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.
Response to Arguments
Applicant’s arguments with respect to claim(s) 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.
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.
Claim(s) 22, 23 and 25-27 is/are rejected under 35 U.S.C. 103 as being unpatentable over “The Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomized controlled trial” to Melling et al. (Melling) in view of WO 2017/035341 A1 to Marquette et al. (Marquette), US 2009/0107984 to Kohn (Kohn) and US 9,744,073 B2 to Van Duren (Van Duren).
Regarding claim 22, Melling teaches a method of heating a region of a user’s body to achieve peri-surgical hyperthermia for improved blood supply to promote heating (pg. 2, section Treatment which states in part “Patients assigned to the local warming group also received the standard care and a minimum of 30 minutes preoperative warming to just the planned wound area using a non-contact, radiant heat dressing…nursing staff applied the warming devices before surgery. Both warming devices were left in situ until just before surgery.” and Discussion section), comprising the steps of providing a heating device (pg. 2, section Treatment which states in part “using a non-contact, radiant heat dressing), placing the heating device so that it is in thermal contact with the user’s body for a period of time before surgery (pg. 2, section Treatment which states in part “a minimum of 30 minutes preoperative warming”), activating the heat source to apply heat to the region of the user’s body to achieve localized hyperthermia, wherein the region of the user’s body is heated to a supraphysiological level (Table 1: Characteristics of the patients in the three treatment groups) and the region corresponds to the location on the user where a surgical intervention is planned (pg. 2, section Treatment which states in part ““Patients assigned to the local warming group also received the standard care and a minimum of 30 minutes preoperative warming to just the planned wound area…”), removing the heating device (pg. 2, section Treatment which states in part “Both warming devices were left in situ until just before surgery.”) and performing the surgery (section Data collection and postoperative surveillance). However, Melling is silent with respect to the specifics of the heating device having a wearable layer conformable to a part of the user’s body, a heat source attached to the wearable layer for applying heat to a region of the user’s body, a blood flow sensor attached to the wearable layer configured to detect a parameter indicative of blood flow in or adjacent to the region of the user’s body and generate a signal indicative thereof, and one or both of (i) a processor in electrical communication with the blood flow sensor for determining the blood flow in or adjacent to the region of the user’s body based on the signal, or (ii) a transmitter for transmitting the signal to a remote device, activating the heat source in a timed periodic pattern, using the blood flow sensors to detect blood flow in the region of the user’s body, placing the wearable layer on the user’s body so that the heating device is in thermal contact with the user’s body for a period of time after the surgery, and activating the heat source to apply heat to a region of the user’s body at a generally constant temperature after surgery.
Marquette teaches an analogous method of heating regions of a user’s body (title and [0002]), comprising the steps of providing a heating device (title and [0002]) comprising a wearable layer (22, 28A-D, 30A-B) conformable to a part of the user’s body, a heat source (24) attached to the wearable layer for applying heat to a region of the user’s body, a blood flow sensor (44 and [0068] which states in part “sensors that may be used include a heat flux sensor, a temperature sensor, a blood flow sensor (e.g., a perfusion sensor), or a combination thereof.”) attached to the wearable layer (see for example Fig. 21) to detect a parameter indicative of blood flow in or adjacent to the region of the user’s body and generate a signal indicative thereof (see for example Fig. 21), and one or both of a processor (20) in electrical communication with the blood flow sensor for determining the blood flow in or adjacent to the region of the user’s body based on the signal, or a transmitter for transmitting the signal to a remote device ([0080] which stats in part “sensor circuitry 98 may be used to obtain readings from sensor 44, and communicate them to ECU 20 (e.g. through wireless signal transmissions to communicate with circuit 42).”), placing the wearable layer on a user’s body so that the heating device is in thermal contact with a user’s body (202, Fig. 19), using the blood flow sensor to detect blood flow in the region of the user’s body ([0068]) and activation of the heat source being generally constant to output a constant temperature ([0010]) which states in part “A control circuit is operable to control a temperature within the thermal housing.” and [0022] which states in part “the control circuit is operable to control the temperature within the thermal housing based on input received from the at least one sensor.”). 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 heating device of Marquette in the method of Melling as an obvious matter of engineering design choice of a selection of a known heating device to perform the desired function of heating.
However, Marquette is silent with respect to applying heat in a timed periodic pattern and placing the wearable layer on the user’s body so that the heating device is in thermal contact with the user’s body for a period of time after the surgery.
Van Duren teaches an analogous device and method (title “warming device for perioperative use”) to that of Marquette including that therapeutic warming may be indicated during any one or more of the perioperative periods and that for a long surgery a person may be warmed for comfort before surgery and warmed therapeutically during and after surgery (Col. 4, lines 1-14). Van Duren teaches that for example, for a short operation in a surgery with no warming equipment available, a person may be warmed preoperatively in a preparation area to raise mean body temperature to a level higher than normal in order to store enough thermal energy to maintain normothermia, without heating, intraoperatively and after surgery, it may be necessary to apply therapeutic warming in a recovery area to raise the core temperature to normothermia and maintain it there for a period of time while anesthesia wears off (Col. 4, lines 1-11). 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 method of Marquette to have warmed before surgery, removed the device, performed the surgery and then placed the device to warm the user for a period of time after surgery to allow as taught by Van Duren therapeutic warming used as needed during one or more of the perioperative periods to prevent or treat hypothermia so as to mitigate its effects.
Kohn teaches an analogous method to that of Marquette where the heating is operable in a constant mode as well as a cyclical heating operation in which the heating pad (10) may repeatedly cycle through a selected temperature range over predefined or user defined periods of time where in a cyclic heating mode, the microprocessor (39) in cooperation with an internal clock (39) operates to control both the time and temperature settings of the heating pad (10) based on a pre-programmed pattern ([0022]). Kohn goes on to teach that while any cyclic heating pattern can be used an exemplary cycle pattern may raise the heating pad’s temperature to between 120oC and 125oF over the first thirty minutes of the cycle. After maintaining such temperature for a predetermined period of time, the pad (10) may cycle its temperature back down to between 105oC and 110oF and remain at that level for a period of approximately thirty minutes. The pad (10) can continue to cycle between the higher and lower temperature ranges for any period of time ([0022]). 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 timed periodic pattern as taught by Kohn to allow for an increase in blood flow while avoiding unnecessary risk of burns as taught by Kohn ([0004-0005]).
Regarding claim 23, the combination teaches the method of claim 22 as well as Marquette teaching wherein the controller is configured to maintain the temperature of the heat source to between 40oC and 50oC before surgery. The controller of Marquette is capable of without further modification maintaining the temperature of the heat source as claimed as Marquette teaches a control circuit operable to control a temperature with the heating device (abstract and [0010, 0022]).
Regarding claim 25, the combination teaches the method of claim 22 as well as Kohn teaching wherein the timed periodic pattern comprises periods of high temperature heating and periods of low temperature heating ([0022]). 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 timed periodic pattern as taught by Kohn to allow for an increase in blood flow while avoiding unnecessary risk of burns as taught by Kohn ([0004-0005]).
Regarding claim 26, the combination teaches the method of claim 22, but not specifically wherein the heating device is configured to maintain the temperature of the heat source to between 30oC and 40oC after surgery. It is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have maintained the temperature of the hat source to between 30oC and 40oC after surgery, 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 claim 27, the combination teaches the method of claim 22, as well as Melling teaching wherein the surgery is one of abdominoplasty, mastectomy, vascular surgery, breast surgery, caesarean section, spinal surgery, foot surgery, ankle surgery, knee surgery, sternotomy, laparotomy, complex free tissue reconstructions or other cosmetic procedures (Table 4: Characteristics of patient by wound infection).
Claim(s) 28, 29, 31-40, 42 and 43 is/are rejected under 35 U.S.C. 103 as being unpatentable over “The Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomized controlled trial” to Melling et al. (Melling) in view of WO 2017/035341 A1 to Marquette et al. (Marquette) and US 2009/0107984 to Kohn (Kohn).
Regarding claim 28, Melling teaches a method of heating a region of a user’s body to achieve peri-surgical hyperthermia for improved blood supply to promote heating (pg. 2, section Treatment which states in part “Patients assigned to the local warming group also received the standard care and a minimum of 30 minutes preoperative warming to just the planned wound area using a non-contact, radiant heat dressing…nursing staff applied the warming devices before surgery. Both warming devices were left in situ until just before surgery.” and Discussion section), comprising the steps of providing a heating device (pg. 2, section Treatment which states in part “using a non-contact, radiant heat dressing), placing the heating device so that it is in thermal contact with the user’s body for a period of time before surgery (pg. 2, section Treatment which states in part “a minimum of 30 minutes preoperative warming”), activating the heat source to apply heat to the region of the user’s body to achieve localized hyperthermia, wherein the region of the user’s body is heated to a supraphysiological level (Table 1: Characteristics of the patients in the three treatment groups) and the region corresponds to the location on the user where a surgical intervention is planned (pg. 2, section Treatment which states in part ““Patients assigned to the local warming group also received the standard care and a minimum of 30 minutes preoperative warming to just the planned wound area…”), removing the heating device (pg. 2, section Treatment which states in part “Both warming devices were left in situ until just before surgery.”) and performing the surgery (section Data collection and postoperative surveillance). However, Melling is silent with respect to the specifics of the heating device having a wearable layer conformable to a part of the user’s body, a heat source attached to the wearable layer for applying heat to a region of the user’s body, a blood flow sensor attached to the wearable layer configured to detect a parameter indicative of blood flow in or adjacent to the region of the user’s body and generate a signal indicative thereof, and one or both of (i) a processor in electrical communication with the blood flow sensor for determining the blood flow in or adjacent to the region of the user’s body based on the signal, or (ii) a transmitter for transmitting the signal to a remote device, activating the heat source in a timed periodic pattern, using the blood flow sensors to detect blood flow in the region of the user’s body
Marquette teaches a method of heating a regions of a user’s body (title and [0002]), comprising the steps of providing a heating device (title and [0002]) comprising a wearable layer (22, 28A-D, 30A-B) conformable to a part of the user’s body, a heat source (24) attached to the wearable layer for applying heat to a region of the user’s body, a blood flow sensor (44 and [0068] which states in part “sensors that may be used include a heat flux sensor, a temperature sensor, a blood flow sensor (e.g., a perfusion sensor), or a combination thereof.”) attached to the wearable layer (see for example Fig. 21) to detect a parameter indicative of blood flow in or adjacent to the region of the user’s body and generate a signal indicative thereof (see for example Fig. 21), and one or both of a processor (20) in electrical communication with the blood flow sensor for determining the blood flow in or adjacent to the region of the user’s body based on the signal, or a transmitter for transmitting the signal to a remote device ([0080] which stats in part “sensor circuitry 98 may be used to obtain readings from sensor 44, and communicate them to ECU 20 (e.g. through wireless signal transmissions to communicate with circuit 42).”), placing the wearable layer on a user’s body so that the heating device is in thermal contact with a user’s body (202, Fig. 19), using the blood flow sensor to detect blood flow in the region of the user’s body ([0068]) and activation of the heat source being generally constant to output a constant temperature ([0010]) which states in part “A control circuit is operable to control a temperature within the thermal housing.” and [0022] which states in part “the control circuit is operable to control the temperature within the thermal housing based on input received from the at least one sensor.”). 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 heating device of Marquette in the method of Melling as an obvious matter of engineering design choice of a selection of a known heating device to perform the desired function of heating.
However, Marquette is silent with respect to applying heat in a timed periodic pattern to heat the user’s body to 43oC.
Kohn teaches an analogous method to that of Melling where the heating is operable in a constant mode as well as a cyclical heating operation in which the heating pad (10) may repeatedly cycle through a selected temperature range over predefined or user defined periods of time where in a cyclic heating mode, the microprocessor (39) in cooperation with an internal clock (39) operates to control both the time and temperature settings of the heating pad (10) based on a pre-programmed pattern ([0022]). Kohn goes on to teach that while any cyclic heating pattern can be used an exemplary cycle pattern may raise the heating pad’s temperature to between 120oC and 125oF over the first thirty minutes of the cycle. After maintaining such temperature for a predetermined period of time, the pad (10) may cycle its temperature back down to between 105oC and 110oF and remain at that level for a period of approximately thirty minutes. The pad (10) can continue to cycle between the higher and lower temperature ranges for any period of time ([0022]). 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 timed periodic pattern as taught by Kohn to allow for an increase in blood flow while avoiding unnecessary risk of burns as taught by Kohn ([0004-0005]).
Regarding the temperature of 43oC, it is asserted that it would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have heated the region of the user’s body to 43oC, since it has held that discovering the optimum value of a results effective variable involves only routine skill in the art. This is especially true as Kohn teaches the clinical studies have shown that in order to achieve full vasodilation a heat treatment of at least 102oF (39oC) must be achieved in order to obtain the benefits from heat therapy ([0004]).
Regarding claim 29, the combination teaches the method of claim 28 as well as Marquette teaching wherein the controller is configured to maintain the temperature of the heat source to between 40oC and 53oC. The controller of Marquette is capable of without further modification maintaining the temperature of the heat source as claimed as Marquette teaches a control circuit operable to control a temperature with the heating device (abstract and [0010, 0022]).
Regarding claim 31, the combination teaches the method of claim 28 but not specifically wherein in each period of low temperature heating, the temperature of the heat source is between 37oC and 40oC. It is asserted that 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 heating temperature of the heat source to be between 37oC and 40oC, 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 claim 32, the combination teaches the method of claim 28, but not specifically wherein in each period of low temperature heating the temperature of the heat source is 40oC. It is asserted that 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 low period temperature of 40oC, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
Regarding claim 33, the combination teaches the method of claim 28, but not specifically wherein in each period of low temperature the heating source is inactive (i.e. has a temperature of 0oC). It is asserted that 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 low temperature of 0oC, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
Regarding claim 34, the combination teaches the method of claim 28, but not wherein in each period of high temperature heating the temperature of the heating source is 43oC. It is asserted that 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 high temperature of 43oC, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art.
Regarding claim 35, the combination teaches the method of claim 28, as well as Melling teaching wherein the surgery is one of abdominoplasty, mastectomy, vascular surgery, breast surgery, caesarean section, spinal surgery, foot surgery, ankle surgery, knee surgery, sternotomy, laparotomy, complex free tissue reconstructions or other cosmetic procedures (Table 4: Characteristics of patient by wound infection).
Regarding claim 36, the combination teaches the method of claim 28, as well as Kohn teaching wherein each period of low temperature heating has a duration of at least 5 minutes ([0022]).
Regarding claim 37, the combination teaches the combination of claim 28, but not specifically wherein each period of low temperature heating has a duration of no more than 10 minutes. It is asserted that 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 duration of each period of low temperature heating having a duration of no more than 10 minutes, 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 claim 38, the combination teaches the method of claim 28 as well as Kohn teaching wherein each period of high temperature heating has a duration of at least 5 minutes ([0022]).
Regarding claim 39, the combination teaches the method of claim 28, but not specifically wherein each period of high temperature heating has a duration of no more than 10 minutes. It is asserted that 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 duration of each period of high temperature heating having a duration of no more than 10 minutes, 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 claim 40, the combination teaches the method of claim 28 as well as Kohn teaching wherein in each period of low temperature heating the temperature of the heat source is at least 37oC ([0022]).
Regarding claim 42, the combination teaches the method of claim 28, but not specifically wherein each period of low temperature heating has a duration of at least 8 minutes. It is asserted that 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 duration of each period of low temperature heating having a duration of at least 8 minutes, 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 claim 43, the combination teaches the method of claim 28, but not specifically wherein each period of high temperature heating has a duration of at least 8 minutes. It is asserted that 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 duration of each period of high temperature heating having a duration of at least 8 minutes, 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.
Claim(s) 41 is/are rejected under 35 U.S.C. 103 as being unpatentable over “The Effects of preoperative warming on the incidence of wound infection after clean surgery: a randomized controlled trial” to Melling et al. (Melling) in view of WO 2017/035341 A1 to Marquette et al. (Marquette) and US 2009/0107984 to Kohn (Kohn).
Regarding claim 41, Melling teaches a heating device (pg. 2, section Treatment which states in part “using a non-contact, radiant heat dressing) that is placed so that it is in thermal contact with the user’s body for a period of time before surgery (pg. 2, section Treatment which states in part “a minimum of 30 minutes preoperative warming”), the heat source applies heat to a region of the user’s body to achieve localized hyperthermia, wherein the region corresponds to the location on the user where a surgical intervention is planned (pg. 2, section Treatment which states in part ““Patients assigned to the local warming group also received the standard care and a minimum of 30 minutes preoperative warming to just the planned wound area…”). However, Melling is silent with respect to the specifics of the wearable heating layer.
Marquette teaches an analogous heating device (title and [0002]) to that of Melling and comprising a wearable layer (22, 28A-D, 30A-B) conformable to a part of the user’s body, a heat source (24) attached to the wearable layer for applying heat to a region of the user’s body, a blood flow sensor (44 and [0068] which states in part “sensors that may be used include a heat flux sensor, a temperature sensor, a blood flow sensor (e.g., a perfusion sensor), or a combination thereof.”) attached to the wearable layer (see for example Fig. 21) to detect a parameter indicative of blood flow in or adjacent to the region of the user’s body and generate a signal indicative thereof (see for example Fig. 21), and one or both of a processor (20) in electrical communication with the blood flow sensor for determining the blood flow in or adjacent to the region of the user’s body based on the signal, or a transmitter for transmitting the signal to a remote device ([0080] which stats in part “sensor circuitry 98 may be used to obtain readings from sensor 44, and communicate them to ECU 20 (e.g. through wireless signal transmissions to communicate with circuit 42).”). 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 heating device of Marquette in the method of Melling as an obvious matter of engineering design choice of a selection of a known heating device to perform the desired function of heating.
However, Marquette does not teach a timed periodic pattern to heat a region of the user’s body to 43oC.
Kohn teaches an analogous device to that of Marquette where the heating is operable in a constant mode as well as a cyclical heating operation in which the heating pad (10) may repeatedly cycle through a selected temperature range over predefined or user defined periods of time where in a cyclic heating mode, the microprocessor (39) in cooperation with an internal clock (39) operates to control both the time and temperature settings of the heating pad (10) based on a pre-programmed pattern ([0022]). Kohn goes on to teach that while any cyclic heating pattern can be used an exemplary cycle pattern may raise the heating pad’s temperature to between 120oC and 125oF over the first thirty minutes of the cycle. After maintaining such temperature for a predetermined period of time, the pad (10) may cycle its temperature back down to between 105oC and 110oF and remain at that level for a period of approximately thirty minutes. The pad (10) can continue to cycle between the higher and lower temperature ranges for any period of time ([0022]). 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 timed periodic pattern as taught by Kohn to allow for an increase in blood flow while avoiding unnecessary risk of burns as taught by Kohn ([0004-0005]).
While Kohn does not specifically teach a temperature of 43oC, it is asserted that it would have been obvious to one having ordinary skill in the art to reach a temperature of 43oC, since it has been held that discovering the optimum value of a results effective variable involves only routine skill in the art. This is especially true as Kohn teaches the clinical studies have shown that in order to achieve full vasodilation a heat treatment of at least 102oF (39oC) must be achieved in order to obtain the benefits from heat therapy ([0004]).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 KAITLYN E SMITH whose telephone number is (571)270-5845. The examiner can normally be reached Monday-Friday 9am-5pm.
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/KAITLYN E SMITH/Primary Examiner, Art Unit 3794
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