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 .
Priority
This application, filed 01/06/2023 is a National Stage entry of PCT/KR2021/008079, International Filing Date: 06/28/2021. PCT/KR2021/008079 claims foreign priority to 10-2020-0083622, filed 07/07/2020. A certified copy of the foreign priority document is of record.
Status of Claims
Claims 7-8, 10-13, and 18-19 are pending as of the response filed on 8/22/25. Claims 1-6, 9, and 14-17 have been canceled.
Applicant’s election of invention II, claims 8, 10, 11, and 13, and new claim 19 in the response filed on 8/22/25 is noted. However, upon further consideration of Applicant’s remarks, the restriction is withdrawn. Claims 7-8, 10-13, and 18-19 were included for examination.
Claims 7-8, 10-13, and 18-19 were examined and are rejected.
Claim Rejections-35 USC § 112
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 8, 10-11, 13, and 19 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.
Claim 8 recites “the monomer unit M1 or M2 is bonded to the linking group L…”. From this language, is it implied that not both M1 and M2 are required to be bonded to L. This is confusing as the beginning of the claim is drawn to a compound of formula III: M1-L-M2, which clearly implies both M1 and M2 are bonded to L. The claim is therefore indefinite. Claims 10-11, 13, and 19 are similarly rejected as these claims depend directly from claim 8.
Claim 11 recites several compounds, (48)-(50), which contain “chloromene” as part of the name. However, chloromene is not an IUPAC recognized name. Therefore, it is uncertain what these compounds actually are, and the claim is indefinite.
Claim 11 also recites the following compounds:
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. For compound (51), the linking group L is attached through R2. However, claim 8, from which claim 11 depends from doesn’t recite Rc of -Orc for R2 as optionally present. Therefore, as Rc of R2 is required as recited by claim 8, and Rc is not present for compound (51), there is insufficient antecedent basis for this compound in the claim.
For compounds (52)-(55), the linking group L is connected via the -C(O)N(Ra)(Rb) group for Y, and one of Ra or Rb is absent. However, for the linking group to be connected here and as is shown for these compounds, Ra and/or Rb have to be optionally present. However, claim 8, from which claim 11 depends doesn’t recite these groups as being optional but required. There is insufficient antecedent basis for these compounds in the claim.
Claim 13 recites “The pharmaceutical composition according to claim 8”, however, claim 8 is drawn to a compound, not a pharmaceutical composition. There is insufficient antecedent basis for this limitation in the claim.
Claim Rejections-35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claim(s) 7, 12, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Hong et. al., USP 6500846 B1, patented 12/31/2002.
Hong teaches flavone derivative compounds and their pharmaceutically acceptable salts, hydrates, solvates, and isomers thereof as inhibitors of cyclin dependent kinases, for the treatment of neurodegenerative diseases as well as anti-cancer agents (title & abstract). The flavone derivatives are taught to have the following chemical structure (col. 1, lines 7-57):
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Hong includes the following compounds as exemplary (col. 57, Ex. 68; col. 77-78, no. 8):
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;
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.
This compound is structurally very similar to the compounds of instant claim 7, 2-(2,5-difluorophenyl)-3-hydroxy-7-methoxy-4H-chromen-4-one; and 2-(3,5-difluorophenyl)-3-hydroxy-7-methoxy-4H-chromen-4-one:
Structure
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2-(3,5-difluorophenyl)-3-hydroxy-7-methoxy-4H-chromen-4-one
Structure
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2-(2,5-difluorophenyl)-3-hydroxy-7-methoxy-4H-chromen-4-one
. The difference between the claimed compounds and the compounds exemplified by Hong is with regards to the substituents on the phenyl ring. The claimed compounds have the phenyl ring disubstituted with fluoro, while the compounds exemplified by Hong has the phenyl ring substituted by a single chloro group, and or disubstituted with hydroxyl. However, Hong also broadly teaches the flavone derivatives can have the phenyl ring substituted with more than one halogen (col. 1, lines 7-57). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have modified the compounds exemplified by Hong by replacing the single halogen substituent or hydroxyl substituents with two fluoro groups attached at either the 2-, 5-, or 3-, 5- positions, and have had a reasonable expectation of success, in consideration of the teachings of Hong.
In particular, Hong teaches the compounds to inhibit CDK2, CDK4, and CDK5 (see Table 1; col. 4, lines 1-16), and that CDK5 inhibition has activity for treating neurodegenerative diseases such as Alzheimer’s (col. 3, lines 8-16). As such, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have arrived at the claimed compounds, 2-(2,5-difluorophenyl)-3-hydroxy-7-methoxy-4H-chromen-4-one; and 2-(3,5-difluorophenyl)-3-hydroxy-7-methoxy-4H-chromen-4-one, and to have administered these compounds to treat Alzheimer’s disease, in consideration of Hong’s teaching that the flavone derivatives have utility for treating this condition.
Claim(s) 7, 12, and 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et. al., KR 20170000426 A, publ. 1/3/2017. An English translation is provided for discussion.
Jung teaches chromenone derivatives that activate cardiac myosin function, for the treatment or prevention of heart failure (Title; para [0001]). Jung teaches the chromenone derivatives to have the following structural formula (claim 1):
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Jung teaches treatment or preventing heart failure comprising administering a composition comprising a chromenone derivative as described above in an effective amount (para [0064]). Jung exemplifies the chromenone derivatives, 7-chloro-2-(4-chlorophenyl)-3-methoxy-4H-chromen-4-one; and 2-(4-chlorophenyl)-3,7-dimethoxy-4H-chromen-4-one (para [0038-0039]):
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7-chloro-2-(4-chlorophenyl)-3-methoxy-4H-chromen-4-one
Structure
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2-(4-chlorophenyl)-3,7-dimethoxy-4H-chromen-4-one
.
7-chloro-2-(4-chlorophenyl)-3-methoxy-4H-chromen-4-one is very structurally similar to the claimed compounds, 7-chloro-2-(2,5-difluorophenyl)-3-methoxy-4H-chromen-4-one; and 7-chloro-2-(3,5-difluorophenyl)-3-methoxy-4H-chromen-4-one:
Structure
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7-chloro-2-(2,5-difluorophenyl)-3-methoxy-4H-chromen-4-one
Structure
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7-chloro-2-(3,5-difluorophenyl)-3-methoxy-4H-chromen-4-one
. The above shown compounds differ from 7-chloro-2-(4-chlorophenyl)-3-methoxy-4H-chromen-4-one of Jung only by the substituents attached to the non-fused phenyl ring; the above shown compounds have two fluoro groups instead of a chloro group attached to the phenyl ring. However, Jung also teaches the phenyl ring substituent, R3, can be one or more of various functional groups including halogen (claim 1). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have modified the compound exemplified by Jung by replacing the single halogen substituent on the non-fused phenyl ring with two fluoro groups attached at either the 2-, 5-, or 3-, 5- positions, and have had a reasonable expectation of success, in consideration of the teachings of Jung.
Jung’s compound 2-(4-chlorophenyl)-3,7-dimethoxy-4H-chromen-4-one is very structurally similarly to the claimed compounds, 2-(2,5-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one; 2-(3,5-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one; and 2-(2,4-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one:
Structure
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2-(2,5-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one
Structure
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2-(3,5-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one
Structure
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2-(2,4-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one
. The claimed compounds differ from 2-(4-chlorophenyl)-3,7-dimethoxy-4H-chromen-4-one only by the substituents attached to the non-fused phenyl ring; the above shown compounds have two fluoro groups instead of a chloro group attached to the non-fused phenyl ring. However, Jung also teaches the phenyl ring substituent, R3, can be one or more of various functional groups including halogen (claim 1). Therefore, it would have been prima facie obvious to one of ordinary skill in the art, before the effective filing date of the claims to have modified the compound exemplified by Jung by replacing the single halogen substituent with two fluoro groups attached at either the 2-, 5-; 2-,4-; or 3-, 5- positions, and have had a reasonable expectation of success, in consideration of the teachings of Jung.
As Jung teaches the chromenone derivatives for the treatment of heart failure, it would have been prima facie obvious to have administered the claimed compounds arrived at from the teachings of Jung for the treatment of heart failure in a subject in need thereof, and have had a reasonable expectation of success.
Information Disclosure Statements
The IDS filed on 1/8/24, 4/17/24, and 1/14/25 have been considered.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SARAH PIHONAK whose telephone number is (571)270-7710. The examiner can normally be reached Monday-Friday 9:00-5:30 EST.
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SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/ Primary Examiner, Art Unit 1627