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 .
DETAILED ACTION
1. This application is a 371 of PCT/US2022/016378 02/15/2022; PCT/US2022/016378 has PRO 63/150,695 02/18/2021.
Claims 1-19 are pending.
Response to Amendments
2. The rejection of claims 4-5 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of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends is withdrawn based upon the amendments.
The rejection of claim(s) 1-4, 6, 11 under 35 U.S.C. 102(a)(1) as being anticipated by Wang US 20140275026 A1 is withdrawn based upon the amendments. The rejection of claim(s) 1-3, 6-7, 11 under 35 U.S.C. 102(a)(1) as being anticipated by Li is withdrawn based upon the amendments.
Claim Interpretation
3. The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The definition of A has a series of three structures containing A’ and A” rings, which “may contain one of more heteroatoms selected from N, O or S”, however “contain” is not defined in the specification. Based upon the examples in specification and claim 4, contain appears to intended to mean replacement of a carbon atom with a heteroatom. However this is not the only interpretation since “contain” could reasonably include structures where the ring size is not limited to five or six membered rings and would include rings with more members containing heteroatoms not as replacements but internal additions, such that the heteroatoms are contained between the bonds in the structures.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
4. Claims 1-4, 6, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Wang US 20140275026 A1 (cited on the IDS). The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
A) Determining the scope and contents of the prior art.
B) Ascertaining the differences between the prior art and the claims at issue.
C) Resolving the level of ordinary skill in the pertinent art.
D) Considering objective evidence present in the application indicating obviousness or nonobviousness.
A) Determining the scope and contents of the prior art:
Wang teaches species including but not limited to Example 51 4-(2,4-difluorophenoxy)-3-(1-methyl-7-oxo-6,7-dihydro-1H-pyrrolo[2.3-c]pyridin-3-yl)benzene sulfonamide on page 54 1st column where R1 is H, D is phenyl, A is the second structure, the ring A’ being the aromatic ring pyrrole, A” being the aromatic ring pyridine, where in both cases each ring contains a nitrogen heteroatom, where n is 2 and R2 is either -OR where R is H or oxo1 and C1 alkyl (methyl), p is 2 and R3 is halo (F).
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Wang also teaches a genus at page 1, where R1 is both alkyl and H.
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B) Ascertaining the differences between the prior art and the claims at issue. The sole distinction between the prior art and the instant claim 2 which defines n as 2, excluding the species of Wang.
C) Resolving the level of ordinary skill in the pertinent art: The level of ordinary skill is high. Someone preparing these compounds would be trained in medicinal chemistry and would recognize the very close structural similarity.
D) Considering objective evidence present in the application indicating obviousness or nonobviousness: Claim 1 embraces compounds where n is 1 and Wang’s R1 is H, which are simply the desmethyl variants of the prior art compounds. The interchangeability of hydrogen and methyl generally creates a case of prima facie obviousness. In re Grabiak 226 USPQ 870, "[w]hen chemical compounds have "very close" structural similarities and similar utilities, without more a prima facie case may be made", In re Deuel 34 USPQ2d 1210, "a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (emphasis added) (e.g. ortho v. para)". Since Wang suggests the desmethyl compounds by defining R1 as H, the instant claims drawn to the R1 embodiment of H are prima facie obvious.
5. Claim(s) 1-3, 6-7, 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Li, Zizhou “Discovery of 8-Methyl-pyrrolo[1,2-a]pyrazin-1(2H)-one Derivatives as Highly Potent and Selective Bromodomain and Extra-Terminal (BET) Bromodomain Inhibitors.”
Journal of Medicinal Chemistry, 2020, 63(8), 3956-3975 (cited on the IDS). The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
A) Determining the scope and contents of the prior art.
B) Ascertaining the differences between the prior art and the claims at issue.
C) Resolving the level of ordinary skill in the pertinent art.
D) Considering objective evidence present in the application indicating obviousness or nonobviousness.
A) Determining the scope and contents of the prior art:
Li teaches anticipatory species including but not limited to compounds 28 and 35 on page 3960 where R1 is alkyl (t-Bu), D is pyridine or phenyl, A is the second structure, the ring A’ being the aromatic ring pyrrole, A” being the aromatic ring pyrazine where in both cases each ring contains a nitrogen heteroatom, where n is 2 and R2 is either -OR where R is H or oxo and C1 alkyl (methyl), p is 2 and R3 is halo (F). The compounds were formulated in DMSO and used in various assays.
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B) Ascertaining the differences between the prior art and the claims at issue. The sole distinction between the prior art and the instant claim 2 which defines n as 2, excluding the species of Li.
C) Resolving the level of ordinary skill in the pertinent art: The level of ordinary skill is high. Someone preparing these compounds would be trained in medicinal chemistry and would recognize the very close structural similarity.
D) Considering objective evidence present in the application indicating obviousness or nonobviousness: Claim 1 embraces compounds where n is 1, which are simply the desmethyl variants of the prior art compounds. The interchangeability of hydrogen and methyl generally creates a case of prima facie obviousness. In re Grabiak 226 USPQ 870, "[w]hen chemical compounds have "very close" structural similarities and similar utilities, without more a prima facie case may be made", In re Deuel 34 USPQ2d 1210, "a known compound may suggest its analogs or isomers, either geometric isomers (cis v. trans) or position isomers (emphasis added) (e.g. ortho v. para)".
Objections
6. Claim 5 is objected to for depending from a rejected base claim, but would be allowable in independent format with all the limitations of the base claim and any intervening claim.
Conclusion
7. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID K O'DELL whose telephone number is (571)272-9071. The examiner can normally be reached on Monday - Friday 9:30 - 7:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID K O'DELL/Primary Examiner, Art Unit 1621
1 The hydroxy pyridine is the tautomeric form of the pyridin-2-one when the heteroaromatic pyridine substituted with oxo. According to the specification page 43 lines 10ff. “[A]ll tautomeric forms are also intended to be included….A "tautomer" refers to a molecule wherein a proton shift from one atom of a molecule to another atom of the same molecule is possible. The compounds presented herein, in certain embodiments, exist as tautomers. In circumstances where tautomerization is possible, a chemical equilibrium of the tautomers will exist. The exact ratio of the tautomers depends on several factors, including physical state, temperature, solvent, and pH.” Page 44 lines 11-12, “Where compounds of Formula I are capable of tautomerization, all individual tautomers as well as mixtures thereof are included in the scope of this invention.”
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