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 .
Status of Claims
Applicant' s arguments, filed 10/02/2025, have been fully considered. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Applicants have amended their claims, filed 10/02/2025, and therefore rejections newly made in the instant office action have been necessitated by amendment.
Applicant has newly added claims 21-23 in the response filed on 10/02/2025, which have been acknowledged and entered.
Applicant canceled claims 3, 7, and 16 in the response filed on 10/02/2025.
Claims 1-2, 4-6, 8-15, and 17-23 are the current claims hereby under examination.
Claim Objections
Claim 8 is objected to because of the following informalities: "monitor healing of the first tissue" should read "monitoring healing of the first tissue". Appropriate correction is required.
Claim 10 is objected to because of the following informalities: "the corresponding applied first electrical signals" should read "the corresponding plurality of applied first electrical signals" for claim language consistency. Appropriate correction is required.
Claim 12 is objected to because of the following informalities: "the first set of contacts and the second set of contacts" should read "the first set of electrical contacts and the second set of electrical contacts" for claim language consistency. Appropriate correction is required.
Claims 4 and 14 are objected to because of the following informalities: "the impedance phase angle" should read "the first impedance phase angle" and "the predetermined frequency" should read "the predetermined single frequency". Appropriate correction is required.
Claim 5, 6, and 15 are objected to because of the following informalities: "the single frequency" should read "the predetermined single frequency" for claim language consistency. Appropriate correction is required.
Claims 18 and 19 are objected to because of the following informalities: "the first electrical contacts" should read "the first set of electrical contacts" and "each of the first electrical signals being applied" should read "the plurality of the first electrical signal each being applied" for claim language consistency. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 20-23 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Regarding Claim 20, the claim recites “a processor operable to:… detect a rate of wound healing of the first tissue based on a ratio of the first impedance phase angle and the second impedance phase angle”. In paragraph [0087] of the specification as filed, Applicant discloses “normalized impedance phase angle may be used to track wound healing versus time and may be a metric usable to asses and/or compare relative rates and quality of healing”. However, the specification as filed, fails to adequately disclose a processor is operable to detect a rate of wound healing of the first tissue based on a ratio of the first impedance phase angle and the second impedance phase angle. Therefore, claim 20 is rejected due to lack of adequate written description.
Regarding Claims 21-23, the claims recite determining “if an action is required based on the ratio, wherein the action includes one of changing a dressing at the first tissue, cleaning the first tissue, or administering therapeutics to the first tissue, or combinations thereof”. In paragraph [0033] of the specification as filed, Applicant discloses “simply knowing if (and to what degree) a wound is healing or not will inform clinicians or the patient/customer if intervention is required or not (e.g., changing the dressing, cleaning the wound, administering therapeutics to the wound)” as an advantage to monitoring wound healing without removing a dressing. However the specification as filed, has failed to link these interventions with the system, method, and dressing recited in the claims. Specifically, there is not adequate description of determining an action is required based on the ratio. Therefore, claims 21-23 are rejected due to lack of adequate written description.
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 4-6 and 10-11 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.
Regarding Claim 4, the claim recites “determine the impedance phase angle”. It is unclear if the impedance phase angle to be determined is the first impedance phase angle or the baseline impedance phase angle. Therefore, claim 4 is rendered indefinite. For the purposes of examination, the impedance phase angle to be determined is herein interpreted to be the first impedance phase angle or the baseline impedance phase angle. Claims 5 and 6 are rejected due to their dependence on claim 5.
Regarding Claims 10 and 11, the claims recite “monitor healing of the first tissue based on… one or more baseline impedance phase angles”. It is unclear how more than one baseline impedance phase angles can be used to monitor healing of the first tissue when claim 1, from which claims 10 and 11 are dependent, only "determine(s) a baseline impedance phase angle". Therefore, claims 10 and 11 is rendered indefinite. For the purposes of examination, “monitor healing of the first tissue based on… one or more baseline impedance phase angles” is herein interpreted to be monitor healing of the first tissue based on… the baseline impedance phase angle.
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, 8-15, and 17-23 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 13 follows.
STEP 1
Regarding claim 13, the claim recites a series of steps or acts, including monitoring based on a ratio of the first impedance phase angle and the baseline impedance phase angle. 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 monitoring healing of the first tissue based on a ratio of the first impedance phase angle and the baseline impedance phase angle 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.
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 13 fails to recite any additional elements that integrate the judicial exception into a practical application. Monitoring healing of the first tissue does not provide an improvement to the technological field, the method does not effect a particular treatment or effect a particular change based on monitoring healing of the first tissue, 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 of applying a first electrical signal through a first tissue via a first set of electrical contacts, wherein the first tissue corresponds to wounded tissue; applying a second electrical signal through a second tissue via a second set of electrical contacts, wherein the second tissue corresponds to healthy tissue spaced away from the first tissue; determining a first impedance phase angle of the first tissue based on the first applied electrical signal; and determining a baseline impedance phase angle based on the second applied electrical signal. Applying a stimulus (first and second electrical signals) to obtain data (impedance phase angles) is well-understood, routine and conventional activity for those in the field of medical diagnostics. Obtaining data (first impedance phase angle) in order to compare it to baseline data taken under known conditions (baseline impedance phase angle) is well-understood, routine and conventional activity for those in the field of medical diagnostics. Further, the applying an electrical signal through a tissue via a set of electrical contacts step is 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. Furthermore, 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)).
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 claim 1, the device recited in the claim is a generic device comprising generic components configured to perform the abstract idea. The recited electrical contacts are generic electrodes configured to perform pre-solutional data gathering activity. The recited processor is a generic computer component 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.
Regarding claim 20, the device recited in the claim is a generic dressing comprising generic components configured to perform the abstract idea. The recited electrical contacts are generic electrodes configured to perform pre-solutional data gathering activity. The recited backing and adhesive are generic components of a dressing and the recited processor is generic processing circuitry 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 dependent claims also fail to add something more to the abstract independent claims as they generally recite method steps pertaining to data gathering. The determining steps recited in the independent claims maintain a high level of generality even when considered in combination with the dependent claims. Dependent claims 2, 4-6, 9-11, 14-15, and 18-19 further limit their respective independent claims with regards to how the electrical signals are applied and how impedance phase angles are determined. Dependent claims 8 and 17 further limit their respective independent claims by further defining “monitoring healing of the first tissue”. Dependent claim 12 further limits the structural relationship between the first and second sets of electrical contacts. Dependent claims 21-23 further limit their respective independent claims with regards to the ratio. Determining if an action is required based on the ratio is merely adding insignificant extra-solution activity to the judicial exception as it does not provide an improvement to the technological field, effect a particular treatment, or a particular change based on the determination if an action is required.
Claim Rejections - 35 USC § 102
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 4-6, 8, 11-15, 17, and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by McAdams (WO 2004049937 A1 – previously cited).
Regarding Claim 1, McAdams discloses a system (Figure 9 is a block diagram of a wound mapping system (pg. 8, line 22)) comprising:
a first set of electrical contacts configured to be coupled to a first tissue and apply a first signal thereto, wherein the first tissue corresponds to wounded tissue (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); figs 7-9; Examiner notes that any one of the test electrodes 10 shown in figures 7 and 8 can serve as the first set of electrical contacts);
a second set of electrical contacts configured to be coupled to a second tissue and apply a second electrical signal thereto (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); figs 7-9; Examiner notes that any one of the test electrodes 10 shown in figures 7 and 8 can serve as the first set of electrical contacts), wherein the second tissue corresponds to healthy tissue spaced away from the first tissue (Mapping, for example, the low-frequency impedance of skin sites in and around a wound site will evidence clearly the major differences between healthy skin (high impedance) and the wound (low impedance). (pg. 5, lines 30-32); an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16 (pg. 6, lines 21-22); fig 5; Examiner notes that figure 5 shows test electrodes 10 in contact with both healthy tissue 16 and wounded tissue 14);
a processor in communication with the first and second sets of electrical contacts (An impedance analyser 64 is connected to the electrode array via the interface circuit 62 and the rotary switch 50 (pg. 11, lines 30-31); fig 9), wherein the processor is configured to:
determine a first impedance phase angle based on the first applied electrical signal (If an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16, the individual impedances of the tissue underlying each test electrode 10 can be used to create a two-dimensional map of the wound. (pg. 6, lines 21-23); phase angle measured at a given frequency (pg. 13, line 14));
determine a baseline impedance phase angle based on the second applied electrical signal (the low-frequency impedance of skin sites in and around a wound site will evidence clearly the major differences between healthy skin (high impedance) and the wound (low impedance) (pg. 5, lines 30-32); phase angle measured at a given frequency (pg. 13, line 14));
and monitor healing of the first tissue based on a ratio of the first impedance phase angle and the baseline impedance phase angle (For research purposes, for example, to study the effects of electromagnetic fields on wound healing, one may be interested in measuring the skin or tissue impedances over a wide frequency range using numerous frequencies. Maps of the calculated parameters of mathematical models (e.g. Cole equation (equation 1 )) or equivalent circuit models (e.g. Figure 4) may then be presented on a monitor screen or printed for records. Alternatively, for example, the areas of specific regions as revealed by impedance parameters, ratios of parameters or other calculations involving such parameters may be calculated and presented, dispensing with the need to present, inspect and interpret maps. (pg. 13, lines 1-8); Maps of calculations based on the following can be used to highlight difference regions in the wound site and differences in the tissues involved:
(i) Magnitude of the impedance (or admittance or similar electrical property) (modulus, real and imaginary components) and phase angle measured at a given frequency. (ii) Ratios of the above where two or more such measurements are carried out at different frequencies. (pg. 13, lines 10-16)).
Regarding Claim 2, McAdams discloses the invention as discussed above in claim 1. McAdams further discloses wherein to determine the first impedance phase angle, the processor is configured to determine a phase angle of a voltage of the first applied electrical signal and a phase angle of a current of the first applied electrical signal, and determine the first impedance phase angle based on a difference in the phase angle of the voltage of the first applied electrical signal and the phase angle of the current of the first applied electrical signal (The electrode-skin interface impedance Z-i under study is simply obtained by dividing the measured voltage drop ΔV by the applied current I. (pg. 10, lines 30-31); the impedance analyser 64 is actuated to generate an alternating test current and measure the resulting impedance of the tissue under the currently selected test electrode 10 according to the principles described with reference to Figure 6 (pg. 11, lines 32-34)).
Regarding Claim 4, McAdams discloses the invention as discussed above in claim 1. McAdams further discloses wherein to apply the first electrical signal, the first set of electrical contacts is configured to apply a sinusoidal wave at a predetermined single frequency (For each test electrode the measurement may be made at one AC frequency (pg. 12, line 8)), and wherein to determine the first impedance phase angle, the processor is configured to determine the impedance phase angle at the predetermined frequency (phase angle measured at a given frequency (pg. 13, line 14); the impedance analyser 64 is actuated to generate an alternating test current and measure the resulting impedance of the tissue under the currently selected test electrode 10 according to the principles described with reference to Figure 6 (pg. 11, lines 32-34)).
Regarding Claim 5, McAdams discloses the invention as discussed above in claim 4. McAdams further discloses wherein the single frequency is in range of approximately 10 kHz to 300 kHz (a suitable range of frequencies is from 1 milliHz to 100 kHz, preferably from 1 Hz to 50 kHz (pg. 12, lines 10-11)).
Regarding Claim 6, McAdams discloses the invention as discussed above in claim 4. McAdams further discloses wherein the single frequency is approximately 100 kHz (“a suitable range of frequencies is from 1 milliHz to 100 kHz, preferably from 1 Hz to 50 kHz” (pg. 12, lines 10-11)).
Regarding Claim 8, McAdams discloses the invention as discussed above in claim 1. McAdams further discloses wherein monitoring healing of the first tissue comprises monitoring an amount of new epithelial monolayer regenerated in the tissue, amount of size or thickness of regenerated epithelium, or relative maturation of stratus corneum, or combinations thereof (when the stratum corneum at a given skin site is punctured, abraded or absent (as a consequence of trauma or disease, for example) the measured low- frequency impedance at the site will be dramatically reduced due the absence of the large stratum corneum impedance (pg. 5, lines 23-26); monitor the skin's electrical impedance and thus to assess the size, shape, depth and composition of the wound (pg. 6, lines 16-17); changes in the wound shape and size can be followed using this technique. (pg. 6, lines 25-26)).
Regarding Claim 11, McAdams discloses the invention as discussed above in claim 1. McAdams further discloses wherein the first set of electrical contacts is configured to apply a plurality of first electrical signals through the first tissue, each first electrical signal being applied at each of a plurality of predetermined locations within the first tissue (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); fig 9; Examiner notes that each test electrode 10 applies a first electrical signal at a predetermined location), wherein the processor is configured to:
determine a plurality of first impedance phase angles of the first tissue corresponding to the plurality of predetermined locations and based on the corresponding plurality of applied first electrical signals (If an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16, the individual impedances of the tissue underlying each test electrode 10 can be used to create a two-dimensional map of the wound. (pg. 6, lines 21-23); phase angle measured at a given frequency (pg. 13, line 14));
and monitor healing of the first tissue based on a plurality of ratios of the plurality of first impedance phase angles and the baseline impedance phase angles (For research purposes, for example, to study the effects of electromagnetic fields on wound healing, one may be interested in measuring the skin or tissue impedances over a wide frequency range using numerous frequencies. Maps of the calculated parameters of mathematical models (e.g. Cole equation (equation 1 )) or equivalent circuit models (e.g. Figure 4) may then be presented on a monitor screen or printed for records. Alternatively, for example, the areas of specific regions as revealed by impedance parameters, ratios of parameters or other calculations involving such parameters may be calculated and presented, dispensing with the need to present, inspect and interpret maps. (pg. 13, lines 1-8); Maps of calculations based on the following can be used to highlight difference regions in the wound site and differences in the tissues involved:
(i) Magnitude of the impedance (or admittance or similar electrical property) (modulus, real and imaginary components) and phase angle measured at a given frequency. (ii) Ratios of the above where two or more such measurements are carried out at different frequencies. (pg. 13, lines 10-16)).
Regarding Claim 12, McAdams discloses the invention as discussed above in claim 1. McAdams further discloses the first set of contacts and the second set of contacts are coupled to a single dressing (an array of test electrodes 10, incorporated in a wound dressing 12 (pg. 6, lines 21-22)).
Regarding Claim 13, McAdams discloses a method (a method of mapping tissue (pg. 6, line 7)) comprising:
applying a first electrical signal through a first tissue via a first set of electrical contacts, wherein the first tissue corresponds to wounded tissue (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); figs 7-9; Examiner notes that any one of the test electrodes 10 shown in figures 7 and 8 can serve as the first set of electrical contacts);
applying a second electrical signal through a second tissue via a second set of electrical contacts (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); figs 7-9; Examiner notes that any one of the test electrodes 10 shown in figures 7 and 8 can serve as the first set of electrical contacts), wherein the second tissue corresponds to healthy tissue spaced away from the first tissue (Mapping, for example, the low-frequency impedance of skin sites in and around a wound site will evidence clearly the major differences between healthy skin (high impedance) and the wound (low impedance). (pg. 5, lines 30-32); an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16 (pg. 6, lines 21-22); fig 5; Examiner notes that figure 5 shows test electrodes 10 in contact with both healthy tissue 16 and wounded tissue 14);
determining a first impedance phase angle of the first tissue based on the first applied electrical signal (If an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16, the individual impedances of the tissue underlying each test electrode 10 can be used to create a two-dimensional map of the wound. (pg. 6, lines 21-23); phase angle measured at a given frequency (pg. 13, line 14));
determining a baseline impedance phase angle based on the second applied electrical signal (the low-frequency impedance of skin sites in and around a wound site will evidence clearly the major differences between healthy skin (high impedance) and the wound (low impedance) (pg. 5, lines 30-32); phase angle measured at a given frequency (pg. 13, line 14));
and monitoring healing of the first tissue based on a ratio of the first impedance phase angle and the baseline impedance phase angle (For research purposes, for example, to study the effects of electromagnetic fields on wound healing, one may be interested in measuring the skin or tissue impedances over a wide frequency range using numerous frequencies. Maps of the calculated parameters of mathematical models (e.g. Cole equation (equation 1 )) or equivalent circuit models (e.g. Figure 4) may then be presented on a monitor screen or printed for records. Alternatively, for example, the areas of specific regions as revealed by impedance parameters, ratios of parameters or other calculations involving such parameters may be calculated and presented, dispensing with the need to present, inspect and interpret maps. (pg. 13, lines 1-8); Maps of calculations based on the following can be used to highlight difference regions in the wound site and differences in the tissues involved:
(i) Magnitude of the impedance (or admittance or similar electrical property) (modulus, real and imaginary components) and phase angle measured at a given frequency. (ii) Ratios of the above where two or more such measurements are carried out at different frequencies. (pg. 13, lines 10-16)).
Regarding Claim 14, McAdams discloses the invention as discussed above in claim 13. McAdams further discloses wherein applying the first electrical signal comprises applying a sinusoidal wave at a predetermined single frequency (For each test electrode the measurement may be made at one AC frequency (pg. 12, line 8)),
and wherein determining the first impedance phase angle comprises determining the impedance phase angle at the predetermined frequency (phase angle measured at a given frequency (pg. 13, line 14); the impedance analyser 64 is actuated to generate an alternating test current and measure the resulting impedance of the tissue under the currently selected test electrode 10 according to the principles described with reference to Figure 6 (pg. 11, lines 32-34)).
Regarding Claim 15, McAdams discloses the invention as discussed above in claim 14. McAdams further discloses wherein the single frequency is in range of approximately 10 kHz to 300 kHz (a suitable range of frequencies is from 1 milliHz to 100 kHz, preferably from 1 Hz to 50 kHz (pg. 12, lines 10-11)).
Regarding Claim 17, McAdams discloses the invention as discussed above in claim 13. McAdams further discloses wherein monitoring healing of the first tissue comprises monitoring an amount of new epithelial monolayer regenerated in the tissue, amount of size or thickness of regenerated epithelium, or relative maturation of stratus corneum, or combinations thereof (when the stratum corneum at a given skin site is punctured, abraded or absent (as a consequence of trauma or disease, for example) the measured low- frequency impedance at the site will be dramatically reduced due the absence of the large stratum corneum impedance (pg. 5, lines 23-26); monitor the skin's electrical impedance and thus to assess the size, shape, depth and composition of the wound (pg. 6, lines 16-17); changes in the wound shape and size can be followed using this technique. (pg. 6, lines 25-26)).
Regarding Claim 19, McAdams discloses the invention as discussed above in claim 13. McAdams further discloses the method further comprises: applying a plurality of first electrical signals through the first tissue via the first electrical contacts, each of the first signals being applied at a plurality of predetermined locations at the first tissue (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); fig 9; Examiner notes that each test electrode 10 applies a first electrical signal at a predetermined location);
determining a plurality of first impedance phase angles of the first tissue corresponding to the plurality of predetermined locations and based on the plurality of applied first electrical signals (If an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16, the individual impedances of the tissue underlying each test electrode 10 can be used to create a two-dimensional map of the wound. (pg. 6, lines 21-23); phase angle measured at a given frequency (pg. 13, line 14));
and monitoring healing of the first tissue based on a plurality of ratios of the plurality of first impedance phase angles and the baseline impedance phase angle (For research purposes, for example, to study the effects of electromagnetic fields on wound healing, one may be interested in measuring the skin or tissue impedances over a wide frequency range using numerous frequencies. Maps of the calculated parameters of mathematical models (e.g. Cole equation (equation 1 )) or equivalent circuit models (e.g. Figure 4) may then be presented on a monitor screen or printed for records. Alternatively, for example, the areas of specific regions as revealed by impedance parameters, ratios of parameters or other calculations involving such parameters may be calculated and presented, dispensing with the need to present, inspect and interpret maps. (pg. 13, lines 1-8); Maps of calculations based on the following can be used to highlight difference regions in the wound site and differences in the tissues involved:
(i) Magnitude of the impedance (or admittance or similar electrical property) (modulus, real and imaginary components) and phase angle measured at a given frequency. (ii) Ratios of the above where two or more such measurements are carried out at different frequencies. (pg. 13, lines 10-16)).
Claim Rejections - 35 USC § 103
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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 9, 10, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAdams (WO2004049937 A1 – previously cited) as applied to claims 1 and 13 above, and further in view of Petrofsky (US Patent. Pub. No. 20040147977 – previously cited).
Regarding Claim 9, McAdams discloses the invention as discussed above in claim 1. McAdams fails to disclose the first tissue is monitored without using a magnitude of the first applied electrical signal.
However, Petrofsky teaches determining an impedance phase angle without using a magnitude of an applied electrical signal (the impedance across any pair of electrodes can be measured… Phase angle can be measured by cross comparing the phase of the sine wave between A-D 4 48 and A-D 0 50, A-D 1 52, A-D 2 54 and A-D 3 56 [0070]).
Petrofsky is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to modify the system of McAdams such that the first tissue is monitored without using a magnitude of the first applied electrical signal, as taught by Petrofsky. As taught by Petrofsky, it is known in the art to determine impedance angles when the magnitude is unknown. All the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 (2007) (see MPEP §§ 2143, A. and 2143.02).
Regarding Claim 10, McAdams discloses the invention as discussed above in claim 1. McAdams fails to disclose wherein the first set of electrical contacts is configured to apply a plurality of first electrical signals through the first tissue, each signal being applied at each of a plurality of predetermined times over a period of time,
wherein the processor is configured to: determine a plurality of first impedance phase angles of the first tissue based on the corresponding applied first electrical signals at each of the plurality of predetermined times;
and monitor healing of the first tissue based on a plurality of ratios of the plurality of first impedance phase angles and one or more baseline impedance phase angles.
However, Petrofsky teaches a device configured to apply a plurality of first electrical signals through tissue via electrical contacts, each signal being applied at each of a plurality of predetermined times over a period of time (the electrode placement and cross sectional area of the electrodes varied, the extent of the sores (stages I-IV) varied, as did the length of time the areas were stimulated. [0011]). Petrofsky also teaches “applying a positive current for a long period of time may be good for one part of the wound, but may be very poor for another portion of the wound, and may in fact inhibit healing” [0014].
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the system of McAdams such that the first set of electrical contacts is configured to apply a plurality of first electrical signals through the first tissue, each signal being applied at each of a plurality of predetermined times over a period of time, as taught by McAdams, because it would better healing of the wounded tissue by customizing the time a plurality of first electrical signals are applied. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
The modified system of McAdams in view of Petrofsky teaches the processor is configured to: determine a plurality of first impedance phase angles of the first tissue based on the corresponding applied first electrical signals at each of the plurality of predetermined times;
and monitor healing of the first tissue based on a plurality of ratios of the plurality of first impedance phase angles and one or more baseline impedance phase angles.
Regarding Claim 18, McAdams discloses the invention as discussed above in claim 13. McAdams fails to disclose the method further comprising:
applying a plurality of first electrical signals through the first tissue via the first electrical contacts, each of the first signals being applied at a plurality of predetermined times;
determining a plurality of first impedance phase angles of the first tissue corresponding to the plurality of predetermined times and based on the plurality of applied first electrical signals;
and monitoring healing of the first tissue based on a plurality of ratios of the plurality of first impedance phase angles and the baseline impedance phase angle.
However, Petrofsky teaches a device configured to apply a plurality of first electrical signals through tissue via electrical contacts, each signal being applied at each of a plurality of predetermined times over a period of time (the electrode placement and cross sectional area of the electrodes varied, the extent of the sores (stages I-IV) varied, as did the length of time the areas were stimulated. [0011]). Petrofsky also teaches “applying a positive current for a long period of time may be good for one part of the wound, but may be very poor for another portion of the wound, and may in fact inhibit healing” [0014].
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of McAdams such that the method includes applying a plurality of first electrical signals through the first tissue via the first electrical contacts, each of the first signals being applied at a plurality of predetermined times, as taught by McAdams, because it would better healing of the wounded tissue by customizing the time a plurality of first electrical signals are applied. The combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395 – 97 (2007) (see MPEP § 2143, A.).
The modified method of McAdams in view of Petrofsky teaches determining a plurality of first impedance phase angles of the first tissue corresponding to the plurality of predetermined times and based on the plurality of applied first electrical signals; and monitoring healing of the first tissue based on a plurality of ratios of the plurality of first impedance phase angles and the baseline impedance phase angle.
Claim(s) 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAdams (WO2004049937 A1 – previously cited), and further in view of Kekonen et al. (WO 2018220121 A1) hereinafter Kekonen.
Regarding Claim 20, McAdams discloses a dressing (a wound dressing (pg. 6, line 11)), comprising:
a backing (insulating substrate 18 (pg. 8, lines 27));
an adhesive to couple the backing to a patient (A hydrogel layer 32 is used as an electrode gel as hydrogels are well tolerated by the skin and are currently used in wound dressings (e.g. SW 200 or SW 206 hydrogels from First Water, Ramsbury, England) (pg. 9, lines 16-18); fig 8; Examiner notes that the hydrogel layer 32 serves as an adhesive to couple the substrate 18 to a patient);
a first set of electrical contacts coupled to the backing (a rectangular 5 x 5 array of test electrodes 10 is screen printed onto a thin flexible insulating substrate 18 (pg. 26-27); figs 7-8) and configured to apply a first electrical signal to a first tissue (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); figs 7-9; Examiner notes that any one of the test electrodes 10 shown in figures 7 and 8 can serve as the first set of electrical contacts);
a second set of electrical contacts coupled to the backing (a rectangular 5 x 5 array of test electrodes 10 is screen printed onto a thin flexible insulating substrate 18 (pg. 26-27); figs 7-8) and configured to apply a second electrical signal to a second tissue (a set of test electrodes for application to the surface of tissue under investigation (pg. 5, lines 37-38); the test electrodes 10 may be used to apply iontophoretic or other therapeutic electrical signals to the wound. In that case a suitable therapeutic signal generator 68 is connected to the interface circuitry 62, and the latter contains switching circuits which switch over... to the signal generator 68 when it is desired to apply such therapy (pg. 12, lines 14-18); figs 7-9; Examiner notes that any one of the test electrodes 10 shown in figures 7 and 8 can serve as the second set of electrical contacts), wherein the second tissue corresponds to tissue that is healthier than the first tissue and is spaced away from the first tissue (Mapping, for example, the low-frequency impedance of skin sites in and around a wound site will evidence clearly the major differences between healthy skin (high impedance) and the wound (low impedance). (pg. 5, lines 30-32); an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16 (pg. 6, lines 21-22); fig 5; Examiner notes that figure 5 shows test electrodes 10 in contact with both healthy tissue 16 and wounded tissue 14);
and a processor (An impedance analyser 64 is connected to the electrode array via the interface circuit 62 and the rotary switch 50 (pg. 11, lines 30-31); fig 9) configured to:
determine a first impedance phase angle of the first tissue based on the first applied electrical signal (If an array of test electrodes 10, incorporated in a wound dressing 12, is located over a wound site 14 in intact skin 16, the individual impedances of the tissue underlying each test electrode 10 can be used to create a two-dimensional map of the wound. (pg. 6, lines 21-23); phase angle measured at a given frequency (pg. 13, line 14));
determine a second impedance phase angle of the second tissue based on the second applied electrical signal (the low-frequency impedance of skin sites in and around a wound site will evidence clearly the major differences between healthy skin (high impedance) and the wound (low impedance) (pg. 5, lines 30-32); phase angle measured at a given frequency (pg. 13, line 14));
and monitoring healing of the first tissue based on a ratio of the first impedance phase angle and the second impedance phase angle(For research purposes, for example, to study the effects of electromagnetic fields on wound healing, one may be interested in measuring the skin or tissue impedances over a wide frequency range using numerous frequencies. Maps of the calculated parameters of mathematical models (e.g. Cole equation (equation 1 )) or equivalent circuit models (e.g. Figure 4) may then be presented on a monitor screen or printed for records. Alternatively, for example, the areas of specific regions as revealed by impedance parameters, ratios of parameters or other calculations involving such parameters may be calculated and presented, dispensing with the need to present, inspect and interpret maps. (pg. 13, lines 1-8); Maps of calculations based on the following can be used to highlight difference regions in the wound site and differences in the tissues involved:
(i) Magnitude of the impedance (or admittance or similar electrical property) (modulus, real and imaginary components) and phase angle measured at a given frequency. (ii) Ratios of the above where two or more such measurements are carried out at different frequencies. (pg. 13, lines 10-16)).
McAdams fails to disclose the processor is configured to detect a rate of wound healing of the first tissue based on a ratio of the first impedance phase angle and the second impedance phase angle.
However, Kekonen teaches monitoring healing of a first tissue comprises detecting a rate of wound healing of the first tissue based on a ratio of a first impedance phase angle and a second impedance phase angle (The wound healing may be determined based on the change of the Z(f.sub.n).sub.ratio over time, Z(f.sub.n).sub.ratio at a high end 304 of the frequency range, Z(f.sub.n).sub.ratio at a low end 304 of the frequency range and/or decreasing difference between Z(f.sub.n).sub.ratio at a high end 304 and low end 306 of the frequency range. [0048]; Examiner notes Z(f.sub.n).sub.ratio is a ratio of the wound impedance and the reference impedance and the formula can be found in paragraph [0040]). Kekonen also teaches the relationship between skin impedance and wound healing (At the high end of the frequency range the measured impedance is significantly affected by the capability of the cellular membranes to conduct electricity. The capability of the cellular membranes to conduct electricity is negatively affected by missing and/or damaged cellular membranes in the wound, whereby at the beginning of the healing, the wound impedance Z(f.sub.n).sub.w is high. When the healing of the wound progresses, cells are generated and cellular membranes are reconstructed, whereby the capability of the wound to conduct electricity is improved and the wound impedance is decreased. The healing of the wound may be observed from the frequency response at the high end of the frequency range, where the impedance of the wound is first higher than the reference impedance and the frequency response decreases from the first day to the ninth day as the healing proceeds. At the high end of the frequencies the capability of the cellular membranes to conduct electricity is better than the bulk extracellular fluid and the current will travel via the cellular membranes and through the extracellular fluid between the cells. One or more thresholds may be determined for the Z(f.sub.n).sub.rati.sub.0 for determining corresponding levels of wound healing from the Z(f.sub.n).sub.rati.sub.0 meeting a specific threshold. [0049]… At the low end of the frequencies the impedance of the wound is first lower than the reference impedance and the frequency response increases from the first day to the ninth day as the healing proceeds and the swelling diminishes. Accordingly, the frequency response at the low end of the frequencies may particularly indicate an amount of extracellular fluid for example in lymphedema. [0050]).
Kekonen is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the dressing of McAdams such that the processor is configured to detect a rate of wound healing of the first tissue based on a ratio of the first impedance phase angle and the second impedance phase angle, as taught by Kekonen, because it can provide more detailed information regarding the progression of wound healing.
Claim(s) 21-22 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAdams (WO2004049937 A1 – previously cited) as applied to claims 1 and 13 above, and further in view of Martinez et al. (US Patent Pub. No. 20200297255) hereinafter Martinez.
Regarding Claim 21, McAdams discloses the invention as discussed above in claim 1. McAdams fails to disclose the processor is further operable to determine if an action is required based on the ratio, wherein the action includes one of changing a dressing at the first tissue, cleaning the first tissue, or administering therapeutics to the first tissue, or combinations thereof.
However, Martinez teaches electrical measurements from a smart wound dressing applied to a wound can be used to determine if any actions, such as changing the smart wound dressing, cleaning the wound, or administering therapeutics to the wound, or combinations thereof, are required (Replacing OPSBs enables wound monitoring over longer periods of time; (v) the wearable potentiostat wirelessly reports quantitative information about the status of the wound, which can be used to inform the patient and remote medical staff about the need to change the bandage, disinfect the wound, or apply preventive treatment. [0080]).
Martinez is considered analogous art to the present invention because it is directed towards the same field of endeavor.
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the system of McAdams such that the processer is further operable to determine if an action is required based on the ratio, wherein the action includes one of changing a dressing at the first tissue, cleaning the first tissue, or administering therapeutics to the first tissue, or combinations thereof, as taught by Martinez, because it would improve wound healing.
Regarding Claim 22, McAdams discloses the invention as discussed above in claim 13. McAdams fails to disclose the method further comprises determining if an action is required based on the ratio, wherein the action includes one of changing a dressing at the first tissue, cleaning the first tissue, or administering therapeutics to the first tissue, or combinations thereof.
However, Martinez teaches electrical measurements from a smart wound dressing applied to a wound can be used to determine if any actions, such as changing the smart wound dressing, cleaning the wound, or administering therapeutics to the wound, or combinations thereof, are required (Replacing OPSBs enables wound monitoring over longer periods of time; (v) the wearable potentiostat wirelessly reports quantitative information about the status of the wound, which can be used to inform the patient and remote medical staff about the need to change the bandage, disinfect the wound, or apply preventive treatment. [0080]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the method of McAdams such that it includes determining if an action is required based on the ratio, wherein the action includes one of changing a dressing at the first tissue, cleaning the first tissue, or administering therapeutics to the first tissue, or combinations thereof, as taught by Martinez, because it would improve wound healing.
Claim(s) 23 is/are rejected under 35 U.S.C. 103 as being unpatentable over McAdams (WO2004049937 A1 – previously cited) in view of Kekonen (WO 2018220121 A1) as applied to claim 20 above, and further in view of Martinez et al. (US Patent Pub. No. 20200297255) hereinafter Martinez.
Regarding Claim 23, McAdams in view of Kekonen teaches the invention as discussed above in claim 20. McAdams in view of Kekonen fails to teach the processor is further operable to determine if an action is required based on the ratio, wherein the action includes one of changing a dressing at the first tissue, cleaning the first tissue, or administering therapeutics to the first tissue, or combinations thereof.
However, Martinez teaches electrical measurements from a smart wound dressing applied to a wound can be used to determine if any actions, such as changing the smart wound dressing, cleaning the wound, or administering therapeutics to the wound, or combinations thereof, are required (Replacing OPSBs enables wound monitoring over longer periods of time; (v) the wearable potentiostat wirelessly reports quantitative information about the status of the wound, which can be used to inform the patient and remote medical staff about the need to change the bandage, disinfect the wound, or apply preventive treatment. [0080]).
It would have been obvious to one having ordinary skill in the art at the time of the effective filing date to have modified the dressing of McAdams in view of Kekonen such that the processer is further operable to determine if an action is required based on the ratio, wherein the action includes one of changing a dressing at the first tissue, cleaning the first tissue, or administering therapeutics to the first tissue, or combinations thereof, as taught by Martinez, because it would improve wound healing.
Response to Arguments
Applicant’s arguments, see page 9 of Remarks, filed 10/02/2025, with respect to the drawing objections have been fully considered and are persuasive. The objection of drawings has been withdrawn.
Applicant’s arguments, see page 9 of Remarks, filed 10/02/2025 with respect to the objections of claims 1, 2, 9, 10, 13, 14, 16, and 18-20 have been fully considered and are partially persuasive. The previous objection to claim 14 has been maintained. The previous objections to claims 1, 2, 9, 10, 13, 16, 18, 19, and 20 have been withdrawn. However, upon further consideration, a new ground(s) of objection is made in view of Applicant’s amendments.
Applicant’s arguments, see pages 9-10 of Remarks, filed 10/02/2025, with respect to claim interpretations under 35 U.S.C. 112(f) have been fully considered and are persuasive. The claim interpretations under 35 U.S.C. 112(f) have been withdrawn.
Applicant’s arguments, see page 10 of Remarks, filed 10/02/2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C 112(b) have been fully considered and are partially persuasive. The previous rejections of claims 4-6 and 10 have been maintained. The previous rejections of claims 1-3, 7-9, and 12-20 have been withdrawn.
Applicant’s arguments, see page 10 of Remarks, filed 10/02/2025, with respect to the rejection(s) of claim(s) 1-20 under 35 U.S.C 101 have been fully considered and are not persuasive because Applicant has failed to provide any actual arguments. While, Applicant asserts the amendments overcome the 35 U.S.C. 101 rejections, as discussed in paragraph 18 above, they do not. As such, the previous rejections of claims 1-2, 4-6, 8-15, and 17-20 have been maintained and a new grounds of rejection for claims 21-23 is made in view of Applicant’s amendments.
Applicant’s arguments, see pages 10-13 of Remarks, filed 10/02/2025, with respect to the prior art rejections have been fully considered but are not persuasive and are moot in view of the new grounds of rejections. Applicant argues that McAdams fails to disclose a second set of electrical contacts configured to be coupled to a second tissue and apply a second electrical signal thereto, wherein the second tissue corresponds to healthy tissue and is spaced away from the first tissue. Examiner respectfully disagrees. McAdams discloses arrays of test electrodes capable of applying electrical signals that are in contact with both healthy and wounded tissue. Any one of the test electrodes can be considered a first or second set of electrical contacts. See paragraph 21 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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/JANKI M BAVA/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791