DETAILED ACTION
Claims 4, 5, 12, 13, 16, 17, 20-22, 26, 30-34, and 44-48 are currently pending in the instant application. Claims 4, 5, 12, 13, 17, and 21 are rejected. Claims 16 and 20 are objected. Claims 22, 26, 30-34 and 44-48 are withdrawn from consideration as being for non-elected subject matter.
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 .
Election/Restrictions
Applicant’s election without traverse of Group I and the species:
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in the reply filed on 21 May 2025 is acknowledged.
According to MPEP 803.02, the examiner has determined whether the elected species is allowable. Applicants’ elected species appears allowable. Therefore, the search and examination has been extended to the compounds of claim 16 and 20 which also appear allowable, and further to the compounds
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,
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, and
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which are not allowable. Claims 4, 5, 12, 13, 16, 17, 20 and 21 have been examined to the extent that they are readable on the elected embodiment, the elected species and the above mentioned compounds.
Response to Amendment and Arguments
Applicant's amendment and arguments filed 6 October 2025 have been fully considered and entered into the instant application. As claim 4 is rejected, the objection to claim 16 for being dependent upon a rejected base claim is maintained. Claim 20 has been amended to overcome the objection of the “,” before the period, therefore, claim 20 is not objected to as being dependent upon a rejected base claim. Applicant’s amendment to claim 4 to amend the definition of variables R16, R17, and R18 has overcome the 35 USC 102(a)(1) rejection of claims 4, 5, 12, 13, 17 and 21 as being anticipated by Registry No. 1348682-76-7.
Priority
Applicant’s claim for the benefit of a prior-filed application under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Applicant has not complied with one or more conditions for receiving the benefit of an earlier filing date under 35 U.S.C. 119(e) as follows:
The later-filed application must be an application for a patent for an invention which is also disclosed in the prior application (the parent or original nonprovisional application or provisional application). The disclosure of the invention in the parent application and in the later-filed application must be sufficient to comply with the requirements of 35 U.S.C. 112(a) or the first paragraph of pre-AIA 35 U.S.C. 112, except for the best mode requirement. See Transco Products, Inc. v. Performance Contracting, Inc., 38 F.3d 551, 32 USPQ2d 1077 (Fed. Cir. 1994).
The disclosure of the prior-filed application, Application No. 62/939,263 fails to provide adequate support or enablement in the manner provided by 35 U.S.C. 112(a) or pre-AIA 35 U.S.C. 112, first paragraph for one or more claims of this application. Specifically, Application No. 62/939,263 provides the compounds of the formula
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, and
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on pages 78 and 79 wherein R5 is found on page 3 to be:
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with page 88 to include:
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(applicant’s instant claim 16). Please note that instant claim 4 defines R5 to be
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which includes multiple R5 values not found in Application 62/939,263. The species of instant claim 20 are found on pages 112-113 of the 62/939,263 application. As claim 4 and its dependent claim 5, 12, 13, 17, and 21 have R5 values outside the scope of the 62/939,263 application, claims 4, 5, 12, 13, 17, and 21 are not entitled to the benefit of the prior application and the date for prior art purposes for claims 4, 5, 12, 13, 17 and 21 is 20 November 2020.
Claim Objections
Claims 16 and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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) 4, 5, 13, 17 and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Registry No. 2415779-23-4 entered STN 05 May 2020.
Registry No. 2415779-23-4 discloses the compound:
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which corresponds, for example, to the compound of formula of claim 4:
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wherein L3 is -C(O)-; W1 is -NH-; W2 is =CH-; z2 is 1; and R2 is halogen, specifically Cl; R1.2, R1.3, R1.4, and R1.5 are each hydrogen; L4 is -NR4-; R4 is hydrogen; R5 is
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; and R17 is unsubstituted alkyl, specifically CH3.
Registry number 2415779-23-4 is available as prior art as of 05 May 2020 the date it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compound anticipates the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Regarding the composition of claim 21, comprising the anticipatory compounds and a carrier, the Registry entry for Registry no. 2415779-23-4 discloses a mass solubility in unbuffered water. This teaching in water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
Claim(s) 4, 13, 17 and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Registry No. 2415758-96-0 entered STN 05 May 2020.
Registry No. 2415758-96-0 discloses the compound:
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which corresponds, for example, to the compound of formula of claim 4:
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wherein L3 is -C(O)-; W1 is -NH-; W2 is =CH-; z2 is 1; and R2 is OR2D; R2D is unsubstituted alkyl, specifically CH3; R1.2, R1.3, R1.4, and R1.5 are each hydrogen; L4 is -NR4-; R4 is hydrogen; R5 is
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; and R17 is unsubstituted alkyl, specifically CH3.
Registry number 2415758-96-0 is available as prior art as of 05 May 2020 the date it was indexed into the CAplus database.
See MPEP 2128: ELECTRONIC PUBLICATIONS AS PRIOR ART Status as a "Printed Publication" An electronic publication, including an on-line database or Internet publication, is considered to be a “printed publication” within the meaning of 35 U.S.C. 102(a) and (b) provided the publication was accessible to persons concerned with the art to which the document relates. See In re Wyer, 655 F.2d 221, 227, 210 USPQ 790, 795 (CCPA 1981) Since this date represents the date that each compound entered the CAPlus database on STN, this represents the date that each compound was made accessible to the public.
The aforementioned compound anticipates the instantly claimed compounds: It is further noted that for the purposes of determining if a reference is a “printed publication” for the purposes of 102(b), MPEP 2128 states the following:
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where “prior art disclosures…on an on-line database are considered to be publicly available as of the date the item was publicly posted.” Since each of the database entries above lists the date that each compound was entered into the on-line database, the compounds were made publicly available as of that date in each citation, and the claims are anticipated.
Regarding the composition of claim 21, comprising the anticipatory compounds and a carrier, the Registry entry for Registry no. 2415758-96-0 discloses a mass solubility in unbuffered water. This teaching in water anticipates the claimed composition, wherein the compounds are present with an excipient (i.e., water).
Claim(s) 4, 12, 13, and 21 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by WO 2022/072741 A1, filed 30 September 2021, claiming priority to EP 20199435.7, filed 30 September 2020.
WO 2022/072741 discloses the compound 048 on page 165:
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in table 1 which is structures of example compounds of the disclosure. Pharmaceutical compositions are disclosed on page 144, which provides conventional carriers, to page 150. The compound 048 corresponds to the formula
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, for example, wherein z11 is 0; R1.4 and R1.5 are each hydrogen; L4 is -NR4-; R4 is hydrogen; R5 is
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; R18, R16, and R17 are each hydrogen; L3 is a bond; z2 is 1; and R2 is CX23; wherein X2 is -F. In regards to claim 12, the compound 038 anticipates instant claim 12 as claim 12 does not limit the formula of claim 4 to
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, but merely further limits the formula
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, however, the formula of claim 12 can still be
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. EP provides support for the compound 038 on page 138
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.
Conclusion
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 REBECCA L ANDERSON whose telephone number is (571)272-0696. The examiner can normally be reached Monday-Friday from 6am-2pm.
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, Andrew Kosar can be reached at 571-272-0913. 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.
/REBECCA L ANDERSON/Primary Examiner, Art Unit 1626 ____________________ 26 January 2026
Rebecca Anderson
Primary Examiner
Art Unit 1626, Group 1620
Technology Center 1600
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