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
Election/Restriction
Acknowledgement is made of Applicant’s election without traverse of Group I, subgenus compound of Formula (Ia-2) and species, compound of Example 36 having following structure, in the reply filed on 09/03/2025.
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Claims 1, 3-7, 9, 15-16, 20-22, and 27 read on the elected species.
Claims 11-14 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 8, 17-19, 23-26 and 28 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim.
The elected species, Example 36 (CAS#2762354-69-6, entered STN database on March 16, 2022) is found free of anticipatory 102 prior art. The examiner has expanded the search to non-elected species, wherein G is dimethoxyphenyl, A is piperidinyl or phenyl substituted with -L-R4, L is a bond, R4 is piperidinyl or piperazinyl, R1 is H or alkyl (e.g. CH3 ); R3 is hydrogen or alkyl, R5 is hydrogen.
. These non-elected species are rejected under the 102 and 103 rejections shown below. Other non-elected species are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a non-elected species. The absence of other citations of prior art should not be interpreted as an indication that other subgenera within Formula (Ia-2) are free of prior art. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reconsidered. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reconsideration that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Status of Claims
Claims 1, 3-9 and 11-28 are pending in the instant application.
Claims 8, 11-14, 17-19, 23-26 and 28 are withdrawn.
Claims 1, 3-7, 9, 15-16, 20-22, and 27 are currently under examination.
Priority
This instant application 18/042,018 filed 02/17/2023, is a 371 of PCT/US2021/046475 filed 08/18/2021, which claims benefit of US provisional application 63/067,389 filed 08/19/2020.
Information Disclosure Statement
The information disclosure statement dated 05/24/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the reference listed in IDS are being considered by the Examiner.
Claim Rejections - 35 USC § 112 – Improper Markush Group
Claims 1, 3-6 and 9 are rejected on the judicially-created basis that it contains an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature.
A Markush claim contains an “improper Markush grouping” if: (1) The species of the Markush group do not share a single structural similarity,” or (2) the species do not share a common use. Members of a Markush group share a "single structural similarity” when they belong to the same recognized physical or chemical class or to the same recognized physical or chemical class or to the same art-recognized class. Members of a Markush group share a common use when they are disclosed in the specification or known in the art to be functionally equivalent (see Federal Register, Vol. 76, No. 27, Wednesday, February 9, 2011, p. 7166, left and middle columns, bridging paragraph).
The members of the improper Markush grouping do not share a substantial feature and/or a common use that flows from the substantial structural feature for the following reasons:
In the present case, claims 1 and 3-6 are drawn to a compound of formula (Ia-2) comprising vast alternatives which are in different recognized physical classes and the Markush list embraces different chemical compounds that do not share significant structural similarity between the species. The Markush grouping for compounds of Formula (Ia-2) recites vast variety of moieties A, G in combination with different L, R groups, etc.. For example, claim 1 recites limitations of G moiety being various heterocyclic ring structures in (i), (ii), (iii), (iv) (v) or (vi), for example:
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…
The compounds comprising bridged A moiety azabicyclo[3.2.1]octanyl, or diazabicyclo[3.2.1]octanyl would have been classified in C07D 491/08, e.g. the elected species, that’s different from phenyl group.
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The compounds comprising sulfonyl group in G moiety as recited in the claim 5 would have been classified in C07B 45/04, that’s different from methoxyphenyl ring as G moiety.
There is only minimal structure moiety in common -- azaindole ring
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among the alterative compounds claimed in Formula (Ia-2), which is a minimal part of the structures compared with other varieties of A and G Markush groups. The core azaindole ring shared among the species do not necessarily share a common use flows from the azaindole ring. It’ noted instant azaindole compound species exhibit vast different TLR activity ranging from 0.094 uM to >50uM ( See page 90, Table ). It’s also noted azaindole is versatile scaffolds for variety of kinase inhibitors, e.g. for Aurora A kinase, M1 mAChR PAM, etc. (See Motati 2020).
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Each of these findings demonstrates that not all members recited in this Markush group belong to the same recognized chemical class, i.e., the species fail to share a substantial structural feature and/or a common use associated the azaindole ring.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1) (emphasis provided).
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) 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.
(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.
As noted above in Election/Restriction section, the elected species, Example 1 as disclosed in specification, is found free of anticipatory 102 prior art. Examiner has expanded the search of several non-elected species and rejected these non-elected species under the 102 rejection shown below.
Claims 1, 3-4, 6, and 9 are rejected under 35 U.S.C. §102(a)(1) and (a)(2) as being anticipated by Dyckman et al. (WO2019/125977A1, hereafter Dyckman’977, family member of US10544143B2, Applicant’s IDS dated 05/24/2023).
This 102 rejection is directed to non-elected compounds of Formula (Ia-2) wherein:
G is phenyl substituted with dimethoxy; A is piperidinyl or phenyl or pyridinyl substituted with -L-R4, L is a bond, R4 is piperidinyl or pyridinyl or piperazinyl, R1 is H or CH3; R3 is hydrogen or alkyl, R5 is hydrogen.
Dyckman’977 teaches 4-azaindole compound of Formula I and pharmaceutical salt thereof as Toll-like TLR 7/8/9 inhibitors, pharmaceutical composition comprising aforementioned compound, and a method of treating disease/disorder related to TLR modulation(e.g. inflammatory, autoimmune diseases)(See abstract; page 2, lines 14-32; page 4-14 ; Examples 1-1078, Tables 1-4, claims 1-15).
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Wherein G moiety is selected from groups (i)- (v)
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and (iv) 9-mernbered heterocyclic ring and (v) 10-membered heterocyclic ring ( See page 4-14) that are the same or similar as instant G moiety.
A moiety is selected from
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A moiety taught by Dyckman’977, e.g. an aromatic group selected from phenyl, pyridinyl or CRxR12R13, wherein R12 and R13 together with the carbon atom to which they are attached form a cyclic group selected from azabicyclo[4.1.1]octanyl, piperazinyl, piperidinyl, etc. (See page 8, lines 2-15; page 26, line 15-25;) read on instant claimed phenyl or pyridinyl, piperazine group, etc. R14a is 8-azabicyclo[3.2.1]octanyl, phenyl, piperazinyl!, piperidinyl, pyrazolyl, pyridinyl, etc. (See e.g. page 14, lines 5-14) read on instant R4. Dyckman’977 embodiment comprising piperidinyl as A moiety and R14a is 8-azabicyclo[3.2.1]octanyl substituted with CH2CH(CH3)2 would read on instant elected species.
It’s noted 4-azaindole compound of Formula I in Dyckman’977 having the same 4-azaindole core structure and similar moieties A, G, R groups and other variables overlaps with instantly claimed compound of Formula Ia-2. Dyckman’97 teaches variety of compound species comprising A moiety and/or G moiety that read on the non-elected compound species that fall under the present definition of compounds of claim 1 and withdrawn in this office action (See e.g. compounds 529, 531, 532, 537, 540, 544-545, 549-551, 570, 576-577, 585, 586).
Dyckman’977 teaches preparation of compound of Formula I and compounds species that are encompassed by or very similar to instant claimed compounds (See Examples 1-1078, Tables 1-3), and activity thereof (See Table 4).
Dyckman’977 teaches Example 5 (See page 105) ,
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wherein G is phenyl substituted with dimethoxy; A is piperidinyl with -L-R4, L is a bond, R4 is piperidinyl substituted with R4a; and R4a is-CH2CH(CH3)2; R1 is H; R3 is CH3, R5 is hydrogen.
As such , Dyckman’977 read on instant claims 1, 3-4, 6 and 9.
Regarding instant claim 9, Dyckman’977 teaches pharmaceutical composition comprising compound of formula I and pharmaceutical acceptable carrier (See page 76, lines 3-20) that can be administered via different route (See page 77). As such Dyckman’977 anticipates instantly claimed invention.
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.
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.
Claims 1, 3-4, 6-7, 9 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Dyckman et al. (WO2019/125977 A1, hereafter Dyckman’977, Applicant’s IDS dated 05/24/2023),
The collective teachings of Dyckman’977 is elaborated in preceding 102 rejection and applied as before. Dyckman’97 teaches variety of compound species comprising A moiety and/or G moiety that read on the non-elected compound species that are withdrawn in this office action.
Dyckman’977 teaches variety of A moiety, e.g. an aromatic group selected from phenyl, pyridinyl or CRxR12R13, wherein R12 and R13 together with the carbon atom to which they are attached form a cyclic group selected from azabicyclo[4.1.1]octanyl, piperazinyl, piperidinyl, etc. (See page 8, lines 2-15; page 26, line 15-25) (which read on instant claimed phenyl or pyridinyl, piperazine group). R14a is 8-azabicyclo[3.2.1]octanyl, phenyl, piperazinyl!, piperidinyl, pyrazolyl, pyridinyl, etc. (See page 14, lines 5-14) read on instant R4.
Dyckman’977 teaches variety of compound species comprising piperidyl and piperazinyl ,diazabicyclo[3.2.1]octane as A moiety (See e.g. 42, 738- 996, Table 1, Table 2).
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In search for more 4-azaindole as alternative TLR inhibitor, it would have been obvious to one of ordinary skill in the art to further explore more A moiety and/or G moiety based on the collective teachings of Dyckman’977 and general knowledge of structure similarity and bioisosteric modification. According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The further modification of 4-azaindole compounds as TLR inhibitors taught by Dyckman’977 based on general knowledge of structure similarity and bioisosteric modification of SAR study would provide more alternative 4-azaindole compounds that are reasonably expected to exbibit TLR inhibiting activity. For example, Example 5 of Dyckman’977 could be modified at A moiety, by modifying piperidinyl to phenyl group (which was taught by Dyckman’977), wherein R4 piperidyl could be further modified to piperazine group and arrive at instant non-elected compound 1 of claim 7. A skilled artisan would have had reasonable expectation of success because Dyckman’977 teaches A moiety could be phenyl substituted with R14a piperazine/piperidyl and teaches variety of compound species comprising piperazinyl and piperidinyl moiety wherein piperazinyl an piperidinyl are classic bioisosteres with difference of N vs CH based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, which is also within general knowledge of SAR study to a skilled artisan.
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One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of structure similarity and bioisosteric modification of SAR study .
Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Claims 1, 3-4, 6-7, 9 and 15-16 are rejected under 35 U.S.C. 103 as being unpatentable over Dyckman (WO 2019/126253 A1, hereafter Dyckman’253), in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176).
Dyckman’253 teaches compound of Formula I, N-oxide or salt thereof, as Toll-like receptor 7, 8, or 9 (TLR7, TLR8, TLR9) inhibitor for treating inflammatory and autoimmune diseases (See abstract, pages 4-9; Examples, Table 1, claims 1-11) .
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wherein G is
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and a 9-membered heterocyclic ring; 10-membered heterocyclic ring, etc. (See page 4-7).
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Dyckman’253 teaches embodiments where A moiety is phenyl or pyridinyl group substituted with R14a (e.g. piperazinyl, piperidinyl, 8-azabicyclo[3.2.1]octanyl, etc. ) (See page 15, line 9; page 22, lines 19-30)( which reads on instant A moiety and R4 group)
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Dyckman’253 teaches embodiments comprising phenyl as A moiety further substituted with piperazine as R14 that read on instant A moiety, L is bond and R4 ( See Table 2, e.g. compound 368-371, 380-384, 390-393, etc.).
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Dyckman’253 also teaches embodiments comprising 8-azabicyclo[3.2.1]octanyl as R14a (See cpd 452) which reads on R4 of instant elected species.
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The difference of Dyckman’253 compound with instant compound is indole vs azaindole, CH vs N which is classic bioisosteres based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, which is within general knowledge of SAR study to a skilled artisan as taught by Patani. Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds. Patani et al. teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (See p. 3148-3149).
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Patani et al. further teaches other divalent linkers that have been obtained as modifications of the above classical isosteres include higher oxidation states of the thioether linker resulting in sulfoxide and sulfone derivatives (See page 3156, right column), where corresponding sulfoxide and sulfone analogues. are more potent than the corresponding sulfides and the greater size associated with the sulfone moiety has also been shown to be a factor that modulates biological activity (See page 3167, right column).
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As such, SO2CH3 is considered as bioisosteric replacement of OCH3.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
In search for alternative TLR inhibitor, it would have been obvious to one of ordinary skill in the art before the effective filing date of instant application to modify indole of Dyckman’253 to azaindole (CH to N) as taught by Patani and further explore more A moiety and/or G moiety based on the collective teachings of Dyckman’253 and general knowledge of structure similarity and bioisosteric modification. The combined teachings of Dyckman’253 indole TLR inhibitors with further modification based on general knowledge of structure similarity and bioisosteric modification of SAR study would provide alternative 4-azaindole compounds that are reasonably expected to exbibit TLR inhibiting activity.
One of ordinary skill in the art would have had reasonable expectation of success in producing the claimed invention based on the combined teachings of prior art and general knowledge of structure similarity and bioisosteric modification of SAR study. For example, Example 382 of Dyckman’253 could be modified from indole to azaindole and arrive at non-elected species compound 1 of claim 7, wherein OMe could be further modified to SO2CH3 as taught by Patani, and arrive at non-elected species of claim 16. Please note piperazine group could be further modified to 8-azabicyclo[3.2.1]octanyl because Dyckman’253 teaches A moiety could be phenyl substituted with 8-azabicyclo[3.2.1]octanyl and piperazine as R14a.
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Therefore, the invention as a whole is prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claim 1 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 21 of U.S. Patent No. 10544143 B2 (family member of WO2019/125977A1), in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176).
Reference claims are directed to azaindole compound formula I with similar core structure,
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Reference claimed A moiety reciting cyclohexyl group could be modified to piperidinyl group as taught by Patani et al. According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists. Therefore, the reference claims render instant claimed invention prima facie obvious.
Claim 1, 3-4 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 12 of U.S. Patent No. 10730877B2 . Although the claims at issue are not identical, they are not patentably distinct from each other because they claimed the same pharmaceutical use of the compounds and pharmaceutical compositions comprising it based on obviousness.
Reference claims are directed to azaindole compound formula I with similar core structure,
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wherein:
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A is —CRxR12R13, wherein R12 and R13 together with the carbon atom to which they are attached form a cyclic group selected from piperidinyl substituted with zero to 3 R12a .The A moiety of reference claims read on instant claimed A piperidinyl moiety.
Reference claim 11 recite compound species that falls within the scope of instant claim 1 or very similar to instant claimed compounds.
According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists. Therefore, the reference claims render instant claimed invention prima facie obvious.
Claim 1, 3-4, and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 14 of U.S. Patent No. 11180474B2, in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176).
Reference claims are directed to compounds of Formula (I)
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It’s noted reference formula I read on instant A moiety is piperidyl, and reference R3 comprising A group, e.g. 8-azabicyclo[3.2.1]octanyl, 8-oxa-3-azabicyclo[3.2.1]octanyl, phenyl, piperidinyl, piperidinyl, piperazinyl, etc. read on instant R4.
The difference between reference compound above and instant application is indole (CH) vs azaindole (N) which are classical bioisosteres as taught by Patani. According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists. Therefore, the reference claims render instant claimed invention prima facie obvious.
Claim 1, 3-4 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 14 of U.S. Patent No. 11878975B2, in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176).
Reference claims are directed to compounds of Formula (I) comprising
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The difference between reference compound above and instant application is indole (CH) vs azaindole (N) which are classical bioisosteres as taught by Patani. According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists. Therefore, the reference claims render instant claimed invention prima facie obvious.
Claim 1 and 9 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 9 of U.S. Patent No. 11,427,580 B2, in view of Patani et al. (Chemical Reviews, 1996. Vol. 96, 8: 3147-3176).
Reference claims are directed to compounds of Formula (I)
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It’s noted A is CRXR12R13, wherein R12 and R13 together with the carbon atom to which they are attached form a cyclic group selected from azabicyclo[4.1.1]octanyl, piperazinyl, piperidinyl, pyrrolidinyl, each substituted with zero to 4 R12a or (vii) an aromatic group selected from phenyl read on instant claimed A moiety.
The difference of reference claims and instant claims are 6-azaindole vs instant 4-azaindole which are considered as regional isomers. According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists. Therefore, the reference claims render instant claimed invention prima facie obvious.
Claims 1, 3-7, 9, 15-16, 20-22, and 27 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 9 of U.S. patent application No. 18/041,719 (reference application), in view of Dyckman’977 (WO2019/125977A1). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a compound of Formula I,
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Reference compound and instant compound are considered as regio-isomers with N at different positions of core structure. As elaborated in preceding 102 and 103 rejections, Dyckman’977 (WO2019/125977A1) teaches 4-azaindole compounds as TLR inhibitor.
Reference G is phenyl substituted with SO2(C1-3 alkyl) which reads on instant claim 3- 5 and 15.
Reference claim 8 recites compound species that are very similar to instant compounds. For example, 6-(l-(8-isobutyl-8-azabicyclo[3.2.1]octan-3-yl)piperidin-4-yl)-4-methyl-2-(4- (methylsulfonyl)phenyl)-lH-benzo[d]imidazole (121) , having following structure, is very similar to instant elected species.
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists. Therefore, the reference claims render instant claimed invention prima facie obvious.
Claim 1, 3-5, 9 and 15-16 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1- 12 of U.S. Patent No. 18042069(reference application). This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Reference claims are directed to a compound of Formula IIIb,
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Reference compound and instant compound are considered as regio-isomers with N at different positions of core structure. G is phenyl substituted with SO2CH3 read on instant claim 3- 5.
Reference claim 11 recites compound species that’s are very similar to instant claimed compound recited in instant claim 16. For example, reference 6-(3 -(4-isopropylpiperazin- 1 -yl)phenyl)-1,4-dimethyl-2-(4-(methylsulfonyl)phenyl)- 1H-pyrrolo[3,2-c]pyridine (67) having following structure:
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According to MPEP § 2144.09, A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
The instant application shares at least one common inventor /applicant with the reference patent. Furthermore, the instant application is not related to the reference patent based on the record, thus no 35 USC 121 shield exists. Therefore, the reference claims render instant claimed invention prima facie obvious.
Conclusion
NO claims are allowed.
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/L.M./ Examiner, Art Unit 1628
/JARED BARSKY/Primary Examiner, Art Unit 1628