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.
The amendment received July 7, 2026 amended claims 1, 6, 8, 9, and 11-19.
Claims 1-19 are currently pending.
Claims 1-7 are currently under consideration.
Please note: “via introduction” should read “via introducing” so that all method steps are recited as active, positive steps (see claim 11).
Election/Restrictions
Applicants elected, without traverse, claims 1-3 and 5-7 in the reply filed on November 28, 2025. 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 appears that the election of claim 1 regarding the compound 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; residues 1-12 of SEQ ID NO: 3) fused to residues 190-208 (B domain) of G3BP1 (residues 13-31 of SEQ ID NO: 3).
Claims 8-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.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).
Drawings
The drawings are objected to because the polynucleotide sequences in Figures 27-29 should be in lower case. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
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 (SEQ ID NO: 2 is a polypeptide and not the recited polynucleotide) and 261 (the correct SEQ ID NO: was not provided).
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. The response received July 7, 2026 stated that replacement drawings were provided, but Figures 27-29 were not provided. A table labeled both as Table 5 and Table 29 was provided which appears to correspond with Figure 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 paragraph 231.
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 6 is objected to because of the following informalities: claim 6 should depend on claim 1. Appropriate correction is required.
Withdrawn Objections
The objection to the specification regarding embedded hyperlinks or other forms of browser-executable code is withdrawn in view of the amendments received July 7, 2026.
The objection to claim 1 regarding “and to restore local protein synthesis events” should read “thereby restoring disrupted axonal and synaptic protein synthesis” to correlate with the preamble is withdrawn in view of the amendments received July 7, 2026.
The objection to claim 1 regarding “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) is withdrawn in view of the amendments received July 7, 2026.
The objection to claim 6 regarding “reverses effects” should read “reverses the effects” is withdrawn in view of the amendments received July 7, 2026.
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.
Withdrawn Rejections
The rejection of claims 1-7 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 is withdrawn in view of the amendment received July 7, 2026.
Please note: only a written description rejection was made. An enablement rejection was not made.
The rejection of claim 1 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 is withdrawn in view of the amendment received July 7, 2026.
The rejection of claims 1-7 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 is withdrawn in view of the amendment received July 7, 2026.
The rejection of claims 1-7 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 is withdrawn in view of the amendment received July 7, 2026.
Maintained Rejections
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 binding protein" in line 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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 1 were considered but are not persuasive for the following reasons.
Applicants contend that the scope is reasonably ascertainable.
Applicants’ arguments are not convincing since there are two alternative method steps in independent claim 1 and “the binding protein” of alternative method step 2 lacks antecedent basis.
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 condensates (independent claim 1, dependent claims 6 and 7) or binding proteins (dependent claim 2) are required due to the “at least one” language. Please note: “at least one” was deleted from independent claim 1, alternative method step 1. However, dependent claim 2 still contains the “at least one” language regarding the binding protein.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 1 were considered but are not persuasive for the following reasons.
Applicants contend that “at least one” is commonly utilized in patent claims and has a well-understood meaning of one or more.
Applicants’ arguments are not convincing since the metes and bounds of the single phrase “at least one” is clear as meaning one or more. It is the limitations of “at least one condensate” or “at least one binding protein” within the method step that are indefinite. The method must be clear as to what exactly the required reagents are and what exactly the required interaction is to “thereby restoring disrupted axonal and synaptic protein synthesis”.
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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 112(b) as being indefinite for claim 1 were considered but are not persuasive for the following reasons.
Applicants contend that the scope is definite.
Applicants’ arguments are not convincing since according to the sequence interpretation section above, the sequence requirements are indefinite.
New Rejections Necessitated by Amendment
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 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 what the scope of “comprising residues 190-208 of the B domain of G3BP1” is. It is unclear if the claim only requires residues 190-208 of the B domain of G3BP1 (i.e. closed consisting language should be utilized), if the entire B domain may be utilized, if the entire G3BP1 may be utilized, etc. Applicant may utilize closed consisting of language and then further comprising language for any fusion polypeptides (i.e. further comprising residues 1-12 of SEQ ID NO: 3).
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 what residues 190-208 of the B domain of G3BP1 are. If specific residues are indicated, a SEQ ID NO: should be utilized to clarify the sequence.
Claim 2 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 2 recites the limitation "the at least one binding protein" in line 2. There is insufficient antecedent basis for this limitation in the claim. Independent claim 1 does not refer to “at least one” binding protein.
Maintained Rejections
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.
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 102 (a)(1) as being anticipated by Twiss et al. for claims 1-4 were considered but are not persuasive for the following reasons.
Applicants contend that Twiss et al. is directed to targeting G3BP proteins to accelerate nerve regeneration and claims methods of treating nerve injury in a mammal by introducing a polypeptide to a nerve injury site. Applicants contend that Twiss et al. does not disclose a method for correcting disrupted axonal and synaptic protein synthesis in a subject by restoring an amount of a binding protein or by disassociating a condensate.
Applicants’ arguments are not convincing since the teachings of Twiss et al. anticipate the method of the instant claims.
The present claims do not refer to a specific subject population, a specific binding protein (with the exception of dependent claim 2; TDP-43 which Twiss et al. discloses), or a specific condensate. Therefore, the introduction of residues 190-208 of the B domain of G3BP1 into a subject (both alternatives 1 and 2 of present independent claim 1) reads on the presently claimed method.
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).
Regarding Twiss et al., one of skill in the art would readily understand that increasing axon growth in both naïve and injury-conditioned neurons would require correcting protein synthesis (i.e. new growth would require new protein synthesis; see paragraphs 6, 75, and 145 of Twiss et al.). Twiss et al. Figures 5, 6, 7, 11B, 11C, 15A, 16B, and 16C show that G3BP domain 3 increases neurite length which would require protein synthesis (also see paragraph 96). Figures 19 and 20 show that the addition of a polypeptide (i.e. G3BP 190-208; paragraphs 77 and 78; Figure 7) increases intra-axonal protein synthesis and increases the intra-axonal rates of translation of proteins. Also see paragraphs 12, 13, 19-21, 43-49, 58, 62, and 63 (i.e. increases intra-axonal rates of translation of proteins needed for nerve regeneration).
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) and In re Petering, 301 F.2d 676, 681(CCPA 1962).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) and Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
"Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
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).
Arguments and Response
Applicants’ arguments directed to the rejection under 35 USC 103 as being unpatentable over Twiss et al. and Ravanidis et al. for claims 1-7 were considered but are not persuasive for the following reasons.
Applicants contend that Twiss et al. is directed to targeting G3BP proteins to accelerate nerve regeneration and claims methods of treating nerve injury in a mammal by introducing a polypeptide to a nerve injury site. Applicants contend that Twiss et al. does not disclose a method for correcting disrupted axonal and synaptic protein synthesis in a subject by restoring an amount of a binding protein or by disassociating a condensate. Applicants contend that Ravanidis et al. do not teach administering residues 190-208 of the B domain of G3BP1. Applicants contend that one of skill in the art would not be motivated to combine Twiss et al. and Ravanidis et al. and that neither reference teaches “thereby restoring disrupted axonal and synaptic protein synthesis”. Applicants contend that there is no reasonable expectation of success.
Applicants’ arguments are not convincing since the teachings of Twiss et al. and Ravanidis et al. render the method of the instant claims prima facie obvious.
The present claims do not refer to a specific subject population (except for present claims 5 and 6 which Ravanidis et al. disclose), a specific binding protein (with the exception of dependent claim 2; TDP-43 which both Twiss et al. and Ravanidis et al. disclose), or a specific condensate (except for present claim 7 which Ravanidis et al. disclose). Therefore, the introduction of residues 190-208 of the B domain of G3BP1 into a subject (both alternatives 1 and 2 of present independent claim 1) reads on the presently claimed method.
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).
A reference disclosure can anticipate a claim when the reference describes the limitations but "'d[oes] not expressly spell out' the limitations as arranged or combined as in the claim, if a person of skill in the art, reading the reference, would ‘at once envisage’ the claimed arrangement or combination." See Kennametal, Inc. v. Ingersoll Cutting Tool Co., 780 F.3d 1376, 1381, 114 USPQ2d 1250, 1254 (Fed. Cir. 2015) and In re Petering, 301 F.2d 676, 681(CCPA 1962).
"The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain." See In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) and In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. See Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) and Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998).
"Products of identical chemical composition can not have mutually exclusive properties." See In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
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).
Regarding Twiss et al., one of skill in the art would readily understand that increasing axon growth in both naïve and injury-conditioned neurons would require correcting protein synthesis (i.e. new growth would require new protein synthesis; see paragraphs 6, 75, and 145 of Twiss et al.). Twiss et al. Figures 5, 6, 7, 11B, 11C, 15A, 16B, and 16C show that G3BP domain 3 increases neurite length which would require protein synthesis (also see paragraph 96). Figures 19 and 20 show that the addition of a polypeptide (i.e. G3BP 190-208; paragraphs 77 and 78; Figure 7) increases intra-axonal protein synthesis and increases the intra-axonal rates of translation of proteins. Also see paragraphs 12, 13, 19-21, 43-49, 58, 62, and 63 (i.e. increases intra-axonal rates of translation of proteins needed for nerve regeneration).
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.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 17/839,820 for claims 1, 3, and 4 were considered but are not persuasive for the following reasons.
Applicants contend that copending Application No. 17/839,820 does not require the same desired outcome of the method as presently claimed.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 17/839,820 renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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).
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 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.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over copending Application No. 17/839,820 in view of Ravanidis et al. for claims 1-7 were considered but are not persuasive for the following reasons.
Applicants contend that copending Application No. 17/839,820 does not require the same desired outcome of the method as presently claimed and one of skill in the art would not conbine the references.
Applicants’ arguments are not convincing since the claimed invention of copending Application No. 17/839,820 in view of Ravanidis et al. renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
Copending Application No. 17/839,820 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 1-10 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).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,382,947 for claims 1, 3, and 4 were considered but are not persuasive for the following reasons.
Applicants contend that the desired outcome of the present method is not claimed.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,382,947 renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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).
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).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,382,947 in view of Ravanidis et al. for claims 1-7 were considered but are not persuasive for the following reasons.
Applicants contend that the desired outcome of the present method is not claimed and that one of skill in the art would not combine the references.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,382,947 in view of Ravanidis et al. renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 10,668,128 for claims 1, 3, and 4 were considered but are not persuasive for the following reasons.
Applicants contend that the desired outcome of the present method is not claimed.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 10,668,128 renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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).
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).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 10,668,128 in view of Ravanidis et al. for claims 1-7 were considered but are not persuasive for the following reasons.
Applicants contend that the desired outcome of the presently claimed method is not present and one of skill in the art would not combine the references.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 10,668,128 in view of Ravanidis et al. renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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 1-6 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 and the neurodegeneration disease is ALS.
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,851,462 for claims 1-6 were considered but are not persuasive for the following reasons.
Applicants contend that the desired outcome of the presently claimed method is not taught.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,851,462 renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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 and the neurodegeneration disease is ALS. The present claims and the claims of U.S. Patent No. 11,851,462 have the same method step of administering the same peptide which would necessarily result in the same outcome.
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 and the neurodegeneration disease is ALS.
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. subspecies of ALS) 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).
Arguments and Response
Applicants’ arguments directed to the rejection on the ground of nonstatutory obviousness-type double patenting as being unpatentable over U.S. Patent No. 11,851,462 in view of Ravanidis et al. for claims 1-7 were considered but are not persuasive for the following reasons.
Applicants contend that the desired outcome of the present method is not taught and the one of skill in the art would not combine the references.
Applicants’ arguments are not convincing since the claimed invention of U.S. Patent No. 11,851,462 in view of Ravanidis et al. renders obvious the method of the instant claims. In addition, while a request may be made that objections or requirements as to form not necessary to further consideration of the claims be held in abeyance until allowable subject matter is indicated, the present is a rejection and will not be held in abeyance (see MPEP § 714.02).
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 and the neurodegeneration disease is ALS. The present claims and the claims of U.S. Patent No. 11,851,462 have the same method step of administering the same peptide which would necessarily result in the same outcome.
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. subspecies of ALS) 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).
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Future Communications
Any inquiry concerning this communication or earlier communications from the examiner should be directed to AMBER D STEELE whose telephone number is (571)272-5538. The examiner can normally be reached M-F 8-5.
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/AMBER D STEELE/Primary Examiner, Art Unit 1658
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