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 Application
Claims 1-13 and 16-17 are pending as of the response filed on 01/08/2026. Claims 14-15 are cancelled. Claims 16-17 are newly added. Applicant’s election of Group I claims and elected species is maintained. Claims 12-13 remains withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Claims 1-11 and 16-17 are examined herein.
The 35 U.S.C. 112(b) rejection of previous record is withdrawn in consideration of the claim amendments.
The 35 U.S.C. 102 rejection of previous record over Park et al. is withdrawn since the claim amendments overcome the rejection of record.
In consideration of the certified English translation of the foreign priority application submitted by Applicant, it has been ascertained that the subject matter of the instant claims is not fully supported by the foreign priority application. Therefore, the effective filing date of the instant claims is 08/31/2021 (as elaborated in the “Priority” section below). Hence, the intervening Shin et al. reference remains prior art under 35 U.S.C. 102(a)(1).
The claim amendments do not overcome the rejection of record over Shin et al.. The rejection is maintained and modified to reflect the claim amendments.
A new 35 U.S.C. 112(d) is made necessitated by the amendments.
Priority
This application is a 371 of PCT/KR2021/011710 filed 08/31/2021 and claims foreign priority to REPUBLIC OF KOREA 10-2020-0115104 filed 09/09/2020.
Applicant’s submission of a certified English translation of the foreign application is acknowledged and accepted. However, it is noted that Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 365(c) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or earlier-filed nonprovisional application or provisional application for which benefit is claimed). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. REPUBLIC OF KOREA 10-2020-0115104 filed 09/09/2020 fails to provide adequate support and enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. The ‘104 application does not disclose wherein the variable X is “S” in the compound of Formula 1, as instantly claimed. Moreover, compounds 126 and 128-136 of instant claim 8 do not have support in the ‘104 application. Accordingly, the effective filing date of claims 1-11 and 16-17 is 08/31/2021, since the subject matter of the claims are supported by PCT/KR2021/011710 filed 08/31/2021.
Examiner’s note: Compounds 101-103, 105-125 and 127 of instant claim 8, wherein the variable X (if present) is O, are all supported by the ‘104 foreign priority application. A claim drawn to just these compounds would get the benefit of the foreign priority application filing date of 09/09/2020. The Shin reference would not serve as prior art for these compounds.
Information Disclosure Statement
The information disclosure statement submitted on 12/30/2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 112 - New
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 3 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding claim 3, the claim depends from claim 2 and recites “R1 is arylalkyl in which any one hydrogen of C1-C10 linear or branched alkyl is substituted with C6-C20 aryl unsubstituted or substituted with one or more substituents selected from the group consisting of halogen, C1-C10 linear or branched alkyl, C1-C10 linear or branched alkoxy, and azide”. The recitation of “arylalkyl” is broader than the “C6-C20 aryl-C1-C10 linear or branched alkyl” recited for R1 in claim 2. This broadens the scope of the compounds of claim 3, which is improper.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim interpretation
The instant claims 10-11 and 16-17 have been interpreted as intended use claims drawn to a product, i.e., a pharmaceutical composition.
Claim Rejections - 35 USC § 102 – Maintained and modified
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 for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-11 and 16-17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Shin et al. (Phenotypic Discovery of Neuroprotective Agents by Regulation of Tau Proteostasis via Stress-Responsive Activation of PERK Signaling, 18 November 2020, hereinafter Shin, in the IDS).
Applicant may rely on the exception under 35 U.S.C. 102(b)(1)(A) to overcome this rejection under 35 U.S.C. 102(a)(1) by a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application, and is therefore not prior art under 35 U.S.C. 102(a)(1).
Regarding instant claim 1, Shin teaches identifying a small molecule, SB1617, capable of suppressing abnormal tau protein aggregation (Abstract), having the following structure (Pg. 1832, first column, Figure 1D).
PNG
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72
173
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Greyscale
SB1617 anticipates the instantly elected species of compound of Formula 1 of instant claim 1, wherein
X is O;
Y is NRy, Ry is H;
m is 1;
n is 1;
Ra is -NRa1Ra2, Ra1 is C1 alkyl (methyl), Ra2 is arylalkyl (chloro substituted benzyl);
Rb is H;
Rc is -SO2R1, R1 is nitro substituted phenyl.
SB1617 falls within the scope of Formula 2 of instant claim 2, wherein
X is O;
R1 is arylalkyl in which one hydrogen of C1 linear alkyl (methyl) is substituted with chloro substituted C6 aryl (phenyl);
R2 is C1 linear alkyl (methyl);
R3 is hydrogen;
R4 is SO2R’, R’ is nitro substituted C6 aryl (phenyl);
Y is NRy, Ry is hydrogen.
SB1617 anticipates the compounds of instant claims 3-7 and compound 117 of instant claim 8. Therefore, SB1617 of Shin anticipates the limitations of instant claims 1-8.
Regarding instant claim 9, Shin teaches SB1617 suppresses the assembly of overexpressed, aggregation-prone tau protein by regulating protein homeostasis (Abstract; Pg. 1832, second column, first full paragraph). Shin teaches SB1617 enhances PERK signaling pathway by inhibition of PDIA3 and DNAJ3 targets (Abstract; Pg. 1834, second column, last paragraph; Figure 2D; Figure 3A). Thus, Shin anticipates the limitations of instant claim 9 drawn to a tau aggregation inhibitor.
Regarding instant claims 10-11 and 16-17 (see claim interpretation above), Shin teaches intraperitoneal administration of SB1617 to mice in the study of its pharmacokinetic and blood–brain barrier penetration properties and in TBI experiments (Pg. 1836, first column, first full paragraph; Supplement page S8, first paragraph, second paragraph, fourth paragraph). The disclosure of Shin anticipates the limitation drawn to pharmaceutical compositions. Shin teaches tau protein aggregates are a recognized neuropathological feature in Alzheimer’s disease as well as many other neurodegenerative disorders, known as tauopathies (Abstract). Shin teaches inhibition of SB1617 targets PDIA3 and DNAJC3, as an effective strategy for regulating proteostasis in tauopathies (Abstract). The pharmaceutical composition of Shin is capable of performing the intended use function, i.e., preventing or treating tauopathies, as instantly claimed.
Additionally, according to MPEP 2111.02(II), "[C]lear reliance on the preamble during prosecution to distinguish the claimed invention from the prior art transforms the preamble into a claim limitation because such reliance indicates use of the preamble to define, in part, the claimed invention.…Without such reliance, however, a preamble generally is not limiting when the claim body describes a structurally complete invention such that deletion of the preamble phrase does not affect the structure or steps of the claimed invention." Consequently, "preamble language merely extolling benefits or features of the claimed invention does not limit the claim scope without clear reliance on those benefits or features as patentably significant."
Therefore, the intended use limitations in claims 10-11 and 16-17, “for preventing or treating tauopathies, wherein the tauopathies is any one selected from the group consisting of Alzheimer’s disease, frontotemporal dementia, progressive supranuclear palsy, traumatic brain injury, Pick’s disease, Chronic traumatic encephalopathy, Argyrophilic grain disease, corticobasal degeneration, Parkinson’s disease, Huntingtin’s disease, and Amyotrophic lateral sclerosis”; are held unpatentable.
Conclusion
Claims 1-11 and 16-17 are rejected.
No claims are allowed.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PADMAJA S RAO whose telephone number is (571)272-9918. The examiner can normally be reached 9:00-5:30 pm EDT.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney L Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PADMAJA S RAO/Examiner, Art Unit 1627
/Kortney L. Klinkel/Supervisory Patent Examiner, Art Unit 1627