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 of Species and Status of the Claims
Applicant’s election without traverse of Compound 1 as the single MetAP2 inhibitor and palbociclib as the single CDK 4/6 inhibitor in the response filed on April 16th 2026 is acknowledged. Claims 2, 5-7, 20-23, and 26-29 are pending. Claims 22-23 have been withdrawn from further consideration as being directed towards nonelected species until a generic claim has been found allowable. Claims 2, 5-7, 20-21, and 26-29 are examined on their merits.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
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.
Claims 2, 5-7, 20-21, and 26-29 are rejected under 35 U.S.C. 103 as being unpatentable over Cornelius (US 2017/0196830 A1 published on July 13th 2017).
Claim 2 is directed towards the treatment of a cancer comprising administration of a MetAP2 inhibitor of the structure:
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and a CDK 4/6 inhibitor.
Cornelius teaches administration of HR+/HER2- breast cancer (Cornelius, claim 37), via administration of an identical MetAP2 inhibitor (Cornelius, claims 3, 1), as well as the administration of a second active agent (Cornelius, claim 50).
Cornelius does not explicitly embody the combination therapy comprising the MetAP2 inhibitor and a CDK 4/6 inhibitor. However, one of ordinary skill in the art would have had a reasonable expectation of success in treating the described breast cancer with such a combination, because Cornelius suggests such CDK 4/6 inhibitors as a combination therapy:
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One such CDK 4/6 inhibitor taught by Cornelius is PD 332991 (see above), which is commonly known as palbociclib.
One of ordinary skill in the art would thereby have a reasonable expectation of success in treating HR+/HER2- breast cancer with the combination of Compound 1 and palbociclib, and claim 2 is thereby prima facie obvious.
Claim 5 is directed towards the method of claim 2 wherein the two drugs are administered within temporal proximity to each other. As defined in the specification, this is interpreted as the two drugs being administered within a time period wherein their effects overlap. As Cornelius teaches a combination therapy (Cornelius, claim 50), claim 5 is prima facie obvious.
Claim 6 is directed towards a pharmaceutical composition comprising the two drugs above. As the described administration would necessarily be in the form of a pharmaceutical composition, claim 6 is prima facie obvious.
Claim 7 is directed towards a kit comprising the two drugs above. See MPEP 2112.01:
“Where the only difference between a prior art product and a claimed product is printed matter that is not functionally related to the product, the content of the printed matter will not distinguish the claimed product from the prior art. In re Ngai, 367 F.3d 1336, 1339, 70 USPQ2d 1862, 1864 (Fed. Cir. 2004) (Claim at issue was a kit requiring instructions and a buffer agent. The Federal Circuit held that the claim was anticipated by a prior art reference that taught a kit that included instructions and a buffer agent, even though the content of the instructions differed, explaining "[i]f we were to adopt [applicant’s] position, anyone could continue patenting a product indefinitely provided that they add a new instruction sheet to the product."). See also In re Gulack, 703 F.2d 1381, 1385-86, 217 USPQ 401, 404 (Fed. Cir. 1983) ( "Where the printed matter is not functionally related to the substrate, the printed matter will not distinguish the invention from the prior art in terms of patentability….[T]he critical question is whether there exists any new and unobvious functional relationship between the printed matter and the substrate." ); In re Miller, 418 F.2d 1392, 1396 (CCPA 1969) (finding a new and nonobvious relationship between a measuring cup and writing showing how to "half" a recipe); In re Seid, 161 F.2d 229, 73 USPQ 431 (CCPA 1947) (matters relating to ornamentation only which have no mechanical function cannot be relied upon to patentably distinguish the claimed invention from the prior art); In re Xiao, 462 Fed. App'x 947, 950-51 (Fed. Cir. 2011) (non-precedential) (affirming an obviousness rejection of claims directed to a tumbler lock that used letters instead of numbers and had a wild-card label instead of one of the letters); In re Bryan, 323 Fed. App'x 898, 901 (Fed. Cir. 2009) (non-precedential) (printed matter on game cards bears no new and nonobvious functional relationship to game board). “
As such a kit is obvious, claim 7 is prima facie obvious.
Claims 20-21 limit the CDK 4/6 inhibitor of claim 2 to palbociclib, and are prima facie obvious for the same reasons as claim 2.
Claims 26-28 limit the cancer of claim 2 to HR+/HER2- breast cancer and are prima facie obvious for the same reasons as claim 2.
Claim 29 requires that, in the method of claim 2, the MetAP2 inhibitor is administered in an amount of about 27, 36, or 49 mg/m2. Cornelius teaches identical dosages of the MetAP2 inhibitor (Cornelius, pg. 75), and claim 29 is thereby 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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