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 .
Response to Amendment
The 2026 June 10 amendment containing newly amended claims 1-4, 17, 24, 26, 27, 37, 46, 51, 54 and newly added claims 55-62 are examined on the merits. The 35 U.S.C. 112 rejections are overcome because claim 1 recites enabled subject matter and has clear metes and bounds between variables L1, L2, and a linker of formula X. Support for this amendment is found in the specification (page 36, paragraph [0148] to page 42, paragraph [0173]).
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 1-4, 17, 26, 27, 37, 46, 54-57, 60, and 61 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. The newly amended moieties for ligands L1 and L2 are unclear due to the usage of the word “comprising”. This usage implies that each moiety contains other chemical group is part of each ligand. The claims are unclear to what other chemical groups are present in ligands L1 and L2.
Claim Rejections - 35 USC § 103
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) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102 of this title, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived 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 nonobviousness.
Claim 4 and 55-58 are rejected under 35 U.S.C. 103(a) as being unpatentable over RUSSELL (WO 2024073106, published 2024 April 4, priority to provisional application 63/411550, filed 2022 September 22) and KATOH (Medicinal Research Reviews, 2013, 1-21).
Determining the scope and contents of the prior art
Russell describes compounds I-1 through I-11 (pages 27-30, paragraph [0096]). The table below shows how each compounds meets the limitation of a compound of claim 1.
Compound
L1
L2
X1
X2
I-1
Moiety A
Moiety A
-O-ethylene-O-ethylene-
-O-ethylene-O-ethylene-
I-2
Moiety A
Moiety A
-O-ethylene-
-O-ethylene-
I-3
Moiety A
Moiety A
-O-pentylene-
-O-pentylene-
I-4
Moiety A
Moiety A
Direct bond
Direct bond
I-5
Moiety A
Moiety B
-O-ethylene-
-ethylene-O-ethylene-
I-6
Moiety B
Moiety B
-ethylene-O-ethylene-
-ethylene-O-ethylene-
I-7
Moiety B
Moiety B
Butylene
butylene
I-8
Moiety B
Moiety B
Pentylene
Pentylene
I-9
Moiety A
Moiety A
-O-propylene-
-O-propylene-
I-10
Moiety A
Moiety A
-O-butylene-
-O-butylene-
I-11
Moiety A
Moiety A
-O-hexylene-
-O-hexylene-
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146
184
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Moiety A
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144
174
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Moiety B
Pharmaceutical compositions comprising these compounds are described (page 31, paragraph [0047] to page 37, paragraph [0117]); page 63, claim 37). Biological activity is described (page 43, paragraph [0138] to page 48, paragraph [0144]). Lung adenocarcinoma and gastric cancer are specifically discussed in example 3.
Provisional application 63/411550 provides support for the following: compounds I-1 through I-11 (specification, pages 21-24, paragraph [0069]); pharmaceutical compositions (specification, page 24, paragraph [0070] to page 29, paragraph [0090]); and biological activity (specification page 35, paragraph [01111] to page 39).
Katoh describes that ponatinib treats breast cancer, lung cancer, gastric cancer, endometrial cancer, bladder cancer, and colon cancer (page 10, table II).
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422
616
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Ascertaining the differences between the prior art and the claims at issue
Russell and Katoh do not describe a composition containing both an IAP inhibitor of formula I and ponatinib.
Resolving the level of ordinary skill in the pertinent art
Those of relative skill in the art are those with level of skill of the authors of the references cited to support the examiner’s position (MD’s, PhD’s, or those with advanced degrees and the requisite experience in preparation of compounds of the elected group).
Considering objective evidence present in the application indicating obviousness or nonobviousness
In re Kerkhoven (205 USPQ 1069, 626 F2d 846) teaches:
It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition which is to be used for the very same purpose.
When Kerkhoven is combined with the teachings of Russell and Katoh, there is a reasonable expectation of success that combination therapy of lung or gastric cancer. Since the compounds of both Russell and Katoh both treat lung cancer and gastric cancer, a combination containing both would be expected to have therapeutic success.
A reference is good not only for what it teaches by direct anticipation but also for what one of ordinary skill in the art might reasonably infer from the teachings. (In re Opprecht 12 USPQ 2d 1235, 1236 (Fed Cir. 1989); In re Bode 193 USPQ 12 (CCPA) 1976). In light of the foregoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103(a). From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
The Supreme Court in KSR International Co. v. Teleflex Inc., 550 U.S. 398, 127 S. Ct. 1727, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper “functional approach” to the determination of obviousness as laid down in Graham. The key to supporting any rejection under 35 U.S.C. 103 is the clear articulation of the reason(s) why the claimed invention would have been obvious. The Supreme Court in KSR noted that the analysis supporting a rejection under 35 U.S.C. 103 should be made explicit.
Exemplary rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) “Obvious to try” – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Note that the list of rationales provided is not intended to be an all-inclusive list. Other rationales to support a conclusion of obviousness may be relied upon by Office personnel.
Conclusion
Claims 1-4, 17, 26, 27, 37, 46, 54-58, 60, and 61 are not allowed.
Claims 24, 51, 59, and 62 are 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.
The following is a statement of reasons for the indication of allowable subject matter: SENECI (WO 2013124701, published 2013 August 29, cited previously) describes C19-22, C92-C97, C116-121 (pages 48-49; page 60; and pages 63-64). Each of these compounds is an IAP inhibitor. In these compounds a ligand comprises a bicyclic ring (page 4, formula (I). This reference does not anticipate or render obvious a composition of claim 1 due to no composition with a cellular kinase inhibitor described explicitly or implicitly.
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174
404
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Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NOBLE E JARRELL whose telephone number is (571)272-9077. The examiner can normally be reached 8:00 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Fereydoun Sajjadi can be reached at 571-272-3311. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
