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.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-5, 7, 9, 11-12, and 15-27 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 1 recites the limitation "said SEM values" in Line 17, 20. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites the limitation "said at least two SEM values" in Line 23. There is insufficient antecedent basis for this limitation in the claim.
Claim 1 recites ‘a difference’ twice in the claim making it unclear if each recitation refers to the same element or not.
Claim 11 recites the limitation "said SEM values" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites the limitation "said relative measurement locations" in Line 2. There is insufficient antecedent basis for this limitation in the claim.
Claim 11 recites ‘a difference’ and is dependent back to claim 1 which recites the same making it unclear if the recitation in claim 11 is meant to refer to that claim 1 or not.
Claim 17 recites the limitation "said SEM values" in Line 8. There is insufficient antecedent basis for this limitation in the claim.
Claim 17 recites ‘a difference’ twice in the claim making it unclear if each recitation refers to the same element or not.
Claim 19 recites ‘said SEM value’ and ‘said SEM measurements’ after reciting ‘consecutive pluralities of SEM measurements’ making it unclear if each recitation refers to the same element or not.
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, and 15-27 are rejected under 35 U.S.C. 101 because the claimed invention is directed to an abstract idea without significantly more.
Step 1
The claimed invention in claims 1-5, 7, 9, 11-12, and 15-27 are directed to statutory subject matter as the claims recite a system (claims 1-5, 7, 9, 11-12, and 23-27) and a method (claims 19-22).
Step 2A, Prong One
Regarding claims 1, 17, and 19, the recited steps are directed mental process of performing concepts in a human mind or by a human using a pen and paper (see MPEP 2106.04(a)(2) subsection (III)).
Specifically from claims 1, 17, and 19:
1. An apparatus for identifying damaged tissue, said apparatus comprising
one or more coaxial electrodes capable of interrogating tissue at and around an anatomical site,
wherein each of said one or more coaxial electrodes is configured to emit and receive a radiofrequency signal to generate a capacitance signal;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said capacitance signal into a sub-epidermal moisture (SEM) value;
a processor electronically coupled to said circuit and configured to receive said SEM value; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored thereon that when executed on said processor, perform the steps of
receiving from said processor at least two of said SEM values measured at and around said anatomical site over a time interval;
determining a maximum SEM value from said SEM values measured at and around said anatomical site for a predetermined portion in said time interval;
determining a difference between said maximum SEM value and each of the remaining said at least two SEM values measured at and around said anatomical site for said predetermined portion of said time interval; and
flagging said tissue associated with a difference greater than a predetermined threshold for said time interval as damaged tissue.
17. A non-transitory computer readable medium for identifying damaged tissue, comprising instructions stored thereon that when executed on a processor, perform the steps of
receiving from said processor at least two sub-epidermal moisture (SEM) values measured at and around said anatomical site for a predetermined portion of a time interval;
determining a maximum SEM value from said SEM values measured at and around said anatomical site for said predetermined portion of said time interval;
determining a difference between said maximum SEM value and each of the remaining said at least two SEM values measured at and around said anatomical site for each said predetermined portion of said time interval; and
flagging said tissue associated with a difference greater than a predetermined threshold for said predetermined portion of said time interval as damaged tissue.
19. A method for identifying damaged tissue, said method comprising the steps of:
obtaining consecutive pluralities of sub-epidermal moisture (SEM) measurements at and around an anatomical site using an apparatus over a specific time period,
determining a delta value of each of said consecutive pluralities of SEM measurements,
determining whether each of said delta values exceeds a threshold, and
identifying damaged tissue when said delta values during a predetermined portion of a time interval exceed said threshold,
wherein said apparatus comprises:
one or more coaxial electrodes configured to emit and receive a radiofrequency signal to generate a capacitance signal;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said capacitance signal into said SEM measurements;
a processor electronically coupled to said circuit and configured to receive said SEM value; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored.
These underlined 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 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.
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.
Step 2A, Prong Two
This judicial exceptions (abstract ideas) in claims 1-5, 7, 9, 11-12, and 15-27 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 perfuming the abstract ideas merely invoke a computer as a tool.
•The data-gathering step 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 performing the abstract ideas.
•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 to perform the abstract ideas. 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.
Step 2B
The additional elements are identified as follows:
From claim 1: one or more coaxial electrodes capable of interrogating tissue at and around an anatomical site,
wherein each of said one or more coaxial electrodes is configured to emit and receive a radiofrequency signal to generate a capacitance signal;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said capacitance signal into a sub-epidermal moisture (SEM) value;
a processor electronically coupled to said circuit and configured to receive said SEM value; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored thereon that when executed on said processor, perform the steps of
From claim 17: A non-transitory computer readable medium for identifying damaged tissue, comprising instructions stored thereon that when executed on a processor, perform the steps of
From claim 19: wherein said apparatus comprises:
one or more coaxial electrodes configured to emit and receive a radiofrequency signal to generate a capacitance signal;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said capacitance signal into said SEM measurements;
a processor electronically coupled to said circuit and configured to receive said SEM value; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored.
From claim 2-5: “substrate”, “conformal pressure pad”
From claim 7: “a first pressure sensor”
From claim 9: “a second pressure sensor”
From claim 11: “a user interface”
From claim 12: “a second circuit”, ‘a remote device’
From claim 16: “a temperature probe”
From claim 18: “a handheld device”
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 each of 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.
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 into a practical application 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.
Claims 11-12 is additional data output
Claims 2-5,7,9,11,12,15-16,18 recites additional elements at a high level of generality which are conventional in the art
Claims 20-27 are steps that are also abstract as a mental process through additional data gathering or analysis
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, and 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-22 of U.S. Patent No. 10182740 as evidenced by Hettrick et al. (US 2011/0190654) or Dunn et al. (US Patent No. 5766432).
See the chart below for the overlap between the instant application and the patented claims. The patent does not claim a capacitance signal. Examiner notes that the Patent discloses that “the bioimpedance signal may be a capacitance signal” (Column 8, Lines 54-55).
The patent does not disclose the delta difference of independent claim 19. 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 statistical calculations is merely an obvious design choice that one could find through routine experimentation of manipulating the gathered data. The patent does not disclose the time interval but that is implied given a measurement would happen over some time interval. The differences between the patent and in the instant application are all merely design choices that one of ordinary skill in the art could make through routine experimentation to yield predictable results.
Instant Application 18/405,868
Conflicting US Patent No. 10182740
1. An apparatus for identifying damaged tissue, said apparatus comprising
one or more coaxial electrodes capable of interrogating tissue at and around an anatomical site,
wherein each of said one or more coaxial electrodes is configured to emit and receive a radiofrequency signal to generate a capacitance signal;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said capacitance signal into a sub-epidermal moisture (SEM) value;
a processor electronically coupled to said circuit and configured to receive said SEM value; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored thereon that when executed on said processor, perform the steps of
receiving from said processor at least two of said SEM values measured at and around said anatomical site over a time interval;
determining a maximum SEM value from said SEM values measured at and around said anatomical site for a predetermined portion in said time interval;
determining a difference between said maximum SEM value and each of the remaining said at least two SEM values measured at and around said anatomical site for said predetermined portion of said time interval; and
flagging said tissue associated with a difference greater than a predetermined threshold for said time interval as damaged tissue.
1. An apparatus for identifying damaged tissue in a patient, said apparatus comprising
one or more coaxial electrodes capable of interrogating tissue at and around an anatomical site of a patient,
wherein each of said one or more coaxial electrodes is configured to generate bioimpedance signals;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said bioimpedance signals into sub-epidermal moisture (SEM) values;
a processor electronically coupled to said circuit and configured to receive said SEM values; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored thereon that when executed on said processor, perform the steps of
receiving from said processor one of said SEM values measured at said anatomical site of a patient and at least two of said SEM values measured around said anatomical site and their relative measurement locations;
determining a maximum SEM value from said SEM values measured at and around said anatomical site of a patient;
determining a difference between said maximum SEM value and each of said SEM values measured at and around said anatomical site of a patient; and
flagging said anatomical site associated with a difference greater than a predetermined threshold as damaged tissue.
17. A non-transitory computer readable medium for identifying damaged tissue, comprising instructions stored thereon that when executed on a processor, perform the steps of
receiving from said processor at least two sub-epidermal moisture (SEM) values measured at and around said anatomical site for a predetermined portion of a time interval;
determining a maximum SEM value from said SEM values measured at and around said anatomical site for said predetermined portion of said time interval;
determining a difference between said maximum SEM value and each of the remaining said at least two SEM values measured at and around said anatomical site for each said predetermined portion of said time interval; and
flagging said tissue associated with a difference greater than a predetermined threshold for said predetermined portion of said time interval as damaged tissue.
17. A non-transitory computer readable medium for identifying damaged tissue in a patient, comprising instructions stored thereon that when executed on a processor, perform the steps of
receiving from said processor at least one sub-epidermal moisture (SEM) values derived from at least one bioimpedance measurements measured at an anatomical site of a patient and at least two of SEM values derived from at least two bioimpedance measurements measured around said anatomical site and their relative measurement locations;
determining a maximum SEM value from said SEM values measured at and around said anatomical site of a patient;
determining a difference between said maximum SEM value and each of said SEM values measured at and around said anatomical site of a patient; and
flagging said anatomical site associated with a difference greater than a predetermined threshold as damaged tissue.
19. A method for identifying damaged tissue, said method comprising the steps of:
obtaining consecutive pluralities of sub-epidermal moisture (SEM) measurements at and around an anatomical site using an apparatus over a specific time period,
determining a delta value of each of said consecutive pluralities of SEM measurements,
determining whether each of said delta values exceeds a threshold, and
identifying damaged tissue when said delta values during a predetermined portion of a time interval exceed said threshold,
wherein said apparatus comprises:
one or more coaxial electrodes configured to emit and receive a radiofrequency signal to generate a capacitance signal;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said capacitance signal into said SEM measurements;
a processor electronically coupled to said circuit and configured to receive said SEM value; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored.
19. A method for identifying damaged tissue, said method comprising
measuring at least three sub-epidermal moisture values at and around an anatomical site of a patient using an apparatus comprising:
one or more coaxial electrodes capable of interrogating tissue at and around an anatomical site, wherein each of said one or more coaxial electrodes is configured to generate bioimpedance signals;
a circuit electronically coupled to said one or more coaxial electrodes and configured to convert said bioimpedance signals into sub-epidermal moisture (SEM) values;
a processor electronically coupled to said circuit and configured to receive said SEM values; and
a non-transitory computer readable medium electronically coupled to said processor and comprising instructions stored thereon that when executed on said processor, perform the steps of
receiving from said processor one of said SEM values measured at said anatomical site of a patient and at least two of said SEM values measured around said anatomical site and their relative measurement locations;
determining a maximum SEM value from said SEM values measured at and around said anatomical site of a patient;
determining a difference between said maximum SEM value and each of said SEM values measured at and around said anatomical site of a patient; and
flagging said anatomical site associated with a difference greater than a predetermined threshold as damaged tissue; and
obtaining said measurement locations flagged as damaged tissue from said apparatus.
Claims 1-5, 7, 9, 11-12, and 15-27 are rejected on the ground of nonstatutory double patenting as being unpatentable over 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 values or differences. 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. 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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