DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application is being examined under the pre-AIA first to invent provisions.
Election/Restrictions
Claims 50-55 and 61-73 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/4/2026. Claims 56-58 have been elected without traverse and are pending this application.
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 56-58 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a method of delivering non-invasive stimulation without significantly more. The claims recites delivering two forms of non-invasive stimulation with one stimulation specific to auditory stimulation which is synchronized by a device, the delivery of these two stimulations is considered to be an abstract idea. The first stimulation is a non-invasive stimulation of an auditory pathway which could be someone speaking to the patient, a bell ringing, tapping or any form of non-invasive auditory stimulation. The second stimulation is to a non-auditory pathway and could be any type of tactile stimulation, electrical stimulation, flashing of lights etc. This judicial exception is not integrated into a practical application because these types of stimulation are only controlled by “a device” which could be something as simple as a clock or metronome, the device is merely used for the coordination of the stimulation. The claim(s) does/do not include additional elements that are sufficient to amount to significantly more than the judicial exception because there are no elements claimed which would be used to perform the method steps.
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 56-58 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.
Claim 56, in the final line, recites “wherein the neural plasticity comprises auditory brain regions”. As is known, neural plasticity is the brains ability to learn and adapti. The definition of comprise is “to be made up of”ii. Neural plasticity therefore can occur in auditory brain regions however it is unclear how it can comprise or be made up of auditory brain regions. For the purposes of expedited prosecution this will be considered language specific to intended outcome.
Claim 56 is also rejected in that there is only one step in the method claim “delivering to a subject at least one stimulation”, the remainder of the language is directed towards wherein clauses. The scope of the claim cannot be determined in that this could be any type of stimulation. As is known neural plasticity occurs continually through the lifetime of a patient with the brain capable of learning, reorganizing and recovering from injury therefore this language does not clarify the scope of the claimed invention.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of pre-AIA 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 –
Claims 56 and 59 are rejected under pre-AIA 35 U.S.C. 102(a)(1) as being anticipated by Beck et al. US 2014/0126752 note that the earliest foreign priority is 4/30/2011.
Regarding claim 56: Beck disclose delivering a first non-invasive stimulation to an auditory pathway (“emission of an acoustic signal into the auditory canal of the ear”, abstract) and a second non-invasive to a non-auditory neuronal pathway (“transcutaneous electrical stimulus to the surface of a portion of the human ear”, abstract); wherein the delivery of the two stimulation signals is coordinated via a device 1 (figures 2-3, paragraphs 0007, 0016, 0027, 0053). Regarding the language “to promote the neural plasticity” and “wherein the neural plasticity comprises auditory brain regions” found in claim 56. This language is considered to be intended outcome and does not further narrow the claim nor does it add any additional steps to the claim. The steps of the claim must be distinguished from the prior art, in this case there is a single step of delivering stimulation and this step is found in Beck as discussed above.
Regarding claim 59: Beck discloses stimulation of the skin of the ear which is considered to be the non-auditory neuronal pathway. As is known in the art and the field of neuroscience, the skin of the ear is innervated by the trigeminal nerve this neural signal eventually reaches the somatosensory cortexiii, therefore Beck is disclosing that the non-auditory pathway includes the somatosensory neuronal pathway. Beck further discloses that this is associated with the ear (figure 2).
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.
Claims 57-58 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beck et al. US 2014/0126752 in view of Kilgard et al. US 2010/0004717.
Regarding claims 57-58: Beck discloses the claimed invention including delivering the stimulation signals at the same time (paragraphs 0003, 0013, 0061) however Beck does not disclose that one of the stimulation signals include a pulse train as a pattern lasting up to one second. Kilgard however teaches of a similar stimulation device which uses a stimulation pulse train to stimulate a nerve, including the vagus nerve (paragraph 0038) with the train including .5 seconds of a biphasic pulse (paragraph 0036) to treat tinnitus. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Beck to include stimulation using a pulse train lasting up to one second, as taught by Kilgard, in order to treat tinnitus.
Claim 60 is rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Beck et al. US 2014/0126752 in view of Cameron et al. US 2012/0203301.
Regarding claim 60: Beck discloses the claimed invention however Beck does not specifically disclose stimulation to more than one non-auditory body location. Cameron discloses a treatment device and method which stimulates the trigeminal nerves to treat tinnitus (abstract). Cameron further teaches of stimulating the head and face (paragraphs 0012, 0020) in order to target nerves innervating the skin of the head and face. It therefore would have been obvious to one of ordinary skill in the art at the time the invention was filed to modify Beck to include stimulating the head and face of the subject, as taught by Cameron, in order to treat neurological disorders such as tinnitus.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 56 and 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 2 of U.S. Patent No. 10,265,527. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
18/903,394
10,265,527
Claim 56:
A method for promoting neural plasticity, comprising: delivering to a subject at least one stimulation to promote the neural plasticity, wherein the stimulation comprises a first non-invasive stimulation of at least one auditory neuronal pathway with a second non-invasive stimulation of at least one non-auditory neuronal pathway, wherein the delivery of stimulation to the at least one auditory neuronal pathway and the stimulation to the at least one non-auditory neuronal pathway is coordinated for delivery via a device, and wherein the neural plasticity comprises auditory brain regions.
Claim 1:
A method for treating a patient having tinnitus, comprising delivering to the patient's brain at least one synchronized stimulation, wherein the synchronized stimulation to the brain is effective to treat the tinnitus and comprises stimulation from at least one auditory neuronal pathway and stimulation from multiple non-auditory neuronal pathways from different body sites, wherein each stimulation is evoked non-invasively, wherein the synchronized stimulation involves a stimulus pattern lasting between 0.01 to 100 ms for each activated pathway with a specifically determined time between each activated pathway that ranges between 0-1000 ms, wherein the auditory stimulation is caused by sound, wherein the sound is delivered using headphones and is one or more pure tone frequencies, bandwidth filtered sinusoids or noise, and the non-auditory stimulation is caused by transcutaneous electrical nerve stimulation (TENS) delivered using a TENS unit, wherein the delivery of the sound from the headphones and the non-auditory stimulation from the TENS unit is synchronized and delivered by a device having a user interface to adjust the stimulation pattern to treat the tinnitus.
Claim 59: The method of claim 56, wherein the at least one non- auditory neuronal pathway is a somatosensory neuronal pathway, and wherein the at least one non-auditory neuronal pathway is a pathway associated with at least one of the subject's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Claim 2:
The method of claim 1, wherein at least one non-auditory pathway is a pathway from the patient's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Claims 56, 57 and 59 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 of U.S. Patent No. 10,265,527. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
18/903,394
10,265,527
Claim 56:
A method for promoting neural plasticity, comprising: delivering to a subject at least one stimulation to promote the neural plasticity, wherein the stimulation comprises a first non-invasive stimulation of at least one auditory neuronal pathway with a second non-invasive stimulation of at least one non-auditory neuronal pathway, wherein the delivery of stimulation to the at least one auditory neuronal pathway and the stimulation to the at least one non-auditory neuronal pathway is coordinated for delivery via a device, and wherein the neural plasticity.
Claim 57: The method of claim 56, wherein at least one of the first non-invasive stimulation or the second non-invasive stimulation comprises a stimulus pattern lasting up to 1 second, and wherein stimulation of each activated pathway is separated by a time that ranges between greater than 0 ms and no more than 1000 ms such that the first non-invasive stimulation and the second non-invasive stimulation activate one or more brain regions of the subject comprises auditory brain regions.
Claim 1:
A method for treating a patient having tinnitus, comprising delivering to the patient's brain at least one synchronized stimulation, wherein the synchronized stimulation to the brain is effective to treat the tinnitus and comprises stimulation from at least one auditory neuronal pathway and stimulation from multiple non-auditory neuronal pathways from different body sites, wherein each stimulation is evoked non-invasively, wherein the synchronized stimulation involves a stimulus pattern lasting between 0.01 to 100 ms for each activated pathway with a specifically determined time between each activated pathway that ranges between 0-1000 ms, wherein the auditory stimulation is caused by sound, wherein the sound is delivered using headphones and is one or more pure tone frequencies, bandwidth filtered sinusoids or noise, and the non-auditory stimulation is caused by transcutaneous electrical nerve stimulation (TENS) delivered using a TENS unit, wherein the delivery of the sound from the headphones and the non-auditory stimulation from the TENS unit is synchronized and delivered by a device having a user interface to adjust the stimulation pattern to treat the tinnitus.
Claim 59: The method of claim 56, wherein the at least one non- auditory neuronal pathway is a somatosensory neuronal pathway, and wherein the at least one non-auditory neuronal pathway is a pathway associated with at least one of the subject's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Claim 2:
The method of claim 1, wherein at least one non-auditory pathway is a pathway from the patient's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Claims 56-57 and 59-60 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 12,138,456. Although the claims at issue are not identical, they are not patentably distinct from each other as shown below.
18/903,394
12,138,456
Claim 56:
A method for promoting neural plasticity, comprising: delivering to a subject at least one stimulation to promote the neural plasticity, wherein the stimulation comprises a first non-invasive stimulation of at least one auditory neuronal pathway with a second non-invasive stimulation of at least one non-auditory neuronal pathway, wherein the delivery of stimulation to the at least one auditory neuronal pathway and the stimulation to the at least one non-auditory neuronal pathway is coordinated for delivery via a device, and wherein the neural plasticity.
Claim 57: The method of claim 56, wherein at least one of the first non-invasive stimulation or the second non-invasive stimulation comprises a stimulus pattern lasting up to 1 second, and wherein stimulation of each activated pathway is separated by a time that ranges between greater than 0 ms and no more than 1000 ms such that the first non-invasive stimulation and the second non-invasive stimulation activate one or more brain regions of the subject comprises auditory brain regions.
Claim 1:
A method for treating a neurological disorder or deficit, comprising: delivering to a subject having the neurological disorder or deficit at least one stimulation, wherein the stimulation comprises a first non-invasive stimulation of at least one auditory neuronal pathway with a second non-invasive stimulation of at least one non-auditory neuronal pathway, wherein at least one of the first non-invasive stimulation or the second non-invasive stimulation comprises a stimulus pattern lasting up to 1 second, wherein stimulation of each activated pathway is separated by a time that ranges between greater than 0 ms and no more than 1000 ms such that the first non-invasive stimulation and the second non-invasive stimulation activate one or more brain regions of the subject, and wherein the delivery of stimulation to the at least one auditory neuronal pathway and the stimulation to the at least one non-auditory neuronal pathway is coordinated for delivery via a device.
Claim 59: The method of claim 56, wherein the at least one non- auditory neuronal pathway is a somatosensory neuronal pathway, and wherein the at least one non-auditory neuronal pathway is a pathway associated with at least one of the subject's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Claim 2: The method of claim 1, wherein the at least one non-auditory neuronal pathway is a somatosensory neuronal pathway.
Claim 3: The method of claim 1, wherein the at least one non-auditory neuronal pathway is a pathway associated with at least one of the subject's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Claim 60: The method of claim 58, wherein the stimulation comprises stimulation of multiple non-auditory neuronal pathways associated with at least two different body locations of the at least one of the subject's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Claim 4: The method of claim 3, wherein the stimulation comprises stimulation of multiple non-auditory neuronal pathways associated with at least two different body locations of the at least one of the subject's head, face, ear, eye, nose, mouth, lip, tongue, tooth, neck, body, limb, genital areas, buttocks/anus regions, hand, finger, foot, or toe.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Paula J. Stice whose telephone number is (303)297-4352. The examiner can normally be reached Monday - Friday 7:30am -4pm MST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Benjamin Klein can be reached at 571-272-5213. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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PAULA J. STICE
Primary Examiner
Art Unit 3796
/PAULA J STICE/Primary Examiner, Art Unit 3796
i What Is Neuroplasticity? How It Works https://health.clevelandclinic.org/neuroplasticity
ii COMPRISE Definition & Meaning - Merriam-Webster https://www.merriam-webster.com/dictionary/comprise
iii The trigeminal pathways - PubMed https://pubmed.ncbi.nlm.nih.gov/35249132/
Prosecution Insights