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
Claims 1, 3-8, 30-31, and 33-42 are currently pending.
Election/Restriction
Applicant’s election without traverse of Group I (Claims 1, 3-8, 30-31, 33-37, and 39-41, drawn to methods of treating cancers with compounds of Formula I) and the elected species, Compound 1
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, and renal cancer in the reply filed on 5/19/2026 is acknowledged.
Claims 38 and 42 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected Group II or unelected species, there being no allowable generic or linking claim. Thus, Claims 1, 3-8, 30-31, 33-37, and 39-41 are being examined on the merits herein.
The requirement is deemed proper and is therefore made final.
Specification
The specification (second filed on 2/12/2024) is objected to because the sequences listed in at least Paras 329, 331, 343, 346, 358, 364, 367, 376, 380, 386, 389, 393, and 397 must be accompanied by sequence ID numbers. All such sequences throughout the specification require said numbers.
Specific deficiency – Nucleotide and/or amino acid sequences appearing in the specification are not identified by sequence identifiers in accordance with 37 CFR 1.821(d).
Required response – Applicant must provide:
A substitute specification in compliance with 37 CFR 1.52, 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
A copy of the amended specification without markings (clean version); and
A statement that the substitute specification contains no new matter.
Appropriate correction is required.
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.
Claims 1, 3-8, 30-31, 33-37, and 39-40 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Janji (WO2020/008046, 4/15/2025 IDS).
Janji teaches the elected species SB02024 (4-[(3R)-3-methylmorpholin-4-yl]-6-[(2R)-2-(trifluoromethyl)-1-piperidyl]-1 H-pyridin-2-one,
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) as one of eight preferred VPS34 inhibitors for treating a “RENCA Clear Cell Carcinoma model”, a kidney cancer model, as well as melanoma (B16-F10) cells (Page 86, Claims 61-62; Fig. 1A and 33; Page 24, Line 19-21; Pages 39-40, and 48). Co-administration with MK-1454, a STING agonist, is envisaged in Claims 73-74 (Pages 87-88). CCL5 and CXCL10 protein and RNA levels are increased (Fig. 8A-10B and 12A-B):
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. Co-therapy with the elected compound and anti-PD1 antibodies in vivo is specifically taught in Fig. 16A (described Page 21, Lines 30+).
Regarding the following limitation of Claim 1: “wherein administering the therapeutically effective amount of the STING agonist and the compound results in an increased expression level of at least one chemokine in the patient as compared to any increase in the expression level of the at least one chemokine resulting from administering the compound alone to the patient”, Claims 73-74 require the administration of a therapeutic amount of a STING agonist, MK-1454, alongside the VPS34 inhibitor. Applicant does not preclude particular STING species or amounts thereof from achieving the effect in the specification, nor does the language of the claim impose such restrictions. In fact, applicant in Para 8 of the specification recites “a STING agonist in an amount sufficient to increase the expression level of the at least one chemokine in the cell”, which is not a limitation integrated into the clause or an amount specifically required by Claim 1. It is only required that the STING agonist be administered at an effective amount with a compound of Formula I, which is satisfied by the art teaching the administration of both as explained above. Further, the instant specification at Fig. 11A-12C (Para 29-30), at least, demonstrate that such an increase in chemokines results from the coadministration of the elected compound (Compound 1) with a STING agonist. Lastly, a claim is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. Because both components are administered in therapeutic amounts in Janji as required by the active claim step of the examined method of Claim 1, the limitation describing the intended result of said step is satisfied.
Claim Rejections - 35 USC § 103
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.
Claims 1, 3-8, 30-31, 33-37, and 39-41 are rejected under 35 U.S.C. 103 as being unpatentable over Janji (WO2020/008046, 4/15/2025 IDS).
Janji teaches the elected species SB02024 (4-[(3R)-3-methylmorpholin-4-yl]-6-[(2R)-2-(trifluoromethyl)-1-piperidyl]-1 H-pyridin-2-one,
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) as one of eight preferred VPS34 inhibitors for treating a “RENCA Clear Cell Carcinoma model”, kidney cancer model, as well as melanoma (B16-F10) cells (Page 86, Claims 61-62; Fig. 1A and 33; Page 24, Line 19-21; Pages 39-40, and 48). Co-administration with MK-1454, a STING agonist, is taught in Claims 73-74 (Pages 87-88). CCL5 and CXCL10 protein and RNA levels are increased (Fig. 8A-10B and 12A-B):
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. Co-therapy with the elected compound and anti-PD1 antibodies in vivo is specifically taught in Fig. 16A (described Page 21, Lines 30+).
Janji does not explicitly teach a co-therapy with ADU-S100 as required in examined Claim 41.
Janji does teach ADU-S100 as a STING agonist alongside the envisaged MK-1454 on Page 38 among other immunotherapeutic agents (Line 31). One of skill in the art seeking to practice the method taught by Janji to treat the identified and embodied cancers according to the methods of Janji Claims 73-74 would find it obvious, before the effective filing date of the instant claims, to select ADU-S100 as the STING agonist or substitute ADU-S100 for MK-1454 because Janji teaches ADU-S100 as an acceptable agonist and that STING agonists broadly may be used in cotherapy. The same person would expect success in the treatment of the cancers as claimed because Janji teaches the use of STING agonists broadly for combination treatment with VPS34 inhibitors.
Regarding the following limitation of Claim 1: “wherein administering the therapeutically effective amount of the STING agonist and the compound results in an increased expression level of at least one chemokine in the patient as compared to any increase in the expression level of the at least one chemokine resulting from administering the compound alone to the patient”, Claims 73-74 require the administration of a therapeutic amount of a STING agonist, MK-1454, alongside the VPS34 inhibitor. Applicant does not preclude particular STING species or amounts thereof from achieving the effect in the specification, nor does the language of the claim impose such restrictions. In fact, applicant in Para 8 of the specification recites “a STING agonist in an amount sufficient to increase the expression level of the at least one chemokine in the cell”, which is not a limitation integrated into the clause or an amount specifically required by Claim 1. It is only required that the STING agonist be administered at an effective amount with a compound of Formula I, which is satisfied by the art teaching the administration of both as explained above. Further, Fig. 11A-12C (Para 30-31), at least, demonstrate that such an increase in chemokines results from the coadministration of the elected compound (Compound 1) with a STING agonist. Lastly, a claim is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. Because both components are administered in therapeutic amounts in Janji and it would be obvious to select ADU-S100 as the STING agonist as required by the active claim step of the examined method, the limitation describing the intended result of said step is satisfied. Again, applicant does not teach that such an effect is limited to any particular STING agonist or amount and is not expected to result from ADU-S100, which is an acceptable agonist. Therefore, such an effect is expected to result from the co-therapy with ADU-S100.
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.
NONPROVISIONAL:
Claims 1, 3-8, 30-31, 33-37, and 39-41 are rejected on the grounds of nonstatutory double patenting as being unpatentable over Claims 1-31 and 35-36 of U.S. Patent No. 11179399 (hereinafter referred to as Andersson) in view of Janji (WO2020/008046, 4/15/2025 IDS).
Although the claims at issue are not identical, they are not patentably distinct from each other because both applications are directed to compounds of overlapping Formulae I, encompassing the same compound as the elected species: 4-[(3R)-3-methylmorpholin-4-yl]-6-[2-(trifluoromethyl)-1-piperidyl]-1H-pyridin-2-one,
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(Claim 29 of Andersson; Structure given in Col 55, Example 25), for use in methods of treating cancer comprising co-administering anti-cancer therapeutics. The particular (2R) stereoisomer is not claimed. However, compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) 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 MPEP 2144.09. The copending compound differs only in this respect with regard to the elected species and thus “there is a presumed expectation that such compounds [the Anderson compound and the elected stereoisomer] possess similar properties”. Examined Formula I makes no such stereoisomer requirement:
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, and the species of Anderson reads clearly on said Formula I without modification or stereoisomer selection.
Regarding the claims directed to compositions of matter, In AbbVie Inc. v. Kennedy Institute of Rheumatology Trust, 764 F.3d 1366, 112 USPQ2d 1001 (Fed. Cir. 2014), the court explained that it is also proper to look at the disclosed utility in the reference disclosure to determine the overall question of obviousness in a nonstatutory double patenting context. See Sun Pharm. Indus., Ltd. v. Eli Lilly & Co., 611 F.3d 1381, 95 USPQ2d 1797 (Fed. Cir. 2010). See MPEP 804 (II) (B) (1). Claims 30-31 teach the compounds are useful for methods for the treatment of cancer including melanoma.
Regarding the acceptable A groups of Claim 21, the following Anderssen group differs from that of the elected species in that X is a bond rather than a methylene
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, which is also permitted by instant Formula I of Claim 1. Compounds which are 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 MPEP 2144.09. Anderssen teaches both groups (
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in Claim 24) as acceptable for forming VPS34 inhibitors. Therefore, one of skill in the art would expect a VPS34 inhibitor to result successfully from the routine modification of adding a successive methylene group because Anderssen teaches the modified moiety as functional for the same purpose.
Anderssen does not explicitly teach renal cancer types, co-therapeutics, or chemokine elevation.
However, Janji teaches the elected species SB02024 (4-[(3R)-3-methylmorpholin-4-yl]-6-[(2R)-2-(trifluoromethyl)-1-piperidyl]-1 H-pyridin-2-one,
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) for treating a “RENCA (renal/kidney) Clear Cell Carcinoma model” as well as melanoma (B16-F10) cells (Fig. 1A and 33; Page 24, Line 19-21; Pages 39-40, and 48). Co-administration with MK-1454, a STING agonist, is taught in Claims 73-74 (Pages 87-88). CCL5 and CXCL10 protein and RNA levels are increased (Fig. 8A-10B and 12A-B):
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. Co-therapy with the elected compound and anti-PD1 antibodies in vivo is specifically taught in Fig. 16A (described Page 21, Lines 30+). Janji does teach ADU-S100 as a STING agonist alongside the envisaged MK-1454 on Page 38 (Line 31).
Therefore, one of skill in the art seeking to practice the method taught by Anderssen to treat the identified and embodied cancers would find it obvious, before the effective filing date of the instant claims, to specify and/or modify the methods claimed in Anderssen according to Janji to more precisely treat the cancers described in the examined claims because Janji teaches the same or similar compounds which are effective for the same use in the same diseases. One would expect success in selecting the particular co-therapeutics and cancers because Janji provides ample experimentation with the elected compound, the particular isomer of the Anderson compound, to demonstrate its efficacy in methods of treating cancer and elevating the claimed chemokines.
Regarding the following limitation of Claim 1: “wherein administering the therapeutically effective amount of the STING agonist and the compound results in an increased expression level of at least one chemokine in the patient as compared to any increase in the expression level of the at least one chemokine resulting from administering the compound alone to the patient”, Claims 73-74 require the administration of a therapeutic amount of a STING agonist, MK-1454, alongside the VPS34 inhibitor. Applicant does not preclude particular STING species or amounts thereof from achieving the effect in the specification, nor does the language of the claim impose such restrictions. In fact, applicant in Para 8 of the specification recites “a STING agonist in an amount sufficient to increase the expression level of the at least one chemokine in the cell”, which is not a limitation integrated into the clause or an amount specifically required by Claim 1. It is only required that the STING agonist be administered at an effective amount with a compound of Formula I, which is satisfied by the art teaching the administration of both as explained above. Further, Fig. 11A-12C (Para 30-31), at least, demonstrate that such an increase in chemokines results from the coadministration of the elected compound (Compound 1) with a STING agonist. Lastly, a claim is not limited by claim language that suggests or makes optional but does not require steps to be performed, or by claim language that does not limit a claim to a particular structure. However, examples of claim language, although not exhaustive, that may raise a question as to the limiting effect of the language in a claim are:
(A) "adapted to" or "adapted for" clauses;
(B) "wherein" clauses; and
(C) "whereby" clauses.
The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 285 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a "wherein" clause limited a process claim where the clause gave "meaning and purpose to the manipulative steps"). In In re Giannelli, 739 F.3d 1375, 1378, 109 USPQ2d 1333, 1336 (Fed. Cir. 2014), the court found that an "adapted to" clause limited a machine claim where "the written description makes clear that 'adapted to,' as used in the [patent] application, has a narrower meaning, viz., that the claimed machine is designed or constructed to be used as a rowing machine whereby a pulling force is exerted on the handles." In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a "‘whereby’ clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention." Id. However, the court noted that a "‘whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited.’" Id. (quoting Minton v. Nat’l Ass’n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)). See MPEP 2111.04. Because both components are administered in therapeutic amounts in Janji as required by the active claim step of the examined method, the limitation describing the intended result of said step is satisfied. Again, applicant does not teach that such an effect is limited to any particular STING agonist or amount and is not expected to result from ADU-S100, which is an acceptable agonist. Therefore, such an effect is expected to result from the co-therapy with ADU-S100.
Since both claim sets teach the same compounds for administration to treat cancer in a patient, the examiner maintains that the aforementioned claims of the instant application are substantially overlapping in scope as discussed hereinabove and are prima facie obvious over the cited claims of Andersson.
Conclusion
No claim is allowable.
Inquiries
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Richard G. Peckham whose telephone number is (703)756-4621. The examiner can normally be reached 8:30am - 4:30pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached on (571) 270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RICHARD GRANT PECKHAM/Examiner, Art Unit 1627
Prosecution Insights