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 .
Claims 26-35 are cancelled. A complete action on the merits of pending claims 1-25 appears herein.
Specification
The disclosure is objected to because of the following informalities:
Par. [0009], [00016], [00026], [00073]-[00075] and [00088] recite the term “Thermal Compacity.” The term “thermal compacity” is not a recognized term in the art and the specification does not provide a definition or adequate description/context for one of ordinary skill in the art to determine said term’s meaning.
Appropriate correction is required.
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 fluid flow disrupting mechanisms configured to both protrude within the flow channels and comprise a number of orifices extending through an exterior wall of the pad between the TTM fluid and the environment of claims 11 and 20 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 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 10 and 19 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 claims 10 and 19, the claims recite the term “thermal compacity.” It is unclear what is meant by the term “thermal compacity.” The term “thermal compacity” is not recognized/known in the art and applicant’s specification does not provide a definition for said term. As best understood by examiner, thermal compacity could refer to the density of a material, the thermal mass of a material, the thermal capacity of a material, or have another meaning entirely. Further examination of claims 10 and 19 in view of the prior art is currently withheld until clarification/a definition can be provided for the term “thermal compacity.”
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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1, 2, 4-6, 12, 14, 15, 21, 23, and 24 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rose (US 2015/0335468 A1).
Regarding claims 1, 5, 14, and 23, Rose teaches
a TTM module (Fig. 1, Char. 10: thermal regulation system) configured to provide a TTM fluid at a defined fluid temperature in accordance with a TTM therapy; (Par. [0099]-[0100])
one or more thermal-contact pads (Fig. 1, Char. 20: interface pack) fluidly coupled with the TTM module via a fluid delivery line (FDL) extending between the TTM module and the pad, (Fig. 1, Char. 36: conduit) the pad configured to:
receive the TTM fluid from the TTM module, (Par. [0099]-[0100]) and
circulate the TTM fluid within flow channels of the pad (Par. [0099]-[0100] and Fig. 1, 7, and 8) to define a thermal energy exchange between the TTM fluid and the patient, (Claim 35 and Par. [0116]) and
a fluid agitator operatively coupled with the TTM fluid, (Fig. 1 and 8, Char. V8: valve) the fluid agitator configured to cause an agitation of the TTM fluid within the pad. (Par. [0124])
a fluid flow disrupting mechanism configured to inhibit low-flow conditions of the TTM fluid within the flow channels of the pad. (Par. [0134] and Fig. 8, Char. 150: flow constrictor)
Regarding claims 2 and 24, Rose, as applied to claims 1 and 14 above respectively, teaches the agitator causes an oscillation of the TTM fluid. (Par. [0124])
Rose, as applied to claim 1 above, is silent regarding the oscillation of the TTM fluid being at a frequency greater than 20 KHz.
However, absent a statement of criticality AND unexpected results, the oscillation frequency of the TTM fluid of Rose is interpreted to read on the claimed 20KHz.
Regarding claim 4, Rose further teaches the agitator (Fig. 1, Char. V8: valve) is coupled with the TTM fluid within a TTM fluid supply tank (Fig. 1, Char. 14: supply unit) of the TTM module. (Fig. 1)
Regarding claims 6 and 15, Rose further teaches the fluid flow disrupting mechanism includes a number of fluid flow disrupting members protruding within the flow channels, the disrupting members configured to enhance a TTM fluid flow velocity through otherwise low-flow areas of the flow channels. (Par. [0134]: Flow constrictors (150) protrude into the flow path, reducing the radius of said flow path, thereby increasing flow velocity)
Regarding claims 12 and 21, Rose further teaches the flow channels include a spiral flow path extending between a first end located at a central portion of the spiral and a second end located at a perimeter of the spiral. (Fig. 7)
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) 3, 8, 17, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2015/0335468 A1), as applied to claim 6 and 15 respectively above, in view of Srinivasan (US 2020/0275859 A1).
Regarding claims 3, 8, 17, and 25, Rose, as applied to claims 6 and 15 respectively above, is silent regarding the agitator is coupled with the TTM fluid at the pad; and wherein at least a second subset of the number of disrupting members are configured to rotate in response to a torque applied by the TTM fluid flow.
Srinivasan, in a similar field of endeavor, teaches a thermal exchange device (Fig. 6A-B) comprising an interior space (Fig. 6A-B, Char. 45: interior space) configured to receive a flowing heat transfer fluid/liquid; (Par. [0078]) wherein the thermal exchange device comprises an agitator coupled to the heat transfer fluid/liquid at the interior space and configured to rotate in response to a torque applied by the fluid/liquid flow. (Par. [0082] and Fig. 6A-B, Char. 53: pump)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Rose, as applied to claims 6 and 15 respectively above, to incorporate the teachings of Srinivasan, and use a spinning/rotary pump disposed in the interface pack (20) of Rose to drive movement of the fluid through said pack (20) in place of valve (v8) of Rose. Doing so would be a substitution of one fluid pump mechanism for another for the predictable result of driving the fluid flow within interface pack (20).
Claim(s) 7 and 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2015/0335468 A1), as applied to claims 6 and 15 respectively above, in view of Diller (US 2020/0383825 A1).
Regarding claims 7 and 16, Rose, as applied to claims 6 and 15 respectively above, is silent regarding at least a first subset of the number of disrupting members are configured to deflect in response to a force applied by the TTM fluid flow.
Diller, in a similar field of endeavor, teaches a heat exchange pad comprising a plurality of disrupting members disposed within a fluid flow path; (Par. [0077]: internal extended surfaces) wherein said disrupting members are configured to deflect in response to a force applied by the fluid flow. (Par. [0077]: Internal structures deform elastically to periodically disrupt the flow pattern into pulsations that cause breakdown of laminar structure)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Rose, as applied to claims 6 and 15 respectively above, to incorporate the teachings of Diller, and include a plurality of internal structures in the flow path of interface pack (20) of Rose, such that said disrupting members are configured to deflect in response to a force applied by the fluid flow. Doing so would allow for disruption of the flow pattern, causing further breakdown of laminar flow structure and enhancing convection effects, as suggested in Diller. (Par. [0077])
Claim(s) 9 and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2015/0335468 A1), as applied to claim 6 above, in view of Fletcher (US 2005/0065581 A1).
Regarding claims 9 and 18, Rose, as applied to claims 6 and 15 respectively above, teaches the TTM fluid is water. (Par. [0099])
Rose, as applied to claims 6 and 15 respectively above, is silent regarding at least a third subset of the number of disrupting members are formed of a material having a thermal conductivity greater than a thermal conductivity of the TTM fluid.
Fletcher, in a similar field of endeavor, teaches a heat exchange pad comprising a plurality of flow disrupting members disposed in a fluid flow path; (Fig. 1A-C, Char. 14: thermally conductive members) wherein the flow disrupting members have a thermal conductivity of at least 50 W/mk. (Par. [0013])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Rose, as applied to claims 6 and 15 respectively above, to incorporate the teachings of Fletcher, and include the thermally conductive members (14) of Fletcher within the flow path of interface pack (20) of Rose. Doing so would allow for further disruption of the flow pattern, causing further breakdown of laminar flow structure and enhancing convection effects
In this combination, the thermally conductive member (14) of Fletcher would have a thermal conductivity higher than the TTM fluid of Rose due to water having a thermal conductivity of around 0.6W/mK. (Please see attached evidentiary reference “Heat Conductivity of Water”)
Claim(s) 11 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2015/0335468 A1), as applied to claim 6 above, in view of Horne (US 2008/0300590 A1).
Regarding claims 11 and 20, Rose, as applied to claims 6 and 15 respectively above, is silent regarding the fluid flow disrupting mechanism includes a number of orifices extending through an exterior wall of the pad between the TTM fluid and the environment, a negative pressure of the TTM fluid within the flow channels draws air through the orifices into the flow channels causing air bubbles within the flow channels, and the air bubbles cause a flow disturbance of the TTM fluid to agitate the TTM fluid.
Horne, in a similar field of endeavor, teaches a fluid circulation system (Fig. 6A-D) comprising a housing (Fig. 6A-D, Char. 600: resilient housing) comprising a plurality of orifices (Fig. 6A, Char. 520: orifices) configured to seal against a target tissue when a vacuum is applied (Par. [0068]) and allow fluids to contact said target tissue. (Par. [0066])
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Rose, as applied to claims 6 and 15 above respectively, to incorporate the teachings of Horne, and configure interface pack (20) of Rose to comprise a plurality of orifices such that fluid can be delivered to a target tissue and to use a vacuum applied to said orifices to secure interface pack (20) against a target tissue. Allowing fluid to be delivered through orifices would help wash and/or remove debris from the target area. Providing a vacuum through said orifices would help secure interface pack against a target tissue, minimizing the risk of interface pack (20) from becoming dislodged accidentally.
Claim(s) 13 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Rose (US 2015/0335468 A1), as applied to claims 1 and 14 respectively above, in view of Wasowski (US 9,883,967 B2).
Regarding claims 13 and 22, Rose, as applied to claims 1 and 14 respectively above, is silent regarding the TTM fluid includes a surfactant to enhance a thermal energy exchange between the TTM fluid and an inside surface of the flow channels.
Wasowski, in a similar field of endeavor, teaches a heat exchange pad comprising a circulating coolant comprising water and a surfactant. (Claim 15)
It would have been obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention, to have modified Rose, as applied to claim 1 and 14 respectively above, to incorporate the teachings of Wasowski, and configure the thermoregulation fluid of Rose to comprise the fluidic coolant of Wasowski. Doing so would be a simple substitution of one circulated coolant for another for the predictable result of providing a cooling effect to a user.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICHOLAS SHEA BORSCH whose telephone number is (571)272-5681. The examiner can normally be reached Monday-Thursday 7:30AM-5:30PM EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne Rodden can be reached at 3032974276. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.S.B./Examiner, Art Unit 3794
/JOANNE M RODDEN/Supervisory Patent Examiner, Art Unit 3794
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