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 with traverse of Group II, claims 9-16 and the species of formula (2-1-2), as depicted in paragraph [0043] of the specification in the reply filed on January 14, 2026 is acknowledged. The traversal is on the grounds that “the present application would appear to be part of an overlapping search area” and, therefore, that there is no burden search all the claims and species. This is not found persuasive because the compounds embraced by the claims are patentably distinct and independent. The search required for any one of the compounds is not required for another.
The rings embraced at formula “(1-1)” according to claim 1 alone are so diverse in scope that a serious burden exists to search the application as a whole. Therefore, restriction to a specific core is required. Each ring system supports a different patent. The search required is too burdensome for the office. The compounds claimed embrace varying sizes of rings with multiple heteroatoms and further ring fusions that a reasonable search of the entire genus could not be conducted without undue burden.
The claims embrace compounds which are structurally dissimilar. They are made and used independently. They are independent and patentably distinct.
If, say a compound of formula (1-1) wherein X1 as C(R1)(R2) were anticipated, applicants would not acquiesce in the rejection of, say, a compound where everything else is the same, X1 is NR6 thereover or vice-versa. They are patentably distinct.
The search required for any one of the compounds at (1-1) is not required for another, let alone the compounds embraced by the claims.
Group I raises different issues of patentability and considerations.
The elected species has the structural formula
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The elected species was not found and the search was expanded according to MPEP 803.02 to embrace compounds of formula (2-1-1), (2-1-2), (2-1-3), (2-1-4), (2-1-5), (2-1-6) and (2-1-7) as depicted in paragraph [0043]-[0044] in pages 24-25 of the specification. These compounds are free from prior art rejections and are allowable.
Claims 1-8 are withdrawn from consideration as being drawn to non-elected subject matter.
The requirement is still deemed proper and is therefore made FINAL.
Improper Markush Rejection
Claims 9-16 are rejected under a judicially created doctrine as being drawn to an improper Markush group, that is, the claims lack unity of invention. The claimed compound/composition is defined in such a way that it keeps changing the core of the compound that determines the classification. By changing the values of the variables, several patentably distinct and independent compounds are claimed. In order to have unity of invention the compounds must have “a community of chemical or physical characteristics” which justify their inclusion in a common group, and that such inclusion is not repugnant to principles of scientific classification” In re JONES (CCPA) 74 USPQ 149 (see footnote 2). The compound does not have a significant structural feature that is shared by all of its alternatives which is inventive. The structure has only two carbons in a ring as common. This feature is not inventive. Compounds embraced by the claims are so diverse in nature that a prior art anticipating a claim with respect to one member under 35 USC 102 would not render obvious the same claim under 35 USC 103. This is evidentiary of patentably distinct and independent inventions.
Limiting the claims to a single “core” would overcome this rejection.
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.
Claims 9-16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims require a pyridine ring structure or a pyrimidine ring structure and a partial structure as depicted below:
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The claims do not require that the composition possess any particular conserved structure, or other distinguishing feature. Thus, the claims are drawn to a genus of compounds that is defined by novelty.
To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing identifying characteristics of the genus. The specification does not identify any particular portion of the structure that must be conserved, nor does it provide a disclosure of structure/function correlation. The distinguishing characteristics of the claimed genus are not described. Accordingly, the specification does not provide adequate written description of the claimed genus.
To satisfy the written-description requirement, the specification must describe every element of the claimed invention in sufficient detail so that one of ordinary skill in the art would recognize that the inventor possessed the claimed invention at the time of filing. Vas-Cath, 935 F.3d at 1563; see also Lockwood v. American Airlines, Inc., 107 F.3d 1565, 1572 [41 USPQ2d 1961] (Fed. Cir. 1997) (patent specification must describe an invention and do so in sufficient detail that one skilled in the art can clearly conclude that “the inventor invented the claimed invention”); In re Gosteli, 872 F.2d 1008, 1012 [10 USPQ2d 1614] (Fed. Cir. 1989) (“the description must clearly allow persons of ordinary skill in the art to recognize that [the inventor] invented what is claimed”). Thus, an applicant complies with the written-description requirement “by describing the invention, with all its claimed limitations, not that which makes it obvious,” and by using “such descriptive means as words, structures, figures, diagrams, formulas, etc., that set forth the claimed invention.” Lockwood, 107 F.3d at 1572.
According to the MPEP §2163 I. A. “the issue of a lack of adequate written description may arise even for an original claim when an aspect of the claimed invention has not been described with sufficient particularity such that one skilled in the art would recognize that the applicant had possession of the claimed invention. The claimed invention as a whole may not be adequately described if the claims require an essential or critical feature which is not adequately described in the specification and which is not conventional in the art or known to one of ordinary skill in the art.”
The MPEP states in §2163 II 3 ii) “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice (see i)(A), above), reduction to drawings (see i)(B), above), or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus (see i)(C), above).
According to the MPEP §2163.02 Standard for Determining Compliance With the Written Description Requirement,
“The courts have described the essential question to be addressed in a description requirement issue in a variety of ways. An objective standard for determining compliance with the written description requirement is, “does the description clearly allow persons of ordinary skill in the art to recognize that he or she invented what is claimed". In re Gosteli, 872 F.2d 1008, 1012, 10 USPQ2d 1614, 1618 (Fed. Cir. 1989). Under Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991), to satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. The test for sufficiency of support in a parent application is whether the disclosure of the application relied upon “reasonably conveys to the artisan that the inventor had possession at that time of the later claimed subject matter". Ralston Purina Co. v. Far-Mar-Co., Inc., 772 F.2d 1570, 1575, 227 USPQ 177, 179 (Fed. Cir. 1985) (quoting In re Kaslow, 707 F.2d 1366, 1375, 217 USPQ 1089, 1096 (Fed. Cir. 1983)).”
This case was filed before Applicants had a clear idea of the structures of their desired compounds, how to make their compounds and how to use them.
Applicants are reminded of what the U.S. Court of Appeals Federal Circuit wrote in University of California v. Eli Lilly and Co. 43 USPQ2d 1398, "In claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass. One skilled in the art can distinguish such a formula from others and can identify many of the species that the claims encompass. Accordingly, such a formula is normally an adequate description of the claimed genus." "A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the gene does, rather than what it is. See Fiers, 984 F.2d at 1169-71, 25 USPQ2d at 1605-06 (discussing Amgen). "It is only a definition of a useful result rather than a definition of what achieves that result." "The description requirement of the patent statute 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.")".
Therefore, the full breadth of the claim fails to meet the written description provision of 35 U.S.C. §112, first paragraph. Applicant is reminded that Vas-Cath makes clear that the written description provision of 35 U.S.C. §112 is severable from its enablement provision.
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 9-16 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.
i) The claims are unclear as to what is intended. Is it a compound or a composition? A composition comprises more than one ingredient and the claims do not set forth the different components that make up a composition. Is the solvent (also, which?) the additional component so that the compound is in solution? A clarification is required. Also, a compound cannot “comprise” other ingredients. Replacing “comprising” with “having” or other appropriate language is suggested in claim 9.
ii) The claims require a compound comprising a pyridine or a pyrimidine and a partial structure represented by formula (1-1) or (1-2). It is unclear whether these need to be connected or whether these are separate. Can the pyridine or pyrimidine be substituted or fused to other rings? If they are connected, then one skilled in the art cannot say how these are connected. There is not complete structure for one skilled in the art to begin to understand the metes and bounds of the claimed compound. The claims are indefinite.
iii) It is unclear which atoms are present in Ar11 and Ar12 in claim 10. One skilled in the art cannot say whether heteroatoms are intended or how many of each is present. Also, to which carbon atom is R7 attached? How many groups of (X-1) or (X-2) are permitted? A clarification is required.
iv) The term “substituted” without saying which substituents are intended is indefinite. One skilled in the art cannot say which substituents are permitted and which ones are not.
v) The group “a monovalent organic group having 1 to 20 carbon atoms” is indefinite. Are other atoms permitted or is this just a group of solely 1-20 carbon atoms? Is it a ring, chain, saturated, unsaturated, aromatic?
vi) The term “comprises” is open-ended. It is suggested to use more definite language, such as, “selected from” or similar language throughout the claims. See claim 10.
vii) In claim 12 it is said that R5 and/or R6 may be represented by (X-1) or (X-2). However, in claim 10 it is clearly stated that * is a bond with a carbon atom. R5 and R6 are bonded to a nitrogen. See also claim 13. This is inconsistent and lacks antecedent basis.
viii) The metes and bounds of the composition in claim 15 is unclear. Applicants are requiring to imagine all of the compositions embraced by claim 9 and to calculate the ratio of hydrogen. This is undue amount of experimentation to understand the metes and bounds of a claim.
ix) Claim 16 is a duplicate of claim 9. The intended use of a composition does not carry patentability weight. Applicants either need to distinguish this claim from claim 9 or delete the claim.
The search was limited to compounds of formula (2-1) according to claim 14.
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 9-16 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Hussein et al. (RSC Advances (2019), 9(68), 40118-40130). The claims read on the compounds depicted below. See Abstract.
RN 2407781-68-2 CAPLUS
CN 3-Pyridinecarbonitrile, 2,6-di-9H-fluoren-2-yl-4-phenyl- (CA INDEX
NAME)
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505
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RN 2407781-69-3 CAPLUS
CN 3-Pyridinecarbonitrile, 4-[4-(dimethylamino)phenyl]-2,6-di-9H-fluoren-2-
yl-(CA INDEX NAME)
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411
505
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RN 2407781-70-6 CAPLUS
CN 3-Pyridinecarbonitrile, 2,6-di-9H-fluoren-2-yl-4-(4-methoxyphenyl)- (CA
INDEX NAME)
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411
505
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RN 2407781-71-7 CAPLUS
CN 3-Pyridinecarbonitrile, 4-(4-chlorophenyl)-2,6-di-9H-fluoren-2-yl- (CA
INDEX NAME)
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399
505
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RN 2407781-72-8 CAPLUS
CN 3-Pyridinecarbonitrile, 4-(4-cyanophenyl)-2,6-di-9H-fluoren-2-yl- (CA
INDEX NAME)
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436
505
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RN 2407781-73-9 CAPLUS
CN 3-Pyridinecarbonitrile, 2,6-di-9H-fluoren-2-yl-4-(4-nitrophenyl)- (CA
INDEX NAME)
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418
505
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Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRUCK KIFLE whose telephone number is (571)272-0668. The examiner can normally be reached 8 AM - 6 PM, M-F.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jeffrey H. Murray can be reached at 571-272-9023. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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March 26, 2026
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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