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 .
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.
Current Status of 18/702,429
This Office Action is responsive to the amended claims of 24 April 2024.
Claims 1-7, 9, 11, 14-16, and 19-27 have been examined on the merits. Claims 1-19 are original. Claims 20-27 are currently amended.
Priority
The effective filing date is 21 October 2021.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 18 April 2024, is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive since it contains “Novel”. Words such as “New”, “Improvement”, and “Novel” are not permitted in an application’s title. See MPEP 606. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: -- [[Novel]] Bicyclic Heteroaryl Derivatives as SOS1:KRAS Protein-Protein Interaction Inhibitors -- . This suggestion strikes “Novel” in the application title. Please revise title accordingly.
Claim Objections
Claim 1 is objected to for containing “Novel”. This word is not permitted in the claims as the Examiner is applying prior art (below) showing these compounds are not “novel”. Claims 2-7, 9, 11, 14-16, and 20-23 are similarly objected to as these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for objecting to claim 1. Please remove “novel” from all the claims.
Claim 1 contains “with the exclusion that R1 [regular numbering] is not alkyl when E is CR1 [note “1” as superscript]”. At least this statement is exemplary because there’s inconsistent reference to R1. The illustration and most of the claim narrative references it as “R1“ (note the superscript “1”) but on occasion, as here, its just regular R1. Please revise so that all variables are consistently referenced throughout the claims. Claims 2-7, 9, 11, 14-16, and 20-23 are similarly objected to as these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for objecting to claim 1.
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 1-7, 9, 11, 14-16, and 20-23 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.
Claim 1 contains “Novel”. This renders the metes and bounds of the claim undefined (hence rendering claim 1 indefinite under 35 USC 112(b)) because “novel” is not permitted in the claims and because it contrasts with the presence of prior art (see, below). Hence the claims cannot be “novel”. Claims 2-7, 9, 11, 14-16, and 20-23 are similarly rejected as indefinite as these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
Claim 1 recites the limitation "S(O)nalkyl" and “S(O)nNH2” as alternative embodiments for variable R1a. There is insufficient antecedent basis for this limitation in the claim since variable “n” is not further defined within claim 1.
As drafted, the “n” renders the metes and bounds of claim 1 undefined (hence rendering claim 1 indefinite under 35 USC 112(b)) since the artisan is not certain what integer range “n” stands for. Variable “n” is not further defined (hence lacks antecedent basis) within base/parent claim 1. Claims 2-7, 9, 11, 14-16, and 20-23 are similarly rejected as indefinite as these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for rejecting claim 1.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 20, 22, 24, and 26 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Dependent claim 20 begins with “The pharmaceutical composition”. This implies a parent claim drawn to -- A pharmaceutical composition -- . However, claim 20 refers back to compound claim 1. Thus, claim 20 does not properly further limit parent claim 1; rather, claim 20 is drawn to a different scope than parent claim 1. Thus, claim 20 is rejected under 35 USC 112(d). Claims 22, 24, and 26 are similarly rejected under 35 USC 112(d) because these claims, too, begin with “The method” or “The composition” without referring back to -- A method -- or -- A composition -- , respectively.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-2 and 19-27 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by:
HILLIG (Hillig, Roman C., et al. “Discovery of potent SOS1 inhibitors that block RAS activation via disruption of the RAS-SOS1 interaction.” PNAS. (February 12, 2019). Vol. 116, no. 7, pp 2551-2560).
The prior art reference HILLIG teaches the following compound 1:
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(page 2554), which is a species of genus formula I of instant claim 1, wherein: variables “F” and “D” are each N; ring A is a 10-membered aryl (a “naphthyl”); variable “E” is -CR1, wherein R1 is H; R3, R4, and (all) R5 are each H; variables “Z” is -CR1e , wherein R1e is H; and “Y” is -CR1d wherein R1d is methoxy; variable “X” is “OR1e” and R1e is methyl; and R2 and R2’ are each absent. This anticipates instant claims 1-2 and 19.
Claims 21 and 25 contain “for use as a medicament.” This statement is intended use. Nothing precludes the use as claimed. Therefore, claims 21 and 25 are anticipated, too.
The Abstract defines compound 1 and the compounds of HILLIG as possessing antiproliferative activities by inhibiting KRAS-SOS1 formation. As such, the HILLIG authors created a (inherent) pharmaceutical composition comprising compound 1 (anticipating instant claims 20 and 24) since other compounds in the solution constitute “carrier or excipient”.
Moreover, the HILLIG authors anticipated the methods of instant claims 22-23 and 26-27 (see “Abstract”) by determining compound 1’s (and the other HILLIG compounds’) antiproliferative activity.
Conclusion
No claims are presently allowable as written.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Andrew D 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.
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/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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