DETAILED ACTION
This Office action is responsive to the Response to Non-Final Office Action filed December 18, 2025. The Examiner acknowledges the amendments to the Drawings, the amendments to the Specification, and the amendments to claims 1-3. Claims 1-5 are pending.
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 .
Drawings
Replacement drawing sheets were received on December 18, 2025. These drawings are acceptable.
Claim Objections
Claim 3 is objected to because of the following informalities: at line 4, “layer” should read --layers--. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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.
Claims 1 and 3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
U.S. Patent No. US 9,310,257 B2 to Bieberich et al. (hereinafter “Bieberich”).
Regarding claim 1, Bieberich discloses a non-invasive thermometry apparatus
(a deep tissue temperature probe (OTT probe) as described in Column 3, lines 9-10 and 18-22; wherein deep tissue temperature measurement using a probe supported on the skin provides an accurate and non-invasive means for monitoring body core temperature as described in Column 2, lines 24-26) comprising:
a top surface (Figure 3C, major surface A; Examiner notes the support assembly 500 is preferably oriented with respect to a location on a body where a deep tissue temperature reading is to be taken by denominating the heater as the top of the assembly as described in Column 4, lines 27-31; wherein the heater is on major surface A as described in Column 3, lines 66-67);
a bottom surface (Figure 3C, major surface F; Column 4, lines 27-31, the support assembly 500 is preferably oriented with respect to a location on a body where a deep tissue temperature reading is to be taken by denominating ... major surface F as the bottom);
one or more thermally-reactive layers extending across an area of the apparatus captured between the top surface and the bottom surface (Figure 3X depicts surface C comprising a thermocouple junction 508; Examiner notes the disk of copper film inside the ring on the Surface C may be used as one element of a thermocouple, joined at a thermocouple junction 508 to one end of an insulated chrome wire at or near the center of the surface C as described in Column 4, lines 10-15; wherein thermocouples are recognized as thermal sensors as described in Column 6, line 51; Examiner notes surface C as thermally-reactive layer since it comprises a thermocouple junction serving as a thermal sensor); and
a bus in operable connectivity with each of the one or more thermally-reactive layers (Figure 3D depicts pins 1-6 on tab 520 of folded support assembly; Table 1 depicts thermocouple pin assignments; Examiner notes the connectors on the composite tab 520 provide electrical access to each of the thermal sensors and to the heater as described in Column 4, lines 38-40, wherein in the table, the lower thermocouple is on major surface E and the upper thermocouple is on major Surface C as described in Column 4, lines 36-38; Examiner notes lower thermocouple as pins 1 and 2, upper thermopile as pins 3 and 4, surfaces C and E as thermally-reactive layers, and pins 1-6 on composite tab 520 as a bus because they provide electrical access to the thermal sensors on surface C and E).
Regarding Claim 3, Bieberich discloses the apparatus of claim 1 wherein the one or more thermally-reactive layers comprises two or more thermally-reactive layers (Column 4, lines 37-38, the lower thermocouple is on major surface E and the upper thermocouple is on major Surface C; wherein thermocouples are recognized as thermal sensors as described in Column 6, line 51; Examiner notes surfaces C and E as two thermally-reactive layers since they each comprise a thermocouple serving as a thermal sensor) having a separator positioned between each thermally-reactive layer (Column 5, lines 31-44, The layers are, as follows: Major surface A is the electric heater, Major surface B is a plastic film, Major Surface C is a copper layer that supports a thermal sensor, Major surface D is a plastic film, Major Surface E is a copper layer that supports a thermal sensor, Major surface F is a plastic film. The assembled OTT probe may include additional layers added to the structure of the probe during assembly. For example, layers of pressure-sensitive adhesive (PSA) may be disposed between the folded sections and on the top and bottom major surfaces, Examiner notes major surfaces B and D and PSA layers as separators).
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 2 is rejected under 35 U.S.C. 103 as being unpatentable over Bieberich in view of U.S. Patent No. US 10,393,594 B2 to Merrikh et al. (hereinafter, Merrikh).
Regarding Claim 2, Bieberich discloses the apparatus of claim 1. However, Bieberich does not disclose the thermally reactive layer is a grid of thermallyreactive wires.
Merrikh teaches where the thermally-reactive layer is a grid of thermally-reactive wires (Column 9, line 64 - Column 10, line 5, a grid structure of the thermopile mesh sensor (450/460) is composed of a first conductor (Conductor 1) of a first material and a second conductor (Conductor 2) of a second material different from the first material. The thermopile mesh sensor 450 may be composed of a first set of wires (Conductor 1) of a first material extending in a first direction, and a second set of wires (Conductor 2) of a second material, different from the first material, extending in a different direction relative to the first direction).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have substituted the thermocouple junction of major surfaces C and E with the grid of thermally-reactive wires of Merrikh. Doing so would allow for the calculation of a temperature of an active region of the device (Column 2, lines 8-10) and estimation of a thermal map of the device (Column 2, lines 5-8), as recognized by Merrikh and since it would only require the routine skill of simple substitution of one known element for another to obtain predictable results (MPEP 2143 I. B.) in this case substituting the thermocouple junction of major surfaces C and E with the grid of thermally-reactive wires of Merrikh wherein both elements are used to sense/measure temperature.
Claims 4-5 are rejected under 35 U.S.C. 103 as being unpatentable over Bieberich in view of U.S. PG Publication No. US 2011/0245713 A1 to Rensen et al. (hereinafter, Rensen).
Regarding Claims 4 and 5, Bieberich discloses the apparatus of claim 1 and a data connection connected to the bus (Examiner notes a compression connector may be attached to the composite tab as described in Column 4, lines 41-42, wherein the connectors on the composite tab 520 provide electrical access to each of the thermal sensors as described in Column 4, lines 39-41; Examiner notes connectors of composite tab as a bus). However, Bieberich does not disclose the apparatus the data connection being adapted to operably connect the bus to an external processor.
Rensen teaches a data connection adapted to operably connect to an external processor (Paragraph [0033], lines 11-13, the wireless data transmission may occur directly between the probe and the outside analyzing device; Examiner notes transmitting data to an outside device as indicating operative connection to an external device), wherein the data connection is a wireless data connection (Paragraph [0033], lines 4-6, the probe may include means for wirelessly transmitting information about the temperature data measured by one of the piles or each of the plurality of piles of the probe).
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have modified the non-invasive thermometry apparatus of Bieberich to include the teachings of Rensen by connecting to an external processor and including wireless data connection capability. Doing so would allow for thermal gradients to be used to distinguish ablated tissue from nonablated tissue in ablation procedures with tumors, as recognized by Rensen (Paragraph [0002], line 14 - Paragraph [0003], line 6) and would omit the necessity of direct wiring that may act as a thermal bridge, as recognized by Rensen (Paragraph [0033], lines 13-17).
Response to Arguments
Applicant’s arguments, see page 6 of the Remarks, filed December 18, 2025, with respect to the objections to the drawings and the claims have been fully considered and are persuasive. The objections to the drawings and the claims have been withdrawn; however, the claim amendments of December 18, 2025 necessitate a new claim objection to claim 3 as set forth hereinabove.
Applicant's arguments filed December 18, 2025 regarding the claim rejections based on the rejections of claims 1 and 3 under 35 USC 102 as being anticipated by Bieberich have been fully considered but they are not persuasive.
Applicant initially argues Bieberich does not disclose "One or More Thermally-Reactive Layers Extending Across an Area of the Apparatus,” stating that although Bieberich uses the term "layer" to describe individual films or metallic elements, these layers do not extend across an area of the apparatus as claimed. Regarding the argument that the layers of Bieberich do not extend across an area of the apparatus, the examiner notes that the specification and claims of the instant application do not offer any definition or context for the “area” of the apparatus referred to in the claim. Notably, the claims do not define “an area” as extending any significant portion or the entirety of the apparatus. An “area” could describe a space for a specific purpose, a part of an object or surface, the extent or measurement of a surface, or a subject or range of interest. In the remarks provided December 18, 2025, Applicant states that that the thermally-reactive layers that extend across an area, meaning the thermally-reactive structure spans a region of the apparatus. Examiner respectfully submits that the layers of Bieberich can be said to extend across a region of the apparatus, even if the regions are solely at isolated junctions or localized disks, especially since the extent of the region of the apparatus is not defined by the claim.
Applicant next argues that Bieberich’s “Probe Architecture Is Structurally Distinct from the Claimed Apparatus.” In support of this position, applicant contends that Bieberich describes a deep tissue temperature probe constructed from disk-shaped sections that include heaters, insulating films, and discrete thermocouple junctions. These elements are assembled by folding into a stacked probe structure designed to infer deep tissue temperature via heat-flux equilibrium, while the claimed apparatus is architechted around thermal interaction. The examiner respectfully disagrees. In its broadest sense, claim 1 requires a top surface, a bottom surface, one thermally-reactive layer disposed therebetween, and a bus operably connected with the thermally-reactive layer. The claim does not limit the shape or surfaces or layers, the relative orientation of the thermally-reactive layers (i.e., stacked versus in the same plane), or that the thermally-reactive layers are for temperature measurement. Bieberich has all of these structural features as claimed and outlined in the rejection hereinabove.
In response to Applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., the thermometry apparatus of the instant application offers an areal sensing structure and the capture of surface temperature spatial data) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Applicant finally argues that the “Remaining Elements [of Bieberich] Are Not Arranged as in the Claim” because Bieberich lacks the required areal thermally-reactive layer, such the remaining elements of claim 1 are not arranged as claimed. The examiner respectfully disagrees that Bieberich lacks the required areal thermally-reactive layer at least for the reasons set forth above.
In view of the foregoing, the rejections of claims 1 and 3 under 35 USC 102(a)(1) as being anticipated by Bieberich have been maintained.
Applicant's arguments filed December 18, 2025 regarding the claim rejections based on the rejections of claims 2 and 4-5 under 35 USC 103 as being obvious over Bieberich in view of Merrikh and/or Rensen have been fully considered but they are not persuasive. Applicant contends that Bieberich is an Improper Base Reference and that Merrikh and Rensen fail to teach thermally-reactive layers extending across an apparatus area. These arguments are not persuasive as Bieberich teaches thermally-reactive layers across an apparatus area as described above.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
In view of the foregoing, the rejection of claim 2 under 35 USC 103 as being obvious over Bieberich in view of Merrikh and the rejection of claims 4-5 under 35 USC 103 as being obvious over Bieberich in view of Rensen have been maintained.
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 Charles A Marmor, II whose telephone number is (571)272-4730. The examiner can normally be reached Monday-Friday 9AM-5PM.
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/CHARLES A MARMOR II/Supervisory Patent Examiner
Art Unit 3791