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 1, 6, and 11-12 are pending.
Claims 2-5, and 7-10 are cancelled.
Claim 12 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 06/12/2025 have been fully considered and have been found not persuasive.
In a non-final dated 03/12/2026, Claims 1, 6, and 11 were examined upon their merits.
In a non-final dated 03/12/2026, Claims 1, 6, and 11 were rejected under 35 U.S.C 103. In response, the Applicant amended claim 1, 6, and 11. The Applicant also added new claim 12.
An interview was conducted after the non-final with Attorney Johanna Schwartz. No agreement was reached but the Examiner and her SPE advised the Applicant to include data to showcase their invention and “unexpected results” to back up their previous argument. The Applicant did not include any additional data of their compounds in the most recent response.
With respect to the 103 rejection, Applicant makes three major arguments:
Modifying Mu's PROTAC to replace its BI2536 moiety with Beria's Compound 49 would render Mu's PROTAC unsatisfactory for its intended purpose of dual BRD4 and PLK1 protein degradation. Applicant argues that Mu’s “entire purpose” is to design a PROTAC that can target and degrade two proteins, BRD4 and PLK1. Applicant quotes different excerpts from Mu highlighting their discovery of dual target PROTAC.
Examiner argues again that PROTAC is a known strategy in medicinal chemistry with a plethora of different known compounds and inhibitors as targeting moieties. The Examiner could use prior art on PROTAC that has nothing to do with PLK1 and still arrive at the instant invention in combination with Beria and any art that says PLK1 degradation would be beneficial. However, the Examiner found more relevant prior art. It is common to take a known compound and use it as a targeting moiety in PROTAC. Mu is used to show that a person skilled in the art would have the motivation to use a PLK1 inhibitor in a PROTAC compound. Then, Beria is used to exemplify that the exact PLK1 inhibitor of the instant application is already known. So, the Examiner reiterates: PROTAC is a known strategy in medicinal chemistry with a plethora of different known compounds and inhibitors as targeting moieties. Therefore, this argument by the Applicant is not persuasive.
A POSITA recognizes that linker attachment influences PROTAC degradation activity and because both Mu and Beria fail to teach or suggest how to attach Beria's Compound 49 to Mu's linker group, the Office has failed to establish that there would have been a reasonable expectation of success in arriving at a PLK1-degrading PROTAC.
The Examiner agrees, and also agreed in the interview, that linker attachment may influence PROTAC degradation activity. It does and sometimes it doesn’t. This is why the Examiner and her SPE encouraged the Applicant to include data showing that linker length and attachment influences this specific type of PROTAC in the interview. The Applicant did not provide this data. The Applicant did provide art to explain the concept of PROTAC linker influence to the Examiner. This art does not once mention PLK1. Applicant provides binding pocket projections of both compounds of Mu, Beria, and then Mu and Beria for PLK1. The Examiner once again encourages the Applicant to provide data to back up these predictions (predictions are not data nor are they fact). Therefore, this argument is not found persuasive.
Neither Mu nor Beria teaches or suggests how to attach Compound 49 to Mu's PROTAC and the Office has not established a reasonable expectation of success in making this modification; therefore, the Office has not satisfied the second prong under a lead compound analysis.
Examiner reiterates previous argument: It is common to take a known compound and use it as a targeting moiety in PROTAC. Mu is used to show that a person skilled in the art would have the motivation to use a PLK1 inhibitor in a PROTAC compound, which would be considered the lead compound. Then, Beria is used to exemplify that the exact PLK1 inhibitor of the instant application is already known. So, the Examiner reiterates: PROTAC is a known strategy in medicinal chemistry with a plethora of different known compounds and inhibitors as targeting moieties. Therefore, this argument by the Applicant is not persuasive.
The arguments are not found persusive. The Examiner once again encourages the applicat to provide data to show the linker attachment and linker length matters. 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 11-12 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; “Mu”) 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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(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 11-12 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 11-12 would have been obvious to a person who is skilled in the art prior to the effective filing date.
Conclusion
Claims 1, 6, and 11-12 are rejected.
THIS ACTION IS MADE FINAL. 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 NICOLA MARIA BAUER whose telephone number is (703)756-1269. The examiner can normally be reached Monday-Friday 7:30-5 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, 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
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