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 .
Response to Arguments
Applicant’s arguments with respect to claim 1 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.
Applicants’ arguments with respect to claim 7 and 8 made on page 10 of their remarks are persuasive, as such, the rejection of these claims is hereby withdrawn.
Applicants’ amendments necessitated the shift in grounds of rejections of claims 1-6 and 9-19. As such, this rejection is hereby made FINAL.
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.
Claims 1-6 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Vergara (U.S. Patent Application Publication No. 2019/0262169) in view of Stelea (U.S. Patent Application Publication No. 2007/0016270).
Regarding claim 1.
Vergara discloses Figs. 5-9):
A medical pad for exchanging thermal energy between a targeted temperature management (TTM) fluid and a patient, the pad comprising:
a fluid channel(226, to 224) extending between a fluid inlet and a fluid outlet(inlet outlet 224 and 222), and a bottom channel wall(Bottom of 8, see fig. 5, bottom being 188, 184), the wall disposed between the fluid and the patient during use of the pad, wherein:
the wall (i) is formed of a material having a first thermal conductivity(wall being made of material between each 188 and an adjacent 188 and 184 and each adjacent 184, see [0143]-[0159]) and (ii) includes elements embedded within the wall, the elements formed of a material having a second thermal conductivity to define a composite thermal conductivity of the wall that is greater than the first thermal conductivity, and thermal energy exchange between the fluid and the patient is defined in accordance with the composite thermal conductivity. (plates 188 and 184 having a greater thermal conductivity.)
Verara discloses that that plates 188 and 184 are connected by materials 186 and material between each 188. While they appear to be embedded in the walls of the fluid channel, it also would have been obvious to embed them in the walls of the device as a matter of design choice for the obvious benefit of easing manufacturing of the device. See MPEP 2144.07. The selection of a known material or known method has been held to be obvious. Here, the embedding of the thermal pads in the walls of the device would provide thermal conduction which is the same function as the prior art, and as such, would have bene obvious tone having ordinary skill In the art.
Verara does not disclose:
a bottom channel wall disposed between the fluid and the patient during use of the pad, the bottom channel wall having an inner surface in contact with the TTM fluid and an outer surface in contact with the patient, the inner surface and the outer surface defining a thickness of the bottom channel wall
in related art, Stelea discloses (Figs. 1-2):
a bottom channel wall(bottom walls under 34 including 26 28 32) disposed between the fluid (34)and the patient during use of the pad([0010]-[0012]), the bottom channel wall having an inner surface in contact with the TTM fluid and an outer surface in contact with the patient, the inner surface and the outer surface defining a thickness of the bottom channel wall (34 contacting inside of 30 and outside of 30 32 28 bottom contacting patient. ([0012])).
Stelea discloses that the recited features provide the benefit of allowing the coolant to act as the heat sink to the patient and for the device 12 to be flexibly arranged on the patent. Further, the recited features allow a leak to be detected. As such, the recited features would have been obvious to one having ordinary skill in the art.
Regarding claim 2.
Vergara discloses Figs. 8-9):
The medical pad according to claim 1, wherein the elements include one or more of particles, nano-particles, composites, fibers, fluid pockets, bars extending across the thickness of the wall, or layers extending along the wall. (includes 188 and 184, being tiles)
Regarding claim 3.
Vergara discloses Figs. 8-9):
The medical pad according to claim 1, wherein the fluid channel comprises channel portions disposed laterally adjacent one another. (See Fig. 9, fluid channels each including 226 and 224, laterally adjacent to each other)
Regarding claim 4.
Vergara discloses Figs. 8-9):
The medical pad according to claim 3, wherein the channel portions are arranged parallel to one another. (See Fig. 9, fluid channels each including 226 and 224, parallel to each other, 4 shown, all parallel adjacent to each other)
Regarding claim 5.
Vergara discloses Figs. 8-9):
The medical pad according to claim 3, wherein adjacent channel portions are separated by a single dividing wall. (See Fig. 8, middle wall divides the channels)
Regarding claim 6.
Vergara discloses Figs. 8-9):
The medical pad according to claim 5, wherein the fluid flow in adjacent channel portions is in opposite directions. (disclosing that the channels may be divided using dividers. As shown in fig. 9. The inlet of the first would flow in the opposite direction of the other, as the inlet of one is at the bottom and the next inlet is at the top. )
Regarding claim 9.
Vergara discloses all of the features of claim 1.
Vergara does not disclose:
The medical pad according to claim 1, wherein: centrifugal acceleration of the fluid flow within the channel induces turbulence of the fluid flow within the channel, the induced turbulence defines a first enhancement of a convection coefficient of the fluid with respect to the bottom wall, and the thermal energy exchange between the fluid and the patient is defined in accordance with a convection coefficient including the first enhancement. Vergara discloses [0091] “One of ordinary skill in the art will understand and be enabled to design and construct TECs of the disclosure of any size, shape, and consistency depending on the desired purpose.” (this feature would inherently occur with the features of fig. 9-, as there would be at least a bit of turbulence in the fluid flow of 14 and the thermal exchange would be defined in accordance with the enhancement of convection based on the turbulence )
Regarding claim 10.
Vergara discloses all of the features of claim 1.
Vergara does not disclose:
The medical pad according to claim 1, wherein: the channel comprises at least one pair of channel walls extending along the channel, the channel walls face each other from opposite sides of the channel, the channel further comprises a plurality of wall segments extending across at least a majority of the channel, a first subset of the wall segments extends away from one of the pair of channel walls, a second subset of the wall segments extends away from the other of the pair of channel walls, and each wall segment of the second subset is disposed between adjacent wall segments of the first subset.
The recited features are a mere change in shape of the working parts of the device of Verara which would provide the benefit of allowing the device to be used in a desired application to fit desired patients. See MPEP 2144.04(VI)(B). See [0091] “One of ordinary skill in the art will understand and be enabled to design and construct TECs of the disclosure of any size, shape, and consistency depending on the desired purpose.” As such, the recited feature would have been obvious to one having ordinary skill in the art.
Regarding claim 11.
Vergara discloses all of the features of claim 1.
Vergara does not disclose:
The medical pad according to claim 10, wherein: fluid flow between the wall segments induces turbulence of the fluid flow within the channel, the induced turbulence defines a second enhancement of the convection coefficient of the fluid with respect to the bottom wall, and the thermal energy exchange between the fluid and the patient is defined in accordance with the convection coefficient including the second enhancement.
The recited features are a mere change in shape of the working parts of the device of Verara which would provide the benefit of allowing the device to be used in a desired application. See MPEP 2144.04(VI)(B). See [0091] “One of ordinary skill in the art will understand and be enabled to design and construct TECs of the disclosure of any size, shape, and consistency depending on the desired purpose.” See Fig. 11 including walls inside device 148 As such, the recited feature would have been obvious to one having ordinary skill in the art.
Regarding claim 12.
Vergara discloses all of the features of claim 1.
Vergara does not disclose:
The medical pad according to claim 1, wherein: the channel comprises a plurality of inward protruding ribs disposed along one or more walls of the channel, the ribs are disposed at an angle with respect to the channel, the ribs induce a swirling turbulence of the fluid flow along the channel, the swirling turbulence defines a third enhancement of the convection coefficient of the fluid with respect to the bottom wall, and the thermal energy exchange between the fluid and the patient is defined in accordance with the convection coefficient including the third enhancement.
See Fig. 11, fig. 23 including walls inside device 148
The recited features are a mere change in shape of the working parts of the device of Verara which would provide the benefit of allowing the device to be used in a desired application. See MPEP 2144.04(VI)(B). See [0091] “One of ordinary skill in the art will understand and be enabled to design and construct TECs of the disclosure of any size, shape, and consistency depending on the desired purpose.” As such, the recited feature would have been obvious to one having ordinary skill in the art.
Regarding claim 13.
Vergara discloses The medical pad according to claim 1, further comprising: a first pad portion defining a first patient contact area; and(fig. 9 first pad including a 226 and 224 connected to adjacent pads. 4 shown in fig. 9)
a separate second pad portion defining a second patient contact area, wherein the second pad portion is directly coupleable with the first pad portion to define a combined patient contact area equaling a sum of the first patient contact area and the second patient contact area. (fig. 9 second pad including a 226 and 224 connected to adjacent pads. 4 shown in fig. 9 each pad coupleable to the other)
Regarding claim 14.
Vergara
The medical pad according to claim 1, wherein a patient contact area of the pad includes: a first patient contact area defined by a first pad portion(fig. 9 first pad including a 226 and 224 connected to adjacent pads. 4 shown in fig. 9); and
a second patient area defined by a second pad portion, wherein the second pad portion is separable from the first pad portion to define a reduced patient contact area equaling the first patient contact area. (fig. 9 second pad including a 226 and 224 connected to adjacent pads. 4 shown in fig. 9 each pad coupleable to the other)
Regarding claim 15. A method of providing a targeted temperature management (TTM) therapy to a patient, comprising:
Vergara discloses(Fig. 9) :
applying a thermal contact pad to a patient, altering a patient contact area of the pad to accommodate a size of the patient(Fig. 9, 222 may be added to the prior 222 at 226 and 224), and
establishing a flow of TTM fluid through the pad([0154], fluid flows through 224 and 226)
Vergara does not disclose that the contact is altered for the purpose of accommodating the patient size.
However, Vergara disclose that the recited features provide the benefit of allowing the area to be expanded. IT would have been obvious to expand the area or reduce the area by adding and removing a section based on the size of a patient. As such, the features of claim 15 would have been obvious to one having ordinary skill in the art.
Verara does not disclose:
exchanging thermal energy with the patient through a bottom wall of the thermal contact pad, wherein: the bottom wall is disposed between the fluid and the patient during use of the pad, the bottom channel wall has an inner surface in contact with the TTM fluid and an outer surface in contact with the patient, and the bottom wall comprises embedded elements configured to enhance a thermal conductivity of the bottom wall.
in related art, Stelea discloses (Figs. 1-2):
exchanging thermal energy with the patient through a bottom wall of the thermal contact pad, wherein: the bottom wall is disposed between the fluid and the patient during use of the pad,(Figs. 1 and 2 bottom wall shown in fig. 2 including bottom 30 32 28) the bottom channel wall has an inner surface in contact with the TTM fluid(bottom 30 in contact with 34) and an outer surface in contact with the patient(bottom 28 in contact with patient), and the bottom wall comprises embedded elements configured to enhance a thermal conductivity of the bottom wall(bottom 32 being a conductor which is thermally conductive [0032]).
Stelea discloses that the recited features provide the benefit of allowing the coolant to act as the heat sink to the patient and for the device 12 to be flexibly arranged on the patent. Further, the recited features allow a leak to be detected. As such, the recited features would have been obvious to one having ordinary skill in the art.
Regarding claim 16.
Vergara discloses:
The method according to claim 15, wherein altering the patient contact area comprises coupling a second thermal contact pad to the thermal contact pad to increase the patient contact area.(See Fig. 9, an addition pad may be added at 226 and 224 and see [0154])
Regarding claim 17.
Vergara discloses:
The method according to claim 15, wherein altering the patient contact area comprises removing a separable portion of the thermal contact pad from the thermal contact pad to decrease the patient contact area to an area defined by a remaining portion of the thermal contact pad. (See Fig. 9, an addition pad may be added at 226 and 224 and see [0154] or pads may be removed)
Regarding claim 18.
Vergara discloses:
The method according to claim 15, wherein establishing a flow of TTM fluid comprises directing TTM fluid flow along a spiraling fluid channel to enhance a heat transfer convection coefficient of the thermal pad. (See Fig. 9, an addition pad may be added at 226 and 224 and see [0154]. The flow of the liquid is from each 226 to each 224, up and down which is a spiraling fluid channel. See fig. 16 also)
Regarding claim 19.
Vergara discloses Figs. 9-11:
The method according to claim 15, wherein: establishing a flow of TTM fluid comprises directing TTM fluid flow along a fluid channel configured to enhance the heat transfer convection coefficient of the thermal pad, the fluid channel comprises at least one pair of channel walls extending along the channel (Fluid flows through 226 to 224), the channel walls face each other from opposite sides of the channel(channel walls face each other in 226 to 224), the channel further comprises a plurality of wall segments extending across at least a majority of the channel(see Fig. 11 module may include walls. Making segments 184),
Vergara does not disclose:
a first subset of the wall segments extends away from one of the pair of channel walls, a second subset of the wall segments extends away from the other of the pair of channel walls, and each wall segment of the second subset is disposed between adjacent wall segments of the first subset.
Vergara discloses all embodiments shown in figs. 6-16. The recited features are a mere change in shape of the working parts of the device of Verara which would provide the benefit of allowing the device to be used in a desired application. See MPEP 2144.04(VI)(B). See [0091] “One of ordinary skill in the art will understand and be enabled to design and construct TECs of the disclosure of any size, shape, and consistency depending on the desired purpose.” As such, the recited feature would have been obvious to one having ordinary skill in the art.
Allowable Subject Matter
Claims 7 and 8 are objected to as being dependent on a rejected base claim but would be allowed if rewritten in independent form.
The following is the Examiner's Reasons for Allowance:
the prior art fails to disclose and would not have rendered obvious:
Regarding claim 7.
Vergara discloses all of the features of claim 1.
Vergara does not disclose:
The medical pad according to claim 1, wherein the channel defines a spiral shape converging radially inward from an inlet positioned at a permitter edge of the pad toward an outlet centrally positioned on the pad, as recited in claim 7; and
the channel defines a double spiral shape comprising: a first channel portion converging radially inward from an inlet disposed at a permitter edge of the pad toward a central location of the pad; a second channel portion expanding radially outward from the central location toward an outlet disposed at the permitter edge of the pad; a fluid connection at the central location between the first channel portion and the second channel portion, and the second channel portion is disposed between adjacent wraps of the first channel portion, as recited in claim 8.
Conclusion
THIS ACTION IS MADE FINAL. 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 ROBERT G BACHNER whose telephone number is (571)270-3888. The examiner can normally be reached on Monday-Friday, 10-6 EST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Leonard Chang can be reached at (571) 270-3691. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/ROBERT G BACHNER/Primary Examiner, Art Unit 2898