Detailed Action
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Objections
Claim 1 is objected to because of the following informalities: limitations are better represented when separated by punctuation such as a semicolon between elements rather than a comma that keeps the elements as a continuous item instead of providing separation. For example, the limitation “normal skin sympathetic nerve activity in a living subject” would be separated from “the subject having skin” by a semicolon so that it reads “normal skin sympathetic nerve activity in a living subject; the subject having a skin”.
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 6, 8, 10-12, and 23-29 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 6, the limitation “the predefined threshold” recited in the claim is indefinite. It is unclear which “predefined threshold level” the claim is referring to given that Claim 6 is dependent on Claim 1 that recites a “predefined threshold level” in line 9 of the claim as well as dependent on Claim 5 that recites “predefined threshold level” in line 4 of the claim. It is being interpreted that Claim 6 is referring to the “predefined threshold level” recited in Claim 5.
Regarding Claim 8, it is unclear what the limitation "microsiemensSecond" recited in the claim represents. This recited unit of measurement is not a known unit in the art. It is not understood if this limitation is supposed to read as "microsimens per second" or what this unit is supposed to represent.
Furthermore, the limitation “the predefined threshold” recited in the claim is indefinite. It is unclear which “predefined threshold level” the claim is referring to given that Claim 8 is dependent on Claim 1 that recites a “predefined threshold level” in line 9 of the claim as well as dependent on Claim 7 that recites “predefined threshold level” in line 3 of the claim. It is being interpreted that Claim 8 is referring to the “predefined threshold level” recited in Claim 7.
Regarding Claim 10, the limitation “the predefined threshold” recited in the claim is indefinite. It is unclear which “predefined threshold level” the claim is referring to given that Claim 10 is dependent on Claim 1 that recites a “predefined threshold level” in line 9 of the claim as well as dependent on Claim 9 that recites “predefined threshold level” in line 3 of the claim. It is being interpreted that Claim 10 is referring to the “predefined threshold level” recited in Claim 9.
Regarding Claim 23, the limitation recites an apparatus configured to perform method steps but fails to recite any structure that the apparatus comprises. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited. Without recited structure, the claim is indefinite.
Regarding Claim 26, the limitation recites an apparatus configured to perform method steps but fails to recite any structure that the apparatus comprises. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited. Without recited structure, the claim is indefinite.
Regarding Claim 27, the limitation recites an apparatus configured to perform method steps but fails to recite any structure that the apparatus comprises. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited. Without recited structure, the claim is indefinite.
Regarding Claim 28, the limitation recites an apparatus configured to perform method steps but fails to recite any structure that the apparatus comprises. The structure which goes to make up the device must be clearly and positively specified. The structure must be organized and correlated in such a manner as to present a complete operative device. The claim(s) must be in one sentence form only. Note the format of the claims in the patent(s) cited. Without recited structure, the claim is indefinite.
Regarding Claim 29, the limitation “increase electrodermal response” recited in lines 2-3 of the claim are indefinite. It is unclear what parameters are involved or what parameters would satisfy the limitation “increase electrodermal response”. It is unclear if these parameters are visual indicators, temperature-related indicators, etc.
Additionally, the phrase "such as" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Furthermore, the phrase "like" renders the claim(s) indefinite because the claim(s) include(s) elements not actually disclosed (those encompassed by "like"), thereby rendering the scope of the claim(s) unascertainable. See MPEP § 2173.05(d).
Claims not explicitly rejected above are rejected due to their dependence on the above 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, 5-6, and 11-29 are rejected under 35 U.S.C. 103 as being unpatentable over Storm et. al.’850 (WO Patent Publication 2018141850 – as cited by applicant) as evidence by Gunther et. al.’2011 (Skin Conductance Variability in ICU Patients: An Observational Study of the Relation to Pain and Motor Activity Assessment Scale Level).
Regarding Claim 1, Storm et. al.’850 discloses a method of assessing or monitoring the normal skin sympathetic nerve activity in a living subject (Page 2 lines 38-39 - In any of the above-mentioned methods and aspects, neural block may be for a sympathetic nerve);
the subject having a skin (Page 1 line 23 - the subject having a skin);
the method comprising assessing or measuring electrodermal activity (Page 2 lines 1-4 - the electrodermal activity is chosen from the group consisting of skin conductance, galvanic skin response, electrodermal response, psychogalvanic reflex, skin conductance response, sympathetic skin response and skin conductance level), wherein the electrodermal activity assessed or measured is skin conductance (Page 2 lines 9-10 - the electrodermal activity assessed or measured is skin conductance);
the skin conductance is assessed or measured by calculating skin conductance fluctuation peaks per time unit (Page 2 lines 10-11 - Advantageously, the skin conductance is assessed or measured by calculating skin conductance fluctuation peaks per time unit).
Storm et. al.’850 fails to disclose wherein the predefined threshold level is 0.13 skin conductance fluctuations per sec, but discloses (Page 2 Lines 10-11 - the skin conductance is assessed or measured by calculating skin conductance fluctuation peaks per time unit). It is noted that the applicant has failed to provide details or criticality or unexpected results in the specification with regard to the threshold of number of skin conductance fluctuations. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine optimal threshold for number of skin conductance fluctuations as evidence by Gunther et. al.’2011 (Sensitivity and specificity of NSCF at a cut-off value > 0.13 for detecting expressed pain/discomfort). Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
It is noted that the limitation “wherein when the number of the skin conductance fluctuations is above or equal to a predefined threshold level in the analyzing window the skin sympathetic nerve activity is assessed and obtained and defined as successful or normal” does not need to be found because it is contingent on whether or not a threshold level is met and there is no mentioning of a processor or computer within the claims that would make this known that a computer is using a binary system that would ensure this step takes place.
Regarding Claim 23, the sections of Storm et. al.’850 as evidence by Gunther et. al.’2011 cited above disclose an apparatus comprising the elements set forth in the claim.
Regarding Claim 5, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the skin conductance is assessed or measured by calculating the rise time of the skin conductance fluctuations (Page 2 lines 17-18 - The skin conductance may be assessed or measured by calculating rise time of skin conductance fluctuation).
It is noted that the limitation “wherein if the rise time decreases or increases with a predefined threshold level in the analyzing window, the skin sympathetic nerve activity is assessed and obtained and defined as successful or normal” does not need to be found because it is contingent on whether or not a threshold level is met and there is no mentioning of a processor or computer within the claims that would make this known that a computer is using a binary system that would ensure this step takes place.
Regarding Claim 6, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 5 above. Storm et. al.’850 further discloses calculating a rise time of skin conductance fluctuations (Page 8 Lines 14-19 - The method further proceeds to a calculating step 230, wherein a rise time of skin conductance fluctuations is calculated…The method further proceeds to the determining step 240. In the determining step 240, when the rise time decreases in an analyzing window, the method proceeds to the establishing step 250), but fails to disclose wherein the predefined threshold level is 0.02 microsiemens per second. It is noted that the applicant has failed to provide details or criticality or unexpected results in the specification with regard to the threshold of rise time of skin conductance fluctuations. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine optimal threshold for rise time of skin conductance fluctuations. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 11, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is 15 to 60 seconds (Page 7 line 27 - the analysis window has a length in time of about 15 to 60 seconds).
Regarding Claim 12, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 11 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is about 15 seconds (Page 7 lines 28-29 - the length of the analyzing window is about 15 seconds).
Regarding Claim 13, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the skin conductance is measured in an entire body of the subject (Page 2 line 36 - The skin conductance may be in the entire body of the subject).
Regarding Claim 14, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the subject is an animal (Page 1 line 25 - the subject may be an animal).
Regarding Claim 15, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the subject is a human (Page 1 line 24 - the subject is a human).
Regarding Claim 16, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the skin sympathetic nerve activity is for a mixed nerve activity where all or some of skin conductance variables are chosen from the group consisting of skin conductance fluctuations per second, amplitude of the skin conductance fluctuations, area under the skin conductance fluctuations and changes in rise time of the mean skin conductance level (Page 2 lines 39-41 - However, the neural block may be for a mixed nerve block chosen from the group consisting of motor+sympathetic, sensory+sympathetic, and motor+sensory+sympathetic; Page 2 lines 10-11 - the skin conductance is assessed or measured by calculating skin conductance fluctuation peaks per time unit; Page 2 lines 17-18 - The skin conductance may be assessed or measured by calculating rise time of skin conductance fluctuation; Page 2 lines 23-24 - The skin conductance may be assessed or measured by calculating size on amplitude of the skin conductance fluctuation peaks; Page 2 lines 29-30 - The skin conductance may be assessed or measured by calculating area under the curve of skin conductance fluctuation peaks).
Regarding Claim 17, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the normal skin sympathetic nerve activity is obtained when the nerves are not disturbed by injuries, toxicity or nerve blocking agencies (Page 21 lines 38-42 - According to this study, the pre-block skin sympathetic nerve activity that is mirrored by skin conductance responses per sec was within normal range. The lowest levels were about 0.06 responses per sec which according to other studies show normal activity in relaxed patients).
Regarding Claim 18, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the normal skin sympathetic nerves are assessed or measured at a skin level of the subject (Page 5 lines 34-35 - the inventors have found that it is possible to monitor the sympathetic activity at the skin level).
Regarding Claim 19, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the normal skin sympathetic nerve activity is assessed or measured in the subject's limbs, a palmar side of the subject's wrist, the subject's palm, the subject's ankle area, or a plantar part of the subject's foot (Page 3 lines 7-9 - In any of the above-mentioned methods, the neural block may be assessed or measured in the limbs including but not limited to the palmar side of the wrist, the palm, the ankle area, dorsum of the knee or the plantar part of the foot).
Regarding Claim 20, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses further comprising the use of an additional process to assess or measure normal skin sympathetic nerve activity, wherein the additional process is chosen from the group consisting of unilateral thermometry monitoring, bilateral comparative thermometry monitoring, change in waveform amplitude in pulse oximetry plethysmography, and any combination thereof (Page 3 lines 11-15 - Any of the methods described above with reference to figures 1, 2 and/or 3 may further comprise the use of additional methods to assess or measure a neural block. Such additional methods may be chosen from the group consisting of unilateral thermometry monitoring, bilateral comparative thermometry monitoring, change in waveform amplitude in pulse oximetry plethysmography, and any combination thereof).
Regarding Claim 21, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses wherein the electrodermal activity at two or more extremities of the subject is assessed or measured, wherein in the electrodermal activity of one extremity with injured or blocked nerves and one or more extremity(ies) without injured or blocked nerves are compared (Page 4 lines 5-7 - The apparatus can be used to assess electrodermal activity at two or more extremities to compare the extremity with neural block to extremity(ies) without neural block).
Regarding Claim 22, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 1 above. Storm et. al.’850 further discloses further comprising stimulating electrodermal activity in the subject that shows normal skin sympathetic nerve activity is assessed or measured to have been obtained or successful (Page 3 lines 22-24 - stimulating electrodermal activity that disappears when the nerve block is assessed or measured to have been obtained or successful).
Regarding Claim 24, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the apparatus outlined in Claim 23 above. Storm et. al.’850 further discloses the apparatus comprises a wireless sensor with bluetooth connection to a computer or cell phone wherein a signal is processed through a computer software application and wherein the apparatus can send wireless information through a wireless technology to other computers, or mobile devices or tablets with computer software program (Page 3 Lines 29-33 - The apparatus may comprise a wireless sensor with bluetooth connection to a computer or cell phone wherein a signal is processed through a computer software application and wherein the apparatus can send wireless information through a wireless technology to other computers, or mobile devices or tablets with computer software program).
Regarding Claim 25, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the apparatus outlined in Claim 23 above. Storm et. al.’850 further discloses comprising a measurement device with electrodes and a computer software display on any computer tablet (Page 3 Lines 35-36 - The apparatus may comprise a measuring box with electrodes and computer software display on any computer tablets).
Regarding Claim 26, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the apparatus outlined in Claim 23 above. Storm et. al.’850 further discloses the apparatus is configured to be used together with an accelerometer which will inform about movements of the living subject to the apparatus and give information about movement artefacts (Page 3 Lines 38-39 - The apparatus may be used together with an accelerometer which will inform about movements to and give information about movement artefacts).
Regarding Claim 27, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the apparatus outlined in Claim 23 above. Storm et. al.’850 further discloses the apparatus configured to perform an additional process which can assess normal nerve activity, wherein the additional process is chosen from the group consisting of unilateral thermometry monitoring, bilateral comparative thermometry monitoring, change in waveform amplitude in pulse oximetry plethysmography, and any combination thereof (Page 3 Lines 41-42 to Page 4 Lines 1-3 - assess neural block, wherein additional methods are chosen from the group consisting of unilateral thermometry monitoring, bilateral comparative thermometry monitoring, change in waveform amplitude in pulse oximetry plethysmography, and any combination thereof).
Regarding Claim 28, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the apparatus outlined in Claim 23 above. Storm et. al.’850 further discloses the apparatus assess electrodermal activity at two or more extremities to compare an extremity with normal skin sympathetic nerve activity to one or more extremities without normal skin sympathetic nerve activity (Page 12 Lines 5-8 - More specifically, the features of figure 6 enables the assessment or measurement of electrodermal activity, e.g., skin conductance, at two or more extremities, wherein in the electrodermal activity of one extremity with neural block and one or more extremities without neural block are compared).
Regarding Claim 29, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the apparatus outlined in Claim 23 above. Storm et. al.’850 further discloses the apparatus comprises an electrodermal activity stimulator which is configured to increase electrodermal response to give information about the normal skin sympathetic nerve activity such as to define when the nerve activity can be used for clinical assessment (Page 4 Lines 9-11 - The apparatus can be used together with an electrodermal activity stimulator which can be used to give information about when the neural block starts to work and/or a successful block; Page 11 Lines 33-38 - The stimulating devices may be arranged to stimulate electrodermal activity in the subject (e.g., the patient). When neural block is given and electrodermal activity is assessed, a stimulator to secure electrodermal responses may be used as an additional option. This stimulating device should be a sensor stimulator of a certain strength which gives rise to one or several electrodermal response(s) in the subject. It could be e.g sound, pressure, electrical, light, or smell stimulus/stimuli).
Claims 7 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Storm et. al.’850 (WO Patent Publication 2018141850 – as cited by applicant) as evidence by Gunther et. al.’2011 (Skin Conductance Variability in ICU Patients: An Observational Study of the Relation to Pain and Motor Activity Assessment Scale Level), as applied to Claim 5 above, in view of Shahar Arzy’679 (WO Patent Publication 2018029679 – previously cited).
Regarding Claim 7, Storm et. al.’850 as evidence by Gunther et. al.’2011 discloses the method outlined in Claim 5 above. Storm et. al.’850 further discloses wherein the skin conductance is assessed or measured by calculating the area under the fluctuations (Page 2 lines 29-30 - The skin conductance may be assessed or measured by calculating area under the curve of skin conductance fluctuation peaks), and wherein if the area analyzed within an analyzing window assesses skin sympathetic nerve activity and is defined as successful (Page 2 lines 30-33 - When the area under the curve of skin conductance fluctuations peaks decrease or disappear an analyzing window with a length of about 15 to 60 seconds, the neural block is assessed as being obtained or successful). Storm et. al.’850 fails to disclose a predetermined threshold for calculating area under fluctuations. Shahar Arzy’679 teaches a threshold for area under a curve (Page 39 lines 18-20 - with the area under the curve (AUC) accounting for the overall test discriminability. Additionally, an optimal threshold, maximizing sensitivity and specificity). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Storm et. al.’850 to include a threshold to observe area under the fluctuations in order to maximize sensitivity and specificity that improves understanding data and its trends as seen in Shahar Arzy’679.
Regarding Claim 11, Storm et. al.’850 as evidence by Gunther et. al.’2011 and in view of Shahar Arzy’679 discloses the method outlined in Claim 7 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is 15 to 60 seconds (Page 7 line 27 - the analysis window has a length in time of about 15 to 60 seconds).
Regarding Claim 12, Storm et. al.’850 as evidence by Gunther et. al.’2011 and in view of Shahar Arzy’679 discloses the method outlined in Claim 11 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is about 15 seconds (Page 7 lines 28-29 - the length of the analyzing window is about 15 seconds).
Claims 8 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Storm et. al.’850 (WO Patent Publication 2018141850 – as cited by applicant) as evidence by Gunther et. al.’2011 (Skin Conductance Variability in ICU Patients: An Observational Study of the Relation to Pain and Motor Activity Assessment Scale Level), in view of Shahar Arzy’679 (WO Patent Publication 2018029679 – previously cited), as applied to Claim 7 above.
Regarding Claim 8, Storm et. al.’850 as evidence by Gunther et. al.’2011 and in view of Shahar Arzy’679 discloses the method of Claim 7, but fails to disclose wherein the predefined threshold is 2 microsiemens per second. Storm et. al.’850 teaches calculating an area under fluctuations to be analyzed (The method further proceeds to a calculating step 330, wherein an area under the curve of skin conductance fluctuation peaks in an analyzing window is calculated…The method further proceeds to the determining step 240. In the determining step 340, when the area under the curve of skin conductance fluctuations peaks decreases or disappears in the analyzing window, the method proceeds to the establishing step 350). It is noted that the applicant has failed to provide details or criticality or unexpected results in the specification with regard to the threshold of mean amplitude of skin conductance fluctuations. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine optimal threshold when calculating area under skin conductance fluctuations. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 11, Storm et. al.’850 as evidence by Gunther et. al.’2011, and in view of Shahar Arzy’679 discloses the method outlined in Claim 8 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is 15 to 60 seconds (Page 7 line 27 - the analysis window has a length in time of about 15 to 60 seconds).
Regarding Claim 12, Storm et. al.’850 as evidence by Gunther et. al.’2011, and in view of Shahar Arzy’679 discloses the method outlined in Claim 11 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is about 15 seconds (Page 7 lines 28-29 - the length of the analyzing window is about 15 seconds).
Claims 9 and 11-12 are rejected under 35 U.S.C. 103 as being unpatentable over Storm et. al.’850 (WO Patent Publication 2018141850 – as cited by applicant) as evidence by Gunther et. al.’2011 (Skin Conductance Variability in ICU Patients: An Observational Study of the Relation to Pain and Motor Activity Assessment Scale Level), in view of Shahar Arzy’679 (WO Patent Publication 2018029679 – previously cited), as applied to Claim 7 above, and further in view of Hanne Storm’699 (WO Patent Publication 2005117699 – previously cited).
Regarding Claim 9, Storm et. al.’850 as evidence by Gunther et. al.’2011 and in view of Shahar Arzy’679 discloses the method of Claim 7 above. Storm et. al.’850 further discloses wherein the skin conductance is assessed or measured by calculating the amplitude of the skin conductance fluctuations (Page 2 lines 23- 24 - The skin conductance may be assessed or measured by calculating size on amplitude of the skin conductance fluctuation peaks), and wherein the mean amplitude of the skin conductance fluctuations has a predefined threshold level in the analyzing window the skin sympathetic nerve activity is assessed and obtained and defined as successful or normal (Page 2 line 24-26 - When the size on the amplitude decrease or disappear in an analyzing window with a length of about 15 to 60 seconds, the neural block is assessed as being obtained or successful). Storm et. al.’850 fails to disclose using a mean amplitude of the skin conductance fluctuation. Hanne Storm’699 teaches a mean amplitude of fluctuations (Page 9 Paragraph 4 - The mean amplitude of the fluctuations calculated in step 33 is stored and used as the amplitude during the execution of the comparison step 35 below). It would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have modified the method of Storm et. al.’850 as evidence by Gunther et. al.’2011 and in view of Shahar Arzy’679 to include a mean amplitude in order to use as a baseline and comparative value for amplitude of fluctuation as seen in Hanne Storm’699.
Regarding Claim 11, Storm et. al.’850 as evidence by Gunther et. al.’2011, in view of Shahar Arzy’679, further in view of Hanne Storm’699 discloses the method outlined in Claim 9 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is 15 to 60 seconds (Page 7 line 27 - the analysis window has a length in time of about 15 to 60 seconds).
Regarding Claim 12, Storm et. al.’850 as evidence by Gunther et. al.’2011, in view of Shahar Arzy’679, further in view of Hanne Storm’699 discloses the method outlined in Claim 11 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is about 15 seconds (Page 7 lines 28-29 - the length of the analyzing window is about 15 seconds).
Claims 10-12 are rejected under 35 U.S.C. 103 as being unpatentable over Storm et. al.’850 (WO Patent Publication 2018141850 – as cited by applicant) as evidence by Gunther et. al.’2011 (Skin Conductance Variability in ICU Patients: An Observational Study of the Relation to Pain and Motor Activity Assessment Scale Level), in view of Shahar Arzy’679 (WO Patent Publication 2018029679 – previously cited), and further in view of Hanne Storm’699 (WO Patent Publication 2005117699 – previously cited), as applied to Claim 9 above.
Regarding Claim 10, Storm et. al.’850 as evidence by Gunther et. al.’2011, in view of Shahar Arzy’679, and further in view of Hanne Storm’699 discloses the method outlined in Claim 9 above. Storm et. al.’850 fails to disclose wherein the predefined threshold level is 0.02 microsiemens. It is noted that the applicant has failed to provide details or criticality or unexpected results in the specification with regard to the threshold of mean amplitude of skin conductance fluctuations. As such, it would have been obvious to one of ordinary skill in the art, through routine experimentation, to determine optimal threshold for mean amplitude of skin conductance fluctuations. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover optimal or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955).
Regarding Claim 11, Storm et. al.’850 in view of Shahar Arzy’679, further in view of Hanne Storm’699 discloses the method outlined in Claim 10 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is 15 to 60 seconds (Page 7 line 27 - the analysis window has a length in time of about 15 to 60 seconds).
Regarding Claim 12, Storm et. al.’850 in view of Shahar Arzy’679, further in view of Hanne Storm’699 discloses the method outlined in Claim 11 above. Storm et. al.’850 further discloses wherein the length of the analyzing window is about 15 seconds (Page 7 lines 28-29 - the length of the analyzing window is about 15 seconds).
Response to Arguments
Applicant's arguments filed 19 January 2026 have been fully considered and they are not entirely persuasive.
Applicant’s amendments have overcome the prior drawing objections.
Applicant’s amendments have overcome the prior claim objections.
Applicant’s amendments have overcome the prior 35 U.S.C. 112f interpretations.
Applicant’s amendments have overcome most of the prior 35 U.S.C. 112b rejections, but a rejection for Claim 8 remains as well as additional rejections. These rejections are addressed in Paragraph 4 above.
Claims 1-6, 8-18, 20-30, and 32 are rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraphs 5-9 above. It is noted that Claims 1-3, 5, and 11-22 that were once rejected under 35 U.S.C. 102 are now rejected under 35 U.S.C. 103 as necessitated by amendments, as discussed in Paragraph 5 above.
The examiner has considered the applicant's arguments regarding that Storm et. al.'850 does not disclose "normal sympathetic nerve activity", but these arguments were found to not be persuasive. The examiner provides an additional citation that showcases wherein Storm et. al.'850 discloses determining "baseline" levels (Page 18 Lines 21-23 - The SCM was applied to the affected lower extremity (Figure 7), immediately prior to the procedure to obtain baseline readings). Given that the measurements that define one subject’s “normal” are likely to be different from the measurements that define another subject’s “normal”, “baseline” values can be indicative of each subject’s version of “normal”. Therefore, it would have been obvious to one of ordinary skill in the art at the time the invention was effectively filed to have considered “baseline” levels of a subject to be considered “normal” activity of said subject. Additionally, it is to be noted that the definition of the term “normal” is not the same or analogous to the term “healthy”.
Furthermore, the examiner has considered the applicant’s arguments regarding the relevance and/or importance of determining “normal” levels prior to a procedure in order to determine a level of “success”. The examiner notes that Storm et. al.’850 discloses determining baseline – normal – levels prior to a procedure in order to determine a level of success (Page 17 Lines 5-8 - Temperatures in the affected (Tl) and unaffected limb (T2) were continuously measured and recorded prior to the procedure which constituted baseline; Page 17 Lines 19-21 - Pulse amplitude [6, 7] of the affected extremity was measured at baseline and then at 1 minute intervals until 10 minutes after completion of procedure by using plethysmography (Table 2). To determine the success of the sympathetic block).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Picard et. al.’185 (U.S. Patent Publication 20130080185) teaches analyzing area under a curve for electrodermal activity.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH ANN WESTFALL whose telephone number is (571) 272-3845. The examiner can normally be reached Monday-Friday 7:30am-4:30pm EST.
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/SARAH ANN WESTFALL/Examiner, Art Unit 3791
/ETSUB D BERHANU/Primary Examiner, Art Unit 3791