DETAILED ACTION
The Examiner inherited this application from another Examiner.
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 .
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.
Election/Restriction
Applicant’s election without traverse of Group II, claims 1, 3, 5-12, 14-26, 28 and 30-36, drawn to compounds of Formula (Ib) and related composition and methods of treatment, in the reply filed on September 30, 2024 is acknowledged.
Claims 2, 4 and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected inventions of Groups I and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 30, 2024.
Applicant’s election of species, XPA-0064, read on the above claims, without traverse is acknowledged.
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A search for Applicants’ elected species XPA-0064 does not retrieve prior art.
Therefore, the Markush search is extended to a compound, XPA-0070 (page 50, Table 7, PCT application).
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which is a species of genus formula Ib of claim 1, wherein:
Formula (I) is (Ib) (elected invention)
R1 = Adamantyl, (Adamantyl has 10 C atoms, within “C8-C14 tricycloalkyl” recited in instant claim 1);
R2-R5 = H;
X1=X2=X3=X4 = CR8, R8 = H;
Z1 and Z2 are together “=O”; and
Y = OCH2CH3.
This search retrieved applicable prior art. Therefore, the Markush search will not be extended unnecessarily to additional species of instant claim 1 in this Office Action following Markush search practice.
Examiner identifies claims 1, 3, 6-12, 14-19, 25-26, 28, 30-36, as reading on the extended compound XPA-0070, illustrated and described, above.
Claim 5, 20-24 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species of Group II, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on September 30, 2024.
Therefore, claims 1, 3, 6-12, 14-19, 25-26, 28, 30-36 are currently under examination on the merits in view of the elected invention group and the elected species.
Priority
This application is a 35 U.S.C. 371 National Phase Entry Application from PCT/EP2019/072640, filed August 23, 2019, which claims the benefit of European Patent Application No. 18190756.9 filed on August 24, 2018.
The effective filing date is August 24, 2018.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 09/08/2021, 11/15/2023, 02/20/2024, 09/30/2024 and 11/20/2024 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Specification
The title of the invention is not descriptive and includes a term “novel” which is considered subjective and non-specific; therefore, the term “novel” should be removed from the title. A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: Biaryl Ether Compounds.
Appropriate correction is requested.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 6, 7, 8, 19 and 30-36 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, 6, 7, 8 and 19 recite “preferably”.
Claims 1, 35 and 36 recite “particularly”.
Claims 7, 30-34 recite “including”.
Claims 1 and 30-34 recite “such as”.
Claim 33 recites “e.g.”.
The above claims recite terms of “preferably”, “including”, “such as”, “e.g.” and “particularly”, which renders the claims indefinite. According to MPEP 2173.05 (d), “description of examples or preferences is properly set forth in the specification rather than the claims. If stated in the claims, examples and preferences may lead to confusion over the intended scope of a claim.”
These terms should be deleted.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 3, 6-12, 14-19, 25-26, 28, and 30-36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by D1 (Reinmueller, et al., WO2017158190A1).
Regarding claim 1, D1 teaches the following compound, on page 19.
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Which corresponds to instant claim 1, wherein
Formula (I) is (Ib) (elected invention)
R1 = Adamantyl, (Adamantyl has 10 C atoms, within “C8-C14 tricycloalkyl” recited in instant claim 1);
R2-R5 = H;
X1=X2=X3=X4 = CR8, R8 = H;
Z1 and Z2 are together “=O”; and
Y = OCH2CH3; and prior art reference REINMUELLER teaches “or a salt or solvate thereof” (see “Abstract”).
Therefore claim 1 is anticipated by D1.
Claim 3 depending upon claim 1, further recites formula (1b), which is anticipated by D1, according to the above discussion. Furthermore, prior art reference REINMUELLER teaches “or a salt or solvate thereof” (see “Abstract”).
Claim 6 depends upon claim 1 with a further limitation of R1. D1 teaches the following compound, on page 19:
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Which corresponds to instant claim 6, wherein
Formula (I) is (Ib) (elected invention)
R1 = adamantyl;
R2-R5 = H;
X1= N, X2=X3=X4 = CR8, R8 = H;
Z1 and Z2 are together “=O”; and
Y = OCH2CH3.
D1 compound V150 is a species of instant claim 6. Therefore claim 6 is anticipated by D1.
Regarding claim 7, which depends upon claim 1 with a further limitation for R1. D1 teaches the following compound, on page 19.
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Which corresponds to instant claim 7, wherein
Formula (I) is (Ib) (elected invention)
R1 =
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R2-R5 = H;
X1= X2=X3=X4 = CR8, R8 = H;
Z1 and Z2 are together “=O”; and
Y = OCH2CH3.
D1 compound V150 is a species of instant claim 7.
Therefore claim 7 is anticipated by D1.
Regarding claim 8, which depends upon claim 1 with further limitations of R2-R5. D1 teaches the following compound, on page 19.
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Which corresponds to instant claim 8, wherein
Formula (I) is (Ib) (elected invention)
R1 =
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R2-R3 = H, R4 = H, and R5 = H;
X1= X2=X3=X4 = CR8, R8 = H;
Z1 and Z2 are together “=O”; and
Y = OCH2CH3.
D1 compound V150 is a species of instant claim 8. Therefore claim 8 is anticipated by D1.
Regarding claim 9, which depends upon claim 1 with a further limitation of the six-membered aromatic ring, to which substituents R1 to R5 are bound. D1 teaches the following compound
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Corresponding to claim 9, wherein “the six-membered aromatic ring, to which substituents R1 to R5 are bound as defined in general formula (I)”, is
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and
R1 is adamantly.
D1 teaches every element of claim 9. Therefore, claim 9 is anticipated by D1.
Regarding claim 10, which depends upon claim 1 with a further limitation regarding “the six-membered aromatic ring containing X1-X4”. D1 teaches the following compound
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Corresponding to claim 10 (further depends upon claim 1), wherein “the six-membered aromatic ring containing X1-X4 as defined in general formula (I)”, is
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D1 teaches every element of claim 10. Therefore, claim 10 is anticipated by D1.
Regarding claim 11, which depends upon claim 1 with a further limitation of Y. D1 teaches the following compound
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Corresponding to claim 11 (further depends upon claim 1), wherein Y is OCH2CH3.
D1 teaches every element of claim 11. Therefore, claim 11 is anticipated by D1.
Regarding claim 12, which depends upon claim 1 with a further limitation of “Z1 and Z2 are together =O”. D1 teaches the following compound
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Corresponding to claim 12 (further depends upon claim 1), wherein Z1 and Z2 are together =O.
D1 teaches every element of claim 12. Therefore, claim 12 is anticipated by D1.
Regarding claim 14, which depends upon claim 1 with a further limitation for Y. D1 teaches the following compound
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Corresponding to claim 14 (further depends upon claim 1), wherein Y is OCH2CH3.
D1 teaches every element of claim 14. Therefore, claim 14 is anticipated by D1.
Regarding claim 15, which depends upon claim 1 with a further limitation of R1 “containing no heteroatom.” D1 teaches the following compound
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Corresponding to claim 15 (further depends upon claim 1), wherein R1 contains no heteroatom.
D1 teaches every element of claim 15. Therefore, claim 15 is anticipated by D1.
Regarding claim 16, depending upon claim 1, with a further limitation of “R 1 is selected from cyclic, bicyclic and tricyclic structures”, D1 teaches the following compound
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Corresponding to claim 16 (further depends upon claim 1), wherein R1 is Adamantyl, a tricyclic structure.
D1 teaches every element of claim 16. Therefore, claim 16 is anticipated by D1.
Regarding claims 17 and 18, which depends upon claim 1 with a further limitation for R1. D1 teaches the following compound
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Corresponding to claims 17 (further depends upon claim 1) and 18 (depends upon claim 17), wherein R1 is adamantyl.
D1 teaches every element of claims 17 and 18. Therefore, claims 17 and 18 are anticipated by D1.
Regarding claim 19, which depends upon claim 1 with a further limitation of R1 containing four or more, preferably six or more and even more preferably seven or more carbon atoms, D1 teaches the following compound
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Corresponding to claim 19 (further depends upon claim 1), wherein R1 contains 10 carbon atoms.
D1 teaches every element of claim 19. Therefore, claim 19 is anticipated by D1.
Regarding claim 25, D1 teaches the following compound, on page 19.
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Which is compound XPA-0070 recited in claim 25, table 7, bottom row.
Therefore claim 25 is anticipated by D1.
Claim 26 recites “A pharmaceutical composition comprising the compound of claim 1 in combination with a pharmaceutically acceptable carrier suitable for human medicine or veterinary medicine.”
According to the above discussion, D1 anticipates claim 1.
D1 also teaches the further limitation of claim 26, on page 117, first paragraph, as “The present invention further provides pharmaceutical compositions comprising a compound as described herein or a pharmaceutically acceptable salt thereof for use in medicine, e.g. in human or veterinary medicine. In some embodiments, the composition further comprises a pharmaceutically acceptable carrier.”
Therefore, D1 teaches every element of Claim 26. D1 anticipates claim 26.
Claim 28 recites “A method for enhancing Notch signaling, comprising administering the compound of claim 1 to a patient in need of such treatment.”
According to the above discussion, D1 anticipates claim 1.
D1 further teaches on page 1, first paragraph under the section of “Description of the Invention”, as “According molecules were found to enhance the Notch signaling pathway.” D1 teaches the instant compounds are Notch signaling pathway enhancer.
D1 also teaches “administering the compound of claim 1 to a patient in need of such treatment “ (page 113, 3rd para.)
D1 teaches every element of claim 28. Therefore, D1 anticipates claim 28.
Regarding claim 30, which depends upon claim 1, D1 teaches “A method for treating diseases and malignant, non-malignant and hyperproliferative disorders of the skin, mucosa, skin and mucosa! appendages, cornea, and epithelial tissues, including cancer…” (page 113, 3rd paragraph). According to the above discussion, D1 anticipates claim 1, and D1 also teaches the further limitation as recited in claim 30. Therefore claim 30 is anticipated by D1.
Regarding claim 31, which depends upon claim 1, D1 teaches “treating hyperproliferative disorders, cancers…” (page 113, 3rd paragraph, as “… antiproliferative effects in medicinal treatments, preferably in the treatment of hyperproliferative disorders including cancer”). According to the above discussion, D1 anticipates claim 1, and D1 also teaches the further limitation as recited in claim 31. Therefore claim 31 is anticipated by D1.
Regarding claim 32, which depends upon claim 1, D1 teaches “A method of treating malignant and non-malignant muscular diseases” (7th paragraph on page 115). According to the above discussion, D1 anticipates claim 1, and D1 also teaches the limitation as recited in claim 32. Therefore claim 32 is anticipated by D1.
Regarding claim 33, which depends upon claim 1, D1 teaches “A method of treating immune system-related disorders,” (2nd paragraph on page 115). According to the above discussion, D1 anticipates claim 1, and D1 also teaches the limitation as recited in claim 33. Therefore claim 33 is anticipated by D1.
Regarding claim 34, which depends upon claim 1, D1 teaches “A method for improving therapeutic immune system-related applications including immunotherapy and other immunotherapy methods,” (3rd paragraph on page 115). According to the above discussion, D1 anticipates claim 1, and D1 also teaches the limitation as recited in claim 34. Therefore claim 34 is anticipated by D1.
Regarding claims 35, which depends upon claim 1, D1 teaches “a hyperproliferative disorder comprising administering a subject in need thereof, particularly a human subject, a therapeutically effective amount of a compound” (3rd paragraph on page 115). According to the above discussion, D1 anticipates claim 1, and D1 also teaches the limitation as recited in claim 35. Therefore claim 35 is anticipated by D1.
Regarding Claim 36, which depends upon claim 1, D1 teaches “A method of treating a disorder associated with, accompanied by and/or caused by dysfunctional Notch signaling,” (page 1, 1st paragraph under the section of “Description of the Invention”; 3rd paragraph on page 113).
Regarding the limitation recited in claim 36 “comprising administering a subject in need thereof, particularly a human subject, a therapeutically effective amount of a compound”, Examiner interpretates it as “medicinal treatments”, which is taught by D1 in 3rd paragraph on page 113, same embodiment, see above.
Therefore, D1 teaches every element of claim 36. D1 anticipates claim 36.
Conclusion
No claims are allowable.
The co-pending US patent application 17/270,665, claim 27, was considered as a non-statutory double patent reference because compound XPW-I-0004
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(in reference Table 39 of reference claim 27) is similar to instant Claims 1, 3, 6-12, 14-19, 25-26, 28, and 30-36.
However, the examiner determined that such a rejection would involve impermissible “picking and choosing” with no “immediately envisage”. Therefore, the double patenting rejection using the ‘665 application as a reference was not made.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to XIAOBIN (Amy) DING whose telephone number is (703)756-1409. The examiner can normally be reached Monday-Friday 10a-6p.
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/XD/Examiner, Art Unit 1692
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
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