DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 47, 101, and 113-130 are pending. Claims 1-46, 48-100, and 102-112 are cancelled. Examiner previously required a restriction (dated August 20, 2025) which restricted the pending claims into four groups: Group I (claims 1,2, and 4), Group II (claim 3), Group III (claims 5 and 6), and Group IV (claims 47, 89, and 98-101).
In response, Applicant elected, without traverse, Group IV which encompassed claims 47, 89, and 98-101. Now, Group IV encompasses claims 47, 101, and 113-130.
Status of Priority
The present application is a continuation of U.S. Application No.: 16/331,181, filed March 7, 2019, now U.S. Patent No. 11,583,516 B2; which is the U.S. National Stage of PCT/US2017/050445, filed September 7, 2017; which claims the benefit of priority to United States Provisional Patent Application serial numbers 62/384,403, filed September 7, 2016; 62/384,407, filed September 7, 2016; and 62/482,750, filed April 7, 2017.
Election/Restrictions
As a reminder, Applicant elected, without traverse, invention Group (IV) which now corresponds to claims 47, 101, and 113-130. In Applicant’s response to restriction required by Examiner, Applicant also elected compound 4175CH as depicted below:
PNG
media_image1.png
178
221
media_image1.png
Greyscale
and indicated that claims 47, 89, 98, and 101 read on said species. The elected species was not found in the prior art and, thus, the search was expanded.
Information Disclosure Statement
Examiner previously did not consider a majority of the references cited by Applicant in the IDS filed on February 17, 2023 (i.e., the references marked with a double asterisk [**]) because the electronic copies of those foreign patent documents and non-patent literature documents were not provided for the instant application. All remaining references that had a corresponding electronic copy filed were considered.
Applicant states the following in response on the 1st page of the remarks file (dated March 17, 2026):
“In response, and as noted on page 2 of the SB-08 and on page 1 of the information disclosure statement dated February 17, 2023, the references in question are marked with a double asterisk (**) and were not supplied because they were previously submitted in a prior application relied upon in this application for an earlier filing date under 35 U.S.C. 120. Accordingly, the Applicant is not required to submit copies of them in the present application. MPEP §609.04(a) & 37 C.F.R. § 1.98(d)(1). Applicant requests that the Examiner fully consider all of the references listed in the information disclosure dated February 17, 2023, and issue the corresponding PTO-892.”
According to MPEP §609.04(a) & 37 C.F.R. § 1.98(d)(1):
“First, 37 CFR 1.98(d) states that a copy of any patent, publication, pending U.S. application, or other information listed in an information disclosure statement is not required to be provided if: (A) the information was previously cited by or submitted to, the Office in a prior application, provided that the prior application is properly identified in the IDS and is relied on for an earlier filing date under 35 U.S.C. 120; and (B) the IDS submitted in the earlier application complies with 37 CFR 1.98(a)-(c). If both of these conditions are met, the examiner will consider the information previously cited or submitted to the Office and considered by the Office in a prior application relied on under 35 U.S.C. 120.
Accordingly, the references cited by Applicant in the IDS filed on February 17, 2023 and marked with a double asterisk is now considered. The only reference that was not considered is:
CN 104003922 A
because Examiner could not locate an electronic copy for this reference. All other references have been considered.
Withdrawn Rejections
Applicant is notified that any outstanding rejection or objection that is not expressly maintained in this office action has been withdrawn or rendered moot in view of applicant' s amendments and/or remarks.
Specification - Disclosure
The specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
Claim Objections
Claim 114 is objected to because of the following informalities:
In claim 114, a period should be added to the end of the sentence.
Appropriate correction is required.
--------------------------------------------- Maintained Rejections -----------------------------------------
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 47, 101, 115-117, and 119-130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
Claims 2, 3, and 8 of U.S. Patent No. US 11,583,516 B2 (‘516B2).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is overlap between the instant claims and the claim set from the granted patent.
Regarding ‘516B2:
This patent claims the following compounds which read on the claims as indicated in the parentheses:
PNG
media_image2.png
229
333
media_image2.png
Greyscale
(see claim 2; reads on instant claims 47, 115, 117, 119, 122-125, 127, 129, and 130)
PNG
media_image3.png
231
334
media_image3.png
Greyscale
(see claim 2; reads on instant claims 47, 116, 117, 119-121, 123-126, 128)
PNG
media_image4.png
261
320
media_image4.png
Greyscale
(see claim 3 and 8; reads on instant claims 47, 115, 117, 119, 122-125, 127, 129, and 130)
PNG
media_image5.png
249
286
media_image5.png
Greyscale
(see claim 3 and 8; reads on instant claims 47, 116, 117, 119-121, 123-126, 128).
Additionally, instant claim 101 is directed to a pharmaceutical composition comprising a compound of instant formula (I) wherein a compound of instant formula (I) encompasses the compounds disclosed in ‘516B2 as listed above. ‘516B2 does not claim a pharmaceutical composition comprising any of the compounds listed above, however, It would have been obvious to one of ordinary skill in the art to formulate the claimed compound of ‘516B2 (as listed above) into a pharmaceutical composition by combining the compound with a pharmaceutically acceptable excipient. Such a formulation is a conventional and routine step in the preparation of therapeutically useful compounds. Thus, the instantly claimed pharmaceutical composition is also not patentably distinct from the compound (as listed above) claimed in ‘516B2.
--------------------------------------------- Added Rejections -----------------------------------------
Claim Rejections - 35 USC § 112(a)
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.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
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 of carrying out his invention.
Claims 47, 101, and 113-130 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim 47 recites the following limitations:
R2 represents, for each occurrence… alkyl, alkynyl…
R3 represents, for each occurrence… a substituted or unsubstituted alkyl, alkenyl, …
R4 represents… an alkyl, an alkenyl, an alkynyl… -(CH2)n-S-alkyl, -(CH2)n-S-alkenyl, -(CH2)n-S-alkynyl…
However, the instant specification (pg. 8-9_ only provides written description support for, specifically, the following limitations:
R2 represents, for each occurrence… lower alkyl, lower alkynyl…
R3 represents, for each occurrence… a substituted or unsubstituted lower alkyl, lower alkenyl, …
R4 represents… a lower alkyl, a lower alkenyl, a lower alkynyl… -(CH2)n-S-lower alkyl, -(CH2)n-S-lower alkenyl, -(CH2)n-S-lower alkynyl…
Claims 101, and 113-130, which are dependent on claim 47, are also rejected for further requiring and/or reciting the limitations (from claim 47) with written description issues.
Double Patenting
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. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); 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); 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) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 47, 101, and 113-130 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over:
claims 1-29 of U.S. Patent No. US 11,096,924 B2 (‘924B2) and
claims 1-31 of U.S. Patent Application No. 19/384,002 (‘002).
Although the claims at issue are not identical, they are not patentably distinct from each other because there is significant overlap between the instant claims and the two claim sets from the patent and patent application listed above.
Regarding ‘924B2:
The reference patent claims a method for enhancing an immune response against a tumor, comprising administering to a subject in need thereof a therapeutically effective amount of a combination of an I-DASH inhibitor and a PGE2 antagonist, wherein the I-DASH inhibitor can be a compound represented by formula (I) (see claim 21 of ‘924B2).
The instant claims are directed to a compound of formula (I), which is the same compound of formula (I) recited in claim 21 of ‘924B2.
The method of ‘924B2 requires the use of the instantly claimed compound of formula (I). Thus, the instant claims directed to a compound of formula (I) is not patentably distinct from the subject matter of the reference patent claims as the compound of formula (I) is an inherent component of the claimed method in ‘924B2. One of ordinary skill in the art would have understood that such a compound may be employed as the active agent or formulated into a pharmaceutical composition for administration to a subject.
Accordingly, the instant claim is not patentably distinct from the claims of ‘924B2.
Regarding ‘002:
The reference patent application claims a method for enhancing an immune response against a tumor, comprising administering to a subject in need thereof a therapeutically effective amount of an I-DASH inhibitor and a PGE2 antagonist, wherein the I-DASH inhibitor can be a compound represented by formula (I) (see claim 23 of ‘002).
The instant claims are directed to a compound of formula (I), which is the same as the compound of formula (I) recited in claim 23 of ‘002.
The method of ‘002 requires the use of the instantly claimed compound of formula (I). Thus, the instant claims directed to a compound of formula (I) is not patentably distinct from the subject matter of the reference patent claims as the compound of formula (I) is an inherent component of the claimed method in ‘002. One of ordinary skill in the art would have understood that such a compound may be employed as the active agent or formulated into a pharmaceutical composition for administration to a subject.
Accordingly, the instant claim is not patentably distinct from the claims of ‘002.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to KRISTEN ROMERO whose telephone number is (571)272-6478. The examiner can normally be reached M-F 9:30 AM - 6:00 PM ET.
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 H. MURRAY can be reached at (571) 272-9023. 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.
/KRISTEN W ROMERO/Examiner, Art Unit 1624
/JEFFREY H MURRAY/Supervisory Patent Examiner, Art Unit 1624
Prosecution Insights