curving to more closely conform’. For instance, the limitation implies knowledge of a baseline curvature/conformance which is not defined by the claim. It is unclear how POSITA could determine whether a stay pattern satisfies the limitation of ‘more closely conform[ing]’ if the baseline level of curvature/conformance is not established by the claim.
Regarding claims 21-22, the claims recite the limitation “wherein the second air chamber comprises an extension portion that extends into, while remaining separate from, the first air chamber.” The limitation “extends into, while remaining separate from” is internally contradictory and geometrically ambiguous. POSITA would not understand how the extension portion could physically occupy space within the internal volume/boundary of the first air chamber while simultaneously remaining separate from it. To the extent that the claims intend to recite that the extension portion extends into a recess, notch, or channel formed along an exterior perimeter of the first air chamber without fluidly communicating with an interior of the first air chamber, the claims fail to recite such a structural relationship. Therefore, since the claims recite competing contradictory limitations, the scope of the claims is indefinite.
Claim Rejections - 35 USC § 103
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.
Claim(s) 1, 5-6, 11-13, and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Dilligan et al. (US 20200375793, “Dilligan”) in view of Balachandran et al. (US 20100210982, “Balachandran”).
Regarding claim 1, Dilligan teaches a device for applying compressive therapy (Abstract, ‘These systems and methods may comprise a cooling cap assembly comprising a heat exchanger configured to be wrapped around a head of a patient and a compression assembly releasably coupled to the heat exchanger.’), the device comprising: a top layer (Fig. 1B, enclosure 140); a bottom layer adapted to contact a body surface of a user (Fig. 1B, liner 112); and a compressive element disposed between the top layer and the bottom layer (Fig. 1B, inflatable member 130; Abstract, ‘The compression assembly may comprise an enclosure and an inflatable member’), the compressive element comprising: a first layer (Par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); a second layer (Par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); a first air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’) formed between the first layer and the second layer (Par. 94); a second air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’) formed between the first layer and the second layer (Par. 94); and at least one stay located between the first and second air chambers (Fig. 1B depicts stays between the different chambers of inflatable members 130), wherein the at least one stay pneumatically isolates the second air chamber from the first air chamber (Par. 7, ‘In some of these variations, each of the plurality of chambers may be independently inflatable. ’); wherein the compressive element is configured such that, upon activation of the compressive element: (i) a compressive force is applied to the body surface (Par. 6, ‘In some variations, the compression assembly may be configured to generate from about 0.1 lb/in2 to about 10 lb/in2 of compression to the head when the inflatable member is in the inflated configuration.’) and (ii) the compressive element curves to towards the bottom layer (Par. 84, ‘As the inflatable member is inflated, the enclosure may be configured to resist deformation from the inflatable member and provide a counter force such that the compression assembly may apply a compressive force to the heat exchanger. This compressive force may increase a contact area between the heat exchanger and the scalp, by for example, pressing the heat exchanger into a patient's scalp such that the heat exchanger better conforms to the shape of the patient's scalp.’).
Dilligan fails to explicitly teach that the at least one stay located between the first and second air chambers bonds a first portion of the first layer to a second portion of the second layer.
In the same field of endeavor, Balachandran teaches a device for applying compressive therapy (Abstract, “A system for providing segmental gradient compression to a body of a patient of the type comprising a wrap applied to an appendage of the patient.”), the device comprising: a compressive element (Fig. 11 and par. 51, “Referring now to FIG. 11, there is shown a trapezoidal calf wrap 1802 of the type that may be used for compression and/or thermal therapy.”), the compressive element comprising: a first layer (Fig. 11 and par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802.”); a second layer (Fig. 11 and par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802.”); a first air chamber formed between the first layer and the second layer (Fig. 11 and par. 51, “Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814.”); a second air chamber formed between the first layer and the second layer (Fig. 11 and par. 51, “Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814.”); and at least one stay located between the first and second air chambers (Fig. 11 and welds 1812/1814), wherein the at least one stay pneumatically isolates the second air chamber from the first air chamber (Fig. 11, showing that chambers 1804, 1806 and 1808 are pneumatically isolated by welds 1812/1814; par. 11, ‘sequential inflation’ of the different chambers implies pneumatic isolation) by bonding a first portion of the first layer to a second portion of the second layer (Par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802. The front 1800 and the back 1820 are sealed or sewn together at a sealed edge 1810. Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814 […] In various embodiments, all welding may be accomplished by radio-frequency (RF) welding.”; claim 3, “wherein the first and second barriers are formed from first and second air-tight welds between an upper layer and a lower layer of the compression bladder.”); wherein the compressive element is configured such that, upon activation of the compressive element: (i) a compressive force is applied to the body surface (Abstract, “A system for providing segmental gradient compression to a body of a patient”).
Therefore, in view of Balachandran, it would have been obvious to POSITA at the time that the invention was filed to modify Dilligan by constructing the different air chambers through RF welding the first layer of the compression element to the second layer of the compression element, in order to efficiently manufacture discrete, pneumatically controlled air chambers within a flexible multi-layer wrap using standard cost-effective manufacturing techniques (RF welding) that securely join opposing layers and define independent fluid spaces without requiring additional internal structural components, as taught by Balachandran.
Regarding claim 13, Dilligan, as modified, teaches a method for applying compressive therapy (Abstract, ‘These systems and methods may comprise a cooling cap assembly comprising a heat exchanger configured to be wrapped around a head of a patient and a compression assembly releasably coupled to the heat exchanger.’), the method comprising the steps of: providing a device for applying compressive therapy (Fig. 1B), the device comprising: a top layer (Fig. 1B, enclosure 140); a bottom layer adapted to contact a body surface of a user (Fig. 1B, liner 112); a compressive element disposed between the top layer and the bottom layer (Fig. 1B, inflatable member 130; Abstract, ‘The compression assembly may comprise an enclosure and an inflatable member’), the compressive element comprising: a first layer (Par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); a second layer (Par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); a first air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’) formed between the first layer and the second layer (Par. 94); a second air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’) formed between the first layer and the second layer (Par. 94); and at least one stay located between the first and second air chambers (Fig. 1B depicts stays between the different chambers of inflatable members 130), wherein the at least one stay pneumatically isolates the second air chamber from the first air chamber (Par. 7, ‘In some of these variations, each of the plurality of chambers may be independently inflatable.’) by bonding a first portion of the first layer to a second portion of the second layer (Dilligan has previously been modified in view of Balachandran to construct the first and second air chambers using RF welding between the first and second layers; see Balachandran, par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802. The front 1800 and the back 1820 are sealed or sewn together at a sealed edge 1810. Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814 […] In various embodiments, all welding may be accomplished by radio-frequency (RF) welding.”; claim 3, “wherein the first and second barriers are formed from first and second air-tight welds between an upper layer and a lower layer of the compression bladder.”); and applying the bottom layer of the device to the body surface (Fig. 1B); and activating the compressive element of the device (Par. 16, ‘The inflatable member may be inflated to compress the heat exchanger between the inflatable member and the scalp.’), wherein, upon activation, the compressive element (i) applies a compressive force to the body surface (Par. 6, ‘In some variations, the compression assembly may be configured to generate from about 0.1 lb/in2 to about 10 lb/in2 of compression to the head when the inflatable member is in the inflated configuration.’) and (ii) curves to more closely conform to the bottom layer (Par. 84, ‘As the inflatable member is inflated, the enclosure may be configured to resist deformation from the inflatable member and provide a counter force such that the compression assembly may apply a compressive force to the heat exchanger. This compressive force may increase a contact area between the heat exchanger and the scalp, by for example, pressing the heat exchanger into a patient's scalp such that the heat exchanger better conforms to the shape of the patient's scalp.’).
Regarding claims 5 and 17, Dilligan, as modified, further teaches wherein the compressive element comprises an inflatable bladder (Fig. 1B, inflatable member 130).
Regarding claims 6 and 18, Dilligan, as modified, further teaches wherein the device further comprises an air compressor adapted to selectively inflate the inflatable bladder (Par. 87, “In other variations, the inflatable member may be fluidly coupled to a separate pump, for example, an air pump contained in the cooling unit, via the one or more fluid connectors.”).
Regarding claim 11, as far as the claim can be understood, Dilligan, as modified, further teaches wherein the compressive element further comprises: a plurality of stays configured based on usage parameters (Par. 94, “In some variations, the inflatable member (1200) may comprise a set of fluid barriers (1210) (e.g., walls, welds) configured to provide a predetermined shape to the inflatable member (1200) in an inflated configuration. The fluid barriers described herein may aid in promoting even and consistent inflation of the inflatable member (1200). For example, the fluid barriers may be configured to reduce expansion of one or more portions of an inflatable member (1200).”) to define a pattern that facilitates the compressive element curving to more closely conform to the bottom layer (Par. 94 and fig. 1B, showing inflatable member having a plurality of stays which separate the different chambers and which facilitate shaping the inflatable member to better conform to the head of the user) wherein the usage parameters are associated with one or more of a desired curvature, a body part, a body shape, or a body size (Par. 94, “In some variations, the inflatable member (1200) may comprise a set of fluid barriers (1210) (e.g., walls, welds) configured to provide a predetermined shape to the inflatable member (1200) in an inflated configuration.”).
Regarding claim 12, Dilligan, as modified, further teaches at least one temperature modulation assembly adapted to apply temperature treatment to the body surface of the user (Fig. 1B, heat exchanger 120; par. 52, ‘The heat exchanger (120) may generally comprise fluid channels through which fluid may circulate to remove heat from a patient's scalp.’).
Claim(s) 1-3, 5-9, 11-15 and 17-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vergara et al. (US 20190262169, “Vergara”) in view of Dilligan and Balachandran.
Regarding claim 1, Vergara teaches a device for applying compressive therapy (Par. 311, ‘[…] the HEM device shall contain an air bladder capable of generating compression up to 2 psi.’), the device comprising: a top layer (Fig. 66, top layer of soft-good 192; fig. 5, layer of soft-good 192 furthest from user 132); a bottom layer adapted to contact a body surface of a user (Fig. 66, bottom layer of soft-good 192; fig. 5, layer of soft-good 192 in contact with user 132); and a compressive element disposed between the top layer and the bottom layer (Figs. 5 and 66, air bladder 176 located between the top and bottom layers of the soft-good 192), the compressive layer comprising: a first layer (Par. 278, “Second, the inner and outer layer of an air bladder is welded using methods known in the art (e.g. ultrasonic welding, thermosonic bonding, etc.)”); a second layer (Par. 278, “Second, the inner and outer layer of an air bladder is welded using methods known in the art (e.g. ultrasonic welding, thermosonic bonding, etc.)”); wherein the compressive element is configured such that, upon activation of the compressive element: (i) a compressive force is applied to the body surface (Figs. 5, 66 and par. 310, ‘With the wrap in place the bladder can be inflated to the desired size/pressure by squeezing the bulb, and thereby compressing the module against the body part for improved performance.’) and (11) the compressive element curves towards the bottom layer (Par. 310, when the air bladder 176 is inflated it pushes against the bottom layer of soft-good 192, and therefore ‘curves towards’ the bottom layer of soft-good 192).
Vergara fails to teach that the compressive element comprises a first air chamber formed between the first layer and the second layer; a second air chamber formed between the first layer and the second layer; and at least one stay located between the first and second air chambers, wherein the at least one stay pneumatically isolates the second air chamber from the first air chamber by bonding a first portion of the first layer to a second portion of the second layer.
Dilligan teaches a device for applying compressive therapy (Abstract, ‘These systems and methods may comprise a cooling cap assembly comprising a heat exchanger configured to be wrapped around a head of a patient and a compression assembly releasably coupled to the heat exchanger.’), the device comprising: a top layer (Fig. 1B, enclosure 140); a bottom layer adapted to contact a body surface of a user (Fig. 1B, liner 112); and a compressive element disposed between the top layer and the bottom layer (Fig. 1B, inflatable member 130; Abstract, ‘The compression assembly may comprise an enclosure and an inflatable member’), the compressive element comprising: a first layer (Par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); a second layer (Par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); a first air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’) formed between the first layer and the second layer (Par. 94); a second air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’) formed between the first layer and the second layer (Par. 94); and at least one stay located between the first and second air chambers (Fig. 1B depicts stays between the different chambers of inflatable members 130), wherein the at least one stay pneumatically isolates the second air chamber from the first air chamber (Par. 7, ‘In some of these variations, each of the plurality of chambers may be independently inflatable. ’); wherein the compressive element is configured such that, upon activation of the compressive element: (i) a compressive force is applied to the body surface (Par. 6, ‘In some variations, the compression assembly may be configured to generate from about 0.1 lb/in2 to about 10 lb/in2 of compression to the head when the inflatable member is in the inflated configuration.’) and (ii) the compressive element curves to towards the bottom layer (Par. 84, ‘As the inflatable member is inflated, the enclosure may be configured to resist deformation from the inflatable member and provide a counter force such that the compression assembly may apply a compressive force to the heat exchanger. This compressive force may increase a contact area between the heat exchanger and the scalp, by for example, pressing the heat exchanger into a patient's scalp such that the heat exchanger better conforms to the shape of the patient's scalp.’).
Dilligan further teaches that the multiple chamber design of the compressive element allows for each chamber to be inflated and controlled independently which facilitates uniform heat-transfer with the body (Par. 99, ‘This may allow for more uniform cooling of the head by allowing for individual adjustment of the inflation pressure of each inflation portion and/or chamber as necessary.’)
Therefore, in view of Dilligan, it would have been obvious to POSITA at the time that the invention was filed to modify Vergara by configuring the compression member with multiple pneumatically isolated chambers between the first and second layers, in order to facilitate more uniform heat transfer with the body, as taught by Dilligan.
Vergara, as modified, still fails to teach that the at least one stay which pneumatically isolates the second air chamber from the first air chamber is formed by bonding a first portion of the first layer to a second portion of the second layer.
In the same field of endeavor, Balachandran teaches a device for applying compressive therapy (Abstract, “A system for providing segmental gradient compression to a body of a patient of the type comprising a wrap applied to an appendage of the patient.”), the device comprising: a compressive element (Fig. 11 and par. 51, “Referring now to FIG. 11, there is shown a trapezoidal calf wrap 1802 of the type that may be used for compression and/or thermal therapy.”), the compressive element comprising: a first layer (Fig. 11 and par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802.”); a second layer (Fig. 11 and par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802.”); a first air chamber formed between the first layer and the second layer (Fig. 11 and par. 51, “Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814.”); a second air chamber formed between the first layer and the second layer (Fig. 11 and par. 51, “Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814.”); and at least one stay located between the first and second air chambers (Fig. 11 and welds 1812/1814), wherein the at least one stay pneumatically isolates the second air chamber from the first air chamber (Fig. 11, showing that chambers 1804, 1806 and 1808 are pneumatically isolated by welds 1812/1814; par. 11, ‘sequential inflation’ of the different chambers implies pneumatic isolation) by bonding a first portion of the first layer to a second portion of the second layer (Par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802. The front 1800 and the back 1820 are sealed or sewn together at a sealed edge 1810. Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814 […] In various embodiments, all welding may be accomplished by radio-frequency (RF) welding.”; claim 3, “wherein the first and second barriers are formed from first and second air-tight welds between an upper layer and a lower layer of the compression bladder.”); wherein the compressive element is configured such that, upon activation of the compressive element: (i) a compressive force is applied to the body surface (Abstract, “A system for providing segmental gradient compression to a body of a patient”).
Therefore, in view of Balachandran, it would have been obvious to POSITA at the time that the invention was filed to further modify Vergara, as modified, by constructing the different air chambers through RF welding the first layer of the compression element to the second layer of the compression element, in order to efficiently manufacture discrete, pneumatically controlled air chambers within a flexible multi-layer wrap using standard cost-effective manufacturing techniques (RF welding) that securely join opposing layers and define independent fluid spaces without requiring additional internal structural components, as taught by Balachandran.
Regarding claim 13, Vergara, as modified, teaches a method for applying compressive therapy (Par. 311, ‘[…] the HEM device shall contain an air bladder capable of generating compression up to 2 psi.’), the method comprising the steps of: providing a device for applying compressive therapy (Figs. 5 and 66), the device comprising: a top layer (Fig. 66, top layer of soft-good 192; fig. 5, layer of soft-good 192 furthest from user 132); a bottom layer adapted to contact a body surface of a user (Fig. 66, bottom layer of soft-good 192; fig. 5, layer of soft-good 192 in contact with user 132); and a compressive element disposed between the top layer and the bottom layer (Figs. 5 and 66, air bladder 176 located between the top and bottom layers of the soft-good 192); the compressive element comprising: a first layer (Par. 278, “Second, the inner and outer layer of an air bladder is welded using methods known in the art (e.g. ultrasonic welding, thermosonic bonding, etc.)”); a second layer (Par. 278, “Second, the inner and outer layer of an air bladder is welded using methods known in the art (e.g. ultrasonic welding, thermosonic bonding, etc.)”); a first air chamber formed between the first layer and the second layer (Vergara has previously been modified in view of Dilligan to configure the compression member with multiple inflatable chambers; see Dilligan, par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’; par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); a second air chamber formed between the first layer and the second layer (Vergara has previously been modified in view of Dilligan to configure the compression member with multiple inflatable chambers; see Dilligan, par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’; par. 94, “opposing layers (e.g., top layer, bottom layer) of the inflatable member (1200)”); and at least one stay located between the first and second air chambers (See Dilligan, fig. 1B depicts stays between the different chambers of inflatable members 130), wherein the at least one stay pneumatically isolates the second air chamber from the first air chamber (See Dilligan, par. 7, ‘In some of these variations, each of the plurality of chambers may be independently inflatable.’) by bonding a first portion of the first layer to a second portion of the second layer (Vergara has previously been modified in view of Balachandran to manufacture the different air chambers through RF welding; see Balachandran, par. 51, “The calf wrap 1802 includes two sheets of biocompatible material that form a front 1800 and a back 1820 of the calf wrap 1802. The front 1800 and the back 1820 are sealed or sewn together at a sealed edge 1810. Additionally, the calf wrap 1802 is divided into three chambers (1804, 1806, and 1808) by welds 1812 and 1814 […] In various embodiments, all welding may be accomplished by radio-frequency (RF) welding.”; claim 3, “wherein the first and second barriers are formed from first and second air-tight welds between an upper layer and a lower layer of the compression bladder.”); and applying the bottom layer of the device to the body surface (Fig. 5, showing the surface of soft-good 192 in contact with user 132); and a activating the compressive element of the device (Figs. 5, 66 and par. 310, ‘With the wrap in place the bladder can be inflated to the desired size/pressure […].’), wherein, upon activation, the compressive element (i) applies a compressive force to the body surface (Figs. 5, 66 and par. 310, ‘thereby compressing the module against the body part for improved performance.’) and (ii) curves towards the bottom layer (Par. 310, when the air bladder 176 is inflated it pushes against the bottom layer of soft-good 192, and therefore ‘curves towards’ the bottom layer of soft-good 192).
Regarding claims 2 and 14, Vergara, as modified, further teaches wherein the top layer comprises a flexible, elastic material (Par. 276, ‘It will be understood by one of ordinary skill in the art, that the soft good can be washable either by machining or hand and will be made from a plurality of materials including but not limited to […] elastic’).
Regarding claim 3 and 15, Vergara, as modified, further teaches wherein the bottom layer comprises an inelastic material (Par. 276, for instance cotton is an inelastic material).
Regarding claims 5 and 17, Vergara, as modified, further teaches wherein the compressive element comprises an inflatable bladder (Vergara has previously been modified in view of Dilligan to comprise a multi-chambered inflatable member; see Dilligan, fig. 1B, inflatable member 130).
Regarding claims 6 and 18, Vergara, as modified, further teaches an air compressor adapted to selectively inflate the inflatable bladder (Par. 148, ‘The umbilical connector 198 can contain an air pump 200, an air pump control PCB board 202 with control circuitry and a pressure sensor 178 and air release valve 204 that control pressure within the air bladder.’).
Regarding claims 7 and 19, Vergara teaches an air compressor located within a control module (Par. 138, ‘In another embodiment, the air pump can be included, as a component, in the control unit 100.’; par. 148, ‘The umbilical connector 198 can contain an air pump 200, an air pump control PCB board 202 with control circuitry and a pressure sensor 178 and air release valve 204 that control pressure within the air bladder.’), which can be integrated into the soft-good (Par. 91, ‘The control unit 100 can be a portable console which is easily transported by hand or integrated into a soft good, as the case may be, which provides an additional advantage of system mobility.’), but fails to teach that the control module located within the top layer.
The examiner maintains, however, that it would have been obvious to POSITA at the time that the invention was filed to locate the control module within the top layer as needed or desired, since it has been held that rearranging parts of an invention involves only routine skill in the art. In re Japikse, 86 USPQ 70.
Regarding claims 8-9 and 20, Vergara, as modified, fails to teaches wherein the compressive element is bonded to the bottom layer at a perimeter of the bottom layer; and wherein the compressive element is bonded to the bottom layer solely at the perimeter of the bottom layer.
The examiner maintains, however that it would have been obvious to POSITA to bond the compressive element to the bottom layer of soft-good at a perimeter of the bottom layer or solely at a perimeter of the bottom layer as needed or desired, since it has been held that forming in one piece an article which has formerly been formed in two pieces and put together involves only routine skill in the art. Howard v. Detroit Stove Works, 150 U.S. 164 (1893).
Regarding claim 11, as far as the claim can be understood, Vergara, as modified, further teaches wherein the compressive element further comprises: a plurality of stays (Vergara has previously been modified in view of Dilligan to comprise a multi-chambered compressive element; see Dilligan, fig. 1B, showing inflatable member having a plurality of stays) configured based on usage parameters (See Dilligan, par. 94, “In some variations, the inflatable member (1200) may comprise a set of fluid barriers (1210) (e.g., walls, welds) configured to provide a predetermined shape to the inflatable member (1200) in an inflated configuration. The fluid barriers described herein may aid in promoting even and consistent inflation of the inflatable member (1200). For example, the fluid barriers may be configured to reduce expansion of one or more portions of an inflatable member (1200).”) to define a pattern that facilitates the compressive element curving to more closely conform to the bottom layer (See Dilligan, par. 94 and fig. 1B, showing inflatable member having a plurality of stays which separate the different chambers and which facilitate shaping the inflatable member to better conform to the head of the user), wherein the usage parameters are associated with one or more of a desired curvature, a body part, a body shape, or a body size (See Dilligan, par. 94, “In some variations, the inflatable member (1200) may comprise a set of fluid barriers (1210) (e.g., walls, welds) configured to provide a predetermined shape to the inflatable member (1200) in an inflated configuration.”).
Regarding claim 12, Vergara, as modified, further teaches at least one temperature modulation assembly adapted to apply temperature treatment to the body surface of the user (Fig. 5, flexible frame assembly 186 with embedded thermoelectric elements 180; Abstract, ‘A heat transfer tile is in thermal contact with a user side of the TEC. The module is configured to be operatively positionable with the tile in heat transfer relation with skin of a patient.’).
Regarding claims 21-22, Vergara, as modified, teaches that the compressive element has first and second air chambers which border each other (Vergara has previously been modified in view of Dilligan to comprise a multi-chambered inflatable member; see Dilligan, fig. 1B, inflatable member 130), but fails to teach that the border between the first and second chambers is curved (as far as the claim is definite this is how the examiner interprets the structure being claimed as shown in fig. 13e of applicant’s drawings) such that the second air chamber comprises an extension portion that extends into, while remaining separate from, the first air chamber.
The examiner maintains, however, that it would have been an obvious matter of design choice to make the different portions of the first and second chambers of whatever form or shape was desired or expedient. A change in form or shape is generally recognized as being within the level of ordinary skill in the art, absent any showing of unexpected results. In re Dailey et al., 149 USPQ 47.
Claim(s) 4 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Vergara in view Dilligan and Balachandran, as applied to claims 1-3, 5-9, 11-15 and 17-22, above, and further in view of Zimmerman (US 20180242555).
Regarding claims 4 and 16, Vergara fails to teach wherein the bottom layer comprises molded silicone.
However, Zimmerman teaches an analogous thermotherapeutic compress (Abstract, ‘The systems and methods include harnesses and related devices, including compresses and heating/icing devices.’) which comprises a silicone bottom layer (Figs. 1-2, compress 2; par. 60, ‘Compress devices 2 of the present disclosure preferably comprise a silicone material wherein the device is flexible such that it may conform to an animal body part.’).
Therefore, in view of Zimmerman, it would have been obvious to POSITA at the time that the invention was filed to modify Vergara by constructing the bottom layer of silicone in order to enhance flexibility of the device, as taught by Zimmerman.
Regarding the ‘molded’ aspect, MPEP 2113 states:
"[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985)
Therefore, in light above citation, it is the examiner’s opinion that the manner in which the bottom layer is produced does not add patentable weight to the claim since patentability of a product does not depend on its method of production.
Response to Arguments
Applicant's arguments, see “Remarks”, filed 5/15/26, with respect to the rejection of claims 21-22 under 35 U.S.C 112(b) have been fully considered but they are not persuasive. As discussed above, the examiner disagrees that the amendment to the claims resolves the internal structural/geometric contradiction recited by the claim.
Applicant’s arguments, see “Remarks”, filed 5/15/26, with respect to the rejections of the claims under 35 U.S.C. 102(a)(2) and 35 U.S.C. 103 have been fully considered and are persuasive. Therefore, the rejections have been withdrawn. However, upon further consideration, new grounds of rejection are made in view of Balachandran.
Conclusion
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ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794
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