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 .
Application Status
The preliminary amendment filed on 1/19/2024 is acknowledged. Claims 1-15 and 17-18 are currently pending and under consideration.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement filed on 1/19/2024 is acknowledged and has been considered.
Specification
The use of the term Biotage®, which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Claim Objections
Claims 1 and 17 are objected to because of the following informalities: Regarding claim 1, there should be a comma inserted between colon cancer and melanoma. Regarding claim 17, “is” should be inserted between tumor and selected Appropriate correction is required.
Claim 7 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 6. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Note: Claim 6 recites the structure, chemical name and compound “name”, while claim 7 recites the chemical name and compound “name”.
Claim 15 is objected to under 37 CFR 1.75 as being a substantial duplicate of claim 14. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Note: Claim 14 recites the structure, chemical name and compound “name”, while claim 15 recites the chemical name and compound “name”.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 3-4 and 11 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 3-4 and 11, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 1-2, 4-10, 13-15 and 17-18 is/are rejected under 35 U.S.C. 103 as being unpatentable over International Society for Drug Development S.R.L (WO2016055454, 2016-04-14, IDS) referred to herein as International in view of Sinnberg et al. (Journal of Investigative Dermatology 2009; 129: 1500-1515).
International teaches a combination comprising at least one 2-oxo-indole derivatives of formula (I):
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and at least one antitumor drug, wherein the combination is used in the treatment of tumors such as glioblastoma multiforme, breast tumor and pancreatic tumor(Abstract). Specifically, International teaches that the combination comprising one or more molecules that are able to interfere with the effectors involved in the PI3K-Akt-mTOR pathway in order to improve the activity of the antitumor agent, wherein said combination advantageously had a synergistic effect with respect to the activity of the single elements constituting the combination, overcoming the effectiveness limits of the mono-therapy treatment (page 4, lines 16-22). With regards to the 2-oxo-indole derivatives, International teaches derivatives including, but not limited to,
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referred to as cmpd 9 and
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referred to as cmpd 10 which read on the instantly claimed compound of formula I, wherein R1 or R2 is a thienyl or a 1H-imidazol-2-yl (page 13). Moreover, International teaches an in vitro experiments testing compound 9 alone or in combination with temozolomide (TMZ) in glioblastoma multiforme cells, wherein compound 9 alone inhibits cell viability and induced significant increase in inhibition of cell viability when combined with temozolomide (page 14, Example 2).
International does not specifically teach that the tumor is melanoma. Moreover, International does not specifically teach that the imidazolyl is 1H-imidazol-2yl having the structure
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.
Sinnberg et al. teach that in melanoma, the PI3K-AKT-mTOR (AKT) and RAF-MEK-ERK (MAPK) signaling pathways are constitutively activated and appear to play a role in chemoresistance (Abstract). Specifically, Sinnberg et al. teach that cotreatment of melanoma cells with AKT pathway inhibitors and chemotherapeutics (cisplatin and Temozolomide) led to 2- to 3-fold increase of apoptosis and completely suppressed invasive tumor growth in organotypic cultures (abstract).
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the method taught by International so as to include melanoma cancer in view of the teachings of Sinnberg et al.. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
- International teaches that the combination comprising one or more molecules are able to interfere with the effectors involved in the PI3K-Akt-mTOR pathway in order to improve the activity of the antitumor agent, wherein said combination advantageously had a synergistic effect with respect to the activity of the single elements constituting the combination, overcoming the effectiveness limits of the mono-therapy treatment; and
- Sinnberg et al. teach that cotreatment of melanoma cells with AKT pathway inhibitors and chemotherapeutics (cisplatin and Temozolomide) led to 2- to 3-fold increase of apoptosis and completely suppressed invasive tumor growth in organotypic cultures.
Moreover, it would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify compound 9 which is a 1H-imazol-5-yl as taught by International for a structurally similar IH-imidazol-2-yl for treatment of cancer. One of ordinary skill in the art would have been motivated to make such a modification, with a reasonable expectation of success, because:
"An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979).
Conclusion
Therefore, No claim is allowed. Claims 1-11, 13-15 and 17-18 are rejected.
Claim 12 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Claims 3 and 11-12 appear to be free of the prior art. The closest prior art is considered to be International Society for Drug Development S.R.L (WO2016055454, 2016-04-14, IDS) as cited above. The prior art differs from the compounds of claims 3 and 11 in that R1 or R2 is a 1H-pyrazolyl vs. the thienyl or 1H-imidazolyl. Claim 12 of the instant invention differs in that when R1 or R2 is thienyl, R3 is not a methyl. However, there is no suggestion or motivation to make the required substitutions of the prior art to arrive at the claimed inventions.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey S Lundgren can be reached at 571-272-5541. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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BRANDON J. FETTEROLF, PHD
Primary Patent Examiner
Art Unit 1626
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626