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 .
Status of the Claims
Claims 1-19 were originally filed November 18, 2022.
Claims 1-19 are currently pending.
Claims 1-7 are currently under consideration.
Please note: claim 8 should be dependent claim 7.
Please note: “mislocalization” in claim 9 lacks antecedent basis.
Please note: “therapeutic treatment” should read “method” (see claims 11-19).
Please note: “the binding protein” in claim 11 lacks antecedent basis.
Please note: “via introduction” should read “via introducing” so that all method steps are recited as active, positive steps (see claim 11).
Election/Restrictions
Applicant’s election of claims 1-3 and 5-7 in the reply filed on November 28, 2025 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Please note: it is respectfully noted that the election of claim 1 for a species of compound is not an election of a single, specific species (i.e. claim 1 simply refers to the genus of a compound). Therefore, the genus was searched. In addition, it appears that this election conflicts with the “or”/alternative of the introducing method step and the disassociating method step which was also elected (i.e. claim 3 as the peptide and claim 6 as the desired outcome of the method). However, in order to advance prosecution, the election was accepted. This does not preclude any future species requirements.
Please note: the election of claim 1 for a species of any and all method steps does not correlate with the “or”/alternative of the introducing method step and the disassociating method step. However, in order to advance prosecution, the election was accepted. This does not preclude any future species requirements.
Please note: SEQ ID NO: 1 in claim 2 is TDP-43.
Please note: SEQ ID NO: 3 in claim 3 is an alternative HIV tat CPP (i.e. asparagine/N replacing arginine/R) fused to residues 190-208 (B domain) of G3BP1.
Claims 8-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on November 28, 2025.
Priority
The present application is a CIP of 16/881,096 filed May 22, 2020 (now U.S. Patent 11,851,462) which claims the benefit of 62/876,852 filed July 22, 2019.
Please note: present claim 1 and all dependent claims thereof were not disclosed in 16/881,096 (e.g. a method for correcting disrupted synaptic protein synthesis, at least one compound, at least one binding protein, at least one condensate are not disclosed). Therefore, the present claims have a priority date of November 18, 2022 (i.e. the filing date of the present application).
Information Disclosure Statement
The information disclosure statements (IDS) submitted on February 15, 2023 (2) are being considered by the examiner.
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 - Sequences appearing in the specification are not identified by sequence identifiers (i.e., “SEQ ID NO:X” or the like) in accordance with 37 CFR 1.831(c).
See paragraphs 231, 239, 261, 485, 493, 509, 517, 525, 533, 541, 549, 557, 565, 573, 581, 589, 597, 605, 613, 621, 629, 637, 645, 653, 661, 669, 677, 685, 693, 701, 709, 717, 725, 733, 741, 749, 757, 765, 773, 781, 789, 797, 805, 913, 822, 831, 839, 947, 855, 863, 871, 879, and 887. SEQ ID NOs: should be directly after each sequence comprising 4 specifically defined amino acids and 10 specifically defined nucleic acids.
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 sequence identifiers, 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.
B. Specific deficiency - Sequences appearing in the drawings are not identified by sequence identifiers in accordance with 37 CFR 1.831(c). Sequence identifiers for sequences (i.e., “SEQ ID NO:X” or the like) must appear either in the drawings or in the Brief Description of the Drawings.
See Figures 27, 28, and 29.
Required response – Applicant must provide:
Amended drawings in accordance with 37 CFR 1.121(d) inserting the required sequence identifiers;
AND/OR
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3), and 1.125 inserting the required sequence identifiers (i.e., “SEQ ID NO:X” or the like) into the Brief Description of the Drawings, 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: nucleic acids should be written in lower case – see paragraphs 613, 621, 629, 637, 645, 653, 661, 669, 677, 717, 725, 733, 741, 749, 757, 765, 773, 781, 789, 797, 805, 813, 822, 831, 839, 847, 855, 863, 871, 879, and 887.
Appropriate correction is required.
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 paragraphs 271, 275, 292, and 325.
The disclosure is objected to because of the following informalities: the sequence listing should not be reiterated in the specification (see pages 127-150).
Appropriate correction is required.
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 1 is objected to because of the following informalities: “and to restore local protein synthesis events” should read “thereby restoring disrupted axonal and synaptic protein synthesis” to correlate with the preamble. Appropriate correction is required.
Claim 1 is objected to because of the following informalities: “via introduction of at least one peptide” should read “via introducing at least one peptide” (i.e. all method steps are recited as active, positive steps). Appropriate correction is required.
Claim 6 is objected to because of the following informalities: claim 6 should depend on claim 5. Appropriate correction is required.
Claim 6 is objected to because of the following informalities: “reverses effects” should read “reverses the effects”. Appropriate correction is required.
Sequence Interpretation
The Office interprets claims comprising SEQ ID NOs: in the following manner: “comprising a sequence of SEQ ID NO: 1” requires only a 2mer of SEQ ID NO: 1, “comprising the sequence of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 with any N-/C-terminal additions or any 5’/3’ additions, “consisting of SEQ ID NO: 1” requires the full-length sequence with 100% identity to SEQ ID NO: 1 and the same length as SEQ ID NO: 1, and “selected from the group consisting of SEQ ID NOs: 1, 2, and 3” requires the full-length sequence with 100% identity to SEQ ID NOs: 1, 2, or 3 and the same length as SEQ ID NOs: 1, 2, or 3. Any claim requiring a specific percent identity, necessarily requires at least the recited percent identity.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-7 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a written description rejection.
Claim 1 is drawn to a method for correcting disrupted axonal and synaptic protein synthesis comprising introducing an effective amount of at least one compound to a subject to restore an amount of at least one binding protein OR disassociating at least one condensate in the subject comprising the binding protein via introducing at least one peptide. The invention as claimed encompasses all known compounds and all potential compounds; all known binding proteins and all potential proteins; all known condensates and all potential condensates, and all known peptides and all potential peptides since virtually any compound, binding protein, condensate, and peptide could work in the present claim. For example, in alternative method step 1, if the compound is the same as the binding protein, then the compound would “restore an amount” of the binding protein (e.g. the same would be true for a gene therapy method – compound is an AAV vector encoding the binding protein, etc.). For example, in alternative method step 2, any peptide which is an antagonist, binding partner, etc. could disassociate a condensate. The claimed invention does not include any structural information regarding the compound, or condensate. While dependent claim 2 identifies SEQ ID NO: 1 (TDP-43) as the binding protein, this does not alter the scope of the compound, the condensate, or the peptide except that the function must be to restore TDP-43 or disassociate the condensate comprising TDP-43 (i.e. functional requirements do not supersede the written description requirement). While dependent claim 3 identifies SEQ ID NO: 3 (alternative HIV tat CPP wherein asparagine replaces arginine fused to G3BP1 B domain – residues 190-208) as the peptide, this does not alter the scope of the condensate or the binding protein except that the function must be to disassociate the condensate comprising the binding protein (i.e. functional requirements do not supersede the written description requirement).
The specification teaches G3BP1 B domain – residues 190-208 (please refer to all of the present Figures and the Brief Description of the Drawings). Therefore, applicants have only disclosed G3BP1 B domain – residues 190-208 as the compound or the peptide. In addition, the entire specification is related to in vitro models and not to in vivo methods of treating a subject (see paragraph 3; Figures; Brief Description of the Drawings; Examples). Therefore, one skilled in the relevant art would not reasonably conclude that the Applicants had possession of the invention as claimed since the structural limitation of G3BP1 B domain – residues 190-208 in an in vivo method is not included in the claimed invention.
See Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear that "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See page 1116.).
With the exception of G3BP1 B domain – residues 190-208 as disclosed by the specification, the skilled artisan cannot envision the method of claim 1. Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. V. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. In Fiddes v. Baird, 30 USPQ2d 1481, 1483, claims directed to mammalian FGF's were found unpatentable due to lack of written description for the broad class wherein the specification provided only the bovine sequence.
Additionally, Cf. University of Rochester v G.D. Searle & Co., Inc., Monsanto Company, Pharmacia Corporation, and Pfizer Inc., No. 03-1304, 2004 WL 260813 (Fed. Cir., Feb. 13, 2004) held that:
Regardless whether a compound is claimed per se or a method is claimed that entails the use of the compound, the inventor cannot lay claim to that subject matter unless he can provide a description of the compound sufficient to distinguish infringing compounds from non-infringing compounds, or infringing methods from non-infringing methods.
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.
Claim 1 is 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 1 recites the limitation "the subject" in line 5. There is insufficient antecedent basis for this limitation in the claim. While the first alternative method step does refer to “a subject”, the first method step is not required by the claim (i.e. only method step 2 could be performed). It is respectfully suggested that “a subject” should be incorporated into the preamble.
Claim 1 is 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 1 recites the limitation "the binding protein" in lines 5 and 6. There is insufficient antecedent basis for this limitation in the claim. While the first alternative method step does refer to “a binding protein”, the first method step is not required by the claim (i.e. only method step 2 could be performed). It is respectfully suggested that “a binding protein” should be incorporated into the second alternative method step.
Claims 1-7 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear if the preamble is required or if “to restore local protein synthesis events” (last line of claim 1) is required. It is respectfully noted that the preamble is more narrow than the last line (e.g. specific to axonal and synaptic protein synthesis).
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation to restore local protein synthesis events, and the claim also recites a method for correcting disrupted axonal and synaptic protein synthesis which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claims 1-7 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear which of the compounds, binding proteins, condensates, and peptides are required due to the “at least one” language. For example, claim 2 requires that the binding protein is SEQ ID NO: 1 (TDP-43). However, since TDP-43 would only be one of the binding proteins, it is unclear if TDP-43 would be the target for the compound or peptide or not.
Claims 2 and 3 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. One of skill in the art would not be able to determine the scope of the present method. For example, it is unclear what the scope of SEQ ID NOs: 1 and 3 are (i.e. 2mer, 100% identity, etc.; see the “Sequence Interpretation” section above).
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.
Claims 1-4 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Twiss et al. U.S. Patent Application Publication 2018/0250356 published September 6, 2018.
For present claims 1-4, Twiss et al. teach methods of treating neurological conditions associated with requiring nerve regeneration via enhancing protein synthesis and disrupting stress granules (i.e. condensate) including condensate with TDP-43 via administering residues 190-208/B domain of G3BP1 or YGNKKNNNQNNN (HIV tat alternative CPP wherein asparagine is replacing arginine)-VVEPEPEPEPEPEPEPVSD (residues 190-208/B domain of G3BP1; present SEQ ID NO: 3 wherein the C-terminal E is replaced by D; see paragraph 78 which teaches that an E to D substitution is a conservative amino acid substitution; paragraph 145) (please refer to the entire specification particularly the abstract; paragraphs 3, 6, 7, 11-70, 75-78, 87, 88, 90-100, 102, 104, 106-168; Figures; claims).
Therefore, the teachings of Twiss et al. anticipate the presently claimed method.
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.
Claims 1-7 are rejected under 35 U.S.C. 103 as being unpatentable over Twiss et al. U.S. Patent Application Publication 2018/0250356 published September 6, 2018 and Ravanidis et al., 2018, Unraveling the Pathways to Neuronal Homeostasis and Disease: Mechanistic Insights into the Role of RNA-Binding Proteins and Associated Factors, International Journal of Molecular Sciences, 19: 2280 (49 pages).
For present claims 1-7, Twiss et al. teach methods of treating neurological conditions associated with requiring nerve regeneration via enhancing protein synthesis and disrupting stress granules (i.e. condensate) including condensate with TDP-43 via administering residues 190-208/B domain of G3BP1 or YGNKKNNNQNNN (HIV tat alternative CPP wherein asparagine is replacing arginine)-VVEPEPEPEPEPEPEPVSD (residues 190-208/B domain of G3BP1; present SEQ ID NO: 3 wherein the C-terminal E is replaced by D; see paragraph 78 which teaches that an E to D substitution is a conservative amino acid substitution; paragraph 145) (please refer to the entire specification particularly the abstract; paragraphs 3, 6, 7, 11-70, 75-78, 87, 88, 90-100, 102, 104, 106-168; Figures; claims).
For present claims 1-7, Ravanidis et al. teach the roles of TDP43, stress granules, and ribonucleoprotein (RNP) granules in amyotrophic lateral sclerosis (ALS) (please refer to the entire specification particularly the abstract; Figures 1, 2; pages 2, 3; Table 1; section 5.1).
The claims would have been obvious because the substitution of one known element (i.e. genus of neurological conditions) for another (i.e. species of ALS with RNP granules) would have yielded predictable results (i.e. treatment of ALS via disrupting stress granules comprising TDP43 and RNP via administering residues 190-208/B domain of G3BP1) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
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, 3, and 4 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 17/839,820 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of copending Application No. 17/839,820 are drawn to a method of accelerating nerve recovery and treating nerve injury via disassembling stress granules and increasing axonal protein synthesis via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2).
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 17/839,820 in view of Ravanidis et al., 2018, Unraveling the Pathways to Neuronal Homeostasis and Disease: Mechanistic Insights into the Role of RNA-Binding Proteins and Associated Factors, International Journal of Molecular Sciences, 19: 2280 (49 pages).
Copending Application No. 17/839,820 are claims a method of accelerating nerve recovery and treating nerve injury via disassembling stress granules and increasing axonal protein synthesis via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2).
Ravanidis et al. teach the roles of TDP43, stress granuales, and ribonucleoprotein (RNP) granules in amyotrophic lateral sclerosis (ALS) (please refer to the entire specification particularly the abstract; Figures 1, 2; pages 2, 3; Table 1; section 5.1).
The claims would have been obvious because the substitution of one known element (i.e. genus of nerve injury) for another (i.e. species of ALS with TDP43 and RNP granules) would have yielded predictable results (i.e. treatment of ALS via disrupting stress granules comprising TDP43 and RNP via administering residues 190-208/B domain of G3BP1) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
This is a provisional nonstatutory double patenting rejection.
Claims 1, 3, and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,382,947. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,382,947 are drawn to a method of accelerating nerve recovery and treating nerve injury via disassembling stress granules and increasing axonal protein synthesis via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2).
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,382,947 in view of Ravanidis et al., 2018, Unraveling the Pathways to Neuronal Homeostasis and Disease: Mechanistic Insights into the Role of RNA-Binding Proteins and Associated Factors, International Journal of Molecular Sciences, 19: 2280 (49 pages).
U.S. Patent No. 11,382,947 claims a method of accelerating nerve recovery and treating nerve injury via disassembling stress granules and increasing axonal protein synthesis via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2).
Ravanidis et al. teach the roles of TDP43, stress granuales, and ribonucleoprotein (RNP) granules in amyotrophic lateral sclerosis (ALS) (please refer to the entire specification particularly the abstract; Figures 1, 2; pages 2, 3; Table 1; section 5.1).
The claims would have been obvious because the substitution of one known element (i.e. genus of nerve injury) for another (i.e. species of ALS with TDP43 and RNP granules) would have yielded predictable results (i.e. treatment of ALS via disrupting stress granules comprising TDP43 and RNP via administering residues 190-208/B domain of G3BP1) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1, 3, and 4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,668,128. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 10,668,128 are drawn to a method of increasing axon growth or accelerating nerve regeneration via disassembling stress granules and increasing axonal protein synthesis via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2).
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-8 of U.S. Patent No. 10,668,128 in view of Ravanidis et al., 2018, Unraveling the Pathways to Neuronal Homeostasis and Disease: Mechanistic Insights into the Role of RNA-Binding Proteins and Associated Factors, International Journal of Molecular Sciences, 19: 2280 (49 pages).
U.S. Patent No. 10,668,128 claims a method of increasing axon growth or accelerating nerve regeneration via disassembling stress granules and increasing axonal protein synthesis via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2).
Ravanidis et al. teach the roles of TDP43, stress granuales, and ribonucleoprotein (RNP) granules in amyotrophic lateral sclerosis (ALS) (please refer to the entire specification particularly the abstract; Figures 1, 2; pages 2, 3; Table 1; section 5.1).
The claims would have been obvious because the substitution of one known element (i.e. genus of nerve injury) for another (i.e. species of ALS with TDP43 and RNP granules) would have yielded predictable results (i.e. treatment of ALS via disrupting stress granules comprising TDP43 and RNP via administering residues 190-208/B domain of G3BP1) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
Claims 1-4 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,851,462. Although the claims at issue are not identical, they are not patentably distinct from each other because both the present claims and the claims of U.S. Patent No. 11,851,462 are drawn to a method of blocking stress granule aggregation or blocking neurodegeneration disease associated with axon degeneration via disassembling stress granules via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2) wherein TDP43 is present in the stress granules.
Claims 1-7 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 11,851,462 in view of Ravanidis et al., 2018, Unraveling the Pathways to Neuronal Homeostasis and Disease: Mechanistic Insights into the Role of RNA-Binding Proteins and Associated Factors, International Journal of Molecular Sciences, 19: 2280 (49 pages).
U.S. Patent No. 11,851,462 are drawn to a method of blocking stress granule aggregation or blocking neurodegeneration disease associated with axon degeneration via disassembling stress granules via administering the B domain – residues 190-208 - of G3BP1 (see SEQ ID NO: 2) wherein TDP43 is present in the stress granules.
Ravanidis et al. teach the roles of TDP43, stress granuales, and ribonucleoprotein (RNP) granules in amyotrophic lateral sclerosis (ALS) (please refer to the entire specification particularly the abstract; Figures 1, 2; pages 2, 3; Table 1; section 5.1).
The claims would have been obvious because the substitution of one known element (i.e. genus of nerve injury) for another (i.e. species of ALS with RNP granules) would have yielded predictable results (i.e. treatment of ALS via disrupting stress granules comprising RNP via administering residues 190-208/B domain of G3BP1) to one of ordinary skill in the art at the time of the invention. See KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 (U.S. 2007).
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/AMBER D STEELE/Primary Examiner, Art Unit 1658