DETAILED ACTION
Claims 51-60, 63, 64, 68, 73, 74, and 81-85 are currently pending in the instant application. Claims 51-60, 63, 64, 68, 73, 74, and 81-83 are rejected. Claims 84 and 85 are withdrawn from consideration as being for non-elected subject matter.
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, claims 51-60, 63, 64, 68, 73, 74 and 81-83 along with the election of the species compound 13A:
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in the reply filed on 10 March 2026 is acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been extended to the compound:
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which is not allowable. Claims 51-60, 63, 64, 68, 73, 74 and 81-83 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 63/116,723 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, applicant’s instant claims have D2 as a warhead radical (instant claim 51, 73, 74, 81, and 83) which can be selective (claim 52) for KRAS (claim 53) which covalently modifies KRAS and/or mutant KRAS G12C Lite (claim 54) which does not covalently modify KRAS WT protein (claim 55) which binds to , disrupts, and/or modifies KRAS G12C and/or mutant KRAS G12C Lite (claim 56) which comprises various warhead groups, such as an aryl substituted, a sulfone, or sulfoxide, etc. (claims 57-60, 63, 64, and 68). The prior filed application 63/116,723 provides compounds of the formula (I):
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wherein the position equivalent to Applicant’s instant D2 is always:
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. Instant Claim 82 provides the compounds of Table 8 which includes compounds: 1A-52A which are not all found in the prior application 63/116,723. Applicant’s elected species 13A is not found in the prior application 63/116,723, for example.
Accordingly, claims 51-60, 63, 64, 68, 73, 74, and 81-83 are not entitled to the benefit of the prior application 63/116,723.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because the abstract has the legal phraseology “said.” A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
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 51-60, 63, 64, 68, 73, 74, 81, and 83 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 instant claims are drawn to compounds of the formula (I-A): D1-L-D2 wherein D1 is a radical of a KRAS-binding ligand and D2 is a warhead radical and L is a linker. As a result of the definition of the structural limitation (i.e. the particular structure of the claimed compounds) with functional language (i.e. whether or not the radical is a KRAS-binding ligand, functions as a warhead, or functions as a linker), the metes and bounds of the claims cannot be fully ascertained. MPEP 2173.05(g) provides that, while there are permissible instances for the use of functional language to define a claim, “A functional limitation must be evaluated and considered, just like any other limitation of the claim, for what it fairly conveys to a person of ordinary skill in the pertinent art in the context in which it is used.” Further, “Examiners should consider the following factors when examining claims that contain functional language to determine whether the language is ambiguous: (1) whether there is a clear cut indication of the scope of the subject matter covered by the claim; (2) whether the language sets forth well-defined boundaries of the invention or only states a problem solved or a result obtained; and (3) whether one of ordinary skill in the art would know from the claim terms what structure or steps are encompassed by the claim. These factors are examples of points to be considered when determining whether language is ambiguous and are not intended to be all inclusive or limiting. Other factors may be more relevant for particular arts. The primary inquiry is whether the language leaves room for ambiguity or whether the boundaries are clear and precise.”. In the present case, it is unclear precisely what structures are intended for the claimed molecules, at least because the functional language used leaves room for ambiguity. For example, there is no definition or guidance as to what structural features are necessary for a compound to be capable of binding KRAS and how much binding is necessary. There is no definition or guidance as to what structural features are necessary for a compound to be an acceptable warhead and there is no guidance as to what is required for the linker. While there are a multitude of examples, these examples vary extensively, see for example page 8 of the specification which provides that the warhead can be or comprise amino, aryl, alkoxy, alkyl, sulfone. Pages 9-10 provides examples of linkers, such as non-releasable, a bond, or is O, amino, alkyl, or heteroalkyl (all of which vary extensively). Pages 10-12 provides possible structures for D1, which vary extensively such as :
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and
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The exemplary structures of D1, L and D2 very greatly and without clear direction as to which particular structural features, at a minimum, are necessary to render the compound capable of binding to KRAS, linking D1 and D2, or functioning as a warhead, how much binding is required, etc. the skilled artisan would not be reasonably apprised as to the intended scope of the claimed invention.
Claims 57-60, 63, 64, 68, and 74 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 multiple instances of the term “comprises” in the definition of the compound, for example:
Regarding claim 57, the claim recites the following phrases:
Wherein D2 comprises one or more warhead groups…
Regarding claims 58-60
Wherein D2 comprises…
Regarding claims 63, 64, 68
Wherein D2 is or comprises
Regarding claim 74
Wherein the linker comprises one or more linker group…
In the abovementioned phrases, 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 whether the abovementioned variables have additional unrecited elements present and would read on the abovementioned limitations. Accordingly, the metes and bounds of this claim is unclear, which rendered this claim 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 "including", "containing", 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 in the claims because 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 the claims indefinite.
Claim 64 is 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 64 is as follows:
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. Claim 64 utilizes “and” and “or” along with commas and a semi-colon. Claim 64 becomes unclear as to what D2 must have as both commas and semi-colons are utilized along with “and’ and “or”. Claim 64 can be read multiple ways which renders the claim indefinite. Possible readings of claim 64 could include wherein D2 is or comprises
-an aryl substituted with halogen and also requires an alkyl substituted with halogen OR is or comprises a halogen, hydroxy, unsubstituted alkoxy, or alkoxy substituted with halogen
OR
-an aryl substituted with halogen and the aryl is also substituted with an alkyl substituted with halogen
-hydroxy
-unsubstituted alkoxy
or-alkoxy substituted with halogen
OR
-an aryl substituted with halogen
-an alkyl substituted with halogen
-hydroxy
-unsubstituted alkoxy
or-alkoxy substituted with halogen
OR
-an aryl substituted with halogen
-an alkyl substituted with halogen, hydroxy, unsubstituted alkoxy or alkoxy substituted with halogen.
Claim 82 is 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 82 refers back to the Table 8 of the specification to define a compound. Claims must, under modern claim practice, stand alone to define an invention, and incorporation into claims by express reference to the specification is not permitted. Ex parte Fressola, 27 USPQ 2d 1608 (1993).
Claim Rejections - 35 USC § 102
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 51-60, 63, 64, 68, 73, 74, and 81-83 is/are rejected under 35 U.S.C. 102(a)(1) and as being anticipated by WO 2021/099842 A1 (Cite No. 028 Foreign Patent Documents, IDS filed 9/26/2023).
Additionally, claim(s) 51-60, 63, 64, 68, 73, 74, and 81-83 is/are rejected under 35 U.S.C. 102(a)(2) and as being anticipated by WO 2021/0099842 A1.
WO 2021/099842A1 discloses compounds of the formula (I):
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wherein G is an organic residue, page 1 and X1 is O or NR. Page 3 provides pharmaceutic compositions comprising formula (I) and one or more pharmaceutically acceptable excipients. Page 50 provides the compound 32a:
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in Table 1 (see page 34 also):
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. This compound 32a corresponds to instant compound 3a in instant claim 82:
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. The compound 32a corresponds to instant claim 51 wherein D1 is a radical of KRAS-binding ligand; D2 is a warhead radical; and L is a linker. The compound 32a corresponds to instant claims 52-60, 63, 64, and 68 as the position equivalent to D2 is
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. The compound 32a corresponds to instant claim 73 and 74 as the linker is amino. The compound 32a corresponds to instant claim 81 wherein D1 has a structure represented by:
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. Page 3, which provides pharmaceutical compositions corresponds to instant claim 83.
In regards to claims 52-56, these product claims are product claims with intended use for specific variables, such as seen in claim 52 wherein D2 is selective or in claim 54 wherein D2 covalently modifies KRAS or in claim 56 wherein D2 binds, disrupts or modifie. A recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. An intended use generally is not limiting when the claim body describes a structurally complete invention such that deletion of the intended use phrase does not affect the structure or steps of the claimed invention. It is noted that recitation of the intended utility into a compound claim which can otherwise stand alone is not considered a further limitation of the claim. In re Ridden, 318 F.2d 761, 138 USPQ 112. A recitation of the intended utility does not impart patentability to a known composition. In re Spada, 911 F.2d 705, 15 USP! 2d 1655 (Fed. Cir. 1990).
In regards to the 35 USC 102(a)(2) rejection, the applied reference has a common assignee and inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
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.
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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 ____________________ 3 June 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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