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/Restrictions and Status of the Claims
Applicant’s election without traverse of Group I, comprising claims 1-2, 8, 65, and 67, as well as ‘palbociclib’ as the single CDK 4/6 inhibitor in the response filed on March 9th 2026 is acknowledged. Claims 1-2, 8, 33-34, 40, 57-59, 64-65, 67-74, 76, and 94 are pending. Claims 33-34, 40, 57-59, 64, 68-74, 76, and 94 are withdrawn from further consideration as being directed towards nonelected inventions. Claims 1-2, 8, 65, and 67 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The Information Disclosure Statements filed on March 9th 2026, August 28th 2025, June 4th 2025, September 23rd 2024, July 2nd 2024, October 18th 2023, and August 1st 2023 are in compliance with the provisions of 37 CFR 1.97 and have been considered in full. A signed copy of references cited from the IDS is included with this Office Action.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (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 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)(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.
Claims 1, 2, and 65 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Ruscetti (US 2021/0205319 A1 effectively filed on July 6th 2018).
Claim 1 is directed towards a method of treating cancer via administration of a combination of a CDK 4/6 inhibitor and a dual RAF/MEK inhibitor. One such inhibitor is
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a compound known in the art as avutometinib or RO5126766.
Ruscetti teaches the treatment of pancreatic cancer via administration of a combination of a CDK 4/6 inhibitor and an MEK inhibitor (Ruscetti, pg. 25, claim 1), wherein the MEK inhibitor is RO5126766 (Ruscetti, pg. 25, claim 1). Ruscetti thereby anticipates claim 1.
Claim 2 limits the CDK 4/6 inhibitor of claim 1 to be selected from a group that contains palbociclib, ribociclib, and abemaciclib. Ruscetti teaches that the CDK 4-6 inhibitor is palbociclib, ribociclib, or abemaciclib, anticipating claim 2.
Claim 65 requires that the MEK inhibitor of claim 1 is
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As Ruscetti teaches the treatment of pancreatic cancer via administration of a combination of a CDK 4/6 inhibitor and an MEK inhibitor (Ruscetti, pg. 25, claim 1), wherein the MEK inhibitor is RO5126766 (Ruscetti, pg. 25, claim 1), Ruscetti anticipates claim 65.
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.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Ruscetti in view of Nair (Nair et al., A simple practice guide for dose conversion between animals and human. J Basic Clin Pharm. 2016 Mar;7(2):27-31)
Claim 8 requires that the dose of the CDK 4/6 inhibitor administered in the method of claim 1 is 1-1000 mg. For the teachings of Ruscetti as they are relevant to claim 1, see the above 102 rejection for claim 1. Regarding the dosage, Ruscetti teaches administration of palbociclib to mice at a dose of 100 mg/kg (Ruscetti, paragraph [0262]). Using a standard conversion of effective mouse dosage to effective human dosage (Nair, pg. 29):
100
m
g
k
g
×
1
12.3
=
8.13
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k
g
h
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a
n
d
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s
a
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e
and standardizing to a 60 kg human (Nair, pg. 29):
8.13
m
g
k
g
×
60
k
g
=
487.8
m
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h
u
m
a
n
d
o
s
e
As this is in the range of 1-1000 mg, one of ordinary skill in the art would have a reasonable expectation of success in administering the dosage described by the claim, and claim 8 is prima facie obvious.
Claim 67 is rejected under 35 U.S.C. 103 as being unpatentable over Ruscetti in view of Berge (WO 2019/096397 A1 published on May 23rd 2019). Claim 67 requires that, in the method of claim 65, the compound is a potassium salt of the compound,
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For the teachings of Ruscetti as they are relevant to claim 65, see the above 102 rejection over claim 65. Regarding the potassium salt of the compound, while Ruscetti does not explicitly teach the potassium salt of the compound, one of ordinary skill in the art would have a reasonable expectation of success in using the potassium salt in Ruscetti’s treatment, because the potassium salt is already known in the art to be used for the treatment of cancers. See Banerji (Banerji, pg. 31, claim 2). One of ordinary skill in the art would thereby have a reasonable expectation of success in treating a cancer with the combination of a CDK 4/6 inhibitor and the potassium salt of RO5126766 and claim 67 is prima facie obvious.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Anthony Seitz whose telephone number is (703)756-4657. The examiner can normally be reached 7:30 AM ET - 5:00 PM ET M-F.
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/A.J.S./Examiner, Art Unit 1629
/JEFFREY S LUNDGREN/Supervisory Patent Examiner, Art Unit 1629
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