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 .
Response to Arguments
Applicant’s arguments combined with the claim amendments have been fully considered and are found persuasive with respect to the previous rejection(s); however, upon further search and consideration due to the change in scope, an updated grounds of rejection is presented below, necessitated by amendment.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994)
The disclosure of the prior-filed applications, Application No. 16/838,953, 16/229,299 and 62/609,807, fail to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, these parent cases fail to support the claim language of applying an electrical impulse transcutaneously wherein the electrical impulse is sufficient to reduce a level C-reactive protein or procalcitonin.
Parent Application No. 17/471,962 does mention these elements; accordingly, the present application is awarded a priority date of September 10, 2021.
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 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.
In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(e), (f) or (g) prior art under 35 U.S.C. 103(a).
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 of this title, 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 1-3 and 5-11 are rejected under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2011/0152967; hereinafter “Simon”) in view of Faltys et al. (US 2011/0106208; hereinafter “Faltys”), further in view of Shuros et al. (US 2009/0125076; hereinafter “Shuros”).
Regarding Claim 1, Simon teaches a method of treating a medical disorder associated with a virus in a patient, the method comprising: positioning a contact surface of a device in contact with an outer skin surface of a neck of the patient (e.g. Abstract, ¶¶ 31-33, etc.); applying, via the device, when the contact surface is in contact with the outer skin surface of the neck of the patient, an electrical impulse transcutaneously, via the contact surface, through the outer skin surface of the neck of the patient to a vagus nerve of the patient (e.g. ¶¶ 33 – “the device is ordinarily applied to the patient's neck”); wherein the electrical impulses comprises bursts of pulses (e.g. ¶¶ 34 – “current is passed through the coils in bursts of pulses”) and each of the pulses has a frequency of about 1 kHz to about 20 kHz (e.g. ¶¶ 34 – “pulses have duration of 20 to 1000 microseconds….and there may be 1 to 20 pulses per burst” – where 20 pulses per burst at a duration of 1000 microseconds = 20/.001= a frequency of 20 khz).
Simon discloses an electrical impulse duration of about 1 minute (e.g. ¶¶ 236 –“stimulation may be performed for 1 to 200 minutes”) but fails to expressly disclose a treatment paradigm based on applying the electrical impulse as a first and second dose applied 2-5 times per day. The examiner notes that two of the same stimulation impulses would read on the first and second dosages as claimed; furthermore, the examiner is of the position that the same stimulation dosage applied 4-10 times a day would read on the claim language “first and second doses applied from 2 to 5 times per day”. In the same field of endeavor, Faltys discloses vagal stimulation where the stimulation is a plurality of times a day – anywhere from 2-12 times per day, in order to provide the most beneficial stimulation to the patient (e.g. ¶¶ 28). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of repeating a first and second dosage from 2-5 times per day, as taught by Faltys, to the known device of Simon, to yield the predictable results of providing the most beneficial stimulation therapy to the patient. In addition, it would have been routine optimization to arrive at the claimed stimulation parameters of consecutive application of the first and second doses applied from 2-5 times per day, in order to obtain a beneficial response for the patient. Lastly, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). In this situation, modifying the repetition of parameters based on the most effective therapy would be the optimum value of that results effective variable.
Simon discloses that the purpose of the invention is to stimulate “…the vagus nerve to reduce neuro-inflammation, wherein pathways involving anti-inflammatory cytokines… and/or pathways involving pro-inflammatory cytokines are inhibited.” (e.g. ¶¶ 20). Simon fails to expressly disclose the treatment paradigm is sufficient to reduce the level of the C-reactive protein (or CRP), a specific cytokine, in a blood of the patient; however, CRP is commonly measured and analyzed in the art. In the same field of endeavor, Shuros teaches that CRP “…is an acute phase reactant produced by the liver that can be indicative of inflammation, e.g., the level of CRP rises as inflammation occurs within the body. In an example, CRP can be indicative of inflammation, increased blood pressure, and cardiac heart failure.” (e.g. ¶¶ 46). Shuros further teaches the analysis of CRP, after vagal stimulation, in order to determine the level of inflammation in the patient (e.g. ¶¶ 97, etc.). Accordingly, it would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of delivering a vagal stimulation treatment paradigm at a sufficient level to reduce a level of CRP in the blood of a patient, as taught by Shuros, to the known device of Simon, ready for improvement, to yield the predictable results of providing a cytokine measurement, that is known to be indicative of inflammation in the patient.
Simon discloses a plurality of time periods for ceasing application of the electrical impulse as cited above, but fails to expressly disclose ceasing application of the electrical impulse to the patient for a period of time less than five minutes. The examiner is of the position that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the off time or ceasing of application in between the first and second doses, for a time period of less than five minutes, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In this scenario, individual patient responses commonly dictate the specifics of stimulation parameters and in this scenario the off time may be dependent on the severity of the patient’s condition and/or their response to the stimulation. In addition, the examiner notes that it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 2-3, Simon fails to teach reducing the level of C-reactive protein by at least 10 or 25 mg/L. In the cited sections of Shuros above, the prior art is clear in indicating that the stimulation can be adjusted for a targeted C-reactive protein level. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to apply an electrical pulse sufficient to reduce the level of C-reactive protein at least 10 or 25 mg/L, based on the combination of Simon in view of Shuros as expounded above, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 5, Simon teaches the electrical impulse is sufficient to inhibit a release of a pro-inflammatory cytokine (e.g. ¶¶ 2 – “pathways involving pro-inflammatory cytokines are inhibited”).
Regarding claim 6, Simon teaches the cytokine includes a tumor necrosis factor(TNF)-alpha (e.g. ¶¶ 24).
Regarding claim 7, Simon teaches the electrical impulse is sufficient to reduce the magnitude of constriction of smooth bronchial muscle (e.g. ¶¶ 63 – “bronchoconstriction”; ¶¶ 120 – “can be used to directly or indirectly stimulate or otherwise modulate nerves that innervate smooth or skeletal muscle”; e.g. ¶¶ 127-128 – “Methods for compensating for motion and other confounding factors were disclosed by the present applicant in co-pending application Ser. No. 12/859,568 entitled Non-Invasive Treatment of Bronchial Constriction, to SIMON, which is hereby incorporated by reference”).
Regarding claim 8, Simon teaches the device comprises one or more electrodes (e.g. ¶¶ 17).
Regarding claim 10, Simon teaches the electrical impulse comprises bursts of 2-20 pulses with each of the bursts having a frequency of about 5 Hz to about 100 Hz (e.g. ¶¶ 34-35).
Regarding claim 11, Simon fails to teach the medical disorder is a virus in the coronaviridae family. The examiner notes that the present application’s disclosure does not appear to offer any specific stimulation parameters, discussion, or details as to how the stimulation applied to a virus in the coronaviridae family would differ from any other viruses and medical disorders listed throughout applicant’s disclosure (e.g. ¶¶ 97-98 – i.e. “Parkinson’s Disease”). Additionally, the claims require no specific stimulation parameters other than the dosage which Simon anticipates as indicated above. Simon also indicates treating a plurality of different medical conditions including different viruses causing inflammation (e.g. Abstract - “Parkinson’s Disease”). Accordingly, the examiner is of the position that it would have been obvious to apply the method of treating a medical disorder as taught by Simon, to treat a virus in the coronaviridae family, in order to treat a patient suffering from inflammation in the same manner, as known work in one field of endeavor may prompt variations of it for use in either the same field or a different one, if the variations are predictable to one of ordinary skill in the art. In this situation, the predictability would be in treating the inflammation from any viral condition whether it stems from Parkinson’s or coronaviridae.
Claims 9, 12-18, and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Faltys, further in view of Schwab et al. (US 2017/0100605; hereinafter “Schwab”).
Regarding claim 12, Simon teaches a method of treating a medical disorder associated with a virus in a patient, the method comprising: positioning a contact surface of a device in contact with an outer skin surface of a neck of the patient (e.g. Abstract, ¶¶ 31-33, etc.); applying, via the device, when the contact surface is in contact with the outer skin surface of the neck of the patient, an electrical impulse transcutaneously, via the contact surface, through the outer skin surface of the neck of the patient to a vagus nerve of the patient (e.g. ¶¶ 33 – “the device is ordinarily applied to the patient's neck”); wherein the electrical impulses comprises bursts of pulses (e.g. ¶¶ 34 – “current is passed through the coils in bursts of pulses”) and each of the pulses has a frequency of about 1 kHz to about 20 kHz (e.g. ¶¶ 34 – “pulses have duration of 20 to 1000 microseconds….and there may be 1 to 20 pulses per burst” – where 20 pulses per burst at a duration of 1000 microseconds = 20/.001= a frequency of 20 khz).
Simon discloses an electrical impulse duration of about 1 minute (e.g. ¶¶ 236 –“stimulation may be performed for 1 to 200 minutes”) but fails to expressly disclose a treatment paradigm based on consecutive application of a first and second dose applied 2-5 times per day. The examiner notes that two of the same stimulation impulses would read on the first and second dosages as claimed; furthermore, the examiner is of the position that the same stimulation dosage applied 4-10 times a day would read on the claim language “first and second doses applied from 2 to 5 times per day”. In the same field of endeavor, Faltys discloses vagal stimulation where the stimulation is a plurality of times a day – anywhere from 2-12 times per day, in order to provide the most beneficial stimulation to the patient (e.g. ¶¶ 28). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of repeating a first and second dosage from 2-5 times per day, as taught by Faltys, to the known device of Simon, to yield the predictable results of providing the most beneficial stimulation therapy to the patient. In addition, it would have been routine optimization to arrive at the claimed stimulation parameters of consecutive application of the first and second doses applied from 2-5 times per day, in order to obtain a beneficial response for the patient. Lastly, it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980). In this situation, modifying the repetition of parameters based on the most effective therapy would be the optimum value of that results effective variable.
Simon’s stimulation parameters are within the claimed parameters; accordingly, one would expect that the stimulation would be sufficient to reduce a level of procalcitonin in a blood of the patient as claimed. However, Simon fails to expressly disclose the electrical impulse is sufficient to reduce a level of procalcitonin in a blood of the patient. In the same field of endeavor, Schwab teaches delivering vagal stimulation at a sufficient level to reduce a level of procalcitonin in a blood of the patient (e.g. ¶¶ 66-67, 70, 73, etc.) to ensure that the level of stimulation is appropriate. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of delivering electrical vagal stimulation at a sufficient level to reduce a level of procalcitonin, as taught by Schwab, to the known device of Simon, ready for improvement, to yield the predictable results of ensuring that the stimulation applied is effective at reducing inflammation as reflected in the procalcitonin data.
Simon discloses a plurality of time periods for ceasing application of the electrical impulse as cited above, but fails to expressly disclose ceasing application of the electrical impulse to the patient for a period of time less than five minutes. The examiner is of the position that it would have been obvious to one having ordinary skill in the art at the time the invention was made to modify the off time or ceasing of application in between the first and second doses, for a time period of less than five minutes, since it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 105 USPQ 233. In this scenario, individual patient responses commonly dictate the specifics of stimulation parameters and in this scenario the off time may be dependent on the severity of the patient’s condition and/or their response to the stimulation. In addition, the examiner notes that it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claims 13-14, Simon fails to teach the level of procalcitonin is reduced by at least 2 ng/L or 5 ng/L. In the cited sections of Schwab above, the prior art is clear in indicating that the stimulation can be adjusted for a targeted procalcitonin level. Therefore, it would have been obvious to one having ordinary skill in the art at the time the invention was made to apply an electrical pulse sufficient to reduce the level of procalcitonin at least 2 or 5 ng/L, based on the combination of Simon in view of Schwab as expounded above, since it has been held that discovering an optimum value of a result effective variable involves only routine skill in the art. In re Boesch, 617 F.2d 272, 205 USPQ 215 (CCPA 1980).
Regarding claim 15, Simon teaches the device comprises one or more electrodes (e.g. ¶¶ 17).
Regarding claims 9 and 16, Simon teaches the device comprises a housing coupled to the one or more electrodes, the housing comprising an energy source that generates the electrical impulse (e.g. Fig. 3; ¶¶ 11).
Regarding claim 17, Simon teaches the electrical impulse comprises bursts of 2-20 pulses with each of the bursts having a frequency of about 5 Hz to about 100 Hz (e.g. ¶¶ 34-35).
Regarding claim 18, Simon fails to teach the medical disorder is a virus in the coronaviridae family. The examiner notes that the present application’s disclosure does not appear to offer any specific stimulation parameters, discussion, or details as to how the stimulation applied to a virus in the coronaviridae family would differ from any other viruses and medical disorders listed throughout applicant’s disclosure (e.g. ¶¶ 97-98 – i.e. “Parkinson’s Disease”). Additionally, the claims require no specific stimulation parameters other than the dosage which Simon anticipates as indicated above. Simon also indicates treating a plurality of different medical conditions including different viruses causing inflammation (e.g. Abstract - “Parkinson’s Disease”). Accordingly, the examiner is of the position that it would have been obvious to apply the method of treating a medical disorder as taught by Simon, to treat a virus in the coronaviridae family, in order to treat a patient suffering from inflammation in the same manner, as known work in one field of endeavor may prompt variations of it for use in either the same field or a different one, if the variations are predictable to one of ordinary skill in the art. In this situation, the predictability would be in treating the inflammation from any viral condition whether it stems from Parkinson’s or coronaviridae.
Regarding claim 20, Simon teaches the electrical impulse is sufficient to inhibit a release of a pro-inflammatory cytokine (e.g. ¶¶ 2 – “pathways involving pro-inflammatory cytokines are inhibited”).
Claim 4 is rejected as under 35 U.S.C. 103 as being unpatentable over Simon in view of Faltys, further in view of Shuros, further in view of Schwab. Simon fails to teach the electrical impulse is sufficient to reduce a level of procalcitonin in a blood of the patient. In the same field of endeavor, Schwab teaches delivering vagal stimulation at a sufficient level to reduce a level of procalcitonin in a blood of the patient (e.g. ¶¶ 66-67, 70, 73, etc.) to ensure that the level of stimulation is appropriate. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of delivering electrical vagal stimulation at a sufficient level to reduce a level of procalcitonin, as taught by Schwab, to the known device of Simon, ready for improvement, to yield the predictable results of ensuring that the stimulation applied is effective at reducing inflammation as reflected in the procalcitonin data. In addition, the examiner notes that because Simon’s stimulation parameters are within the claimed parameters, one would expect that the stimulation would be sufficient to reduce a level of procalcitonin in a blood of the patient as claimed.
Claim 19 is rejected as under 35 U.S.C. 103 as being unpatentable over Simon in view of Faltys, further in view of Schwab, further in view of Shuros. Simon fails to teach the electrical impulse is sufficient to reduce a level of C-reactive protein in a blood of the patient. In the same field of endeavor, Shuros teaches delivering vagal stimulation at a sufficient level to reduce a level of C-reactive protein in a blood of the patient (e.g. ¶¶ 41-46, 49, 51, 97, etc.) to ensure that the level of stimulation is appropriate. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date of the present invention, to apply the known technique of delivering electrical vagal stimulation at a sufficient level to reduce a level of C-reactive protein, as taught by Shuros, to the known device of Simon, ready for improvement, to yield the predictable results of ensuring that the stimulation applied is effective at reducing inflammation as reflected in the C-reactive protein data. In addition, the examiner notes that because Simon’s stimulation parameters are within the claimed parameters, one would expect that the stimulation would be sufficient to reduce a level of C-reactive protein as claimed.
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 extension fee 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 date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michael D’Abreu whose telephone number is (571) 270-3816. The examiner can normally be reached on 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, David Hamaoui can be reached at (571) 270-5625. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MICHAEL J D'ABREU/Primary Examiner, Art Unit 3796