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 .
Status of Claims
The amendments to the claims filed November 15, 2023 are acknowledged and entered. Claims 1-24 and 27 are pending.
Priority
This application is a 371 of PCT/US2021/053865, filed October 6, 2021, which claims benefit of 63/088,883 filed October 7, 2020.
Specification
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any of the errors of which applicant may become aware of in the specification.
Information Disclosure Statement
Acknowledgement is made of the Information Disclosure Statements filed on January 5, 2024 and October 21, 2025. All references have been considered except where marked with a strikethrough.
Election/Restriction
Applicant’s election without traverse of species of Formula I (Compound 29; pictured below for convenience) in the reply filed on October 21, 2025 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)). Therefore this restriction is considered proper and thus made FINAL.
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The elected species corresponds to Formula I wherein
Ring A is
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which corresponds to
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substituted with phenyl, wherein A-2 contains four unsaturated bonds and 3 ring carbon atoms are replaced by nitrogen; and Z is phenyl. Applicant submits that claims 1, 6, 8, 23, 24 and 27 encompass the elected species.
The guidelines in MPEP § 803.02 provide that upon examination if prior art is found for the elected species, the examination will be limited to the elected species. Relevant portion of MPEP § 803.02 is provided here for convenience:
As an example, in the case of an application with a Markush-type claim drawn to the compound X-R, wherein R is a radical selected from the group consisting of A, B, C, D, and E, the examiner may require a provisional election of a single species, XA, XB, XC, XD, or XE. The Markush-type claim would then be examined fully with respect to the elected species and any species considered to be clearly unpatentable over the elected species. If on examination the elected species is found to be anticipated or rendered obvious by prior art, the Markush-type claim and claims to the elected species shall be rejected, and claims to the nonelected species would be held withdrawn from further consideration. A second action on the rejected claims can be made final unless the examiner introduces a new ground of rejection that is neither necessitated by applicant’s amendment of the claims nor based on information submitted in an information disclosure statement filed during the period set forth in 37 CFR 1.97(c) with the fee set forth in 37 CFR 1.17(p). See MPEP § 706.07(a).
If the elected species or group of patentably indistinct species is not anticipated by or obvious over the prior art, the examiner should extend the search and examination to a non-elected species or group of species that falls within the scope of a proper Markush grouping that includes the elected species. The search and examination should be continued until either (1) prior art is found that anticipates or renders obvious a species that falls within the scope of a proper Markush grouping that includes the elected species, or (2) it is determined that no prior art rejection of any species that falls within the scope of a proper Markush grouping that includes the elected species can be made. The examiner need not extend the search beyond a proper Markush grouping. In other words, the examiner need not extend the search to any additional species that do not share a single structural similarity and a common use with the elected species (i.e., do not belong to the same recognized physical or chemical class or to the same art-recognized class and/or do not have a common use and/or do not share a substantial structural feature of a chemical compound and a use that flows from the substantial structural feature). The examiner should continue examination of the Markush claim to determine whether it meets all other requirements of patentability (e.g., 35 U.S.C. 101 and 112, nonstatutory double patenting, and proper Markush grouping).
The elected species was not found in the prior art and the search was expanded to include the subgenus of Formula (I) wherein
Ring A is
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wherein A-2 has the structure
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; and Z is phenyl. And art was found. Claims 1, 6, 8, 23, 24 and 27 read on the expanded subgenus.
The examiner need not extend the search beyond a proper Markush grouping. Therefore the search has been limited to the abovementioned expanded subgenus of Formula I.
Accordingly, claims 2-5, 7 and 9-22 (in full) and claims 1, 6, 8, 23, 24 and 27 (all in part, other than the above indicated subgenus) are additionally withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species.
Claims Objections
Claims 6 and 23 are objected to because of the following informalities:
Claim 23, lines 1-2, recites “tautomer, deuterated derivative, or pharmaceutically acceptable salt”, and the final two lines of the claim also recites “tautomer, deuterated derivative, or pharmaceutically acceptable salt”. The phrases appear to be duplicative. Examiner recommends amending the claim so that it recites on one “tautomer, deuterated derivative, or pharmaceutically acceptable salt”.
Claim 6 is objected to for having extraneous text. The phrase indicated below is regarded as extraneous because the definitions of each of these variables carry over from the claim 1. For instance, in claim 6 the limitations of R1 carry over from claim 1 and do not need to be repeated. The extraneous phrase indicated below should be deleted.
Claim 6, final two lines, recite the extraneous phrase “R1 groups as defined in claim 1”
Appropriate correction is required.
Improper Markush Grouping Rejection
Claims 1, 6, 8, 23, 24 and 27 are rejected on the basis that they contain an improper Markush grouping of alternatives. See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 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 Ring A and Z is improper because the alternatives defined by the Markush grouping do not share both a single structural similarity and a common use for the following reasons:
The compounds embraced by the scope of Formula I are not all members of the same recognized physical or chemical class or the same art-recognized class. The claims are drawn to compounds comprising many different heterocyclic and carbocyclic groups which do not overlap. For instance, Ring A can be a bicyclic or tricyclic ring system corresponding to any of A1 to A-7 (pictured below), and the only requirements are that each of the structures contain one or more unsaturated bonds and at least one heteroatom. A1 to A-7 therefore include hundreds of different and nonoverlapping heterocyclic cores. Furthermore, Z can be phenyl or various different heterocyclic rings.
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The only structural feature which is required by the claims is the sulfonamide,
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; however, this is not substantial structural feature and there is no evidence to suggest the use of the compounds flow from this substructure. The claims are thus drawn to an improper Markush group, that is, the claims lack unity of invention. 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). In this case, there is no substantial structural feature in common between the compounds of the instant claims therefore this rejection is proper.
This rejection may be overcome by amending claims consistent with the elected species
Claim Rejections - 35 USC § 112a
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, 6, 8, 23, 24 and 27 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.
The claims require a “deuterated derivative”. The claims do not require that derivative possess any particular conserved structure, or other distinguishing feature, nor does the specification describe any derivatives of Formula I which are deuterated. Thus, the claims are drawn to a genus of compounds that is defined by novelty.
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). See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.”
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
Claim Rejections - 35 USC § 112b
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, 6, 8, 23, 24 and 27 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. [A] claim is indefinite when the boundaries of the protected subject matter are not clearly delineated and the scope is unclear (MPEP 2173.04). The following terms and/or phrases render the scope of the claims unclear because the specification does not provide sufficient direction for ascertaining the scope of the limitation indicated by the term or phrase. Accordingly, one skilled in the art could not ascertain the metes and bounds of the claimed invention. The claims are indefinite for the reasons that follow:
The claims require a “derivative” of Formula I (e.g. see claim 1, line 2; “deuterated derivative”). This limitation renders the scope of the invention unclear because the specification does not provide any limit or definition to what may be regarded as a deuterated derivative. The limitation includes derivatives of Formula I wherein a hydrogen atom is replaced by a deuterium atom; however, there is no direction provided for ascertaining what Applicant regards as a derivative of Formula I. The structure of a derivative of Formula I that is deuterated is open to different interpretations and therefore the metes and bounds of the invention cannot be ascertained.
In claim 24, “an effective amount” of the compound of claim 1 would be required to be present for the pharmaceutical composition to be effective. Insertion of the phrase “an effective amount” following “comprising” is suggested to indicate that what is intended.
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 and 24 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Gray et al. (WO2019147783)(hereinafter “Gray”).
Gray teaches compound 16 ([00196], pictured below for convenience) and a pharmaceutical composition thereof (Abstract; [0027]). Compound 16 corresponds to instant Formula I wherein Ring A is unsubstituted A-2 wherein A-2 has the structure
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; and Z is phenyl.
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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.
Claims 1 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Gray et al. (WO2019147783)(hereinafter “Gray”).
Gray teaches a generic group of compounds which embraces applicants’ claimed compounds (See pages 1-4) for use as pharmaceuticals and compositions for the treatment of cancer (Abstract, [0007]). The claims differ from the reference by reciting specific species and a more limited genus than the reference. However, it would have been obvious to one having ordinary skill in the art before the effective filing date of the invention to select any of the species of the genus taught by the reference, including those instantly claimed, because the skilled chemist would have the reasonable expectation that any of the species of the genus would have similar properties and, thus, the same use as taught for the genus as a whole. One of ordinary skill in the art would have been motivated to select the claimed compounds from the genus in the reference since such compounds would have been suggested by the reference as a whole. 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), followed by the Federal Circuit in Merck & Co. v. Biocraft Laboratories, 847 F.2d 804, 10 USPQ 2d 1843, 1846 (Fed. Cir. 1989).”
In the instant case, Gray teaches compound 16 which discussed the above rejection which corresponds to instant Formula I wherein Ring A is unsubstituted A-2 wherein A-2 has the structure
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; and Z is phenyl.
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The difference between compound 16 and the instant claims is that the instant claims require A-2b. The instant claims are therefore drawn to a positional isomer of the prior art compound and only differ regarding the point of attachment of Ring A in Formula I.
The instantly claimed compound would have been prima facie obvious to a person of ordinary skill in the art prior to the effective filing date of the instant application because the instant claims are drawn to a positional isomer of compound 16. 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). Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus)…are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See MPEP 2144.09.
One would have been motivated to make the instant claims because Gray disclosed that compound 16 had use in treating cancer. One would have prepared positional isomers of compound 16, including those claimed, as a matter of making additional compounds for treating cancer.
One would have had a reasonable expectation of success because the instant claims are positional isomers of the prior art compound and compounds of such close structural similarity are expected to have similar properties.
Conclusion
No claim is allowed.
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November 21, 2025
/K.S.M./Examiner, Art Unit 1624
/BRUCK KIFLE/Primary Examiner, Art Unit 1624
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