DETAILED ACTION
Claims 1, 2, 4, 10-15, 17, 19, 20, and 25-28 are currently pending in the instant application. Claims 11 and 20 are withdrawn from consideration as being for non-elected subject matter. Claims 1, 2, 4, 10, 12-15, 17, 19, and 27-28 are rejected. Claims 25 and 26 are allowable.
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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 6 January 2026 has been entered.
Election/Restrictions
Applicant’s election of Group I and the species of compound 12 (C8):
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in the reply filed on 26 June 2024 has been previously acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been previously extended to the compounds of claims 25 and 26 which also appear allowable, and the search and examination has now been extended to the compounds:
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and
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which are not allowable.
Claims 1, 2, 4, 10, 12-15, 17, 19, and 25-28 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 6 January 2026 have been fully considered and entered into the instant application. Applicant’s amendment to claim 1 to delete “optionally” from the substitution on the heteroaryl of R2 has overcome the 35 USC 102 rejection of claims 1, 2, 4, 10, 12-15, 17 and 19 as being anticipated by Registry No. 852453-71-5, as the heteroaryl of R2 of formula (I) of the instant claims must have a Rsb1 substituent and has also overcome the 35 USC 102 rejection of claims 1, 2, 4, 10, 12-15, 17 and 19 as being anticipated by US Patent No. 8,648,069 for the same reasons. The 35 USC 103 as being unpatentable over the compound
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in US Patent No. 8,648,069 is overcome as claim 27 has been amended to delete the compound:
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Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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.
Claim(s) 1, 2, 4, 10, 12-15, 17 and 19 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Registry No. 19768-68-4.
Registry No. 19768-68-4 is
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. This compound corresponds to the instant formula (I), for example, wherein R1’ is H; R1 is (CHR5)n1-R1a; n1 is 0; R1a is C(O)(C1-4)alkyl; m is 0; X is CR3; R3 is H; Y is H; and R2 is C6 aryl substituted with one Rsb1 which is halogen.
Registry number 19768-89-4 is available as prior art as of 16 November 1984 the date it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compound anticipates the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Regarding the compositions of claim 19, comprising the anticipatory compounds and a carrier, the Registry entry for Registry no. 19768-68-4 discloses a mass solubility in unbuffered water at pH 7.00. This teaching in of water anticipates the claimed composition, wherein the compounds are present with a carrier (i.e., water).
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 (i.e., changing from AIA to pre-AIA ) 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.
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.
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.
Claim(s) 27 and 28 is/are rejected under 35 U.S.C. 103 as being unpatentable over US Patent No. 8,648,069.
Determination of the scope and content of the prior art (MPEP §2141.01)
US Patent No. 8,648,069 discloses the compound of formula (I): column 5:
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wherein A can be:
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and wherein R1 and R2 can be hydrogen, column 7. The compound of formula (I) which is
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of the formula:
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is disclosed on column 14, line 5. Column 8 provides pharmaceutical composition of formula (I). Methods of treatment of diseases is found on columns 8 and 9. This compound corresponds a positional isomer of the compound
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, page 19 of instant claim 27.
Ascertainment of the difference between the prior art and the claims (MPEP §2141.02) and motivation (MPEP §2142-2413)
The difference between the prior art and the instant claims 27 and 28 is that the prior art compound:
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differs from compound
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found in claim 27 by being a positional isomer.
However, nothing unobvious is seen in substituting the known claimed isomer for the structurally similar isomer, as taught by the prior art reference, since such structurally related compounds suggest one another and would be expected to share common properties absent a showing of unexpected results. In re Norris, 84 USPQ 458 (1950). Additionally, please see MPEP 2144.09, Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds 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).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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, Andrew Kosar can be reached at 571-272-0913. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 13 January 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600