DETAILED ACTION
Claims 1-9 and 11 are currently pending in the instant application. Claims 1-6 and 9 are rejected. Claims 7, 8 and 11 are withdrawn as being for non-elected subject matter.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 of Group I, claims 1-6 and 9 and the further election of the species:
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in the reply filed on 11 February 2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
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 compounds of claim 6 which also appear allowable over the prior art of record, and further to the compound:
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which is not allowable.
Claims 1-6 and 9 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds.
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 and its dependent claims 2-5 and 9 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 claim 1 has multiple instances of the term “comprise” and “comprises” in the definition of the compound, for example:
Regarding claim 1, the claim recites the following phrases, for example:
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In the abovementioned exemplary phrases, the term, “comprise” and “comprises”, are 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 rings containing heteroatom(s) outside of the abovementioned recited heteroatoms (e.g. N, O, S, S(=O), and S(=O)2), such as phosphorus (P) or if a larger number of heteroatoms could be 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 “comprising” 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 "comprising." 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 "comprising" is synonymous with "including", "containing", and "characterized by". "Comprising" 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 claim 1 and its dependent claims 2-5 and 9 because a "compound" requires a definite chemical formula, and the open-ended term "comprising" does not exclude unrecited elements. Furthermore, "comprising", 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 1-5 and 9 indefinite.
It is suggested that an amendment to change forms of “comprise” and “comprises” to a form such as “with”, for example
Regarding claims 2-5 and 9 these claims are dependent of claim 1, and they failed to correct the indefiniteness issue of claim 1, which rendered these claims indefinite.
Claim 1 and its dependent claims 2-5 and 9 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 defines R5 as
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which has 1 Rb substituent. However, claim 1 also states “when multiple substituents are present, they are the same or different” in reference to Rb. Therefore, claims 1-5 and 9 are considered indefinite as it is unclear how there are multiple Rb substituents on Formula I, when only one Rb substituent is shown on the structure.
Claim 6 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 6 recites the limitation “and/or, the pharmaceutically acceptable salt of the heterocyclic compound represented by formula I is any one of the following structures:…” There is insufficient antecedent basis for this limitation in the claim as there is no heterocyclic compound represented by formula I in independent claim 6. It is suggested that the reference to “the pharmaceutically acceptable salt of the heterocyclic compound represented by formula I” be deleted from the claim. Additionally, for clarity, it is suggested that the term “which” be added after “A heterocyclic compound” at the beginning of claim 6.
Claims 4 and 5 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 4 has multiple instances of “e.g.” Regarding claim 4 the phrase "e.g." renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d). Instant claim 5 has multiple instances of “for example”. Regarding claim 5, the phrase "for example" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-5 and 9 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Mainolfi et al. J. Med. Chem. 2020, 63, 5697-5722, published online 19 February 2020 (IDS filed 2/7/2023, Cite No. 1 NPL).
Mainolfi et al. provides the LNP023, compound 41, in the abstract, page 5697 and in Table 5, page 5704, which provides in vitro and in vivo profiles of advanced FB inhibitors. LNP023, compound 41 is:
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. Compound 41 corresponds to the formula I of instant claim 1:
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, for example, wherein W is C(R7’R7”), one of R7’ and R7” is hydrogen and the other is C1-C4alkyl-O-; R7 is hydrogen; m is 1; R4 is hydrogen; R4’ is hydrogen; R5 is
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wherein ring B is phenyl and Rb is H; R6 is hydrogen; A is
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wherein Z8 is CH; R14 is C1-C4alkyl-O-; R24 is H; and R34 is C1-C4alkyl. The compound 41 corresponds to the formula I of instant claim 2 wherein, for example, W is C(R7’R7”), or R7 is hydrogen, or m is 1, etc. Please note instant claim 2 has “and/or” between options, so only one option need be present. The compound 41 corresponds to the formula I of instant claim 3, for example, wherein formula I is formula Ib
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or W is C(R7’R7”), one of R7’ and R7” is hydrogen and the other is C1-C4alkyl-O-; R7 is hydrogen; m is 1; R4 is hydrogen; R4’ is hydrogen; R5 is
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wherein ring B is phenyl and Rb is H; R6 is hydrogen; A is
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wherein Z8 is CH; R14 is C1-C4alkyl-O-; R24 is H; and R34 is C1-C4alkyl. Please note that instant claim 3 has multiple solutions to choose from with and/or between them, therefore, only one solution need be present. The compound 41 corresponds to the formula I of instant claim 4, for example, wherein when R34 is C1-4 alkyl, then the C1-C4alkyl is methyl. Please note that instant claim 4 has “and/or” between options, so only one option need be present. The compound 41 corresponds to instant claim 5, for example, wherein R7’ and R7” are independently hydrogen or ethyl-O or R5 is
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. Please not instant claim 5 has “and/or” between options, so only one option need be present. Instant claim 9 is a pharmaceutical composition comprising the compound of formula I according to instant claim 1 and a pharmaceutically acceptable carrier. Mainolfi et al. provides pharmaceutical compositions as seen by the IC50 values in Table 5, page 5704 and the last 3 paragraphs on page 5704 where compound 41 is discussed. Page 5705 also provides the compound 41 in an oral dose of 10mg/kg in a mouse study and also provides Wister Han rats and beagle dogs good oral bioavailability. Page 5706 also provides dosages orally at a relatively low dose of 3mg/kg. Page 5717 provides plasma pharmacokinetic studies in Mice with compound 41, and page 5718 provides plasma pharmacokinetic studies in Rats, ocular pharmacokinetic studies in rats, and plasma pharmacokinetic studies in dogs.
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.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 28 May 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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