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 .
Information Disclosure Statements
The information disclosure statements filed June 17, 2026, February 5, 2026, July 21, 2025 and October 8, 2024 have been entered and the references cited therein have been considered by the examiner.
Preliminary Amendment
The preliminary amendment filed September 6, 2024 has been entered and made of record.
Election/Restrictions
Applicant’s election without traverse of the invention of Group II (claims 20-31) in the reply filed on May 19, 2026 is acknowledged. Accordingly, claims 1-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Drawings
The drawings are objected to under 37 CFR 1.83(a). The drawings must show every feature of the invention specified in the claims. Therefore, the “at least two TC modules” (claim 22) and “one or more TC modules along a first side of the heat exchanger and a second side of the heat exchanger” (claim 23) must be shown or the feature(s) canceled from the claim(s). No new matter should be entered.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Objections
Claim 30 is objected to because of the following informalities: In claim 30, “hydraulicly” should be “hydraulically.” 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 20-31 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.
In claim 20, the phrase “and/or” renders the claim vague and indefinite as the metes and bounds of the claim cannot be determined.
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)(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) 20, 21, 24-29 and 31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Marquette et al. (PCT Publication No. 2017/035341).
In regard to claims 20 and 24, Marquette et al. teach a medical system (see Figs. 14-16 and paras. 73-76) for exchanging thermal energy with a patient, the assembly comprising: a thermal contact pad (Figs. 14-16, glove 22; para. 74) configured for placement on the patient (Figs. 14-16) the pad (22) including a fluid compartment (Figs. 14-16, conduit 24; paras. 73, 75) configured for circulation of a thermal exchange (TE) fluid therein (para. 68); a temperature control (TC) module (Fig. 16: the detachable forearm sleeve 68 with its internal components forms the temperature control module, see para. 74: “the forearm sleeve 68 and glove 22 are detachable (e.g., along dotted line 70); a heat exchanger (thermoelectric device (TED) 72 is configured to heat or cool fluid in circulation loop and the TED 72 may be a Peltier device with first and second faces 73A-73B and thermally conductive sleeves 74 that are part of the first and second faces; the sleeves 74 mounted on first and second faces 73A-73B act as a heat exchanger and a heat sink; Figs. 16-17, para. 0076) where the fluid channels of circulation loop 61 pass through the sleeves 74 and are coupled to the fluid delivery lines 24 in glove 22; a pump (Fig. 16; pump 38; para. 75) configured to circulate the TE fluid (para. 68) between the TC module and the fluid compartment; and an electronic control unit (ECU) 20 configured to control a temperature of the thermal transfer elements (para. 58). In regard to claim 21, as broadly as claimed, the TED 72 with its sleeves 74 is configured to couple with more than one TC module (e.g., it could be utilized with any of the other garments discloses (para. 59). In regard to claim 25, see para. 76. In regard to claims 26 and 27, see Figs. 21 and 22 and paras. 58, 67, 68 and 80-82. In regard to claims 28-30, see para. 0068. In regard to claim 31, see paras. 66 and 88.
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) 30 is/are rejected under 35 U.S.C. 103 as being unpatentable over Marquette et al. (PCT Publication No. 2017/035341) in view of Voorhees et al. (PCT Publication No. WO 2016/123500).
In regard to claim 30, Marquette et al. are silent as to a pressure sensor to provide an electrical signal for comparison to a pressure limit and potential alteration of electrical power to the pump. However, Voorhees et al. teach a medical pad 10 for contact and thermal exchange with skin region of a patient (see Figs. 1-4) where a thermal exchange fluid is circulated into and out of a fluid circulation layer of the pad 10 (see page 6). The system 1 includes a controller 50 for use in the operation of a fluid conditioning assembly 20 that includes a fluid pump 21 for circulating the thermal exchange fluid (see page 11). A pressure sensor 28 may be provided to sense the pressure of the circulated fluid returning from medical pads 10 and the pressure sensor 28 may provide a pressure signal to controller indicative of the sensed pressure and, in turn, the controller 50 may utilize the pressure signal to generate output signals 52 provided to fluid pump 21, e.g., to control the speed of fluid pump 21 to provide for a desired negative pressure within the medical pads 10 (see Fig. 6 and page 15). Voorhees et al. thus demonstrate that the use of pressure sensors to provide an electrical signal for comparison to a pressure limit and potential alteration of electrical power to the pump is 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 provide the device of Marquette et al. with the pressure sensor 28 of Voorhees et al., positioned between the pad and the pump, in order to provide the device with a means to measure the pressure of the fluid and adjust/control the pump to provide for a desired negative pressure, in the manner disclosed by Voorhees et al.
Allowable Subject Matter
Claims 22 and 23 would be allowable if rewritten to overcome the rejection(s) under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), 2nd paragraph, set forth in this Office action and to include 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. The following prior art reference teaches a system for controlling temperature in a therapy device: Aguiar et al., U.S. Patent No. 11,564,831.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at (303) 297-4276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/BEVERLY M FLANAGAN/Primary Examiner, Art Unit 3794
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