DETAILED ACTION
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 Amendments
The amendments filed on November 4, 2025 have been acknowledged and entered.
Claims 1-21, 28, and 30-34 are pending. Claims 22-27 and 29 are withdrawn.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of Applicant’s amendments and/or remarks.
Status of Priority
The present application is a 35 U.S.C. § 371 national stage patent application of International patent application PCT/US2020/024702, filed on March 25, 2020. This application also claims the benefits of United States Provisional Patent Application No. 62/823,384, filed on March 25, 2019.
Election/Restrictions
As a reminder, Applicant elected, without traverse, Group (I) which is drawn to a compound or composition having the structure represented by Formula (I) according to claims 1-21, 28, and 30-34.
Specification - Disclosure
The 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 3 is objected to because of the following informalities:
In claim 3, the structures corresponding to formulae VIII and IX are not present. Please ensure that these structures are included in the claim.
Appropriate correction is required.
Claims 30 and 32 are objected to under 37 CFR 1.75 as being a substantial duplicate of claim 28. Even though claim 28 is directed towards a composition and claim 30 is directed towards a pharmaceutical composition, these compositions are the same as they comprise the same components: a compound according to claim 1 and a pharmaceutically acceptable carrier.
Claim 32 recites “The pharmaceutical composition according to claim 30 [i.e., compound of claim 1 + a pharmaceutically acceptable carrier], further comprising at least one pharmaceutically acceptable carrier or excipient.” Claim 32 never specifies that the at least one pharmaceutically acceptable carrier has to be different than the pharmaceutically acceptable carrier already present in the pharmaceutical composition according to claim 30. Thus, if the added pharmaceutically acceptable carrier in claim 32 is the same as the pharmaceutically acceptable carrier already present in the pharmaceutical composition according to claim 30, then the pharmaceutical composition of claim 32 would be the same as the pharmaceutical composition of claim 30.
Claim 31 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 1. Claim 31 is directed towards a pharmaceutical composition comprising a compound represented by the structure of instant Formula I (which is the same compound as the compound of claim 1) with no additional components specified. The claim language of claim 31 suggests that the pharmaceutical composition can be made up of 100% of the compound represented by the structure of instant Formula I (i.e., the compound of claim 1). Thus, claim 31 is a substantial duplicate of claim 1.
When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Maintained rejections
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 1-5, 6-8, 10-14, 16-21, and 31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-5, 9, 11, 15-17, and 19-25 of U.S. Patent Application No. 18/178,192.
Note: From the non-final Office action dated June 4, 2025, claims 1-4, 6-8, 10-13, 17-21, and 30-31 were provisionally rejected on the ground of nonstatutory double patenting. After a second review, claims 5, 14, and 16 are also provisionally rejected. Claim 30 is no longer provisionally rejected due to amendment of the claim.
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap in compound species between the instant claims and the claim set from the co-pending application. For example, compounds A-1, A-5, A-20, A-95, A-106, A-124 through A-127, A-212, and A-217 of U.S. Patent Application No. 18/178,192 are also species of the instant claim set.
The co-pending application discloses agents for the treatment of diseases by inhibition of FOXO1. Since:
there is overlap between the compound species disclosed in the instant application and those disclosed in the co-pending application, and
the instant application teaches compounds that can selectively inhibit the FOXO1 transcription factor
it would be reasonable for one of ordinary skill in the art to conclude that the compounds of the co-pending application that overlap with the instant application likewise exhibit selective FOXO1 transcription factor inhibition. Hence, instant claim 14 is provisionally rejected on the ground of nonstatutory double patenting.
The co-pending application discloses a compound of formula (Ib) wherein the A-ring can be an aryl or heteroaryl according to the formulas given in claim 1 and wherein any of the X variables within the A-ring can be a CR1 group, for instance. If the R1 is a substituted alkyl group that is substituted with an amino group, then the compound would overlap with a compound of instant claim 5.
In the prior non-final Office action (dated June 4, 2025), claim 17 was provisionally rejected. As claim 17 incorporates the limitations of claim 16, claim 16 is, likewise, provisionally rejected.
Added rejections
Claim Rejections - 35 USC § 112(a) – Scope of enablement
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 1-21, 28, and 30-34 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for the following:
A compound having a structure represented by Formula I (as recited in claim 1)
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OR a pharmaceutical composition comprising a compound having a structure represented by Formula I (as recited in claim 31)
wherein a, b, c, d, e, f, g, h, X, Y, R1, R4, R5, R6, R7, R9, R10, R11, R12, R13, R14, and R15 is as recited in claims 1 and 31
wherein each R2 moiety, if present, is independently selected from the group consisting of C1-C6 alkyl and phenyl
wherein, if present, A is a cyclic moiety selected from the group consisting of phenyl and pyridyl
wherein each R3 moiety, if present, is as recited in claims 1 and 31 EXCEPT C6-C14 aryl
i.e., R3 = C6-C14 aryl is not enabled
wherein each R8 moiety is independently selected from the group consisting of
H, C1-C3 alkoxy, Cl, F, C1-C6 alkyl, CF3, OH,
an amine moiety as defined in claim 4
an alkyl amine moiety as defined in claim 5
an amide moiety as defined in claim 6
a heterocyclic amine moiety as defined in claim 7, specifically:
wherein the heterocyclic amine moiety has a structure represented by Formula XIII
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(XIII),
wherein i is selected from the group consisting of 0 and 1;
wherein, if present, R23 is selected from the group consisting of H, C1-C6 alkyl, and –(C=O)CH3
wherein Z is selected from the group consisting of C, N, and O; and
wherein W is selected from the group consisting of C and N; provided that at least one of Z and W is N
also, a heterocyclic amine moiety as defined in claim 8
wherein, if present, B is a heteroaryl moiety as defined in claim 9
or a pharmaceutically acceptable salt or tautomer thereof, with the proviso that
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or tautomers of these compounds are excluded,
does not reasonably provide enablement for elements that are outside the scope of the enabling elements listed above.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
As stated in the MPEP 2164.01(a), “There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is “undue.”
In evaluating the enablement question, several factors are to be considered. According to In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988), these factors include:
1) The nature of the invention,
2) the state of the prior art,
3) the predictability or lack thereof in the art,
4) the amount of direction or guidance present,
5) the presence or absence of working examples,
6) the breadth of the claims, and
7) the quantity of experimentation needed, and
8) the level of the skill in the art.
In the instant case, the Wands factors are relevant for the following reasons:
The nature of the invention
The nature of the invention claims a compound (represented by Formula I):
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and a pharmaceutical composition comprising the compound represented by Formula I wherein the compound may selectively inhibit a Forkhead Box O1 (FOXO1) transcription factor. The variables of formula (1) are defined in instant claim 1.
State of the prior art
Prior art referenced:
Langlet et al. (Langlet) (Langlet, F. et al. Cell 2017, 171, 824-835.; published online October 19, 2017).
Langlet discloses instant compounds 1 and 2 (i.e., compounds 9 and 10, respectively, in Langlet, Figure S7) which can selectively inhibit Forkhead Box O1 (FOXO1) over Forkhead Box A2 (FOXA2) (Table S3). Additionally, Langlet discloses instant compound 1 to have an IC50 for FOXO1 inhibition that is less than or equal to 50 nM and both instant compounds 1 and 2 have a maximal inhibition of FOXO1 that is greater than 40% (Table S3).
The level of the skill in the art
The level of ordinary skill in the art is relatively high. A person of ordinary skill would typically have formal training in medicinal chemistry and organic synthesis and would be familiar with standard methods for evaluating therapeutic efficacy of compounds.
The presence or absence of working examples, the amount of direction or guidance present, and quantity of experimentation necessary
While the instant application does provide working examples of FOXO1 transcription factor inhibitors having a structure represented by Formula I (structures provided in Table 1 on pg. 52-63 of the instant specification dated 11/04/2025; data on the instant compounds’ FOXO1 transcription factor inhibitory activity also provided in Table 1, last column on pg. 52-63), there are no working examples of FOXO1 transcription factor inhibitors with structural elements that are outside the scope of the enabling elements listed above.
In the absence of clear guidance, a person of ordinary skill in the art would require undue experimentation to:
make compounds represented by Formula 1 that possess structural elements outside the scope of the enabling elements listed above AND
determine which of these said compounds are FOXO1 transcription factor inhibitors.
Furthermore, according to MPEP § 2163:
“Satisfactory disclosure of a ‘representative number’ depends on whether one of skill in the art would recognize that the inventor was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. See, e.g., Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are ‘representative of the full variety or scope of the genus,’ or by the establishment of ‘a reasonable structure-function correlation.’ Such correlations may be established ‘by the inventor as described in the specification,’ or they may be ‘known in the art at the time of the filing date.’ See AbbVie, 759 F.3d at 1300-01, 111 USPQ2d 1780, 1790-91 (Fed. Cir. 2014).
In the instant case, even though the specification provides data on the FOXO1 transcription factor inhibitory activity of compounds of diverse structures (see Table 1 on pg. 52-63), it does not include any data on the FOXO1 transcription factor inhibitory activity of compounds of Formula I with structural elements that are outside the scope of the enabling elements listed above. For example, there are no working examples of a compound of Formula I wherein the A-ring is a C7-C14 aryl or a C6 heteroaryl nor are there any working examples of a compound of Formula I wherein R8 is, for instance, a more complicated amine moiety like a diphenylamine moiety. Thus, the specification is not adequately reflecting the structural diversity of the claimed genus.
The breadth of the claims
The claims are broad insofar as the instant claims recite a compound of formula (1) or a pharmaceutical composition comprising the compound of formula (1) wherein the compound can possess a structurally diverse range of chemical groups.
Claims 2-21, 28, 30, and 32-34, which are dependent on claim 1, are also rejected for further requiring and/or reciting elements that are outside the scope of the enabling elements listed above. Claim 31 is not dependent on claim 1, however, it is a substantial duplicate of claim 1 (as explained in the “Claim Objections” section above) and, therefore, is also rejected for requiring and/or reciting elements that are outside of the scope of the enabling elements listed above.
Claim Rejections - 35 USC § 112(b)
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 33 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 33 recites “or excipient.” There is insufficient antecedent basis for this limitation in the claim. Claim 33 is dependent on claim 30 which recites “A pharmaceutical composition comprising a pharmaceutically acceptable carrier and a compound according to Claim 1.” Claim 30 does not mention an “excipient.” Thus, there is insufficient antecedent basis for the limitation, “excipient,” in claim 33.
Note on 35 USC § 102 and § 103 Rejections
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 § 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
102 Rejection part 1:
Claims 1, 7, 16, 18, 19, 21, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
STN registry entry, RN 1808418-76-9, entered into the database on September 29, 2015.
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There are no references citing compound 1808418-76-9, however, this compound can be purchased from the company, Enamine, as stated in the STN output (see “Source of Registration” line above).
This compound reads on instant claims 1, 7, 16, 18, 19, and 21 wherein:
b = 0 (i.e., the cyclic moiety, A, is absent)
c = 0 (i.e., R3 is absent)
a = 0 (i.e., R2 is absent)
R1 = C1 alkyl
d = 0 (i.e., R4 is absent)
e = 1
R5 = C1 alkyl
R6 = H
R7 = a moiety represented by Formula II:
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wherein
X = C
g = 0 (i.e., the “B” moiety is absent)
f = 5
the first three R8 substituents are H, the fourth R8 substituent is F, and the last R8 substituent is a morpholinyl group (i.e., a heterocyclic amine moiety)
Recall from the “Claim Objections” section above, claim 31 is a substantial duplicate of claim 1. Hence, compound 1808418-76-9 also reads on claim 31.
102 Rejection part 2:
Claims 28, and 30-33 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
STN registry entry, RN 1808418-76-9, entered into the database on September 29, 2015 in view of:
Product no. Z1443394225; Enamine. https://enaminestore.com/catalog/Z1443394225. (Accessed December 2, 2025).
As stated above in the “102 Rejection part 1” section, compound 1808418-76-9 can be purchased from the company, Enamine (see “Source of Registration” line from STN output).
According to the Enamine company webpage, compound 1808418-76-9 can be purchased in the form of a solution wherein the compound is dissolved in DMSO, a known excipient (See McKim et al. Pharmaceutical Technology. 2008, 32; 1st sentence of article). This composition comprising compound 1808418-76-9 and DMSO reads on instant claims 28 and 30-33:
[AltContent: rect]
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.
(Recall from the “Claim Objections” section above, claims 30 and 32 are substantial duplicates of claim 28).
Since the instant specification does not define “pharmaceutically acceptable carrier,” Examiner interprets this term to include excipients/diluents like DMSO.
102 Rejection part 3:
Claims 1, 16, 20, 21, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
STN registry entry, RN 2224450-22-8, entered into the database on May 21, 2018.
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This compound reads on instant claims 1, 16, 20, 21, and 31 wherein:
b = 0 (i.e., the cyclic moiety, A, is absent)
c = 0 (i.e., R3 is absent)
a = 0 (i.e., R2 is absent)
R1 = C1 alkyl
d = 0 (i.e., R4 is absent)
e = 1
R5 = C1 alkyl
R6 = H
R7 = a moiety represented by Formula II:
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wherein
X = C
g = 0 (i.e., the “B” moiety is absent)
f = 5
four R8 substituents are H and the last R8 substituent is a C1 alkoxy
102 Rejection part 4:
Claims 1, 4, 16, 18-21, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
STN registry entry, RN 1583090-29-2, entered into the database on April 11, 2014.
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This compound reads on instant claims 1, 4, 16, 18-21, and 31 wherein:
b = 0 (i.e., the cyclic moiety, A, is absent)
c = 0 (i.e., R3 is absent)
a = 0 (i.e., R2 is absent)
R1 = C1 alkyl
d = 0 (i.e., R4 is absent)
e = 1
R5 = C1 alkyl
R6 = H
R7 = a moiety represented by Formula II:
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wherein
X = C
g = 0 (i.e., the “B” moiety is absent)
f = 5
four R8 substituents are H and the last R8 substituent is -NH2 (i.e., an amine moiety)
specifically, the amine moiety has a structure represented by Formula X wherein R16 = R17 = H
102 Rejection part 5:
Claims 1, 5, 16, 18-21, and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by
STN registry entry, RN 1607100-83-3, entered into the database on May 19, 2014.
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This compound reads on instant claims 1, 5, 16, 18-21, and 31 wherein:
b = 0 (i.e., the cyclic moiety, A, is absent)
c = 0 (i.e., R3 is absent)
a = 0 (i.e., R2 is absent)
R1 = C1 alkyl
d = 0 (i.e., R4 is absent)
e = 1
R5 = C1 alkyl
R6 = H
R7 = a moiety represented by Formula II:
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wherein
X = C
g = 0 (i.e., the “B” moiety is absent)
f = 5
four R8 substituents are H and the last R8 substituent is -CH2NH2 (i.e., an alkyl amine moiety)
specifically, the alkyl amine moiety has a structure represented by Formula XI wherein R20 is a C1 alkyl and R18 = R19 = H.
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 28 and 30-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 13, 14, 17, and 18 of U.S. Patent Application No. 17/420,955 (‘955)
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap between the instant claims and the claim set from the co-pending application.
Claims 13, 14, 17, and 18 of application ‘955 are directed towards a pharmaceutical composition comprising an effective amount of a FOXO1 inhibitor and a Notch inhibitor or Rock inhibitor, or both, wherein the FOXO1 inhibitor and the Notch inhibitor or Rock inhibitor, or both, are in an orally administrable enteric form.
According to the specification of ‘955, “the term ‘FOXO1 inhibitor’ is intended to include, but is not limited to, molecules which neutralize the effect of FOXO1, in particular its function as a transcription factor” (‘955, pg. 14, lines 4-6). In other words, claims 13, 14, 17, and 18 of application ‘955 encompass a pharmaceutical composition or composition comprising a FOXO1 inhibitor (including those disclosed in the instant application) and a Notch inhibitor or Rock inhibitor or both, wherein the FOXO1 inhibitor and the Notch inhibitor or Rock inhibitor, or both, are in an orally administrable enteric form (i.e., in a pharmaceutically acceptable carrier) which reads on instant claims 28 and 30-34.
Even though the instant claims do not explicitly specify that the claimed pharmaceutical composition comprises a Notch inhibitor or Rock inhibitor or both, the open-ended transitional phrase “comprising” in instant claims 28 and 30-34 indicates that the composition disclosed in the instant case can also include other components like a Notch inhibitor or Rock inhibitor or both.
Furthermore, even though claims 13, 14, 17, and 18 of ‘955 do not explicitly state that the pharmaceutical composition comprises a pharmaceutically acceptable carrier or excipient selected from the group consisting of a diluent, a disintegrating agent, a binder, and a lubricating agent, it is implied that such components would be included in a pharmaceutical composition that is in an orally administrable enteric form as “[t]echniques for formulation and administration can be found in ‘Remington: The Science and Practice of Pharmacy’ (20.sup.th edition, Gennaro (ed.) and Gennaro, Lippincott, Williams &Wilkins, 2000)” (‘955, pg. 41, para. 0165, 3rd sentence).
Also, even though claims 13, 14, 17, and 18 of ‘955 do not explicitly state that the pharmaceutical composition is in a form selected from the group consisting of tablets, powders, granules, dragees, pellets, pills, and capsules, the specification states that “[f]or oral administration, the agent can be contained in enteric forms to survive the stomach or further coated or mixed to be released in a particular region of the GI tract by known methods… For the purpose of oral therapeutic administration, the active agent can be incorporated with excipients and used in the form of tablets, troches, or capsules” (‘955, pg. 41, para. 0165, 4th and 5th sentences). Thus, the pharmaceutical composition disclosed in claims 13, 14, 17, and 18 of ‘955 may be in the form of a tablet or capsule which reads on instant claim 34.
Rejections necessitated by the amended claims
Claim Rejections - 35 USC § 112(a) – Written description
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 1-21, 28, and 30-34 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.
Regarding claims 1 and 31, the instant specification only states the following:
“Various embodiments may exclude Compound 1 and Compound 2:
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” (pg. 5).
The instant specification does not state that various embodiments may exclude Compound 1, Compound 2, AND
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and
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as recited in instant claims 1 and 31.
Thus, claims 1 and 31 fail to comply with the written description requirement.
Since claims 2-21, 28, 30, and 32-34 are dependent on claim 1, these claims are also rejected for further requiring and/or reciting the elements that fail to comply with the written description requirement.
Claim Rejections - 35 USC § 112(b)
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 2, 3, and 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.
Claims 2 and 3 state that the cyclic moiety, A, is a pyridine moiety. However, there is insufficient antecedent basis for this limitation in the claim. Claims 2 and 3 are dependent on claim 1. According to claim 1, the cyclic moiety, A, can be a C6-C14 aryl OR a C6 heteroaryl. A pyridine moiety is NOT a C6 heteroaryl because it only contains 5 carbon atoms, not 6.
Claim 7 recites “wherein if R23 is a ketone moiety, then the bond between Z and R23 is a double bond.” However, the metes and bounds of this limitation cannot be clearly ascertained. The specification provides only a single working example in which R23 is a ketone moiety and in that example, the bond between Z and R23 is a single bond rather than a double bond:
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(compound 35, pg. 56).
Accordingly, it is unclear what ketone moiety Applicant intends to encompass in claim 7 and, thus, the scope of claim 7 is rendered indefinite.
Claim Rejections - 35 USC § 112(d)
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 32 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.
Claim 32 recites “The pharmaceutical composition according to claim 30 [i.e., compound of claim 1 + a pharmaceutically acceptable carrier], further comprising at least one pharmaceutically acceptable carrier or excipient.” Claim 32 never specifies that the at least one pharmaceutically acceptable carrier has to be different than the pharmaceutically acceptable carrier already present in the pharmaceutical composition according to claim 30. Thus, if the added pharmaceutically acceptable carrier in claim 32 is the same as the pharmaceutically acceptable carrier already present in the pharmaceutical composition according to claim 30, then the pharmaceutical composition of claim 32 would be the same as the pharmaceutical composition of claim 30.
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.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624