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
Priority and Status of Claims
1. This application is a 371 of PCT/US22/17777 02/24/2022, which claims benefit of the provisional application: 63/153,645 02/25/2021.
2. Claims 1-20 are pending in the application.
3. 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 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 § 103
4. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1-6 and 10-15 are rejected under 35 U.S.C. 103(a) as being obvious
over Bal et al. CAS: 153: 221765, 2010; Eickhoff et al. US 2015/0018329; Mendlein et
WO 2018/195338; Rutledge et al. CAS: 161: 136817, 2014; ad Epstein et al. CAS:171: 122208, 2019.
Applicants claim a method for treating cerebrovascular or cardiovascular disease
in a subject in need thereof, the method comprising administering a compound
selected from the group consisting of: Ro 31-8220 mesylate; Alvocidib; AZD8055;
Saracatinib; and PF-562271 HCl, see claim 1. Dependent claims 2-6 further limit the
scope of methods, i.e., the compound is Saracatinib in claim 2, the compound is
Ro 31-8220 mesylate in claim 3, the compound is Alvocidib in claim 4, the compound
is AZD8055 in claim 5, and the compound is PF-562271 HCl in claim 6.
Applicants claim a method for reducing inflammation associated with
cardiovascular disease in a subject in need thereof, the method comprising
administering a compound selected from the group consisting of: Ro 31-8220 mesylate;
Alvocidib; AZD8055; Saracatinib; and PF-562271 HCl, see claim 10. Dependent
claims 11-15 further limit the scope of methods, i.e., the compound is Saracatinib in
claim 11, the compound is Ro 31-8220 mesylate in claim 12, the compound is
Alvocidib in claim 13, the compound is AZD8055 in claim 14, and the compound is PF-
562271 HCl in claim 15.
Determination of the scope and content of the prior art (MPEP §2141
Rutledge et al. ‘817 disclose a compound saracatinib (i.e., RN: 379231-04-6) for
treating arrhythmia or myocardial infarction (i.e., cardiovascular disease).
Bal et al. ‘765 disclose a compound Ro 31-8220 (i.e., RN: 125314-64-9) for
treating hypertension.
Eickhoff et al. ‘329 discloses a compound Flavopiridol (i.e., Alvocidib) as a CDK7
inhibitor for inhibiting inflammation, see Table 7 in column 177.
Mendlein et al. ‘338 discloses a compound AZD8055 as a mTOR inhibitor for
inhibiting inflammation, see claims 12, 16 on pages 139-140.
Epstein et al. ‘208 discloses a compound PF-562271 HCl (i.e., RN: RN: 939791-
41-0) for treating scarring (i.e., inflammation).
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Rutledge et al. ‘817, Bal et al. ‘765, Eickhoff et al. ‘329, Mendlein et al. ‘338, and Epstein et al. ‘208 is that the instant claims are embraced within the scope of Rutledge et al. ‘817, Bal et al. ‘765, Eickhoff et al. ‘329, Mendlein et al. ‘338, and Epstein et al. ‘208. Rutledge et al. ‘817, Bal et al. ‘765, Eickhoff et al. ‘329, Mendlein et al. ‘338 and Epstein et al. ‘208 methods of use read on independent claims 1 and 10, and dependent claims 2-6 and 11-15.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1-6 and 10-15 prima facie obvious because one would be motivated to employ methods of use of Rutledge et al. ‘817, Bal et al. ‘765, Eickhoff et al. ‘329, Mendlein et al. ‘338, and Epstein et al. ‘208 to obtain instant invention.
The motivation to make the claimed methods of use derived from the known methods of use of Rutledge et al. ‘817, Bal et al. ‘765, Eickhoff et al. ‘329, Mendlein et al. ‘338, and Epstein et al. ‘208 would possess similar activity to that which is claimed in the reference.
Claim Objections
5. Claims 7-9 and 16-20 are objected to as being dependent on rejected claims 1 and 10.
Conclusion
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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
December 30, 2025