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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on January 13, 2026 has been entered.
Election/Restrictions
Applicant’s election without traverse of Group I, claims 1-15, drawn to a compound of Formula (I), are maintained.
Claims 16-19 remain withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Status of Claims
Acknowledgement is made of the receipt and entry of the amendment to the claims filed on January 13, 2026, wherein claims 1, 2, 11, 21 are amended; claims 3-10, 12, 13-19 are unchanged; and claim 20 is cancelled.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1-19 and 21 are pending. Claims 16-19 remain withdrawn.
Claims 1-15 and 21 are under examination.
Priority
The instant application 17/761,902 filed on March 18, 2022 is a 371 of PCT/IB2020/058735 filed
on September 18, 2020, which claims priority to, and the benefits of Foreign Application No.
PCT/CN2019/107010 filed on September 20, 2019 and Foreign Application No. PCT/CN2020/095916 filed on June 12, 2020.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Action Summary
Acknowledgement is made of the receipt and entry of the amendment filed on February 12,
2024, wherein claims 1-23 are unchanged and claim 24 is newly added, wherein claims 1, 5-9, 11-14, 16 are amended; claims 10, 18 are cancelled; claims 20-23 are added; claims 2-4, 15, 17, 19.
Applicant’s amendment to the claim overcome each and every objection previously sets forth in the Final Office Action mailed on November 13, 2025.
Claims 1-5, 7-8, 10-11 and 13-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,420,970 B1 (referred to herein as ‘970 patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) are maintained, but revisited and modified in light of the claim amendments.
Claim 1-2, 10, and 13-15 rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,312,353 B2 (referred to herein as ‘353 patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) are maintained, but revisited and modified in light of the claim amendments.
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 1-11, 13-15 and 21 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.
Adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016.
Instant claim(s) promises a broad genus of compound of Formula (I)
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and a broad genus of enantiomer, enantiomeric mixture, and pharmaceutically acceptable salt thereof.
In contrast, the specification does not reasonably convey to one of ordinary skill in the art that Applicant was in possession of the full scope of the claimed compound of Formula (I) and the full scope of enantiomer, enantiomeric mixture, and pharmaceutically acceptable salt thereof. It is respectfully noted that the specification only exemplifies limited number of compound species of Formula (I). For example, the exemplified compound species of Formula (I) only has the representative combination of
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as
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;
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as
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; and R1 is H, but broadly claims n is 0 or 1; A is N or CR wherein R is hydrogen or halo; and R1 is H or R1 and R2 together with NH forms a genus 5-8 membered heterocyclyl comprising 1-2 heteroatoms selected from N, O and S as ring members, wherein said 5-8 membered heterocyclyl is unsubstituted or substituted by an oxo substituent. In other words, the disclosure fails to identify any particular species of compound of Formula (I) in which n is 1, A is CR, and R1 and R2 are joined together with NH to form the 5-8 membered heterocyclyl as broadly encompassed by the claims, and the synthetic preparation thereof. Another example is that the exemplified compound species of Formula (I) only has limited representative species of
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:
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,
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,
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,
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,
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,
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, and
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; and
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,
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,
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and
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, or
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at R7, but broadly claims R7, R9 and R10 can independently be C3-6 cycloalkyl, phenyl, or 5-6 membered heteroaryl (comprising 1-3 heteroatoms selected from nitrogen, oxygen and sulfur) independently substituted with 1-2 R20, in which 2 R20 can be joined together to form a broad genus of 5-6 membered ring comprising 0-2 heteroatoms; and R7 and R8, R8 and R9, and R9 together with the phenyl ring to which they are attached form a 9-10 membered benzo-fused carbocycle or benzo-fused heterocycle (comprising 1-3 heteroatoms selected from nitrogen, oxygen and sulfur). In other words, the disclosure fails to identify any particular species of compound of Formula (I) in which the substituents are joined together to form heterocycle comprising 1-3 heteroatoms selected from nitrogen and sulfur, and also fails to exemplify C3-6 cycloalkyl or 5-6 membered heteroaryl at R7, R9 or R10 that are substituted with 1 or 2 R20, including 5-6 membered ring comprising 0-2 heteroatoms at R20.
Furthermore, regarding the limitation of “5-8 membered heterocyclyl comprising 1-2 heteroatoms selected from N, O and S as ring members”, “5-10 membered monocyclic or bicyclic heterocyclic ring comprising 1-4 heteroatoms selected from nitrogen, oxygen and sulfur”, “5-6 membered heteroaryl comprising 1-3 heteroatoms selected from nitrogen, oxygen and sulfur”, “benzo-fused heterocycle comprising 1-3 heteroatoms selected from nitrogen, oxygen and sulfur”, “4-10 membered monocyclic or bicyclic heterocyclic ring comprising 1-3 heteroatoms selected from nitrogen, oxygen and sulfur”, and “two R20 together form a 5-6 membered ring comprising 0-2 heteroatoms selected from nitrogen, oxygen and sulfur” in the claims, each of these limitations uses the transitional term “comprising” that is inclusive or open-ended and does not exclude additional, unrecited elements; therefore, said limitation is reasonably construed as permitting additional heteroatom(s) in addition to the number of heteroatoms positively recited. Under the broadest reasonable interpretation, the heterocyclyl or heteroaryl ring recites therein encompass embodiment in which said rings contain more than one nitrogen, oxygen, sulfur or combination thereof, including the rings with more than 4 nitrogen atoms that are known to be thermodynamically unstable. While applicant is in possession of a limited number of heterocyclyl or heteroaryl ring as exemplified in the disclosure, applicant is not in possession of the full scope of heterocyclyl or heteroaryl as broadly encompassed by the term “comprising”.
While Applicant does not have to exemplify every possible species of compound of Formula (I) to satisfy the written description requirement, applicant needs to provide enough representative species from different corners of the range to represent the claimed genus fairly. Since the claims recite a large set of possible substituents, applicant must provide a reasonable sampling of them so that a relevant artisan can see applicant truly envisioned the whole range.
In view of the foregoing, applicant is not in the possession of the entire scope of compound of Formula (I) and the entire scope of enantiomer, an enantiomeric mixture or a pharmaceutically acceptable salt thereof. Therefore, applicant is also not in the possession of the entire scope of a pharmaceutical composition comprising the genus compound, or enantiomer, an enantiomeric mixture or a pharmaceutically acceptable salt thereof; and the entire scope of combination comprising said genus for the reasons set forth above.
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 1-15 and 21 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.
Regarding claims 1-4, 9, and 21, a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, the claim recites the broad recitation “an enantiomeric mixture”, and the claim also recites “[a] compound of Formula (I)”, which is the narrower statement of the range/limitation. It is not clear if the claimed invention is drawn to a singular compound of formula (I), or a composition that is a mixture of more than one compounds, which includes a compound of formula (I). The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Accordingly, claims 5-8 and 10-15 are rejected base on their dependency on a rejected base claim.
Regarding claim 1,
the recitation of “
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” appears to missing proper punctuation between two separate substituents alternative, and that can lead to numerous interpretations. As written, the claim language may reasonably be interpret as defining a single continuous substituent, i.e., (CRaRb)r-(C=O)-NR12R13-(CRaRb)s-NR12R13. Under this interpretation, when R12 and R13 are hydrogen, the amide nitrogen would necessarily be bonded to the carbonyl carbon, two hydrogen atoms, and the (CRaRb)s group, thereby exceeding the permissible valence of nitrogen. Alternatively, the language may be had been interpreted to define two separate substituent alternatives, which would require punctuation separating the alternatives. Because the claim does not clearly indicate which interpretation is intended, the metes and bounds of the claim are unclear.
the recitation of “R9 together with the phenyl ring to which they are attached form a 9-10 membered benzo-fused carbocycle or benzo-fused heterocycle” renders the claim indefinite. In organic chemistry, a fused ring requires the presence of at least one common bond and two bridgehead carbons; and therefore, a single substituent (i.e., R9) cannot be joined together with a phenyl ring to form a benzo-fused ring. Since the claim appears to encompass chemically impossible or undefined structure, one skilled in the art would not reasonably be apprised by the metes and bounds of the claimed compound.
Accordingly, claims 5-8 and 10-15 are rejected base on their dependency on a rejected base claim.
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.
Claims 2, 5 and 12 are 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.
Regarding claim 2,
the recitation of “(ii) (CRaRb)r-(C=O)-NR12R13” at R2 fails to further limit the compound of Formula (I) set forth in claim 1, because said formula only recites “
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” at R2 and does not include the alternative noted above; and
the recitation of “R9 and R10 together” in the phrase of “R9 and R10 together with the phenyl ring to which they are attached from a 9-10 membered benzo-fused carbocycle or benzo-fused heterocycle” fails to further limit the compound of Formula (I) set forth in claim 1, because said formula does not positively recite R10 can be joined together with R9.
Regarding claim 5,
the recitation of “
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” fails to further limit the compound of Formula (I) set forth in claim 1, because said formula requires the nitrogen atom to be bonded to the carbonyl carbon, two hydrogen atoms, and the (CRaRb)s group (see
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); therefore, said recitation does not satisfy the requirement of R2 set forth in claim 1.
Regarding claim 12, several compounds recite therein fails to further limit the compound of formula (I) set forth in claim 1, which it depends upon. For example,
the claim recites the following compounds:
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, which includes isotopes of hydrogen, that fails to further limit the compound of formula (I) set forth in claim 1, because said genus formula does not include isotopes;
The claims recite:
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(Please note according to p.95 of the specification, said compound has the chemical structure of:
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), which includes benzofuran as the heterocyclic aromatic ring formed by R7 and R8 together, that fails to further limit the compound of formula (I) set forth in claim 1. In the present case, claim 1 does not states R7 and R9 together form a benzo-fused heteroaryl ring, instead they form a benzo-fused “heterocycle”; and based upon applicant’s own definition of “heterocyclyl” or “heterocyclic” (see page 6, line 18-20 of the specification), it refers to a non-aromatic ring, thus, the compound species noted above does not satisfy the claim language;
The claim recites:
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, which includes unsubstituted R7 or R9, that fails to further limit the compound of formula (I) set forth in claim 1. In the present case, claim 1 requires R7 or R9 to be selected from the list including C3-C8 cycloalkyl or 5-6 membered heteroaryl comprising 1-3 heteroatoms selected from nitrogen, oxygen and sulfur, and said C3-C8 cycloalkyl or 5-6 membered heteroaryl is independently substituted with 1-2 R20. Since R20 of claim 1 cannot be absence, the compound species noted above does not satisfy the claim language; and
The claim recites:
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,
which contains pryrazolo[1,5-a]pyrazine ring composed of aromatic pyrazole ring fused to a saturated piperazine ring, that fails to further limit the compound of formula (I) set forth in claim 1. In the present case, claim 1 requires R12 and R13 together to form a 5-10 membered bicyclic heterocyclic ring comprising 1-4 heteroatoms selected from nitrogen, oxygen and sulfur; and based on applicant’s own definition of “heterocyclyl” or “heterocyclic” (see page 6, line 18-20 of the specification), it refers to a non-aromatic ring, thus, the compound species noted above does not satisfy the claim language.
The claims recite:
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, which contains dioxidothiomorpholino ring, that fails to further limit the compound of formula (I) set forth in claim 1. In the present case, claim 1 does not include the sulfur atom of the monocyclic heterocyclic ring joined together by R12 and R13 to be further substituted with two oxo to form said dioxidothiomorpholino; therefore, the compound species noted above does not satisfy the claim language.
Each of these findings demonstrate the compound species recites therein fails to further limit the claimed genus and include all the limitations of the claim genus, Applicant should review the remaining recited species to ensure each species is encompassed by the scope of the genus recited in claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5, 7-8, 10-11 and 13-15 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,420,970 B1 (referred to herein as ‘970 patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176; cited in the previous Office Action).
The claims of ‘970 patent is drawn to a compound of Formula (I) or an enantiomer, an enantiomeric mixture, or a pharmaceutically acceptable salt thereof useful for treating a disease or condition mediated by nuclear SET domain-containing protein 2, such as breast cancer; wherein said compound is selected from a compound in the following table, or a pharmaceutically acceptable salt thereof, inter alia,
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. The claims of ‘970 patent is also drawn to a pharmaceutical composition comprising the compound of Formula (I) or an enantiomer, an enantiomeric mixture, or a pharmaceutically acceptable salt thereof, and one or more pharmaceutically acceptable carrier. Please note compound of Ex No. 85 of ’970 patent has a chemical structure of:
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(see e.g., p. 126, Example 85 of ‘970 patent).
The claims of ‘970 patent does not expressly teach a compound species of Formula (I) instantly claimed.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches the use of the classical bioisosteres benzene and pyridine resulted in analogues with retention of biological activity within different series of pharmacological agents (see e.g., p. 3158, “E. Ring Equivalents” section). Patani et al. further teaches the trivalent substitution of -CH= with -N= is commonly used in modern drug design, for example, said substitution in the (benzothiazolylbenzyl)phosphonate derivatives retained vasodilatory activity as shown below:
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(see e.g., page 3159, right column, under “trivalent ring equivalent” to page 3160, left column, table 30). Patani et al. further teaches the replacement of hydrogen with hydroxyl also results analogues, for example, said substitution in N-[2-(Mercaptomethyl)-3-phenylbutanoyl] amino acids as shown below:
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resulting no significant alteration in preferential activity with either of the peptidases, ACE or NEP (see e.g., p. 3152, “4. Fluorine and Hydroxyl, Amino, or Methyl Groups as Replacements for Hydrogen (Grimm’s Hydride Displacement Law)” section, left column to right column, 1st paragraph).
According to MPEP 2144.09, "[a]n 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);
“[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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 also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)“; and “[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979).”
Applying the same logic(s) to the instant product claims, the difference between the compound 85 of ‘970 patent and the expanded compound species of instant Formula (I) is that the compound of reference patent contains pyridine rather than phenyl, and has difluoro-substituted phenyl attached to the 6-position of pyridine ring rather than 1-position, 2-position or 5-position (
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) as shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound 85 of ‘970 patent, and then modify said compound by replacing the pyridine ring attached to the piperidine moiety with a benzene ring as taught by Patani et al., and then changes the position of difluoro-substituted phenyl from the 6-position to the 1-position, 2-position or 5-position to arrive at the claimed invention. One would have been motivated to do so, because Patani et al. teaches the replacement of pyridine with benzene, which is a bioisosteric replacement technique based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, can results in analogues with retention of biological activity; and one would have understood that changing the point of attachment of the difluoro-substituted phenyl would results in position isomers that are sufficiently close in structure with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by modifying the pyridine ring of compound 85 of ‘970 patent with a benzene ring would have successfully arrive at a compound that exerts the same or substantially similar effect for treating a disease or condition mediated by nuclear SET domain-containing protein 2; and then further modifying the point of attachment of the difluoro-substituted phenyl would successfully arrive at position isomers that is sufficiently close in structure with similar properties; and therefore, one would have reasonably expected that said modified compound can successfully be combined with a pharmaceutically acceptable carrier to arrive at a pharmaceutical composition, or be combine with another compound species of Formula (I) of ‘970 patent as an anti-cancer agent to arrive at combination useful for the same purpose.
Please note the modified compound 85 of ‘970 patent in view of Patani et al., in this case, a compound having the structure of:
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is a compound of Formula (I)
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, wherein A is N; R1 is H; n is 1; R2 is
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, and that meets the limitation of “R2 is … (iv) –(CRaRb)r-C(=O)-NR12R13” (wherein R12 is hydrogen; R13 is a 5-membered monocyclic heterocyclic ring comprises 1 heteroatom selected from oxygen; r is independently 0); R3b, R3a, R4a, R4b, R5a, R5b, R6a and R6b are independently hydrogen; R8, R9 and R10 are independently hydrogen; R7 is phenyl, wherein said phenyl is independently substituted with 2 R20, wherein R20 is fluoro and that meets the limitation of “-halo”; and a compound of subgenus Formula (II)
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, wherein A is N; R2 is
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, and that meets the limitation of “R2 is … (ii) –(CRaRb)r-C(=O)-NR12R13” (wherein R12 is hydrogen; R13 is a 5-membered monocyclic heterocyclic ring comprises 1 heteroatom selected from oxygen; r is 0); R7, R9 and R10 are independently hydrogen; R8 is phenyl, wherein said phenyl is independently substituted with 2 R20, wherein R20 is fluoro and that meets the limitation of “-halo”.
With respect to “wherein R2 is
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” in claim 5, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound 85 of ‘970 patent in view of Patani et al. set forth above by replacing
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with
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at the R2 position of Formula (I) of ‘970 patent. One would have been motivated to do so, because ‘970 patent clearly teaches a list of suitable R2, including –(CRaRb)r-C(=O)-NR12R13 and -C(RaRb)p-C(=O)-OR10, that can arrive a compound of Formula (I) useful for treating NSD2 mediated disease or condition; and specifically teaches compound 78 (“
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”) that is a compound of Formula (I) containing
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at R2. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of
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with a
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at the R2 position of the modified compound 85 of ‘970 patent in view of Patani et al. would have successfully treat NSD2 mediated disease or condition.
With respect to “wherein R2 is
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” in claim 7, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound 85 of ‘970 patent in view of Patani et al. set forth above by replacing
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with
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at the R2 position of Formula (I) of ‘970 patent. One would have been motivated to do so, because ‘970 patent clearly teaches a list of suitable R2, including –(CRaRb)r-C(=O)-NR12R13 with the structure of:
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and those that R12 and R13 can join together to form a 5-6 membered heterocyclic ring that is unsubstituted or substituted with C1-4 alkyl, that can arrive a compound of Formula (I) useful for inhibiting NSD2; and specifically teaches a compound 86 (“
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”) that is a compound of Formula (I) containing
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at R2; and the fact that Patni et al. teaches the replacement of hydrogen with hydroxyl, which is a bioisosteric replacement technique based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, can results in analogues with retention of biological activity. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of the R12R13 moiety of
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with a R12R13 that is a morpholinyl substituted with methyl (
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) at the R2 position of the modified compound 85 of ‘970 patent in view of Patani et al. would have successfully treat NSD2 mediated disease or condition.
With respect to “wherein R2 is
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, 1H-tetrazolyl, 2H-tetrazoly, pyridyl, trifluoromethylpyridyl or phenyl” in claim 8, , it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound 85 of ‘970 patent in view of Patani et al. set forth above by replacing
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with a pyridyl at the R2 position of Formula (I) of ‘970 patent. One would have been motivated to do so, because ‘970 patent clearly teaches a list of suitable R2, including –(CRaRb)r-C(=O)-NR12R13 and 5-6 membered heterocyclylC0-6alkyl, that can arrive a compound of Formula (I) useful for treating NSD2 mediated disease or condition; and specifically teaches compound 271 (“
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”) that is a compound of Formula (I) containing a pyridyl ring at R2. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of
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with a pyridyl at the R2 position of the modified compound 85 of ‘970 patent in view of Patani et al. would have successfully inhibits NSD2.
With respect to “wherein at least two of R7, R8, R9 and R10 are not hydrogen” in claim 10, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound 85 of ‘970 patent in view of Patani et al. set forth above by replacing the hydrogen with a C1-4 alkyl at the R10 position of Formula (I) of ‘970 patent. One would have been motivated to do so, because ‘970 patent clearly teaches a list of suitable alternatives, including hydrogen and C1-4 alkyl, at the R10 position that can arrive a compound of Formula (I) useful for treating NSD2 mediated disease or condition. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of hydrogen with a methyl at the R10 position of the modified compound 85 of ‘970 patent in view of Patani et al. would have successfully treat NSD2 mediated disease or condition.
With respect to claim 11, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by further modifying the compound 85 of ‘970 patent in view of Patani et al. set forth above (see rejection with respect to claim 10) by replacing the
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moiety with a cyclopropyl (
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) as the C3-8cycloalkyl(C0-6 alkyl). One would have been motivated to do so, because ‘970 patent clearly teaches a list of R8 alternatives, including aryl and C3-8 cycloalkyl(C0-6 alkyl), that are contemplate for use to arrive at a compound of Formula (I) useful for treating NSD2 mediated disease or condition; and specifically teaches a compound 275 (“
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”) that is a compound of Formula (I) containing a cyclopropyl ring. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the replacement of
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with a cyclopropyl would have successfully exerts the same or substantially similar effect against NSD2 mediated disease or condition, and therefore, by replacing said difluoro-phenyl of the position isomers set forth above, one would have reasonably expected that the position isomers with cyclopropyl would have also be similarly useful for treating NSD2 mediated disease or condition.
With respect to “wherein said compound is a compound of Formula (III):
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” in claim 3 and “wherein said compound is a compound of Formula (IV):
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“ in claim 4, the difference between the compound 85 of ‘970 patent and Patani et al. set forth above and the claimed compound is that the prior art compound contains piperidine ring rather than the pyrrolidine ring instantly claimed (see shaded:
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). A person of ordinary skill in the art would have understood that piperidine and pyrrolidine are homologs that differ from one another by one -CH2- unit. It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to arrive at the claimed invention by further modifying the piperidine of compound 85 of ‘970 patent and Patani et al. set forth above by adding a -CH2- group to give a pyrrolidine ring, because one would have been motivated to arrive at a homolog that is sufficiently close in structure that possess similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that the modified compound 85 of ‘970 patent and Patani et al. would have exerted the same or substantially similar for treating a disease or condition mediated by nuclear SET domain-containing protein 2. Please note the fact that ‘970 patent teaches a enantiomeric mixture of compound 85, and therefore the modified compound 85 of ’970 patent in view of Patani et al. meets the limitation of
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recites in the claimed Formula (IV).
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Claim 1-2, 10, and 13-15 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,312,353 B2 (referred to herein as ‘353 patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
The claims of ‘353 patent are drawn to a method for treating multiple myeloma, comprising administering to a subject in need thereof of such treatment a therapeutically effective amount of a compound of Formula (I):
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, or an enantiomer, an enantiomeric mixture, or a pharmaceutically acceptable salt thereof, and said compound includes a compound having the following formula:
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. The claims of ‘353 patent teaches the compound of Formula (I)
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, wherein R2 is, inter alia, 5-9 membered heteroarylC0-6 alkyl, wherein said heteroaryl radical is unsubstituted or substituted by, inter alia, halo; R8 is, inter alia, aryl, wherein said R8 is unsubstituted or substituted by 1-3 R17; R17 is, inter alia, halo; and R10 is hydrogen or -C1-4 alkyl (see reference claims indicated above).
The claims of ‘353 patent does not expressly teach a compound species of Formula (I) instantly claimed.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches the use of the classical bioisosteres benzene and pyridine resulted in analogues with retention of biological activity within different series of pharmacological agents (see e.g., p. 3158, “E. Ring Equivalents” section). Patani et al. further teaches the trivalent substitution of -CH= with -N= is commonly used in modern drug design, for example, said substitution in the (benzothiazolylbenzyl)phosphonate derivatives retained vasodilatory activity as shown below:
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(see e.g., page 3159, right column, under “trivalent ring equivalent” to page 3160, left column, table 30).
According to MPEP 2144.09, "[a]n 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);
“[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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 also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)“; and “[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979).”
Applying the same logic(s) to the instant product claims, the difference between the compound of ‘353 patent and the expanded compound species of instant Formula (I) that the reference compound contains pyridine rather than the claimed phenyl ring, and contains difluoromethoxyphenyl rather than difluorophenyl, and said difluoromethoxyphenyl is attached to the 6-position of pyridine ring rather than 1-position, 2-position or 5-position (
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) as shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound of ‘353 patent, and then modify said compound by replacing the pyridine ring attached to the piperidine moiety with a benzene ring as taught by Patani et al., and removing the -O-methyl substituted on the phenyl ring at the R8 position as taught by ‘353 patent, and then changes the position of said substituted phenyl from the 6-position to the 1-position, 2-position or 5-position to arrive at the claimed invention. One would have been motivated to do so, because Patani et al. teaches the replacement of pyridine with benzene, which is a bioisosteric replacement technique based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, can results in analogues with retention of biological activity; ‘353 patent teaches R8 can be unsubstituted or substituted by 1-3 R17; and one would have understood that changing the point of attachment of the substituted phenyl would results in position isomers that are sufficiently close in structure with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by modifying the pyridine ring of compound of ‘353 patent with a benzene ring and removing the -O-methyl as one of the substituents added to the phenyl ring at the R8 position would have successfully arrive at a compound that exerts the same or substantially similar effect for treating multiple myeloma; and then further modifying the point of attachment of the difluoro-substituted phenyl would successfully arrive at position isomers that is sufficiently close in structure with similar properties; and therefore, one would have reasonably expected that said modified compound can successfully be combined with a pharmaceutically acceptable carrier to arrive at a pharmaceutical composition, or be combine with another compound species of Formula (I) of ‘353 patent as the anti-cancer agent to arrive at combination useful for the same purpose.
Please note the modified compound of ‘353 patent in view of Patani et al., in this case, a compound having the structure of:
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, is a compound of Formula (I)
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, wherein A is N; R1 is H; n is 1; R2 is
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, and that meets the limitation of “R2 is … (vi) 6 membered heteroaryl… wherein each said…heteroaryl radical is independently…substituted by… halo”; R3b, R3a, R4a, R4b, R5a, R5b, R6a and R6b are independently hydrogen; R8, R9 and R10 are independently hydrogen; R7 is phenyl, wherein said phenyl is independently substituted with 2 R20, wherein R20 is fluoro and that meets the limitation of “-halo”.
With respect to claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound of ‘353 patent and Patani et al. set forth above by replacing
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with
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. One would have been motivated to do so, because ‘353 patent clearly teaches a list of suitable R2, including 5-9 membered heteroarylC0-6 alkyl, wherein said heteroaryl radical is unsubstituted or substituted by, inter alia, halo, that can arrive a compound of Formula (I) useful for the same purpose. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of the substituted pyridine ring
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with an unsubstituted pyridine
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at the R2 position of the modified compound of ‘353 patent in view of Patani et al. would have successfully treat multiple myeloma.
With respect to “wherein at least two of R7, R8, R9 and R10 are not hydrogen” in claim 10, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound of ‘353 patent in view of Patani et al. set forth above by replacing the hydrogen with a C1-4 alkyl at the R10 position of Formula (I) of ‘353 patent. One would have been motivated to do so, because ‘353 patent clearly teaches a list of suitable alternatives, including hydrogen and C1-4 alkyl, at the R10 position that can arrive a compound of Formula (I) useful for treating multiple myeloma. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of hydrogen with a methyl at the R10 position of the modified compound of ‘353 patent in view of Patani et al. would have successfully treat multiple myeloma.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
Response to Arguments
Applicant's arguments filed on January 13, 2026 with respect to the rejection of claims 1-5, 7-8, 10-11 and 13-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 11,420,970 B1 (referred to herein as ‘970 patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant's arguments filed on January 13, 2026 with respect to the rejection of claims 1-2, 10, and 13-15 on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 12,312,353 B2 (referred to herein as ‘353 patent) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176) have been fully considered but they are not persuasive for the reasons set forth below.
Applicant amends claim 1 by deleting R8 from the recitation of “R7, R8, R9 and R10 are independently hydrogen…” and added the limitation of “R8 is hydrogen, halo, -C1-4 alkyl, -haloC1-6 alkyl, -hydroxyC1-6 alkyl, cyano, -cyanoC1-6 alkyl, -C2-6alkenyl-, -C2-6alkynyl-, -C1-6alkylthio, -(CRaRb)1-4-NR17R18, -(CRaRb)1-4NR17-C(O)-OR18 or -(CRaRb)1-4-OR19”, such that R8 is no longer selected from the same list of R7, R9 and R10 that further contains C3-8cycloalkyl, phenyl, and 5-6 membered heteroaryl comprising 1-3 heteroatoms selected from nitrogen, oxygen and sulfur. Each of these findings demonstrate that the amendment changes the scope of the claims, thus, the rejections of record have been revisited and modified in light of the claim amendments.
In Summary, applicant argues the claim amendments that changes the scope around R8 overcome the rejection of record, because the reference patent fails to teach the R8 substituents intently claimed.
In response, applicant’s argument is not found persuasive. It may well be true ‘970 patent and ‘353 patent both expressly teach compound species with substituted-phenyl attached to the 6-position of pyridine ring, which is equivalent to R8 position of the phenyl ring instantly claimed; However, MPEP 2144.09 states: “[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 “[c]ompounds 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 also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)”. Same logic is applicable to instant product claim(s), the reference compound(s) and the claimed compound are sufficiently close in structure. The primary difference between the reference compound(s) and the claimed compound is that the reference compound contains pyridine rather than phenyl at the core, and the reference compound attached the substituted-phenyl to the 6-position of said pyridine rather than other ring-position (see rejection above). Therefore, the mere fact that the claimed R8 no longer contains substituted phenyl does not render the claimed invention non-obvious, because one skilled in the art would have reasonably expected by changing the position of substituted-phenyl from the 6-position to other position of the modified pyridine ring (i.e., phenyl ring) would have possess similar properties as the one taught by the reference patents, respectively, especially in the absence of evidence to the contrary.
Therefore, the rejection is maintained but revisited and modified in view of the claim amendments.
Claims 1-2, 10, and 13-15 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-27 of copending Application No. 19/213,478 (reference application) in view of Patani et al. (Chem. Rev., 1996. Vol. 96, 8: 3147-3176).
The claims of reference application are drawn to a method for inhibiting a nuclear SET domain-containing protein 2 (NSD2) or treating a disease or condition mediated by NSD2 in a subject, comprising administering to the subject a compound of Formula (I) or a pharmaceutically acceptable salt there of:
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; and said compound includes a compound having the following formula:
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(see claim 15). The claims of reference application teaches the compound of Formula (I)
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, wherein R2 is, inter alia, 5-9 membered heteroarylC0-6 alkyl, wherein said heteroaryl radical is unsubstituted or substituted by, inter alia, halo; R8 is, inter alia, aryl, wherein said R8 is unsubstituted or substituted by 1-3 R17; R17 is, inter alia, halo; and R10 is hydrogen or -C1-4 alkyl (see reference claims indicated above).
The claims of reference application does not expressly teach a compound species of Formula (I) instantly claimed.
Patani et al. teaches bioisosterism represents one approach used by the medicinal chemist for the rational modification of lead compounds into safer and more clinically effective agents (see e.g., “introduction” section on p. 3147). Patani et al. further teaches a group of bioisosteres elicit similar biological activity, and have been classified as either classical or nonclassical, wherein the classical bioisosteres are a series of replacements defined by Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres (see e.g., p. 3148-3149). Patani et al. further teaches the use of the classical bioisosteres benzene and pyridine resulted in analogues with retention of biological activity within different series of pharmacological agents (see e.g., p. 3158, “E. Ring Equivalents” section). Patani et al. further teaches the trivalent substitution of -CH= with -N= is commonly used in modern drug design, for example, said substitution in the (benzothiazolylbenzyl)phosphonate derivatives retained vasodilatory activity as shown below:
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(see e.g., page 3159, right column, under “trivalent ring equivalent” to page 3160, left column, table 30).
According to MPEP 2144.09, "[a]n 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);
“[c]ompounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) 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 also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978)“; and “[p]rior art structures do not have to be true homologs or isomers to render structurally similar compounds prima facie obvious. In re Payne, 606 F.2d 303, 203 USPQ 245 (CCPA 1979).”
Applying the same logic(s) to the instant product claims, the difference between the compound of reference application and the expanded compound species of instant Formula (I) that the reference compound contains pyridine rather than the claimed phenyl ring, and contains difluoromethoxyphenyl rather than difluorophenyl, and said difluoromethoxyphenyl is attached to the 6-position of pyridine ring rather than 1-position, 2-position or 5-position (
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) as shown below (see shaded):
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.
It would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to select the compound of reference application, and then modify said compound by replacing the pyridine ring attached to the piperidine moiety with a benzene ring as taught by Patani et al., and removing the -O-methyl substituted on the phenyl ring at the R8 position as taught by reference application, and then changes the position of said substituted phenyl from the 6-position to the 1-position, 2-position or 5-position to arrive at the claimed invention. One would have been motivated to do so, because Patani et al. teaches the replacement of pyridine with benzene, which is a bioisosteric replacement technique based on Grimm’s Hydride Displacement Law and Erlenmeyer’s definition of isosteres, can results in analogues with retention of biological activity; reference application teaches R8 can be unsubstituted or substituted by 1-3 R17; and one would have understood that changing the point of attachment of the substituted phenyl would results in position isomers that are sufficiently close in structure with similar properties. One would have a reasonable expectation of success to arrive at the claimed invention, because one would have reasonably expected that by modifying the pyridine ring of compound of reference application with a benzene ring and removing the -O-methyl as one of the substituents added to the phenyl ring at the R8 position would have successfully arrive at a compound that exerts the same or substantially similar effect for treating multiple myeloma; and then further modifying the point of attachment of the difluoro-substituted phenyl would successfully arrive at position isomers that is sufficiently close in structure with similar properties; and therefore, one would have reasonably expected that said modified compound can successfully be combined with a pharmaceutically acceptable carrier to arrive at a pharmaceutical composition, or be combine with another compound species of Formula (I) of reference application as the anti-cancer agent to arrive at combination useful for the same purpose.
Please note the modified compound of reference application in view of Patani et al., in this case, a compound having the structure of:
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, is a compound of Formula (I)
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, wherein A is N; R1 is H; n is 1; R2 is
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, and that meets the limitation of “R2 is … (vi) 6 membered heteroaryl… wherein each said…heteroaryl radical is independently…substituted by… halo”; R3b, R3a, R4a, R4b, R5a, R5b, R6a and R6b are independently hydrogen; R8, R9 and R10 are independently hydrogen; R7 is phenyl, wherein said phenyl is independently substituted with 2 R20, wherein R20 is fluoro and that meets the limitation of “-halo”.
With respect to claim 2, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound of reference application and Patani et al. set forth above by replacing
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with
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. One would have been motivated to do so, because reference application clearly teaches a list of suitable R2, including 5-9 membered heteroarylC0-6 alkyl, wherein said heteroaryl radical is unsubstituted or substituted by, inter alia, halo, that can arrive a compound of Formula (I) useful for the same purpose. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of the substituted pyridine ring
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with an unsubstituted pyridine
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at the R2 position of the modified compound of reference application in view of Patani et al. would have successfully treat multiple myeloma.
With respect to “wherein at least two of R7, R8, R9 and R10 are not hydrogen” in claim 10, it would have been prima facie obvious to one of ordinary skill in the art at the time the application was filed to further modify the compound of reference application in view of Patani et al. set forth above by replacing the hydrogen with a C1-4 alkyl at the R10 position of Formula (I) of ‘353 patent. One would have been motivated to do so, because reference application clearly teaches a list of suitable alternatives, including hydrogen and C1-4 alkyl, at the R10 position that can arrive a compound of Formula (I) useful for treating multiple myeloma. One would have a reasonable expectation of success, because one would have reasonably expected that the replacement of hydrogen with a methyl at the R10 position of the modified compound of reference application in view of Patani et al. would have successfully treat multiple myeloma.
Therefore, the claimed invention is prima facie obvious to one of ordinary skill in the art at the time the application was filed, absent factual evidence to the contrary.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claims are allowed.
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/CHIHYI LEE/Examiner, Art Unit 1628 /JEAN P CORNET/Primary Examiner, Art Unit 1628
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