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 September 1, 2026 have been fully considered but they are not persuasive.
Regarding the 101:
From MPEP 2106.04(a)(2) III A: “In contrast, claims do recite a mental process when they contain limitations that can practically be performed in the human mind, including for example, observations, evaluations, judgments, and opinions. 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);” Applicant’s claims are analogous to this example. Applicant’s claims merely acquire data perform data analysis steps at a high level of generality and then displaying said data. Nothing more is recited in the claims. A person can receive SEM data values and look at the data and determine which value is the highest and calculate an average of the values. A human can subtract two numbers and then note certain issues depending on the values. Nothing more specific is being claimed. These limitations describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the 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 an 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 additional elements recited in the claims do not provide significantly more as noted in the 101 rejection below. Thus the claim as a whole was considered and thus the 101 rejection was necessitated.
Examiner notes “a handheld apparatus comprising one or more coaxial electrodes configured to interrogate tissue at different skin depths ranging from 0.5 millimeters (mm) to 4 mm, wherein the dimensions of the one or more coaxial electrodes correspond to the depth of interrogation” is not considered an abstract idea but merely additional elements which do not provide significantly more. These elements are not specialized in any way. They are conventional electrodes. Dimensions of electrodes do not make them specialized. Further the newly added limitation of wherein the dimensions of the one or more coaxial electrodes correspond to the depth of interrogation is broadly claimed and provides no actual distinction. What corresponding means is not defined. The fact that an electrode, that is used for interrogation at a depth, must have dimensions to exist would satisfy that limitation. This does not provide significantly more as this is still just claiming conventional electrodes.
Regarding the conventional nature of the additional elements:
Examiner notes from MPEP 2106.05(d): “As such, an examiner should determine that an element (or combination of elements) is well-understood, routine, conventional activity only when the examiner can readily conclude, based on their expertise in the art, that the element is widely prevalent or in common use in the relevant industry. The analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification. See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. 2016) (supporting the position that amplification was well-understood, routine, conventional for purposes of subject matter eligibility by observing that the patentee expressly argued during prosecution of the application that amplification was a technique readily practiced by those skilled in the art to overcome the rejection of the claim under 35 U.S.C. 112, first paragraph); see also Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984) ("[T]he specification need not disclose what is well known in the art."); In re Myers, 410 F.2d 420, 424, 161 USPQ 668, 671 (CCPA 1969) ("A specification is directed to those skilled in the art and need not teach or point out in detail that which is well-known in the art."); Exergen Corp., 725 Fed. App’x. 959, 965 (Fed. Cir. 2018) (holding that "[l]ike indefiniteness, enablement, or obviousness, whether a claim is directed to patent eligible subject matter is a question of law based on underlying facts," and noting that the Supreme Court has recognized that "the inquiry 'might sometimes overlap' with other fact-intensive inquiries like novelty under 35 U.S.C. § 102"). If the element is not widely prevalent or in common use, or is otherwise beyond those elements recognized in the art or by the courts as being well-understood, routine or conventional, then the element will in most cases favor eligibility.
The required factual determination must be expressly supported in writing, as discussed in MPEP § 2106.07(a). Appropriate forms of support include one or more of the following: (a) A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s); (b) A citation to one or more of the court decisions discussed in Subsection II below as noting the well-understood, routine, conventional nature of the additional element(s); (c) A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and (d) A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). For more information on supporting a conclusion that an additional element (or combination of additional elements) is well-understood, routine, conventional activity, see MPEP § 2106.07(a), subsection III.” (Emphasis added).
Examiner notes the following were provided in the prior office action and are again provided in the 101 below: “(b) A citation to one or more of the court decisions discussed in Subsection II below as noting the well-understood, routine, conventional nature of the additional element(s); (c) A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and (d) A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s).” Examiner further notes it is unclear how the claimed electrodes, circuitry (which can be merely wires), a processor, computer readable medium, and a user interface for displaying are anything beyond what is conventional in the art. A handheld apparatus is conventional in the art and regardless merely indicates field of use which does not provide significantly more. These elements are clearly known in every single technology and art and not even just limited to the field of invention of applicant’s filing. These are clearly conventional elements and not a specialized instrument. The claimed structures merely cover a conventional computer (has a processor, computer readable medium, user interface, circuitry/wires) and electrodes. The depth at which the sensor interrogate tissue is conventional in the art and is also dependent on the tissue desired to be analyzed, the dimensions of the electrodes generically corresponding in any fashion to the depth of interrogation, thus the claim limitations do not provide significantly more as it merely indicates the desired tissue that is being measured for the extra-solutionary data gathering process. This is also conventional as show by the cited prior art on the PTO-892. Examiner further notes the interrogation of tissue is considered an additional element and is part of the extra-solutionary data gathering which does not provide significantly more.
Per MPEP 2106.05(a) II: “Examples that the courts have indicated may not be sufficient to show an improvement to technology include:ii. Using well-known standard laboratory techniques to detect enzyme levels in a bodily sample such as blood or plasma, Cleveland Clinic Foundation v. True Health Diagnostics, LLC, 859 F.3d 1352, 1355, 1362, 123 USPQ2d 1081, 1082-83, 1088 (Fed. Cir. 2017); iii. Gathering and analyzing information using conventional techniques and displaying the result, TLI Communications, 823 F.3d at 612-13, 118 USPQ2d at 1747-48;” This is all applicant’s claims are directed to. Using standard equipment to gather data. Generically analyze said data using analysis that a human can perform in their mind or with pen and paper. And finally merely displaying the result. The claims do not claim anything that signifies an improvement in order to provide significantly more.
Per MPEP 2106.05(b): “Merely adding a generic computer, generic computer components, or a programmed computer to perform generic computer functions does not automatically overcome an eligibility rejection. Alice Corp. Pty. Ltd. v. CLS Bank Int’l, 573 U.S. 208, 223-24, 110 USPQ2d 1976, 1983-84 (2014). See In re Alappat, 33 F.3d 1526, 1545, 31 USPQ2d 1545, 1558 (Fed. Cir. 1994); In re Bilski, 545 F.3d 943, 88 USPQ2d 1385 (Fed. Cir. 2008) and III. WHETHER ITS INVOLVEMENT IS EXTRA-SOLUTION ACTIVITY OR A FIELD-OF-USE Whether its involvement is extra-solution activity or a field-of-use, i.e., the extent to which (or how) the machine or apparatus imposes meaningful limits on the claim. 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 integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011) (citations omitted) (“[N]othing in claim 3 requires an infringer to use the Internet to obtain that data. The Internet is merely described as the source of the data. We have held that mere ‘[data-gathering] step[s] cannot make an otherwise nonstatutory claim statutory.’” 654 F.3d at 1375, 99 USPQ2d at 1694 (citation omitted)). See MPEP § 2106.05(g) & (h) for more information on insignificant extra-solution activity and field of use, respectively.“ This is what Applicant’s claims are. The machine/apparatus used contribute 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) and thus do not integrate the judicial exception or provide significantly more.
Regarding the additional elements being considered conventional equipment:
From MPEP 2106.05(d) I 2.: “The analysis as to whether an element (or combination of elements) is widely prevalent or in common use is the same as the analysis under 35 U.S.C. 112(a) as to whether an element is so well-known that it need not be described in detail in the patent specification. See Genetic Techs. Ltd. v. Merial LLC, 818 F.3d 1369, 1377, 118 USPQ2d 1541, 1546 ( Fed. Cir. 2016) (supporting the position that amplification was well-understood, routine, conventional for purposes of subject matter eligibility by observing that the patentee expressly argued during prosecution of the application that amplification was a technique readily practiced by those skilled in the art to overcome the rejection of the claim under 35 U.S.C. 112, first paragraph); see also Lindemann Maschinenfabrik GMBH v. Am. Hoist & Derrick Co., 730 F.2d 1452, 1463, 221 USPQ 481, 489 (Fed. Cir. 1984) ("[T]he specification need not disclose what is well known in the art."); In re Myers, 410 F.2d 420, 424, 161 USPQ 668, 671 (CCPA 1969) ("A specification is directed to those skilled in the art and need not teach or point out in detail that which is well-known in the art."); Exergen Corp., 725 Fed. App’x. 959, 965 (Fed. Cir. 2018) (holding that "[l]ike indefiniteness, enablement, or obviousness, whether a claim is directed to patent eligible subject matter is a question of law based on underlying facts," and noting that the Supreme Court has recognized that "the inquiry 'might sometimes overlap' with other fact-intensive inquiries like novelty under 35 U.S.C. § 102"). If the element is not widely prevalent or in common use, or is otherwise beyond those elements recognized in the art or by the courts as being well-understood, routine or conventional, then the element will in most cases favor eligibility. For example, even if a particular technique (e.g., measuring blood glucose via an earring worn by a person with diabetes) would have been obvious to one of ordinary skill in the art because it was discussed in several widely-read scientific journals or used by a few scientists, mere knowledge of the particular technique or use of the particular technique by a few scientists is not necessarily sufficient to make the use of the particular technique routine or conventional in the relevant field. The examiner in this situation would already know, based on the examiner's expertise in the field, that blood glucose is routinely and conventionally monitored by other techniques (e.g., via placing a small droplet of blood on a diagnostic test strip, or via an implanted insulin pump with a glucose sensor). Thus, the examiner would not need to perform a prior art search in order to determine that the particular claimed technique using the glucose-sensing earring was not well-understood, routine, conventional activity previously engaged in by scientists in the field.
The required factual determination must be expressly supported in writing, as discussed in MPEP § 2106.07(a). Appropriate forms of support include one or more of the following: (a) A citation to an express statement in the specification or to a statement made by an applicant during prosecution that demonstrates the well-understood, routine, conventional nature of the additional element(s); (b) A citation to one or more of the court decisions discussed in Subsection II below as noting the well-understood, routine, conventional nature of the additional element(s); (c) A citation to a publication that demonstrates the well-understood, routine, conventional nature of the additional element(s); and (d) A statement that the examiner is taking official notice of the well-understood, routine, conventional nature of the additional element(s). For more information on supporting a conclusion that an additional element (or combination of additional elements) is well-understood, routine, conventional activity, see MPEP § 2106.07(a), subsection III.” (emphasis added). The 101 rejection below has established that the additional elements are conventional equipment.
Response to Amendment
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 1-5, 7, 9, 11-12, 15-16, 19-20, and 22 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 1-5, 7, 9, 11-12, 15-16, 19-20, and 22 are all within at least one of the four categories (claims 1-5, 7, 9, 11-12 and 15-16 being apparatuses claims 19-20 and 22 being methods).
Regarding Step 2, the independent claims 1 and 19 recite:
receiving … one or more SEM values and measurement locations of the one or more SEM values;
determining a maximum SEM value an average SEM value from the one or more SEM values;
determining a delta difference by subtracting the average SEM value from the maximum SEM value; and
flagging said measurement locations with the delta difference greater than a predetermined threshold as the damaged tissue.
The above 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).
The claimed steps of receiving, determining, and flagging 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. A person can receive SEM data values and look at the data and determine which value is the highest and calculate an average of the values. A human can subtract two numbers and then note certain issues depending on the values. Nothing more specific is being claimed. These limitations describe a mental process (including an observation, evaluation, judgment, opinion) under the broadest reasonable standard, as a skilled practitioner is capable of performing the recited limitations and making a mental assessment thereafter. Examiner notes that nothing from the claims suggests that the 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 an 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.
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 1-5, 7, 9, 11-12, 15-16, 19-20, and 22 are not integrated into a practical application because:
•The abstract idea amounts to simply implementing the abstract idea on a computer. For example, the recitations regarding the generic computing components for receiving, determining, and flagging merely invoke a computer as a tool.
•The data-gathering step (receiving) do not add a meaningful limitation to the method as they are insignificant extra-solution activity.
•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 recite a computer that is used as a tool for receiving, determining, and flagging.
•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 medical 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 computer obtain(ing), determine(ing), receive(ing), generate(ing), output(ing), store(ing). The claims do not apply the obtained response measurement to a particular machine. Rather, the data is merely output in a post-solution step.
When considered in combination, the additional elements (i.e. the generic computer functions and 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 computer implementation.
Regarding Step 2B:
The additional elements are identified as follows:
-‘one or more coaxial electrodes’ in claims 1 and 15 and 19
‘wherein said one or more coaxial electrodes are further configured to interrogate tissue at different skin depths ranging from 0.5 millimeters (mm) to 4 mm, wherein the dimensions of the one or more coaxial electrodes corresponds to the depth of interrogation;’ in claims 1 and 19
-‘a circuit’ in claims 1 and 19
-‘a processor…configured to receive…and convert’ in claim 1
-‘a non-transitory computer readable medium’ in claims 1 and 19
-‘substrate’ in claims 2, 3, 4
-‘a conformal pressure pad’ in claim 5
-‘pressure sensor’ in claim 7, 8, 9
-‘a user interface’ in claim 11
-‘a second circuit’ in claim 12
-‘a temperature probe’ in claim 16
-‘a processor ‘in claim 19
-‘obtaining said measurement locations’ in claim 19
-‘a user interface to display the measurement locations flagged as the damaged tissue’ in claims 1 and 19
-‘handheld apparatus’ in claims 1 and 19
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 on the PTO-892 which disclose each of the elements (processor, electrodes, sensors, probe, circuits) 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.
Receiving data and the use of the electrodes is merely considered extra-solutionary data gathering which does not provide significantly more. Displaying data is merely extra-solutionary data output which does not provide significantly more. A handheld apparatus is conventional in the art and regardless merely indicates field of use which does not provide significantly more. The depth at which the sensor interrogate tissue is conventional in the art and is also dependent on the tissue desired to be analyzed, thus the claim limitations towards the depth do not provide significantly more as it merely indicates the desired tissue that is being measured for the extra-solutionary data gathering process.
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 merely indicate a substrate used to implement the electrodes. Claim 18 merely indicates the system could be in a handheld. This is not a particular machine and at best merely indicates field of use. 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 integrate a judicial exception or provide significantly more. See Bilski, 561 U.S. at 610, 95 USPQ2d at 1009 (citing Parker v. Flook, 437 U.S. 584, 590, 198 USPQ 193, 197 (1978)), and CyberSource v. Retail Decisions, 654 F.3d 1366, 1370, 99 USPQ2d 1690 (Fed. Cir. 2011). See MPEP 2106.05(b).
• Claims 20 and 22 are extra-solutionary data gathering limitations which do not provide significantly more.
• Claims 9, 11-12 and 15-16 recites additional elements at a high level of generality which are conventional in the art in particular those used for extra-solutionary data-gathering or extra-solutionary data output.
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.
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
