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 .
Information Disclosure Statement
The Information Disclosure Statements (IDS) filed on 02/09/2026 have been considered by the Examiner inasmuch as foreign documents have been submitted into the file wrapper in English.
Claim Status
The claim set and Applicant’s remarks filed February 09, 2026 have been entered. Claims 1-19, 22 and 25-26 are canceled. Thus, claims 20-21 and 23-24 as amended are examined on the merits herein.
Withdrawn Objections and Rejections
With respect to the objections and/or rejections mailed in the non-final office action on November 10, 2025:
The objection of claims 20-21 and 23 is withdrawn in view of Applicant’s amendments to these claims in the claim set discussed above.
Response to Arguments
The rejection of claims 20-21 and 23-24 under 35 U.S.C. 103 is maintained.
Applicant argues:
(A) Applicant reiterates that the amide compounds in Huang have IC50 values of approximately 114 and 28, respectively, which is unremarkable for an application in which 20 of approximately 100 test compounds have an IC50 value below 10, see Applicant’s remarks, pg. 8, first full paragraph.
(B) Huang did not consider the amide-containing compounds worth pursuing: none of the 17 compounds carried forward into biological testing in Huang contained an amide; and thus, one of ordinary skill in the art would not be motivated to modify the amide-containing compounds in Huang at all, see Applicant’s remarks, pg. 8, first full paragraph.
(C) Applicant asserts the remaining compounds in claim 20 are patentable at least because such compounds comprise an amide substituted by a cyclic group or an alkoxy group that is not considered by Huang or Brown, see Applicant’s remarks, pg. 8, second full paragraph.
(D) The Office action does not provide a reference or reasoned explanation relating to alleged obviousness of compounds in present claim 20 other than those now deleted, see Applicant’s remarks, pg. 8, second full paragraph.
(E) The combination of Huang and Brown does not motivate one of ordinary skill in the art to make the specific combinations of changes reflected in the compounds of present claim 20, see Applicant’s remarks, pg. 8, second full paragraph.
With respect to Applicant’s arguments (A)-(E), the Examiner respectfully notes the 103 rejection below has been modified in view of Applicant’s amendments to claim 20 as discussed in further detail in the maintained 103 rejection below.
The Examiner also acknowledges while Applicant has amended claim 20 to delete the remaining alkylamido compounds, including example compounds 2, 3, 8 and 26, see Applicant’s remarks, pg. 8, second full paragraph, the Examiner respectfully notes claim 20 still recites compounds where the amide comprises a cyclic group, specifically a phenyl, and as discussed within the 103 rejection below, Huang teaches amido per se and exemplifies both alkyl and aryl as substituents of an “amide” as defined by Huang; and wherein Huang also defines “aryl” to include phenyl as discussed in greater detail in the maintained 103 rejection below.
New Claim Rejections
The following are new ground(s) or modified rejections necessitated by Applicant's amendment, filed on February 09, 2026, where the limitations in pending claims 20-21 and 23-24 as amended now have been changed.
Therefore, rejections from the previous Office Action, dated November 10, 2025, have been modified and are listed below.
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.
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.
Claims 20-21 and 23-24 are rejected under 35 U.S.C. 103 as being unpatentable over Huang et al. (Published 05 April 2019, CN-109574988-A, IDS filed 03/17/2022 known as CHENGDU HIGHBRED PHARMACEUTICAL CO LTD., et al., English Machine Translation used and provided in PTO-892 mailed 10/08/2024).
Regarding claims 20-21 and 23-24, Huang teaches the compound of general formula (VIII)(g),
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, wherein R26 and R27 are independently selected from and including H and an amido, see CN-109574988-A, pg. 8, claim #18, figure (g).
Huang teaches Ar1 is
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, see pg. 8, claim #19, Ar1.
Huang teaches the compound of claim #18 as discussed above, wherein:
R1 is selected from and including H, see English Machine Translation, pg. 62, claim #19, line 3;
R2 is selected from and including methyl; see English Machine Translation, pg. 62, claim #19, line 4;
R24 is selected from and including H, see English Machine Translation, pg. 62, claim #19, line 5;
R25 is selected from H, see English Machine Translation, pg. 62, claim #19, line 6;
R28 is selected from and including H, see English Machine Translation, pg. 62, claim #19, line 9; and
R27 is selected from and including H and
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, see English Machine Translation, pg. 62, claim #19, line 8 and CN-109574988-A, pg. 8, last line of the page – pg. 9, first line of the page.
Huang teaches “amide” is a chemical formula having the formula -C(O)-NHR, wherein R is selected from the group consisting of alkyl, cycloalkyl, heterocycloalkyl, aryl and heteroaryl, see pg. 15, lines 18-19.
Huang defines “aryl” to include phenyl, see English Machine Translation, pg. 16, lines 4-6.
Huang teaches compounds that modulate indoleamine 2,3-dioxygenase (IDO) as well as corresponding uses, combinations, methods of making and the like, see pg. 6, disclosure of invention, paragraph 1. Huang teaches the use of the compound or its stereoisomer, solvate, hydrate, pharmaceutically acceptable salt or cocrystal for the preparation of a medicament for the treatment of a disease caused by overexpression of indoleamine 2,3-dioxygenase (IDO), see English Machine Translation, pg. 13, paragraph 7.
Huang teaches a pharmaceutical composition containing the compound of the invention or the stereoisomer, solvate, hydrate, pharmaceutically acceptable salt or cocrystal thereof can contain pharmaceutically acceptable auxiliary materials, see pg. 13, paragraph 12; wherein pharmaceutically acceptable auxiliary materials include, a filler (diluent), wherein the diluent comprises lactose (e.g. the pharmaceutically acceptable excipient required in claim 21), see pg. 13, paragraph 14.
Huang teaches and provides a kind of novel chemical compound which has certain inhibitory activity to oxidoreducing enzyme indoleamine 2,3-dioxygenase (IDO), or can be used for treating associated disease, the purposes including cancer and immune correlated disease, see CN-109574988-A, English Machine Translation, pg. 1, abstract. Huang teaches a disease mediated at least in part by IDO or TDO, comprising administering to a subject in need thereof an effective amount of the aforementioned compound, see pg. 13, paragraph 9. Huang also detected the inhibitory effect of compounds on the activity of IDO1 on HeLa cells, see CN-109574988-A, paragraph [0613], and English Machine Translation, pg. 43, biological assay, paragraph 1.
Huang teaches the IC50 of the compounds on inhibition of IDO1 activity on HeLa cells is shown in Table 2, see CN-109574988-A, paragraphs [0621]-[0622] and Table 2; and English Machine Translation, pg. 43, biological assay, 2: the experimental method comprises the following steps, paragraph 4.
Huang teaches the inhibitor is used for the treatment of at least one of the following diseases and includes cancer, see English Machine Translation, pg. 13, paragraph 4; wherein the cancer includes breast cancer, see English Machine Translation, pg. 13, paragraph 5.
Although, the compounds of formula (VIII)(g) of Huang above do not exemplify wherein the benozo[d]imidazole of formula (VIII)(g) is substituted with the specific amido that is further substituted with an aryl, specifically a phenyl, as recited in claim 20, on pg. 4, first row, the first and second recited compounds.
However, in the same field of endeavor of creating compounds that modulate IDO, Huang already teaches R26 and R27 are amido; wherein Huang exemplifies the amido of R27 as an amido substituted with one C1-alkyl as depicted by Huang as,
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, as discussed above.
Moreover, the Examiner reiterates Huang defines “amide” as discussed above and explicitly defines within the term “amide” wherein R is selected from the group consisting of and including alkyl, which is exemplified by Huang above, and aryl, defined to include phenyl as discussed above.
The Examiner also notes replacing the C1-alkyl group as exemplified by Huang above for an aryl, specifically a phenyl as defined by Huang above, would corresponds to and would result in the compounds depicting a phenyl connected to the amido group depicted within the first and second compounds recited in the first row of instant claim 20, on pg. 4 as discussed above.
Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the invention’s effective filing date to have modified formula (VIII)(g) of Huang as discussed above by substituting the exemplified C1-alkyl substituted amido for an aryl substituted amido as discussed above, as Huang teaches R26 and R27 are amido per se, wherein Huang exemplifies the amido of R27 as
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and when combined with Huang defining and explicitly teaching the “amide” has the structure -C(O)-NHR, wherein R is selected from the group consisting of and chosen from alkyl, which is exemplified by Huang above, and aryl as defined by Huang above; the teachings of Huang above teach the first and second compounds recited in the first row on pg. 4 of instant claim 20 as discussed above; as the Examiner respectfully notes the structure of “amide” as defined by Huang above is an amido group which is further substituted with “R”, wherein R is chosen from and including alkyl and aryl as discussed above.
Furthermore, it would have been prima facie obvious to have substituted the C1-alkyl substituted amido of R27 of Huang above for an aryl substituted amido as recited in the first and second compounds in the first row of instant claim 20 on pg. 4 above as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results; as the Examiner respectfully notes Huang teaches R26 or R27 may be an amido per se; wherein the amido is taught to be further substituted with an alkyl group as exemplified by a C1-alkyl group in R27 of Huang as discussed above; and in view of the definition of “amide” as taught by Huang above wherein the “R” group is selected from and including alkyl and aryl; and wherein aryl is defined to include phenyl as discussed above.
One of ordinary skill in the art would have been motivated to have made this substitution in order to create the compounds as taught and defined by Huang above, which as the Examiner notes are a kind of novel chemical compound which has certain inhibitory activity to oxidoreducing enzyme indoleamine 2,3-dioxygenase (IDO) as taught by Huang above. One of ordinary skill in the art would have had a reasonable expectation of success to have made the substitution as discussed above as Huang teaches methods of making these compounds as discussed above; and in view of Huang explicitly teaching alkyl and aryl substitution of the amido as discussed above.
Thus, it would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have arrived at the claimed compounds discussed above by incorporating the definition of “amide” as defined by Huang as discussed above as within the scope of the artisan as combining prior art elements according to known methods to yield predictable results. One of ordinary skill in the art would have been motivated to provide a kind of novel chemical compound which has certain inhibitory activity to oxidoreducing enzyme indoleamine 2,3-dioxygenase (IDO), or can be used for treating associated disease as taught by Huang above. One of ordinary skill in the art would have had a reasonable expectation of success to incorporate the alkyl substituted amido as exemplified by Huang above for the aryl substituted amido as defined by Huang above into formula (VIII)(g) as taught by Huang above, as Huang explicitly teaches an amido per se within formula (VIII)(g) but further defines the amido can contain either an alkyl or an aryl as a substituent as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the combined teachings of the prior art.
Conclusion
No claims are allowed in this action.
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 JARET J CREWS whose telephone number is (571)270-0962. The examiner can normally be reached Monday-Friday: 9:00am-5:30pm EST.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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