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 and Amendment Filed
Applicant’s response and amendment, filed July 20, 2026, has been entered and made of record.
Information Disclosure Statement
The information disclosure statement filed July 20, 2026 has been entered and the references cited therein have been considered by the examiner.
Previously Set Forth Objections and Rejections
The status of the objections and rejections set forth in the previous Office action (mailed April 20, 2026) is as follows:
The objection to the drawings under 37 CFR 1.84(p)(5) is hereby withdrawn.
The 35 USC 112(b) rejection of claim 10 has been overcome by amendments to claim 10.
The 35 USC 103 rejection of claims 1-16 and 18-24 as being unpatentable over Giles et al. (U.S. Patent No. 9,642,404) in view of Spence et al. (U.S. Patent Application Publication No. 2014/0222121) and further in view of Voorhees et al. (U.S. Patent Application Publication No. 2020/0155341) is hereby withdrawn.
The 35 USC 103 rejection of claim 17 as being unpatentable over Giles et al. (U.S. Patent No. 9,642,404) in view of Spence et al. (U.S. Patent Application Publication No. 2014/0222121) and further in view of Voorhees et al. (U.S. Patent Application Publication No. 2020/0155341) and further in view of Medivance (EP1616543) is hereby withdrawn.
The following new grounds of rejection are set forth:
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
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) 1-24 is/are rejected under 35 U.S.C. 103 as being unpatentable over Augustine et al. (U.S. Patent No. 8,597,339) in view of Voorhees et al. (U.S. Patent Application Publication No. 2020/0155341) and further in view of Liao et al. (“Sprayable Hydrogel for Biomedical Applications”, Biomater. Sci, 10, 2759-2771 (April 4, 2022)).
In regard to claims 1 and 18, Augustine et al. teach a pneumatic convective device 110 attached to the inside surface of a hospital gown 112 (see Fig. 1B). The device 110 has an inlet port 127 to receive the end of an air hose from which a stream of pressurized, thermally-treated air flows (see Figs. 1A-1C and col. 7, lines 23-40). Augustine et al. are silent as to a TTM fluid. However, Voorhees et al. teach a medical pad 10 for contact and thermal exchange with a skin region of a patient that includes an inlet port 12a and an outlet port 12b for circulating a thermal exchange fluid into and out of a fluid circulation layer of the pad 10 (see Fig. 1 and para. 0032). Inlet port 12a and outlet port 12b connect with fluid circulation lines 40a, 40b and a fluid conditioning assembly 20 which includes a fluid pump 21 is fluidly connected to the pad 10 for circulating the fluid (see Fig. 6 and paras. 0054-0055). Voorhees et al. thus demonstrate that pads using thermal exchange fluids for patient temperatures control are well known in the art. Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the pad 10 and fluid system of Voorhees et al. as the device 110 in the gown 112 of Augustine et al. in order to provide a thermal exchange fluid system for controlling the patient’s temperature. Voorhees et al. also teach that the pad 10 may comprise a hydrogel layer 16 for thermal conduction between the circulated thermal exchange fluid and a patient (see Figs. 1-1 and para. 0032). Liao et al. teach sprayable hydrogels for a variety of applications (e.g., wound care) for enhancing thermal conduction (see pages 2759-2771). Since Voorhees et al. teach the use of a hydrogel layer 16, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to utilize the sprayable hydrogels taught by Liao et al. as the hydrogel layer 16 in the pad 10 of Augustine et al. in view of Voorhees et al. As such, the hydrogel layer 16 could be removed (wiped off) after the performance of the thermal therapy. With further respect to claim 18 and in regard to claims 2-7, 11 and 19-24, Augustine et al. teach that the gown 112 can be a woven cloth, such as cotton, or a non-woven cloth such a spun-bond-meltblown-spunbond material (SMS) which lend themselves to single use, multiple use, disinfection, sterilization and laundering (see col. 8, lines 37-45). Augustine et al. also teach that the device 110 is removable from the gown 112, thus further permitting disinfection, sterilization and laundering of the gown 112 (see col. 8, lines 47-50). In regard to claims 8-10 and 12-14, Augustine et al. in view of Voorhees et al. only depicts one device 110/pad 10. However, it is well settled that duplicating the components of a prior art device is within the skill in the art. In re Harza, 274 F.2d 449, 104 USPQ 400 (CCPA 1955). Accordingly, it would have been obvious for one of ordinary skill in the art at the effective filing date of the invention to provide more than one device 110/pad 10 in the structure of Augustine et al. in view of Voorhees et al. Furthermore, depending on the size and shape of the patients, these multiple device 110/pad 10 structures could be in contact with first and second sides of the torso of the patient or first and second thighs of the patient. It also follows that when multiple device 110/pad 10 structures are provided, they may be both fluidly interconnected and disconnectable from each other or individually coupled with the fluid flow so that the thermal therapy can be optimized. In regard to claims 15 and 16, see Fig. 1A of Augustine et al. In regard to claim 17, see Fig. 2 of Voorhees et al.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-24 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
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 BEVERLY MEINDL FLANAGAN whose telephone number is (571)272-4766. The examiner can normally be reached Mon-Fri 7:30AM to 5:00PM.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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