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 .
Claims 2, 4, 21, 24-25, 31, 36, 38, 50, 58, 66 and 88-89 are pending and are under examination.
Election/Restrictions
Applicant’s election without traverse of Group II claims 2, 4, 21, 24-25, 36, 38, 50, 58, 66 and 88-89 in the reply filed on 06/24/2026 is acknowledged.
Claims 1, 71, 76-79, 81 and 86-87 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 06/24/2026.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copies have been filed.
Information Disclosure Statement
The information disclosure statements filed 05/17/2024, 04/01/2025,09/10/2024 and 05/17/2024 have been considered and an initialed copies are enclosed.
Nucleotide and/or Amino Acid Sequence Disclosures
Summary of Requirements for Patent Applications Filed On Or After July 1, 2022, That Have Sequence Disclosures
37 CFR 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 CFR 1.831(b) must contain a “Sequence Listing XML”, as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 CFR 1.831-1.835. This “Sequence Listing XML” part of the disclosure may be submitted:
1. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 via the USPTO patent electronic filing system (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/PatentLegalFramework), hereinafter “Legal Framework”) in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 CFR 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 CFR 1.831(a) using the symbols and format requirements of 37 CFR 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 CFR 1.52(e)(1)(ii), labeled according to 37 CFR 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 CFR 1.52(e)(8) and 37 CFR 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
SPECIFIC DEFICIENCIES AND THE REQUIRED RESPONSE TO THIS NOTICE ARE AS FOLLOWS:
Specific deficiency - The incorporation by reference paragraph required by 37 CFR 1.834(c)(1), 1.835(a)(2), or 1.835(b)(2) is missing, defective or incomplete.
Required response - Applicant must:
• Provide a substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required incorporation by reference paragraph, consisting of:
• A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
• A copy of the amended specification without markings (clean version); and
• A statement that the substitute specification contains no new matter.
Specification
The disclosure is objected to because of the following informalities:
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. See p. 23, for example.
Appropriate correction is required.
Claim Objections
Claim 21 and 36 are objected to because of the following informalities: In claim 21, please include the full meaning of SNARE. In claim 36, please include the full meaning of CGRP. Appropriate correction is required.
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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.
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) 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fonfria et al. WO 2021064369 04-08-2021 cited in IDS
Claim 24: Fonfria et al disclose a method for treating a sensory disorder (p. 1 lines 4-6, title) by inhibiting release of a mediator from a neuron comprising an Aδ nerve fiber, the method comprising administering to a subject a chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain). See p. 3 lines 14-31, p. 4 lines 1-2, p. 25 lines 24-36 and p. 26 lines 8-13.
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 2, 4, 21, 24, 25, 31, 36, 38, 50, 66, 88 and 89 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brooks et al. US 20210060144 03-04-2021 in view of Fonfria et al. WO 2021064369 04-08-2021 cited in IDS.
Claim 2: Brooks et al disclose a method of treating pain (paragraphs 29, 30, 42, 76), the method comprising administering to the subject a chimeric clostridial neurotoxin (paragraph 50) .
Claim 25: the pain is associated with headache (paragraph 29).
Claim 36: the pain is CGRP-associated somatic pain selected from: headache pain or facial pain (paragraph 29).
Claim 38: Brooks et al disclose administering the chimeric clostridial neurotoxin to the face, skull or neck. See paragraph 183, 184, 186
Claim 66: Brooks et al disclose the administration is intramuscular (paragraph 49).
Brooks et al does not disclose the chimeric clostridial toxin comprises a botulinum neurotoxin A light chain and translocation domain and a BoNT/B receptor binding domain.
Fonfria et al disclose a chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain). See p. 3 lines 14-31, p. 4 lines 1-2, p. 25 lines 24-36 and p. 26 lines 8-13. Fonfria et al disclose that such hybrid or chimeric clostridial neurotoxins are useful, for example, as a means of delivering the therapeutic benefits of such clostridial neurotoxins to subjects who are immunologically resistant to a given clostridial neurotoxin subtype, to subjects who may have a lower than average concentration of receptors to a given clostridial neurotoxin heavy chain binding domain, or to subjects who may have a protease-resistant variant of the membrane or vesicle toxin substrate (e.g., SNAP-25, VAMP and syntaxin). See p. 25 lines 24-36.
Claim 88-89: Fonfria et al disclose a clostridial neurotoxin comprises a light chain comprising SEQ ID NO: 17 (see sequence alignment in Appendix A SEQ ID NO: 20 of Fonfria et al and p. 48 lines 15-17) and a heavy chain sequence comprising SEQ ID NO: 19 (see sequence alignment in Appendix B SEQ ID NO: 64). Fonfria disclose that the light chain and heavy chain are joined together by a di-sulphide bond. See p. 50 lines 7-15.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have used the chimeric clostridial neurotoxin of Fonfria et al in the method of Brooks et al, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Brooks et al discloses that the clostridial neurotoxin can be chimeric and Fonfria et al disclose a chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain). Fonfria et al disclose that hybrid or chimeric clostridial neurotoxins are useful, for example, as a means of delivering the therapeutic benefits of such clostridial neurotoxins to subjects who are immunologically resistant to a given clostridial neurotoxin subtype, to subjects who may have a lower than average concentration of receptors to a given clostridial neurotoxin heavy chain binding domain, or to subjects who may have a protease-resistant variant of the membrane or vesicle toxin substrate (e.g., SNAP-25, VAMP and syntaxin).
Regarding claim 4 and claim 31: the combination of Brooks et al and Fonfria et al disclose the chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain) of claim 2, thus said chimeric clostridial neurotoxin would (a) bind to a neuron comprising an Aδ nerve fiber or the C nerve fiber; or (b) inhibit secretion from a neuron of the central nervous system, thereby inhibiting the release of a pain mediator from the neuron, wherein the pain mediator is a neurotransmitter.
Regarding claim 21: the combination of Brooks et al and Fonfria et al disclose the chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain) of claim 2, thus said chimeric clostridial neurotoxin would travel by neuronal transport to a neuron of the central nervous system and cleaves a SNARE protein of the neuron.
Regarding claim 50: the combination of Brooks et al and Fonria et al disclose administering the clostridial neurotoxin and teach the use of both intra-muscular injections and saturation of nerve-rich trigeminal administration sites, for example combining injections into at least one, two, three, four, five, six, seven, or eight areas including the nasalis, orbicularis oculi, corrugator, procerus, masseter, occipitalis, temporalis and trapezius muscle regions. Further embodiments can comprise injecting one of but not both of the frontalis and cervical paraspinal muscle regions.
Thus, the administrations in claim 50 part a and part b would have been prima facie obvious as of the effective filing date of the instant invention in view of the teachings of Brooks et al.
Regarding claim 24: The combination of Brooks et al and Fonria et al disclose the method step of claim 24. The recitation of a method of treating a sensory disorder by inhibiting a release of a mediator from a neuron comprising an Aδ nerve fiber or a C nerve fiber is recited in the preamble of the claim. When reading the preamble in the context of the entire claim, this recitation is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
Claim(s) 58 is/are rejected under 35 U.S.C. 103 as being unpatentable over Brooks et al. US 20210060144 03-04-2021 and Fonfria et al. WO 2021064369 04-08-2021 cited in IDS as applied to claims 2, 4, 21, 25, 31, 36, 38, 50, 66, 88 and 89 above, further in view of Grigore et al. WO 2021/186160 9/23/2021 cited IDS.
The combination of Brooks et al and Fonfria et al is set forth above and does not disclose the total dose administered per treatment session is up to 255,000 pg of the chimeric clostridial toxin.
Grigore et al disclose a method of treating pain (p. 1 lines 5-6 and p. 2 lines 16-17) by administering a chimeric clostridial neurotoxin (p. 4 lines 19-23, p. 56-64, p. 68-69) and discloses total dose of up to 255,000 pg. See p. 49 lines 16-26 and p. 50 lines 5-18.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to modified the method of the combination of Brooks et al and Fonfria et al by administering the chimeric clostridial neurotoxin a total dose of up to 255,000 pg per treatment session as taught by Grigore et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Grigore et al disclose that a total dose of up to 255,000 pg can be used in a method of treating pain using a chimeric clostridial neurotoxin.
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 2, 4, 21, 25, 31, 36, 66, and 88-89 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 4-17 of copending Application No. 18711047 (‘047) in view of Fonfria et al. WO 2021064369 04-08-2021 cited in IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘047 claims disclose a method of treating visceral pain or bladder pain or endometriosis pain or cancer pain, the method comprising administering a clostridial neurotoxin by intradermal administration.
The ‘047 claims do not disclose the clostridial toxin is a chimeric clostridial toxin comprising botulinum neurotoxin A light chain and translocation domain and a BoNT/B receptor binding domain.
Fonfria et al disclose a chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain). See p. 3 lines 14-31, p. 4 lines 1-2, p. 25 lines 24-36 and p. 26 lines 8-13. Fonfria et al disclose that such hybrid or chimeric clostridial neurotoxins are useful, for example, as a means of delivering the therapeutic benefits of such clostridial neurotoxins to subjects who are immunologically resistant to a given clostridial neurotoxin subtype, to subjects who may have a lower than average concentration of receptors to a given clostridial neurotoxin heavy chain binding domain, or to subjects who may have a protease-resistant variant of the membrane or vesicle toxin substrate (e.g., SNAP-25, VAMP and syntaxin). See p. 25 lines 24-36.
Claim 88-89: Fonfria et al disclose a clostridial neurotoxin comprises a light chain comprising SEQ ID NO: 17 (see sequence alignment in Appendix A SEQ ID NO: 20 of Fonfria et al and p. 48 lines 15-17) and a heavy chain sequence comprising SEQ ID NO: 19 (see sequence alignment in Appendix B SEQ ID NO: 64). Fonfria disclose that the light chain and heavy chain are joined together by a di-sulphide bond. See p. 50 lines 7-15.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to have used the chimeric clostridial neurotoxin of Fonfria et al in the method of the ‘047 claims, thus resulting in the instant invention with a reasonable expectation of success.
The motivation to do so is that Fonfria et al disclose a chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain). Fonfria et al disclose that such a hybrid or chimeric clostridial neurotoxin is useful, for example, as a means of delivering the therapeutic benefits of such clostridial neurotoxins to subjects who are immunologically resistant to a given clostridial neurotoxin subtype, to subjects who may have a lower than average concentration of receptors to a given clostridial neurotoxin heavy chain binding domain, or to subjects who may have a protease-resistant variant of the membrane or vesicle toxin substrate (e.g., SNAP-25, VAMP and syntaxin).
Regarding claim 4 and claim 31: the combination of the ‘047 claims and Fonfria disclose the chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain) of claim 2, thus said chimeric clostridial neurotoxin would (a) bind to a neuron comprising an Aδ nerve fiber or the C nerve fiber; or (b) inhibit secretion from a neuron of the central nervous system, thereby inhibiting the release of a pain mediator from the neuron, wherein the pain mediator is a neurotransmitter.
Regarding claim 21: the combination of the ‘047 claims and Fonfria disclose the chimeric clostridial neurotoxin comprising a botulinum neurotoxin A (BoNT/A) light chain and translocation domain (HN domain) and a BoNT/B receptor binding domain (HC domain) of claim 2, thus said chimeric clostridial neurotoxin would travel by neuronal transport to a neuron of the central nervous system and cleaves a SNARE protein of the neuron.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 58 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 4-17 of copending Application No. 18711047 (‘047) and Fonfria et al. WO 2021064369 04-08-2021 cited in IDS as applied to claims 2, 4, 21, 25, 31, 36, 66, and 88-89 further in view of Grigore et al. WO 2021/186160 9/23/2021 cited IDS.
Although the claims at issue are not identical, they are not patentably distinct from each other because the combination of the ‘047 claims and Fonfria et al is set forth above and does not disclose the total dose administered per treatment session is up to 255,000 pg of the chimeric clostridial toxin.
Grigore et al disclose a method of treating pain (p. 1 lines 5-6 and p. 2 lines 16-17) by administering a chimeric clostridial neurotoxin (p. 4 lines 19-23, p. 56-64, p. 68-69) and discloses total dose of up to 255,000 pg. See p. 49 lines 16-26 and p. 50 lines 5-18.
It would have been prima facie obvious to a person of ordinary skill in the art as of the effective filing date of the instant invention to modified the method of the combination of the ‘047 claims and Fonfria et al by administering the chimeric clostridial neurotoxin a total dose of up to 255,000 pg per treatment session as taught by Grigore et al, thus resulting in the instant invention with a reasonable expectation of success. The motivation to do so is that Grigore et al disclose that a total dose of up to 255,000 pg can be used in a method of treating pain using a chimeric clostridial neurotoxin.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 24 is provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 2 and 4-17 of copending Application No. 18711047 (‘047). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘047 claims disclose a method of treating visceral pain or bladder pain or endometriosis pain or cancer pain, the method comprising administering a clostridial neurotoxin by intradermal administration.
The ‘047 claims disclose the method step of claim 24. The recitation of a method of treating a sensory disorder by inhibiting a release of a mediator from a neuron comprising an Aδ nerve fiber or a C nerve fiber is recited in the preamble of the claim. When reading the preamble in the context of the entire claim, this recitation is not limiting because the body of the claim describes a complete invention and the language recited solely in the preamble does not provide any distinct definition of any of the claimed invention’s limitations. Thus, the preamble of the claim(s) is not considered a limitation and is of no significance to claim construction. See Pitney Bowes, Inc. v. Hewlett-Packard Co., 182 F.3d 1298, 1305, 51 USPQ2d 1161, 1165 (Fed. Cir. 1999). See MPEP § 2111.02.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Status of Claims
Claims 2, 4, 21, 24, 25, 31, 36, 38, 50, 58, 66 and 88-89 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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/OLUWATOSIN A OGUNBIYI/ Primary Examiner, Art Unit 1645
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