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 Objections
Claim 10 is objected to because of the following informalities: At claim 10, line 3 “an adhesive adhering the proximal surface of the skin” should read --an adhesive adapted to adhere to the proximal surface of the skin--. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 10 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claim 10 recites the limitation “the contact interface”. There is insufficient antecedent basis for this limitation in the claims.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 2, 7-9, 12, 13, and 15 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kwon et al. (US 20230358617 A1), hereinafter Kwon.
Regarding claim 1, Kwon teaches a core body temperature sensor comprising: a thermoresistant structure having a proximal surface configured for attachment to skin of an associated patient, and a distal end opposite from the proximal surface; a plurality of temperature sensors arranged to measure temperatures of the thermoresistant structure at a corresponding plurality of different distances from the proximal surface of the thermoresistant structure (Figure 7A, [0063]); a temperature-changing element configured to change a temperature of the distal end of the thermoresistant structure (Figure 7A, [0063]); an electronic processor programmed to: acquire temperature measurements from the plurality of temperature sensors while operating the temperature-changing element to maintain a temperature of the distal end of the thermoresistant structure at a temperature different from an ambient temperature, and extrapolate a core body temperature of the associated patient from the acquired temperature measurements (Figure 6, [0085]).
Regarding claim 2, Kwon teaches a core body temperature sensor, wherein the plurality of temperature sensors include: a proximal temperature sensor arranged to measure a temperature of the thermoresistant structure at the proximal surface; a distal temperature sensor arranged to measure a temperature of the thermoresistant structure at the distal end; and at least one intermediate-position temperature sensor arranged to measure a temperature of the thermoresistant structure at a location between the proximal surface and the distal end (Figure 7A, [0063]).
Regarding claim 7, Kwon teaches the temperature-changing element comprises one or more heating elements configured to heat a cover (Figure 7A element 620, [0039]). The heating element of Kwon is capable of heating a cover, as it is meant to radiate heat in the apparatus, and it is on the distal end of the structure where the cover would be. The heating element would raise the temperature of the cover due to their proximity to one another.
Regarding claim 8, Kwon teaches the electronic processor is programmed to perform linear extrapolation to extrapolate the core body temperature of the associated patient from the acquired temperature measurements ([0055] and [0056], equation 1).
Regarding claim 9, Kwon teaches the electronic processor is further programmed to calibrate the core body temperature sensor by performing a calibration method comprising: controlling the temperature-changing element to acquire temperature measurements from the plurality of temperature sensors for a plurality of different temperatures of the distal end of the thermoresistant structure; and determining a correction factor that corrects for a temperature drop across an interface between the proximal surface of the thermoresistant structure and the skin of the associated patient ([0048]-[0050], [0055], [0056]).
Regarding claim 12, Kwon teaches a wristwatch, comprising: a watch having a front face with a display and a back face; and a core body temperature sensor as set forth in claim 1 disposed at the back face with the proximal surface of the core body temperature sensor arranged to contact skin of the associated patient when the associated patient wears the wristwatch ([0014], [0085], figure 10).
Regarding claim 13, Kwon teaches a core body temperature measurement method, comprising: disposing a proximal surface of a thermoresistant structure in thermal contact with skin of a patient; measuring temperatures of the thermoresistant structure at a plurality of different distances from the proximal surface of the thermoresistant structure; during the measuring of the temperatures, maintaining a temperature of a distal end of the thermoresistant structure at a temperature different from an ambient temperature using a heating or cooling element; and using an electronic processor, extrapolating a core body temperature of the patient from the measured temperatures (Figure 9, [0014]-[0019]).
Regarding claim 15, Kwon teaches the core body temperature measurement method of claim 13, further comprising: determining a correction factor for a temperature drop over an interface between the proximal surface of the thermoresistant structure and the skin of the patient based on temperatures of the thermoresistant structure measured at the plurality of different distances from the proximal surface of the thermoresistant structure for different temperatures of the distal end of the thermoresistant structure set using the heating or cooling element; wherein the extrapolation of the core body temperature includes applying the correction factor to correct for the temperature drop over the interface between the proximal surface of the thermoresistant structure and the skin of the patient ([0055], [0056], equation 1).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon in view of Blom et al. (US 20220000370 A1), hereinafter Blom.
Regarding claim 3, Kwon discloses all of the elements of the claim as discussed above except the thermoresistant structure comprising a plurality of thermoresistant layers bonded together and the temperature sensors of the plurality of temperature sensors being disposed at bonding interfaces between neighboring thermoresistant layers. Blom teaches a temperature sensor wherein there are layers of a thermoresistant material, with the temperature sensors being disposed at the bonding interfaces between neighboring layers (Figure 3, [0097]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the temperature measuring apparatus of Kwon with the thermoresistant layers of Blom in order to reduce the effect of environmental temperature changes on the temperature sensors.
Regarding claim 4, Kwon discloses all of the elements of the claim as discussed above except the thermoresistant structure comprising foam. Blom teaches a temperature sensor wherein the sensor has thermoresistant foam layers ([0097]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide the temperature measuring apparatus of Kwon with the foam layers of Blom in order to slow the response of the temperature sensors when there are changes in environmental temperature.
Claims 5-6 are rejected under 35 U.S.C. 103 as being unpatentable over Kwon in view of Ishida et al. (US 11744469 B2), hereinafter Ishida.
Regarding claim 5, Kwon discloses all of the elements of the claim as discussed above except the core body temperature sensor, wherein: the temperature-changing element comprises one or more cooling elements configured to cool the distal end of the thermoresistant structure; and the electronic processor is programmed to acquire the temperature measurements from the plurality of temperature sensors while operating the one or more cooling elements to maintain the distal end of the thermoresistant structure at a temperature below the ambient temperature. Ishida teaches a temperature sensor which has a cooling means configured to cool the distal end of the thermoresistant structure and a control unit which acquires temperature measurements and controls the cooling element (Figure 1, column 6 lines 49-62). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to substitute a cooling means like that of Ishida for a heating means like that of Kwon. The result of the substitution would have been predictable to one with ordinary skill in the art, because the heating and cooling means serve the same purpose, which is creating a temperature gradient to enable measurement of a temperature diffusion coefficient and reduce error in the measurement of the core body temperature.
Regarding claim 6, Kwon, as modified with Ishida above, discloses all of the elements of the claim as discussed above except that the one or more cooling elements comprise Peltier elements. Ishida teaches a temperature sensor which uses a Peltier element as a cooling means (Column 10 lines 10-11, column 10 lines 22-26). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to add a Peltier element like that of Ishida to a device like that of Kwon to allow for cooling of the device, which would enable a more accurate temperature measurement.
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Kwon in view of Telfort et al. (US 20230087671 A1), hereinafter Telfort.
Regarding claim 10, Kwon discloses all of the elements of the claim as discussed above except the contact interface between the proximal surface of the thermoresistant structure and the skin of the associated patient comprises an adhesive adhering the proximal surface to the skin. Telfort teaches a temperature measuring device which is secured to a subject’s skin with an adhesive material ([0069], [0094]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide an adhesive like that of Telfort to a device like that of Kwon to comfortably secure the sensor to the subject’s skin.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Kwon in view of Telfort.
Regarding claim 11, Kwon discloses all of the elements of the claim as discussed above except a cover disposed over the distal end of the thermoresistant structure. Telfort teaches a temperature measuring device which has a cover which encloses the electronic components of the device ([0101]). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to provide a cover like that of Telfort to a device like that of Kwon to protect the electronic components of the temperature sensor.
Claims 14 is rejected under 35 U.S.C. 103 as being unpatentable over Kwon in view of Padiy et al. (WO 2008078271) hereinafter Padiy.
Regarding claim 14, Kwon discloses all of the elements of the claim as discussed above except maintaining the temperature of the distal end at a temperature different from the ambient temperature comprises: during the measuring of the temperatures, maintaining the temperature of the distal end of the thermoresistant structure at a temperature which is below the ambient temperature using a cooling element. Padiy teaches a temperature sensor which cools the distal end of the sensor below room temperature (Figure 1C, Page 7, lines 11-15, “changing the heat flux without substantially using energy, but simply influencing the way in which it is given off to ambient, or taken up from it”). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to combine a cooling method like that of Padiy with a method like that of Kwon to measure the temperature more accurately due to a larger temperature gradient.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EMILY R UCHITEL whose telephone number is (571)305-5153. The examiner can normally be reached Mon-Fri from 8:30am – 5:00pm.
Examiner interviews are available via a variety of formats. See MPEP § 713.01. 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, Charles Marmor, can be reached at telephone number (571) 272-4730. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of an application may be obtained from Patent Center. Status information for published applications may be obtained from Patent Center. Status information for unpublished applications is available through Patent Center to authorized users only. Should you have questions about access to the USPTO patent electronic filing system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791
/EMILY R UCHITEL/Examiner, Art Unit 3791
Prosecution Insights