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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 06/08/2026 has been entered.
Claims Accounting
Applicant's arguments, filed 05/14/2026, have been fully considered.
The following rejections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 05/14/2026, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1, 4, 10, and 17 have been amended.
Claim 2 has been canceled.
Claims 1, 4, 6-12, and 16-17 are the current claims hereby under examination.
Claim Objections
Claim 4 is objected to because of the following informalities:
Claim 4 recites “The system of claim1any of claim 1” in line 1. This should read “The system of claim 1”.
Appropriate correction is required.
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, 4, 6-9, 11-12, and 16-17 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.
Regarding claims 1, 6-7, 11, and 17, claim 1 recites “the tissue” in line 14. Claim 1 also recites “a wound tissue” in line 2. It is unclear whether “the tissue” of line 14 refers to the wound tissue recited in line 2, or another tissue. A similar recitation of “the tissue” is present in line 2 of claim 6 and results in similar indefiniteness in combination with recitations of “wound tissue” first recited in claim 1. A similar recitation of “the tissue” is present in line 2 of claim 7. A similar recitation of “the tissue” is present in line 2 of claim 11 and results in similar indefiniteness in combination with recitations of “wound tissue” in claim 10. A similar recitation of “the tissue” is present in line 16 of claim 17 and results in similar indefiniteness in combination with recitations of “wound tissue” first recited in line 2 of claim 17. Clarification is requested.
For the purposes of examination, the recitations of “the tissue” in the claims are interpreted as “the wound tissue”.
All claims not explicitly addressed above are rejected under 35 U.S.C. 112(b) are rejected by virtue of their dependency on a rejected base claim.
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 1-2, 4, 6-12, and 16-17 are rejected under 35 U.S.C. 101 because the claimed invention lacks subject matter eligibility. The claim(s) as a whole, considering all claim elements both individually and in combination, do not amount to significantly more than an abstract idea. A streamlined analysis of claim 1 follows.
Step 1
Regarding claim 1, the claim recites a system comprising devices configured to perform a set of functional limitations, including selectively performing a first action or a second action based on the comparison of the first resistance to the resistance threshold. Thus, the claim is directed to a machine, which is one of the statutory categories of invention.
Step 2A, Prong One
The claim is then analyzed to determine whether it is directed to any judicial exception. The steps of comparing the first resistance to a resistance threshold, selectively performing a first action or a second action based on the comparison of the first resistance to the resistance threshold, determining a of wound healing based on the first impedance, and comparing the second resistance to the resistance threshold set forth judicial exceptions. These steps describe a concept performed in the human mind (including an observation, evaluation, judgment, opinion). A human is capable of comparing a resistance to a resistance threshold, determining a stage of wound healing based upon an impedance value, and selecting an action based on a comparison. Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Further, the steps of determining a first resistance of the tissue based on the measured first impedance and determining a second resistance of the tissue based on the measured second impedance set forth judicial exceptions. These steps describe the use of mathematical relationships, mathematical formulas or equations, and/or mathematical calculations. Thus, the claim is drawn to a Mathematical Concept, which is an Abstract Idea.
Step 2A, Prong Two
Next, the claim as a whole is analyzed to determine whether the claim recites additional elements that integrate the judicial exception into a practical application. The claim fails to recite an additional element or a combination of additional elements to apply, rely on, or use the judicial exceptions in a manner that imposes a meaningful limitation on the judicial exception. Claim 1 recites either determining a stage of wound healing of the tissue based on the first impedance or repeating the steps of applying an electrical signal, measuring an impedance, determining a resistance, and comparing the resistance to the threshold (repeated monitoring steps). The repeated monitoring steps result in a second comparison. Neither the recited determination nor the second comparison provide an improvement to the technological field, the determination or second comparison do not effect a particular treatment or effect a particular change, nor does the determination or second comparison use a particular machine to perform the Abstract Idea. It is noted that the first device (contacts) and second device (processor) do not comprise a particular machine, as the combination of these elements are common components of a to determine electrical signals from the human body.
Step 2B
Next, the claim as a whole is analyzed to determine whether any element, or combination of elements, is sufficient to ensure that the claim amounts to significantly more than the exception. Besides the Abstract Ideas, the claim recites additional steps applying a first and second electrical signal with contacts, at a predetermined frequency and measuring an impedance of the tissue. Applying a signal to a tissue and measuring an impedance of the tissue is well-understood activity for those in the field of medical diagnostics (See Evidentiary Support in par. 12 below). Further, the applying and measuring steps are each recited at a high level of generality such that it amounts to insignificant presolution activity, e.g., mere data gathering step necessary to perform the Abstract Idea. When recited at this high level of generality, there is no meaningful limitation, such as a particular or unconventional step that distinguishes it from well-understood, routine, and conventional data gathering and comparing activity engaged in by research professionals prior to Applicant's invention. The elements of the first device and second device do not constitute significantly more than the judicial exception in combination with the functional limitations of the claim, as they are elements necessary for the application of the electrical signals and provide a processor for performing the judicial exceptions. The recited first device is analogous to an electrode, which is a generic device. The recited second device is analogous to a generic circuit configured to perform pre-solutional data gathering activity, and perform the Abstract Idea.
Consideration of the additional elements as a combination also adds no other meaningful limitations to the exception not already present when the elements are considered separately. Unlike the eligible claim in Diehr in which the elements limiting the exception are individually conventional, but taken together act in concert to improve a technical field, the claim here does not provide an improvement to the technical field. Even when viewed as a combination, the additional elements fail to transform the exception into a patent-eligible application of that exception. Thus, the claim as a whole does not amount to significantly more than the exception itself. The claim is therefore drawn to non-patent eligible subject matter.
Regarding claim 10, the method recites a subset of the functional limitations present in claim 1, and is rejected under 35 USC 101 on similar grounds as stated above.
Regarding claim 17, the system recited in the claim comprises generic devices comprising generic components configured to perform the Abstract Idea. The functional limitations of applying an electrical signal and measuring an impedance are routine and recited at such a high level of generality such that it amounts to insignificant presolution activity, similar to the functional limitations of claim 1. The recited contacts are analogous to one or more electrodes, which is a generic device. The recited processor is analogous to a generic circuit configured to perform pre-solutional data gathering activity, and perform the Abstract Idea. According to section 2106.05(f) of the MPEP, merely using a computer as a tool to perform an Abstract Idea does not integrate the Abstract Idea into a practical application. The additional functional limitations of the first action and the second action are also considered judicial exceptions, as these steps describe concepts capable of being performed in the human mind (including an observation, evaluation, judgment, opinion). Therefore, these limitations fail to ensure that the claim amounts to significantly more than the exception.
Furthermore, regarding claims 1 and 17, it is well established that the mere physical or tangible nature of additional elements such as the obtaining and comparing steps do not automatically confer eligibility on a claim directed to an abstract idea (see, e.g., Alice Corp. v. CLS Bank Int'l, 134 S.Ct. 2347, 2358-59 (2014)).
The dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps and functional limitations pertaining to the further use of mathematical concepts using impedances (claims 6, 8, 9), the further use of mental processes to determine healing stages (claims 4, 6-9, 11-12, 16), and further data gathering (i.e., obtaining a third impedance) for the further use of mental processes (claims 6 and 8). The applying and measuring steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1, 4, 6-7, 10-11, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Publication 2010/0268111 by Drinan et al. – previously cited, hereinafter “Drinan” in view of Bioimpedance Measurement Device For Chronic… by Kekonen et al. – previously cited (2010), hereinafter “Kekonen”.
Regarding claim 1, Fig. 3 of Drinan teaches a system (probe 300) comprising: a first device including contacts configured couple to a wound tissue (Title, [0043]; Probe 300 is a bandage probe and is capable of being placed on the body. The system is configured to monitor wounds (see title)), a second device including a processor in operable communication with the first device ([0040]; Circuitry 310 of probe 300 is capable of the functions of the signal generation and processing, control, and data storage functions of current source 210, a digital-to-analog converter 215, an amplifier 220, an analog-to-digital converter 225, a memory 230, and a controller 235 and may comprise a data processing device) and configured to: to apply, with contacts, a first electrical signal at a predetermined frequency ([0028, 0036]; “Working electrodes 245, 250 can be adapted to conduct current through or along the probed portion of the monitored organism”. The control source 210 may change the frequency or magnitude of the current generated. This indicates that there is an original frequency of the current, this can be considered the predetermined frequency) to the wound tissue ([0028-0029, 0040]; Main body 205 contains 245, 250, 255, 260 are configured to conduct current and measure potential of the organism); measure a first impedance of the tissue based on the applied first electrical signal ([0034-0035], controller 235 can be hardware configured to perform select operations, which can include determine the bioelectric impedance of portions of a monitored organism.); determine a first resistance of the tissue based on the measured first impedance ([0083-0085]; Model 1500 models the impedances between electrodes 245, 250, 255, 260 (i.e., impedances derived from the contacts) and includes a resistive component).
Fig. 3 of Drinan does not teach comparing the first resistance to a resistance threshold.
Fig. 7 of Drinan teaches a system 1100 for monitoring the hydration of an organism. This system includes a probe wireless connected to a data collection apparatus and a data management system. During a setup stage, the parameters regarding the monitoring of the hydration of an individual can be arranged. The probe can determine the baseline measurement and the response to monitoring can include the disease state of the wound. Data analysis can also comprise comparisons of measured data to threshold values, and the comparisons can indicate the stage of healing of the wound ([0066, 0094]). Using parameters related to the baseline of an individual can adjust the standard for a healthy impedance to monitor the disease state accordingly ([0094]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Fig. 3 of Drinan to include the data management system taught by Fig. 7 of Drinan such that the second device is configured to compare the first resistance to a resistance threshold. This combination would allow for an adjustable baseline for an individual to be the standard for a healthy impedance to monitor the disease state accordingly ([0094]).
Modified Drinan does not teach the second device configured to selectively perform a first action or a second action based on the comparison the first resistance to the resistance threshold, wherein: the first action comprises determining a stage of wound healing of the tissue based on the first impedance; and the second action comprises: applying, with the contacts, a second electrical signal to the tissue; measuring a second impedance of the tissue based on the applied second electrical signal; determining a second resistance of the tissue based on the measured second impedance; and comparing the second resistance to the resistance threshold.
Kekonen teaches that the stages of normal wound healing (in order) are the inflammation phase, the proliferation phase, and the tissue remodeling phase (Pages 6-9, Section 2.1: Normal wound healing) and that the inflammation phase lasts about 4-6 days. Kekonen also teaches that a chronic wound can be considered to be trapped in an ongoing inflammation phase, for a period such as 3-4 months (Page 4, par. 3) (i.e., has not exited the inflammation phase or entered the proliferation phase). Monitoring a wound to determine if it is chronic could give valuable time for preventing the re-ulceration of the wound (Page 38, par. 2).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Drinan such that the second device is configured to selectively perform a first action or a second action based on the comparison the first resistance to the resistance threshold, wherein: the first action comprises determining a stage of wound healing of the tissue based on the first impedance; and the second action comprises: applying, with the contacts, a second electrical signal to the tissue; measuring a second impedance of the tissue based on the applied second electrical signal; determining a second resistance of the tissue based on the measured second impedance; and comparing the second resistance to the resistance threshold. It is noted that Drinan teaches that as the wound heals, the impedance of the region increases, and therefore the impedance is indicative of the healing of the wound ([0037]). Therefore, it would have been obvious to have set a threshold and compared the impedance to the threshold to determine if the wound was healing. If the resistance is greater than the threshold, the system would determine the stage of wound healing (as taught by Kekonen) in order to better understand the healing pattern. If the resistance was not above the threshold, the system would continue monitoring in order to determine any subsequent changes to the wound, as determining if the wound is a chronic wound would be beneficial, because it can allow for valuable time for preventing the re-ulceration of the wound, as taught by Kekonen (Page 38, par. 2). This system would monitor the wound until a stage of healing is determined, as defined by the resistance threshold, in order to determine the stage of healing or issues with healing (i.e., a chronic wound), which is an objective of Drinan ([0094]).
Regarding claim 4, Drinan in view of Kekonen teaches the system of claim 1, wherein the stage of wound healing of the tissue comprises one of an inflammation stage, proliferation stage, a remodeling stage, and a healed stage. As the impedance comprises information indicative of a stage of healing, it also comprises indicative of the stages of healing (i.e., inflammation, proliferation, remodeling, and a healed stage. Kekonen teaches these different phases (Pages 6-9, 2.1 Normal wound healing)).
Regarding claim 6, Drinan in view of teaches the system of claim 1, wherein the first device is further configured to apply a third electrical signal to the tissue after applying the first electrical signal, wherein the processor is further configured to: measure a third impedance of the tissue based on the third applied electrical signal; and determine the stage of wound healing is based on the first and third impedances (Drinan, [0038]; Bandage probe 300 is suitable for wound monitoring. Drinan, [0045]; Data is monitored over time, therefore there must be a third impedance determined by applying a third applied electrical signal. The stage of wound healing is determined when each impedance is determined, therefore the stage of wound healing is determined based on the first and third impedances.).
Regarding claim 7, Drinan teaches the system of claim 6, wherein the second action further includes determining a chronic wound stage of the tissue based on the comparison of the second resistance to the resistance threshold (The second action, as noted in the rejection of claim 1, comprises obtaining a second impedance for further monitoring. The monitoring as taught by the combination of Drinan and Kekonen, includes comparing the resistance to the resistance threshold to determine a change in the healing process. Kekonen teaches that after a certain time interval (3-4 weeks) the wound can be considered a chronic wound. The rejection of claim 1 notes that the continued monitoring would determine subsequent changes to the wound in order to identify if the wound was healing properly, or if it is chronic wound).
Regarding claim 10, Drinan in view of Kekonen teaches a method comprising: applying, with contacts coupled to a wound tissue, an electrical signal at a predetermined frequency to the wound tissue (See the rejection of claim 1); measuring an impedance of the wound tissue based on the applied electrical signal (See the rejection of claim 1); determining a resistance of the wound tissue based on the measured impedance (See the rejection of claim 1); comparing the resistance to a resistance threshold (See the rejection of claim 1); and selectively performing a first action or a second action based on the comparison of the resistance to the resistance threshold (See the rejection of claim 1).
Regarding claim 11, Drinan in view of Kekonen teaches the method of claim 10, wherein the first action includes determining a stage of wound healing of the tissue based on the impedance, the stage of wound healing comprising one of an inflammation stage, proliferation stage, a remodeling stage, or a healed stage. (Kekonen, Pages 6-9, Section 2.1: Normal wound healing; As the impedance comprises information indicative of a stage of healing, it also comprises indicative of the stages of healing (i.e., inflammation, proliferation, remodeling, and a healed stage).
Regarding claim 17, Drinan in view of Kekonen teaches a system (See the rejection of claim 1), comprising: contacts contactable with a wound tissue (See the rejection of claim 1, contacts are present on the first device and are capable of contacting tissue); and a processor in operable communication with the contacts (See the rejection of claim 1, the processor is in operable communication with the first device which contains the contacts) and operable to: apply with the contacts, an electrical signal at a predetermined frequency to the wound tissue (See the rejection of claim 1); measure an impedance of the wound tissue based on the applied electrical signal (See the rejection of claim 1); determine a resistance of the wound tissue based on the measure impedance (See the rejection of claim 1); compare the resistance of the wound tissue to a resistance threshold (See the rejection of claim 1); and selectively perform a first action or a second action based on the comparison of the resistance to the resistance threshold (See the rejection of claim 1), wherein: the first action includes determining a stage of wound healing of the tissue (see the rejection of claim 1); and the second action includes determining if the tissue is chronic tissue (See the rejection of claim 7. After a time period of 3-4 weeks, a resistance that has not changed would be considered a chronic wound as it has not left the inflammation phase. This would be completed with continued monitoring, and can be considered to be a part of the second action of continued monitoring).
Claims 8 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Drinan in view Kekonen, as applied to claims 4 and 6, in view of US Patent Publication 2021/0330253 by Wright et al. – previously cited, hereinafter “Wright”.
Regarding claim 8, Drinan in view of Kekonen teaches the system of claim 6, but fails to teach: wherein to determine the stage of wound healing based on the first and third impedances, the processor is further configured to determine a remodeling stage based on a rate of change of one of a reactance rate of change being less than a threshold reactance rate of change, or an impedance phase angle rate of change being less than a threshold impedance phase angle rate of change between the first and third impedances.
Wright teaches that the bioimpedance of a wound can be analyzed by using the reactance of and resistance obtained from the wound. A rapid decrease in reactance (i.e., a rate of change less than a threshold rate of change) can indicate a stage of healing of the wound, namely an infection ([0069]). This combination would enable the system to determine if the wound was infected, which would allow the wound to be treated and avoid further complications.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Drinan in view of Kekonen such that wherein to determine the stage of wound healing based on the first and third impedances, the processor is further configured to determine a remodeling stage based on a rate of change of a reactance rate of change being less than a threshold reactance rate of change, as taught by Wright.
It is noted that Wright teaches using the reactance rate being less than a threshold reactance rate of change to determine if the wound is infected. If the wound is infected, then the state of the wound would be infected and not be a remodeling phase. Therefore, the combination of Drinan, Kekonen, and Wright teach determining a state of remodeling as not being in a state of remodeling based on using the reactance rate being less than a threshold reactance rate of change.
Regarding claim 16, Drinan in view of Kekonen teaches the system of claim 4, wherein the processor is further configured to determine a first reactance based on the measured first impedance (Drinan, [0085; Each transdermal impedance has a reactive component); and determine if the tissue is in the inflammation phase, the proliferation phase, remodeling phase, or the healed stage based on the first resistance (The determination of if the wound is a chronic wound is based on the resistance). Drinan in view of Kekonen does not teach wherein the processor is further configured to determine if the tissue is in the inflammation phase, the proliferation phase, remodeling phase, or the healed stage based on the first reactance.
Wright teaches that the bioimpedance of a wound can be analyzed by using the reactance of and resistance obtained from the wound. A rapid decrease in reactance (i.e., a rate of change less than a threshold rate of change) can indicate a stage of healing of the wound, namely an infection. Wright further teaches that increases in the reactance can be used to determine whether proliferation and granulation (proliferation stage) is occurring ([0069]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of Drinan in view of Kekonen such that wherein the processor is further configured to determine if the tissue is in the inflammation phase, the proliferation phase, remodeling phase, or the healed stage based on the first reactance, as taught by Wright. It is noted that the determination of a chronic wound, would result in a determination that the wound is still in the inflammation phase.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Drinan in view of Kekonen, as applied to claim 6, in view of Impedance Sensing Device for Monitoring… by Liao et al. – previously cited, hereinafter, “Liao”.
Drinan in view of Kekonen teaches the system of claim 6, but does not teach wherein the processor is further configured to determine an amount of granulation tissue based on a resistance change between the first and third impedances.
Liao teaches that granulation tissue is highly vascularized and the impedance is consistently lower in magnitude (resistance) than that of healthy tissue (Page 5132, B. Correlation Impedance with Tissue Health). Therefore, a decrease in magnitude (resistance) would correlate to a greater amount of granulation tissue.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the system of claim 6 taught by Drinan and Kekonen such that the processor is further configured to determine an amount of granulation tissue based on a resistance change between the first and third impedances, as taught by Liao (Page 5132, B. Correlation Impedance with Tissue Health). Kekonen teaches that the formation of granulation tissue is one of the most important processes of the proliferation phase (Page 7, 2.1.2 Proliferation phase, par. 1), therefore it would obvious to one of ordinary skill in the art that it would be important to monitor the progress of this process to monitor the health of the wound. It is noted that Drinan teaches that generally speaking, the wounds healing normally become drier and impedance and reactance increases ([0037]). It is noted that this is a general teaching and the changes in resistance and reactance over the specific healing stages need not follow the general trend of increasing as taught by Drinan.
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Drinan in view Kekonen, as applied to claim 11, in view of Liao in view of Wright.
Drinan in view of Kekonen teaches the method of claim 11, but fails to teach: wherein determining the information indicative of the proliferation stage comprises determining that the impedance comprises a resistance less than a first predetermined threshold value and a reactance greater than a second predetermined threshold value.
Liao teaches that granulation tissue (formed during the proliferation phase) has a lower magnitude (resistance) than healthy tissue (Page 5132, B. Correlation Impedance with Tissue Health). Therefore, a decrease in magnitude (resistance) would correlate to the presence of the proliferation phase.
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method of Drinan in view of Kekonen such that determining the information indicative of the proliferation stage comprises determining that the impedance comprises a resistance less than a first predetermined threshold value.
The combination of Drinan, Kekonen, and Liao fails to teach: wherein determining the information indicative of the proliferation stage comprises determining that the impedance comprises a reactance greater than a second predetermined threshold value.
Wright teaches that the bioimpedance of a wound can be analyzed by using the reactance of and resistance obtained from the wound. Wright teaches that increases in the reactance can be used to determine whether proliferation and granulation (proliferation stage) is occurring ([0069]).
It would have been prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to have modified the method taught by Drinan, Kekonen, and Liao such that determining the information indicative of the proliferation stage comprises determining that the impedance comprises a reactance greater than a second predetermined threshold value, as taught by Wright ([0069]). This combination would allow the stage of wound healing to be better categorized, providing more complete understanding of the health of the wound.
Response to Arguments
Applicant’s arguments, filed 05/14/2026 have been fully considered.
The amendments to the claims do not overcome the rejections under 35 U.S.C. 101.
Applicant argues that the rejections under 35 U.S.C. 101 are directed towards "non-statutory subject matter". Examiner agrees that the rejection is better characterized as lacking subject matter eligibility.
Applicant argues that Examiner abstracts away meaning from the claim limitations (identified Abstract Ideas) by extracting individual phrases, and that the recited electrical measurement architecture and conditional workflow give those phrases operative meaning. This argument is not found persuasive. The Abstract Ideas are considered in combination with the logic steps and electrical measurement architecture in step 2B. The electrical measurement architecture comprises contacts (i.e., electrodes) configured to couple to wound tissue, which reads on any electrical contacts used for bioimpedance, and more broadly reads on electrical contacts for other bioelectrical applications (e.g., surface electromyography (sEMG), surface electroencephalography (sEEG)). Therefore, in combination, the claim amounts to these generic electrodes coupled to tissue and a processor configured to perform the Abstract Ideas. Further, the configuration of electrodes configured to contact to the skin of a user and in communication with a processor is considered well-known (See Evidentiary Support below).
Applicant argues that the analysis must be performed in light of the specification, which provides technical context for the claimed electrical measurement operations and recites hardware arrangements including a signal generator, signal monitor, I/O electronics, processing circuitry, dressing, and a computing device. This argument is not found persuasive. Examination in light of the specification does not amount to the inclusion of elements not recited in the claim. The recited electrical measurement architecture in the claims comprises a first device comprising contacts (i.e., electrodes) and a second device comprising a processor. Applicant further argues that the physical components constitute a particular machine. The electrodes and processor recited in the claims do not recite a particular machine as they recite a generic bioimpedance system, or any system configured to measure surface bioelectrical activity (e.g., sEMG, sEEG).
Applicant argues that the functional limitations recited in the claim 10 and 17 are not mental steps, but are drawn to machine-implemented electrical measurement operations tied to recited physical components, and that the application of the electrical signal and measuring of the impedance cannot be performed in the human mind. This argument is not found persuasive. The rejection under 35 U.S.C. 101 does not consider the applying and measuring limitations to be mental steps, but rather characterizes these steps as data gathering activity necessary to perform the Abstract Ideas. A human mind is capable of comparing a resistance to a threshold and selectively choosing a first or second action based on a comparison. Further, simply carrying out limitations with a computer (such as a processor) does not automatically confer eligibility (See MPEP 2106.05(f)).
Applicant argues that the claims recite a particular method of applying electrical signals, a particular method of determining resistance from measured impedance and comparing that resistance to a threshold, and a particular conditional branching structure, and that any mathematical relationship used to derive resistance from impedance is not the focus of the claims. This argument is not found persuasive. The claim contains a plurality of functional limitations, including mathematical concepts, mental processes, and other limitations. In the application of the Subject Matter Eligibility Test, each of the functional limitations (and other limitations) are considered. Therefore, the identification of the mathematical concept is not the sole reason for the determination of a lack of subject matter eligibility. The claim limitations, considered as a whole, do not amount to significantly more than the identified Abstract Ideas.
Applicant argues that the Office action's mental-process characterization is inconsistent with the MPEP, because the claims, when properly read, are directed towards a specific electrical wound-monitoring arrangement. This argument is not found persuasive. The claims are directed towards methods and systems to measure an impedance of wound tissue, perform a comparison, and based on that comparison, either characterizing the comparison or repeating the process. This amount to using electrical impedance (a well-known bioelectrical technique) repeatedly. The claims do not contain any limitations directed towards using the derived stage of wound healing or comparison of the second resistance to effect a particular treatment or change, or an improvement to wound monitoring with bioelectrical impedance.
Applicant argues that the claims improve technical manner in which wound tissue impedance information is acquired, processed and used. This argument is not found persuasive. Applicant has not provided evidence of an improvement in the acquisition or processing of electrical impedance measurements in the claim. The application of electrical signals, measuring of impedance and determining resistance are known methods of bioimpedance measurements. The conditional branching amounts to a mental process of choosing to continue monitoring (i.e., repeating the steps), or using the measurement to determine a stage of wound healing. The determined stage of wound healing is simply determined, it is not relied upon to effect a particular treatment or change, and it is not used to provide an improvement to the field. In page 12 of the response, Applicant points out how the wound is characterized based on resistance, however, the characterization of wound healing is not relied upon in any way.
Applicant argues that the ordered combination of the claim elements enables a simplified, low-cost technique capable of providing real-time, clinically actionable output related to healing, including determination of whether a wound is chronic. This argument is not found persuasive as it is unclear how the claimed invention provides a lower-cost, simplified technique compared to other bioimpedance systems. Further, the argument that the ordered combination provides a real-time, clinically actionable output related to healing, including determination of whether a wound is chronic is moot as the determination does not comprise an output that is clinically actionable, nor do the claims comprise any clinical actions based on the determination, but rather simply a determination.
Applicant argues that the claims recite a specific arrangement and cooperation of the components. This argument is not found persuasive, as the claims reciting contacts configured to couple to a wound tissue or coupling contacts to a wound tissue does not constitute a specific arrangement and applying an electrical signal and measuring an impedance and determining a resistance does not constitute a specific cooperation of components. Both of the identified "specific arrangement" and "specific cooperation" are well-known in the field of bioimpedance. The selective conditional branching logic comprises a mental process of making a judgment based on the comparison or repeating the process based on the comparison. This amounts to a mental process comprising choosing to make a characterization of the well-known measurement, or repeating the well-known measurement.
Applicants arguments regarding the rejections under 35 U.S.C. 103 are acknowledged. Applicant argues that the hydration-related impedance value of Drinan contrasts with the limitation of comparing a wound tissue. This argument is not found persuasive as the measurements of Drinan are directed towards hydration-related impedance values of ulcers and wounds (See title and par. [0018 and 0046]). Applicant’s argues that the neither Drinan or Kekonen teaches the conditional branching logic and that neither Drinan nor Kekonen teaches a system where the chronic tissue determination is selectively triggered bas a part of a conditional branching structure is not found persuasive. The Office action's characterization of continued monitoring reads on the limitations of the second action, which is a repeat of the first action. Selectively performing continued monitoring or the determination of a healing phase of the wound is taught by the combination of Drinan and Kekonen. Kekonen teaches of the importance of determining chronic wounds, which requires at least 3-4 months to elapse before it can be considered a chronic wound. Therefore, it would be obvious to continue monitoring the wound for 3-4 months until the determination of the chronic wound can be made. Conversely, if another stage of wound healing is determined (i.e., proliferation, remodeling, or healed) before 3-4 months, it would be obvious to make that determination (see the rejection of claim 1 above), as this would determine that the wound is not a chronic wound. Further, Drinan teaches the continued determination (i.e., monitoring) of results in par. [0023] and an output of the determination of whether the wound healing is healthy or poor in par. [0094]. Therefore, the combination of Drinan and Kekonen would teach either a determination of the stage of wound healing or continued monitoring until a determination of chronic wound healing is made.
Evidentiary Support
Using electrodes (i.e., contacts) and a computing part (i.e., processor, controller, computer, circuit, etc.) to obtain the impedance signals for the characteristics of skin have been used in multiple research publications. Evaluation of the Skin Surface Hydration in Vivo by Electrical Measurement by Tagami et al. (1980) teaches a method of monitoring the characteristics of a wound (stripped skin) by impedance measurements obtained from electrodes and a measurement circuit. Surface electrical capacitance as an index of epidermal barrier properties of composite skin substitutes and skin autografts by Goretsky et al. (1995) teaches a method of using electrodes to determine the restoration (i.e., healing) of wounds. Surface Electrical Capacitance as a Noninvasive Index of Epidermal Barrier in Cultured Skin Substitutes in Athymic Mice by Boyce et al. (1996) teaches a method of using electrodes and a measurement circuit to determine impedance measurements of wounds while healing. Surgical wound healing monitored repeatedly in vivo using electrical resistance of the epidermis by Spence et al. (1996) teaches using electrodes and an associated circuit to determine the resistance of a wound during healing.
These examples of publications that each use electrodes and a computing part (i.e., processor, controller, computer, circuit, etc.) were published from 24-40 years prior to the effective filing date of the filed invention.
Conclusion
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791
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