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 .
Detailed Action
This Office Action is in response to the Applicant’s reply received 6/6/25. Claims 1-6, and 11-24 are pending and considered on the merits.
Claim Objections
Claim 19 is objected to for the typo in “anterior transfer process of 06”. It is believed it should read -- anterior transfer process of C6—since this is what is supported in the Specification.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 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 –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-6, 11-16, and 18-23 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Brooks et al. (WO 2021/041982, published March 4, 2021, in IDS 10/15/24).
Brooks et al. teach treating PTSD in a patient by administering 35 units of botulinum type A (a clostridial neurotoxin) into the stellate ganglion (SG) of a patient with a needle (Brooks, Example 1, and 011). Brooks et al. teach an alternative PTSD treatment by injecting 40 units of botulinum type E as well as 2 mL of 2% lidocaine (a local anesthetic) into the SG (Brooks, Example 4). They also teach injecting botulinum toxin into the SG can treat depression, anxiety, headache, and CRPS (Brooks, claims 1, 3, 15-20). The injection can be performed without imaging guidance via palpitation of the anterior transverse process of C6 or the Chassagne tubercle (Brooks, claim 5). Alternatively the injection can be performed with imaging guidance (Brooks, claim 5).
Therefore the invention as a whole is anticipated by the reference.
Claim(s) 1-6, 14, 16 and 17 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ding et al. (EXPERIMENTAL AND THERAPEUTIC MEDICINE 14: 2017, in IDS 10/15/24).
Ding et al. teach treating a patent for insomnia by injecting botulinum toxin A (BTX-A) with ultrasound guidance (Ding, see Abstract). They also teach that local anesthetics are administered with the injection (Ding, pg. 1137, col 1, top).
Therefore the invention as a whole is anticipated by the reference.
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.
Claim(s) 1-6, 11-13, and 21 is/are rejected under 35 U.S.C. 103 as being unpatentable over Borodic (US 2014/0105883, IDS 10/15/24).
Borodic teaches injecting 10-1500 units of botulinum toxin type A-G into the stellate ganglion to create a stellate ganglion block (Borodic, 0039). He teaches this procedure treats various CNS disorders including seizures, anxiety, mania, and biopolar disorders (Borodic, 0021).
While Borodic does not expressly teach all the claim limitations in a single embodiment, it would be obvious for one of ordinary skill in the art to perform the claimed method after reviewing the entire disclosure. Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
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 1-6, and 11-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 34-36, 38-40, and 43-52 of copending Application No. 17/638673. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are to treating a neurological or psychological disorder or symptom by injecting botulinum toxin A-F into the stellate ganglion in a human. The injection can be with ultrasound guidance or without by palpating an anterior transverse process of vertebrate C6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-6, and 11-24 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 39-48 of copending Application No. 17/911089. Although the claims at issue are not identical, they are not patentably distinct from each other because both sets of claims are to treat an angina and arrhythmias by injecting 25-150 units of botulinum toxin A-F into the stellate ganglion in a human. The injection can be with imaging the area with ultrasound.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
In response to this office action the applicant should specifically point out the support for any amendments made to the disclosure, including the claims (MPEP 714.02 and 2163.06).
CONTACT INFORMATION
Any inquiry concerning this communication or earlier communications from the examiner should be directed to THANE E UNDERDAHL whose telephone number is (303) 297-4299. The examiner can normally be reached Monday through Thursday, M-F 8-5 MST.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at (571) 272-3311.The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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