DETAILED ACTION
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 .
Application Status
The amendment filed on 12/04/2025 is acknowledged. Claims 1-6 and 8-15 are currently pending and under consideration.
Priority
Receipt is acknowledged of the translations of the foreign priority applications. The earliest effective filing date for claims 1-6 and 8-15 is determined to be 8/13/2021.
Information Disclosure Statement
The information disclosure statement filed on 12/4/2025 has been considered except where lined through.
Rejections Withdrawn
The rejection of claim 13 under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter is withdrawn in view of Applicants amendments.
The rejection claims 2-3, 5-6 and 13 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or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention is withdrawn in view of Applicants amendments.
The rejection of Claim(s) 1-9 and 11-13 under 35 U.S.C. 102a(1)(2) as being anticipated by Xinthera (WO2023/283338A1, 2023-02-12, priority to US63/220,322 filed on 2021-07-09) is withdrawn in view of Applicants amendments.
Rejections Maintained
Claim Rejections - 35 USC § 102
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 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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 10 remains rejected under 35 U.S.C. 102a(2) as being anticipated by Xinthera (WO2023/283338A1, 2023-02-12, priority to US63/220,322 filed on 2021-07-09).
Xinthera teaches compounds of formula (I) or a pharmaceutically acceptable salt, solvate, stereoisomer or rotamer thereof useful in the treatment of a variety of disorder including, but not limited to, autoimmune disorders and chronic inflammatory disorders, wherein the compound of formula (I) has the generic structure:
PNG
media_image1.png
185
283
media_image1.png
Greyscale
(paragraphs 0041-0042). Specifically, the WO document teaches numerous species including, but not limited to,
PNG
media_image2.png
80
239
media_image2.png
Greyscale
which appears to be identical to the instantly claimed compound 1 in claim 10, as well as,
PNG
media_image3.png
216
271
media_image3.png
Greyscale
(page 27, cmpd 1A, paragraph 0089).
In response to the rejection, Applicants contend that the ‘322 application which is relied upon for its filing date of Xinthera fails to disclose the preparation methods for Compounds 1, 1A, 1B, 5, 25, 29 and 40 claimed in claim 10. Specifically, Applicants contend that the ‘322 application does not contain a clear description of the reagents, steps and conditions for preparing these compounds with experimental data. Accordingly, the ‘322 application fails to adequately describe Compounds 1, 1A, 1B, 5, 25, 29 and 40 claimed in claim 10 and therefore, the filing date of the ‘322 application cannot be relied upon as the effective filing date for the rejection.
These arguments have been carefully considered, but are not found persuasive.
Regarding whether the ‘322 application adequately described Compounds 1, 1A, 1B, 5, 25, 29 and 40 claimed in claim 10, the examiner recognizes that possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing that the invention was “ready of patenting” such as by the disclosure of drawings or structural chemical formula’s that the invention was complete. See MPEP 2163.02. Accordingly, since the compounds are specifically described on pages 31-34 by structural chemical formula’s it is the examiners opinion that the compounds are adequately described. Thus, the rejection is maintained.
New Rejections Necessitated by Applicants Amendments
Claim Rejections - 35 USC § 112
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 8 and 11 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.
Regarding claim 8, claim 8 recites a compound having the formula
PNG
media_image4.png
184
198
media_image4.png
Greyscale
. However, claim 1 from which claim 8 depends does not include an A ring wherein the the bond to the larger molecule occurs next to the nitrogen of the pyridine ring.
Regarding claim 11, claim 11 has been amended to only recite a preamble which is identical to claim 1. As such, the claim does not further limit claim 1.
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.
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.
Claim(s) 1-6 and 8-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Xinthera (WO2023/283338A1, 2023-02-12, priority to US63/220,322 filed on 2021-07-09).
Xinthera teaches compounds of formula (I) or a pharmaceutically acceptable salt, solvate, stereoisomer or rotamer thereof useful in the treatment of a variety of disorder including, but not limited to, autoimmune disorders and chronic inflammatory disorders, wherein the compound of formula (I) has the generic structure:
PNG
media_image1.png
185
283
media_image1.png
Greyscale
(paragraphs 0041-0042). Specifically, the WO document teaches numerous species including, but not limited to,
PNG
media_image2.png
80
239
media_image2.png
Greyscale
which appears to be identical to the instantly claimed compound 1 in claim 10, as well as,
PNG
media_image3.png
216
271
media_image3.png
Greyscale
(page 27, cmpd 1A, paragraph 0089). Moreover, Xinthera teaches a method of treating a p38 MAP kinase-mediated disease in a subject comprising administering to the subject a therapeutically effective amount a compound (paragraph 0012). With regards to the disease, Xinthera teaches that the diseases include, but are not limited to, chronic inflammatory disorders such as rheumatoid arthritis and acute inflammatory disorders (paragraph 0041 and 00109).
While the prior art teaches that the A ring is
PNG
media_image5.png
49
38
media_image5.png
Greyscale
, the prior art does not specifically teach that the A ring is
PNG
media_image6.png
59
58
media_image6.png
Greyscale
or
PNG
media_image7.png
51
74
media_image7.png
Greyscale
.
It would have been prima facie obvious to one of ordinary skill in the art, prior to the effective filing date of the instantly claimed invention, to modify the compound/compounds taught by Xinthera to move the bond linking the pyridine to the larger molecule around pyridine molecule with a reasonable expectation that the compounds would have similar properties. One of ordinary skill in the art would have been motivated to make such a substitution, with a reasonable expectation of success, because:
A prima facie case of obviousness may be made when chemical compounds have very close structural similarities and similar utilities. "An obviousness rejection based on similarity in chemical structure and function entails the motivation of one skilled in the art to make a claimed compound, in the expectation that compounds similar in structure will have similar properties." In re Payne, 606 F.2d 303, 313, 203 USPQ 245, 254 (CCPA 1979). See In re Papesch, 315 F.2d 381, 137 USPQ 43 (CCPA 1963) (discussed in more detail below) and In re Dillon, 919 F.2d 688, 16 USPQ2d 1897 (Fed. Cir. 1990).
Compounds which are position isomers (compounds having the same radicals in physically different positions on the same nucleus) or homologs (compounds differing regularly by the successive addition of the same chemical group, e.g., by -CH2- groups) are generally of sufficiently close structural similarity that there is a presumed expectation that such compounds possess similar properties. In re Wilder, 563 F.2d 457, 195 USPQ 426 (CCPA 1977). See also In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (stereoisomers prima facie obvious).
Conclusion
Therefore, No claim is allowed.
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 BRANDON J FETTEROLF whose telephone number is (571)272-2919. The examiner can normally be reached M-F 6AM-4PM.
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, Jeffrey S Lundgren can be reached at 571-272-5541. 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.
/BRANDON J FETTEROLF/Primary Examiner, Art Unit 1626
Prosecution Insights