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.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on March 25, 2026 has been entered.
Response to Arguments
Applicant's arguments filed March 25, 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. 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.
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. 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 do not provide significantly more as it merely indicates the desired tissue that is being measured for the extra-solutionary data gathering process.
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.
Regarding the double patenting: Examiner notes the updated double patenting rejection below to address the new limitations.
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 1-12, 15-16, and 19-22 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.
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 1-12, 15-16, and 19-22 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;’ 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.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7, 9, 11-12, 15-16, 19-20, and 22 are rejected on the ground of nonstatutory double patenting as being unpatentable overclaims 1-18 of U.S. Patent No. 10182740 and claims 1-11 of U.S. Patent No. 10178961 and 1-14 of U.S. Patent No. 10485447 all in view of in view of Segal (US 2007/0276359) and White et al. (US 2013/0210058) and as evidenced by Hettrick et al. (US 2011/0190654) or Dunn et al. (US Patent No. 5766432).
Although the claims at issue are not identical, they are not patentably distinct from each other because they are all directed to a system with electrodes/sensors to acquire SEM values and to compares the values to minimum and maximum values as indicators for tissue health with calculation of a delta difference. The only differences appear to be the use of electrodes vs sensors, or that the instant application measures capacitance. But all of these changes are design changes which would be obvious to one of ordinary skill in the art as making those modifications would yield predictable results. Examiner further notes the displaying the data on a user interface as in dependent claim 11 of U.S. Patent No. 10182740. For further evidence Examiner points to Paragraph 0054 of Segal (US 2007/0276359) which also teaches said feature. And it would have been obvious to one of ordinary skill in the art to have modified the Patents with Segal because displaying data is well known in the art and helps with treatment of the patient (Paragraph 0054 of Segal). Further White et al. (US 2013/0210058) teaches the interrogation depth as recited in the newly added claim amendments in Paragraph 0260. And it would have been obvious to one of ordinary skill in the art to have modified the Patents with White because it allows for interrogate of water in the dermis of the skin tissue (Paragraph 0260 of White) and thus through routine experimentation to chose the desired depth in order to achieve the predictable results of analyzing the desired tissue layer. The conflicting patent in their disclosures discussed the different delta differences calculations as being obvious variants. Averaging values together, taking maximum values, minimum values, and determining difference between thereof is all common statistical calculations. The calculations themselves are merely commonly used statistical calculations which would routine to one of ordinary skill in the art (See Paragraph 0114 of Hettrick or Column 7, Lines 59-67 of Dunn). A mere change in what data a delta difference is calculated between is merely an obvious design choice that one could find through routine experimentation of manipulating the gathered data.
Conclusion
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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