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 .
FINAL ACTION
Priority
Instant application 17/786,807 filed on 06/17/2022 claims benefit as follow:
CONTINUING DATA:
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Status of the Application
Claims 1, 14, 20-22, 33-35, 37-39 and 42 are pending.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 12/22/2025, 01/17/2023, 08/11/2023, 10/13/2023, 12/18/2023, 08/28/2024, 07/31/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Response to Arguments/Amendments
The amendment filled on 12/22/2025 has been entered.
In response, regarding Improper Markush Grouping rejection, Applicant’s amendment has overcome the rejection. Thus, the Improper Markush Grouping rejection is withdrawn.
Regarding objection to specification, Applicant confirmed that Tables 9-11 do not have data. However, Applicant did not provide the missing data. The instant specification states that results are presented in the mentioned tables.
For example, on page 353 the specification states:
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Therefore, the objection is maintained.
Regarding 103 rejection, Applicant's arguments have been fully considered but they are not persuasive.
Applicant submitted that “Crew does not teach compounds having the amide group orientation or bioisostere thereof in the compounds of formula I-b-1 to I-b-7 as recited in claim 1, particularly with respect to the connectivity of L- DIM. Put differently, Crew does not teach compounds having the linker connected to a ring on the carbonyl end of an amide wherein the amine end of the amide is connected to another ring not connected to the linker in a IRAK4 binding moiety. Thus, Crew fails to teach or suggest all the elements of Applicant's instant claim 1, as well as claims depending directly or indirectly therefrom as required to support an obviousness rejection. Indeed, the Examiner has not articulated how there is anything sufficiently instructive in Crew that would have led one of skill in the art to arrive at Applicant's invention, and especially with an expectation of success.”
Applicant's arguments have been fully considered but they are not persuasive.
CREW teaches and claims bifunctional compounds targeting IRAK-4 comprising E3 ubiquitin ligase binding moiety (see claim 1):
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For example, CREW discloses compound 58 (see page 573):
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Compound 58, disclosed by CREW, differs from compounds of instant formula I-b-1 and I-f-1
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in that the X variable is connected to ring Q/T (fused rings) whereas the instant formulas require the linker to be connected to ring P (a monocyclic ring).
It is the examiner position that combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine E3 ubiquitin ligase binding moiety and IRAK targeting moiety to form alternative bifunctional compound for the same purpose.
Since the only difference between instant compounds of formula I-f-1 and compound 58, disclosed by CREW, is in the attachment point of the X variable, and the two essential parts (E3 ubiquitin ligase binding moiety and IRAK targeting moiety) are still present, a person of ordinary skill would expect retention of activity after the inversion of connection. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose.
MPEP states that “It should be noted that the lead compound cases do not stand for the proposition that identification of a single lead compound is necessary in every obviousness rejection of a chemical compound. For example, one might envision a suggestion in the prior art to formulate a compound having certain structurally defined moieties, or moieties with certain properties. If a person of ordinary skill would have known how to synthesize such a compound, and the structural and/or functional result could reasonably have been predicted, then a prima facie case of obviousness of the claimed chemical compound might exist even without identification of a particular lead compound. As a second example, it could be possible to view a claimed compound as consisting of two known compounds attached via a chemical linker. The claimed compound might properly be found to have been obvious if there would have been a reason to link the two, if one of ordinary skill would have known how to do so, and if the resulting compound would have been the predictable result of the linkage procedure. Thus, Office personnel should recognize that in certain situations, it may be proper to reject a claimed chemical compound as obvious even without identifying a single lead compound.” (MPEP 2143 I, Example 10, last paragraph).
In the instant case, a person of ordinary skill would combine the elements disclosed in prior art using know synthetic methods.
Applicant pointed that there is anything sufficiently instructive in Crew that would have led one of skill in the art to arrive at Applicant's invention, and especially with an expectation of success.
It is examiner position that a person of ordinary skill would expect retention of activity after the inversion of connection. However, if Applicants argue that the ordinary skill would not expect retention of activity after the inversion of connection, 112(a) rejection may be considered. As discussed above, the instant application does not provide any data regarding the IRAKs activity.
Therefore, the 103 rejection is maintained. Examiner will reconsider her position after comparative data are presented. Applicant is encouraged to present comparative data and/or discuss unexpected properties.
Regarding double patenting rejection over Application No. 18/726,753, Applicant pointed that the application has no commonality to the instant case, i.e., no common inventor, Applicant, or owner/assignee, or association within the scope of a qualifying Joint Research Agreement (JRA) under 35 U.S.C. @ 102(c). Therefore, the double patenting rejection over Application No. 18/726,753 is withdrawn.
Regarding double patenting rejection over Application No. 18/315,267, since the Application No. 18/315,267 has been abandoned, thus, the rejection is withdrawn.
Regarding double patenting rejection over Application No. 17/797,311, Applicant pointed that the compounds recited in Application No. 17/797,311 are “having a different cereblon E3 ubiquitin ligase binding moiety and amide orientation connecting Ring Q and Ring A that has no overlap with the scope of the instant claims”. It should be noted that Applicant amended instant claim 1 to recite specific DIM (cereblon E3 ubiquitin ligase binding moiety). Therefore, the rejection over Application No. 17/797,311 is withdrawn.
Regarding double patenting rejection over Application No. 17/597,165, Applicant submitted “The instantly claimed compounds of formula I-b-1 to I-b-7 are directed to compounds where L-X is attached to a 5-membered heteroaryl. In contrast, the compounds of the reference claims are directed to compounds of formula I-k-15 where L-X (L-cyclohexyl) is attached to indazole (a 9-membered heteroaryl).” Applicant's arguments have been fully considered but they are not persuasive because the only difference between instant compounds of formula I-f-1 and compounds of copending Application No. 17597165, is in the attachment point of X variable. It is examiner position that a person of ordinary skill would expect retention of activity after the inversion of connection because the two essential parts (E3 ubiquitin ligase binding moiety and IRAK targeting moiety) are still present. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose.
Therefore, the rejection over Application No. 17/597,165 is maintained.
Regarding double patenting rejection over Application No. 17/912,154, Applicant submitted: “The instantly claimed compounds of formula I-b-1 to I-b-7 are directed to compounds where L-X is attached to a 5-membered heteroaryl. In contrast, the compounds of the reference claims are directed to compounds of formula I-k-15 where L-X (L-cyclohexyl) is attached to imidazo[1,2-a]pyridine (a membered heteroaryl). Applicant's arguments have been fully considered but they are not persuasive. The compounds of copending Application No. 18/912,154 differ from compounds of instant formula I-b-1 and I-f-1 in that the X variable is connected to the ring Q/T (a fused ring) whereas the instant formulas require the liker to be connected to ring P (a monocyclic ring).
It is the examiner position that it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine E3 ubiquitin ligase binding moiety and IRAK targeting moiety to form alternative bifunctional compounds for the same purpose. Since the only difference between instant compounds of formula I-f-1 and compounds disclosed in copending Application No. 18912154 is in the attachment point of the X variable, a person of ordinary skill would expect retention of activity after the inversion of connection because the two essential parts (E3 ubiquitin ligase binding moiety and IRAK targeting moiety) are still present. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose. Therefore, the rejection over Application No. 17/912,154 is maintained.
Regarding double patenting rejection over Application No. 19/012,355, Applicant submitted that the claims are directed to IRAK4 degrading compounds having a different amide orientation connecting Ring B and Ring C that has no overlap with the scope of the instant claims. Further, Applicant submitted that” Crew fails to provide any pointer to flip the amide moiety in formula I-a of the reference claims-let alone substitute with a bioisostere-to support the instant nonstatutory double patenting rejection”. Applicant's arguments have been fully considered but they are not persuasive
The copending Application No. 19/012,355 recite (see claim 46):
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Compound I-360 recited in claims of Application No. 19/012,355 is an isomer of the elected species (instant compound I-8):
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MPEP 2144.09 states: “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)”. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose. In addition, CREW discloses IRAK inhibitors bearing C(O)NR moiety connected to a monocyclic ring through a carbon atom.
Therefore, the rejection over Application No. 19/012,355 is maintained.
Election/Restrictions
Applicant’s election, without traverse, of Group I in the reply filed on 07/31/2025 is acknowledged.
It should be noted that claims directed to methods had been cancelled.
Regarding species election, Applicant’s election of compound I-8 in the reply filed on 07/31/2025 is acknowledged.
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The elected species falls under the general formula I-b-1 and I-f-1 because the linker between ring P and ring Q/T is -C(O)NH-.
Claims and 35, 36-39 and 42 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. Election was made without traverse in the reply filed on 07/31/2025.
Examination will begin with the elected species. In accordance with the MPEP 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. 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 reexamined. 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 reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
As per MPEP 803.02, the Examiner will attempt to determine whether the entire scope of the claims is patentable. Applicants' elected species, as shown above, does make a contribution over the prior art. Therefore, according to MPEP 803.02: should the elected species appear allowable; the search of the Markush-type claim will be extended. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The Examiner need not extend the search beyond a proper Markush grouping.
Specification
The disclosure is objected to because of the following informalities:
Tables 9 (page 350),
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10 (page 351)
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and 11 (page 400)
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are empty. It seems that the results are missing in the file wrapper.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1, 14, 20, 34 is/are rejected under 35 U.S.C. 103 as being unpatentable over CREW WO2019099926 (published also as US 2019/0151295 A1/U.S. Patent No. US11065231B2, made of record on the IDS).
This rejection applies to expanded species.
CREW teaches and claims bifunctional compounds targeting IRAK-4 comprising E3 ubiquitin ligase binding moiety (see claim 1):
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For example, CREW discloses compound 58 (see page 573):
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Regarding instant claim 20, please note that L in compound 58, disclosed by CREW, is straight C6 hydrocarbon chain wherein 2 methylene units are replaced by -O-.
Regarding instant claim 34, note that compound 58, disclosed in WO2019099926, bear -OR group connected to the bifunctional ring corresponding to instant Q/T.
Compound 58, disclosed by CREW, differs from compounds of instant formula I-b-1 and I-f-1
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in that the X variable is connected to ring Q/T (fused rings) whereas the instant formulas require the linker to be connected to ring P (a monocyclic ring).
Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine E3 ubiquitin ligase binding moiety and IRAK targeting moiety to form alternative bifunctional compound for the same purpose.
Since the only difference between instant compounds of formula I-f-1 and compound 58, disclosed by CREW, is in the attachment point of the X variable, and the two essential parts (E3 ubiquitin ligase binding moiety and IRAK targeting moiety) are still present, a person of ordinary skill would expect retention of activity after the inversion of connection. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose.
In addition, MPEP states that “It should be noted that the lead compound cases do not stand for the proposition that identification of a single lead compound is necessary in every obviousness rejection of a chemical compound. For example, one might envision a suggestion in the prior art to formulate a compound having certain structurally defined moieties, or moieties with certain properties. If a person of ordinary skill would have known how to synthesize such a compound, and the structural and/or functional result could reasonably have been predicted, then a prima facie case of obviousness of the claimed chemical compound might exist even without identification of a particular lead compound. As a second example, it could be possible to view a claimed compound as consisting of two known compounds attached via a chemical linker. The claimed compound might properly be found to have been obvious if there would have been a reason to link the two, if one of ordinary skill would have known how to do so, and if the resulting compound would have been the predictable result of the linkage procedure. Thus, Office personnel should recognize that in certain situations, it may be proper to reject a claimed chemical compound as obvious even without identifying a single lead compound.” (MPEP 2143 I, Example 10, last paragraph).
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, 14, 20-22 and 33-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1-7 and 18-20 of copending Application No. 17/797,311 in view of CREW (WO2019099926).
The claims of copending Application No. 17/797311 recite:
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Further, claim 6 of copending Application No. 17/797,311 recites compound I-6 comprising IRAK inhibitor which is an isomer of the IRAK inhibitor present in instant compound I-8 (elected species):
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Furthermore, the claims of copending Application No. 17/797,311 recite compounds bearing the same linker moiety as present in the instant elected species (see claim 6):
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The claims of 17/797,311 fail to recite compounds of formula I-b-1 and instead recite isomers of I-b-1. The compounds recited in 17/79,7311 differ in attachment points between ring P and rings Q/T (-C(O)NH-). Compounds of instant formula I-b-1 necessary bear C(O)NR moiety connected to ring P through a carbon atom whereas compounds of the reference application bear C(O)NR connected through a nitrogen atom.
However, CREW discloses IRAK inhibitors bearing C(O)NR moiety connected to a monocycle ring (corresponding to instant P) through a carbon atom.
For example, CREW discloses compound 58 (see page 573):
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Please also note that compound 58 of CREW comprises the same E3 ubiquitin ligase binding moiety as present in the instant compound I-8 (the elected species).
Applying KSR prong (A) and/or (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine E3 ubiquitin ligase binding moiety and IRAK targeting moiety to form alternative bifunctional compounds for the same purpose. A person of ordinary skill would expect retention of activity because MPEP 2144.09 states: “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)”. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose.
Regarding instant claim 21, the claims of Application No. 17/797,311 recite elements present in compounds recited in instant claim 21. “It should be noted that the lead compound cases do not stand for the proposition that identification of a single lead compound is necessary in every obviousness rejection of a chemical compound. For example, one might envision a suggestion in the prior art to formulate a compound having certain structurally defined moieties, or moieties with certain properties. If a person of ordinary skill would have known how to synthesize such a compound, and the structural and/or functional result could reasonably have been predicted, then a prima facie case of obviousness of the claimed chemical compound might exist even without identification of a particular lead compound. As a second example, it could be possible to view a claimed compound as consisting of two known compounds attached via a chemical linker. The claimed compound might properly be found to have been obvious if there would have been a reason to link the two, if one of ordinary skill would have known how to do so, and if the resulting compound would have been the predictable result of the linkage procedure. Thus, Office personnel should recognize that in certain situations, it may be proper to reject a claimed chemical compound as obvious even without identifying a single lead compound.” (MPEP 2143 I, Example 10, last paragraph)
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 14, 20, 22, 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23-36 of copending Application No. 17/597,165.
The claims of copending Application No. 17/597,165 recite:
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The claims of copending Application No. 17/597,165 recite, for example (see claim 17):
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The compounds of copending Application No. 17/597,165 differ from compounds of instant formula I-b-1 and I-f-1
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in that the X variable is connected to ring Q/T (fused rings) whereas the instant formulas require the liker to be connected to ring P (a monocycle ring).
Applying KSR prong (A) - Combining prior art elements according to known methods to yield predictable results, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine E3 ubiquitin ligase binding moiety and IRAK targeting moiety to form alternative bifunctional compounds for the same purpose.
The only the difference between instant compounds of formula I-f-1 and compounds of copending Application No. 17597165, is in the attachment point of X variable.
A person of ordinary skill would expect retention of activity after the inversion of connection because the two essential parts (E3 ubiquitin ligase binding moiety and IRAK targeting moiety) are still present. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1, 14, 20, 22 and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-37 of copending Application No. 18/912,154.
The claims of copending Application No. 18/912,154 recite:
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For example, the claims of copending Application No. 18/912,154 recite compound I-12 (see claims 37):
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The compounds of copending Application No. 18/912,154 differ from compounds of instant formula I-b-1 and I-f-1.
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in that the X variable is connected to the ring Q/T (a fused ring) whereas the instant formulas require the liker to be connected to ring P (a monocyclic ring).
Applying KSR prong (A) and/or (B), it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine E3 ubiquitin ligase binding moiety and IRAK targeting moiety to form alternative bifunctional compounds for the same purpose. Since the only difference between instant compounds of formula I-f-1 and compounds disclosed in copending Application No. 18912154 is in the attachment point of the X variable, a person of ordinary skill would expect retention of activity after the inversion of connection because the two essential parts (E3 ubiquitin ligase binding moiety and IRAK targeting moiety) are still present. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim 1, 14, 20-22, 33 and 34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 31-50 of copending Application No. 19/012,355 in view of CREW (WO2019099926).
The claims of copending Application No. 19012355 recite isomers of instant formula I-b-1:
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Further, regarding the instant elected species, the claims of copending Application No. 19/012,355 recite (see claim 46):
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Compound I-360 is an isomer of the elected species (instnat compound I-8):
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MPEP 2144.09 states: “Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril.)”. The skilled artisan would have been motivated to prepare alternative bifunctional compounds for the same purpose.
In addition, CREW discloses IRAK inhibitors bearing C(O)NR moiety connected to a monocyclic ring through a carbon atom.
For example, CREW discloses compound 58 (see page 573):
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Applying KSR prong (A) and/or (B) - it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to combine E3 ubiquitin ligase binding moiety and alternative IRAK targeting moiety to form bifunctional compound for the same purpose.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims allowed.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/I.S./ Examiner, Art Unit 1621
/CLINTON A BROOKS/ Supervisory Patent Examiner, Art Unit 1621