DETAILED ACTION
Status of Claims
The amendment submitted February 23, 2023 has been entered.
Claims 1-17 are cancelled by Applicant.
Claims 18-29 are new.
Claims 18-29 are pending and under consideration.
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 .
Information Disclosure Statement
Three information disclosure statements (IDS) submitted on February 23, 2023 are acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 112(d)
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 21 and 27 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 21 recites the limitation where “R3 is H or F,” which broadens the subject matter of claim 18.
Likewise, Claim 27 recites compounds where R3 is not halogen, which broadens the subject matter of claim 18. By example only, compounds 80 and 90 fail to include all the limitations of claim 18 as R3 is hydrogen, not a halogen as required by independent claim 18.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Allowable Subject Matter
Claims 18-20, 22-26, and 28-29 are allowed.
The following is a statement of reasons for the indication of allowable subject matter: The closest prior art is Bonafoux et al. (USPN 9,567,339 B2) which disclose similar compounds and pharmaceutical compositions to instant invention.
Bonafoux teaches compounds of Formula I (see below).
PNG
media_image1.png
227
257
media_image1.png
Greyscale
PNG
media_image2.png
114
151
media_image2.png
Greyscale
However, Bonafoux differs from the instantly claimed invention based on the instant R3 substituent, which is F, Cl or I, whereas Bonafoux’s compounds have a CR4 moiety, where R4 is not halogen. Bonafoux’s compounds additionally differ based on the R3 substituent (i.e.: instant inventions’ A ring motif). Instant invention’s R1 and R2 substituents also differ from Bonafoux as instant R1 is H, CH3, CF3 or substituted phenyl and instant R2 is H, CH3, cyclopropyl or substituted phenyl. Bonafoux teaches heteroaryl and heterocycle motifs, and does not teach cyclopropyl or phenyl substituents.
Bonafoux and what was known in the prior art at the time of filing also does not provide motivation, teachings or suggestions to modify Bonafoux’s compounds to access the instant compounds containing the substituents as claimed nor does Bonafoux suggest methods of treatment for the diseases claimed in claim 29.
In addition to Btk and Ramos’ IC50 values, Applicant teaches that the compounds claimed were effective in treating a Sjögren's syndrome (SS), systemic lupus erythematosus (SLE), and/or rheumatoid arthritis (RA) using in vivo mouse models (NZB/W Mice) (page 292-293 of Applicant’s specification).
Consequently, instant invention’s compounds are non-obvious and allowable.
Conclusion
Claims 18-20, 22-26, and 28-29 are allowed.
Claims 21 and 27 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAROLYN L. LADD whose telephone number is (703)756-5313. The examiner can normally be reached M-Th, 7:00 am to 5:30 pm 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, James H. Alstrum-Acevedo can be reached at 571-272-5548. 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.
/C.L.L./Examiner, Art Unit 1622
/JAMES H ALSTRUM-ACEVEDO/Supervisory Patent Examiner, Art Unit 1622
Prosecution Insights