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 Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 14 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
It appears that applicant did not have possession of the recitation “a wax with a melting point of from about 10C to about 20C.” On page 11 of the written specification, Applicant asserts that “In some embodiments, the thermostatic mixing valve comprises at least one of a liquid-filled bellows, a wax bellows, a bi-metal coil, or combinations thereof. In some embodiments, the wax bellows includes a wax with a melting point of from about 10C to about 20C, and preferably at about 15C.” There are no materials for the wax recited in the written specification. One skilled in the art would recognize that paraffin wax, or blends based thereon, are the primary type of wax used in mixing valves. The lowest melting point known for paraffin wax is 51.7C. As such, it appears that Applicant did not have possession of the type of material used for the wax or the wax bellows/coil. The claim is examined as best understood.
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.
Claim 16-17 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 16 recites the limitation "the control unit portion" in line 2. There is insufficient antecedent basis for this limitation in the claim. For purpose of compact prosecution, the Examiner interprets the term “the control unit portion” as –a control unit portion--.
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.
Claims 1-2, 7-9, 11, and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kane US 2003/0097163.
Regarding claim 1, Kane discloses a body temperature modifying device 10 comprising a heat exchange unit 200 (via 206) connected by at least one tubing unit 202 to a glabrous skin contact unit 100 [0027], wherein the glabrous skin contact unit 100 comprises a housing 104,106 (via 102A,102B) enclosing a bladder 110a,110b (cuffs, [0033-0035]) disposed in an interior region of the glabrous skin contact unit 100, and wherein the housing 104,106 has a molded bottom surface via 108b and a contoured upper surface 108a (fig. 2A, also annotated fig. 2A below, where 108B is molded via protuberance and contoured/adaptable to the shape of the hand, e.g. top of the hand due to pliability of 108a, [0029-0033]).
Regarding claim 2, Kane further discloses the molded bottom surface 108b includes protuberance (see annotated fig. 2A below) that protrudes into an interior region of the glabrous skin contact unit 100, see fig. 2A).
Regarding claim 7, Kane further discloses the glabrous skin contact unit 100 comprises a means 103,117,204b for creating negative pressure via 202 (fig. 5-6, [0030, 0053-0055]).
Regarding claim 8, Kane further discloses the means for creating negative pressure 103,117,204b via 202 creates from about 0.5 mm-Hg to about 50 mm-Hg of pressure (Examiner interprets the claimed values of the negative pressure to be absolute values, and as such the Examiner notes that negative pressure is expressed as a negative value, indicating pressure that is lower than the surrounding atmospheric/ambient pressure, thus Kane discloses negative pressure values as negative and not absolute values [0054]).
Regarding claim 9, Kane further discloses the means for creating negative pressure 103,117,204b via 202 can be selectively operated via 214,224 (control panel 224 allows for control of pumps and selections for appropriate pressures [0056-0063], figs. 5-6).
Regarding claim 11, Kane further discloses the heat exchange unit 200 further comprises an insulating portion (housing shell that defines 200 and holds the electronics, pumps, 206, etc.) and a control unit portion 206,224 [0054-0062].
Regarding claim 16, Kane further discloses the heat exchange unit 200 further comprises a heat exchanger 206 (thermal energy exchange system 206, [0060]) disposed in an interior region (inside the housing of 200) of a control unit portion 200 (the housing defining a cavity inside of which 206 and electronics are located).
Regarding claim 17, Kane further discloses the heat exchanger 206 comprises Peltier elements via 222 [0058].
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Claims 1-3, 7-11, 16-17, and 20 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Muehlbauer US 2014/0194788.
Regarding claim 1, Muehlbauer discloses a body temperature modifying device 100 (figs. 1A,B) comprising a heat exchange unit 102 connected by at least one tubing unit (inherent given 308,309 via which that heating/cooling medium such as water is pumped and transported via inlet 116/outlet 117 to the bladder 113 having channels 115, [0031,0034-0038]) to a glabrous skin contact unit 101,105,106, wherein the glabrous skin contact unit 101,105,106 comprises a housing 105,106 enclosing a bladder 113,114 (113 is a plastic bag having a plurality of channels 115, [0031] and 114 is an inflatable bladder [0027]) disposed in an interior region of the glabrous skin contact unit 101,105,106, and wherein the housing 105,106 has a molded bottom surface 112 (dome shape of 112 and 113) (Examiner Notes: in the written specification of the instant application, Applicant asserts that “molded bottom surface” refers to a non-flat, unitary section of the device that has been shaped to facilitate body temperature modification, see page 3, lines 25-32 and in the same section, Applicant asserts that “contoured upper surface” refers to a non-flat, unitary section that has been shaped to house an appendage of a mammal), and a contoured upper surface (inner concave surface of 105 that is non-flat and via the outer surface of 114 which is also non-flat and assisting in conforming to the shape of the dorsal surface and housing of a mammalian hand, see figs. 1A,b) [0024-0028,0031-0040].
Regarding claim 2, Muehlabuaer further discloses the molded bottom surface 112,113 includes a protuberance (curvature that is dome shaped) that protrudes into an interior region of the glabrous skin contact unit 101,105,106 (see figs. 1A,1B).
Regarding claim 3, Meuhlbauer further discloses the molded bottom surface 112,113 inherently has a Young’s modulus that is greater than a Young’s modulus of the contoured upper surface 114 (plastic bag is attached to pressure platform 112 that supports plastic bag 113, 112 also houses sensors and includes a cover 119, as such, 112 inherently is rigid and provides hardness to 113 when 113 is pressed thereon thus making 112,113 more rigid than inflatable bladder 114 since 114 is inherently made of a material less rigid/less hard thus having a lower Young’s modulus such that it can inflate, therefore, the Young’s modulus of 114 is less than that of the platform 112,113 which is designed to support a hand and is configured to withstand pressures exerted thereon to allow sensing of pressure via pressure sensor, [0026-0031], Examiner also notes that 113 must accommodate heating/cooling medium such as water and thus it necessarily would need to have integrity to support the weight and pressure exerted thereon by the fluid entering/leaving the channels 115 therein and as such, 113 is inherently needs to have a higher Young’s modulus to provide integrity to not explode or fail due to water pressure therein vs. bladder 114 would necessarily needs to inflate and expand and as such, the material thereof would necessarily needs to be more elastic thus needing a lower Young’s modulus).
Regarding claim 7, Meuhlbauer further discloses the glabrous skin contact unit 101,105,106 further comprises a means 301 for creating negative pressure [0035].
Regarding claim 8, Muehlbauer further discloses the means 301 for creating negative pressure creates from about 0.5 mm-Hg to about 50 mm-Hg of pressure (e.g. between 25 mm-Hg to 35 mm-Hg ,[0035]). Examiner notes that it has been held that “If the prior art discloses a point within the claimed range, the prior art anticipates the claim." UCB, Inc. v. Actavis Labs. UT, Inc., 65 F.4th 679, 687, 2023 USPQ2d 448 (Fed. Cir. 2023).
Regarding claim 9, Muehlbauer further discloses the means 301 for creating negative pressure can be selectively operated via 103 [0034-0038].
Regarding claim 10, Meuhlbauer further discloses the at least one tubing unit inherently comprises a first section of tubing (section of inlet line connected to 116 delivering heating/cooling water to channel 115 of bladder 113) and a second section of tubing (section of outlet line connected to 117 that removes heating/cooling water from channel 115 of bladder 113), and wherein the first section of tubing is connected to an inlet port 116 on one end of the bladder 113 and the second section of tubing is connected to an outlet port 117 located on the same end of the bladder 113 as the first section of the tubing via 112,115 (fig. 3B, [0031-0032]).
Regarding claim 11, Muehlbauer further discloses the heat exchange unit 102 further comprises an insulated portion (the housing defining 102) and a control unit portion 310 (see fig. 5, [0034]).
Regarding claim 16, Meuhlbauer further discloses wherein the heat exchange unit 102 further comprises a heat exchanger 306 disposed in an interior region of a control unit portion 102 (fig. 5).
Regarding claim 17, Meuhlbauer further discloses the heat exchanger 306 comprises Peltier elements 316 [0037].
Regarding claim 20, Meuhlbauer further discloses the bladder 113 is removable from the housing to facilitate cleaning (the bladder 113 is disposable thus rendering it removable and since it is a plastic bag, it is capable of being washed/cleaned, [0031]).
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.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Muehlbauer US 2014/0194788 in view of Diller US 2020/0383825.
Regarding claim 4, Muehlbauer discloses the invention as discussed above.
Although Muehlbauer discloses the molded bottom surface 112,113 includes a plastic bag [0031] that inherently has a Young’s Modulus as well, Muehlbauer does not explicitly disclose the Young’s Modulus of the molded bottom surface is from about 0.75 GPa to about 4.15 GPa.
Diller teaches an analogous plastic bag 100 (3-D printed BIHE made of polymer, [0080-0082]) used in an analogous glabrous skin contact unit, wherein the Young’s Modulus of the plastic bag is from about 0.75 GPa to about 4.15 GPa (Diller teaches range of Young’s Moduli for polymers to be from about .001 GPa to about 1 GPa) to provide an acceptable level of flexibility with a relatively low stress necessary to produce a substantial deformation to facilitate optimum fluid perfusion therein [0082].
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to modify the Young’s Modulus of molded bottom surface 113 of 112,113 of Muehlbauer by making the Young’s Modulus of 113 to be about 0.75 GPa to about 4.15 GPa as taught by Diller to have provided an improved molded bottom surface that provides an acceptable level of flexibility with a relatively low stress necessary to produce a substantial deformation to facilitate optimum fluid perfusion therein (Diller [0082]). Also, Applicant is reminded that making the Young’s Modulus of 113 to be about 0.75 GPa to about 4.15 GPa is a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Applicant is reminded that to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). As such, it is noted that applicant places no criticality on the range claimed (see page 4, lines 4-17 of the written specification). Also, see In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). As well as, 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).
Regarding claim 5, Muehlbauer discloses the invention as discussed above.
Although the bladder 113 of Muehlbauer inherently has a thermal conductivity (plastic bag 113 is a thermal exchange member that has a plurality of channels therein that allow perfusion of heating/cooling fluid/water therein, [0031]), Muehlbauer does not explicitly disclose the bladder has a thermal conductivity of from about 0.1 to about 0.5 watts per meter-kelvin.
Diller teaches an analogous bladder 100 (3-D printed BIHE made of polymer, [0080-0083]) used in an analogous glabrous skin contact unit, wherein the bladder 100 could be made with a polymer matrix doped with graphite in order to have a thermal conductivity of 0.15 to 10 watts per meter-Kelvin and as such, Diller teaches the thermal conductivity of the bladder to be from about 0.1 to about 0.5 Watts per meter Kelvin in order to optimize the material thermal conductivity and the rate at which heat can be transmitted between the internal flowing fluid and the environment while maintaining the optimum flexibility of the material for the bladder [0083].
Therefore, it would have been obvious to one having ordinary skill in the art at the time of the invention to have made thermal conductivity of the bladder 113 Muehlbauer by making the thermal conductivity of the bladder to range from about 0.1 to about 0.5 Watts per meter-Kelvin as taught by Diller to have provided an improved bladder that has material thermal conductivity that optimizes the rate at which heat can be transmitted between the internal flowing fluid and the hand of a patient while maintaining the optimum flexibility of the material for the bladder [0083]. Also, Applicant is reminded that making the thermal conductivity of the bladder 113 to be from about 0.1 to about 0.5 Watts per meter-Kelvin is a matter of routine optimization since it has been held that “where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Applicant is also reminded that to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960). As such, it is noted that applicant places no criticality on the range claimed (see page 5, lines 1-11, page 13, 19-21 of the written specification). Also, see In re Bergen, 120 F.2d 329, 332, 49 USPQ 749, 751-52 (CCPA 1941) (The court found that the overlapping endpoint of the prior art and claimed range was sufficient to support an obviousness rejection, particularly when there was no showing of criticality of the claimed range). As well as, 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).
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Muehlbauer US 2014/0194788 in view of Hamilton US 2005/0209663.
Muehlbauer discloses the invention as discussed above.
Muehlbauer further discloses the housing 105,106 comprises at least one opening (see fig. 1B, the opening being the opening/space defined by the rim of 105 when opened via the hinge) and the contoured upper surface 105 comprises at least two passive closure features (105 and 106 may further include fasteners such as buckles or straps, [0024]).
However, Muehlbauer does not explicitly disclose the at least two passive closure features located on at least two edges of the at least one opening.
Hamilton teaches an analogous contoured upper surface 103 of an analogous housing 102,120 of an analogous glabrous skin contact unit (figs. 1,7), the contoured upper surface comprises at least two passive closure features 111 located on at least two edges of the at least one opening (111 is located and extends on and over at least two edges defining the perimeter of 103, see fig. 7, [0058]) of the at least one opening (the opening is defined by the rim/edge defined by the perimeter shown in fig. 7), to secure the contoured upper surface of the upper half of the housing to the lower half of the housing to facilitate placement and removal of the contoured upper surface [0058].
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to have located the at least two passive closure features of Muehlbauer on at least two edges of the at least one opening as taught by Hamilton in order to have provided an improved housing of a glabrous skin contact unit that has an improved contoured upper surface that can be easily and robustly secured to the lower half of the housing to facilitate placement and removal of the contoured upper surface [0058].
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Muehlbauer US 2014/0194788 in view of Klatz US 6277143.
Muehlbauer discloses the invention as discussed above.
Muehlbauer is silent on the bladder comprises a top surface that includes a plurality of protruding spots.
Klatz teaches an analogous bladder 382 that comprises a top surface that includes a plurality of spots (protrusions 389), the protrusions facilitating turbulent flow of the fluids in the bladder 382 for effectively cooling when a cooling fluid is flowing through the bladder (col. 10, lines 30-67, col. 11, lines 1-25, figs. 11-12B).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention to provided the top surface of the bladder 113 of Muehlenbauer with the protruding spots as taught by Klatz in order to have provided an improved bladder that effectively cools a patient’s body part (Klatz, col. 11, lines 1-5).
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over Kane US 2003/0097163 in view of North US 4285465.
Regarding claim 12, Kane discloses the invention as discussed above.
Kane is silent on the control unit portion comprises a thermostatic mixing valve disposed in an interior region of the control unit portion that maintains a temperature of a temperature transfer fluid in a range of from about 1OC to about 25C.
North teaches a thermostatic mixing valve 12 (col. 3, lines 51-67, col. 4, lines 23-55) for disposal and use in a fluid path in an interior region of an analogous control unit portion (col. 4, lines 10-15) that maintains a temperature transfer fluid to specific and pre-set temperature range (col. 6, lines 51-55), providing a themostatic mixing valve that facilitates a constant temperature by providing a fluid mixture having a substantially constant temperature to an outlet (col. 4, lines 57-67).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have provided the control unit portion 206 of Kane with a thermostatic mixing valve 12 that maintains a temperature transfer fluid to a pre-set temperature range as taught by North in order to provide an improved control unit portion that includes a themostatic mixing valve that facilitates a constant temperature by providing a fluid mixture having a substantially constant temperature to an outlet (col. 4, lines 57-67). As such, it would have also been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have caused the device of Kane in view of North to have a pre-set temperature range of the thermostatic mixing valve to be between 10 C to 25C to maintain a substantially constant temperature of the transfer fluid to be in the range of 10C to 20C since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, the device of Kane in view of North would not operate differently with the claimed temperature range since pre-setting the thermostatic mixing valve to the claimed temperature range in the device would function appropriately having the claimed temperature range. Further, applicant places no criticality on the range claimed, indicating simply that “in some embodiments, the thermostatic mixing valve (503) maintains a temperature of the temperature transfer fluid in a range of from about 10C to about 25C. In other embodiments, the temperature of the temperature transfer fluid is maintained in a range of from about 11C to about 20C, while in still other embodiments, the temperature of the temperature transfer fluid is maintained in a range of from about 12C to about 19C. In some embodiments, the temperature of the temperature transfer fluid is maintained in a range of from about lOC, 10.5C, 11C, 11.5C, 12C, 12.5C, 13C, 13.5C, 14C, 14.5C, 15C, 15.5C, 16C, 16.5C, 17C, 17.5C, 18C, 18.5C, 19C, 19.5C, 20C, 20.5C, 21C, 21.5C, 22C, 22.5C, 23C, 23.5C, 24C, or 24.5C to about 10.5C, 11C, 11.SC, 12C, 12.5C, 13C, 13.5C, 14C, 14.5C, 15C, 15.SC, 16C, 16.SC, 17C, 17.SC, 18C, 18.SC, 19C, 19.SC, 20C, 20.SC, 21C,21.SC, 22C, 22.SC, 23C,23.SC, 24C, 24.5C, or 25C (specification pp. 20, lines 5-14). Applicant is reminded that to establish unexpected results over a claimed range, applicants should compare a sufficient number of tests both inside and outside the claimed range to show the criticality of the claimed range. In re Hill, 284 F.2d 955, 128 USPQ 197 (CCPA 1960).
Regarding claim 13, Kane in view of North discloses the invention as discussed above.
North further teaches the thermostatic mixing valve 12 comprises at least one of a liquid-filled bellows (4), a wax bellows (col. 3, lines 58-67 where bellows unit 4 is in chamber 6 which is filled with wax rendering the structure was bellows), a bi-metal coil (7), or combination thereof (col. 3, lines 51-67, col. 4, lines 10-57, col. 6, lines 30-50, figs. 1-3).
Regarding claim 14, Kane in view of North discloses the invention as discussed above.
North further teaches the thermally responsive material may comprise any suitable material, but is preferably a wax of the type including a hydrocarbon and which is blended so that by careful selection provides a thermally responsive filler for the expansion chamber and the preferred reservoir which is effective in both solid and/or liquid phases (col. 7, lines 27-34).
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention to have selected the wax in the wax bellows of Kane in view of North to have a melting point of from about 10C to about 20C for the advantage of maintaining the fluid transfer temperature within a specific range for maintaining body temperature of the patient with that range, also since it has been held that "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation." In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). In the instant case, the device of Kane in view of North would not operate differently with the claimed temperature range since pre-setting the thermostatic mixing valve to the claimed temperature range in the device would function appropriately having the claimed temperature range. Further, applicant places no criticality on the range claimed, indicating in the specification simply that “In some embodiments, the thermostatic mixing valve comprises at least one of a liquid-filled bellows, a wax bellows, a bi-metal coil, or combinations thereof. In some embodiments, the wax bellows includes a wax with a melting point of from about 10C to about 20C, and preferably at about 15C.” (page 11 of the written specification). There are no materials for the wax recited in the written specification.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Kane US 2003/0097163 in view of Nogawa US 5162102.
Kane discloses the invention as discussed above.
Kane is silent on the insulated portion has an R-value of at least R-3.
Nogawa teaches an analogous housing that is made of polystyrene which has an R-value of at least R-3 per Applicant’s own specification and recommended use of materials (see written specification of instant application, page 9, lines 12-24), providing an insulation material that is hydrophobic resin (col. 2, lines 5-20).
Therefore, it would have been obvious to one of ordinary skill in the art at the time of the invention was made to have made the insulated portion (the housing 200) of Kane with the polystyrene material having an R-value of at least R-3 as taught by Nogawa in order to have provided an improved insulated portion that is robust and that is hydrophobic in nature which is another layer of protection against water and moisture (Nogawa, col. 2, lines 5-20). Also, it has been held that “[T]he selection of a known material based on its suitability for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Muehlbauer US 2014/0194788.
Meuhlbauer discloses the invention as discussed above.
Although, Meuhlbauer further discloses the bladder 113 comprises a top surface having a strap via 112 to receive a glabrous skin surface (elastic band or an attached Velcro strap/hook and loop strap, [0026]), Muehlbauer does not explicitly disclose straps.
It would have been obvious to one of ordinary skill in the art at the time the invention was made to have provided two straps of hook and loop to the top surface of bladder 113 via 112 in order to more robustly secure very large or very small hands of patients to the top surface of the bladder and platform to ensure accurate pressure readings from the sensor 119, since it has been held by the court held that mere duplication of parts has no patentable significance unless a new and unexpected result is produced In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claim 21 is rejected under 35 U.S.C. 103 as being unpatentable over Kane US 2003/0097163 in view of Diller US 2011/0066217.
Kane discloses the invention as discussed above.
Kane is silent on the body temperature modifying device is in communication with a mobile device to provide information regarding the status of the body temperature modifying device.
Diller teaches an analogous body temperature modifying device 200 (fig. 1) being in communication with a mobile device 224 (computer 224 can operate in a networked environment and it can be a portable remote computing device [0100]) to provide information regarding the status of the body temperature modifying device 200 (via temperature sensors 308,310,312,314 [0095-0100]), providing an improved body temperature modifying device that can be implemented in a wireless environment such that the processing and computing operations and tasks can be performed by remote processing saving costs for operators [00103].
Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was made to provided the body temperature modifying device of Kane to be in communication with a mobile device 224 to provide information regarding the status of the body temperature modifying device as taught by Diller in order to have provided an improved and cost effective body temperature modifying device that can be implemented in a wireless environment such that the processing and computing operations and tasks can be performed by remote processing saving costs for operators (Diller, 0100-00103]).
Conclusion
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/ALIREZA NIA/Supervisory Patent Examiner, Art Unit 3786