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 .
Claims Accounting
Applicant' s arguments, filed 12/08/2025, 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 12/08/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Claims 1-2, 4, and 6-12 have been amended.
Claims 3, 5, and 13-15 have been canceled.
Claims 16-17 are newly presented.
Claims 1-2, 4, 6-12, and 16-17 are the current claims hereby under examination.
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 is directed to non-statutory subject matter. 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 10 follows.
Step 1
Regarding claim 10, the claim recites a series of steps or acts, including selectively performing a first action or a second action based on the comparison of the resistance to the resistance threshold. Thus, the claim is directed to a process, 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 step of selectively performing a first action or a second action based on the comparison of the resistance to the resistance threshold sets forth a judicial exception. This step describes a concept performed in the human mind (including an observation, evaluation, judgment, opinion). Thus, the claim is drawn to a Mental Process, which is an Abstract Idea.
Further, the step of determining a resistance of the tissue based on the measured impedance and comparing the resistance to a resistance threshold set for a judicial exception. 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 exception in a manner that imposes a meaningful limitation on the judicial exception. Claim 10 does not recite any additional limitations that apply, rely on, or use the judicial exception. Therefore the claim fails to use the judicial exception in order to provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change, nor does the method use a particular machine to perform the Abstract Idea.
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 Idea, the claim recites additional steps applying an electrical signal with contacts, measuring an impedance of the tissue. Applying a signal to a tissue and measuring an impedance of the tissue is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the applying and measuring, and outputting 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 medical professionals prior to Applicant's invention.
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-statutory subject matter.
Regarding claims 1 and 17, the systems recited in the claims comprise a 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 method steps of claim 10. The recited first device (claim 1) and contact (claim 17) are analogous to an electrode with contacts, which is a generic device. The recited second device (claim 1) and processor (claim 17) are 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 pertaining to data gathering and the Abstract idea. 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 1-2, 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 to apply an electrical signal to a tissue ([0028-0029, 0040]; Main body 205 contains 245, 250, 255, 260 are configured to conduct current and measure potential of the organism) configured to couple to a tissue ([0043]; Probe 300 is a bandage probe and is capable of being placed on the body); and 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:
apply, with the contacts, a first electrical signal to the tissue ([0028]; “Working electrodes 245, 250 can be adapted to conduct current through or along the probed portion of the monitored 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, 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).
Regarding claim 2, Drinan in view of Kekonen teaches the system of claim 1, wherein the first and second electrical signals include a predetermined frequency ([0036]; Current source 210 drives one or more frequencies of alternating current controlled by controller 235. The electrical signal may be a single predetermined frequency.).
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).
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, an electrical signal to a tissue (See the rejection of claim 1); measuring an impedance of the tissue based on the applied electrical signal (See the rejection of claim 1); determining a resistance of the 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 11, 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 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 to the tissue (See the rejection of claim 1); measure an impedance of the tissue based on the applied electrical signal (See the rejection of claim 1); determine a resistance of the tissue based on the measure impedance (See the rejection of claim 1); compare the resistance of the 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., 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. 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 12/08/2025 have been fully considered.
The amendments to the claims overcome the provisional double patenting rejections of record.
The amendments to the claim do not invoke claim interpretation under 35 U.S.C. 112(f) for any claim limitations.
The amendments to the claims do not overcome the rejection under 35 U.S.C. 101.
Applicant’s assertion regarding the rejection of claims 1 and 10 under 35 U.S.C. 102 is acknowledged. This assertion is moot as it is based on amendments to the claims not entered at the time of the previous Office action. The newly presented limitations are rejected on new grounds above.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/NELSON ALEXANDER GLOVER/Examiner, Art Unit 3791
/ADAM J EISEMAN/Primary Examiner, Art Unit 3791