DETAILED ACTION
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 8 is objected to because of the following informalities: in lines 1-2, “throughout insulated unit” should read --throughout the insulated unit--. 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 1-15 and 20 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.
Claim 1 recites the limitation "the skin temperature" in line 7. There is insufficient antecedent basis for this limitation in the claim. Dependent claims 2-15 are necessarily rejected as depending upon a rejected base claim.
Claim 9 recites the limitation "the external skin temperature" in line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 20 recites the limitation "the skin temperature" in line 11. There is insufficient antecedent basis for this limitation in the claim.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are: “a thermoelectric unit for providing” in claims 1, 4 and 20, where the “thermoelectric unit” is seen as Peltier unit or the like as seen in [0027].
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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.
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.
Claims 1-3, 5-8, 10-17, and 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Muehlbauer et al. (US PGPub No. 2012/0191022), hereinafter Muehlbauer, in view of Boegelein (US PGPub No. 2017/0224527).
Regarding claims 1, 8, 16, and 20, Muehlbauer teaches a system for regulating skin temperature (Fig. 1A and par. 0011: “The apparatus may be configured to heat or cool a normothermic person, e.g., a person having a normal body temperature, or a sub-normothermic or a hyper-normothermic person”), comprising:
an insulated unit including at least one opening for receiving an appendage of a user (Fig. 1A: appendage opening 107);
a temperature probe for measuring an actual internal temperature of the insulated unit (Fig. 5: temperature sensor 315);
a thermoelectric unit for providing at least one of a heated and cooled thermal medium into the insulated unit for at least one of raising and lowering the actual internal temperature of the insulated unit (Fig. 5: cooler 316 and cooling/heating medium 307; par. 0037: “Cooler 316 may include a Peltier device”);
a controller for setting and maintaining a target internal temperature range of the insulated unit such that the skin temperature is within a therapeutic range for providing medical treatment to the user (Fig. 5: controller 310; par. 0036: “Temperature sensor 315 is configured to sense a temperature at thermal exchange member 113. Sensor 315 may be operatively coupled to programmable controller 310 to regulate operation of medium source 304 to maintain thermal exchange member 113 at substantially a target temperature that may be preprogrammed or input via control panel 35 U.S.C. 103”);
wherein the controller is configured to control power and voltage provided to the thermoelectric unit (par. 0037: “programmable controller 310 may control cooler 316 via cooling control line 319 or wirelessly”).
Muehlbauer does not explicitly teach wherein the cooling or heating medium is air, or providing heated or cooled air via at least one fan that cycles air throughout the insulated unit for ensuring the internal temperature is substantially consistent throughout the insulated unit. However, in an analogous art, Boegelein teaches a system and method for regulating skin temperature that uses air as a cooling medium via at least one fan, which accelerates the process of skin temperature equalizing with the ambient temperature inside a cooled chamber (par. 0025: “the air flow, generated by the at least one fan, is strong enough or can be adjusted to be strong enough to cool the limb to be treated by the wind chill effect, in particular air which is close to the skin being removed convectively and the evaporation rate increasing as an accompanying factor, so that the equalisation of the surface temperature of the limb received in the housing with the ambient temperature of the air in the housing accelerates”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system and method of Muehlbauer by using air as a cooling medium via at least one fan, as taught by Boegelein, in order to accelerate the process of skin temperature equalizing with the ambient temperature inside the insulated unit, as taught by Boegelein.
Regarding claims 2 and 17, the combination teaches the system of claim 1 and the method of claim 16 as described previously. The combination does not explicitly disclose wherein the controller maintains the internal temperature of the insulated unit within a target internal temperature range between 55 °F to 65 °F. However, Boegelein teaches a target internal temperature range between 59 °F and 77 °F (par. 0025: “The skin of the limb received in the housing can be cooled to a temperature range of between, for example, 15° C. to 25° C”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the target internal temperature range of the combined reference from between 59 °F and 77 °F to between 55 °F and 65 °F, since it has been held that “[i]n the case where the claimed ranges ‘overlap or lie inside ranges disclosed by the prior art’ a prima facie case of obviousness exists”. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Regarding claims 3 and 19, the combination teaches the system of claim 1 and the method of claim 16 as described previously. The combination does not explicitly teach further including a safety shut off for stopping power to the thermoelectric unit when the internal temperature is one of below 50 °F and above 70 °F. However, as Muehlbauer teaches both a shutdown safety feature (par. 0041: “Programmable controller 310 preferably also includes preprogrammed safety features, e.g., that shutdown the device if the apparatus sensors, such as the temperature and pressure sensors, fail or become disconnected”) and an upper temperature threshold higher than 70 °F (par. 0039: “programmable controller 310 is configured to control heating or cooling of thermal exchange member 113 to determine if thermal exchange member 113 exceeds a predetermined temperature, e.g., 43 °C”), it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to further modify the system and method of the combined reference to include a preprogrammed safety feature to shut down the device if an upper threshold higher than 70 °F is exceeded, since Muehlbauer already contemplates a safety shut off feature and teaches that it is undesirable to exceed a predetermined temperature higher than 70 °F.
Regarding claim 5, the combination teaches the system of claim 1 as described previously. Muehlbauer further teaches wherein the at least one opening is positioned substantially toward a posterior end of the insulated unit and is configured to receive at least one of hands or feet of the user (Fig. 1A: appendage opening 107; par. 0055: “Tubular sleeve 104 is placed over the user's appendage, e.g., hand, arm, foot, or leg;” examiner interprets the end of the unit closer to appendage opening 107 as a posterior end, as broadly as claimed).
Regarding claim 6, the combination teaches the system of claim 5 as described previously. Muehlbauer further teaches further including a sleeve surrounding an edge of the at least one opening, the sleeve including a cinch to secure the sleeve to the appendage of the user (Fig. 1A: sleeve 104 surrounding an edge of opening 107 and rim 108; par. 0055: “the user inserts their appendage into tubular sleeve 104 having end 104B placed over rim 108 and firmly held in place using an elastic band”).
Regarding claim 7, the combination teaches the system of claim 1 as described previously. Muehlbauer further teaches further including a control panel, the control panel configured to receive input from the user for providing power to the insulated unit and controlling the internal temperature (Fig. 1A: control panel 103; par. 0044: “Control panel 103 may be operatively coupled to programmable controller 310 of FIG. 5 such that programmable controller 310 controls the pumps, heater, cooler, and/or sensors of the apparatus based on user input received at control panel 103”).
Regarding claim 10, the combination teaches the system of claim 1 as described previously. Muehlbauer further teaches a venting grill for expelling exhaust air from insulated unit to maintain the internal temperature of insulated unit (Fig. 1A-1B: venting grill on side of housing 102).
Regarding claims 11-13, the combination teaches the system of claim 1 as described previously. Muehlbauer further teaches further comprising an external cover surrounding the insulated unit; and wherein the external cover further includes a raised protrusion generally towards the posterior end of the insulated unit (Figs. 1A-1B: appendage chamber 101 having external cover comprising upper portion 105 and lower portion 106); wherein the raised protrusion includes a viewing surface (Fig. 1A: transparent upper portion 105 allowing the chamber to be viewed and interpreted as a viewing surface, as broadly as claimed) and a ledge (Figs. 1A-1B: lower portion 106 and connection to rim 108 interpreted as a ledge, as broadly as claimed); and wherein the raised protrusion includes the at least one opening (Figs. 1A-1B: rim 108 and opening 107 connection to raised portion of appendage chamber 101).
Regarding claim 14, the combination teaches the system of claim 1 as described previously. Muehlbauer further teaches further including an insulated bag attached to the at least one opening to surround the appendage in the insulated unit (Fig. 1A: tubular sleeve 104 attached to appendage opening 107; par. 0029: “Sleeve 104 may comprise a flexible and durable material, such as neoprene;” examiner interprets a neoprene sleeve as an insulated bag).
Regarding claim 15, the combination teaches the system of claim 14 as described previously. Muehlbauer further teaches further including a disposable liner to line an inner surface of the insulated bag (Fig. 2B: sleeve 104’ and par. 0030: “a tubular sleeve designed to further reduce cross-contamination by entirely covering the appendage placed in chamber 101. Tubular sleeve 104' preferably comprises a light weight plastic, such as polyethylene, and is disposable after a single use”).
Claims 4, 9, and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Muehlbauer in view of Boegelein and further in view of Kane et al. (US PGPub No. 2013/0190667), hereinafter Kane.
Regarding claims 4 and 18, Muehlbauer in view of Boegelein teaches the system of claim 1 and the method of claim 16 as described previously. The combination is silent with respect to the rate of changing temperature and does not explicitly teach wherein the thermoelectric unit is configured to provide the at least one of heated and cooled air into the insulated unit such that the internal temperature of the insulated unit does not exceed a change of 2 °F per minute. However, in a related thermal therapy art, Kane teaches providing thermal therapy at a rate of changing temperature by about 0.36 °F per minute at a maximum, which does not exceed 2 °F per minute (par. 0142: “the device may use between about 5 watts and about 250 watts of power to raise a body core temperature at a rate of between about 4 °C/hour and about 12 °C/hour”). In light of Kane’s teaching, it would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233.
Regarding claim 9, Muehlbauer in view of Boegelein teaches the system of claim 1 as described previously. The combination does not explicitly teach wherein the temperature probe includes a skin temperature probe for measuring an external skin temperature of the appendage. However, Kane further teaches including a skin temperature probe for measuring an external skin temperature of an appendage in order to indicate whether the appendage is in a state of vasoconstriction or vasodilation (par. 0130: “a temperature probe 862 can be provided to measure the temperature of a portion of a mammal other than a foot, leg, or other extremity where the device is attached to […] The temperature of the skin in the device could be measured to indicate if the body portion is in a state of vasoconstriction or vasodilatation”). It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the system of the combined reference to include a skin temperature probe, as taught by Kane, in order to indicate whether the appendage is in a state of vasoconstriction or vasodilation, as taught by Kane.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVINA E LEE whose telephone number is (571)272-5765. The examiner can normally be reached Monday through Friday between 8:00 AM and 5:30 PM (ET).
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, JOANNE M 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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/D.E.L./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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