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 .
DETAILED ACTION
Status of 17/801,709
Claims 1, 16-17, 22, 28-29, 31-32, 34-36, 38, and 41-53 are currently pending.
Priority
Instant application 17/807,709, filed 8/23/2022, claims priority as follows:
PNG
media_image1.png
79
361
media_image1.png
Greyscale
Support for instant claims 1, 16-17, 22, 28-29, 31-32, 34-36, 38, 41-44, and 48-53 is found in the provisional 62/981,331, and they are therefore granted the priority date of 2/25/2020. Claim 45 recites the limitation “aberrant FAK activity”, which is not found in the ’331 provisional application, but is found in the 63/135,821 provisional application. Therefore, claims 45-47 are granted the priority date of 1/11/2021.
Information Disclosure Statement
All references from the IDS’s submitted on 8/23/2022, 6/3/2024, and 7/16/2025 have been considered unless marked with a strikethrough.
Response to Arguments/Amendments
The amendment filed 7/16/2025 has been entered. Claims 1, 16-17, 22, 29, 31, and 41 have been amended. Claims 2-5, 8-15, 25-26, and 40 have been cancelled, and claims 48-53 have been added, but are not considered new matter.
In the Non-Final dated 4/17/2025, the specification was objected to for pixelated and illegible images. In response, Applicant has provided clear images to overcome the objection. The objection is thus withdrawn.
Claims 1-2, 28, and 31-32 were rejected under Improper Markush groupings in the Non-Final dated 4/17/2025. In response, Applicant has cancelled claim 2, and amended claim 1 to further define the ALK targeting ligand as TL-2. Therefore, the rejection has been overcome and withdrawn.
Claims 1-2, 15-17, 28-29, and 31-32 were rejected under 35 U.S.C. 112(b) in the Non-Final dated 4/17/2025. Upon the amendment to claim 1 to further structurally define the formula and the amendment to claim 31 to include where X6 is absent, the rejections are overcome and withdrawn.
Claims 1-2, 15-17, 28-29, 31-32, and 41 were rejected under 35 U.S.C. 103 in the Non-Final dated 4/17/2025. In response, Applicant has cancelled claims 2 and 15, and amended claims 1, 16-17, 29, 31 and 41. Applicant argues that there is no motivation in the teachings of Shanghai to select the elected species from the genus because there is no compound nor subgenus with the specific attributes of a methoxy on the instant R4 aryl or a linker without an O or NH connection to the degron, and that Shanghai presents nothing more than an invitation to engage in further inventive endeavor. Applicants’ arguments regarding the synthetic method were considered, but are not persuasive for the following reasons.
The reference Shanghai indicates preferred embodiments where R6 can be OR29, where R29 can be a C1-6 alkyl with or without a substituent, and where R7 can be a C1 alkyl group. In the Non-Final dated 4/17/2025, the Examiner initially assigned the C1 alkyl group to R6 and the alkoxy group to R7, but the reverse of assignments is simply another reasonable interpretation of the claims. Thus, though the methoxy group was not explicitly disclosed in one of the compounds of Shanghai, it is still a preferred embodiment of the invention of Shanghai.
Additionally, there are multiple instances of preferred embodiments where W is deleted or missing (page 7), indicating that preferred embodiments do not require an O or NH connection from the degron to the linker. Similar to above, though Shanghai does not explicitly disclose a compound without the O or NH connection, the lack of a W variable is still a preferred embodiment. The Examiner notes Applicant’s arguments to the synthesis of the Shanghai compounds, and acknowledges that they are also not persuasive because the claims at hand are compound claims, not process claims. Thus, the rejection is maintained. The claim numbers have been updated to include the claims changes by the Applicant filed 7/16/2025. See the 103 below.
Claims 1-2, 15-16, 28, and 31-32 were rejected under 35 U.S.C. 102(a)(1) and 102(a)(2) in the Non-Final dated 4/17/2025. Upon Applicants cancellation of claims 2 and 15 and the amendment of claim 1 to solely allow R13 or R14 to be C1-C2 alkoxy, the rejection is overcome and thus, withdrawn.
Election/Restriction
Applicant’s election of Group I, claims 1-5, 8-17, 22, 25-26, 28-29, 31-32, 34-36, 38, and 40-41, drawn to compounds of Formula (I) and sub formulas thereof, in the reply filed 4/1/2025 is acknowledged. Newly added compound claims 48-53 have been added to Group I, and are not considered new matter. Because Applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Applicant’s election of compound 96:
PNG
media_image2.png
204
456
media_image2.png
Greyscale
in the reply filed 4/1/2025, is also acknowledged.
Examination will begin with the elected species. In accordance with MPEP § 803.02, if upon examination of the elected species, no prior art is found that would anticipate or render obvious the instant invention based on the elected species, the search of the Markush-type claim will be extended. If prior art is then found that anticipates or renders obvious the non- elected species, the Markush-type claim will be rejected. It should be noted that the prior art search will not be extended unnecessarily to cover all non-elected species. Should Applicant overcome the rejection by amending the claim, the amended claim will be examined again. The prior art search will be extended to the extent necessary to determine patentability of the Markush-type claim. In the event prior art is found during further examination that renders obvious or anticipates the amended Markush-type claim, the claim will be rejected and the action made final.
In the Non-Final dated 4/17/2025, the elected species was searched and prior art was identified. The rejection was maintained; see the 103 rejection below. In the same Office Action, a 102 rejection was identified in the same reference when the scope was expanded to a compound of Formula (I):
PNG
media_image3.png
73
444
media_image3.png
Greyscale
Where the ALK TL ligand is TL-2:
PNG
media_image4.png
137
316
media_image4.png
Greyscale
R8 is -S(O)2iPr, R10 is Cl, the linker is
PNG
media_image5.png
39
132
media_image5.png
Greyscale
, and the degron is
PNG
media_image6.png
101
171
media_image6.png
Greyscale
, where X5 is NH. Upon the amendment to the claims, the 102 rejection was overcome and thus withdrawn. The full scope of the claims has not yet been searched in accordance with Markush search practice. Claims 1, 16, 28-29, 31-32, 41, and 49 read on the elected species. Claims 17, 22, 34-36, 38, 42-44, 45-48, and 50-53 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species and/or group, there being no allowable generic or linking claim.
MAINTAINED REJECTIONS
Claim Rejections - 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 1, 16, 28-29, 31-32, 41, and 49 are rejected under 35 U.S.C. 103 as being unpatentable over Shanghai Meizer Pharmaceuticals Co., LTD. (WO 2019/042444 A1, herein after “Shanghai”). This rejection applies to the elected species.
Determining the scope and contents of the prior art
The reference Shanghai teaches compounds for inhibiting and degrading tyrosine protein kinase ALK (title). The instant elected species is a compound of Formula (I) of Shanghai (abstract):
PNG
media_image7.png
282
727
media_image7.png
Greyscale
When R12 is X6S(=O)jR32, where X6 is deleted, j is 2, and R32 is a C3 hydrocarbon, f is 0, R11 is H, R10 is a halogen, R9 is H, R8 is H, R6 is a C1 hydrocarbyl group, e is 1, R7 is OR29, where R29 is a C1 hydrocarbyl group, d is 0, A is missing, Y is (CR22R23)h where h is 0, c is 0, Z is C≡C(CR24R25)i, where R24 is H and R25 is a C2 group, i is 1, W is missing, b is 0, X is CR19R20, where R19 and R20 are H, a is 0, and R1 is H (claim 1). Further, compounds of Shanghai are useful for inhibiting and degrading tyrosine protein kinase ALK, and therefore can be used for preparing drugs for treatment of ALK activity-related diseases (abstract).
Ascertaining the differences between the prior art and the claims at issue
The reference Shanghai fails to teach the anticipatory elected species.
Resolving the level of ordinary skill in the pertinent art
The level of ordinary skill in the art is represented by an artisan who has sufficient background in the development of bifunctional compounds capable of degrading ALK via a degradation pathway. An artisan possess the technical knowledge necessary to make adjustments to the bifunctional compounds to enhance their effectiveness. Said artisan has also reviewed the problems in the art as regards to use of said bifunctional compounds capable of degrading ALK via a degradation pathway and understands the solutions that are widely known in the art.
Considering objective evidence present in the application indicating obviousness or nonobviousness
It would have been prima facie obvious to arrive at the elected species because Shanghai teaches the genus of Formula (I) in which the elected species falls, and structurally similar compounds are expected to have similar properties. Further, according to MPEP § 2144.08:
In fact, similar properties may normally be presumed when compounds are very close in structure. Dillon, 919 F.2d at 693, 696, 16 USPQ2d at 1901, 1904. See also In re Grabiak, 769 F.2d 729, 731, 226 USPQ 870, 871 (Fed. Cir. 1985) (“When chemical compounds have ‘very close’ structural similarities and similar utilities, without more a prima facie case may be made.”). Thus, evidence of similar properties or evidence of any useful properties disclosed in the prior art that would be expected to be shared by the claimed invention weighs in favor of a conclusion that the claimed invention would have been obvious. Dillon, 919 F.2d at 697-98, 16 USPQ2d at 1905; In re Wilder, 563 F.2d 457, 461, 195 USPQ 426, 430 (CCPA 1977); In re Lintner, 458 F.2d 1013, 1016, 173 USPQ 560, 562 (CCPA 1972).
Though Shanghai fails to teach the anticipatory species, compounds of the same genera are disclosed and are active in ALK degradation, and one of ordinary skill in the art would be motivated to make the compound before the effective filing date to identify additional compounds active in ALK degradation. A skilled artisan would have reasonably predicted that the elected species would be able to degrade ALK in view of the teachings of Shanghai.
Conclusion
Claims 1, 16, 28-29, 31-32, 41, and 49 are rejected. Claims 17, 22, 34-36, 38, 42-44, 45-48, and 50-53 are withdrawn.
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 Kendall Heitmeier whose telephone number is (703)756-1555. The examiner can normally be reached Monday-Friday 8:30AM-5:00PM ET.
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, Clinton Brooks can be reached on 571-270-7682. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/K.N.H./Examiner, Art Unit 1621
/CLINTON A BROOKS/Supervisory Patent Examiner, Art Unit 1621