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.
Notice of Amendment
In response to the amendment(s) filed on 10/23/25, amended claim(s) 4 is/are acknowledged. The following new and/or reiterated ground(s) of rejection is/are set forth:
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.
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) 1-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent Application Publication No. 2015/0250418 to Ashby (the cited portions of Ashby relied upon below finding support in U.S. provisional patent application no. 61/950,598, filed 3/10/14) in view of U.S. Patent No. 6,862,550 to Cook and U.S. Patent Application Publication No. 2004/0242976 to Abreu.
For claim 1, Ashby discloses a method of providing a health-related indication of a human (Abstract) (para [0046]) comprising the steps of:
placing an earring through an artificially created tissue cavity in a tissue of an ear of the human (i.e., via 20/28, as can be seen in Figs. 2A-B) (para [0055]), the earring comprising a temperature measurement probe (30) (Figs. 2a-b) (para [0053]) (also see para [0046] and [0076]) and measures a temperature (para [0046] and [0076]);
taking at least one temperature reading from the human using the temperature measurement probe of the earring (para [0046] and [0076]) (also see para [0094]-[0095]);
transmitting the at least one measured cavity temperature reading from the earring to a processing device (para [0051]) (also see para [0061], [0063], and [0079]) (also see 58 and 60 in Fig. 4);
using the processing device to process the at least one measured cavity temperature reading to determine a representative cavity temperature reading (as can be seen in Fig. 3b) (para [0075]-[0076]), and
using the processing device to compare at least one additional measured cavity temperature reading to the representative cavity temperature to identify a change in at least one measured cavity temperature (as can be seen in Fig. 3b) (para [0075]-[0076]).
Ashby does not expressly disclose that the temperature measurement probe is positioned within the artificially created tissue cavity and measures a cavity temperature within the artificially created tissue cavity.
Ashby does disclose a thermopile (28) (Fig. 2a) (para [0056]), which is a structure capable of measuring temperature, and that the thermopile is positioned within the artificially created tissue cavity (as can be seen in Fig. 2a). Ashby does not expressly disclose measuring a cavity temperature with the thermopile.
However, Cook teaches a temperature measurement probe (20) (Fig. 2) positioned within an artificially created tissue cavity (as can be seen in Fig. 2) (also see col. 10, lines 43-47) and measures a cavity temperature within the artificially created tissue cavity (col. 10, lines 48-52) (also see col. 10, lines 43-47).
It would have been obvious to modify Ashby such that its thermopile, which is already in the art artificially created tissue cavity, to measure a cavity temperature within the artificially created tissue cavity, in view of the teachings of Cook, because such a modification would be the simple substitution of the location of where temperature is being measured in Ashby which would lead to the predictable result of obtaining a measurement correlated with core body temperature of the female human, which is what Ashby wants to do.
Ashby and Cook do not expressly disclose using the processing device to introduce the at least one additional measured cavity temperature reading and the representative cavity temperature reading to an algorithm to predict an outcome related to the health-related indication.
However, Abreu teaches predicting an outcome of a health-related indication based on a measured temperature reading and a representative temperature reading (Fig. 75E) (para [0489]).
It would have been obvious to a skilled artisan to modify Ashby to include using the processing device to introduce the at least one additional measured cavity temperature reading and the representative cavity temperature reading to an algorithm to predict an outcome related to the health-related indication, in view of the teachings of Abreu, for the obvious advantage of having a device that can perform a suite of diagnostic modalities that also include ovulation detection (in addition to the modalities that Ashby already teaches) based on the temperature signature of the temperature readings (see para [0489] of Abreu), making Ashby’s device more commercially viable due to its increased functionality through this modification.
For claim 2, Ashby further discloses wherein the step of placing an earring through an artificially created tissue cavity in a tissue of an ear of the human further comprises placing a removable earring backing (22) on a distal end of the earring to secure the earring against unintended removal from the artificially created tissue cavity (as can be seen in Fig. 2) (para [0055]).
For claim 3, Ashby and Cook do not expressly disclose wherein the step of taking at least one measured cavity temperature reading form the human comprises taking said reading during rest or sleep using the temperature measurement probe of the earring.
However, Abreu teaches taking at least one temperature reading during rest or sleep (para [0111], [0314], and [0323]).
It would have been obvious to a skilled artisan to modify Ashby wherein the step of taking at least one measured cavity temperature reading form the human comprises taking said reading during rest or sleep using the temperature measurement probe of the earring, in view of the teachings of Abreu, for the obvious advantage of having a device that can perform a suite of diagnostic modalities that also include fever detection (see para [0314 and [0323] in Abreu).
For claim 4, Ashby, as modified, further discloses wherein the step of taking at least one measured cavity temperature reading form the human during rest or sleep using the temperature measurement probe of the earring comprises taking measured cavity temperature readings from the human at least once per fifteen minutes (para [0082]).
For claim 5, Ashby, as modified, further discloses wherein the step of taking at least one measured cavity temperature reading from the human during rest of sleep using the temperature measurement probe of the earring comprises taking measured cavity temperature readings from the human at least once per thirty minutes (para [0082]).
For claim 6, Ashby, as modified, further discloses placing a second earring through a second artificially-created tissue cavity in a second ear tissue of the human, the second earring comprising a second temperature measurement probe which is positioned within the second artificially-created tissue cavity and measures a second cavity temperature within the second artificially-created tissue cavity (para [0099]).
For claim 7, Ashby, as modified, further discloses wherein the outcome relates to fertility (see para [0489] of Abreu).
Response to Arguments
Applicant’s arguments filed 10/23/25 have been fully considered.
With respect to the 112 rejections, Applicant’s amendment and arguments are persuasive and thus the rejections are withdrawn.
With respect to the 103 rejections, Applicant’s arguments will be treated in the order they were presented. With respect to the first argument, Ashby is not relied upon for teaching “using the processing device to introduce the at least one additional measured cavity temperature reading and the representative cavity temperature reading to an algorithm to predict an outcome related to the health-related indication,” as recited in 1, Abreu is. With respect to the second argument, Cook is not relied upon for teaching “using the processing device to introduce the at least one additional measured cavity temperature reading and the representative cavity temperature reading to an algorithm to predict an outcome related to the health-related indication,” as recited in 1, Abreu is. With respect to the third argument, it is not teaching away because the skilled artisan is not modifying the data gathering of Ashby with the data gathering of Abreu. Instead, Ashby’s data processing is being modified by Abreu’s data processing. That is, the manner in which the data is gathered does not limit the way in which it was processed. Abreu may think that there are better ways to gather data, but that doesn’t mean that Ashby’s way to gather data doesn’t work. A reference that “merely expresses a general preference for an alternative invention but does not criticize, discredit, or otherwise discourage investigation into” the claimed invention does not teach away. Galderma Labs., L.P. v. Tolmar, Inc., 737 F.3d 731, 738 (Fed. Cir. 2013). With respect to the fourth argument, the same response can be submitted to this argument as the previous argument. More specifically, although it may be preferable to use the specialized geometry of the brain tunnel in Abreu, that preference does not prevent a skilled artisan from incorporating the data processing of Abreu with the data gathering of Ashby. With respect to the fifth argument, the same response can be submitted to this argument as the previous argument. More specifically, although it may be preferable to use the specialized geometry of the brain tunnel in Abreu, that preference does not prevent a skilled artisan from incorporating the data processing of Abreu with the data gathering of Ashby.
Conclusion
THIS ACTION IS MADE FINAL. 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 extension fee 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 DANIEL LEE CERIONI whose telephone number is (313) 446-4818. The examiner can normally be reached M - F 8:00 AM - 5:00 PM PT.
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/DANIEL L CERIONI/Primary Examiner, Art Unit 3791