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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/15/2026 has been entered.
Status of Claims
Claims 1, 6, and 11 are pending.
Claims 2-5, and 7-10 are cancelled.
Claim 11 is new.
Priority
Applicant’s claim for benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, or 365(c) is acknowledged. This application is a national stage entry of and claims priority to Application Serial No. PCT/KR2021/003809, filed 3/27/2021; and further claims priority to FOR application number KR10-2020-0037875, filed 03/27/2020.
Information Disclosure Statement
All references from IDS(s) received 09/26/2022 and 1/15/2026 have been considered unless marked with a strikethrough.
Response to Arguments
Applicant's arguments filed 01/15/2025 have been fully considered and have been found not persuasive.
In a final dated 10/15/2025, Claims 1, 4, and 6 were examined upon their merits.
In a final dated 10/15/2025, Claims 1, 4, and 6 were rejected under 35 U.S.C 103. In response, the Applicant amended claim 1 to include the limitations of claim 4 and cancelled claim 4. The Applicant also added new claim 11. Therefore, the rejection for claim 4 is moot and withdrawn.
With respect to the 103 rejection, Applicant canceled claim 4 and incorporated it into claim 1, which also included some small amendments. The major response is the applicant’s arguments. The Applicant argues that a POSITA would not be motivated to combine the two known compounds in the art to arrive at the instant invention. The Applicant provides IC50 values to show the secondary reference compound has a less desirable IC50 than the primary reference. The Examiner argues that this would mean the art would discourage the instant invention if it were true that combining the two would worsen the Ic50. Second, the Applicant argues that the Examiner poorly applies the logic that PROTAC is increases predictability. The Applicant cites art that says no plug-and-play approach has been developed for PROTAC. The Applicant also argues that the Examiner improperly refers to PROTAC as "bioconjugate" to support the argument of predictability increase. The Examiner agrees that she should have used the term "bifunctional" although some PROTACS are bioconjugate this does not apply to the instant case. However, it is well known in the field that combining two known molecules with two known mechanisms would increase predictability. Whether or not it alters the Ic50, the odds of the bifunctional molecule working at all in the way desired is significantly more predictable. Also, with only a quick review the Examiner provides a reference that discusses PROTACs as an overarching whole connecting a general "POI" to a known ligase (Sun, X. et al Signal Transduction and Targeted Therapy volume 4, Article number: 64 (2019)). This shows the broad applicability of PROTAC being a more predictable approach in the field of medicinal chemistry. Finally, the applicant argues that the Examiner improperly referred to POSITA as "a person skilled in the art." The Examiner argues that these are used interchangeably in the MPEP. Therefore, the examiner finds the applicants arguments for the 103 rejection against claims 1, 6, and 11 is found as not persuasive and the maintained rejection can be seen below.
MAINTAINED REJECTION
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.
Claims 1, 6, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Mu, X. et al. (Biochemical and Biophysical Research Communications, 2020, 521, 833e839; cited in IDS filed 9/26/2022; “Xu”) in view of Beria, I. et al. (J. Med. Chem. 2010, 53, 9, 3532–3551; “Beria”).
This rejection applies to the elected specie.
Mu teaches PROTAC (bifunctional) compounds for targeting PLK1. Mu teaches Formula I of instant claim 1 linked with the same linker as the elected specie to a similar compound to Formula II of instant claim 1.
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561
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(Mu, Fig. 1A)
Mu fails to explicitly teach the structure of Formula II and the targeting moiety of the elected specie.
However, Beria teaches the structure of Formula II, with respect to the elected specie, as a PLK1 inhibitor.
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(Beria, Abstract)
Although Beria does not teach the structure linked to a E3 ligase degrader, such as thalidomide, it would be obvious to a person skilled in the art to extract the structure taught by Mu and substitute part of the targeting moiety structure for another PLK1 targeting moiety with a similar genus structure, as taught by Beria.
Specifically, the combination of teachings from Mu and Beria teach the structure required by instant claims 1, 6, and 11 as well as teaching the compounds use as a bifunctional PLK 1 degrader for preventing or treating PLK1 related disease, such as cancer.
The Supreme Court in KSR Int'l Co. v. Teleflex Inc., 550 U.S. 398, 415-421, 82 USPQ2d 1385, 1395-97 (2007) identified a number of rationales to support a conclusion of obviousness which are consistent with the proper "functional approach" to the determination of obviousness as laid down in Graham.
Examples of rationales that may support a conclusion of obviousness include:
(A) Combining prior art elements according to known methods to yield predictable results;
(B) Simple substitution of one known element for another to obtain predictable results;
(C) Use of known technique to improve similar devices (methods, or products) in the same way;
(D) Applying a known technique to a known device (method, or product) ready for improvement to yield predictable results;
(E) "Obvious to try" – choosing from a finite number of identified, predictable solutions, with a reasonable expectation of success;
(F) Known work in one field of endeavor may prompt variations of it for use in either the same field or a different one based on design incentives or other market forces if the variations are predictable to one of ordinary skill in the art;
(G) Some teaching, suggestion, or motivation in the prior art that would have led one of ordinary skill to modify the prior art reference or to combine prior art reference teachings to arrive at the claimed invention.
Applying KSR example rationale (B), it would have been prima facie obvious to extract the compound, a bifunctional PLK1 PROTAC, as taught by Mu (labeled as ULM and Linker in the instant claims) and substitute the PLK1 targeting moiety for another known targeting moiety with an overlapping genus structure, as taught by Beria, to optimize the targeting capability of the parent drug.
Therefore, claims 1, 6, and 11 would have been obvious to a person who is skilled in the art prior to the effective filing date.
Conclusion
Claims 1, 6, and 11 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Clint Brooks can be reached at (571) 270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/N.M.B./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621