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 .
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 vital sign sensor (recited in claim 10) 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.
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see par. 0074). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
The disclosure is further objected to because of the following informality: in par. 0083, line 9, “step a 414” should read --a step 414--.
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 4-6 and 9 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 4, it is unclear whether the limitation “a heat exchanger in thermal communication with the first conduit and the second conduit” refers to a singular heat exchanger in thermal communication with both hot and cold fluid conduits, or a separate heat exchanger in thermal communication with each or either fluid conduit. Examiner notes that applicant’s Specification does not appear to disclose a configuration wherein a singular heat exchanger is in thermal communication with both hot and cold fluid conduits (see Fig. 3 of the Drawings: Peltier cooler 340 and radiator 356 in thermal communication with only one fluid conduit). For examination purposes, this limitation will be read as a heat exchanger in thermal communication with the first conduit or the second conduit. Claim 5 is necessarily rejected as being dependent upon a rejected base claim.
In claim 6, it is unclear whether the limitation “distinct temperatures” refers to temperatures that are distinct from all other temperatures (that is, wherein each fluid chamber is maintained at a single constant temperature) or temperatures that are distinct from one another (that is, wherein the fluid chambers are maintained at two different temperatures, which are not necessarily constant). The scope of the claim is therefore unclear. For examination purposes, this limitation will be read as temperatures that are distinct from one another.
In claim 9, which depends upon claim 8, the scope of the limitation “the patient information” is unclear in the condition when the memory recited in claim 8 is used only for storing usage data or treatment session settings. For examination purposes, this claim will be read as wherein the memory is configured to store patient information, and the patient information includes at least one of the features recited thereafter.
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 1-14 are rejected under 35 U.S.C. 103 as being unpatentable over Voorhees et al. (US Patent No. 6,699,267), hereinafter Voorhees, in view of Schaefer et al. (US PGPub No. 2016/0022478), hereinafter Schaefer.
Regarding claims 1 and 6, Voorhees teaches a heating and cooling platform (Fig. 1 and col 2, lines 14-15: “an improved patient temperature control system and method that provides rapid heating/cooling capabilities”) comprising:
a fluid chamber (Fig. 1: circulating reservoir 30) in thermal communication with a heating device (Fig. 1: heater 62) and a cooling device (Fig. 1: radiator/fan 64);
a conduit in fluid communication with the fluid chamber (Fig. 1: main fluid line 50), the conduit comprising at least one connector for joining an interface (Fig. 1: manifolds 5; col 8, line 66 – col 9, line 2: “opposing tubing 3/manifold 5 assemblies may be provided for interconnection to the outlet port 110 and inlet port 120, with one or more pad(s) 1 fluidly interconnectable between the opposing manifolds 5”);
at least one pump for moving fluid through the conduit (Fig. 1: circulating pump 20);
and a controller comprising a processor (Fig. 2; col 11, lines 65-66: “system 10 may include at least one controller, or microprocessor 130”) configured to provide instructions to the heating device, the cooling device, and the at least one pump (col 12, lines 41-46: “Processor 130 may also control the operation (e.g., the speed) of circulating pump 20 and auxiliary pump 68. Further, processor 130 can control the operation of heater 62 and radiator/fan 64 (e.g., via control of the fan) to effect the desired amount of heating and cooling”).
Voorhees does not teach separate fluid chambers for hot fluid and cold fluid, with respective conduits in communication with each fluid chamber, wherein the hot fluid chamber and cold fluid chamber are maintained at distinct temperatures from one another. However, in an analogous art, Schaefer teaches a heating and cooling system with separate fluid chambers for hot fluid and cold fluid (Fig. 2A: hot reservoir 200 and cold reservoir 202) with first and second conduits in fluid communication with the hot and cold fluid chambers, respectively (Fig. 2A: first and second fluid lines in communication with hot reservoir 200 and cold reservoir 202), wherein the hot and cold fluid chambers are maintained at distinct temperatures from one another in order to provide a range of desired fluid temperatures via tempering (par. 0097: “the respective temperatures of the hot heat transfer fluid and cold heat transfer fluid may be maintained relatively constant, and the two fluids may be used in combination to temper one another in various proportions. Such tempering allows a thermal contrast therapy device to provide a range of desired fluid temperatures depending on the degree of tempering, without having to repeatedly heat or cool a reservoir of heat transfer fluid to the desired temperature”).
It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the heating and cooling platform of Voorhees by using separate hot and cold fluid chambers maintained at distinct temperatures from one another, as taught by Schaefer, to provide a range of desired fluid temperatures via tempering, as taught by Schaefer.
Regarding claims 2-3 and 13-14, the combination teaches the platform of claim 1 as described previously. Voorhees further teaches wherein the interface is a treatment pad or a plurality of treatment pads (Fig. 1 and col 8, lines 37-39: “patient temperature control system 10 may be selectively interconnected to one or more contact pad(s) 1 for heating/cooling a patient”), and wherein the at least one connector is a plurality of connectors for joining a plurality of interfaces, wherein the plurality of interfaces is a plurality of treatment pads (Fig. 1: plurality of connectors from manifold 5 connecting to plurality of pads 1).
Regarding claim 4, the combination teaches the platform of claim 1 as described previously. Voorhees further teaches a heat exchanger in thermal communication with the first conduit or the second conduit (Fig. 1: heat exchanger 66; col 8, lines 52-56: “A secondary fluid line 52 (e.g., defined by tubing lines) may be fluidly interconnected at each end to the main fluid line 50 with an in-line heat exchange device 66 to effect further selective fluid cooling/heating via an external interface”).
Regarding claim 5, the combination teaches the platform of claim 4 as described previously. Voorhees further teaches further comprising a second pump for circulating fluid through the heat exchanger (Fig. 1: auxiliary pump 68; col 10, lines 8-11: “a separately controllable auxiliary pump 68 may be interposed along the secondary fluid line 52 for selectively circulating fluid through the heat exchange device 66”).
Regarding claim 7, the combination teaches the platform of claim 1 as described previously. Voorhees further teaches a user interface in operable communication with the controller (Figs. 2 and 7: user interface 150; col 12, lines 15-16: “system 10 may include a user interface 150 interconnected with processor 130”).
Regarding claim 8, the combination teaches the platform of claim 1 as described previously. Voorhees further teaches further comprising a memory for storing patient information, usage data, or treatment session settings (Fig. 2: memory 132; col 12, lines 9-12: “the processor 130 may utilize control algorithms and associated preset/user-defined control limits/ranges stored in a memory 132”).
Regarding claim 9, the combination teaches the platform of claim 8 as described previously. Schaefer further teaches wherein the memory stores patient information, and the patient information includes at least one of patient weight, patient height, patient age, body temperature, patient sex, and diagnosed ailment (Fig. 6: patient profile fields for patient weight, height, age, sex, and diagnosed ailment; par. 0194: “a user profile may include information about the patient, such as personal information, medical history information, a description of the patient's ailment, injury, or condition sought to be treated, and information about the thermal contrast therapy treatment(s) which have been prescribed to the patient and/or selected by the patient”), which facilitates various thermal contrast therapy treatment sequences for use in clinical settings or self-provided care outside of a clinical setting (par. 0195). 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 platform of the combined reference to store patient information in the memory including patient height, weight, age, and diagnosed ailment, as taught by Schaefer, in order to facilitate various thermal contrast therapy treatment sequences for use in clinical settings or self-provided care outside of a clinical setting, as taught by Schaefer.
Regarding claim 10, the combination teaches the platform of claim 1 as described previously. Voorhees further teaches wherein the system comprises a vital sign sensor selected from the group consisting of a body temperature sensor, a pulse rate sensor, and an oxygen saturation sensor (Figs. 2 and 6: external patient temperature sensor 210) but does not explicitly teach wherein the vital sign sensor is incorporated into the interface. However, Schaefer teaches a body temperature sensor (par. 0095: “Temperature sensor(s) 238 may be configured to measure the temperature of the patient's tissue proximate to the treatment cuff”) incorporated into a treatment interface (Fig. 2B and par. 0095: “one or more temperature sensors 238 may be positioned at various locations on or within the treatment cuff 210”), which enables the device to control the temperature of the heat transfer fluid and provide customized thermal contrast therapy treatment sequences (par. 0096: “Temperature sensor(s) 238 may be configured to control the temperature of the heat transfer fluid based on the temperature of the patient's tissue proximate to the treatment cuff and/or the temperature of the fluid at a given point within the treatment cuff. Such temperature control may be configured to enable the device to provide customized thermal contrast therapy treatment sequences based, at least in part, on fluid temperature in accordance with the present disclosure”). 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 heating and cooling platform of the combined reference by incorporating the body temperature sensor of Voorhees into the interface, as taught by Schaefer, in order to control the temperature of the heat transfer fluid and provide customized thermal contrast therapy treatment sequences, as taught by Schaefer.
Regarding claim 11, the combination teaches the platform of claim 1 as described previously. Although Voorhees does not explicitly teach further comprising at least one device sensor located within the hot fluid chamber or the cold fluid chamber for sensing at least one of temperature, pressure, and a fluid level within the chamber, Voorhees teaches a fluid level sensor located within a fluid chamber (Fig. 1: level sensor 80 located at make-up reservoir 40), which may provide for user alert, system control, or system disablement upon sensing of fluid levels below or above predetermined amounts (col 10, lines 53-56). It would therefore have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to modify the platform of the combined reference by providing the hot fluid chamber or cold fluid chamber with a fluid level sensor, as taught by Voorhees at the make-up reservoir, in order to provide for user alert, system control, or system disablement upon sensing of fluid levels below or above predetermined amounts, as taught by Voorhees.
Regarding claim 12, the combination teaches the platform of claim 1 as described previously. Voorhees further teaches further comprising a flow sensor in a fluid conduit (Fig. 1: flow meter 94) and in operable communication with the controller (Fig. 2: flow meter 94 operably connected to processor 130), but the combination does not explicitly teach further comprising a first flow sensor in the first conduit and a second flow sensor in the second conduit. However, in light of the fact that Voorhees teaches that the flow meter allows the system to detect potential undesired fluid flow obstructions in the conduit and facilitate fluid heating/cooling control (col 11, lines 49-58: “The flow meter 94 provides for the sensing of fluid flow through the main fluid line 50, thereby facilitating the monitoring of expected versus actual fluid flow through the pad(s) 1. In turn, such functionality allows system 10 to detect potential, undesired fluid flow obstructions […] Additionally, the monitoring of fluid flow rates facilitates the determination of patient thermal energy exchange and fluid heating/cooling control”), 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 platform of the combined reference by providing both first and second conduits with first and second flow sensors, in order to allow the system to detect potential undesired fluid flow obstructions and facilitate fluid heating/cooling control in each conduit, as taught by Voorhees.
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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