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 .
Response to Amendment
The amendment filed January 13, 2026 has been entered. Claims 1-20 are pending.
Applicant’s amendments necessitate new grounds of rejection under 35 U.S.C. 101 and 103, as well as new claim objections.
Claim Objections
Claims 1 and 11 are objected to because of the following informalities:
Both claims 1 and 11 recite “wherein temperature sensor stabilizes,” which should read instead as “wherein the temperature sensor stabilizes.”
Appropriate correction is required.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Section 33(a) of the America Invents Act reads as follows:
Notwithstanding any other provision of law, no patent may issue on a claim directed to or encompassing a human organism.
Claim 1 and dependent claims thereof are rejected under 35 U.S.C. 101 and section 33(a) of the America Invents Act as being directed to or encompassing a human organism. See also Animals - Patentability, 1077 Off. Gaz. Pat. Office 24 (April 21, 1987) (indicating that human organisms are excluded from the scope of patentable subject matter under 35 U.S.C. 101).
Re. Claim 1: Claim 1 recites a temperature monitoring system which recites a portion of the system “a tube having a first end… is inserted into an internal organ,” which positively requires a living organism (e.g., a human) whose internal organ receives a first end of the tube.
Examiner recommends amending the claim to read instead as “wherein the first end is configured to be inserted into an internal organ.”
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.
Claims 1, 3, 4, 8-11, 13, 14, and 18-20 are rejected under 35 U.S.C. 103 as being unpatentable over:
Yildizyan et al. (US 20120150482 A1) (hereinafter – Yildizyan) in view of
Yu (US 20070248144 A1) (hereinafter – Yu) in further view of
McCarley et al. (US 5794625 A) (hereinafter – McCarley).
Re. Claim 1: Yildizyan teaches an internal organ temperature monitoring system (Applicant states in Paragraph 0062: “For example, the internal organ may be a rectum, an oral cavity, or an artery;” Paragraph 0063: “The measurement mode may also depend on usage of the electronic thermometer 100, e.g., oral, rectal, and underarm temperature measurements”), comprising:
a sensor system (Fig. 1: 100) comprising:
a tube having a first end and a second end (Fig. 1: note elongate probe section 110 and components under metal cap section 116 – portions thereof may be considered “ends” of a tube),
wherein the first end is inserted into an internal organ (as best understood, the claim appears to require a thermometer which is insertable into an internal organ of the patient; Applicant’s Paragraph 0079 describes that an internal organ may be a rectum; Paragraph 0063 and 0120 both describe that the probe may be a rectal thermometer);
a temperature sensor in the tube and located at the first end of the tube (Fig. 1: temperature sensing element 102, as described in Paragraph 0017: “The temperature sensing element is mounted at the end of the probe section and is covered with a conductive cap”),
wherein temperature sensor stabilizes to a temperature of the internal organ within a predetermined stabilization interval (this necessarily occurs due to heat transfer; no material is perfectly thermally insulated);
an electrical connector located at the second end of the tube, coupling the sensor to a controller component (Paragraph 0060: “A temperature sensing element 102 is connected to a powered processor 104 and/or a display 106;” Examiner notes that the term “connected” in the citation implies the existence of at least one electrical connector between the temperature sensing element 102 located the first end of the probe section 110 and the processor 104 and/or display 106 located at the opposite end of the tube); and
the controller component configured to retrieve the temperature data from the temperature sensor (Paragraph 0062: “The processor 104 can receive signals from temperature sensing element 102 related to the temperature of the living being, i.e., the patient”).
Yildizyan does not teach the invention comprising a thermal conductive material occupying space between the temperature sensor and the tube.
Yu teaches analogous art in the technology of thermometers (Abstract). Yu further teaches the invention comprising a thermal conductive material occupying space between the temperature sensor and the tube (Fig. 1-6: thermally conductive adhesive material 10 occupying space between thermal sensor 5 and tube formed by tip member 30 and/or probe body 1).
Yildizyan is silent regarding the particulars of the construction of the temperature probe. Yu teaches a temperature probe possessing a thermally conductive material performing an identical function. Since each individual element and its function are shown in the prior art, albeit shown in separate references, the difference between the claimed subject matter and the prior art rests not on any individual element or function but in the very combination itself. That is in the substitution of the thermometer construction of Yu for the undisclosed thermometer structure of Craig. Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Additionally or alternatively, it would have been obvious to have modified Yildizyan to include the structure and thermally conductive adhesive at the tip of the thermometer as taught by Yu, the motivation being that doing so forms a thermometer which is more durable since it is more difficult to separate the metal tip member containing a temperature sensing element from the probe body (Paragraph 0025).
Yildizyan as modified by Yu does not teach the invention further comprising a timer configured to initiate reading of temperature data after the predetermined stabilization interval.
McCarley teaches analogous art in the technology of temperature monitoring (Abstract). McCarley further teaches the invention comprising a timer configured to initiate reading of temperature data after the predetermined stabilization interval (Col. 3, lines 29-34: “After the timer circuit has activated the microcontroller, the microcontroller causes power to be applied to the temperature sensor described above. After a delay for the temperature measurement to stabilize, the analog-to-digital converter converts the analog output of the temperature sensor to digital data, which is stored in RAM”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Yildizyan as modified by Yu to include a timer circuit to include a delay to allow temperature to stabilize prior to reading by the microcontroller, the motivation being that doing so the temperature sampling described in Yildizyan (Yildizyan, Paragraph 0093) since the device of McCarley merely utilizes a timer as opposed to continuously monitoring temperature changes by the microcontroller.
Re. Claim 3: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 1.
Yu, in teaching further detail regarding the incorporated subject matter, further teaches the invention wherein the thermal conductive material is curable (Paragraph 0023: “a cured thermally conductive adhesive material passing through metal tip member 3…”)
and formulated to minimize gaps between the temperature sensor and the tube (Figs. 1-6: adhesive 10 appears to fill all gaps; Paragraph 0023: “… filling metal tip member 3, narrower space 12 and wider space 14 with thermally conductive adhesive material 10 and then completely curing. Typically, thermally conductive adhesive material is an insulating material with good thermal conductivity, e.g., epoxy resin;” Examiner notes that epoxy resin flows prior to curing and enables gaps to be filled).
Yildizyan further teaches the invention wherein the controller component further includes visual and acoustic indicators that show respective alerts or alarms with respect to the retrieved temperature data (Paragraphs 0024, 0026, 0028-0029: use of lights to convey temperature severity; Paragraph 0084: “In one embodiment, the output indicator 151a may include an audible feedback… when displaying final temperature reading corresponding to a desired measurement mode. The audible feedback may include any type of sound such as beeps, songs, and word(s) in a desired language… Characteristics perceived as more alarming can be used for more severe measured conditions;” Paragraph 0066: “The display 106 can include a transparent or "see-through" liquid crystal display (LCD) 120 for displaying the actual temperature”).
Re. Claim 4: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 3. Yildizyan further teaches the invention wherein the controller component is further configured to store the retrieved temperature data and show the respective alerts or alarms in an instance in which the retrieved temperature data falls out of a normal temperature range (Paragraph 0062: “The processor 104 can also include a memory 118 for storing ranges of temperatures and an adjustment for the display 106. Processor 104 can compare the currently read temperature to the stored temperatures and adjustment values to determine what color to illuminate the display 106”).
Re. Claim 8: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 1. Yildizyan further teaches the invention wherein the sensor system further comprises an insulating seal to insulate the electrical connector and the tube from an ambient environment outside an internal organ, wherein the insulating seal is located at the second end of the tube (Paragraph 0060: “The components are housed in a case 108 having a probe section 110 and a body section 112:” Fig. 1: the connection portions are internal to the probe section 110, thus, the exterior of the probe section and/or case 108 can be considered an “insulating seal” as claimed).
Re. Claim 9: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 1. Yildizyan further teaches the invention wherein the sensor system is configured to be inserted into an internal organ to measure a temperature of the internal organ (Applicant states in Paragraph 0062: “For example, the internal organ may be a rectum, an oral cavity, or an artery;” Paragraph 0063: “The measurement mode may also depend on usage of the electronic thermometer 100, e.g., oral, rectal, and underarm temperature measurements”).
Re. Claim 10: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 1. Yildizyan further teaches the invention wherein the sensor system is replaceable (Examiner notes that without further limitation defining the term “replaceable,” the broadest meaning of “replaceable” includes the definition “to put something new in the place of,” as provided by Merriam-Webster (https://www.merriam-webster.com/dictionary/replace); the entirety of the device of Yildizyan can be replaced with another, thus replacing the sensor system (albeit, also including replacing the controller component)).
Re. Claim 11: Claim 11 recites limitations found in claims 1 and 4. See rejection of claim 4.
Re. Claim 13: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 11. Yildizyan further teaches the invention further comprising:
receiving initialization conditions, by the controller component, before retrieving the temperature data reading from the sensor system, wherein the initialization conditions include
a retrieving rate (Paragraphs 0089, 0093, 0094, 0096, 0107: discussion of various sampling routines; Figs. 2, 4: it is understood that these routines begin after the device is turned on; Paragraph 0079, claims 6, 51, 60, 75: an external/remote device (also considered a controller component) may be used to select which mode of the device to use, including routines) and
the normal temperature range (Paragraph 0027: “In use, in an embodiment the user presses the power/initialization button and waits for the first light emitting element to light indicating that thermometer is ready to read a temperature. The user selects a measurement mode, thereby setting the limits of the temperature ranges…In another embodiment, the measurement mode may be selected first, and then the user presses the power/initialization button”).
Re. Claim 14: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 13.
Yu, in teaching further detail regarding the incorporated subject matter, further teaches the invention wherein the thermal conductive material is curable (Paragraph 0023: “a cured thermally conductive adhesive material passing through metal tip member 3…”)
and formulated to minimize gaps between the temperature sensor and the tube (Figs. 1-6: adhesive 10 appears to fill all gaps; Paragraph 0023: “… filling metal tip member 3, narrower space 12 and wider space 14 with thermally conductive adhesive material 10 and then completely curing. Typically, thermally conductive adhesive material is an insulating material with good thermal conductivity, e.g., epoxy resin;” Examiner notes that epoxy resin flows prior to curing and enables gaps to be filled).
Yildizyan further teaches the invention wherein the controller component is further configured to store the retrieved temperature data (Paragraph 0062: “The processor 104 can also include a memory 118 for storing ranges of temperatures and an adjustment for the display 106. Processor 104 can compare the currently read temperature to the stored temperatures and adjustment values to determine what color to illuminate the display 106”).
Re. Claim 18: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 11. Claim 18 repeats limitations mutatis mutandis those of claim 8. See citations of claim 8.
Re. Claim 19: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 11. Yildizyan further teaches the invention Claim 19 repeats limitations mutatis mutandis those of claim 9. See citations of claim 9.
Re. Claim 20: Yildizyan as modified by Yu and McCarley teaches the invention according to claim 11. Yildizyan further teaches the invention Claim 20 repeats limitations mutatis mutandis those of claim 10. See citations of claim 10.
Claims 2 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over:
Yildizyan et al. (US 20120150482 A1) (hereinafter – Yildizyan) in view of
Yu (US 20070248144 A1) (hereinafter – Yu) in further view of
McCarley et al. (US 5794625 A) (hereinafter – McCarley) in further view of
Tsai et al. (US 20130131541 A1) (hereinafter – Tsai).
Re. Claims 2 and 12: Yildizyan as modified by Yu and McCarley teaches the invention according to claims 1 and 11. Yildizyan further teaches the invention wherein the controller component is further configured to:
dynamically monitor the temperature data in real time by continuously retrieving temperature readings from the temperature sensor (Examiner notes that Yildizyan, after modification to include an initial delay by McCarley, continues to monitor temperature after initiating a temperature read cycle, see Figs. 2, 4).
Yildizyan teaches a transmitter configured to send a status signal from the thermometer to an external or remote device (Paragraph 0079; Claim 75); however, it is unclear if such a status signal contains retrieved temperature data.
Tsai teaches analogous art in the technology of thermometer systems (Abstract). Tsai further teaches the invention wherein the controller component is further configured to transmit data load packages to a remote computing server, a real-time health monitoring system (RTHMS), hospital workflows, or mobile devices, the data load packages including the retrieved temperature data (Abstract: “The thermometer takes temperature measurements, encodes the temperature measurements and transmits the encoded temperature measurements to the mobile communication device”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Yildizyan as modified by Yu and McCarley to include transmission of temperature data to a remote device, the motivation being that such remote devices may determine whether temperature measurements are satisfactory or unsatisfactory, as well as provide feedback to a user in real-time, and further provides capability for additionally analysis of transmitted data to provide an ovulation prediction (Abstract).
Claims 5, 6, 15, and 16 are rejected under 35 U.S.C. 103 as being unpatentable over:
Yildizyan et al. (US 20120150482 A1) (hereinafter – Yildizyan) in view of
Yu (US 20070248144 A1) (hereinafter – Yu) in further view of
McCarley et al. (US 5794625 A) (hereinafter – McCarley) in further view of
Ostroff et al. (US 20120089198 A1) (hereinafter – Ostroff).
Re. Claims 5, 6, 15, and 16: Yildizyan as modified by Yu and McCarley teaches the invention according to claims 1 and 11, but does not teach the invention wherein the temperature sensor
is an active type sensor with an application specific integrated circuits (ASIC) die, and the active type sensor is powered by the controller component (as required by claims 5 and 15) or
is a passive type sensor, and the passive type sensor is a thermocouple or a thermistor (as required by claims 6 and 16).
Both are known types of sensors for measuring temperature. Ostroff teaches analogous art in the technology of temperature sensing devices (Abstract). Ostroff teaches that a the temperature sensor may be either an active type ASIC in communication with the controller (Fig. 3) or a passive type thermistor (Fig. 2).
Incorporating either of these known sensor elements into the invention of Yildizyan as modified by Yu may be seen as an obvious matter of substitution of known components (types of temperature sensors), whose function remains the same after the substitution (sensing temperature). Thus, the simple substitution of one known element for another producing a predictable result renders the claim obvious.
Claims 7 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over:
Yildizyan et al. (US 20120150482 A1) (hereinafter – Yildizyan) in view of
Yu (US 20070248144 A1) (hereinafter – Yu) in further view of
McCarley et al. (US 5794625 A) (hereinafter – McCarley) in further view of
Hanley et al. (US 20090171238 A1) (hereinafter – Hanley).
Re. Claim 7 and 17: Yildizyan as modified by Yu and McCarley teaches the invention according to claims 1 and 11, but does not teach the invention wherein the tube takes a form of a catheter made of a flexible gel-based material
Hanley teaches analogous art in the technology of rectal thermometers (Abstract). Hanley further teaches the invention wherein the tube takes a form of a catheter made of a flexible gel-based material (Paragraph 0057: particularly “The handle can include a material or covering of material that enhances gripping by the user, and the probe ends 130a, 130b can include a material, or covering of material that provides relatively low coefficient of friction against a patient's anatomy, to facilitate easy insertion. A relatively rigid overall structure can be provided, so that the probe ends 130a, 130b can be effectively inserted and accurately oriented with respect to the patient's anatomy. However, the probe ends 130a, 130b themselves can include a layer of compliant material, such as silicone gel, beneath the outer covering. The probe ends 130a, 130b alternatively can be made essentially in their entirety from a compliant material such as silicone rubber”).
It would have been obvious to one having skill in the art before the effective filing date to have modified Yildizyan as modified by Yu and McCarley to include a compliant material such as a silicone gel to form either an end of a probe (e.g., the probe section 110 of Yildizyan) as taught by Hanley, the motivation being that such a material provides a low coefficient of friction to facilitate easy insertion into a patient’s anatomy (Paragraph 0057).
Response to Arguments
Applicant’s arguments with respect to the claims 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.
Applicant's arguments filed January 13, 2026 have been fully considered but they are not persuasive.
Regarding Applicant’s argument:
“Applicant respectfully submits that Yildizyan does not disclose, teach, or suggest an end of the probe section 110 being inserted into an internal organ.”
In light of Applicant’s amendments, Examiner has provided updated citations in the rejection of claim 1, describing a “tube” as comprising both the probe section 110 and conductive cap 116 covering temperature sensing element 102. Applicant appears to argue that Yildizyan is limited in only having the conductive cap 116 (covering temperature sensing element 102) as the portion of the device 100 which is inserted into a rectum. However, even if the probe 110 is the only portion cited for the claim element of a “tube,” Applicant’s reasoning errs in assuming that no portion of the probe section 110 is configured for insertion into the rectum (notwithstanding lack of clarity regarding the limitation “is inserted into an internal organ”). For instance, use of the probe may require varying depths for either validity of rectal measurement or stability of insertion position, either of which may entail inserting the device 100 of Yildizyan to a point where at least some portion of probe section 110 enters the rectum.
Regarding Applicant’s arguments directed to Yu:
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Additionally, Examiner directs Applicant to read the updated citations to Yu, which, in combination with Yildizyan and McCarley, teaches each and every aspect of the invention as claimed. For instance, it is unclear how Yu does not teach a thermally conductive adhesive material 10 occupying space between a temperature sensor and a tube when Yu teaches each of such elements (Fig. 1-6: thermally conductive adhesive material 10 occupying space between thermal sensor 5 and tube formed by tip member 30 and/or probe body 1). With no further substantive analysis by Applicant, such an argument is merely bare allegation.
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.
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/JUSTIN XU/ Primary Examiner, Art Unit 3791