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 February 20, 2026 have been fully considered but they are not persuasive.
See the updated 101 rejection below. The ‘obtaining’, ‘converting’, ‘determining’ and ‘calculating’ steps are all claimed at a high level of generality such that they could be performed in the human mind. Thus an abstract idea is recited within the claim. From MPEP 2106.05(a): “It is important to note, the judicial exception alone cannot provide the improvement. The improvement can be provided by one or more additional elements.” The claims do recite additional elements. The additional elements are identified as follows: ‘contacting a first surface of an apparatus with said skin surface, wherein said apparatus comprises said one or more sensors and one or more contact sensors surrounding each of the said one or more sensors disposed on said first surface,’ in claim 23 and ‘adjusting the pressure and position of the one or more sensors upon a determination that at least one of said one or more contact sensors surrounding said one or more sensors is not in contact with said skin surface,’ in claim 23. The additional elements of contacting the apparatus with a skin surface and adjusting the pressure and position of the sensors is merely part of the extra-solutionary data gathering process and at best indicates field of use. Ensure good contact of sensors with the person being sensed is conventional in the art and is part of the extra-solutionary data gathering process. Further Examiner notes that the adjusting the pressure and position limitation is not even required by claimed invention as it is conditional language due to the ‘upon a determination’ language which means that the limitation is not even required by the claimed invention.
Regarding the Double Patenting rejection: See the updated double patenting rejection below in light of the amendments.
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 23 and 26 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 23 and 26 are all within at least one of the four categories (claims 23 and 26 being methods).
Regarding Step 2, the independent claim 23 recites:
obtaining one or more capacitance signals from said one or more sensors upon a determination that all of said one or more contact sensors surrounding said one or more sensors is in contact with said skin surface,
converting said one or more capacitance signals to one or more sub-epidermal moisture (SEM) values,
determining a maximum SEM value and an average SEM value from said one or more SEM values, and
calculating a delta difference by subtracting said average SEM value from said maximum SEM value.
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 obtaining, converting, determining, and calculating 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 (claim 1), 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 23-26 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 obtaining, converting, determining, and calculating merely invoke a computer as a tool.
•The data-gathering step (obtaining and contacting) 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 do not recite a computer but merely imply that a computer would be used for obtaining, converting, determining, and calculating.
•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 claims do not apply the steps to a particular machine. Rather, data is merely obtained using generic and conventional sensors.
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: ‘contacting a first surface of an apparatus with said skin surface, wherein said apparatus comprises said one or more sensors and one or more contact sensors surrounding each of the said one or more sensors disposed on said first surface,’ in claim 23 and ‘adjusting the pressure and position of the one or more sensors upon a determination that at least one of said one or more contact sensors surrounding said one or more sensors is not in contact with said skin surface,’ in claim 23.
The additional elements of contacting the apparatus with a skin surface and adjusting the pressure and position of the sensors is merely part of the extra-solutionary data gathering process and at best indicates field of use. One of ordinary skill in the art would understand positioning and pressure of an electrode/sensor to skin would help ensure more reliable and higher quality signals and thus this aspect is merely a conventional aspect of extra-solutionary data gathering. Further Examiner notes that the adjusting the pressure and position limitation is not even required by claimed invention as it is conditional language due to the ‘upon a determination’ language which means that the limitation is not even required by the claimed invention.
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 as being known and conventional in the art elements; adjusting the pressure and position of sensors is known in the art to help measure quality signals.
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.
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).
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.
Claim 26 recites additional elements at a high level of generality which are conventional in the art
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 23 and 26 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11534077 in view of Chou (US 2012/0116240) 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 each directed to a method for ensuring contact of one or more sensors to a skin surface, the method comprising: contacting a first surface of an apparatus with said skin surface, wherein said apparatus comprises said one or more sensors and one or more contact sensors surrounding each of the said one or more sensors disposed on said first surface, obtaining one or more capacitance signals from said one or more sensors upon a determination that at least one of said one or more contact sensors surrounding said one or more sensors is in contact with said skin surface, converting said one or more capacitance signals to one or more sub-epidermal moisture (SEM) values, determining a maximum SEM value and a minimum SEM value from said one or more SEM values, and calculating a delta difference. The only difference being what values the delta difference is between. But making this change would be obvious to one of ordinary skill in the art through routine experimentation to determine a delta difference between various obtained values. The conflicting patent in the disclosure (see at least Column 10, Lines 19-61 among full disclosure) 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.
The patent does not disclose “adjusting the pressure and position of the one or more sensors upon a determination that at least one of said one or more contact sensors surrounding said one or more sensors is not in contact with said skin surface,”. Chou teaches adjusting pressure and position of sensors upon a determination that sensors surrounding are not in proper contact with the skin surface (Paragraph 0025). It would have been obvious to one of ordinary skill in the art to have modified the patent with Chou because it would yield the predictable results of ensuring proper and more accurate measurements (Paragraph 0025 of Chou).
Instant Application 18/064,446
Conflicting US Patent No. 11534077
23. A method for ensuring contact of one or more sensors to a skin surface, the method comprising:
contacting a first surface of an apparatus with said skin surface, wherein said apparatus comprises said one or more sensors and one or more contact sensors surrounding each of the said one or more sensors disposed on said first surface,
adjusting the pressure and position of the one or more sensors upon a determination that at least one of said one or more contact sensors surrounding said one or more sensors is not in contact with said skin surface,
obtaining one or more capacitance signals from said one or more sensors upon a determination that all of said one or more contact sensors surrounding said one or more sensors is in contact with said skin surface,
converting said one or more capacitance signals to one or more sub-epidermal moisture (SEM) values,
determining a maximum SEM value and an average SEM value from said one or more SEM values, and
calculating a delta difference by subtracting said average SEM value from said maximum SEM value.
1. A method for ensuring contact of one or more sensors to a skin surface, the method comprising:
contacting a first surface of an apparatus with said skin surface, wherein said apparatus comprises said one or more sensors and one or more contact sensors surrounding each of the said one or more sensors disposed on said first surface,
obtaining one or more capacitance signals from said one or more sensors upon a determination that at least one of said one or more contact sensors surrounding said one or more sensors is in contact with said skin surface,
converting said one or more capacitance signals to one or more sub-epidermal moisture (SEM) values,
determining a maximum SEM value and a minimum SEM value from said one or more SEM values, and
calculating a delta difference by subtracting said minimum SEM value from said maximum SEM value.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Tateno (US Patent No. 3732859) and Elmeskog (US Patent No. 4457309) and Bodlaender et al. (US 2011/0066209) and Mihajlovic (US 2015/0216437) and Bauerfeind et al. (US 2008/0045872) and Chang (US 2015/0112171) and Fein et al. (US Patent No. 6600940) and Church et al. (US 5277197) and Island (US 2004/0176754) and Island et al. (US 2009/0043294) and Chou (US 2012/0116240) and Liu et al. (US 2012/0226268) and Eckhouse et al. (US 2013/0289679) and Hettrick et al. (US 2011/0190654) and Dunn et al. (US Patent No. 5766432)
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PATRICK FERNANDES whose telephone number is (571)272-7706. The examiner can normally be reached Monday-Thursday 9AM-3PM EST.
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/PATRICK FERNANDES/Primary Examiner, Art Unit 3791
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