DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 3/20/2026 has been entered.
Response to Arguments
Applicant’s amendments merit new grounds for rejection under 35 U.S.C. § 103 as unpatentable over Libbus et al. (U.S. Patent Application Publication No. 2006/0122675); in view of Yun et al. (U.S. Patent Application Publication No. 2005/0143788).
Applicant’s arguments with respect to the pending claims have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim Rejections - 35 USC § 103
The following is a quotation of pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims under pre-AIA 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 pre-AIA 35 U.S.C. 103(c) and potential pre-AIA 35 U.S.C. 102(e), (f) or (g) prior art under pre-AIA 35 U.S.C. 103(a).
Claims 1, 8-12, and 19-22 is/are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over; in view of Libbus et al. (U.S. Patent Application Publication No. 2006/0122675) hereinafter referred to as Libbus; in view of Yun et al. (U.S. Patent Application Publication No. 2005/0143788) hereinafter referred to as Yun.
Regarding claim 1, Libbus teaches a device for treating a disorder in a patient (¶[0019]) comprising:
a housing having a contact surface for contacting an outer skin surface of the patient (¶¶[0036-0037, Fig. 2A, 2B ear embodiment and Fig. 3 behind the ear embodiment); and
an energy source within the housing (¶¶[0036-0037] both embodiments are optionally a neurostimulator housed in metal, which also functions as the electrode, Libbus refers to the neurostimulator throughout as the programming component which comprises the power source) configured to transmit electrical impulses through the outer skin surface of the patient to a selected nerve within the patient (¶[0020] stimulate the auricular branch of the vagus nerve using transcutaneous electrodes),
wherein the electrical impulses include bursts of pulses having a burst frequency, a burst duration, and wherein the pulses each have a frequency (¶[0034], ¶[0038], ¶[0045]).
Libbus further teaches varying all of amplitude, frequency, burst frequency, and burst duration, in order to provide a desired effect (¶[0045]). Therefore Libbus teaches that these parameters are results-effective.
Attention is brought to the Yun reference, which teaches transcutaneous (¶[0039]) vagus nerve stimulation (¶[0029] the vagus nerve is part of the parasympathetic nervous system, ¶[0039] teaches any suitable technique including transcutaneous stimulation and parasympathetic innervation, ¶[0041] teaches targeting nerves of the parasympathetic system, and ¶[0125] therefore the Examiner considers the teachings of Yun in the same field of endeavor as the teachings of Libbus), wherein the electrical impulses include bursts of pulses (¶[0121]) having a burst frequency between 5 Hz and 50 Hz (¶¶[0122-0123] ranges overlapping with 5-50Hz, including specifically 50Hz ¶[0140]) and a burst duration between about 800 microseconds and about 1,200 microseconds (¶¶[0122-0123]). Yun also shows that stimulation parameters are results effective, including pulse amplitude, pulse width, pulse frequency, and duty cycle in ¶[0133]).
Notably, Applicant discloses no criticality as to the claimed stimulation parameter ranges in the specification as filed 11/4/2022. One of ordinary skill in the art would have had a reasonable expectation of success in varying the claimed burst stimulation parameters.
Therefore the examiner considers that modifying the burst stimulation of Libbus to include bursts of pulses having a burst frequency between 5 Hz and 50 Hz and a burst duration between about 800 microseconds and about 1,200 microseconds, wherein the pulses each have a frequency of about 4,000 Hz to about 6,000 Hz, because the courts have held that “(i)t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Regarding claim 8, Libbus as modified teaches the device of claim 1.
Libbus further teaches varying all of amplitude, frequency, burst frequency, burst duration, in order to provide a desired effect (¶[0045]). Therefore Libbus teaches that these parameters are results-effective.
Yun further teaches wherein the burst frequency is between about 10 Hz and about 35 Hz (¶¶[0122-0123]).
Therefore the examiner considers that modifying the burst stimulation of Libbus to include bursts of pulses having a burst frequency between 10 Hz and 35 Hz because the courts have held that “(i)t is a settled principle of law that a mere carrying forward of an original patented conception involving only change of form, proportions, or degree, or the substitution of equivalents doing the same thing as the original invention, by substantially the same means, is not such an invention as will sustain a patent, even though the changes of the kind may produce better results than prior inventions." In re Williams, 36 F.2d 436, 438, 4 USPQ 237 (CCPA 1929).
Regarding claim 9, Libbus as modified teaches the device of claim 1.
Libbus further teaches wherein the outer skin surface is on a neck of the patient (Fig. 3, Fig. 4 shows that it is known that the vagus nerve extends down the neck, it is further noted that this is an intended use of the device, and the device of Libbus is capable of placement on any skin surface).
Regarding claim 10, Libbus as modified teaches the device of claim 1.
Libbus further teaches wherein the outer skin surface is on, or near, an ear of the patient (Fig. 2A-B, it is further noted that this is an intended use of the device, and the device of Libbus is capable of placement on any skin surface).
Regarding claim 11, Libbus as modified teaches the device of claim 1.
Libbus further teaches wherein the selected nerve is a vagus nerve (¶[0020]).
Regarding claims 12 and 19-22, the claims are directed to a method comprising substantially the same subject matter as claims 1 and 8-11 and are taught by substantially the same sections of Libby and Yun.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
U.S. Patent Application Publication No. 2005/0075678 to Faul teaches transcutaneous stimulation of the neck with burst stimulation.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMANDA L STEINBERG whose telephone number is (303)297-4783. The examiner can normally be reached Mon-Fri 8-4.
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/AMANDA L STEINBERG/Examiner, Art Unit 3792
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