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 and Response to Restriction Requirement
Claims 1-3, 8 and 12-15 are pending as of the response filed 02/05/2026. Claims 4-7 and 9-11 are cancelled. Applicant’s election of group I claims 1-3, 8 and 12-13 with traverse is acknowledged. Claims 14-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant’s election of a species of compound shown below with traverse is acknowledged.
PNG
media_image1.png
151
197
media_image1.png
Greyscale
Claims 1-3, 8 and 12-13 encompass the elected species. Therefore, claims 1-3, 8 and 12-13 have been examined to the extent to which they are readable on the above identified elected species.
The examiner notes that Applicant’s traversal of the restriction requirement is incomplete. Applicant has not provided any reasons for the traversal. 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)).
The elected species was examined and was found to be free of prior art.
In view of the pending claims, the following objections and rejections are made.
Priority
This application is a 371 of PCT/US2022/020315 filed 03/15/2022, which claims priority to PRO 63/161,232 filed 03/15/2021.
Applicant’s claim for the benefit of a prior filed application under 35 U.S.C. 119(e) or under or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) 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. PRO 63/161,232 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 ‘232 application does not disclose the proviso of claim 1, “that either Z1 is not hydrogen, or Z8 is alkyl when Z7 is N”. Accordingly, claims 1-3 and 13 have an effective filing date of 03/15/2022, the subject matter of which is supported in PCT/US2022/020315 filed 03/15/2022, while claims 8 and 12 have an effective filing date of 03/15/2021, the subject matter of which is supported in PRO 63/161,232 filed 03/15/2021.
Information Disclosure Statement
The information disclosure statement submitted on 10/16/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Interpretation
Given the broadest reasonable interpretation in light of the specification, regarding claim 8 which depends from claim 1, the substituents on ring B and ring C are considered to be limited to the Y1 group of claim 1. The instant specification does not define any of the options for the Y1 group to be further substituted (see Paras. [0028]-[0040] of the instant specification). Thus, ring B and ring C of claim 8 are considered to be limited to be substituted by the Y1 groups of claim 1 without further substitution.
Claim Objections
Claim 1 is objected to because of the following informalities:
In claim 1, the limitation “alkoxy” in the definition of the variable Y1 is repeated twice. It is suggested that the second occurrence of “alkoxy” be removed from the claim.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-3 and 13 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 1 is drawn to a compound having the structure of Formula (I), or a pharmaceutically acceptable salt or prodrug thereof, with variables as defined in claim 1.
The genus of compounds of Formula (I) as claimed, encompass a highly divergent variety of core structures as defined by the variables X1, X2, X3, X4, X5, X6, X7, X8, X9, X10, X11, X12, Z1, Z2, Z3, Z4, Z6, Z7, Z8, Y1 and Y2. Each of the X variables, X1 to X12 (see claim interpretation for X12 in the 35 U.S.C. 112(b) rejection below) are defined to be selected from the group carbon (C), nitrogen (N), sulfur (S), oxygen (O), NH, or CY1, wherein Y1 at each occurrence is independently selected from the group that includes an ester, carboxamide, sulfide, sulfoxide, sulfone, sulfonamide, etc. The instant specification defines the term “ester” to refer to a structure -C(=O)-O-Rc, where Rc may be alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, or aryl groups; the term “carboxamide” to refer to a structure -C(=O)-N-(RdRe), where Rd and Re may be alkyl, alkenyl, alkynyl, cycloalkyl, heterocyclyl, or aryl groups; and similarly the other functional groups are defined to encompass a wide variety of unrelated groups. The specification does not provide a limiting definition of the ester, carboxamide, sulfide, sulfoxide, sulfone, sulfonamide functional groups.
The compounds further include pharmaceutically acceptable salts and prodrugs thereof. The instant specification does not define the term “prodrug”. While it is well known in the art that a prodrug is any compound which is pharmaceutically active in vivo when it undergoes metabolic degradation, the instant specification does not define the term “prodrug” to indicate what constitutes a prodrug with respect to the compounds of Formula (I). Therefore, the scope of the claims is extremely broad and the genus of compounds of Formula (I) encompassed by the claims, includes species that do not share both a substantial structural feature and a common function that flows from the substantial feature. The different groups would be presumed by one of ordinary skill in the art to have different physical properties (e.g. solubility, stability, etc.) that would lead to different biological activities (e.g. ADME and PK/PD, efficacy, toxicity, etc.). However, the specification does not provide a reasonably representative disclosure of the compounds of Formula (I) overall. Specifically, the specification discloses the synthesis of a limited number of species, all representing thiophenyl derivatives (with X1 being S) (Para. [0094] – Para. [00198]). All pharmacodynamic data with respect to in vitro and in vivo assays, and LXRβ-selective agonistic and PPAR/RXR antagonistic activity studies, pertain to thiophenyl compounds (Example 4- Example 11). These are not viewed as being reasonably representative of the genus in its claimed scope because no readily apparent combination of identifying characteristics is provided, other than the disclosure of those specific species as examples of the claimed genus. It is not readily apparent that the genus of compounds claimed have a structural entity in common, that leads to their LXRβ agonistic and PPAR/RXR antagonistic activity.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. Whether the specification shows that the inventor was in possession of the claimed invention is not a single, simple determination, but rather is a factual determination reached by considering a number of factors. Factors to be considered in determining whether there is sufficient evidence of possession include the level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient. See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. See MPEP 2163 (II) 3 (a) (i).
A chemical genus can be adequately described if the disclosure presents a sufficient number of representative species that encompass the genus. If the genus has substantial variance, the disclosure must describe a sufficient number of species to reflect the variation within that genus. The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A) above), reduction to drawings (see i)(B) above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus (see i)(C) above). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The disclosure of only one species encompassed within a genus adequately describes a claim directed to that genus only if the disclosure "indicates that the patentee has invented species sufficient to constitute the gen[us]." See Enzo Biochem, 323 F.3d at 966, 63 USPQ2d at 1615. "A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed. See MPEP 2163 (II) 3 (a) (ii).
In the instant case, there is no evidence Applicants had possession of the full genus of compounds at the time of filing, because the specification does not conclusively demonstrate the structure-activity relationship of the claimed vast array of compounds, towards their LXRβ agonistic and PPAR/RXR antagonistic activity. The instant specification does not describe enough species of compounds having the LXRβ and PPAR/RXR modulating function within the scope of the claimed invention. Thus, the written description requirement for the claimed genus of compounds has not been met.
In response to this rejection, the Applicant can amend the claim(s) to recite only individual species or grouping of species that share a substantial structure as well as a common function that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claim(s) in fact share a common function that flows from the substantial structural feature.
Claims 2-3 and 13 are similarly rejected for depending from a rejected base claim.
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 1-3, 8 and 13 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.
1) Regarding instant claims 1-3 and 8, the claims recite the limitation “… or prodrug thereof”. The instant specification does not define the term “prodrug”. Generally, it is well known in the art that a prodrug is any compound which is pharmaceutically active in vivo when it undergoes metabolic degradation. The specification does not provide any disclosure of what the structure of these compounds might be, that transform in vivo into the instantly claimed compounds. Therefore, the specification does not provide a limiting definition of the term “prodrug”. The full scope of the compounds – possible prodrugs encompassed by the claims have not been defined. Therefore the metes and bounds of the claim are indefinite.
Claim 13 depends from the rejected base claim and is similarly rejected.
2) Further, regarding claim 1, the claim recites the variable “X12”. However, there is no definition of what the variable X12 entails in the claims or in the instant specification. Therefore the metes and bounds of the claim are indefinite.
3) Further, regarding claim 1, the claim recites functional groups for various variables encompassed by the structure of Formula (I) that cannot satisfy the valency of that position. For instance,
the variable X1 is defined to be selected from the group of carbon (C), nitrogen (N), sulfur (S), oxygen (O), NH, or CY1. However, when X1 is S, O, NH or CY1, the valencies of N and C exceed the allowed valency, which is improper;
the variables X3, X4, X5, X6, X7, X8, X9, X10, X11 are defined as independently selected from the group of carbon (C), nitrogen (N), sulfur (S), oxygen (O), NH, or CY1. However, not all of these variables satisfy the valency of the position;
the variable Z3 is defined to be selected from the group O, S, N, NH, C(=O), CH2, hydroxy, or CY2. However, Z3 cannot be hydroxy;
the variables Z1, Z2, Z4, Z6 and Z8 are defined to be selected from the group O, S, N, NH, C(=O), CH2, hydroxy, or CY2. However, Z1, Z2, Z4, Z6 and Z8 cannot be C(=O) since this would not satisfy the valency of carbon.
Therefore, the metes and bounds of the claim are indefinite.
4) Regarding claim 2, the compound of Formula (II) recites the variables (R1)n1, (R2)n2, (R3)m1, (R4)m2, wherein n1 and n2 can be 0, 1, 2, 3, or 4; m1 and m2 can be 0, 1, 2, 3, or 4. When n1 and n2 are both 4 OR m1 and m2 are both 4, this exceeds the allowed number of substituents on the phenyl ring (total of 8 versus a maximum of 5 substituent positions). Additionally, the valency of X1 when it is chosen to be NH or CY1 exceeds that allowed for the position; Z3 cannot be chosen to be hydroxy; Z1, Z2, Z4, Z6 and Z8 cannot be C(=O) since this would not satisfy the valency of carbon.
Therefore, the metes and bounds of the claim are indefinite.
5) A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP 2173.05 (c).
In the present instance, claim 2 recites the limitation “alkoxy” and “-O(C1-C6 alkyl)” for the definition of R1, R2, R3, and R4. Claim 2 recites the broader limitation of “alkoxy” together with the recitation of a specialized subset of an alkoxy group “-O(C1-C6 alkyl)”. Therefore, it is unclear as to when the R1, R2, R3, and R4 group can have the broader set of limitations versus the narrower set of limitations.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
6) Regarding claim 3, the compound of Formula (III) recites the variables (R1)n1, (R2)n2, (R3)m1, (R4)m2, wherein n1 and n2 can be 0, 1, 2, 3, or 4; m1 and m2 can be 0, 1, 2, 3, or 4. When n1 and n2 are both 4 OR m1 and m2 are both 4, this exceeds the allowed number of substituents on the phenyl ring (total of 8 versus a maximum of 5 substituent positions). Additionally, Z3 cannot be chosen to be hydroxy.
Furthermore, the variables Z4, Z5, and Z6 are used in different positions of the core structure of Formula (III) versus Formula (I) of the parent claim, which is confusing. Claim 3 also has the broader recitation of “alkoxy” together with the recitation of a specialized subset of an alkoxy group “-O(C1-C6 alkyl)” for the variables R1, R2, R3, and R4. Therefore, the metes and bounds of the claim are indefinite.
For the purpose of applying prior art, the claims have been interpreted as follows.
Claim 1 has been interpreted
without the limitation “or prodrug thereof” appearing in the claim;
X12 is interpreted to have the same definition as the other X1 to X11 variables;
all the variables – X1, X3, X4, X5, X6, X7, X8, X9, X10, X11, X12 and Z1, Z2, Z3, Z4, Z6 and Z8 have been interpreted to include only the functional groups recited that satisfy the valencies of the respective positions. For example, X1 has been interpreted to be selected from the group of carbon (C), nitrogen (N) (excluding S, O, NH, or CY1).
Claim 2 has been interpreted
without the limitation “or prodrug thereof” appearing in the claim;
not to exceed a combined total of 5 for the R1/R2 or R3/R4 variables;
without the narrower recitation of ““-O(C1-C6 alkyl)” for the definition of R1, R2, R3, and R4;
all the variables – X1, Z1, Z2, Z3, Z4, Z6 and Z8 have been interpreted to include only the functional groups recited that satisfy the valencies of the respective positions.
Claim 3 has been interpreted
without the limitation “or prodrug thereof” appearing in the claim;
not to exceed a combined total of 5 for the R1/R2 or R3/R4 variables;
without the narrower recitation of ““-O(C1-C6 alkyl)” for the definition of R1, R2, R3, and R4;
Z4, Z5, and Z6 are interpreted as Z5, Z6 and Z8 respectively, by applying the narrower definition in as far as it could be translated from the recitation of claim 3.
Claim 8 has been interpreted
without the limitation “or prodrug thereof” appearing in the claim.
Claim Rejections - 35 USC § 112
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.
Claims 2-3 and 8 are 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 2, the claim depends from claim 1 and recites R1, R2, R3, and R4 to be selected from the group that includes “nitro” and “-O(C1-C6 fluoroalkyl)”. However, R1, R2, R3, and R4 that correspond to the Y1 variable of claim 1 does not recite “nitro” or haloalkoxy. This broadens the scope of the claim, which is improper.
Regarding claim 3, the claim depends from claim 1 and recites R1, R2, R3, and R4 of Formula (III) to be selected from the group that includes “nitro” and “-O(C1-C6 fluoroalkyl)”. However, R1, R2, R3, and R4 that correspond to the Y1 variable of claim 1 does not recite “nitro” or haloalkoxy. This broadens the scope of the claim, which is improper.
Regarding claim 8, the claim depends from claim 1 and recites Ring B of Formula (VIII) is selected from groups that include
PNG
media_image2.png
85
105
media_image2.png
Greyscale
,
PNG
media_image3.png
81
112
media_image3.png
Greyscale
,
PNG
media_image4.png
81
115
media_image4.png
Greyscale
,
PNG
media_image5.png
80
104
media_image5.png
Greyscale
,
PNG
media_image6.png
76
151
media_image6.png
Greyscale
,
PNG
media_image7.png
79
134
media_image7.png
Greyscale
,
PNG
media_image8.png
84
93
media_image8.png
Greyscale
,
PNG
media_image9.png
96
203
media_image9.png
Greyscale
,
PNG
media_image10.png
104
149
media_image10.png
Greyscale
,
PNG
media_image11.png
104
205
media_image11.png
Greyscale
,
PNG
media_image12.png
60
111
media_image12.png
Greyscale
,
PNG
media_image13.png
108
106
media_image13.png
Greyscale
,
PNG
media_image14.png
67
105
media_image14.png
Greyscale
,
PNG
media_image15.png
105
93
media_image15.png
Greyscale
,
PNG
media_image16.png
73
100
media_image16.png
Greyscale
,
PNG
media_image17.png
145
159
media_image17.png
Greyscale
,
PNG
media_image18.png
470
545
media_image18.png
Greyscale
PNG
media_image19.png
162
545
media_image19.png
Greyscale
and Ring C to include
PNG
media_image20.png
63
110
media_image20.png
Greyscale
PNG
media_image21.png
63
150
media_image21.png
Greyscale
PNG
media_image22.png
90
118
media_image22.png
Greyscale
PNG
media_image23.png
81
108
media_image23.png
Greyscale
.
However, these groups do not fall within the scope of claim 1 (the specification does not define any of the functional groups listed for Y1, say the ester, carboxamide, 5-6 membered monocyclic heteroaryl, or 5- or 6- membered fused ring to be further substituted). This broadens the scope of the claim, which is improper.
The examiner notes that claim 8 may be supported as an independent claim.
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 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 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 1-3 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ben Aissa et al. (Discovery of Nonlipogenic ABCA1 Inducing Compounds with Potential in Alzheimer’s Disease and Type 2 Diabetes, 05 January 2021, in the IDS, hereinafter Aissa).
Regarding instant claim 1, Aissa teaches nonlipogenic ATP-binding cassette transporter A1 (ABCA1) inducers (Abstract). Aissa teaches an exemplary compound, compound F4, showed selectivity for induction of ABCA1 versus SREBP1c (Pg. 145, second column, first paragraph; Scheme 1).
PNG
media_image24.png
109
134
media_image24.png
Greyscale
Compound F4 of Aissa falls within the scope of Formula (I) of instant claim 1, wherein
X1 is carbon (C);
X2 is sulfur (S);
Z1 and Z2 are each hydrogen;
Z3 is NH;
Z4 is O;
Z6 is O;
Z7 is N;
Z8 is CY2, Y2 is hydrogen (methyl) (it satisfies the proviso that Z8 is alkyl when Z7 is N);
X3, X4, X5 and X7 are each carbon (C);
X6 is CY1, Y1 is ester (-C(O)OEt);
X8, X9, X10 and X11 are each carbon (C);
X12 is CY2, Y2 is alkoxy (ethoxy).
Compound F4 further reads on the limitations of claims 2-3. Aissa teaches mice were treated with F4 for 4 weeks at a dose of 30 mg/kg/day p.o. to study their nonlipogenic ABCA1 inducing activity (Pg. 149, first column, first full paragraph). Aissa teaches the test compounds were administered by oral gavage (p.o.) formulated in 9% PEG-400 and 0.5% Tween-80 (Pg. 151, first column, second full paragraph). Therefore, Aissa anticipates the limitations drawn to a pharmaceutical composition as in claim 13.
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 1-3 and 13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Lewandowski et al. (Metabolomic analysis of a selective ABCA1 inducer in obesogenic challenge provides a rationale for therapeutic development, 19 March 2021, in the IDS, hereinafter Lewandowski) - Lewandowski qualifies as prior art for claims 1-3 and 13 since the effective filing date of these claims is 03/15/2022.
Regarding instant claim 1, Lewandowski teaches a novel small molecule for selective induction of ABCA1 vs. SREBP1c both in vitro and in vivo (Abstract). Lewandowski teaches the exemplary non-lipogenic ABCA1 inducer compound, compound CL2-57, ethyl 3-(5-chloro-3-(N-(3,4-diethoxyphenyl)-N-methylsulfamoyl)thiophene-2-carboxamido)benzoate (Pg. 2, first column, last paragraph – second column, first paragraph). The structure of CL2-57 is as shown below.
PNG
media_image25.png
324
319
media_image25.png
Greyscale
Compound CL2-57 of Lewandowski falls within the scope of Formula (I) of instant claim 1, wherein
X1 is carbon (C);
X2 is sulfur (S);
Z1 is halo (chloro);
Z2 is hydrogen;
Z3 is NH;
Z4 is O;
Z6 is O;
Z7 is N;
Z8 is CY2, Y2 is hydrogen (methyl) (it satisfies the proviso that Z1 is not hydrogen, or Z8 is alkyl when Z7 is N);
X3, X5 and X7 are each carbon (C);
X4 is ester (-C(O)OEt);
X6 is CY1, Y1 is ester;
X8, X9, and X11 are each carbon (C);
X10 and X12 are each CY2, Y2 is alkoxy (ethoxy).
Compound CL2-57 further reads on the limitations of claims 2-3. Further, Lewandowski teaches the lead compound, CL2-57 was administered as an oral gavage (vehicle: 9.5% PEG-200, 5% DMSO, 0.1% Tween-80 in water) plus 10 mg/kg/day CL2-57 in continuous hydrogel (Pg. 2, second column, second paragraph).Thus, Lewandowski anticipates the limitations drawn to a pharmaceutical composition as in claim 13.
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 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359454-01-5 (22/485), entered 02 March 2012, in the IDS.
PNG
media_image26.png
180
230
media_image26.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359453-91-0 (23/485), entered 02 March 2012, in the IDS.
PNG
media_image27.png
172
230
media_image27.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359400-04-6 (33/485), entered 02 March 2012, in the IDS.
PNG
media_image28.png
196
277
media_image28.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359220-15-7 (57/485), entered 01 March 2012, in the IDS.
PNG
media_image29.png
184
253
media_image29.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359206-13-5 (61/485), entered 01 March 2012, in the IDS.
PNG
media_image30.png
190
268
media_image30.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359150-55-2 (69/485), entered 01 March 2012, in the IDS.
PNG
media_image31.png
168
234
media_image31.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359066-75-3 (74/485), entered 01 March 2012, in the IDS.
PNG
media_image32.png
161
233
media_image32.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1359001-29-8 (76/485), entered 01 March 2012, in the IDS.
PNG
media_image33.png
212
225
media_image33.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1358767-56-2 (97/485), entered 29 February 2012, in the IDS.
PNG
media_image34.png
184
257
media_image34.png
Greyscale
Claims 1-3 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Database Registry compound, RN-1358767-07-3 (100/485), entered 29 February 2012, in the IDS.
PNG
media_image35.png
166
233
media_image35.png
Greyscale
Examiner’s note: It is noted that several other compounds of the Database Registry compounds in the IDS anticipate the instant claims. However, only a subset of them representing different embodiments are cited in the rejections.
Allowable Subject Matter
The compounds of claim 12 are free of prior art (It is noted that the compound of Lewandowski cited in the anticipation rejection above represents the first compound of claim 12. However, it does not constitute prior art for claims 8 and 12, since the effective filing date of these claims is 03/15/2021). Claim 12 objected to as being dependent upon a rejected base claim.
Conclusion
Claims 1-3, 8 and 13 are rejected.
Claims 1 and 12 are objected to.
No claims are allowed.
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 9:00-5:30pm EDT.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/PADMAJA S RAO/Examiner, Art Unit 1627