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 .
Election/Restrictions
2. Applicant’s election without traverse of Group I, Claims 1, 2, 9, 11, 12, 19, 23, 25, 26, 37, 40, 43, 44, 48-50, and 55, drawn to a compound having the structure of Formula (A) or pharmaceutically acceptable salt, ester, hydrate, solvate or stereoisomer thereof, and its pharmaceutical composition thereof, in the reply filed on January 20, 2026 is acknowledged with appreciation.
3. Claims58-60, 81 and 85 (Group II), drawn to a method for inhibiting, treating and/or preventing a hyperproliferative disorder in a subject, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, without traverse, there being no allowable generic or linking claim.
4. Applicant additionally elected compound 53 as the single compound species of Formula (A):
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without traverse.
5. The nonelected compound species are withdrawn from consideration as directed to non-elected subject matter without traverse, i.e., claims 9, 11, 12, 19, 23 and 40 are presently withdrawn.
6. Claims 1, 2, 25, 26, 37, 43, 44, 48-50, and 55 are under examination with the elected species are the subject of this office action.
Status of the Claims
7. Applicants’ elected species, compound 53, was found to be free of the prior art. However, no claim reads solely on the elected species. In accord with MPEP 803.02, the search was extended to the extent necessary to determine patentability of the Markush-type claim. As discussed in the 102 rejection below, art was found that reads on the Markush-type claim. In accord with MPEP 803.02 the search is not extended unnecessarily to all species. The scope of the independent invention that encompasses the elected species is as follows:
A compound of Formula (A), according to the following subgenus:
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, wherein “A” is pyrido-pyrimidinyl bicyclic ring substituted by methoxy-hexahydropyrrolizinyl in the 2-position, substituted by naphthyl in the 7-position wherein said naphthyl is optionally substituted, and substituted by fluoro in the 8-position; A1 and A4 are hydrogen; A2 and A3 form a bridge comprising 2 methylene groups; X2 is hydrogen; and Y2 is hydrogen, halogen or di-halo.
Priority
8. Applicant has not filed an English language translation of foreign priority People’s Republic of China Application No. CN202211101617.3. It is suggested that a certified translation of every foreign benefit application or Patent Cooperation Treaty (PCT) application not filed in English be submitted. See 35 U.S.C. 119(b)(3) and 372(b)(3) and 37 CFR 1.55(g)(3)(i) and 41.154(b). A showing of priority that relies on a non-English language application is prima facie insufficient to overcome an intervening reference if no certified translation of the application is on file. See 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
9. The information disclosure statement (IDS) submitted on January 31, 2024 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement has been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Claim Rejections - 35 USC § 112(b)
10. 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.
11. Claims 2, 25, 26, 37, 43 and 44 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.
12. Claim 2 depends from claim 1 and recites the following limitation in the last three lines of the claim:
“optionally wherein the substituted or unsubstituted acyl is saturated or unsaturated aliphatic acyl or aroyl; the substituted or unsubstituted oligopeptide is a dipeptide, a tripeptide, or a tetrapeptide; and/or the substituted or unsubstituted alkylthio is thiocarbonyl,”
which recites species of acyl moieties, oligopeptides, and alkylthio moieties not recited in claim 1. It is not clear if Applicant is intending additional acyl, oligopeptide, and alkylthio species, i.e., expanding the scope of the claim by providing additional alternatives, which is not permitted, or if the recited acyl, oligopeptide, and alkylthio species are exemplary.
In view of a broadest reasonable interpretation of claim 2, the recitation of “optionally wherein the substituted or unsubstituted acyl is saturated or unsaturated aliphatic acyl or aroyl; the substituted or unsubstituted oligopeptide is a dipeptide, a tripeptide, or a tetrapeptide; and/or the substituted or unsubstituted alkylthio is thiocarbonyl,” has not been considered.
13. Claim 25 is unclear in the following aspects:
(a) Claim 25 depends from claim 1, and further limits wherein the compound has a structure according to Formula (II) or Formula (IIA), (it is noted that the subgenus of Formula (III) is drawn to nonelected species):
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or
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. There is insufficient antecedent basis for the limitations of the subgenus of Formula (II) and the subgenus of Formula (III) in the claim, because in claim 1, Applicant failed to set forth that the “A” moiety can be the bicyclic heterocyclic moiety pyrido-pyrimidine; or that said “A” moiety can be substituted by an optionally substituted methoxy-pyrrolizine group, or a halogen, or a substituted naphthyl group.
(b) There is also insufficient antecedent basis for the moieties “R11,” “W,” “X1,” “X2,” “X3,” “Y1a,” “Y1b,” or “Y2,” because Applicant failed to define any of said moieties in claim 1, and only R11 is defined in claim 25.
Clarification is requested.
**In view of a broadest reasonable interpretation of claim 25, the recited moieties in Formula (II) and (IIA) are construed to mean:
“R11“ is hydrogen or fluorine; “W” is oxygen; “X1“ is hydrogen; “X2” is as defined in claim 1; “X3” is
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or a lone pair of electrons; “Y1a “ and “Ylb“ are both hydrogen; and “Y2“ is fluorine.
14. Claim 26 depends from claim 25, and further limits wherein “W” is oxygen; “X1“ is hydrogen (H); “R11“ is hydrogen (H) or fluorine (F); “Y2“ is fluorine (F); and/or “Y1a “ and “Ylb“ are both hydrogen. However, there is insufficient antecedent basis for these limitations in the claim, because Applicant failed to define any of said moieties in claim 1, and only R11 is defined in claim 25. Clarification is requested.
15. Claim 37 depends from claim 25, and further limits wherein “X3” is
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or a lone pair of electrons, however there is insufficient antecedent basis for these limitations in the claim, because Applicant failed to define the moiety “X3” in claims 1 or 25.
There is also insufficient antecedent basis for the moieties “6a,” and “6b,” because Applicant failed to define any of said moieties in claims 1 or 25. Clarification is requested.
16. Claim 43 is unclear in the following aspects:
(a) Claim 43 depends from claim 25, and further limits wherein the compound has a structure according to Formula (VII), (it is noted that the subgenuses of Formulae (IV)-(VI) are drawn to nonelected species):
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. There is insufficient antecedent basis for the limitations of the subgenus of Formula (VII) in the claim, because in claim 1, Applicant failed to set forth that the “A” moiety can be the bicyclic heterocyclic moiety pyrido-pyrimidine; or that said “A” moiety can be substituted by an optionally substituted methoxy-pyrrolizine group, or a halogen, or a substituted naphthyl group.
(b) There is also insufficient antecedent basis for the moieties “R9,” or “R10,” because Applicant failed to previously define said moieties in claim 1 or in this claim.
Clarification is requested.
**In view of a broadest reasonable interpretation of claim 43, the moieties “R9” and “R10” are construed to mean:
“R9 is lower alkyl, substituted or unsubstituted benzyl, substituted or unsubstituted imidazol-5-methyl, oligoglycolyl (-[CH2CH20]1CH3, where n is an integer from 0 to 4), or C2-C20 saturated or unsaturated alkanoyl; and R10 is hydrogen, C1-C6 alkoxy, C2-C20 saturated or unsaturated alkanoyl, C2-C20 substituted or unsubstituted saturated or unsaturated alkanoyl, or saturated or unsaturated alkoxycarbonyl.”
17. Claim 44 depends from claim 43, and further limits the moieties “R9” and “R10.” However, there is insufficient antecedent basis for these limitations in the claim, because Applicant failed to previously define any of said moieties in claims 1 or 43.
18. Claims 26, 37, 43 and 44 are also rejected as being dependent upon and including all of the limitations of claim 25.
19. Claim 55 depends from claim 50, and limits “wherein the composition is suitable for administration by injection, e.g., subcutaneous, intravenous, intramuscular, or intraperitoneal administration.” However, the phrase "e.g.” (for example) renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
In view of a broadest reasonable interpretation, the above limitation is construed to mean: “wherein the composition is suitable for administration by subcutaneous injection, intravenous injection, intramuscular injection, or intraperitoneal injection.”
Claim Rejections - 35 USC § 112(a)
20. 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.
21. Claims 1, 2, 25, 26, 37, 43, 44, 48-50, and 55 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claims contain subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
In particular, support cannot be found for the full scope of compounds of Formula (A), as instantly claimed.
22. The MPEP §2163 states that the purpose of the written description requirement is to ensure that the inventor had possession, as of the filing date of the application, of the specific subject matter later claimed by him. In the case of chemical entities, Applicant's attention is further directed to Regents of the University of California v. Eli Lilly & Co., 119 F.3d 1559 (Fed. Cir. 1997), cert. denied, 523 U.S. 1089, 118 S. Ct. 1548 (1998), which notes that an adequate written description 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.” While the court recognizes that, “[i]n claims involving chemical materials, generic formulae usually indicate with specificity what the generic claims encompass” (Id.), it is also recognized that for a broad generic claim, the specification must provide adequate written description to identify the genus of the claim and/or the genus must be sufficiently detailed to show that applicant was in possession of the claimed invention as a whole (see Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555 (Fed. Cir. 1991)). If a genus has substantial variance, the disclosure must present a sufficient number of representative species that encompass the genus in order to adequately describe the genus (i.e., the disclosure must describe a sufficient variety of species to reflect the variation within that genus). See MPEP § 2163. Otherwise, as stated by the court in Ariad Pharmaceuticals, Inc., v. Eli Lilly and Company (Fed. Cir. 2010), “a generic claim may define the boundaries of a vast genus of chemical compounds, and yet the question may still remain whether the specification, including original claim language, demonstrates that the applicant has invented species sufficient to support a claim to a genus.
23. The factors considered in the Written Description requirement are:
(1) level of skill and knowledge in the art,
(2) partial structure,
(3) physical and/or chemical properties,
(4) functional characteristics alone or coupled with a known or disclosed
correlation between structure and function, and
(5) the method of making the claimed invention.
24. Level of skill and knowledge in the art: The level of skill to practice the art of the instantly claimed invention is high and requires a variety of skills usually found in institutions and companies that employ highly trained and skilled scientists to carry out these tasks.
25. Partial structure; Physical and/or chemical properties; and Functional characteristics: In the instant case, it is evident that the genus of compounds embraced by Formula (A) has substantial variance. The claimed genus of Formula (A) is virtually without limit, embracing hundreds of millions, if not billions, of potential compounds bearing little structural resemblance to one another, i.e., presently the genus of compounds according to Formula (A) embraces compound species wherein “A” can be a cyclic structurer that is any monocyclic ring, any bicyclic ring, any fused ring, any 5-bridged ring, any spiro ring, any heterocyclic ring, any aromatic ring, any aromatic heterocyclic ring, any aliphatic ring, or any combination thereof. For example, Formula (A) embraces the compound 34a:
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and compound 9:
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which bear almost no structural overlap with each other. Furthermore, the instant claims presently embrace any salt, ester, hydrate, solvate, or stereoisomer thereof of any/all of the compounds of Formula (A). The Specification defines “ester” as a structure in which the fragment contains an ester functional group -RCOOR' (where R' is generally another non-H group such as alkyl), wherein R can be for example a lower alkyl or aryl, such as methylene, ethylene, isopropylene, isopropylidene, phenylene, etc., and R' can be for example a lower alkyl or aryl, such as methyl, ethyl, propyl, isopropyl, butyl, phenyl, etc. (paragraph [0165]). The Specification defines “hydrate” as a compound that is bonded to one or more water (H2O) molecule, e.g., by a hydrogen bond, (paragraph [0172]). The Specification defines “solvate” as a physical association of a compound with one or more solvent molecules, whether organic or inorganic, including hydrogen bonding, and goes on to teach that “solvate" encompasses both solution-phase and isolable solvates, including, without limitation, hydrates, ethanolates, methanolates, hemiethanolates, and the like (paragraph [0171]). The Specification defines "stereoisomer" as the isomer produced by the different spatial arrangement of atoms or groups in a molecule, and teaches that stereoisomers are mainly divided into two categories: stereoisomers caused by bond length, bond angle, intramolecular double bond, ring, and the like are called configuration stereoisomers. Stereoisomers caused only by the rotation of a single bond are called conformational stereoisomers, sometimes also known as rotational isomers (paragraph [140]).
While the specification exemplifies the stereochemistry of certain species of Formula (A) at the methox-pyrrolzinyl moiety, the Specification fails to limit or teach the preparation of the extremely broad scope of “a pharmaceutically acceptable… ester, hydrate, solvate, or stereoisomer thereof” of a compound of Formula (A) such that there are no clear structural limitation(s) showing what substitutions/ modifications could be made to the compounds of Formula (A) to arrive at the broad scope of “ester, hydrate, solvate, or stereoisomer thereof.” Thus the subgenus of “ester, hydrate, solvate, or stereoisomer thereof” is virtually without limit.
26. The Specification teaches that the instant compounds are inhibitors of the Kirsten Rat Sarcoma Viral Oncogene Homolog gene (KRAS), in particular KRASG12D, a common gene mutation in human cancer, and alleges that said compounds are useful for treating various types of cancer (paragraph [0007]).
27. The method of making the claimed invention: The instant Specification discloses the preparation of approximately 200 exemplary compound species in Table 2 that correspond to a compound of Formula (A) as recited in the claims, but are limited to compounds according to the following subgenus:
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(see Table 2 at pages 19-36).
28. While the MPEP does not define what constitutes a sufficient number of representative species, the courts have indicated what does not constitute a representative number of species to adequately describe a broad generic. For example, in In re Gostelli, the courts determined that the disclosure of two chemical compounds within a subgenus did not describe that subgenus. In re Gostelli, 872 F.2d 1008 (Fed. Cir. 1989). In the instant case, it is similarly determined that the disclosure of 200 somewhat structurally-related compounds does not adequately describe a genus embracing hundreds of millions, if not billions, of additional compound species bearing no structural relationship with those disclosed compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the extreme variance in the genus.
29. The description requirement of the patent statue 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 fails to provide adequate written description for the genus of the claims and does not reasonably convey to one skilled in the relevant art that the Applicant, at the time the application was filed, had possession of the entire scope of the claimed invention.
30. As such, claims 1, 2, 25, 26, 37, 43, 44, 48-50, and 55 are rejected.
Claim Rejections - 35 USC § 102
31. The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
32. Claims 1, 2, 25, 26, 37, 50 and 55 are rejected under 35 U.S.C. 102(a)(1) and/or 35 U.S.C. 102(a)(2) as being anticipated by Wang et al., WO 2021041671 A1 (published March 4, 2021 and cited on Applicant’s IDS of January 31, 2024).
Claims 1 and 2 are drawn to a compound having the structure of Formula (A) or a pharmaceutically acceptable salt, ester, hydrate, solvate or stereoisomer thereof:
wherein: X2 is hydrogen, substituted or unsubstituted alkyl, substituted or unsubstituted heteroalkyl, substituted or unsubstituted acyl, one or more amino acid residues, substituted or unsubstituted oligopeptide, phosphoryl, phosphonyl, aminophosphonyl, sulfonyl, thioacyl, substituted or unsubstituted benzyl, substituted or unsubstituted alkoxycarbonyl, substituted or unsubstituted aminocarbonyl, substituted or unsubstituted mercaptothiocarbonyl, substituted or unsubstituted alkylthio, substituted or unsubstituted ester alkyl, substituted or unsubstituted benzyloxycarbonyl, glucoside, glucuronide, or cholic acid substituent;
A is an organic group containing a cyclic structure which is a monocyclic ring, a bicyclic ring, a fused ring, a bridged ring, a spiro ring, a heterocyclic ring, an aromatic ring, an aromatic heterocyclic ring, an aliphatic ring, or any combination thereof, wherein the cyclic structure contains two or more substituent groups; and A1, A2, A3 and A4 are independently hydrogen or a C1-C6 hydrocarbyl group, or one or two of the A1, A2, A3 and A4 groups is connected to the piperazine ring and forms a bridged ring, a fused ring, or a spiro ring and the remaining one or two of the A1, A2, A3 and A4 groups are independently hydrogen or a C1- C6 hydrocarbyl group;
more specifically a compound of Formula (A), according to the scope of the independent invention, as set forth in paragraph “7” above:
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, wherein X2 is hydrogen; and Y2 is hydrogen, halogen or di-halo.
Claims 25, 26 and 37 are drawn to claim 1, and further limit wherein the compound has a structure according to Formula (II) or Formula (IIA):
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or
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.
**In view of a broadest reasonable interpretation of claim 25, the recited moieties in Formula (II) and (IIA) are construed to mean:
“R11“ is hydrogen or fluorine; “W” is oxygen; “X1“ is hydrogen; “X2” is as defined in claim 1; “X3” is
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or a lone pair of electrons; “Y1a “ and “Ylb“ are both hydrogen; and “Y2“ is fluorine.
Claim 50 is drawn to a pharmaceutical composition comprising the compound or the pharmaceutically acceptable salt, ester, hydrate, solvate, or stereoisomer thereof of claim 1 and a pharmaceutically acceptable excipient, carrier or diluent. Claim 55 is drawn to claim 50, wherein the composition is suitable for administration by injection, e.g., subcutaneous, intravenous, intramuscular, or intraperitoneal administration.
33. Wang et al. specifically teach dozens of diazabicyclo[3.2.1]octan-3-yl -7-(naphthalenyl)-8-fluoro-pyrido-pyrimidinyl compounds that are the same as species of Applicant’s instantly recited Formula (A):
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and
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(page 22)
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(page 25),
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(page 26),
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(page 27),
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and
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(page 31),
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and
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(page 32),
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(page 33),
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(page 34),
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(page 35), and
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and
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(page 36),
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,
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(page 37),
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(page 38),
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(page 40),
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(page 41),
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(page 44), and
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(page 46), for example.
34. Wang et al. teach pharmaceutical compositions comprising a compound of Formula (I) or a pharmaceutically acceptable salt thereof and a pharmaceutically acceptable carrier, excipient or diluent, wherein said composition is suitable for administration by injection (see paragraphs [0169] and [0170]).
In this case, when the species is clearly named, the species claim is anticipated no matter how many other species are additionally named. Ex parte A, 17 USPQ2d 1716 (Bd. Pat. App. & Inter.1990) (The claimed compound was named in a reference which also disclosed 45 other compounds. The Board held that the comprehensiveness of the listing did not negate the fact that the compound claimed was specifically taught. The Board compared the facts to the situation in which the compound was found in the Merck Index, saying that "the tenth edition of the Merck Index lists ten thousand compounds. In our view, each and every one of those compounds is described' as that term is used in 35 U.S.C. § 102(a), in that publication."). Id. at 1718. See also In re Sivaramakrishnan, 673 F.2d 1383, 213 USPQ 441 (CCPA 1982).
Claim Rejections - 35 USC § 103
35. 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.
36. 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.
37. This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
38. Claim 48 is rejected under 35 U.S.C. 103 as being unpatentable over Wang et al., WO 2021041671 A1, as applied to claims 1, 2, 25, 26, 37, 50 and 55, above.
Claim 48 is drawn to a compound selected from the Markush group recited in claim 48, more specifically the compound:
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(see page 20, second row of compounds).
39. Wang et al. teach a genus of functionally related compounds having the same core structure that is instantly recited by Applicant, (see Formula (I) at pages 2-4) and specifically disclose the following species, differing solely in the substituents on the naphthyl ring and the fluoro- substituent on the hexahydropyrrolizine ring:
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,
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(page 35)
and
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(page 41).
40. The genus of compounds disclosed by Wang et al. fully encompasses the compounds of the instant invention and also demonstrates KRas inhibitory activity, in particular, KRas G12D, (paragraph [0007]), but Wang et al. do not teach a single disclosed compound or species that anticipates the subgenus of species of claim 48.
41. Yet, Wang et al. generically indicate in the first structure above that the methoxy substituent can be in the meta-position on the naphthyl ring, i.e. that the “-OH” substituent can be replaced with methoxy on the naphthyl ring:
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(second row of compounds at page 35). Wang et al. generically indicate in the second structure above that the naphthyl ring can be fluoro-substituted:
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and that the hexahydropyrrolizinyl ring can be fluoro-substituted:
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.
42. As such, one of skill in the art would have been guided by Wang et al. to modify the compound
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by replacing the hydroxy substituent with methoxy, and by adding a fluoro on the hexahydropyrrolizine ring, in order to prepare the recited compound:
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with the expectation that structurally similar compounds are presumed to 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) (stereoisomers prima facie obvious); Aventis Pharma Deutschland v. Lupin Ltd., 499 F.3d 1293, 84 USPQ2d 1197 (Fed. Cir. 2007) (5(S) stereoisomer of ramipril obvious over prior art mixture of stereoisomers of ramipril). One skill in the art before the effective filing date of the claimed invention would have been motivated to modify the compound(s) of Wang et al. and prepare the instantly claimed compound with a reasonable expectation of success, i.e., a structurally similar compound with KRas G12D inhibitory activity.
As such, claim 48 is prima facie obvious.
Claim Objections
43. Claims 43, 44 and 49 are also objected to as being dependent upon a base claim that is rejected under 35 U.S.C. 102 or 35 U.S.C. 103.
Conclusion
44. Claims 1, 2, 9, 11, 12, 19, 23, 25, 26, 37, 40, 43, 44, 48-50, 55, 58-60, 81 and 85 are present in the application. Claims 9, 11, 12, 19, 23, 40, 58-60, 81 and 85 are withdrawn from consideration as directed to non-elected subject matter. Claims 1, 2, 25, 26, 37, 43, 44, 48-50, and 55 are rejected. Claims 43, 44 and 49 are also objected to. No claim is presently allowed.
45. Any inquiry concerning this communication or earlier communications from the examiner should be directed to JANET L COPPINS whose telephone number is (571)272-0680. The examiner can normally be reached Monday-Friday 8:30AM-5PM EST.
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/JANET L COPPINS/Examiner, Art Unit 1628
/AMY L CLARK/Supervisory Patent Examiner, Art Unit 1628