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
Applicant’s election without traverse of Group I, claims 1-9 and 14-17, drawn to a compound of Formula (A) or (A’) and a pharmaceutical composition thereof, in the reply filed on April 21, 2026 is acknowledged with appreciation.
Claims 10-13, drawn to the process of preparation of Group II, are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicant additionally elected the single compound species according to Formula (A) without traverse:
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, which is a compound of Formula (A), wherein
R1 is H, R2 is H; R3 is an ester such as -C(O)O-alkyl; R4 is H; R is an alkyl group, typically C1-C6 (e.g., methyl, ethyl, propyl); specifically CH3; R' is an alkyl group (e.g., an ethyl group); Nu is a 1H-1,2,3-triazol-1-yl group substituted by a polyethylene glycol-containing group; and RA is an acetyl group. Claims 1-9 and 14-17 are readable on the elected species.
Applicant’s elected compound species 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 35 USC 102 and 35 USC 103 rejections 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), wherein R1, R2, R3 and R4 are any atom (i.e. are not limited); R is alkyl; R' is alkyl; RA is H, methyl, or an acetyl group; and Nu comprises -NH-, -O-, -S-, -Se-, -N3- or an optionally substituted heterocyclyl or heteroaryl group.
Claims 1-7, 9, and 14-17 are readable on the scope of the independent invention. Thus, claim 8 is withdrawn as directed to non-elected subject matter. Compounds that fall outside of the scope of the independent invention defined above also withdrawn as directed to non-elected subject matter.
Claims 1-7, 9 and 14-17 are under examination with the scope of the independent invention encompassing the elected species defined above and are the subject of this office action.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 21, 2023 and April 26, 2024, are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements have been considered by the examiner, please refer to the signed copy of Applicant’s PTO-1449 form, attached herewith.
Specification
10. The disclosure is objected to for the following reasons: the Specification employs the term “new” in multiple instances, e.g., “[t]he present invention relates to new tetrahydroquinoline (THQ) compounds and new methods for synthetizing such compounds,” (lines 1-2 at page 1). It is suggested that the term “new” be deleted from the language of the disclosure. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer new/ novel, since the scope of the invention no longer embraces what is considered “new.” Thus, the incorporation of “new” into the language of the Specification is not appropriate. Appropriate correction is required. See MPEP § 608.01(b).
11. The abstract is objected to for employing the term “new” in the first sentence, e.g., “[t]he present invention relates to new tetrahydroquinoline (THQ) compounds and new methods for synthetizing such compounds”, first sentence. It is suggested that the term “new” be deleted from the language of the abstract. Once the determination of the novelty of a claimed invention has been established and the disclosure of the invention made public and/or patented, the claimed invention is no longer new/novel, since the scope of the invention no longer embraces what is considered “new.” Thus, the incorporation of “new” into the language of the abstract is not appropriate. Appropriate correction is required. See MPEP § 608.01(b).
Claim Rejections - 35 USC § 112(b)
12. 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.
13. Claims 2-7, 9 and 17 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.
14. Claim 2 is problematic in the following aspects:
(a) Claim 2 depends from claim 1, and limits wherein the compound has a structure according to Formula (I), Formula (I’), Formula (II), or Formula (II’).
There is insufficient antecedent basis for each of said structural formulas, as follows:
i. In formulae (I) and (I’), “RA” is -C(=O)-R7, however there is no prior recitation of a -C(=O)-R7 group, or the R7 variable, in the definition of “RA” in claim 1.
ii. In formulae (II) and (II’), “RA” is hydrogen, however there is no prior recitation of hydrogen in the definition of “RA” in claim 1.
iii. In formulae (I), (I’), (II) and (II’), “R’ ” is -CH2-R8, however there is no prior recitation of a -CH2-R8 group, or the R8 variable, in the definition of “R’ ” in claim 1.
(b) Claim 2 recites the limitation "wherein R represents an alkyl group" in the fifth line of the claim. There is insufficient antecedent basis for this limitation in the claim, because there is no prior recitation of an alkyl group in the definition of “R” in claim 1.
(c) In the first line of the claim on page 3, the phrase "preferably" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
(d) Claim 2 recites the limitation: "-Nu … [is] preferably selected from the group consisting of -N3, -OR5, -SR5, -SeR5, and
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wherein -N is linked to the heterocycle and wherein the covalent bonds between N and R5, and N and R6 represent single or double bonds with R5 or R6, and wherein R5 and R6 represent each independently an atom or a chemical group of atoms and may form together a heterocycle, optionally substituted, or - Nu together with R form an [sic] heterocycle, for example thereby forming a hexahydropyrroloquinoline,” on page 3. However there is insufficient antecedent basis for this limitation in the claim, because there is no prior recitation of -N3, -OR5, -SR5, -SeR5, or
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or the R5 or R6 variables, in the definition of “Nu” in claim 1.
(i) It is also noted that in the second line of claim 2 on page 3, R5 is notated as “R5” (subscript), however in the group:
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R5 is noted as “R5” (superscript). It is not clear if Applicant is intending to recite two different variables, R5 and R5, or if every recitation of R5 is intended to embrace the same variable. Clarification is requested.
(ii) And in the fourth line of page 3, in the definition of -Nu, the claim recites “wherein -N is linked to the heterocycle” however it is not clear which heterocycle is intended because there is no prior recitation of a heterocycle in the claim.
(c) In the second to last line of the claim, the phrase "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, consistent with the teaching of the Specification, the limitations of claim 2 are incorporated into claim 1.
15. Claim 3 depends from claim 1 and recites the limitation "wherein R1, R2, and R4 are hydrogen atoms." However there is insufficient antecedent basis for this limitation in the claim, because there is no prior recitation of hydrogen in the definition(s) of R1, R2 and R4 in claim 1.
16. Claim 4 depends from claim 1 and recites the limitation "wherein R is CH3." However there is insufficient antecedent basis for this limitation in the claim, because there is no prior recitation of -CH3 in the definition of R in claim 1.
17. Claim 5 depends from claim 2 and recites the limitation "wherein R8 is CH3." However there is insufficient antecedent basis for this limitation in the claim, because there is no prior recitation of -CH3 in the definition of R8 in claim 2.
18. Claim 6 depends from claim 1 and recites the limitation "wherein R5 and R6 are each independently selected from the group consisting of H, C(O)OR9, an aryl or heteroaryl ring optionally substituted, wherein R9 is an alkyl group.” However there is insufficient antecedent basis for this limitation in the claim, because there is no prior recitation of R5, R6, or their definitions thereof, in claim 1.
19. Claim 7 is problematic in the following aspects:
(a) Claim 7 depends from claim 1 and recites the limitation "wherein R5 and R6 form together an heteroaryl of the following structure:
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wherein Ra and Rb are each independently an atom or a chemical group of atoms, preferably selected from the group consisting of H, a halogen atom (Br, Cl, F), an alkyl group optionally comprising one or more heteroatoms (O, N, S), an optionally substituted phenyl ring, and wherein Ra and Rb may form together a cycle or heterocycle, optionally substituted,” however there is insufficient antecedent basis for this limitation in the claim, because there is no prior recitation of R5 and R6, or their definitions thereof, in claim 1.
(b) In the fifth line of the claim, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05.
(c) In lines 5-6 of the claim, the parentheticals “(Br, Cl, F)” and “(O, N, S)” are confusing and render the claim indefinite because it is unclear if the limitations in the parentheticals are part of the claimed invention or are exemplary. See MPEP § 2173.05(d).
(d) In lines 6-7 of the claim, the phrase "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).
20. Claim 9 is indefinite in the following aspects:
(a) Claim 9 depends from claim 1, and further limits the compound to one of the over seventy compound species according to Formula (A) or (A’) recited in the claim. However There is insufficient antecedent basis for each of said compound species in the claim, because there is no prior recitation of any of the groups/ moieties corresponding to R1-R4, Nu, RA, R and R’ of each of said compound species, within claim 1.
(b) On page 8, the last compound structure is cut off/ incomplete such that it is not clear what compound Applicant is intending to recite.
21. Claim 17, the phrase "preferably" in line 2 renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
Claim Rejections - 35 USC § 112(a)
22. 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.
23. Claims 1-7, 9 and 14-17 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 regarding the full scope of compounds and alternatives according to the genus of Formula (A) or (A’). 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.
24. In particular, support cannot be found for the full scope of compounds of Formula (A) and Formula (A’), and compositions thereof, as instantly recited by the claims.
25. 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. The problem is especially acute with genus claims that uses open-ended language such as “or an isotopically labeled derivative thereof.” In such a case, the claim simply recites the generic “derivative,” and may do so without describing species that achieve that result. But the specification must demonstrate that the Applicant has made a generic invention that achieves the claimed result and do so by showing that the Applicant has invented sufficient alternative species to support the claim to the generically-defined genus.
26. 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.
27. 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.
28. Partial structure; Physical and/or chemical properties; and Functional characteristics: The claims are drawn to a compound according to the extremely broad genera of Formula (A), or Formula (A’):
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, or a composition thereof. The claimed genera of Formula (A) and/or (A’) embrace billions of compounds, which bear little structural overlap with one another, e.g., presently each genus of compounds (Formula (A) or (A’)) encompasses compound species wherein each of R1-R4, R, R’, RA and Nu embrace any/all “atom or a chemical group of atoms” without limit. Thus, it is evident that the genera of tetrahydroquinoline compounds and analogs encompassed by the claims has substantial variance.
29. The instant tetrahydroquinoline compounds are taught by the Specification to be bromodomain inhibitors, which are alleged to be useful in the treatment of chronic or chronic autoimmune and/or inflammatory conditions including rheumatoid arthritis, psoriasis, multiple sclerosis, inflammatory bowel disease, atherosclerosis, Alzheimer’s disease, depression, macular edema, lupus, diabetes (Type I and Type II), bacterial diseases, viral infections, inflammatory responses to fungi or parasites, and cancer, for example (Specification at pages 30-31). Applicant demonstrates the in vitro cytotoxic activity of a few dozen compounds according to Formula (A) or (A’) against one murine sarcoma cell line (J774 cells) (Specification at pages 78-90).
30. Method of making: It is evident that the genera of compounds embraced by Formulae (A) and (A’) of the claims has substantial variance, as discussed in paragraph “28” above, embracing billions of compound species without any limit whatsoever. Yet, the instant Specification discloses the preparation of just a few dozen compound species according to instant Formulae (A) or (A’) at pages 34-77, wherein R1, R2 and R4 are limited to hydrogen; R3 is primarily alkoxy, an ester group or a carboxamide-substituted phenyl; R is alkyl; R’ is ethyl or an ester; RA is acetyl or hydrogen; and Nu is primarily -N3, a substituted alkoxy, a substituted amino, a substituted sulfoalkyl, or a substituted triazolyl group.
31. 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 claim. 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 the preparation of a few dozen compound does not adequately describe genera of three separate formulae embracing billions of possible compounds. That is, the Specification does not disclose a sufficient variety of species to reflect the breadth of the possible compound selections recited in the claims.
32. The level of detail required to satisfy the written description requirement varies depending on the nature and scope of the claims and on the complexity and predictability of the relevant technology. Ariad, 598 F.3d at 1351, 94 USPQ2d at 1172; Capon v. Eshhar, 418 F.3d 1349, 1357-58, 76 USPQ2d 1078, 1083-84 (Fed. Cir. 2005). The fields of biology and chemistry are considered “unpredictable” because the complexity and unpredictability of chemical and biological interactions can make it difficult to understand the exact properties of an invention. A person of ordinary skill in the art from the specification or from the prior art cannot predict the pharmacological effects of administration of the instant formulation in subjects in regards to prevention of pain. The pharmaceutical industry is the prototypical example of a highly unpredictable field. Pfizer v. Teva Pharm., 482 F.Supp.2d 390, 413 (D.N.J. 2007); 2 Chisum on Patents § 5.04.
33. Applicants have failed to provide guidance or data or evidence as to how the skilled artisan would be able to extrapolate from the disclosure to use the claimed invention. “A description of what a material does, rather than of what it is, usually does not suffice." Rochester, 358 F 3d at 923; Eli Lilly, 119 at 1568. Instead, the “disclosure must allow one skilled in the art to visualize or recognize the identity of the subject matter purportedly described.” Vas-Cath Inc. v. Mahurkar, 19 USPQ2d 1111, makes clear the "applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention. The invention is, for purposes of the 'written description' inquiry, whatever is now claimed." (See page 1117.) The specification does not "clearly allow persons of ordinary skill in the art to recognize that [he or she] invented what is claimed." (See Vas-Cath at page 1116).
34. 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.").
35. Accordingly, it is deemed that the specification fails to provide adequate written description for the full scope of compounds embraced by Formulae (I)-(III) and their pharmaceutical compositions, as recited by 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.
As such, claims 1-7, 9 and 14-17 are rejected.
Claim Rejections - 35 USC § 102
36. 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.
37. Claims 1, 3, 4, 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No 6590-82-5, 2-Ethyl-1,2,3,4-tetrahydro-3-methyl-N-phenyl-4-quinolinamine, (entered STN November 16, 1984).
Claim 1 is drawn to a compound according to the following structure:
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wherein R, R’, RA, Nu, R1, R2, R3 and R4 are each independently an atom or a group of atoms, more specifically a compound according to the scope of the independent invention:
A compound of Formula (A), wherein R1, R2, R3 and R4 are any atom (i.e. are not limited); R is alkyl; R' is alkyl; RA is H, methyl, or an acetyl group; and Nu comprises -NH-, -O-, -S-, -Se-, -N3- or an optionally substituted heterocyclyl or heteroaryl group.
Claim 3 is drawn to claim 1, and limits wherein R1, R2 and R4 are hydrogen. Claim 4 is drawn to claim 1, and limits wherein R is CH3.
38. CAS Reg. No.6590-82-5 teaches the following compound:
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which is the same as a compound species of Applicant’s formula (A), wherein R1, R2, R3 and R4 are hydrogen; R is methyl; R' is ethyl; RA is acetyl; and Nu comprises an -NH-phenyl moiety.
Claim 14 is drawn to the compound of claim 1, for use as a selective BET inhibitor. Claim 17 is drawn to the compound of claim 1, for use in a method for treating an inflammation or a cancer, preferably a cancer involving BET over-expression.
39. Regarding claims 14 and 17, the preambles recite the compound of claim 1, and while the use of a descriptive clause, i.e., “for use as a selective BET inhibitor…,” when referring to the contemplated use (“intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. A “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Rather, a future intended use is not limiting where a claim defines a structurally complete invention and the only difference is the recited purpose or intended use for the invention. Therefore the future intended use “as a selective BET inhibitor” or “for treating an inflammation or cancer” does not impose any limitation on the product claim.
Thus, claims 14 and 17 are anticipated.
40. Claims 1, 3, 4, 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No 1628625-06-8, Carbamic acid, N-[(2R,3R,4S)-6-bromo-2-ethyl-1,2,3,4-tetrahydro-3-methyl-4-quinolinyl]-, phenylmethyl ester, rel-, (entered STN October 10, 2014).
Claim 1 is drawn to a compound according to the following structure:
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wherein R, R’, RA, Nu, R1, R2, R3 and R4 are each independently an atom or a group of atoms, more specifically a compound according to the scope of the independent invention:
A compound of Formula (A), wherein R1, R2, R3 and R4 are any atom (i.e. are not limited); R is alkyl; R' is alkyl; RA is H, methyl, or an acetyl group; and Nu comprises -NH-, -O-, -S-, -Se-, -N3- or an optionally substituted heterocyclyl or heteroaryl group.
Claim 3 is drawn to claim 1, and limits wherein R1, R2 and R4 are hydrogen. Claim 4 is drawn to claim 1, and limits wherein R is CH3.
41. CAS Registry No 1628625-06-8 teaches the following compound:
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which is the same as a compound species of Applicant’s formula (A), wherein R1, R2 and R4 are hydrogen; R3 is bromine; R is methyl; R' is ethyl; RA is hydrogen; and Nu comprises an -NH-phenyl-methyl-ester moiety. Regarding the stereochemistry of the moieties corresponding to “R” and “R’ ”, it is noted that while the structure depicted shows (R) and (S) orientation for “R” and “R’ ”, the CAS chemical name states that both moieties are (R) orientation.
Claim 14 is drawn to the compound of claim 1, for use as a selective BET inhibitor. Claim 17 is drawn to the compound of claim 1, for use in a method for treating an inflammation or a cancer, preferably a cancer involving BET over-expression.
42. Regarding claims 14 and 17, the preambles recite the compound of claim 1, and while the use of a descriptive clause, i.e., “for use as a selective BET inhibitor…,” when referring to the contemplated use (“intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. A “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Rather, a future intended use is not limiting where a claim defines a structurally complete invention and the only difference is the recited purpose or intended use for the invention. Therefore the future intended use “as a selective BET inhibitor” or “for treating an inflammation or cancer” does not impose any limitation on the product claim.
Thus, claims 14 and 17 are anticipated.
43. Claims 1, 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No 2412697-51-7, (2S,3S,4R)-3-Ethyl-1,2,3,4-tetrahydro-6,7-dimethyl-2-propyl-4-quinolinol, (entered March 26, 2020).
Claim 1 is drawn to a compound according to the following structure:
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wherein R, R’, RA, Nu, R1, R2, R3 and R4 are each independently an atom or a group of atoms, more specifically a compound according to the scope of the independent invention:
A compound of Formula (A), wherein R1, R2, R3 and R4 are any atom (i.e. are not limited); R is alkyl; R' is alkyl; RA is H, methyl, or an acetyl group; and Nu comprises -NH-, -O-, -S-, -Se-, -N3- or an optionally substituted heterocyclyl or heteroaryl group.
44. CAS Registry No 2412697-51-7 teaches the following compound:
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which is the same as a compound species of Applicant’s formula (A’), wherein R1 and R4 are hydrogen; R2 and R3 are methyl; R is ethyl; R' is propyl; RA is hydrogen; and Nu comprises an -OH moiety. Regarding the stereochemistry of the moieties corresponding to “R” and “R’ ”, it is noted that while the structure depicted shows (R) and (S) orientation for “R” and “R’ ”, the CAS chemical name states that both moieties are (S) orientation.
Claim 14 is drawn to the compound of claim 1, for use as a selective BET inhibitor. Claim 17 is drawn to the compound of claim 1, for use in a method for treating an inflammation or a cancer, preferably a cancer involving BET over-expression.
45. Regarding claims 14 and 17, the preambles recite the compound of claim 1, and while the use of a descriptive clause, i.e., “for use as a selective BET inhibitor…,” when referring to the contemplated use (“intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. A “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Rather, a future intended use is not limiting where a claim defines a structurally complete invention and the only difference is the recited purpose or intended use for the invention. Therefore the future intended use “as a selective BET inhibitor” or “for treating an inflammation or cancer” does not impose any limitation on the product claim.
Thus, claims 14 and 17 are anticipated.
46. Claims 1, 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by CAS Registry No 2412697-29-9, (2S,3S,4R)-3-Ethyl-1,2,3,4-tetrahydro-2-propyl-4-quinolinol, (entered March 26, 2020).
Claim 1 is drawn to a compound according to the following structure:
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wherein R, R’, RA, Nu, R1, R2, R3 and R4 are each independently an atom or a group of atoms, more specifically a compound according to the scope of the independent invention:
A compound of Formula (A), wherein R1, R2, R3 and R4 are any atom (i.e. are not limited); R is alkyl; R' is alkyl; RA is H, methyl, or an acetyl group; and Nu comprises -NH-, -O-, -S-, -Se-, -N3- or an optionally substituted heterocyclyl or heteroaryl group.
47. CAS Registry No 2412697-29-9 teaches the following compound:
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which is the same as a compound species of Applicant’s formula (A’), wherein R1, R2, R3 and R4 are hydrogen; R is ethyl; R' is propyl; RA is hydrogen; and Nu comprises an -OH moiety. Regarding the stereochemistry of the moieties corresponding to “R” and “R’ ”, it is noted that while the structure depicted shows (R) and (S) orientation for “R” and “R’ ”, the CAS chemical name states that both moieties are (S) orientation.
Claim 14 is drawn to the compound of claim 1, for use as a selective BET inhibitor. Claim 17 is drawn to the compound of claim 1, for use in a method for treating an inflammation or a cancer, preferably a cancer involving BET over-expression.
48. Regarding claims 14 and 17, the preambles recite the compound of claim 1, and while the use of a descriptive clause, i.e., “for use as a selective BET inhibitor…,” when referring to the contemplated use (“intended use”) of a claimed compound is proper, it is not a limitation and thus of no significance in determining the patentability thereof over the prior art, please refer to In re Thomas (CCPA 1949) 178 F2d 412, 84 USPQ 132. A “mere statement of a new use for an otherwise old or obvious composition cannot render a claim to the composition patentable.” In re Zierden, 411 F.2d 1325, 1328 (CCPA 1969). Rather, a future intended use is not limiting where a claim defines a structurally complete invention and the only difference is the recited purpose or intended use for the invention. Therefore the future intended use “as a selective BET inhibitor” or “for treating an inflammation or cancer” does not impose any limitation on the product claim.
Thus, claims 14 and 17 are anticipated.
Conclusion
49. Claims 1-17 are pending in the application. Claims 8 and 10-13 are presently withdrawn from consideration. Claims 1-7, 9 and 14-17 are rejected.
50. 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
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