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 .
Election/Restrictions
Applicant's reply to the Restriction Requirement, dated October 14, 2025, has been received. By way of this reply, Applicant has elected Group I: Claims 1, 3, 5-7, 13-14, 21-22, 24-28, 36-39, 71, and 56 in part, drawn to isolated fusion proteins, and the species of SEQ ID NO: 5 as J domain sequence, SEQ ID NO: 51 as alpha-synuclein-binding sequence, and SEQ ID NO: 100 as fusion protein sequence.
Applicant’s election in the reply filed on October 14, 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)).
Claims 25-27, 40-41, 44-50, 54-55, 57-67, and 71 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention (40-41, 44-50, 54-55, and 57-67) or species (25-27 and 71), there being no allowable generic or linking claim. Election was made without traverse in the reply filed on October 14, 2025.
Claims 1, 3, 5-7, 13-14, 21-22, 24, 28, 36-39, and 56 are therefore under examination before the Office.
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 3, 21, 36-39 and 56 are rejected under 35 U.S.C. 103 as being unpatentable over Hishiya 2017 (Sci Rep. 2017 Aug 17;7(1):8531, cited in IDS) in view of Arpile (Sci Rep. 2017 Aug 22;7(1):9039).
Hishiya 2017 teaches a protein, comprising a J domain conjugated to a target protein-binding domain (page 1, last paragraph).
Hishiya 2017 teaches that this fusion protein is useful in treating diseases of protein misfolding (page 9, fourth through sixth paragraphs).
Hishiya 2017 also teaches a J domain sequence from human DnaJB1 (page 12), which is pertinent to claim 3.
Hishiya 2017 further teaches a construct comprising a J domain of a J protein, a linker, and a target binding sequence (page 12, seconds paragraph), which is pertinent to claim 21.
Hishiya 2017 further teaches the above protein an in SDS buffer (page 12, fourth paragraph), which is pertinent to claim 56.
However, Hishiya 2017 does not teach an alpha-synuclein-binding domain.
Arpile teaches that aggregations of misfolded alpha-synuclein are associated with Parkinson's Disease (page 1, first paragraph).
Arpile further teaches that the J domain of the J protein DNAJB6 catalyzes the transfer of misfolded proteins to Hsp70, which rescues aggregation of alpha-synuclein (Figure 4 and page 5, third paragraph).
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Hishiya 2017 and Arpile to arrive at the claimed invention. An ordinary artisan would have been motivated to do so, and have a reasonable expectation of success, since both Hishiya 2017 and Arpile are concerned with treatments for diseases of protein misfolding. Starting with the protein of Hishiya 2017, one of ordinary skill could use an alpha-synuclein-binding domain as the target protein-binding domain according to the teachings of Arpile by simple substitution. Each component of the combination would perform its known, usual function, and the combination would yield nothing more that predictable results.
With regard to the claimed properties of claims 36-39, the fusion protein recited in the claims is the same as the protein of Hishiya 2017 and Arpile, and therefore would possess identical properties. Hishiya 2017 and Arpile therefore inherently teach the subject matter of claims 36-39.
It is noted that In re Best (195 USPQ 430) and In re Fitzgerald (205 USPQ 594) discuss the support of rejections wherein the prior art discloses subject matter which there is reason to believe inherently includes functions that are newly cited or is identical to a product instantly claimed. In such a situation the burden is shifted to the applicants to "prove that subject matter shown to be in the prior art does not possess characteristic relied on" (205 USPQ 594, second column, first full paragraph). It is noted that, if the prior art discloses identical chemical structure, the properties applicant discloses and/or claims are necessarily present, In re Spada, 911 F.2d 705, 709, 15 USPQ2d.
Claimd 5-7 are rejected under 35 U.S.C. 103 as being unpatentable over Hishiya 2017 and Arpile as applied to claim 1 above, and further in view of Yarchoan (US20230173049A1).
The teachings of Hishiya 2017 and Arpile have been discussed supra. However, Hishiya 2017 and Arpile do not teach the J domain sequence of SEQ ID NO.: 5.
Yarchoan teaches a human DnaJB1 protein with a sequence of MGKDYYQTLGLARGASDEEIKRAYRRQALRYHPDKNKEPGAEEKFKEIAEAYDVLSDPRKREIFDRYGEEGLKGS, which completely encompasses Applicant's SEQ ID NO.: 5.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Hishiya 2017, Arpile, and Yarchoan to arrive at the claimed invention. Proteins comprising a J domain conjugated to a target protein-binding domain were known in the art according to Hishiya 2017. Hishiya 2017 also teaches that human DnaJB1 is one such sequence that can be used in this context. One of ordinary skill in the art could apply the human DnaJB1 sequence of Yarchoan to the protein of Hishiya 2017 and Arpile by known methods to arrive at the claimed invention, with each component of the combination performing its known, usual function, and the combination would yield nothing more that predictable results.
Claims 13-14, 22, 24, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Hishiya 2017, Arpile, and Yarchoan as applied to claim 1 above, and further in view of Cheruvara (J Biol Chem. 2015 Mar 20;290(12):7426-35, cited in IDS).
The teachings of Hishiya 2017, Arpile, and Yarchoan have been discussed supra. However, Hishiya 2017, Arpile, and Yarchoan do not teach the alpha-synuclein binding peptide KDGIVNGVKA, recited as Applicant's SEQ ID NO.: 51.
Cheruvara teaches the alpha-synuclein binding peptide KDGIVNGVKA (Figure 1), which is identical to Applicant's SEQ ID NO.: 51, which is pertinent to claims 13-14.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the teachings of Hishiya 2017, Arpile, Yarchoan, and Cheruvara to arrive at the claimed invention. Proteins comprising a J domain conjugated to a target protein-binding domain were known in the art according to Hishiya 2017. Arpile suggests the use of alpha-synuclein as a target-binding domain. One such possible domain is the peptide taught by Cheruvara. One of ordinary skill in the art could apply the alpha-synuclein binding sequence of Cheruvara to the protein of Hishiya 2017 and Arpile by known methods to arrive at the claimed invention, with each component of the combination performing its known, usual function, and the combination would yield nothing more that predictable results.
With regards to claims 24 and 28, Applicant's SEQ ID NO.: 100 comprises the sequence of MGKDYYQTLGLARGASDEEIKRAYRRQALRYHPDKNKEPGAEEKFKEIAEAYDVLSDPRKREIFDRYGEEGLKGS, which is taught by Yarchoan, fused to the sequence of KDGIVNGVKA, which is taught by Cheruvara. Hishiya 2017 teaches fusions of DnaJ domains to a target binding sequence. Therefore, it would be obvious to assemble these sequences into a single peptide.
All the claimed elements were known in the prior art and one of ordinary skill in the art could have arrived at the claimed invention by using known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results. Therefore, the invention, as a whole, was prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claimed invention as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1, 3, 5-7, 13-14, 21-22, 24, 28, 36-39, and 56 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over the indicated claims of the following copending applications in view of Arpile and Cheruvera.
Conflicting Conflicting
Application Claims
18/033,454 1, 3, 5-11, 20, 45
17/997,142 1, 3, 5-7, 20, 57
18/698,820 1, 5-6, 19, 62
18/698,585 1, 35, 48, 57-58, 76
By means of example, the '142 application claims an isolated fusion protein comprising a J domain of a J protein and a TDP-43-binding domain (claim 1).
The '142 application further claims that the J domain of a J protein is of human origin (claim 3).
The '142 application further claims a J domain identical to that of Applicant's SEQ ID NO. 5 (claim 7).
The '142 application further claims that the DnaJ domain may be linked to the TDP-43 domain (claim 20).
However, the '142 application does not claim an alpha-synuclein binding domain.
Arpile teaches that aggregations of misfolded alpha-synuclein are associated with Parkinson's Disease (page 1, first paragraph).
Arpile further teaches that the J domain of the J protein DNAJB6 catalyzes the transfer of misfolded proteins to Hsp70, which rescues aggregation of alpha-synuclein (Figure 4 and page 5, third paragraph).
Cheruvara teaches the alpha-synuclein binding peptide KDGIVNGVKA (Figure 1), which is identical to Applicant's SEQ ID NO.: 51.
It would have been prima facie obvious for a person of ordinary skill in the art as of the effective filing date to combine the claims of the '142 application with the teachings of Arpile and Cheruvara to arrive at the claimed invention. Starting with the protein claimed by the '142 application, one of ordinary skill could apply the alpha-synuclein-binding peptide of Cheruvara to arrive at the claimed invention. Motivation for such a combination can be found in Arpile, as Arpile teaches that J domains may rescue aggregation of alpha-synuclein. Each component of the combination would perform its known, usual function, and the combination would yield nothing more that predictable results.
This is a provisional nonstatutory double patenting rejection.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. Sharma (Cell Mol Life Sci. 2017 Feb;74(4):617-629) teaches that DnaJB1 (Hsp40) is part of a disaggregase machinery which may efficiently depolymerize stable a-synuclein aggregates and convert them into less toxic species (page 621, right column, second paragraph).
No claim is allowed.
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/PETER JOHANSEN/Examiner, Art Unit 1644