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 with respect to the previous rejection(s) of the claims have been fully considered and are persuasive. Therefore, the rejection has been withdrawn. However, upon further consideration, a new ground(s) of rejection is made as expounded below.
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.
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), 120, 121, 365(c), or 386(c) 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 Nos. 12/408,131, 12/859,568, 12/612,177, 12/964,050, 13/005,005, 13/075,746, 13/109,250, 13/183,721, 13/183,765, 13/222,087, and 13/603,799 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. The newly added claim language requiring pulses having a frequency of “about 1 kHz to about 20 kHz” fails to be supported or disclosed in the parent applications above.
The latest application where the disclosure has been amended to provide adequate support is 13/858,114; accordingly, the present application is awarded a priority date of 08 April 2013.
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 37-39, 45, 47-54 are under 35 U.S.C. 103 as being unpatentable over Simon et al. (US 2011/0152967; hereinafter “Simon”) in view of Van Curen et al. (USP# 5,913,284; hereinafter “Van Curen”), further in view of Daniellson et al. (US 2010/0069995; hereinafter “Daniellson”).
Regarding claims 37 and 52-54, Simon teaches a method comprising positioning a contact surface of a housing in contact with an outer skin surface of a neck of a patient (e.g. Fig. 6, #30); generating an electrical impulse within the housing (e.g. ¶¶ 73-74), wherein the electrical impulse comprises pulses having a frequency of about 1 kHz to about 20 kHz (e.g. ¶¶ 35 – “frequency between about 1-3000Hz” where 3000 Hz = 3kHz and falls within the claimed range); transmitting the electrical impulse transcutaneously and non-invasively from the contact surface through the outer skin surface of the neck of the patient to a location at or near a vagus nerve within the patient (e.g. ¶¶ 36, 121-128, 224, etc.); and wherein the electrical impulse is sufficient to inhibit inflammation and thereby treats an autoimmune disease or disorder of the patient (e.g. Abstract, ¶¶ 131, etc. – where the examiner notes that the claim limitations are met due to the prior art inhibiting inflammation and therefore would thereby treat an autoimmune disease or disorder as claimed).
Simon fails to expressly disclose causing the medical device to be switched from an activated to deactivated mode after a specific number of single doses have been applied by the medical device. In the same field of endeavor, Van Curen discloses a medical device that switches from an activated to deactivated mode after a specific number of single doses have been applied by the medical device in order to avoid overstimulation (e.g. Col 3, ll 10-14; Col 5, ll 20-30). It would have been an obvious to one of ordinary skill in the art, prior to the effective filing date, to apply the known technique of switching from modes to a deactivated state after a specific number of single doses have been applied, as taught by Van Curen, in order to improve the similar device of Simon by avoiding overstimulation of the patient.
Simon fails to expressly disclose counting each single dose applied and switching the device from activated to deactivated based on the separation of the single doses by a duration of time. In the same field of endeavor, Danielson teaches the application of vagal stimulation including counting each single dose applied and switching the device from activated to deactivated based on the separation of the single doses by a duration of time (e.g. ¶¶ 30-32). 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 similar stimulation parameters as taught by Danielson, to the device of Simon, in order to yield the predictable results of providing known and effective therapy to patients.
Regarding claim 38, Simon teaches the housing comprises an energy source that generates the electrical impulse (e.g. Fig. 1, #310).
Regarding claim 39, Simon teaches the electrical impulse is transmitted via generating a magnetic field exterior to the patient that induces an electrical impulse at or near the vagus nerve within the patient (e.g. ¶¶ 30).
Regarding claim 45, Simon teaches the autoimmune disease or disorder includes at least Alzheimer's disease, Parkinson's disease, multiple sclerosis, temporal arteritis, Type 2 diabetes, Addison's disease, amyloidosis, Celiac disease, fibromyalgia, Graves disease, psoriasis, pernicious anemia (PA), peripheral neuropathy, lupus, or Crohn's disease (e.g. ¶¶ 28).
Regarding claims 47-49, Simon teaches the electrical impulse inhibits a release of a pro-inflammatory cytokine such as TNF alpha and is sufficient to increase an anti-inflammatory competence of a cytokine in the patient such as TGF beta (e.g. ¶¶ 37).
Regarding claim 50, Simon teaches the electrical impulse comprises bursts of about 2-20 pulses (e.g. ¶¶ 34 – “1 to 20 pulses per burst”) with each of the bursts having a frequency of about 5 Hz to about 100 Hz (e.g. ¶¶ 34 – “15-50 Hz”).
Regarding claim 51, Simon teaches each of the pulses has a duration of about 50 to 100 microseconds (e.g. ¶¶ 35 – “duration of 10-1000 microseconds”).
Claims 40-44 are rejected under 35 U.S.C. 103 as being unpatentable over Simon in view of Van Curen, further in view of Micke, as indicated above, further in view of Tracy et al. (US 2009/0247934).
Regarding claims 40-41, Simon fails to expressly teach treating an autoimmune disease or disorder comprising Sjogren's syndrome or Rheumatoid arthritis. In the same field of endeavor, Tracey indicates that vagal stimulation can treat a plurality of diseases including Grave’s disease, Sjogren’s syndrome, Rheumatoid arthritis (e.g. ¶¶ 52). It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to modify the method as taught by Simon to treat additional diseases including Grave’s disease, Sjogren’s syndrome, Rheumatoid arthritis, as taught by Tracey, in order to yield the predictable results of providing a wider range of patient treatment.
Regarding claims 42-44, Simon contemplates stimulation of other nerves including the splenic nerve (e.g. ¶¶ 128 – “stimulation of nerves other than the vagus nerve may also achieve the intended therapeutic results, including those in the sympathetic nervous system, particularly the splenic nerve”); however, it is unclear whether the stimulation would activate a sympathetic fiber in a splenic nerve of the patient to release an amount of norepinephrine into a spleen of the patient and thereby cause a release of an amount of acetylcholine to activate an alpha 7 nicotinic Ach receptor on a macrophage in the spleen to block a transcription factor that promotes at least some inflammation in the patient. In the same field of endeavor, Tracey discloses the correlation between cytokine release through a molecular mechanism that requires the alpha 7 nicotinic Ach receptor on a macrophage to vagal stimulation in the neck (e.g. ¶¶ 3-7, 30, 35, etc.) in order to effectively treat sympathetic system disorders. It would have been obvious to one of ordinary skill in the art, prior to the effective filing date, to modify the method of Simon in view of Tracey as expounded above, to activate a sympathetic fiber in a splenic nerve of the patient to release an amount of norepinephrine into a spleen of the patient and thereby cause a release of an amount of acetylcholine to activate an alpha 7 nicotinic Ach receptor on a macrophage in the spleen to block a transcription factor in order to yield the predictable results of providing relief from inflammation stemming from sympathetic system issues.
Conclusion
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