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 .
Status of Claims
Claims 7-8, 10-13, and 18-19 are pending as of the response and amendments filed on 2/17/26. Claims 1-6, 9, and 14-17 have been canceled.
The amendments to claims 8, 13, and 18 in an attempt to overcome the rejection under 35 USC 112(b) are appreciated. Applicant’s remarks in response to this rejection have been considered. However, the amendments introduce a new issue; a new rejection under 35 USC 112(b) is made in view of the amendments, presented in the action below.
The rejection of claim 11 under 35 USC 112(b) is withdrawn in view of the amendments.
Applicant’s amendments to the claims to overcome the rejections over claims 7, 12, and 18 under 103 over Hong, and over Jung have been fully considered but are not found sufficient. Applicant has argued neither Hong nor Jung discloses, teach, or suggest all of the limitations of claim 7 as amended, or of instant claim 12. However, upon further review it is maintained the teachings of Hong and Jung would still render the amended claims prima facie obvious, as discussed in the action.
Claims 7-8, 10-13, and 18-19 were examined. Claims 7-8, 10, 12-13, and 18-19 are rejected. Claim 11 is objected to.
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, 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 in one embodiment wherein R2 is independently halo or -ORc, however, in another limitation recited by the claim, R2 is recited as containing N or O atoms. This amendment introduces indefiniteness, since the first embodiment of R2, being halo or -ORc doesn’t allow for N atoms. It is uncertain which limitation applies to R2 in the claim, and the metes and bounds of the claim aren’t clear. Claims 10, 13, and 19 are similarly rejected as these claims depend from claim 8 and don’t provide further clarity.
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, of record.
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):
PNG
media_image1.png
200
400
media_image1.png
Greyscale
.
Claim 7 is drawn to the following compounds:
7-chloro-2-(2,5-difluorophenyl)-3-hydroxy-4H-chromen-4-one
PNG
media_image2.png
226
695
media_image2.png
Greyscale
7-chloro-2-(3,5-difluorophenyl)-3-hydroxy-4H-chromen-4-one
PNG
media_image3.png
226
695
media_image3.png
Greyscale
;
PNG
media_image4.png
200
400
media_image4.png
Greyscale
7-chloro-2-(3,4-difluorophenyl)-3-hydroxy-4H-chromen-4-one;
PNG
media_image5.png
226
695
media_image5.png
Greyscale
2-(2,5-difluorophenyl)-7-fluoro-3-hydroxy-4H-chromen-4-one;
PNG
media_image6.png
226
695
media_image6.png
Greyscale
2-(3,5-difluorophenyl)-7-fluoro-3-hydroxy-4H-chromen-4-one; and
PNG
media_image7.png
226
695
media_image7.png
Greyscale
2-(2,3-difluorophenyl)-7-fluoro-3-hydroxy-4H-chromen-4-one. These compounds would be prima facie obvious in consideration of the teachings of Hong, since Hong allows for position R3 to be halogen; position R5 to be hydroxy; positions R1, R2, and R4=hydrogen; and positions R6 and R7 to be halogen.
In addition, Hong includes the following compounds as exemplary (col. 57, Ex. 68; col. 77-78, no. 8):
PNG
media_image8.png
200
400
media_image8.png
Greyscale
;
PNG
media_image9.png
200
400
media_image9.png
Greyscale
.
This compound is structurally very similar to the compounds of instant claim 18, 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
Molecule Title
PNG
media_image10.png
200
400
media_image10.png
Greyscale
2-(3,5-difluorophenyl)-3-hydroxy-7-methoxy-4H-chromen-4-one
Structure
Molecule Title
PNG
media_image11.png
200
400
media_image11.png
Greyscale
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 above, 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) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Jung et. al., KR 20170000426 A, publ. 1/3/2017, of record. 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):
PNG
media_image12.png
200
400
media_image12.png
Greyscale
.
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]):
Structure
Molecule Title
PNG
media_image13.png
200
400
media_image13.png
Greyscale
7-chloro-2-(4-chlorophenyl)-3-methoxy-4H-chromen-4-one
Structure
Molecule Title
PNG
media_image14.png
200
400
media_image14.png
Greyscale
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
Molecule Title
PNG
media_image15.png
200
400
media_image15.png
Greyscale
7-chloro-2-(2,5-difluorophenyl)-3-methoxy-4H-chromen-4-one
Structure
Molecule Title
PNG
media_image16.png
200
400
media_image16.png
Greyscale
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
Molecule Title
PNG
media_image17.png
200
400
media_image17.png
Greyscale
2-(2,5-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one
Structure
Molecule Title
PNG
media_image18.png
200
400
media_image18.png
Greyscale
2-(3,5-difluorophenyl)-3,7-dimethoxy-4H-chromen-4-one
Structure
Molecule Title
PNG
media_image19.png
200
400
media_image19.png
Greyscale
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.
Claim Objection
Claim 11 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Kortney Klinkel can be reached at 571-270-5239. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
SARAH . PIHONAK
Primary Examiner
Art Unit 1627
/SARAH PIHONAK/Primary Examiner, Art Unit 1627
Prosecution Insights