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.
Response to Arguments
Applicant's arguments filed October 27, 2025 have been fully considered but they are not persuasive.
Regarding the 112s: Applicant’s specification provides no details regarding any type of scale for freshness. So, for this property of the item to be determined relative to what Applicant is claiming one would need to know what the scale of that term is meant to be. One would need to know the scope of the claimed invention. This is not disclosed and therefore remains unclear.
Regarding the 101: Examiner notes the abstract idea claimed is: “analyzing the electrical response to determine information about the thermal property of the target portion.” in claim 1 and “analyzing the electrical response to determine compositional information about the target material.” in claim 6. These are directed to mental processes as per MPEP 2106.04(a)(2) III A:
Examples of claims that recite mental processes include:
• • a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group v. Alstom, S.A., 830 F.3d 1350, 1353-54, 119 USPQ2d 1739, 1741-42 (Fed. Cir. 2016);
The steps to gather the compositional data are just that, mere extra-solutionary data gathering and/or indicating field of use which does not provide significantly more. MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a probe and a resistive element both claimed at a high level of generality for data gathering steps. This does not provide significantly more.
Regarding the prior art: In light of the amendments to claim 1: the previously used Beetner reference has been provided as the now primary reference for claims 1-5. Further Examiner notes Kasevich discloses that dielectric properties of tissue change due to temperature (Column 13, Lines 11-33), thus one of ordinary skill in the art would recognize measuring impedance would constitute a thermal property. Applicant does not disclose any specific thermal property and as such the term is broadly claimed. Should Applicant intend specifically for a more specific thermal property such as temperature than that should be claimed.
Regarding claim 6: Lele, in the field of “apparatus and methods for measuring tissue temperature and other tissue properties” (Column 1, Lines 12-13) which is analogous to the field of measuring temperature of animal tissue as in Niu (See full disclosure). Further both applications discuss providing current and measuring properties of tissue based on that to tissue. Thus one of ordinary skill in the art would recognize they are in the same field of invention whether or not they are solving the same problem. And thus both of are analogous art to the claimed invention. See MPEP 2141.01(a) I: “In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103 , the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that “same field of endeavor” and “reasonably pertinent” are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212.”
Niu and Lele both measure electrical responses, both involve inducing a current/voltage into tissue and measuring a response based on that. Inducing a current/voltage means providing energy to tissue which one of ordinary skill in the art would understand would mean heat however nominal. Thus, measuring a response of this current/voltage would inherently include an electrical response to said heat produced by the current/voltage. The claimed invention does not require any certain amount of heating. Regardless Examiner notes that the combination with Lele was essentially an alternative as noted in the rejection: “Should Niu be found silent on driving an electrical current to apply heating to a resistive element and measuring an electrical responsive to the heating to determine the information. Lele, in the field of “apparatus and methods for measuring tissue temperature and other tissue properties” (Column 1, Lines 12-13) which is analogous to the field of measuring temperature of animal tissue as in Niu (See full disclosure), teaches driving an electrical current through the resistive element to apply heating to the resistive element (Column 5, Lines 42-45); measuring an electrical response of the resistive element to the heating (Column 5, Lines 42-45); and analyzing the electrical response to determine information about the target material (Column 6, Lines 33-48).It would have been obvious to one of ordinary skill in the art to have modified Niu with Lele because it would provide enhanced signal gain, higher resolution, and low noise (Column 5, Lines 36-37 of Lele).”
Examiner further notes that electrical currents generate heat, that would be measured in the impedance measurement and would qualify as an electrical response of heating. The claims do not require a specific amount of heating or detail exactly the relationship between the electrical response and the heating. One of ordinary skill in the art would understand that current heating would affect impedance measurement in some form and would be included in the impedance measurement even if they are done at the same time. The claimed invention does not distinguish any temporal order or timing of the steps. Further per Applicant’s specification Paragraph 0055: “The measurement system16 may be configured to deliver power to the resistive element5 by driving an electrical current through the resistive element5 at the same time as measuring the resistance (and therefore temperature, where a calibration is available) of the resistive element5.” Thus it is readily apparent that the current and measurement can occur simultaneously. The claimed invention does not even require that only the electrical response to specifically only heating is measured. If all electrical response is measured near where heating of any amount occurs, this electrical response would naturally include any response due to the heating.
Further the limitation in claims 1 and 6 is “driving an electrical current through the resistive element to apply heating”, the claimed invention only requires driving an electrical current, ‘to apply heating’ is merely the result of that current. The claimed invention does not actively apply heat, the heat is merely a result of the active step of the current being driven. One of ordinary skill in the art would understand applying a current would induce an amount of heating. MPEP 2111.04: “However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).”
Response to Amendment
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 2-5 and 7 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.
Claim 4 recites ‘at least one other portion’, ‘the portion’, and the other portions’ and is dependent back to claim 1 which recites ‘a target portion’ making it unclear how each of these terms relate to each other. In claim 4, ‘the portion’ and ‘the other portions’ lack antecedent basis.
In claim 5 ‘the other portions’ lack antecedent basis’. It would appear this should read ‘the at least one other portion’.
The term “different” in claim 5 is a relative term which renders the claim indefinite. The term “different” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
The term “freshness” in claim 7 is a relative term which renders the claim indefinite. The term “freshness” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
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.
Claims 1-7 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Regarding Step 1, claims 1-7 are all within at least one of the four categories (claims 1-7 being methods).
Regarding Step 2, the independent claim 1 recites:
A method of detecting a medically abnormal portion of human or animal skin, comprising:
bringing a resistive element of a probe element into contact with a target portion of the human or animal skin;
driving an electrical current through the resistive element to apply heating to the resistive element while the resistive element is in contact with the target portion;
measuring an electrical response of the resistive element to the heating; and
analyzing, using a processing unit, the electrical response to determine information about a thermal property of the target portion and using the determined information to detect whether the target portion is medically abnormal.
Independent claim 6 recites:
A method of sensing compositional information of a target material, comprising:
providing a needle probe having a tip region and a resistive element attached to the tip region;
bringing the tip region into contact with the target material;
driving an electrical current through the resistive element to apply heating to the resistive element;
measuring an electrical response of the resistive element to the heating; and
analyzing, using a processing unit, the electrical response to determine compositional information about the target material.
The above underlined claim limitations are tied to the abstract idea of mental processes in that they are concepts that can be performed in the human mind. This group encompasses concepts performed in the human mind (including an observation, evaluation, judgment, opinion). Examiner notes that nothing from the claims suggests that the underlined limitations cannot be practically performed by a medical, biomedical or engineering professional with the aid of a pen and paper; their knowledge gained from education, background, or experience; or by using a generic computer as a tool to perform mental process steps in real time. Examiner additionally notes that nothing from the claims suggests and undue level of complexity that the mental process steps cannot be practically performed by a human with the aid of a pen and paper, or using a generic computer as a tool to perform the mental process steps.
The claimed steps of analyzing can be practically performed in the human mind using mental steps or basic critical thinking, which are types of activities that have been found by the courts to represent abstract ideas.
Examples of ineligible claims that recite mental processes include:
• a claim to “collecting information, analyzing it, and displaying certain results of the collection and analysis,” where the data analysis steps are recited at a high level of generality such that they could practically be performed in the human mind, Electric Power Group, LLC v. Alstom, S.A.;
• claims to “comparing BRCA sequences and determining the existence of alterations,” where the claims cover any way of comparing BRCA sequences such that the comparison steps can practically be performed in the human mind, University of Utah Research Foundation v. Ambry Genetics Corp.
• a claim to collecting and comparing known information, which are steps that can be practically performed in the human mind, Classen Immunotherapies, Inc. v. Biogen IDEC.
See p. 7-8 of October 2019 Update: Subject Matter Eligibility.
Regarding Step 2A (prong 2):
This judicial exceptions (abstract ideas) in claims 1-7 are not integrated into a practical application because:
•The data-gathering steps (see the bolded limitations above) do not add a meaningful limitation to the method as they are insignificant extra-solution activity necessary to perform the abstract idea
•There is no improvement to a computer or other technology. “The McRO court indicated that it was the incorporation of the particular claimed rules in computer animation that "improved [the] existing technological process", unlike cases such as Alice where a computer was merely used as a tool to perform an existing process.” MPEP 2106.05(a) II.
•The claims do not apply the abstract idea to effect a particular treatment or prophylaxis for a disease or medical condition. Rather, the abstract idea is utilized to determine a relationship among data to provide a measurement.
•The claims do not apply the abstract idea to a particular machine. “Integral use of a machine to achieve performance of a method may provide significantly more, in contrast to where the machine is merely an object on which the method operates, which does not provide significantly more.” MPEP 2106.05(b). II. “Use of a machine that contributes only nominally or insignificantly to the execution of the claimed method (e.g., in a data gathering step or in a field-of-use limitation) would not provide significantly more.” MPEP 2106.05(b) III. The pending claims utilize a probe and a resistive element claimed at a high level of generality for data gathering steps.
When considered in combination, the additional elements (i.e. conventional equipment/steps) do not amount to significantly more than the abstract idea. Looking at the claim limitations as a whole adds nothing that is not already present when looking at the elements taken individually. There is no indication that the combination of elements improves the functioning of a computer or improves any other technology. Their collective functions merely provide conventional implementation.
Regarding Step 2B:
The additional elements are identified as the bolded elements above.
Those in the relevant field of art would recognize the above-identified additional elements as being well-understood, routine, and conventional means for data-gathering and computing, as demonstrated by
The prior art provided by the Applicant in the IDS and by the Examiner in PTO-892 which disclose the elements as being known and conventional in the art elements;
Thus, the claimed additional elements “are so well-known that they do not need to be described in detail in a patent application to satisfy 35 U.S.C. § 112(a).” Berkheimer Memorandum, III. A. 3. Furthermore, the court decisions discussed in MPEP § 2106.05(d)(ll) note the well-understood, routine and conventional nature of such additional elements as those claimed. See option III. A. 2. in the Berkheimer memorandum.
Regarding the dependent claims, the dependent claims are directed to either 1) steps that are also abstract or 2) additional data output that is well-understood, routine and previously known to the industry or 3) further recite additional elements at a high level of generality which are conventional in the art.
Claims 2-5 and 7 just further limit the data that is being gathered and how its gathered
Although the dependent claims are further limiting, they do not recite significantly more than the abstract idea. A narrow abstract idea is still an abstract idea and an abstract idea with additional well-known equipment/functions is not significantly more than the abstract idea.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1-5 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beetner (Reference V on PTO-892; 2003) in view of Lele (US Patent No. 4960109) as evidenced by Kasevich (US Patent No. 6181970).
Regarding claim 1, Beetner teaches a method of detecting a medically abnormal portion of human or animal skin (Abstract), comprising:
bringing a resistive element (electrodes of the probe shown in Figure 1) of a probe element (Figure 1) into contact with a target portion of the human or animal skin (Page 1021; Last paragraph of Left Column-Right Column);
driving an electrical current through the resistive element to apply heating to the resistive element, while the resistive element is in contact with the target portion (Page 1021; Last paragraph of Left Column-Right Column; one of ordinary skill in the art would realize that a current would inherently provide heating of some amount);
measuring an electrical response of the resistive element to the heating (Page 1021; Last paragraph of Left Column-Right Column; one of ordinary skill in the art would realize that a current would inherently provide heating of some amount; measurement of impedance); and
analyzing, using a processing unit, the electrical response to determine information about a thermal property of the target portion and using the determined information to detect whether the target portion is medically abnormal (Sections III. Results and IV. Discussion).
Kasevich discloses that dielectric properties of tissue change due to temperature (Column 13, Lines 11-33), thus one of ordinary skill in the art would recognize measuring impedance would constitute a thermal property.
Should Beetner be found silent on driving an electrical current to apply heating to a resistive element and measuring an electrical responsive to the heating to determine the information.
Lele teaches driving an electrical current through the resistive element to apply heating to the resistive element (Column 5, Lines 42-45); measuring an electrical response of the resistive element to the heating (Column 5, Lines 42-45); and analyzing the electrical response to determine information about the target material (Column 6, Lines 33-48).
It would have been obvious to one of ordinary skill in the art to have modified Beetner with Lele because it would provide enhanced signal gain, higher resolution, and low noise (Column 5, Lines 36-37 of Lele).
Regarding claim 2, Beetner teaches wherein the information about the thermal property of the target portion is obtained at a plurality of different times and the using the determining information to detect whether the target portion is medically abnormal comprises detecting a change in a composition of the target portion over time that is indicative of the target portion being medically abnormal (Table II has mean and standard deviation of values implying multiple measurements taken and thus multiple times).
Regarding claim 3, Beetner teaches wherein the target portion comprises a mole or other irregularity on the human or animal skin (Abstract).
Regarding claim 4, Beetner teaches wherein the information about the thermal property is obtained for a plurality of target portions in order to detect a difference in the thermal property in one target portion in comparison to one or more other target portions (Tables II and III show measurements on various target portions).
Regarding claim 5, Beetner teaches wherein the target portion is a first mole on the human or animal skin and at least one of the other portions is a second mole on the human or animal skin, or the target portion is a first irregularity on the human or animal skin and at least one of the other portions is a second irregularity on the human or animal skin (Abstract).
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Beetner (Reference V on PTO-892; 2003) in view of Lele (US Patent No. 4960109) as evidenced by Kasevich (US Patent No. 6181970) and in further view of Hedengren et al. (US Patent No. 6419635).
Regarding claim 4, Should Beetner be found to not be explicit on the thermal properties obtained for a plurality of target positions. Hedengren teaches wherein the information about the thermal property is obtained for a plurality of target portions in order to detect a difference in the thermal property in one target portion in comparison to one or more other target portions (Column 7, Lines 16-21 and Column 7, Lines 29-33; collecting data from multiple spaced apart sensors and then creating a profile which would be comparing the values at the multiple spaced apart target portions). It would have been obvious to one of ordinary skill in the art to have modified Beetner with Hedengren because it can provide added information to radiologists and may be helpful in avoiding the more severe forms of biopsy procedures (Column 7, Lines 49-52 of Hedengren).
Claim(s) 6-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Niu et al. (Reference U on PTO-892; 2000) in view of Lele (US Patent No. 4960109).
Regarding claim 6, Niu teaches a method of sensing compositional information of a target material (Abstract), comprising:
providing a needle probe having a tip region and a resistive element attached to the tip region (Electrode fabrication section Page 784);
bringing the tip region into contact with the target material (Analysis procedures Pages 784-785; ‘The NTE was inserted into the fish immediately after it was killed, and on-line monitoring of impedance changes began simultaneously’);
driving an electrical current through the resistive element to apply heating to the resistive element (Analysis procedures Pages 784-785; current being energy would inherently create heating);
measuring an electrical response of the resistive element to the heating (Analysis procedures Pages 784-785); and
analyzing, using a processing unit, the electrical response to determine compositional information about the target material (Analysis procedures Pages 784-785; Examiner notes a processor is implied through the analysis steps taught by Niu).
Should Niu be found silent on driving an electrical current to apply heating to a resistive element and measuring an electrical responsive to the heating to determine the information.
Lele, in the field of “apparatus and methods for measuring tissue temperature and other tissue properties” (Column 1, Lines 12-13) which is analogous to the field of measuring temperature of animal tissue as in Niu (See full disclosure), teaches driving an electrical current through the resistive element to apply heating to the resistive element (Column 5, Lines 42-45); measuring an electrical response of the resistive element to the heating (Column 5, Lines 42-45); and analyzing the electrical response to determine information about the target material (Column 6, Lines 33-48).
It would have been obvious to one of ordinary skill in the art to have modified Niu with Lele because it would provide enhanced signal gain, higher resolution, and low noise (Column 5, Lines 36-37 of Lele).
Regarding claim 7, Niu teaches wherein the target material comprises one or more of the following:
a food item, wherein the tip region is inserted into the food item (Page 784; ‘The NTE was inserted into the fish immediately after it was killed, and on-line monitoring of impedance changes began simultaneously’) and the determined compositional information comprises information about a freshness of the food item (Page 784; ‘determinations from 3 fish species using the NTE-EIS system confirmed that the dielectric properties of fish tissue are spoilage dependent’); and
a product sealed in a container, wherein the tip region is inserted through a closure of the container and the determined compositional information comprises information about a composition of the product.
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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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791