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 .
DETAILED ACTION
Final Rejection
Claim Status
Claims 1-20 were pending in the prior Office Action.
Upon amendment entry, Claim 11 is cancelled.
Upon amendment entry, Claims 1-5, 9, 10 and 14-16 are amended.
Claims 1-6, 8-10, 12, 14-19 are pending examination.
Priority Status
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No foreign priority was claimed; Effective filing date is 02/10/2023.
Examiner Responses to Arguments/Amendments
The issues raised in the prior Office Action, are addressed below:
I. Claim Amendments -
Upon entry of Applicant’s amendment, Independent Claims 1, 9 and 14 was amended with additional limitations.
II. Response to Double Patenting –
The terminal disclaimer filed on 02/23/2026 disclaiming the terminal portion of any patent granted on this application which would extend beyond the expiration date of US Application No. 18/971,536 (US Patent No. pending) has been reviewed and is accepted. The terminal disclaimer has been recorded.
In view of the approved terminal disclaimer, the Double Patenting rejection over Pat’536 is withdrawn.
III. Response to Claim Rejections - 35 USC § 112 -
Claims 1-8 were rejected under 35 U.S.C. 112(a) to comply with the written description; Applicant traversed the rejection.
Applicant’s arguments, filed 02/23/2026, with respect to the rejection(s) of Claim(s) 1-8 under 35 U.S.C. 112(a) have been fully considered and are persuasive.
Therefore, the rejection has been withdrawn due to the additional limitations.
IV. Response to Claim Rejections - 35 USC § 103 –
The 35 USC § 103 rejections is withdrawn because Applicant amended independent Claims 1, 9 and 14 with additional limitations.
However, upon further consideration, a new ground(s) of rejection is made in view of Applicant’s amendments and newly found prior art.
Please see the rejection below.
V. New Rejections –
Applicant’s amendment necessitated the new ground(s)
of rejection presented in this Office action.
Review of Election Specie
In response to the Specie Requirement:
Applicant has elected compound 2444-32 as the specie.
The election was made without traverse.
The elected specie is seen below:
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Claims 1-10, 12-20 read on the elected species.
The elected specie was not identified in the art.
The elected specie would be allowable if an independent claim were drafted to the elected specie alone.
Examiner expanded her search to the full scope of the claims as per MPEP 802.03.
An additional specie(s) was found in the art (see rejection below).
The rejection on the additional specie(s) reads on the Claims 1-6, 8-10, 12, 14-19 (see below); and have been fully search and examined.
Claims 7, 13 and 20 have not been fully searched; the subject matter of the Markush claim was searched for another subject matter and prior art was found.
Subject matter outside of the searched/examined scope in Claims 7, 13 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-2, 5-6, and 8 are rejected under 35 U.S.C. 102(a)(1) & 102 (a)(2)] as being anticipated by M.K. Lakshmana in US 9,994,536 B2 (hereinafter “Patent’536”).
With respect to Claim 1-2, 5-6: Patent’536 discloses thiazole compounds, compositions, and methods of treatment of a neurological disease. The prior art states, specifically in col. 12, lns. 49-50, “The term "disease" refers to neurological diseases such as Alzheimer's disease (AD), Parkinson's disease (PD),…and the like.”
According to MPEP 2112.02.II:
The discovery of a new use for an old structure based on unknown properties of the structure might be patentable to the discoverer as a process of using. In re Hack, 245 F.2d 246, 248, 114 USPQ 161, 163 (CCPA 1957). However, when the claim recites using an old composition or structure and the “use” is directed to a result or property of that composition or structure, then the claim is anticipated. In reMay, 574 F.2d 1082, 1090, 197 USPQ 601, 607 (CCPA 1978).
Patent’536 also teaches the additional specie(s) below:
a. Additional Specie 1 (A1)
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Cpd. 1821346-30-8 reads on the claims through the genus/subgenus of thiazole cmpds (overlapping general structures shown above):
R1 is a substituted aryl; supported in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (pg. 16, lns. 1-3); also supported that “aryl” are preferred as phenyl or naphthyl (pg. 15, lns. 13-19).
Therefore based on guidance given a substituted benzyl group reads on a substituted aryl; as well as a substituted alkyl with further substitution.
R2 is hydrogen; supported in the Instant Claims (Claim 1; pg. 10, lns. 9-13).
R3 is substituted alkyl; support in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (Fig. 3.1A, pg. 16, lns. 1-3); though heteroalkyl is not specifically defined in the Specification, under BRI it is understood that it is an alkyl chain with one or more heteroatoms replacing one or more carbon atoms within the chain (heteroatoms) and one or more attached substituted groups.
Therefore based on guidance given, a substituted benzyl amide group reads on a substituted alkyl with further substitution.
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b. Additional Specie 2 (A2)
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Instant App. General Structure Fig.3.1A Cpd. 2055-205
Prior Art: US 9,994,536 B2
Cpd. 2055-205 in Fig. 3.1A reads on the claims through the genus/subgenus of thiazole cmpds (overlapping general structures shown above):
R1 is a substituted aryl; supported in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (pg. 16, lns. 1-3); also supported that “aryl” are preferred as phenyl or naphthyl (pg. 15, lns. 13-19).
Therefore based on guidance given a substituted benzyl group reads on a substituted aryl; as well as a substituted alkyl with further substitution.
R2 is hydrogen; supported in the Instant Claims (Claim 1; pg. 10, lns. 9-13).
R3 is substituted alkyl; support in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (Fig. 3.1A, pg. 16, lns. 1-3); though heteroalkyl is not specifically defined in the Specification, under BRI it is understood that it is an alkyl chain with one or more heteroatoms replacing one or more carbon atoms within the chain (heteroatoms) and one or more attached substituted groups.
Therefore based on guidance given, a substituted benzyl amide group reads on a substituted alkyl with further substitution.
Claim 5: Patent’536 discloses, the neurodegenerative disease being selected from Parkinson's disease (Example 4 & 5 – col. 27-30)
Claim 6: Patent’536 teaches the subject being a human (col. 10, lns. 27-30)
Claim 8: Patent’536 teaches the administration being oral, buccal, bronchial, nasal, topical, transdermal, intra-articular, parenteral, or intraspinal administration. (col. 10, lns. 34-39)
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Graham v. Deere, Test for Obviousness
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.
Joint Inventors
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.
A. First Rejection -
Claim(s) 9-10, 12, 14-15 are rejected under 35 U.S.C. 103 as being unpatentable over M.K. Lakshmana in US 9,994,536 B2 (hereinafter “Patent’536”).
With respect to Claim 9-10: Patent’536 discloses thiazole compounds, compositions, and methods of treatment of a neurological disease. The prior art states, specifically in col. 12, lns. 49-50, “The term "disease" refers to neurological diseases such as Alzheimer's disease (AD), Parkinson's disease (PD),…and the like.”
Patent’536 also teaches the additional specie(s) below:
a. Additional Compound (A1) -
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Cpd. 1821346-30-8 (A1) is an additional compound which reads on the claims through the genus/subgenus of thiazole cmpds (overlapping general structures shown above):
R1 is a substituted aryl; supported in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (pg. 16, lns. 1-3); also supported that “aryl” are preferred as phenyl or naphthyl (pg. 15, lns. 13-19).
Therefore based on guidance given a substituted benzyl group reads on a substituted aryl; as well as a substituted alkyl with further substitution.
R2 is hydrogen; supported in the Instant Claims (Claim 1; pg. 10, lns. 9-13).
R3 is substituted alkyl; support in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (Fig. 3.1A, pg. 16, lns. 1-3); though heteroalkyl is not specifically defined in the Specification, under BRI it is understood that it is an alkyl chain with one or more heteroatoms replacing one or more carbon atoms within the chain (heteroatoms) and one or more attached substituted groups.
Therefore based on guidance given, a substituted benzyl amide group reads on a substituted alkyl with further substitution.
b. Additional Compound (A2) -
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Instant App. General Structure Fig.3.1A Cpd. 2055-205
Prior Art: US 9,994,536 B2
Cpd. 2055-205 (A2) in Fig. 3.1A reads on the claims through the genus/subgenus of thiazole cmpds (overlapping general structures shown above):
R1 is a substituted aryl; supported in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (pg. 16, lns. 1-3); also supported that “aryl” are preferred as phenyl or naphthyl (pg. 15, lns. 13-19).
Therefore based on guidance given a substituted benzyl group reads on a substituted aryl; as well as a substituted alkyl with further substitution.
R2 is hydrogen; supported in the Instant Claims (Claim 1; pg. 10, lns. 9-13).
R3 is substituted alkyl; support in the Instant Specification that a “substituted” group may be substituted with one or more groups individually and independently (Fig. 3.1A, pg. 16, lns. 1-3); though heteroalkyl is not specifically defined in the Specification, under BRI it is understood that it is an alkyl chain with one or more heteroatoms replacing one or more carbon atoms within the chain (heteroatoms) and one or more attached substituted groups.
Therefore based on guidance given, a substituted benzyl amide group reads on a substituted alkyl with further substitution.
With respect to Claim 9-10, 12, and 14-16, 18-19:
Patent’536 continues teaching in Col 21, lns. 1-4, teaches THPI-244 compounds (including the ones above) injected intraperitoneally into the brain of the subject (at 0.2 mg/kg body weight). When a subject is injected with a composition or compound, the cells of the subject will have contact with the composition containing that compound.
Patent’536 regarding Claim 9 – has the cells in the subject, which contain Drp1 and were contacted with the compound or composition. The characteristics disclosed in the claim preamble would have necessarily happened upon contacting the cells with the claim compound (THPI-244). The only physical step recited in the body of the claim is that the cells of the subject will have contact with the composition containing that compound.
Also in regard to Claims 9, 12, and 14: soluble amyloid-beta (sAPP) proteins act as a trigger that hijacks the normal mitochondrial regulation machinery (Drp1) by triggering oxidative stress and toxic Drp1-mediated mitochondrial fission, forcing Drp1) to overly fragment mitochondria, resulting in impaired energy production, synaptic loss, and cell death.
Thus, for Claims 9-10, 14-15: The composition of the prior art is the same as that of the claims and the patient is the same as that of the claims. The administration of the compound as disclosed in the prior art, would have necessarily resulted in the claimed effects, even if not recognized by the prior art, since products of identical chemical composition cannot have mutually exclusive properties when administered under the same circumstances, and to the same host. The purpose for which the claimed method is accomplished is insufficient to distinguish it from the prior art.
Patent’536 continue to disclose:
Claim 16: Patent’536 teaches administering the THPI Cpd to a subject suffering from Parkinson’s disease.
Claim 18: Patent’536 discloses the administration (col. 10, lns. 27-39) being local, oral, bronchial, nasal, topical, transdermal, parenteral, or intraspinal administration.
Claim 19: Patent’536 discloses, the subject being a human (Example 4 & 5 – col. 27-30; Figure 1.5 THPl-244 on human primary neurons and fibroblasts).
Patent’536 fails to teach an embodiment that teaches Parkinson’s disease.
However, it would be obvious to arrive at this patient population because, for example, in Example 1 (col. 20, lns. 5-20) “there were multiple lines of evidences suggesting that it is not only increased Αβ, but also decreased sAPPa levels play a critical role in the pathogenesis of AD (Alzheimer’s disease)”. It is known in the art Alzheimer’s is a neurological disease, since they share the feature of sAPPa levels. Further, the reference teaches it can be given to one suffering from Parkinson’s disease. Given the finite list of diseases, according to MPEP 2143.I.E.(2)., a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem. This is addressed through the background of the reference, as it is geared towards “(2) a finding that there had been a finite number of identified, predictable potential solutions to the recognized need or problem in using compositions or pharmaceutical compositions for the treatment of neurological diseases (abstract).
B. Second Rejection -
Claim(s) 1, 3-4, 14, 16-17 are rejected under 35 U.S.C. 103 as being unpatentable over M.K. Lakshmana in US 9,994,536 B2 (hereinafter “Patent’536”) in view of EA Zemskov (Antioxid Redox Signal. 2019 Oct 20;31(12):819-842; hereinafter “Zemskov”).
The teachings of Patent’536 is disclosed above and at least those teachings are incorporated by reference herein.
Patent’536 discloses thiazole compounds, compositions, and methods of treatment of a neurological disease. The prior art states, specifically in col. 12, lns. 49-50, “The term "disease" refers to neurological diseases such as Alzheimer's disease (AD), Parkinson's disease (PD),…and the like.”
Patent’536 fails to disclose how the dysregulation of the cellular redox system has consequential effects on cell signaling pathways that are involved in disease progression such as acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).
Zemskov teaches in Claims 3-4, 16-17, wherein the disease is acute lung injury and ventilator-induced lung injury (pg. 829, col. 1-2; Figure 6).
Zemskov continues teaching in Figure 4, pg. 824, effects of biomechanical forces on the mitochondria. Biomechanical forces exert effects on the mitochondria at multiple levels. For example, the lung is exposed to biomechanical forces (fluid shear stress, cyclic stretch, and pressure) due to the passage of blood through the pulmonary vessels and the distension of the lungs during the breathing cycle. Cells within the lung respond to these forces by activating signal transduction pathways that alter their redox state with both physiologic and pathologic consequences (abstract).
Therefore, the combination of Patent’536 and Zemskov, discloses thiazole derivatives used in PD (as well as ALI and ARDS), its methods of treatment (ALI, ARDS and PD), with its use of soluble amyloid precursor protein-α (sAPP-α) to indicate Drp1 cell-affected activity. These are linked through the dysregulation of the cellular redox system within the mitochondria which have significant effects on cell signaling pathways that are involved in disease progression such as the endothelial barrier function dysfunction seen in acute lung injury (ALI) and acute respiratory distress syndrome (ARDS).
Finally, the combination of Patent’536 and Zemskov, is obvious since it discloses a thiazole derivative species used in PD (as well as ALI and ARDS), and mitochondrial dysfunction as seen in the Instant Case. This gives motivation and suggestion (KSR – Prong B) for the combination of the prior arts for their utility as inhibitors in mitochondrial dysfunction and their treatment in ALS, ARDS and PD.
Conclusion
Claims 1-6, 8-10, 12, 14-19 are rejected.
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 Josmalen M. Ramos-Lewis whose telephone number is (571)272-0084. The examiner can normally be reached M-F 9:30-5:30 pm.’
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton A. Brooks can be reached on (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Josmalen M. Ramos-Lewis, Ph.D.
Patent Examiner
Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621
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