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 .
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.
Claim Objections
Applicant is advised that should claim 2 be found allowable, claim 16 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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.
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) 1-5, 16 and 17 is/are rejected under 35 U.S.C. 103 as being unpatentable over US 6,375,674 B1 to Carson (Carson) in view of US 2003/0212416 A1 to Cinelli et al. (Cinelli) and US 2003/0163183 A1 to Carson (183 Carson).
Regarding claim 1, Carson teaches a patient temperature control system (title “Cooling/Heating Pad and System” and Figs. 13-15), comprising a fluid conditioning assembly (fluid circulating system 310, 310’) configured to cool, warm, and circulate a thermal exchange fluid throughout the system, a controller (Col. 12, lines 52-54 and Col. 13, lines 1-7, 31-35) configured to operate the fluid conditioning assembly, one or more medical pads (medical pad 10) for thermal exchange with a patient, the one or more medical pads including a fluid circulation layer (see for example 12, 112, 212, Figs. 8-12C) for circulating the thermal exchange fluid therethrough, a hydrogel layer (see for example 16. 116. 216, 616, 716) layer defining an adhesive surface for adhering to skin of the patient (Col. 2, line 61-Col. 3, line 30) and wherein the hydrogel layer has a thermal conductivity between 1.0-2.37 cal/hr-cm-oC (Col. 3, lines 8-11). However, Carson does not teach that the hydrogel layer is an ultraviolet light cured composition comprising a cross-linked polymer and having a thermal conductivity of 1.9 cal/hr-cm-oC or a patient temperature sensor configured to sense patient temperature and provide a patient temperature signal indicative thereof to the controller for operating the fluid conditioning assembly.
With respect to the hydrogel thermal conductivity being 1.9 cal/hr-cm-oC, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a thermal conductivity being 1.9 cal/hr-cm-oC, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]).
183 Carson teaches an analogous system (title “Patient Temperature Control System”) to that of Carson including a patient temperature sensor configured to sense patient temperature and provide a patient temperature signal indicative thereof to the controller for operating the fluid conditioning assembly ([0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carson with the patient temperature sensor of 183 Carson to allow for maintaining a desired temperature as taught by 183 Carson ([0089]).
Regarding claims 2 and 16, the combination teaches the system of claim 1 as well as 193 Carson teaching wherein the patient temperature sensor is configured to sense a core body temperature of the patient ([0089]).
Regarding claim 3, the combination teaches the system of claim 1 as well as Carson teaching a fluid temperature sensor configured to sense a fluid temperature of the thermal exchange fluid and provide a fluid temperature signal indicative thereof to the controller for operating the fluid conditioning assembly (see for example 334 and 392 and Col. 13, lines 25-35).
Regarding claim 4, the combination teaches the system of claim 3 as well as 183 Carson teaching the controller comprises a programmable control module ([0051] which states in part “The processor 70 may be pre-programmed to proves digital signals to provide various controlled functionalities…”) configured to generate control signals for a heat exchanger of the fluid conditioning system, thereby providing a desired temperature of the thermal exchange fluid for a target patient temperature ([0054] which states in part “Further, processor 70 can control the operation of the heater 86 and radiator/fan 83 to affect the desired amount of heating and cooling.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carson to include the programmable controller of 183 Carson to allow for control of the amount of heating and cooling as taught by 183 Carson.
Regarding claim 5, the combination teaches the system of claim 3 as well as 183 Carson wherein each signal of the patient temperature signal and the fluid temperature signal is utilized by the programmable control module together with control data and preset algorithms to generate control signals for the heat exchanger and provide the desired temperature of the thermal exchange fluid for the target patient temperature ([0044, 0051]).
Regarding claim 17, the combination teaches the system of claim 1 as well as Cinelli teaching wherein the cross linked co-polymer can comprise sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid ([0035-0039]). While Cinelli doesn’t specifically disclose the cross linked co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid as taught by Cinelli, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of tis suitability for the intended use.
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Carson, Cinelli and 183 Carson as applied to claim 3 above, and further in view of US 2009/0099629 A1 to Carson et al. (629 Carson).
Regarding claim 6, Carson in view of Cinelli and 183 Carson, but not the controller comprising a graphic display configured to visually present a plot including an adjustment rate for a target patient temperature and the fluid temperature sensed by the fluid temperature sensor in corresponding time relation to the adjustment rate for the target patient temperature. 629 Carson teaches an analogous system to that of Carson (title “System and Method for Patient Temperature Control”) including a programmable control module (20) with an interactive user interface (200) for providing phase-related control and alarm data, and measured data, to a user and for prompting and receiving user control input via interactive screen displays (Figs. 3A-3I). 629 Carson goes on to teach that phase-specific target patient temperature and phase duration data sets may be represented graphically in a s portion (212) of the user interface (200) (see Fig. 3B, 3C and 3D). The phase-specific target patient temperature and phase duration data may be utilized to generate a plot of a target temperature level as a function of time-in-therapy and may be characterized as a target temperature adjustment rate ([0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a graphical display as taught by 629 Carson to facilitate medical personnel monitoring of a given patient therapy procedure so as to enhance overall control and responsive action as necessary as taught by 629 Carson.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-12 of U.S. Patent No. 12,193,968 B2 in view of Carson.
Regarding claim 1 of the instant application, each of claims 1, 11 and 12 of the patent teach all of the limitations of claim 1 of the instant application, but not specifically a thermal conductivity of 1.9 cal/hr-cm-oC.
Carson teaches an analogous system (title “Cooling/Heating Pad and System” and Figs. 13-15), comprising a fluid conditioning assembly (fluid circulating system 310, 310’) configured to cool, warm, and circulate a thermal exchange fluid throughout the system, a controller (Col. 12, lines 52-54 and Col. 13, lines 1-7, 31-35) configured to operate the fluid conditioning assembly, one or more medical pads (medical pad 10) for thermal exchange with a patient, the one or more medical pads including a fluid circulation layer (see for example 12, 112, 212, Figs. 8-12C) for circulating the thermal exchange fluid therethrough, a hydrogel layer (see for example 16. 116. 216, 616, 716) layer defining an adhesive surface for adhering to skin of the patient (Col. 2, line 61-Col. 3, line 30) and wherein the hydrogel layer has a thermal conductivity between 1.0-2.37 cal/hr-cm-oC (Col. 3, lines 8-11). While Cason does not specifically teach the hydrogel thermal conductivity being 1.9 cal/hr-cm-oC, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a thermal conductivity being 1.9 cal/hr-cm-oC, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
Regarding claims 2 and 16 of the instant application, claim 2 of the patent in view of Carson (see rejection above) teaches all of the limitations of claim 2 of the instant application.
Regarding claim 3 of the instant application, claim 3 of the patent in view of Carson (see rejection above) teaches all of the limitations of claim 3 of the instant application.
Regarding claim 4 of the instant application, claim 4 of the patent in view of Carson (see rejection above) teaches all of the limitation of claim 4 of the instant application.
Regarding claim 5 of the instant application, claim 5 of the patent in view of Carson (see rejection above) teaches all of the limitations of claim 5 of the instant application.
Regarding claim 6 of the instant application, claim 7 of the patent in view of Carson (see rejection above) teaches all of the limitations of claim 6 of the instant application.
Regarding claim 7 of the instant application, claims 1, 11 and 12 of the patent in view of Carson (see rejection above) teach all of the limitations of claim 7 of the instant application.
Regarding claim 8 of the instant application, claim 8 of the patent in view of Carson (see rejection above) teaches all of the limitations of claim 8 of the instant application.
Regarding claim 9 of the instant application, claim 9 of the patent in view of Carson (see rejection above) teaches all of the limitations of claim 9 of the instant application.
Regarding claim 10 of the instant application, claim 10 of the patent in view of Carson (see rejection above) teaches all of the limitations of claim 10 of the instant application.
Regarding claims 11-13, claims 1, 11 and 12 of the patent in view of Carson (see rejection above) teach all of the limitations of claims 11-13 of the instant application, but not specifically wherein the ultraviolet light-cured composition includes the cross-linked copolymer in an amount of about 28% by weight, the water in an amount of about 34% by weight or the glycerol in an amount of about 30% by weight. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the amounts as claimed, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
Claims 14, 15 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-12 of U.S. Patent No. 12,193,968 B2 in view of Carson and Cinelli.
Regarding claim 14 of the instant application, claims 1, 11 and 12 of the patent in view of Carson (see rejection above) teaches the limitations of claim 14 of the instant application, but not wherein the ultraviolet-light cured composition includes potassium chloride in an amount of about 2% by weight.
Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli teaches many different materials in different percentages contained in the ultraviolet light-cured composition it does not specifically teach potassium chloride in an amount of about 2% by weight. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the patent in view of Carson to include potassium chloride in an amount of about 2% by weight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 15 of the instant application, claims 1, 11 and 12 of the patent in view of Carson (see rejection above) teaches the limitations of claim 15 of the instant application, but not wherein the ultraviolet-light cured composition includes (poly)vinyl pyrrolidone in an amount of about 1.5% by weight. Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli teaches many different materials in different percentages contained in the ultraviolet light-cured composition it does not specifically teach (poly)vinyl pyrrolidone in an amount of about 1.5% by weight. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the patent in view of Carson to include potassium chloride in an amount of about 2% by weight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 17 of the instant application, claims 1, 11 and 12 of the patent in view of Carson (see rejection above), teaches the limitations of claim 17, but not wherein the cross linked co-polymer can comprise sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid ([0035-0039]). Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli doesn’t specifically disclose the cross linked co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid as taught by Cinelli, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of tis suitability for the intended use.
Claims 1 and 7-13 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,234,859.
Regarding claim 1 of the instant application, claim 17 of the patent teaches the limitations of claim 1, but not specifically a thermal conductivity of 1.9 cal/hr-cm-oC. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a thermal conductivity being 1.9 cal/hr-cm-oC, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
Regarding claim 7 of the instant application, claim 17 of the patent (see rejection above) teaches all the limitations of claim 7 of the instant application.
Regarding claims 8-10 of the instant application, claim 17 of the patent (see rejection above) teaches all the limitations of claims 8-10, but not the specific percentage ranges of the cross-linked copolymer, the water and the glycerol. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the claimed ranges, 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.
Regarding claims 11-13 of the instant application, claim 17 of the patent (see rejection above) teaches all of the limitations of claims 11-13, but not the specific percentage of the cross-linked copolymer, the water and the glycerol. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the amounts as claimed, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
Claims 2-5 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,234,859 in view of 183 Carson.
Regarding claims 2 and 16 of the instant application, claim 17 of the patent teaches the limitations of claim 1, but not specifically a thermal conductivity of 1.9 cal/hr-cm-oC or wherein the temperature sensor is configured to sense a core body temperature of the patient.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a thermal conductivity being 1.9 cal/hr-cm-oC, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
183 Carson teaches an analogous system (title “Patient Temperature Control System”) to that of claim 17 of the patent including a patient temperature sensor configured to sense patient temperature and provide a patient temperature signal indicative thereof to the controller for operating the fluid conditioning assembly ([0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 17 of the patent with the patient temperature sensor of 183 Carson to allow for maintaining a desired temperature as taught by 183 Carson ([0089]).
Regarding claim 3 of the instant application, claim 17 of the patent in view of 183 Carson (see rejection above) teaches the limitations of claim 3 of the instant application including 183 Carson teaching a fluid temperature sensor configured to sense a fluid temperature of the thermal exchange fluid and provide a fluid temperature signal indicative thereof to the controller for operating the fluid conditioning assembly ([0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 17 of the patent with the fluid temperature sensor of 183 Carson to allow for enhanced system performance ([0044]).
Regarding claim 4 of the instant application, claim 17 of the patent in view of 183 Carson (see rejection above) teaches the limitations of claim 4 of the instant application including 183 Carson teaching the controller comprises a programmable control module ([0051] which states in part “The processor 70 may be pre-programmed to proves digital signals to provide various controlled functionalities…”) configured to generate control signals for a heat exchanger of the fluid conditioning system, thereby providing a desired temperature of the thermal exchange fluid for a target patient temperature ([0054] which states in part “Further, processor 70 can control the operation of the heater 86 and radiator/fan 83 to affect the desired amount of heating and cooling.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the programmable controller of 183 Carson to allow for control of the amount of heating and cooling as taught by 183 Carson.
Regarding claim 5 of the instant application, claim 17 of the patent in view of 183 Carson (see rejection above) teaches the limitations of claim 5 of the instant application including 183 Carson wherein each signal of the patient temperature signal and the fluid temperature signal is utilized by the programmable control module together with control data and preset algorithms to generate control signals for the heat exchanger and provide the desired temperature of the thermal exchange fluid for the target patient temperature ([0044, 0051]).
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,234,859 in view of 183 Carson and 629 Carson.
Regarding claim 6 of the instant application, claim 17 of the patent teaches the limitations of claim 6, but not but not specifically a thermal conductivity of 1.9 cal/hr-cm-oC, a fluid temperature sensor configured to sense a fluid temperature of the thermal exchange fluid and provide a fluid temperature signal indicative thereof to the controller for operating the fluid conditioning assembly or the controller comprising a graphic display configured to visually present a plot including an adjustment rate for a target patient temperature and the fluid temperature sensed by the fluid temperature sensor in corresponding time relation to the adjustment rate for the target patient temperature.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a thermal conductivity being 1.9 cal/hr-cm-oC, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
183 Carson teaches an analogous system (title “Patient Temperature Control System”) to that of claim 17 of the patent including a fluid temperature sensor configured to sense a fluid temperature of the thermal exchange fluid and provide a fluid temperature signal indicative thereof to the controller for operating the fluid conditioning assembly ([0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 17 of the patent with the fluid temperature sensor of 183 Carson to allow for enhanced system performance ([0044]).
629 Carson teaches an analogous system to that of Carson (title “System and Method for Patient Temperature Control”) including a programmable control module (20) with an interactive user interface (200) for providing phase-related control and alarm data, and measured data, to a user and for prompting and receiving user control input via interactive screen displays (Figs. 3A-3I). 629 Carson goes on to teach that phase-specific target patient temperature and phase duration data sets may be represented graphically in a s portion (212) of the user interface (200) (see Fig. 3B, 3C and 3D). The phase-specific target patient temperature and phase duration data may be utilized to generate a plot of a target temperature level as a function of time-in-therapy and may be characterized as a target temperature adjustment rate ([0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a graphical display as taught by 629 Carson to facilitate medical personnel monitoring of a given patient therapy procedure so as to enhance overall control and responsive action as necessary as taught by 629 Carson.
Claims 14, 15 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 17 of U.S. Patent No. 11,234,859 in view of Carson and Cinelli.
Regarding claim 14 of the instant application, claims 17 of the patent in view of Carson (see rejection above) teaches the limitations of claim 14 of the instant application, but not wherein the ultraviolet-light cured composition includes potassium chloride in an amount of about 2% by weight.
Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli teaches many different materials in different percentages contained in the ultraviolet light-cured composition it does not specifically teach potassium chloride in an amount of about 2% by weight. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the patent in view of Carson to include potassium chloride in an amount of about 2% by weight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 15 of the instant application, claim 17 of the patent in view of Carson (see rejection above) teaches the limitations of claim 14 of the instant application, but not wherein the ultraviolet-light cured composition includes (poly)vinyl pyrrolidone in an amount of about 1.5% by weight. Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli teaches many different materials in different percentages contained in the ultraviolet light-cured composition it does not specifically teach (poly)vinyl pyrrolidone in an amount of about 1.5% by weight. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the patent in view of Carson to include potassium chloride in an amount of about 2% by weight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 17 of the instant application, claim 17 of the patent in view of Carson (see rejection above) teaches the limitations of claim 17 of the instant application, but not wherein the cross linked co-polymer can comprise sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid ([0035-0039]). Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli doesn’t specifically disclose the cross linked co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid as taught by Cinelli, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of tis suitability for the intended use.
Claims 1-5, 7-13 and 16 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8 of U.S. Patent No. 10,441,458 B1 in view of 183 Carson.
Regarding claim 1 of the instant application, claims 1-5 and 8 of the patent teach the limitations of claim 1 of the instant application, but not a fluid conditioning assembly configured to cool, warm, and circulate a thermal exchange fluid throughout the system, a controller configured to operate the fluid conditioning assembly or a patient temperature sensor configured to sense patient temperature and provide a patient temperature signal indicative thereof to the controller for operating the fluid conditioning assembly.
183 Carson teaches an analogous system to that of the patent (title “Patient Temperature Control System”) including a fluid conditioning assembly (blood/water heat exchanger temperature control system 10) configured to cool, warm and circulate a thermal exchange fluid throughout the system ([0025]), a controller configured to operate the fluid conditioning assembly ([0050-0055]), and a patient temperature sensor configured to sense patient temperature and provide a patient temperature signal indicative thereof to the controller for operating the fluid conditioning assembly ([0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the patent with the fluid conditioning assembly, controller and patient temperature sensor of 183 Carson to allow for maintaining a desired temperature as taught by 183 Carson ([0050, 0055]).
Regarding claims 2 and 16 of the instant application, claims 1-5 and 8 of the patent in view of 183 Carson (see rejection above) teach the system of claim 2 of the instant application including 183 Carson teaching wherein the patient temperature sensor is configured to sense a core body temperature of the patient ([0055]). It would have been obvious to one having ordinary skill in the before the effective filing date of the claimed invention to have modified the patent with the fluid conditioning assembly, controller and patient temperature sensor of 183 Carson to allow for maintaining a desired temperature as taught by 183 Carson ([0050, 0055]).
Regarding claim 3 of the instant application, claims 1-5 and 8 of the patent in view of 183 Carson (see rejection above) teaches the limitations of claim 3 of the instant application including 183 Carson teaching a fluid temperature sensor configured to sense a fluid temperature of the thermal exchange fluid and provide a fluid temperature signal indicative thereof to the controller for operating the fluid conditioning assembly ([0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 17 of the patent with the fluid temperature sensor of 183 Carson to allow for enhanced system performance ([0044]).
Regarding claim 4 of the instant application, claims 1-5 and 8 of the patent in view of 183 Carson (see rejection above) teaches the limitations of claim 4 of the instant application including 183 Carson teaching the controller comprises a programmable control module ([0051] which states in part “The processor 70 may be pre-programmed to proves digital signals to provide various controlled functionalities…”) configured to generate control signals for a heat exchanger of the fluid conditioning system, thereby providing a desired temperature of the thermal exchange fluid for a target patient temperature ([0054] which states in part “Further, processor 70 can control the operation of the heater 86 and radiator/fan 83 to affect the desired amount of heating and cooling.”). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the programmable controller of 183 Carson to allow for control of the amount of heating and cooling as taught by 183 Carson.
Regarding claim 5 of the instant application, claims 1-5 and 8 of the patent in view of 183 Carson (see rejection above) teaches the limitations of claim 5 of the instant application including 183 Carson wherein each signal of the patient temperature signal and the fluid temperature signal is utilized by the programmable control module together with control data and preset algorithms to generate control signals for the heat exchanger and provide the desired temperature of the thermal exchange fluid for the target patient temperature ([0044, 0051]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to include the programmable controller of 183 Carson to allow for control of the amount of heating and cooling as taught by 183 Carson.
Regarding claim 7 of the instant application, claims 1-5 and 8 of the patent in view of 183 Carson (see rejection above) teaches the limitations of claim 7 of the instant application.
Regarding claims 8-10 of the instant application, claims 1-5 and 8 of the patent (see rejection above) teaches all the limitations of claims 8-10, but not the specific percentage ranges of the cross-linked copolymer, the water and the glycerol. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized the claimed ranges, 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.
Regarding claims 11-13 of the instant application, claims 1-5 and 8 of the patent (see rejection above) teaches all of the limitations of claims 11-13, but not the specific percentage of the cross-linked copolymer, the water and the glycerol. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected the amounts as claimed, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
Claim 6 is rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8 of U.S. Patent No. 10,441,458 B1 in view of 183 Carson and 629 Carson.
Regarding claim 6 of the instant application, claim 17 of the patent teaches the limitations of claim 6, but not but not specifically a thermal conductivity of 1.9 cal/hr-cm-oC, a fluid temperature sensor configured to sense a fluid temperature of the thermal exchange fluid and provide a fluid temperature signal indicative thereof to the controller for operating the fluid conditioning assembly or the controller comprising a graphic display configured to visually present a plot including an adjustment rate for a target patient temperature and the fluid temperature sensed by the fluid temperature sensor in corresponding time relation to the adjustment rate for the target patient temperature.
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have selected a thermal conductivity being 1.9 cal/hr-cm-oC, since it has been held that discovering an optimum value of a results effective variable involves only routine skill in the art.
183 Carson teaches an analogous system (title “Patient Temperature Control System”) to that of claim 17 of the patent including a fluid temperature sensor configured to sense a fluid temperature of the thermal exchange fluid and provide a fluid temperature signal indicative thereof to the controller for operating the fluid conditioning assembly ([0044]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified claim 17 of the patent with the fluid temperature sensor of 183 Carson to allow for enhanced system performance ([0044]).
629 Carson teaches an analogous system to that of Carson (title “System and Method for Patient Temperature Control”) including a programmable control module (20) with an interactive user interface (200) for providing phase-related control and alarm data, and measured data, to a user and for prompting and receiving user control input via interactive screen displays (Figs. 3A-3I). 629 Carson goes on to teach that phase-specific target patient temperature and phase duration data sets may be represented graphically in a s portion (212) of the user interface (200) (see Fig. 3B, 3C and 3D). The phase-specific target patient temperature and phase duration data may be utilized to generate a plot of a target temperature level as a function of time-in-therapy and may be characterized as a target temperature adjustment rate ([0055]). It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a graphical display as taught by 629 Carson to facilitate medical personnel monitoring of a given patient therapy procedure so as to enhance overall control and responsive action as necessary as taught by 629 Carson.
Claims 14, 15 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 8 of U.S. Patent No. 10,441,458 B1 in view of 183 Carson and 629 Carson and Cinelli.
Regarding claim 14 of the instant application, claims 1-5 and 8 of the patent in view of 183 Carson and 629 Carson (see rejection above) teaches the limitations of claim 14 of the instant application, but not wherein the ultraviolet-light cured composition includes potassium chloride in an amount of about 2% by weight.
Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli teaches many different materials in different percentages contained in the ultraviolet light-cured composition it does not specifically teach potassium chloride in an amount of about 2% by weight. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the patent in view of Carson to include potassium chloride in an amount of about 2% by weight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 15 of the instant application, claims 1-5 and 8 of the patent in view of Carson (see rejection above) teaches the limitations of claim 15 of the instant application, but not wherein the ultraviolet-light cured composition includes (poly)vinyl pyrrolidone in an amount of about 1.5% by weight. Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli teaches many different materials in different percentages contained in the ultraviolet light-cured composition it does not specifically teach (poly)vinyl pyrrolidone in an amount of about 1.5% by weight. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified the patent in view of Carson to include potassium chloride in an amount of about 2% by weight, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use as a matter of obvious design choice.
Regarding claim 17 of the instant application, claims 1-5 and 8 of the patent in view of Carson (see rejection above) teaches the limitations of claim 17 of the instant application, but not wherein the cross linked co-polymer can comprise sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid ([0035-0039]). Cinelli teaches hydrogel adhesives with enhanced cohesiveness and peel force for use on hair or fiber-populated surface (titled) that is ultraviolet light cured. It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have modified Carso with a hydrogel adhesive as taught by Cinelli so as to allow for a hydrogel which adheres on skin surface which have hair present and which will reduce pain level on removal ([0005]), which can embed hair and adheres to the skin, thus providing good gasketing, while still allowing painless removal ([0006]), exhibits an ability to adhere to skin upon reapplication, particularly multiple reapplications while still allowing painless removal ([0007]) and which is pleasing to the skin upon application, and yet causes no discomfort upon removal and minimal residues ([0008]). While Cinelli doesn’t specifically disclose the cross linked co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid, it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized a co-polymer comprising sodium 2-acyrylamido-2mrthylpropanesulfonate and acrylic acid as taught by Cinelli, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of tis suitability for the intended use.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Joanne M Rodden can be reached at (303) 297-4726. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
Prosecution Insights