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 .
Election/Restrictions
Applicant’s election without traverse of group I and compound I-1 as the IAP inhibitor and ponatinib as a cellular kinase inhibitor in the reply filed on 2024 May 20 is acknowledged. As a courtesy to applicants, the whole scope of claim 1 has been searched. Claims 1-4, 6-8,10-15,17, 19, 24-27, 37, 46, and 51-54 are pending in the examined case. Claims 1-4, 17, 19, 24-27, 37, 46, 51, and 54 are examined on the merits.
Claims 6-8, 10-15, 52, and 53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 2026 May 20.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim(s) 1-4, 19, 24-27, 37, 46, and 54 is/are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph due to lack of written description.
The MPEP states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him.
The MPEP lists factors that can be used to determine if sufficient evidence of possession has been furnished in the disclosure of the Application. These include “level of skill and knowledge in the art, partial structure, physical and/or chemical properties, functional characteristics alone or coupled with a known or disclosed correlation between structure and function, and the method of making the claimed invention. Disclosure of any combination of such identifying characteristics that distinguish the claimed invention from other materials and would lead one of skill in the art to the conclusion that the applicant was in possession of the claimed species is sufficient.” MPEP § 2163. While all of the factors have been considered, a sufficient amount for a prima facie case are discussed below.
In the instant case, claims 1-4, 19, 24-27, 37, 46, and 54 are drawn to a pharmaceutical composition comprising an inhibitor of inhibitor of apoptosis (IAP) of formula I and cellular kinase inhibitor. In a compound of formula I, a linker comprises a squaramide group.
PNG
media_image1.png
60
288
media_image1.png
Greyscale
(1) Level of skill and knowledge in the art:
SENECI (WO 2013124701, published 2013 August 29) 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).
PNG
media_image2.png
174
404
media_image2.png
Greyscale
PNG
media_image3.png
484
608
media_image3.png
Greyscale
DAUB (Biochimica and Biophysica Acta, 2005, 1734, 183-190) describes various kinase inhibitors (page 168, figure 2). These kinase inhibitors each have different structural features with no consensus structure.
PNG
media_image4.png
822
804
media_image4.png
Greyscale
(2) Partial structure:
A partial structure of a compound of formula I comprises a squaramide group and two same or different ligands, directly or indirectly connected to a squaramide group.
(3) Physical and/or chemical properties and (4) Functional characteristics:
Example 2 describes a composition of I-1 and ponatinib (page 66, paragraph [0231] to page 68, paragraph [0243]).
The MPEP states that written description for a genus can be achieved by a representative number of species within a broad generic. It is unquestionable that claim(s) 1-4, 19, 24-27, 37, 46, and 54 is/are broad and generic, with respect to all possible compounds encompassed by the claims. The possible structural variations are limitless to any composition comprising an IAP inhibitor comprising a squaramide group and a cellular kinase inhibitor. Although the claims may recite some functional characteristics, the claims lack written description because there is no disclosure of a correlation between function and structure of the compounds beyond those compounds specifically disclosed in the examples in the specification. Moreover, the specification lack sufficient variety of species to reflect this variance in the genus. While having written description of ligands recited in claims 19 and 24, IAP inhibitors of claim 51, and compounds identified in the specification tables and/or examples, the specification does not provide sufficient descriptive support for the myriad of compounds embraced by the claims.
The description requirement of the patent statue requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736, F.2d 1516, 1521, 222 USPQ 369, 372-73 (Fed. Cir. 1984) (affirming rejection because the specification does “little more than outlin[e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate.”) Accordingly, it is deemed that the specification fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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, 19, 24-27, 37, 46, 51, and 54 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 structural metes and bounds of an IAP inhibitor are unclear. In a compound of formula I, variables L1 and L2 are each a ligand with no clear metes and bounds. Additionally, what functional group beside squaramide is present as part of the linker? As shown by Seneci (WO 2013124701, published 2013 August 29), a compounds in which two ligands are connected by a squaramide-containing linker is described. What are the boundaries between the ligands and the linker? In Seneci, the linker is -pentylene-squaramide-pentylene-. Is this linker encompassed by the examined claims?
The structural metes and bounds of a cellular kinase inhibitor are unclear. DAUB (Biochimica and Biophysica Acta, 2005, 1734, 183-190) describes various kinase inhibitors (page 168, figure 2). These kinase inhibitors each have different structural features with no consensus structure.
PNG
media_image4.png
822
804
media_image4.png
Greyscale
Claims 19, 24-27, 37, 46, and 51 recite limitations that specify what variables L1, L2, and linker can be. There is insufficient antecedent basis for these limitations in the claims because claim 1 does not recite clear metes and bounds for these variables.
Conclusion
Claims 1-4, 17, 19, 24-27, 37, 46, 51, and 54 are not allowed.
The following is a statement of reasons for the indication of allowable subject matter: SENECI (WO 2013124701, published 2013 August 29) 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.
PNG
media_image2.png
174
404
media_image2.png
Greyscale
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 9:00 AM to 5:00 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, 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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/NOBLE E JARRELL/Primary Examiner, Art Unit 1699
Prosecution Insights