DETAILED ACTION
This action is responsive to the application filed 10/3/25.
Claims 1-9 and 11-22 are finally 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 Objections
Claim 13 is objected to because of the following informalities:
Claim 13 omits the word ‘chamber’ from the limitation ‘a second air chamber’. Appropriate correction is required.
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 11, 21-22 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 claim 11, the claim is indefinite since the claim depends from cancelled claim 10.
Regarding claims 21-22, it is not clear what is meant by the limitation ‘wherein the air chamber comprises an extension portion that extends into the first air chamber’. For instance, how could the second chamber extend into the first chamber if the two chambers have previously been claimed to be pneumatically isolated. The examiner suggests amending the claims to clarify the desired structure.
Claim Rejections - 35 USC § 102
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 5-6, 12-13, and 17-18 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by of Dilligan et al. (US 20200375793).
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 air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’); a second air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’); 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 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 claim 13, Dilligan 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 air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’); a second air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’); 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.’); 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 further teaches wherein the compressive element comprises an inflatable bladder (Fig. 1B, inflatable member 130).
Regarding claims 6 and 18, Dilligan 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, Dilligan further teaches wherein the compressive element further comprises: a plurality of stays the configured in a pattern that facilitates the compressive element curving to more closely conform to the bottom layer (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).
Regarding claim 12, Dilligan 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 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) 1-3, 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 et al. (US 20200375793).
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), 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 to more closely conform to the bottom layer (Par. 310, when the air bladder 176 is inflated it pushes against the bottom layer of soft-good 192, and therefore conforms more closely to the bottom layer of soft-good 192).
Vergara fails to teach that the compressive element comprises a first chamber; a second air chamber; 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.
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 air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’); a second air chamber (Par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’); 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 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.’).
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 chambers, in order to facilitate more uniform heat transfer with the body, as taught by Dilligan.
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 air chamber (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.’); a second air chamber (See Dilligan, par. 7 ‘In some variations, the inflatable member may comprise at least three chambers.’); 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.’); 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 to more closely conform to the bottom layer (Par. 310, when the air bladder 176 is inflated it pushes against the bottom layer of soft-good 192, and therefore conforms more closely to the bottom layer of soft-good 192, which is curved to conform to the body of the user as shown in fig. 1).
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, Vergara, as modified, further teaches wherein the compressive element further comprises: a plurality of stays the configured in a pattern that facilitates the compressive element curving to more closely conform to the bottom layer (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 which separate the different chambers and which facilitate shaping the inflatable member to better conform to the head of the user).
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 the first air chamber.
The examiner maintains 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, 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.
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 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 inelastic material 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 10/3/25, with respect to the rejection(s) of claim(s) 1-3, 5-6, 12-15 and 17-18 under 35 U.S.C. 102 have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made in view of Dilligan.
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 ADAM JOSEPH AVIGAN whose telephone number is (571)270-3953. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joseph Stoklosa can be reached at (571) 272-1213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
ADAM JOSEPH. AVIGAN
Examiner
Art Unit 3739
/ADAM J AVIGAN/Examiner, Art Unit 3794
/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794