Detailed Action
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 .
Status of the Claims
Claims 1-15 are pending. Claims 8-15 are withdrawn. Claims 1-7 are rejected.
Information Disclosure Statement
The Information Disclosure Statements (IDS’s) submitted on 3/22/2024 and 1/30/2026 were considered by the Examiner.
Priority
This is a 35 U.S.C. 371 National Stage Filing of International Application No.
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17
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, which claims priority under 35 U.S.C. 119(a-d) to
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42
308
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. Receipt is acknowledged of papers submitted under 35 U.S.C. 119(a)-(d).
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-7) and the species of omeprazole and irinotecan in the reply filed on 6/29/2026 is acknowledged.
Claims 1-7 embrace Applicant’s elected species and are therefore under examination. The elected species are not allowable.
Claims 8-15 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
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.
Claim(s) 1-3 and 5-7 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fais et al. (US20080160106-as disclosed on 3/22/2024 IDS).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Fais et al. teach that “PPI drugs appear to be equally effective in treatment of tumours. Particularly preferred are omeprazole….” (see para. [0036]). The PPI may be administered with other drug, wherein the other drug may be irinotecan (see para. [0044]-[0045]). The PPI may be administered continuously (simultaneously) with the other drug or before the other drug (see para. [0044]).
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
The prior art does not teach a single embodiment of a pharmaceutical composition with omeprazole and irinotecan.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claims 1-3 and 5-7, “for the prevention or treatment of cancer” is considered intended use and does not further limit the claims. Additionally, “prevention” embraces all cancer types that a population may acquire and consequently embraces all populations.
Specifically, regarding instant claims 1-3 and 5, it would have been obvious a skilled artisan to arrive at a pharmaceutical composition with a CAC inhibitor (omeprazole) and an anticancer agent (irinotecan) as these were previously demonstrated to be co-administered successfully. A PHOSITA would have been motivated to combine them in a single pharmaceutical composition with a reasonable expectation of success in treatment efficacy. Regarding instant claims 6-7, because “prevention” embraces all populations of subjects and all cancer types, a pharmaceutical composition to “prevent” any type of cancer in any population would have been obvious for the instantly claimed combination of CAC inhibitor and anticancer agent.
Claim(s) 4 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fais et al. (US20080160106) as applied to claims 1-3 and 5-7 above, and further in view of van der Bol et al. (European Journal of Cancer, 47, 2011, 831-838- as disclosed on 3/22/2024 IDS).
Determining the scope and contents of the prior art. (See MPEP § 2141.01)
Fais fails to disclose the ratios of carnitine acylcarnitine carrier inhibitor and the anticancer agent of instant claim 4.
Van der Bol teaches the following in Abstract (methods): “Fourteen patients were treated with single agent irinotecan (600 mg i.v., 90 min) followed 3 weeks later by a second cycle with concurrent use of omeprazole 40 mg once daily, which was started 2 weeks prior to the second cycle”.
Ascertainment of the differences between the prior art and the claims. (See MPEP § 2141.02)
There is not a single embodiment of the exact ratios of instant claim 4 in the prior art.
Finding of prima facie obviousness --- rationale and motivation (See MPEP § 2142-2143)
Regarding instant claim 4, the prior art first cycle constitutes a 560 mg (40 mg x 14 days) omeprazole (carnitine acylcarnitine carrier inhibitor) to 600 mg irinotecan (anticancer agent), which is ~0.93:1 ratio, close to the instant claims. “[A] prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close.” See MPEP 2144.05(I). It would have been obvious to a PHOSITA to arrive at the instantly claims 1:1 ratio as a result of routine experimentation.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MEGHAN C HEASLEY whose telephone number is (571)270-0785. The examiner can normally be reached Monday - Friday 8:30-4:30 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Amy Clark can be reached at 571-272-1310. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MEGHAN C HEASLEY/Examiner, Art Unit 1626
/MATTHEW P COUGHLIN/Primary Examiner, Art Unit 1626
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