NOVEL PHOSPHOINOSITIDE 3-KINASE (PI3K) INHIBITOR, COMPOSITIONS COMPRISING THE SAME, METHODS OF MAKING, AND METHODS OF TREATING A DISEASE

DETAILED ACTION Claims 1-20 are currently pending in the instant application. Claims 1, 10, and 18 are objected. Claims 1-20 are rejected. 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 . Claim Objections Claims 1, 10, and 18 objected to because of the following informalities: Claim 1 does not end in a period. Claims 10 and 18 have the formula (I) structure after the period. Appropriate correction is required. 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 1-20 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. Specifically, the variables n and/or R are not defined in formula (I) in the claims. Claims 1 and 10-20 do not define the variable n in formula (I) and do not define the variable R in formula (I), or the R in the linker (claim 11). While claim 2 defines variable n, claim 2 does not have a definition for variable R. While claims 3-9 define variable R, these claims do not have a definition for variable n. In regards to claim 11, which defines the linker R, this R does not appear to be the R of formula (I) as claim 10, from which claim 11 depends, states that the composition comprises a compound of formula (I), which has a variable R, and comprises a linker. Claims 3 and 17 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. Specifically, claims 3 and 17 have the phrase “a substituent alkyl group” in the definition of R in claim 3 and linker in claim 17. It is unclear what the phrase is intended to mean. Please note that claim 17 also includes “an alkyl chain”. The phrase “substituent alkyl” is unclear. It is unclear if the meaning is “a substituent which is an alkyl group” or if applicant is intending to state “substituted alkyl group”. As R is a substituent on formula (I), it is unclear why the term “substituent” is in the definition of R in claim 3 as R could be defines as H or an alkyl group. It is suggested that the word “substituent” be deleted from both claims 3 and 17. Claims 4-9, 12, and 17 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 instant claims have the term “comprises” in the definition of variables in the compound of formula (I), in the definition of targeting compound, and in the definition of the linker of the composition of claim 10. The term, “comprises”, is open-ended and thus, does not exclude additional, unrecited elements, according to MPEP 2111.03(I). Subsequently, it is unclear to the Examiner what else is present in the compound of formula (I) or in the targeting compound, or in the linker. Accordingly, the metes and bounds of the claims is unclear, which renders the claims indefinite. The term “comprises” or forms of the term are considered open-ended language and therefore include additional subject matter that is not described in the instant specification and is not particularly pointed out or distinctly claimed. The identity of the additional atoms or groups is unknown and how to determine the identity of the additional atoms or groups is not pointed out or distinctly claimed. The term “compound” contradicts the open language "comprises." A "compound" is defined as a substance whose molecules consist of unlike elements and whose constituents cannot be separated by physical means. Grant & Hackh's Chemical Dictionary (5th Ed. 1987) at page 148. By contrast, a composition is defined as elements or compounds forming a material or produced from it by analysis. Id. In other words, a compound is a molecule with more than one element, and a composition is a mixture of two or more compounds or molecules. The transitional term "comprises" is synonymous with "includes", "contains", and "characterized by". "Comprises" is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) (“Comprising” is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) (“comprising” leaves “the claim open for the inclusion of unspecified ingredients even in major amounts”). Thus, a contradiction arises within the definition of instant discussed variables as a "compound" requires a definite chemical formula, and the open-ended term "comprises" does not exclude unrecited elements. Furthermore, "comprises", used in conjunction with "compound" fails to articulate exactly what subject matter is excluded from the claimed scope of compounds, thereby rendering the scope of claims 4-9, 12, and 17 indefinite. Claims 10-17 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. Specifically, claim 10 claims a composition comprising the compound of formula (I) and a linker, two items. The compound of formula (I) has an undefined variable n and an undefined variable R. Claim 11 defines the linker to be R, which is undefined in claim 11. Claim 15 provides wherein the linker connects the carrier to the compound. It is unclear if the composition of claim 10 has a compound of formula (I) in addition to a linker, two items, or if the linker is R on the compound of formula (I) as formula (I) has R and claim 11 defines linker to be R. It is therefore unclear if claim 10 is a composition comprising two items, the compound of formula (I) and also a linker, or if the composition comprises one item, the compound of formula (I) which has R as a linker. Conclusion Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm. 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, Andrew Kosar can be reached at 571-272-0913. 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. /REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ October 12, 2026 Rebecca Anderson Primary Examiner Art Unit 1626, Group 1620 Technology Center 1600