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 § 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.
Claim(s) 10-26 is/are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 2006/0122672) in view of Betkowski (US 2019/0029877).
With regard to claim 10, 13, 19, Anderson discloses a patient warming device including a breastplate intended to be placed over the body of an injured patient (e.g. seen generally in Fig. 2A, convective apparatus 15), the breastplate comprising a neckline and a lower part respectively hugging the necline for the neck and thorax and the abdomen for the lower part of the breastplate (e.g. Fig. 2A shows the warming device fashioned into a typical garment which includes a neckline portion, the garment lays on the patient and also covers the thorax and abdomen regions of the patient), one or more heating elements arranged and positioned within the breastplate to heat the thorax, abdomen and neck of the injured patient after appropriate application the heating breastplate to the body of the injured patient (e.g. sections 32/42 represent heating regions where convective fluid paths are defined to heat the patient; see also paragraph 32 which describes the convective regions), the neckline and lower part of the breastplate are arranged, by their respective shapes and dimensions, to be positioned and adjusted on the body of the injured patient, from the front face of the body and without mobilizing the injured patient (e.g. due to the open gown shape of the warming device, Examiner considers the prior art device to be capable of being placed on the patient without mobilizing the patient).
Anderson fails to teach a lower third of the heating breastplate comprises one or more pockets configured to receive the one or more batteries so as to make it easier to deploy and hold the breastplate on the injured patient’s body by gravity.
In a similar field of endeavor, Betkowski discloses a heating garment with dedicated pockets for holding a control module and battery pack for the heater. See for example Fig. 5 which shows pockets 117 and 119 for receiving a heater pad and respective power pack and battery (e.g. see paragraph 34). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson with including pockets for receiving a battery/batteries since such a modification would provide the predictable results providing efficiency of deployment of the device with a semi-self-contained arrangement that is ready to be deployed. It is of note, Examiner considers the modification including pockets for batteries to necessarily hold the heating breastplate on the injured patient’s body by gravity since the pockets would hold batteries and the added weight of the batteries necessarily provides weight.
Additionally or alternatively, It would also be obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson with using an electrical heating element as taught by Betkowski, instead of the convective air heater of Anderson, since such modification would provide an known alternate heating mechanism for providing reliable patient warming/heating.
With regard to claim 11 and 21, Anderson fails to explicitly teach a controller connected to the one or more batteries and the heating element to regulate a temperature of the body of the injured patient, the controller is programmed to regulate the temperature to provide a target temperature and provide a uniform and constant temperature of the body of the injured patient. Betkowski teaches that it is known to use a controller configured to regulate a temperature of the body of the injured patient, the controller is programmed to regulate the temperature to provide a target temperature and provide a uniform and constant temperature of the body of the injured patient as set forth in paragraph 13 for providing efficient and safe treatment. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson with a controller configured to regulate a temperature of the body of the injured patient, the controller is programmed to regulate the temperature to provide a target temperature and provide a uniform and constant temperature of the body of the injured patient since such a modification would provide the predictable results of providing efficient and safe treatment.
With regard to claim 12 and 23, Anderson fails to teach the one or more batteries are configured to connect to a battery charger while remaining positioned within the breastplate. Betkowski teaches that the relied upon batteries can be rechargeable and can connect to a power source without being removed through use of a conventional means like a USBC and led lights for indicating charging status as set forth in paragraph 36. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson in view of Betkowski with the one or more batteries are configured to connect to a battery charger while remaining positioned within the breastplate since such a modification would provide the predictable results of ease of use to ensure the system is properly powered and ready to be used at all times.
With regard to claim 14, Anderson in view of Betkowski as applied above disclose the invention as claimed but fails to teach the heating element comprises at least one flexible heating resistor formed of electrical conductors powered by batteries, the at least one flexible heating resistor configured to transform electrical energy into thermal energy. Betkowski teaches that it is known to use a resistive heater connected to batteries to provide thermal energy as a heating element in a patient warming system as set forth in paragraph 32. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Anderson with the heating element comprises at least one flexible heating resistor formed of electrical conductors powered by batteries, the at least one flexible heating resistor configured to transform electrical energy into thermal energy since such modification would provide a known alternate heating means for reliably providing thermal therapy to a patient.
With regard to claim 15, Anderson in view of Betkowski disclose the invention as claimed but fails to teach a multilayer textile including a first and second layer of polyamide coated with a polyurethane polymer and enclosing a heating layer, the first outer layer corresponding to a front face of the heating breastplate being in contact with an external environment and the second outer layer corresponding to a rear face of the heating breastplate being in contact with the body of the injured patient. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson in view of Betkowski with a multilayer textile including a first and second layer of polyamide coated with a polyurethane polymer and enclosing a heating layer, the first outer layer corresponding to a front face of the heating breastplate being in contact with an external environment and the second outer layer corresponding to a rear face of the heating breastplate being in contact with the body of the injured patient since multilayer constructions are well known and since it has been held that where the general conditions of a claim are disclosed by the prior at, it is within the level of ordinary skill in the art to select a known material on the basis of its suitability for its intended use (see In re Leshin, 277 F.2d 197; MPEP 2144.07).
With regard to claim 16-17, Anderson in view of Betkowski disclose the invention as claimed but fail to teach the heating layer comprises a printed circuit comprising a polyester substrate covered with a flexible conductive layer of aluminum, the at least one heating resister being etched on the aluminum layer and the printed circuit being covered in a protective layer of polyester. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson in view of Betkowski with the heating layer comprises a printed circuit comprising a polyester substrate covered with a flexible conductive layer of aluminum, the at least one heating resister being etched on the aluminum layer and the printed circuit being covered in a protective layer of polyester since use of etched conductive traces in printed circuit boards are well known in the medical circuit arts and would provide for a known means of providing for a known thermos electric output.
With regard to claim 18, the combination of Anderson in view of Betkowski disclose the invention as claimed but fails to teach the multilayer textile comprises a thermal insulation layer between the first outer layer and the heating layer, the thermal insulation layer comprising a laminate of cellulose and aluminum. It would have been obvious to modify the multilayer textile of Anderson in view of Betkowski with a thermal insulation layer between the first outer layer and the heating layer, the thermal insulation layer comprising a laminate of cellulose and aluminum since it has been held that where the general conditions of a claim are disclosed by the prior at, it is within the level of ordinary skill in the art to select a known material on the basis of its suitability for its intended use (see In re Leshin, 277 F.2d 197; MPEP 2144.07).
With regard to claim 20, Anderson in view of Betkowski disclose the invention as claimed but fail to teach the heating breastplate comprises a storage pockets having a closure system, a storage bag of the heating breastplate and one or more power cables for batteries, the storage pocket being positioned on a lower part of the heating breastplate and configured to contain the storage bag and the power cables. Betkowski teaches that it is known to incorporate pockets into a patient heating garment as set forth in Fig. 5 which shows pockets 117 and 119 for receiving a heater pad and respective power pack and battery (e.g. see paragraph 34). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Anderson with the heating breastplate comprises a storage pockets having a closure system, a storage bag of the heating breastplate and one or more power cables for batteries, the storage pocket being positioned on a lower part of the heating breastplate and configured to contain the storage bag and the power cables since such a modification would provide the predictable results of providing for a self-contained system that is deployable without the need of additional components. Examiner notes that the proposed combination of Anderson in view of Betkowski would incorporate pockets into Anderson. The claim limitation at hand is largely functionally recited and it is Examiner’s position that the use of the pocket(s) from Betkowski would be capable of performing the function of storing cables, batteries, and/or miscellaneous items.
With regard to claim 22 and 24, Anderson in view of Betkowski disclose the invention as claimed but fails to teach determining a first temperature value of the one or more heating elements based on a resistance of the one or more heating elements, compare the first temperature value of the one or more heating elements to a temperature threshold, and regulate the temperature of the one or more heating elements to the target temperature by increasing or decreasing the temperature of the one or more heating elements base on comparing the first temperature value of the one or more heating elements to the temperature threshold and the temperature threshold can be set by a user of the heating breastplate. Betkowski discloses determining a first temperature value based on resistance (e.g. paragraph 31, thermistor measures the temperature in the heater pad), compare the first temperature value to a temperature threshold and regulate the temperature of the one or more heating elements to a target temperature by increasing or decreasing the temperature of the on or more heating elements based on comparing the first temperature value of the one or more heating elements to the temperature threshold and the temperature threshold can be set by a user of the heating breastplate (e.g. paragraph 32 talks about logic chip adjusting resistance into the heater pad to achieve a selected temperature value). It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson in view of Betkowski with determining a first temperature value of the one or more heating elements based on a resistance of the one or more heating elements, compare the first temperature value of the one or more heating elements to a temperature threshold, and regulate the temperature of the one or more heating elements to the target temperature by increasing or decreasing the temperature of the one or more heating elements based on comparing the first temperature value of the one or more heating elements to the temperature threshold and the temperature threshold can be set by a user of the heating breastplate since such a modification would provide the predictable results of ensuring the heating system is outputting thermal energy at the appropriate temperature for treatment and also avoiding any potential additional patient injury.
With regard to claim 25, Anderson in view of Betkowski disclose the invention as claimed but fail to teach the controller comprises a minimum temperature threshold and regulating the temperature of the one or more heating elements to maintain a temperature of the one or more batteries above the minimum temperature threshold. Betkowski clearly discloses the use of a logic circuit to regulate the temperature of the heating pad device as discussed above with respect to claim 22, but fails to teach using a minimum threshold per se. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system of Anderson in view of Betkowski with a controller configured to use a minimum temperature threshold since such a modification would provide a similar result as Betkowski’s logic circuit for providing a feedback loop to ensure the patient is being warmed to the appropriate temperature levels. Additionally, Examiner considers the claims to only require the use of a minimum temperature threshold, and the limitations directed to maintaining a temperature of the one or more batteries is strictly functional, and it is examiner’s position that the use of a minimum temperature threshold whether it be for maintaining the patient at a temperature or for batteries would still arrive at the batteries being maintained above a temperature. This is also supported by the combination of Anderson in view of Betkowski since the combination would be incorporating Betkowski’s pockets which house the heating pad and batteries together.
With regard to claim 26, Anderson in view of Betkowski disclose the invention as claimed including a rechargeable battery and charging system as discussed above with respect to claim 12. However Anderson in view of Betkowski as applied fail to teach a display for the level of charge of the one or more batteries. Betkowski discloses the rechargeable system to use a display in the form of LED lights for indicating a level of charge which would inherently also indicate a duration of use associated with a battery (e.g. a fully charged battery will have a known duration) as set forth in paragraphs 36-37. It would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the system as taught by Anderson with a display for the level of charge of the one or more batteries since such a modification would provide the predictable results of ensuring the system will be able to provide sufficient therapy to the patient as a function of the duration of time it would be applied.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH A STOKLOSA whose telephone number is (571)272-1213. The examiner can normally be reached M-F 930AM-530PM.
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/JOSEPH A STOKLOSA/Supervisory Patent Examiner, Art Unit 3794