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 .
This application is made special under Track I, granted October 22, 2025.
Election/Restrictions
(I) The Examiner notes the claim set filed June 12, 2026 specifically deletes the compound known as YK-GAL-501 which was the elected species as discussed on pp. 2-3 of the non-final rejection mailed March 13, 2026.
Therefore, in view of the foregoing reason, the Examiner hereby modifies the election of species to the compound known as YK-GAL-502, depicted as
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recited in claim 6, line 5; and therefore, said election reads on claims 6-7 of originally elected Invention I as discussed in the Election/Restrictions section on pp. 2-3 of the non-final rejection mailed March 13, 2026.
(II) Applicant argues Inventions I-III are related inventions in view of the reasons discussed in their remarks filed June 12, 2026, see pp. 8 of 12 – 9 of 12, Election/Restriction.
The Examiner reiterates their remarks written on pp. 2-3 of the non-final rejection discussed above in support of why Inventions I-III are separate and distinct inventions.
Information Disclosure Statement
The Information Disclosure Statement (IDS) filed on 04/17/2026 has 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 June 12, 2026 have been entered.
Claims 1-5 and 8-13 have been cancelled. Claim 21 is new.
Claims 14-21 are withdrawn from further consideration as being drawn to nonelected inventions.
Thus, claims 6-7 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Withdrawn Objections and Rejections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 March 13, 2026:
(I) The rejection of claims 1-7 under 35 U.S.C. 102(a)(2) is withdrawn in view of Applicant’s cancelation of claims 1-5 and amendments to claims 6-7.
(II) The rejection of claims 1-7 under 35 U.S.C. 103 is withdrawn in view of Applicant’s remarks on pp. 9 of 12 - 11 of 12; as well as the HUANG declaration filed June 12, 2026.
New Claim Rejections
The following is a new ground rejection necessitated by Applicant's amendment, filed on June 12, 2026, where the limitations in pending claims 6-7 as amended now have been changed.
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 6-7 are rejected under 35 U.S.C. 103 as being unpatentable over Kumar et al. (Filed 22 March 2024, WO-2025196508-A1, PTO-892 mailed 03/13/2026).
Kumar teaches a compound, wherein the compound is a compound of Formula (IX), see pg. 452, claim #19, lines 1-2.
Kumar exemplifies the compound of Formula (IX), wherein the compound is of the formula
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, see pg. 457, claim #20, line 6.
Although, Kumar does not exemplify the -O-C2 alkylene which connects the protected ribose to the amide corresponding to the compound known as YK-GAL-502 as required in claim 6, line 5.
However, Kumar further teaches Formula (IX) is of Formula (IX-f), wherein R10 (e.g. which corresponds to the C1 alkylene of the exemplified compound of Kumar depicted above) is chosen from and includes an unsubstituted C1-8 alkylene having 0-3 carbon atoms replaced with -O-, see pg. 247, paragraph [0558].
Accordingly, the Examiner respectfully notes as a whole the combined teachings of Kumar as discussed above teach each and every structural limitation required of the compound known as YK-GAL-502, specifically when R10 is a C3 alkylene having 1 carbon atom replaced with -O- as taught by Kumar above; and consequently, the Examiner further respectfully notes when combined together the teachings of Kumar as a whole would include and make obvious the compound known as YK-GAL-502 as recited within instant claim 6, line 5.
Furthermore, with respect to the limitation of “wherein the compound is capable of binding to an asiaoglycoprotein receptor”, as required in claim 7; the Examiner reasonably interprets this limitation as a functional limitation of the compounds recited within claim 6. Since the teachings of Kumar encompass the compound YK-GAL-502 of claim 6 as discussed above, the Examiner reasonably interprets the compounds of Kumar meet the functional limitation as required within claim 7.
It would have been prima facie obvious to one of ordinary skill in the art before the invention was filed to have chosen from the disclosed teachings of Kumar above and therefore one of ordinary skill in the art would have arrived at the compound known as YK-GAL-502 of instant claim 6, line 5 as discussed above as within the scope of the artisan as combining prior art elements according to known compounds to yield predictable results. One of ordinary skill in the art would have been motivated to create the compound of formula (IX) of Kumar as discussed above.
One of ordinary skill in the art would have had a reasonably expectation of success to have chosen from the disclosed teachings of Kumar and thus would have arrived at the elected compound of YK-GAL-502 of instant claim 6, line 5, because Kumar teaches all structural limitations required of YK-GAL-502 are within the scope of the compound of formula (IX) of Kumar as discussed above.
Thus, the claimed invention as a whole would have been prima facie obvious over the teachings of the prior art.
Conclusion
No claims are allowed in this action.
Applicant's amendment necessitated the new ground 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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached at (571) 272-8394. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JARET J CREWS/Examiner, Art Unit 1691
/RENEE CLAYTOR/Supervisory Patent Examiner, Art Unit 1691
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