DETAILED ACTION
Claim Objections
Claims 2 and 10 are objected to because of the following informalities: “Penne’s” should be --Pennes'--. Appropriate correction is required.
Claim 13 is objected to because of the following informalities: “the heating device configured to” should be --the heating device is configured to--. Appropriate correction is required.
Claim 16 is objected to because of the following informalities: “thermophysical information is known and,” should be --thermophysical information is known, and--. 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.
Claims 1-20 are 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.
Claims 1, 9, and 17 recite deriving inherent thermal conductivity based on the first temperature data, the second temperature data, and “heat transfer due to blood perfusion within the tissue”. Heat transfer is a physical phenomenon occurring in the subject; it is not data, a parameter, or any measured value that the claim requires be obtained and used. Accordingly, it is unclear what act, if any, the claim requires beyond deriving thermal conductivity from the two temperature data sets, because it could be read as a mere statement of the physical environment in which the method/device is being practiced. Applicant is advised to incorporate the measure of heat transfer that is being used to derive the inherent thermal conductivity.
Claims 8 and 16 recite measuring thermal diffusivity of the temperature sensor and deriving heat flow flowing into the tissue from heat flow generated from the heating device based on the thermal diffusivity of the temperature sensor. The specifications state that the thermal diffusivity is configured as in Equation 5, reproduced here:
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54
342
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That is not the equation for what is conventionally known in the art as thermal diffusivity, but for thermal “effusivity”, which is a different measurement. Diffusivity is a measure of how fast heat spreads internally, while effusivity is a measure of boundary contact and how fast a material exchanges heat with its surface.
Meanwhile, it appears that the conventional definition of thermal diffusivity is found within Equation 6:
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294
446
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It is noted that while the applicant may act as their own lexicographer, but a definition that both departs from the ordinary and customary meaning of the term AND contradicts the specification’s own use of that same term does not provide requisite reasonable certainty. See MPEP 2173.05(a); Nautilus, Inc. v. Biosig Instruments, Inc., 572 U.S. 892, 901 (2014).
Claim 9 recites a heating device configured to apply a first heat flow including constant heat flow and as second heat flow including a sinusoidal heating “method” to the tissue. As a heat flow is a physical quantity, it cannot be a method. Moreover, it is also unclear whether this is an attempt to incorporate a method step into an apparatus element.
Claim 16 recites the limitation "the heat flow" in line 5. There is insufficient antecedent basis for this limitation in the claim.
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.
Claim(s) 1-20 is/are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Park et al. (“In vivo measurement of intrinsic thermal conductivity of living blood-perfused tissue”).
Claims 1-20 are taught by the Park reference, which appears to be a research paper was written, in part, by the inventors of the instant application. While certain terms are different (e.g. intrinsic in the paper versus inherent in the claims or phase difference in the claims versus phase shift in the paper), they essentially mean the same thing and teach the recited claims.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Liu et al. (“Estimation of Blood Perfusion Using Phase Shift in Temperature Response to Sinusoidal Heating at the Skin Surface”) teaches a method of measuring thermal conductivity of tissue using a device including a heating device and a temperature sensor (p1039), the method comprising: applying a first heat flow to the tissue, the first heat flow including a constant heat flow (p1038 – apply a constant heat flux); generating first temperature data by sensing a temperature change in the tissue as the first heat flow is applied (p1038 – transient temperature response; p1040 – using a thermos-couple to measure temperature); applying a second heat flow to the tissue, the second heat flow including a sinusoidal heat flow (p1038 – introduce the sinusoidal surface heating); generating second temperature data by sensing a temperature change in the tissue as the second heat flow is applied (p1040). Liu does not teach deriving inherent thermal conductivity of the tissue based on the first temperature data, the second temperature data, and heat transfer due to blood perfusion within the tissue, instead treating it as a known input (p1039 – k = 0.5 W/m*oC) within the Pennes’ equation (p1038 – equation 1). Bowman(USP #4,859,078) teaches a non-invasive measurement of “thermal conductivity, thermal diffusivity, and fluid perfusion measured in body tissues such as a cutaneous layer (col. 4 lines 25-29). Bowman teaches that a thermal measurement performed on perfused living tissue returns an effective conductivity affected by blood flow, and that the tissue’s intrinsic (i.e. inherent) conductivity (col. 8 lines 52-67 – where Bowman states that keff (effective thermal conductivity) includes thermal effect of perfusion and that in the absence of perfusion it is equal to Km (intrinsic thermal conductivity), the measurements being derived from a process which involves the application of a constant heat flux (col. 7 line 51). The examiner notes that Km of Bowman is the same conduction coefficient of the tissue energy equation. However, Bowman also fails to measure Km directly.
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CHRISTIAN JANG
Primary Examiner
Art Unit 3791
/CHRISTIAN JANG/ Primary Examiner, Art Unit 3791 8/6/26
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