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 .
Priority
The instant application, filed 07/18/2023, is a 371 filing of PCT/US2022/013223, filed 01/21/2022, which claims domestic priority to U.S. provisional application number 63/140,308, filed 01/22/2021.
Amendments and Claim Status
The amendment filed on 05/28/2026 is acknowledged and entered.
Claims 1-23 are cancelled;
Claims 24-36 are pending and are under prosecution.
Information Disclosure Statement
The Information Disclosure Statements filed on 07/25/2024, 10/14/2025 and 12/01/2025 are acknowledged and found to be in compliance with the provisions of 37 CFR § 1.97. Accordingly, the Information Disclosure Statements are considered.
The Information Disclosure Statement filed 08/02/2024 fails to comply with 37 CFR § 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. Specifically, several CAS Registry Number entries are cited, but copies of the entries are not provided by Applicant. The information disclosure statement has been placed in the application file, but the information referred to therein has not been considered.
Restriction/Election
Applicant’s election without traverse of Group I in the reply filed on 05/28/2026 is acknowledged. Applicant selection of species MBX-4055 as a specific species of a compound of Formula (I) is also acknowledged.
In accordance with the MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non-elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be reexamined. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during reexamination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
Figure 1. Elected Species
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Figure 1. MBX-4055, Applicant’s elected species
As per MPEP § 803.02, the Examiner will determine whether the entire scope of the claims is patentable. Applicants' elected species (Figure 1) makes a contribution over the prior art of record. Therefore, according to MPEP § 803.02: should the elected species appear allowable, the search of the Markush-type claim will be extended. The Markush-type claim shall be rejected and claims to the nonelected invention held withdrawn from further consideration. It has been determined that the entire scope claimed is not patentable.
Status of Claims
Claims 23-36 are pending in the instant application. Claims 27-36 are withdrawn from further consideration pursuant to 37 CFR § 1.142(b), as being drawn to a non-elected invention and species. Therefore, claims 23-26 read on an elected invention and species and are therefore under consideration in the instant application.
Specification
The disclosure is objected to because of the following informalities:
The two dimensional structures of the disclosure are of very low and inconsistent resolution. For instance, on pages 12-14, 18-21, 32-35, 41-53, and 57-62, the following example compounds are disclosed:
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The resolution of these structures, in addition to nearly all of the other structures disclosed, is incredibly low, making it very difficult to discern the two-dimensional structure of the compounds of the instant disclosure.
Appropriate correction is required.
Drawings
The drawings filed on 07/18/2023 are found to be in compliance with 37 CFR 1.121 § 1.84, and are hereby accepted.
Claim Objections
Claim 26 for the following informalities:
Throughout the claim, two-dimensional structures of inconsistent resolution are recited. For example, the claim recites the following compounds, whose resolution is poor, and inconsistent. In order to be consistent throughout, the claim should be amended to provide compounds of higher and self-consistent resolution.
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Appropriate correction is required.
Claim Rejections - 35 U.S.C. § 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 23-25 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 claim(s) contains 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.
Claims 23-25 of the instant application are drawn to compounds having following substituents:
A is independently selected from C, S, O or N combined through either single or double bonds to form a five-member heteroaromatic ring of 1-4 carbon atoms, 0-3 nitrogen atoms, 0-1 oxygen atom, and 0-1 sulfur atom; A as O or N combined through either single or double bonds to form a five-member heteroaromatic ring of 1-3 carbon atoms, 0-3 nitrogen atoms, 0-1 oxygen atom, and 0 sulfur atoms;
R3 is a monovalent substituent group independently selected from alkenyl, alkoxy, alkyl, alkynal, having from 1 to 12 carbons, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, guanidino, halo, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, or thiol, and, when said substituent group is alkenyl, alkoxy, alkyl, alkynal, amido, amidino, aminoalkyl, aminoaryl, aryl, aryloxy, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cycloalkyl, ester, guanidino, heteroaryl, heterocyclyl, imino, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, or thiocarbonyl, said substituent group may be further substituted with 0-3 groups independently selected from alkenoxy, alkenyl, alkoxy, alkyl, alkylamino, alkynal, alkynoxy, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, arylalkyl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, ether, guanidino, haloalkoxy, haloalkyl, halo, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, thioether, or thiol;
n is an integer from 0-3;
m is an integer from 0-3;
Y is —COCH2—, —SO2—, —CO—, —CH2—, —CH(CH3)—, —NHCO—, —NCH3CO—, —CONH—, —CONCH3—, —O(CO)—, —(CO)O—, —NH—, or —O—;
R1 is a divalent non-aromatic, heterocyclic ring of 5-7 members containing 0-2 nitrogen atoms, 0-1 oxygen atom, and 3-6 carbon atoms, with the proviso that Y and R2 are separated by at least 3 atoms, which non-aromatic, heterocyclic ring may bear 0-3 substituent groups defined as for R3, with the proviso that two or more such substituent groups on R1 may be fused with R1 to form one or more cycloalkyl, heterocyclic, aromatic, or heteroaromatic rings, or alternatively R1 may be fused, optionally incorporating 0-2 substituent groups, with R2 to form a fused heterocyclyl ring of 3-7 members, optionally substituted with 0-2 substituent groups defined as for R3;
R2 is a 5- or 6-membered heteroaryl ring bearing 0-24 substituent groups independently selected from substituent groups defined as for R3, or substituents on R2 may be optionally fused to R2 to form one or more cycloalkyl, heterocyclic, aryl or heteroaryl rings, or 0-2 R2 substituents may, together with R1, form a fused substituted or unsubstituted heterocyclyl ring bearing 0-2 additional substituents selected from alkenoxy, alkenyl, alkoxy, alkyl, alkylamino, alkynal, alkynoxy, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, arylalkyl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, ether, guanidino, haloalkoxy, haloalkyl, halogen, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, thioether, or thiol;
G is selected from C or N and is part of a heterocyclic ring which is optionally substituted with (R6)q,;
q is an integer from 0-4;
R6 is as defined for R3, with the additional proviso that R6 substituents on the heterocyclic ring containing G may be optionally fused to each other or a carbon atom of the ring containing G to form one or more cycloalkyl, heterocyclic, aromatic, or heteroaromatic rings; or 0-2 substituents on the heterocyclic ring containing G may, together with R2, form a fused substituted or unsubstituted cycloalkyl or heterocyclyl ring bearing 0-2 additional substituents selected from alkenoxy, alkenyl, alkoxy, alkyl, alkylamino, alkynal, alkynoxy, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, arylalkyl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, ether, guanidino, haloalkoxy, haloalkyl, halo, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, thioether, or thiol;
35 U.S.C. 112(a) and the first paragraph of pre-AIA 35 U.S.C. 112 require that the "specification shall contain a written description of the invention ...." This requirement is separate and distinct from the enablement requirement. Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010) (en banc); Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1560, 19 USPQ2d 1111,1114 (Fed. Cir. 1991); see also Univ. of Rochester v. G.D. Searle & Co., 358 F.3d 916, 920-23, 69 USPQ2d 1886, 1890-93 (Fed. Cir. 2004) (discussing the history and purpose of the written description requirement); In re Curtis, 354 F.3d 1347, 1357, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004) ("conclusive evidence of a claim’s enablement is not equally conclusive of that claim’s satisfactory written description"). The written description requirement has several policy objectives. "[T]he ‘essential goal’ of the description of the invention requirement is to clearly convey the information that an applicant has invented the subject matter which is claimed." In re Barker, 559 F.2d 588, 592 n.4, 194 USPQ 470, 473 n.4 (CCPA 1977). Another objective is to convey to the public what the applicant claims as the invention. See Regents of the Univ. of Cal. v. Eli Lilly, 119 F.3d 1559, 1566, 43 USPQ2d 1398, 1404 (Fed. Cir. 1997), cert, denied, 523 U.S. 1089 (1998). "The ‘written description’ requirement implements the principle that a patent must describe the technology that is sought to be patented; the requirement serves both to satisfy the inventor’s obligation to disclose the technologic knowledge upon which the patent is based, and to demonstrate that the patentee was in possession of the invention that is claimed." Capon v. Eshhar, 418 F.3d 1349, 1357, 76 USPQ2d 1078, 1084 (Fed. Cir. 2005). Further, the written description requirement promotes the progress of the useful arts by ensuring that patentees adequately describe their inventions in their patent specifications in exchange for the right to exclude others from practicing the invention for the duration of the patent’s term.
To satisfy the written description requirement, a patent specification must describe the claimed invention in sufficient detail that one skilled in the art can reasonably conclude that the inventor had possession of the claimed invention. See, e.g., Moba, B.V. v. Diamond Automation, Inc., 325 F.3d 1306, 1319, 66 USPQ2d 1429, 1438 (Fed. Cir. 2003); Vas-Cath, Inc. v. Mahurkar, 935 F.2d at 1563, 19 USPQ2d at 1116.
An applicant shows possession of the claimed invention by describing the claimed invention with all of its limitations using such descriptive means as words, structures, figures, diagrams, and formulas that fully set forth the claimed invention. Lockwood v. Amer. Airlines, Inc., 107 F.3d 1565, 1572, 41 USPQ2d 1961, 1966 (Fed. Cir. 1997). Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was "ready for patenting" such as by the disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention. See, e.g., Pfaffv. Wells Bees., Inc., 525 U.S. 55, 68, 119 S.Ct. 304, 312, 48 USPQ2d 1641, 1647 (1998); EliLilly, 119 F.3d at 1568, 43 USPQ2d at 1406; Amgen, Inc. v. Chugai Pharm.,927 F.2d 1200, 1206, 18 USPQ2d 1016, 1021 (Fed. Cir. 1991). An application specification may show actual reduction to practice by describing testing of the claimed invention.
In the present case, the important factors leading to a conclusion of inadequate written description is the lack of a representative number of species that characterizes the entire claimed genus disclosed within the instant specification.
In the instant specification, there is no disclosure of compounds having the following claimed substituents:
A as O or N combined through either single or double bonds to form a five-member heteroaromatic ring of 1-3 carbon atoms, 0-3 nitrogen atoms, 0-1 oxygen atom, and 0 sulfur atoms;
R3 as a monovalent substituent group independently selected from alkenyl, alkoxy, alkynal, having from 1 to 12 carbons, amidino, aryloxy, azido, azo, carbamate, carbonyl, cycloalkyl, guanidino, heteroaryl, heterocyclyl, hydroxyl, imino, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, or thiol, and, when said substituent group is alkenyl, alkoxy, alkyl, alkynal, amido, amidino, aminoalkyl, aminoaryl, aryl, aryloxy, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cycloalkyl, ester, guanidino, heteroaryl, heterocyclyl, imino, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, or thiocarbonyl, said substituent group may be further substituted with 0-3 groups independently selected from alkenoxy, alkenyl, alkoxy, alkylamino, alkynal, alkynoxy, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, arylalkyl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, ether, guanidino, haloalkoxy, haloalkyl, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, thioether, or thiol;
n as 1-3;
m as 2 or 3;
Y as —COCH2—,—CO—, —CH2—, —CH(CH3)—, —NHCO—, —NCH3CO—, —CONH—, —CONCH3—, —O(CO)—, —(CO)O—, —NH—, or —O—;
R1 as a divalent non-aromatic, heterocyclic ring of 5 or 7 members containing 0-1 nitrogen atoms, 0-1 oxygen atom, and 3 or 5-6 carbon atoms, with the proviso that Y and R2 are separated by at least 3 atoms, which non-aromatic, heterocyclic ring may bear 0-3 substituent groups defined as for R3, with the proviso that two or more such substituent groups on R1 may be fused with R1 to form one or more cycloalkyl, heterocyclic, aromatic, or heteroaromatic rings, or alternatively R1 may be fused, optionally incorporating 0-2 substituent groups, with R2 to form a fused heterocyclyl ring of 3-7 members, optionally substituted with 0-2 substituent groups defined as for R3;
R2 as a 5- or 6-membered heteroaryl ring bearing 3-4 substituent groups independently selected from substituent groups defined as for R3, or substituents on R2 may be optionally fused to R2 to form one or more cycloalkyl, or aryl, or 0 -2 R2 substituents may, together with R1, form a fused substituted or unsubstituted heterocyclyl ring bearing 0-2 additional substituents selected from alkenoxy, alkenyl, alkoxy, alkyl, alkylamino, alkynal, alkynoxy, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, arylalkyl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, ether, guanidino, haloalkoxy, haloalkyl, halogen, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, thioether, or thiol;
G as C;
q as 1-4;
R6 is as defined for the breadth of R3, with the additional proviso that R6 substituents on the heterocyclic ring containing G may be optionally fused to each other or a carbon atom of the ring containing G to form one or more cycloalkyl, heterocyclic, aromatic, or heteroaromatic rings; or 0-2 substituents on the heterocyclic ring containing G may, together with R2, form a fused substituted or unsubstituted cycloalkyl or heterocyclyl ring bearing 0-2 additional substituents selected from alkenoxy, alkenyl, alkoxy, alkyl, alkylamino, alkynal, alkynoxy, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, arylalkyl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, ether, guanidino, haloalkoxy, haloalkyl, halo, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, thioether, or thiol;
The instant specification (pages 12-14, 18-21, 32-35, 41-53, and 57-62) teaches compounds which are characterized as having only the following substituents:
A is C and S, combined through either single or double bonds to form a five-member heteroaromatic ring of 4 carbon atoms and 1 sulfur atom;
R3 is a monovalent substituent group independently selected alkyl, amido, amino, aminoalkyl, aminoaryl, aryl, carbamide, carboxamido, carboxylate, cyano, ester, halo, nitro, when said substituent group is alkyl, amido, aminoalkyl, carbonyl, carboxamido, ester, said substituent group may be further substituted with 0-3 groups independently selected from alkyl and halo
n is 0
m is 0 and 1
Y is—SO2—
R1 is an unsubstituted divalent non-aromatic, heterocyclic ring of 6 members containing 2 nitrogen atoms and 4 carbon atoms
R2 is a 5- or 6-membered heteroaryl ring bearing 0-2 substituent groups independently selected from substituent groups defined as for R3, or substituents on R2 may be optionally fused to R2 to form one or more cycloalkyl, heterocyclic, or heteroaryl rings
G is N
q is 0
R6 is CH3
Therefore, the compounds described in the instant specification detail only a limited number of the total substituents claimed (see substituents 1-10, above). All working examples presented in the instant specification are related to the compounds containing a fraction of the total claimed substituents (see substituents 21-30, above).
There are no working examples in the instant specification for the wide range of substituents claimed, but for which evidence of possession has not been provided (see substituents 11-20, above). Thus, the instant specification does not provide any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application.
Vas-Cath Inc. Mahurkar, 19 USPQ2d 1111, makes clear the "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. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
Finally, University of California v. Eli Lilly and Co., 43 USPQ2d 1398, 1404, 1405 held that: ...To fulfill the written description requirement, a 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." Lockwood v. American Airlines, Inc., 107 F. 3d 1565, 1572, 41 USPQ2d 1961, 1966(1997); In re Gosteli, 872 F.2d 1008, 1012,10 USPQ2d 1614, 1618 (Fed Cir. 1989) ("[T]he 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, 41 USPQ2d at 1966.
It is noted that the pharmaceutical art is unpredictable, requiring each embodiment to be individually assessed for physiological activity. For inventions in emerging and unpredictable technologies, or for inventions characterized by factors not reasonably predictable which are known to one of ordinary skill in the art, more evidence is required to show possession. For example, disclosure of only a method of making the invention and the function may not be sufficient to support a product claim other than a product-by-process claim. See, e.g., Fiers v. Revel, 984 F.2d at 1169, 25 USPQ2d at 1605; Amgen, 927 F.2d at 1206, 18 USPQ2d at 1021.
Thus, since Applicant has not described in adequate detail methods to synthesize compounds containing the claimed substituents, or provided evidence that said compounds have been characterized, or that they exist, an ordinary skilled artisan could not completely envisage Applicants’ invention. Moreover, it is clear that the written description requirement has not been met since Applicant has not provided any evidence that Applicant was in possession of the claimed invention prior to the effective filing of the instant application. Thus, claims 23-25 of the instant application are not supported by the instant specification and thus a rejection under 35 U.S.C. § 112 (a) for failing to comply with the written description requirement is proper.
Improper Markush Rejection
Claims 23-25 are rejected on the basis of containing an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984). A Markush grouping is proper if the alternatives defined by the Markush group (i.e., alternatives from which a selection is to be made in the context of a combination or process, or alternative chemical compounds as a whole) share a “single structural similarity” and a common use. A Markush grouping meets these requirements in two situations. First, a Markush grouping is proper if the alternatives are all members of the same recognized physical or chemical class or the same art-recognized class, and are disclosed in the specification or known in the art to be functionally equivalent and have a common use. Second, where a Markush grouping describes alternative chemical compounds, whether by words or chemical formulas, and the alternatives do not belong to a recognized class as set forth above, the members of the Markush grouping may be considered to share a “single structural similarity” and common use where the alternatives share both a substantial structural feature and a common use that flows from the substantial structural feature. See MPEP § 2117.
The Markush grouping of claims 23-25 is improper because the alternatives defined by the Markush grouping do not share a single structural similarity. The cited claims of the instant application claim a compound represented by the following general formulas recited in claims 23, 24, and 25 as Formulas (I), (I(a)), and (I(b)), respectively.
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Each of the general formulas recited in the claims have independent and distinct core structures that are not obvious variants of the other, as outlined further below.
This determination is based on the recitation of A, Y, and R1 that form the core of the compounds—whose definitions as instantly claimed result in a widely varied compounds that do not share a common core structure.
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For example, regarding the definition of A, wherein “A is independently selected from C, S, O or N combined through either single or double bonds to form a five-member heteroaromatic ring of 1-4 carbon atoms, 0-3 nitrogen atoms, 0-1 oxygen atom, and 0-1 sulfur atom,” this definition would result in a myriad of structurally distinct ring moieties. Some limited examples of possible ring moieties are included herein (right), which vary both in their structural composition, as well as in their chemical properties. As a result, the definition of A in Formulas (I), (I(a)), and (I(a)) is determined to be an improper Markush grouping.
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Regarding the definition of Y, as a “group comprising, —COCH2—, —SO2—, —CO—, —CH2—, —CH(CH3)—, —NHCO—, —NCH3CO—, —CONH—, —CONCH3—, —O(CO)—, —(CO)O—, —NH—, or —O—," this includes a wide range of chemical linkages, such as sulfonates, amides, amines, ethers, etc.—all of which differ in their structural composition and resultant chemical properties. As a result, the definition of Y in Formulas (I), (I(a)), and (I(a)) is determined to be an improper Markush grouping. Regarding the definition of R1 wherein “R1 is a divalent non-aromatic, heterocyclic ring of 5-7 members containing 0-2 nitrogen atoms, 0-1 oxygen atom, and 3-6 carbon atoms, … with the proviso that two or more such substituent groups on R1 may be fused with R1 to form one or more cycloalkyl, heterocyclic, aromatic, or heteroaromatic rings,” his definition would result in a myriad of structurally distinct ring moieties. Some limited examples of possible ring moieties are included herein (above, left), which vary both in their structural composition, as well as in their chemical properties. As a result, the definition of R1 in Formula (I) is determined to be an improper Markush grouping.
Moreover, the general formulas are patentably distinct from one another because the core structures are different and are not obvious variants for one another.
Members of a Markush group share a "single structural similarity" when they belong to the same recognized physical or chemical class or to the same art-recognized class. A recognized physical class, a recognized chemical class, or an art-recognized class is a class wherein there is an expectation from the knowledge in the art that members of the class will behave in the same way in the context of the claimed invention. In other words, each member could be substituted one for the other, with the expectation that the same intended result would be achieved. Such is not the case in the instant claims because none of the rings in each of the core structures of each of the general formulas are obvious variants nor could they be substituted for one another with a reasonable expectation of similar results.
Thus the claims are rejected since the Markush claim contains an improper Markush grouping because the members of the Markush group do not share a single structural similarity.
To overcome this rejection, Applicant may set forth each alternative (or grouping of patentably indistinct alternatives) within an improper Markush grouping in a series of independent or dependent claims and/or present convincing arguments that the group members recited in the alternative within a single claim in fact share a single structural similarity as well as a common use.
Claim Rejections - 35 U.S.C. § 112 (b)
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 23 and 26 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.
Regarding claim 23, the claim recites “Y.. is selected from the group comprising.” According to the broadest reasonable interpretation set forth by MPEP §211.03, the transitional term “comprising,” is open ended and does not exclude additional, un-recited elements. This is considered indefinite because it is unclear what other alternatives are intended to be encompassed by the claim limitation. A Markush grouping is a closed group of alternatives, i.e., the selection is made from a group “consisting of” rather than “comprising”, “having” or “including”. Pursuant to MPEP §2173.05(h), if a Markush grouping requires a material selected from an open list of alternatives, the claim should be rejected under 35 U.S.C. § 112 (b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim.
Regarding claim 26, the claim recites compounds of very poor resolution, which are difficult to read and discern. For instance, the following example compound found on page 6 of the claim set filed 05/28/2026 contains a substituent on R2 which is not sufficiently legible
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. A person of ordinary skill in the art would not be able to ascertain the identity of the substituent—It could be -ON, -CN, or the like. As such, the claim is determined to be indefinite, as the low-resolution of the compounds does not permit a person of ordinary skill in the art to ascertain the structure of the compounds as recited.
The issue in resolution of the two-dimensional structures is present throughout the claim, and is not limited to the aforementioned compound. In the interest of brevity, Applicant is directed to revise the two-dimensional structures recited to include compounds of higher resolution to represent the two-dimensional structures of the compounds.
Further regarding claim 26, within the definition of R1, the claim recites wherein, “R1 may be fused, optionally incorporating 0-2 substituent groups, with R2 to form a fused heterocycle ring of 3-7 members, optionally substituted with 0-2 substituent groups.” However, neither the claim nor the specification defines what it means for substituent group to be “incorporated” into a fused ring as a distinction from being a substituent on that ring. The fused ring is separately recited to be “optionally substituted.” Under the broadest reasonable interpretation as set forth by MPEP § 2111, a “substituent group” is defined as an exocyclic moiety. Therefore, it is unclear whether “incorporating” required the substituents atoms to be part of the ring skeleton itself, or is instead a redundant statement of ordinary substitution. If R1 is fused with R2, this will necessarily incorporate at least one atom. It is unclear which substituent groups are incorporated, and where within the fused heterocycle ring. A person of ordinary skill would not be able to ascertain the limitations of the claim as written. For the reasons set forth above, the claim is determined to be indefinite.
Claim Rejections - 35 U.S.C. § 112 (d)
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.
Claim 26 is 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.
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Regarding claim 26, the claim recites several compounds in which is R3 is an oligoethylene glycol ester—such as in the following compound (right). This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R3 in claim 23, on which claim 23 is based. Specifically, R3 is defined only as being monovalent substituent group independently selected from alkenyl, alkoxy, alkyl, alkynal, having from 1 to 12 carbons, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, guanidino, halo, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, or thiol, and, when said substituent group is alkenyl, alkoxy, alkyl, alkynal, amido, amidino, aminoalkyl, aminoaryl, aryl, aryloxy, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cycloalkyl, ester, guanidino, heteroaryl, heterocyclyl, imino, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, or thiocarbonyl, said substituent group may be further substituted with 0-3 groups independently selected from alkenoxy, alkenyl, alkoxy, alkyl, alkylamino, alkynal, alkynoxy, amido, amidino, amino, aminoalkyl, aminoaryl, aryl, arylalkyl, aryloxy, azido, azo, carbamate, carbamide, carbonyl, carboxamido, carboxylate, cyano, cycloalkyl, ester, ether, guanidino, haloalkoxy, haloalkyl, halo, heteroaryl, heterocyclyl, hydroxyl, imino, nitro, phosphate, sulfinyl, sulfonamidyl, sulfonyl, thioalkyl, thioaryl, thiocarbonyl, thioether, or thiol, and not as being oligoethylene glycol ester. For all the reasons set forth above, a compound wherein R3 is oligoethylene glycol ester is not encompassed by the limitations of instant claim 23, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
Further regarding claim 26, the claim recites several compounds (page 7) in which either R3 is N=O, also known as N-oxide substituent—such as in
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the following compound (left). This limitation contains subject matter that is not within the scope of the claim on which it depends. This determination is based on the definition of R3 in claim 23, on which claim 26 is based. Specifically, R3 is defined only as being the substituents set forth above, and not as being N-oxide. For all the reasons set forth above, a compound wherein R3 is N-oxide is not encompassed by the limitations of instant claim 1, nor is it encompassed by any special definition found within the instant specification. As such, it has been determined that this claim limitation contains subject matter that is not within the scope of the claim on which it depends.
With respect to the example compounds included within the above rejections based on subject matter that is not within the scope of the claim on which it depends: the exemplary compounds are in no way a complete listing of the compounds within the claim. Over 90 unique compounds have been listed in claim 98. In the interest of brevity, only singular examples of the various substituents which contain subject matter that is not within the scope of claim 23 have been included so as to guide Applicant. To make the record clear, many more compounds listed in claim 6 are identified as including subject matter beyond that which is defined by claim 23. Applicant is expected to properly address every instance in which unsupported subject matter is included in all compounds in any forthcoming amendments to claim 26 based on the substituents identified herein. Particular attention should be paid to MPEP § 608.04, regarding new matter upon amendment of the instant dependent claim, as well as the independent claim.
Claim Rejections - 35 U.S.C. § 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.
(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.
Claims 23-25 are rejected under 35 U.S.C. § 102(a)(1) as being anticipated by Aurora Fine Chemicals, hereinafter Aurora, teaches CAS Registry Number: RN 932347-69-8. [Database Registry Chemical Abstracts Service, Columbus, Ohio, Accession No. RN 932347-69-8.
The instant claims are drawn to a compound of Formula (I) (see Figure 2a, below).
Figure 2. Structural comparison of prior art compound and instantly claimed Formula (I)
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Figure 2. a) instantly claimed Formula (I); b) Aurora Fine Chemicals CAS Registry Number: RN 932347-69-8
Regarding Formula (I), the compound taught by Aurora, anticipates the instant claims according to Figure 1, wherein:
A is S and C, where in there are 1 S and 4 C atoms
m is 0
n is 0
Y is —SO2—
R1 is a divalent non-aromatic, heterocyclic ring of 6 members containing 2 nitrogen atoms
R2 is a 5- or 6-membered heteroaryl ring
Regarding Formula (II) Q-Y-R1-R2,
Q is a heteroaryl ring of 5 members having group Y bound to the ring at a non-adjacent site to a 6-pyridazin-3-(2H)-one
Y is —SO2—
R1 is divalent non-aromatic heterocyclic ring of 6 members containing 2 nitrogen atoms
R2 is a 6-membered heteroaryl ring
See MPEP § 2128 “Printed Publications” as prior art. An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. § 102 (a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981): since this date represents the date that each compound entered the REGISTRY database on STN, this represents the date that each compound was made accessible to the public.
It is further noted that for the purposes of determining if a reference is a “printed publication,” MPEP § 2128 (I) states the following:
A reference is proven to be a "printed publication" "upon a satisfactory showing that such document has been disseminated or otherwise made available to the extent that persons interested and ordinarily skilled in the subject matter or art, exercising reasonable diligence, can locate it." In re Wyer, 655 F.2d 221, 210 USPQ 790 (CCPA 1981) (quoting I.C.E. Corp. v. Armco Steel Corp., 250 F. Supp. 738, 743, 148 USPQ 537, 540 (SDNY 1966)) ("We agree that ‘printed publication’ should be approached as a unitary concept.
where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
The prior art compound anticipates the compounds described by Formula (I/II) in claims 26 and 32 of the instant application. CAS Registry number RN 932347-69-8 is available as prior art as of 25 Apr 2007, the day it was indexed into the REGISTRY database.
Correspondence
Claim 26 is objected to.
Claims 23-26 are rejected.
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/SOPHIA P HIRAKIS/Examiner, Art Unit 1623
/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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