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 .
Receipt of the response filed on 06/23/2026 regarding the restriction/election requirement is acknowledged. Claims 1-3, 6-7, 9, 11-12, 14, 17-19, 21, 28 and 31-35 are currently pending in this Application.
Response to Election/Restriction
Applicant's election, with traverse, of Group I, drawn to a compound of formula (I)
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, (I’)
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or (III)
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, and pharmaceutical composition , and species Example 60
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, in the reply filed of June 23, 2026 is acknowledged. Claims 1, 3, 9, 11-12, 17, 21, 28, 31-32 and 34 read on the elected species.
The traversal is on the grounds that MPEP 803.02 states that if the search and examination can be made without serious burden, the Examiner must examine it on the merits. Applicant argues that it would not place an undue burden on the Examiner to search the subject matter of Groups II and III.
Applicant’s argument is found unpersuasive for the reasons of record and the following reasons. Applicant is reminded that this application is a National Stage Application submitted under 35 USC 371, and as such unity of invention (not restriction practice pursuant to 37 CFR 1.141 - 1.146 ) is applicable. See MPEP 1893.03(d). The examiner previously stated that under PCT Rule 13.1 and 13.2 the claims herein lack unity of invention. Arguments that the search would not impose a serious burden on the Office are not germane to the showing of Lack of Unity. MPEP 1893.03(d) states, “The expression special technical features is defined as meaning those technical features that define the contribution which each claimed invention, considered as a whole, makes over the prior art.” In this case, all that is common among the compound and method groups is the compounds, but these are not novel; see the reference cited in the restriction requirement. Therefore, the technical feature fails to make a “contribution” over the prior art, and therefore fails to constitute a “special technical feature.” See PCT International Search and Preliminary Examination Guidelines, as in force from March 25, 2004, chapter 10, page 80 section 10.21, Example 1, stating “However, if substance X is known in the art, unity would be lacking because there would not be a special technical feature common to all the claims.”
The requirement is deemed proper and therefore made FINAL.
Claims 2, 6-7, 14, 18-19, 33, 35 and 36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 06/23/2026.
Examination
Examination will begin with the elected species. In accordance with 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 be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
A search for the elected species yielded relevant prior art and therefore, the search and examination were stopped, and art has been applied against the claims. The elected species is not allowable.
The need to limit examination is warranted based on the extensive permutations permitted on all the available variables, which require separate electronic searches and which structures are classified in different classes.
Subject matter outside of the searched/examined scope are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to non-elected inventions there being no allowable generic or linking claim.
Specification Objection - Abstract
Applicant is reminded of the proper content of an abstract of the disclosure.
With regard particularly to chemical patents, for compounds or compositions, the general nature of the compound or composition should be given as well as the use thereof, e.g., The compounds are of the class of alkyl benzene sulfonyl ureas, useful as oral anti-diabetics. Exemplification of a species could be illustrative of members of the class. For processes, the reactions, reagents and process conditions should be stated, generally illustrated by a single example, unless variations are necessary. See MPEP § 608.01(b), Section B.
The abstract of the disclosure is unrelated to the disclosure of this application. A new abstract is required that is indicative of the current application and that illustrates the compounds in this application and their claimed use.
Correction is required. See MPEP § 608.01(b).
Specification Objection - Drawings
The drawings at Fig. 1 and 2 appear to be incomplete and have errors. From the graph, it is unclear what the following means:
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. In addition, it is unclear why the graphs have dots representing the same compound dispersed vertically. In addition, the graphs lack the time at which the lung and spleen burden were measured or each item.
Specification Objection -
Table 2 appears to have incorrect data. It does not represent the results discussed at Example 54. IC50 studies that refer to Table 2. Table 2 appears to be a copy of Table 1.
Applicant is advised that if material is added which is not supported by the original disclosure the introduction of new matter into the disclosure will be objected toand applicant will be required to cancel the new matter.
35 U.S.C. 132(a) states that no amendment shall introduce new matter into the disclosure of the invention.
Improper Markush Grouping Rejection
Claims 1, 3, 9, 11-12, 17, 21, 28, 31-32 and 34 are rejected as being drawn to an improper Markush group of alternatives. The claims are drawn to multiple inventions due to the lack of a common core between the compounds and the unlimited variations in the variables. 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 § 706.03(y).
The Markush grouping of the rejected claims is improper because the alternatives defined by the Markush grouping do not share both a substantial structural feature and a common use. There are marked structural differences in the compounds claimed. There is no common core or substantial structural feature shared among the compounds. See all the variables and distinct classes of rings encompassed by the definitions for X1-X7, G, X1a, and R1-R8 in the formula (I)
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, (I’)
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or (III)
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. The amount of structural variation present is enormous given the presence of no fixed core and the permutations of the variables, which vary extensively, some even forming additional rings (e.g., R1 +R1, X2-X4 , R6+R7 and R2+R3 ), and which are not considered as art-recognized equivalents. A common use would not be expected from the structurally dissimilar compounds.
In re Thompson and Tanner, 69 USPQ 148, In re Swenson, 56 USPQ 180, and In re Kingston, 65 USPQ 371. Note In re Milas 71 USPQ 212 in which the structural difference between vitamin A and D was sufficient to uphold the improper Markush rejection. Also see In re Winnek 73 USPQ 225 and In re Ruzicka 66 USPQ 226 in which structural differences were small and yet a similar holding was maintained. All these cases involved compounds in the pharmaceutical art known to be structure-sensitive. Of particular interest is Ex Parte Hozumi, 3 USPQ2d 1059, which reversed an improper Markush rejection “in view of the relatively large proportion of the structure of the compounds in the claimed class which is common to the entire class”. In contrast the amount of structural variation present herein is enormous given the presence of no common core and all the variables with their extensive variations, which are not all considered as art-recognized equivalents. All these cases involved compounds in the pharmaceutical art known to be structure-sensitive.
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 1, 3, 9, 11-12, 17, 21, 28, 31-32 and 34 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention. Applicants claim a compound of formula (I)
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, (I’)
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And a compound of formula (III)
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To provide adequate written description and evidence of possession of a claimed genus, the specification must provide sufficient distinguishing characteristics of the genus. The factors to be considered include disclosure of complete or partial structure, physical and/or chemical properties, functional characteristics, structure/function correlation, methods of making the claimed product, or any combination thereof.
A description of a genus may be achieved by means of a recitation of a representative number of species falling within the scope of the genus or of a recitation of structural features common to the members of the genus, which features constitute a substantial portion of the genus. Regents of the University of California v. Eli Lilly & Co., 119 F3d 1559, 1569, 43 USPQ2d 1398, 1406 (Fed. Cir. 1997). In Regents of the University of California v. Eli Lilly (43 USPQ2d 1398-1412), the court held that a generic statement which defines a genus of nucleic acids by only their functional activity does not provide an adequate written description of the genus. The court indicated that, while applicants are not required to disclose every species encompassed by a genus, the description of the genus is achieved by the recitation of a representative number of species falling within the scope of the claimed genus. At section B(i), the court states, "An adequate written description of a DNA ... requires a precise definition, such as by structure, formula, chemical name, or physical properties, not a mere wish or plan for obtaining the claimed chemical invention."
The scope of the claims covers billions of compounds under the genus of the formula, polymorphs and prodrugs. The claims are drawn to different classes of chemical compounds with divergent structure. There is no common structural feature in the genus claimed, all varies greatly to form very distinct compounds. In addition, the specification of this application does not describe the manner and process of making and using the full scope of the claimed compounds, polymorphs and prodrugs. It appears that 67 compounds were exemplified in the specification. The 67 exemplified compounds represent an extremely small portion of the invention that is being claimed, and contain only very similar groups. No prodrugs or polymorphs were exemplified. The specification describes how to prepare compounds that were exemplified, however, does not disclose how to make any other compound of the claimed genus. The ordinary chemist would not expect that the widely varied compounds claimed would be prepared in a similar way as those exemplified. The specification lacks written description of the manner and process of making the full scope of the claimed invention.
The invention is in a class of inventions which the CAFC has characterized as "the unpredictable arts such as chemistry and biology." Mycogen Plant Sci., Inc. v. Monsanto Co., 243 F.3d 1316, 1330 (Fed. Cir. 2001). The state of the art is that “chemical reactions are known as unpredictable”. In re Marzocchi, et al., 169 USPQ 367, 370 (CCPA 1971); In re Fisher, 166 USPQ 18, 24 (CCPA 1970).
“The examples and description should be of sufficient scope as to justify the scope of the claims”. See MPEP § 608.01(p). “If a representative number of adequately described species are not disclosed for a genus, the claim to that genus must be rejected as lacking adequate written description under 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph.” (MPEP 2163). A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014) (Claims directed to a functionally defined genus of antibodies were not supported by a disclosure that "only describe[d] one type of structurally similar antibodies" that "are not representative of the full variety or scope of the genus."). In this case, the few species exemplified are not a “representative number of species” that would account for all the variation within the claimed genus.
In addition, the genus of the claims profess that all types of compounds claimed here will have the same use. Applicant’s assumption that the very structurally different compounds included in the claims will work the same way is scientifically unreasonable. The disclosure here does not have sufficient guidance and data for one of ordinary skill in the art to extrapolate the basic structural features required in the compounds for the claimed activity. In this case, it is not possible to figure out what compounds would be active for the described use since structurally similar compounds that were tested against tuberculosis and nontuberculous mycobacterial infection did not work. See the IC50 studies, the in vivo studies and Figures. For example, even at 200 mg/kg compounds 31 and 19 were not efficient to reduce lung burden. See Fig. 1 Applicant has only properly described how to use those compounds that have been found efficient for the claimed use. Applicant has not described with reasonable clarity how to use the full scope of the claimed invention.
A need for greater disclosure derives from the fact it is not obvious from the disclosure of one species, what other species will work.
"A patentee will not be deemed to have invented species sufficient to constitute the genus by virtue of having disclosed a single species when … the evidence indicates ordinary artisans could not predict the operability in the invention of any species other than the one disclosed." In re Curtis, 354 F.3d 1347, 1358, 69 USPQ2d 1274, 1282 (Fed. Cir. 2004)”. The Federal Circuit has explained that a specification cannot always support expansive claim language and satisfy the requirements of 35 U.S.C. 112 "merely by clearly describing one embodiment of the thing claimed." LizardTech v. Earth Resource Mapping, Inc., 424 F.3d 1336, 1346, 76 USPQ2d 1731, 1733 (Fed. Cir. 2005). The issue is whether a person skilled in the art would understand applicant to have invented, and been in possession of, the invention as broadly claimed.
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"). Accordingly, it is deemed that the specification does not describe in sufficient detail the genus of compounds in the claims, how to make them and how to use them, and does not reasonably convey to one skilled in the relevant art that the inventor(s), at the time the application was filed, had possession of the entire scope of the claimed invention.
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, 3, 9, 11-12, 17, 21, 28, 31-32 and 34 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.
Claims 1 and 32 recite that X1 is O, however, the claimed compound in which oxygen has three bonds cannot exist.
In claims 1, 28 and 32, the recitations of “R5 can be H or R1” and “R2 and R3 can each independently be” are interpreted as open language. This language makes the claims indefinite because it is unclear what other alternatives are intended to be encompassed by the claims. A Markush grouping is a closed group of alternatives. Pursuant to MPEP 2173.05(h), if a Markush grouping requires a material selected from an open list of alternatives, the claim should generally be rejected under 35 USC 112(b) as indefinite because it is unclear what other alternatives are intended to be encompassed by the claim. “R5 can be H or R1” and “R2 and R3 can each independently be” allow for inclusion of indefinite number of members. This rejection can be overcome by replacing the “can be” with “is” or “are”.
Claim 17 describes the following two structures
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which represent exactly the same. It is noted that X7 and X6 have the same exact definition. Thus, there is no difference between the first and second structure. Appropriate correction is required.
The dependent claims contain the same issues as the independent claims and are therefore rejected.
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.
Claim(s) 1, 3, 9, 11-12, 17, 21, 28, 31-32 and 34 are rejected under 35 U.S.C. 102(a)(1) as being clearly anticipated by Day et al. (WO 2019/169158).
The prior art teaches pharmaceutical compositions comprising carriers and antimycobacterial heterocyclic amides of the Formula (I)
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This teaching anticipates claims 1, 3, 9, 11-12, 17, 21, 28, 31-32 and 34.
For particular embodiments see the example section and the table. Compound #151 of formula
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was taught by the prior art and anticipates instant claims 1, 3, 9, 11-12, 17, 21, 28, 31 and 34. See the table and claim 4 of Day et al.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 1, 3, 9, 11-12, 17, 21, 28, 31-32 and 34 are rejected under 35 U.S.C. 103 as obvious over Day et al. (WO 2019/169158) above.
Applicant claims a compound of formula I
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Determination of the Scope and Content of the Prior Art (MPEP §2141.01)
As in the 102 rejection above, Day disclosed compounds of Formula I
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for the treatment of mycobacterial infections, such as tuberculosis, in which particular embodiments prepared contained a 5,6-halo-1H-1,3-benzodiazol-2-yl core. Exemplary embodiments are compounds 119, 151 and 164. Compound #151 has the following structure:
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.
Day disclosed that in the compounds of Formula (I), the structure of formula
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includes “1-methylcyclohexane-1-carbonyl”. See at least claim 3 and exemplary compounds 133, 134 and 135.
Ascertainment of the Difference Between Scope the Prior Art and the Claims
(MPEP §2141.012)
The elected species is generically described by the Formula (I) of Day et al., however, Day et al. did not prepare the elected species.
Finding of prima facie obviousness--rational and motivation (MPEP §2142-2413)
One of ordinary skill in the art is a chemist practitioner with the knowledge and skills of the authors of the cited reference. Day taught that the antimycobacterial heterocyclic amides compounds of Formula I
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in which the structure of formula
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is “1-methylcyclohexane-1-carbonyl” and the core is 5,6-halo-1H-1,3-benzodiazol-2-yl core are particularly useful for the treatment of diseases such as tuberculosis. Artisans interested in antimycobacterial heterocyclic amides having said uses would have found the Formula I and compound examples of Day et al. to be appropriate leads on the basis of their known biological activity. Once the artisans would have found these to be appropriate leads, they would have been motivated to follow the teachings of Day to make and use the compounds of Formula I wherein formula
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is “1-methylcyclohexane-1-carbonyl” and the core is 5,6-dichloro-1H-1,3-benzodiazol-2-yl core
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, because Day taught that this would provide additional compounds with the same advantageous properties against mycobacterial infections. The groups in the exemplified compounds of Day et al., and particularly in compound #151
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with formula
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being “1-methylcyclohexane-1-carbonyl”, provide support and motivation for the selection of the species of formula
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from the prior art genus.
It has been held that a prior art disclosed genus of useful compounds is sufficient to render prima facie obvious a species falling within a genus. In re Susi, 440 F.2d 442, 169 USPQ 423, 425 (CCPA 1971). MPEP 2144.08: The closer the physical and/or chemical similarities between the claimed species or subgenus and any exemplary species or subgenus disclosed in the prior art, the greater the expectation that the claimed subject matter will function in an equivalent manner to the genus. See, e.g., Dillon, 919 F.2d at 696, 16 USPQ2d at 1904 (and cases cited therein). Cf. Baird, 16 F.3d at 382-83, 29 USPQ2d at 1552 (disclosure of dissimilar species can provide teaching away).
Applicant is selecting a compound species from the genus of the prior art, however, the indiscriminate selection of “some” among “many” is prima facie obvious, In re Lemin, 141 USPQ 814 (C.C.P.A. 1964). The motivation to make and use the claimed compound derives from the expectation that structurally similar compounds would have similar use.
In addition, pursuant to MPEP 2144.09: A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990) for an extensive review of the case law pertaining to obviousness based on close structural similarity of chemical compounds. The elected species and compound #151 of Day are methyl homologues and so very close in structure, and having the same exact utility.
Conclusion
Claims 1, 3, 9, 11-12, 17, 21, 28, 31-32 and 34 are rejected. No claim is allowable.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to VALERIE RODRIGUEZ-GARCIA whose telephone number is (571)270-5865. The examiner can normally be reached Monday-Friday 9:30am-5:30pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached at 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/VALERIE RODRIGUEZ-GARCIA/Primary Examiner, Art Unit 1621
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