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
Priority and Status of the Claims
1. This application is a 371 PCT/US2022/027888 05/05/2022, which claims benefit of the provisional application: 63184439 05/05/2021.
2. Claims 1-2, 5, 7, 13, 17, 19, 22-23, 27, 34, 38-39, 44, 46, 50, 55-56, 62, 66, 68, 75-76, 78, 81, 86, 90 and 93-94 are pending in the application.
Claim Rejections - 35 USC § 112
3. The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
Claim 1 is rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112, first paragraph
(pre- AIA ), because the specification does not reasonably provide enablement of the
instant “DSM” without limitation (i.e., no named moiety). The specification
does not enable any person skilled in the art to which it pertains, or with which it is most
nearly connected, to make the invention commensurate in scope with these claims.
ln In re Wands, 8 USPQ2d 1400 (1988), factors to be considered in determining
whether a disclosure meets the enablement requirement of 35 U.S.C. 112, first
paragraph, have been described. They are:
1. the nature of the invention,
2. the state of the prior art,
3. the predictability or Iack thereof in the art,
4. the amount of direction or guidance present,
5. the presence or absence of working examples,
6. the breadth of the claims,
7. the quantity of experimentation needed, and
8. the level of the skill in the art.
In the instant case:
The nature of the invention
The nature of the invention is a compound of formula (A) having “DSM” without limitation (i.e., no named moiety), see claim 1.
The state of the prior art and the predictability or Iack thereof in the art
The state of the prior art is Marx et al. US 2023/0025892 A1, it discloses a similar
Chemical moiety, see columns 184-185.
The amount of direction or guidance present and the presence or absence
of working examples
The only direction or guidance present in the instant specification is the description of a number of “DSM” on pages 10-15 of the specification. There is no data present in the instant specification for the “DSM” without limitation (i.e., no named moiety).
The breadth of the claims
The instant breadth of the rejected claims is broader than the disclosure,
specifically, the instant “DSM” are without limitation (i.e., no named moiety).
The quantity or experimentation needed and the Ievel of skill in the art
While the level of the skill in the chemical arts is high, it would require
undue experimentation of one of ordinary skill in the art to resolve any “DSM” without limitation. There is no guidance or working examples present for constitutional any “DSMr” without limitation for the instant invention. Incorporation of the limitation of “DSM” supported by specification (i.e., claim 46) into claim 1 would overcome this rejection.
4. 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 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.
Claim Rejections - 35 USC § 103
5. The following is a quotation of 35 U.S.C. 103(a) 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 set forth in Graham v. John Deere Co., 383 U.S. 1, 148 USPQ 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103(a) 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 non-obviousness.
This application currently names joint inventors. In considering patentability of the claims under 35 U.S.C. 103(a), the examiner presumes that the subject matter of the various claims was commonly owned at the time any inventions covered therein were made absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and invention dates of each claim that was not commonly owned at the time a later invention was made in order for the examiner to consider the applicability of 35 U.S.C. 103(c) and potential 35 U.S.C. 102(f) or (g) prior art under 35 U.S.C. 103(a).
Claims 1 and 93-94 are rejected under 35 U.S.C. 103(a) as being obvious over
Marx et al. US 2023/0025892 A1. It is noted that Marx et al. ‘892 is a 102(a)(2)
reference.
Applicants claim a of formula of formula (A), BTK-L-DSM or a pharmaceutical acceptable salt thereof, wherein DSM is a degradation signaling moiety that is covalently attached to the linker L, and L is a linker that covalently attaches BTK to DSM; and BTK is a Buk binding moiety represented by formula (I) or formula (II) that is
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464
818
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, or a pharmaceutically acceptable salt thereof,
wherein A is selected from CR7 and N; B1 is selected from CR8, N, and NR8; B2 is C or N; B3 is selected from CR8, N, NR8 and S; one of Q1 and Q2 is N, and the other one is C; or both of Q1 and Q2 are C; X is selected from O and NR2, R1-R6 are carbocycle, heterocycle, H, alkyl, or halogen, see claim 1. Dependent claims 93-94 further limit the scope of compounds, i.e., a composition, and methods of use for treating autoimmune disorders.
Determination of the scope and content of the prior art (MPEP §2141.01)
Marx et al. ‘892 discloses a compound/composition of formula (II),
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338
284
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, wherein R1-R6 are carbocycle, heterocycle, alkyl, H, alkyl or
halogen, and R8 is alkyl and alkyl substituted with R80 and R80 is alkyl, carbocycle,
or heterocycle, alkenyl, carbocycle or heterocycle(i.e., mimic the instant L-DSM), see
columns 184-185. Marx et al. ‘892 compound/composition is used for treating
autoimmune disorders, see column 190.
Determination of the difference between the prior art and the claims (MPEP §2141.02)
The difference between instant claims and Marx et al. ‘892 is that the instant claims are embraced within the scope of Marx et al. ‘892.
Finding of prima facie obviousness-rational and motivation (MPEP §2142-2143)
One having ordinary skill in the art would find the claims 1 and 93-94 prima facie obvious because one would be motivated to employ the compound/composition and methods of use of Marx et al. ‘892 to obtain instant invention.
The motivation to make the claimed compound/composition and methods of use derived from the known compound/composition and methods of use of Marx et al. ‘892 would possess similar activity to that which is claimed in the reference.
Double Patenting
6. The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the "right to exclude" granted by a patent and to prevent possible harassment by multiple assignees. See In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); and In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 1 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claim 1 of Marx et al. US 12,391,697. Although the conflicting claims are not identical, they are not patentably distinct from each other and reasons are as follows.
Applicants claim a of formula of formula (A), BTK-L-DSM or a pharmaceutical acceptable salt thereof, wherein DSM is a degradation signaling moiety that is covalently attached to the linker L, and L is a linker that covalently attaches BTK to DSM; and BTK is a Buk binding moiety represented by formula (I) or formula (II) that is
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464
818
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Greyscale
, or a pharmaceutically acceptable salt thereof,
wherein A is selected from CR7 and N; B1 is selected from CR8, N, and NR8; B2 is C or N; B3 is selected from CR8, N, NR8 and S; one of Q1 and Q2 is N, and the other one is C; or both of Q1 and Q2 are C; X is selected from O and NR2, R1-R6 are carbocycle, heterocycle, H, alkyl, or halogen, see claim 1.
Marx et al. ‘697 claims a compound of formula (I),
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320
218
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, or a pharmaceutically acceptable salt thereof, wherein: A1 is selected from CR7 and N; B1 and B2 are each independently selected from CR8, N, and NR8 and and R8 is alkyl and alkyl substituted with R80 and R80 is alkyl, carbocycle, or heterocycle, alkenyl, carbocycle or heterocycle(i.e., mimic the instant L-DSM); one of Q1 and Q2 is N, and the other one is C; R1-R6 is carbocycle, heterocycle, H, alkyl, or halogen, and R8 is carbocycle, heterocycle, H, alkyl, or halogen, see column 345-350.
The difference between instant claims and Marx et al. ‘697 is that the instant claims are embraced within the scope of Marx et al. ‘697.
One having ordinary skill in the art would find the claim 1 prima facie obvious because one would be motivated to employ the compounds of Marx et al. ‘697 to obtain instant invention.
The motivation to make the claimed compounds derived from the known compounds of Marx et al. ‘697 would possess similar activity to that which is claimed in the reference.
Claim Objections
7. Claims 2, 5, 7, 13, 17, 19, 22-23, 27, 34, 38-39, 44, 46, 50, 55-56, 62, 66, 68, 75-76, 78, 81, 86 and 90 are objected to as being dependent on rejected claim 1.
Conclusion
Any inquiry concerning this communication or earlier communications from the
examiner should be directed to REI TSANG SHIAO whose telephone number is
(571)272-0707. The examiner can normally be reached on 8:30 am-5:00 pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Renee Claytor can be reached on 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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/REI TSANG SHIAO/
Rei-tsang Shiao, Ph.D.Primary Examiner, Art Unit 1691
February 09, 2026