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 .
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/Restrictions
Applicant’s election in the reply filed on 22 May 2026, is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Applicants provided a compliant species election of: “kidney transplant”.
This elected species is free of the prior art.
The Examiner extended the Markush search to the full scope of instant claim 1’s “transplant rejection” but did not find any prior art.
Therefore, the Election of Species Requirement of 25 March 2026, is withdrawn, as all claims are free of the prior art.
All claims have been examined on the merits.
Current Status of 18/286,677
This Office Action is responsive to the amended claims of 12 October 2023.
Claims 1-14 and 16 have been examined on the merits. Claims 1-14 are currently amended. Claim 16 is original.
Priority
The instant application’s effective filing date is 6 April 2022.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12 October 2023, is 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 contains “Novel”, and hence is not descriptive. Application titles cannot have “New”, “Novel”, “Improvement”, and “Improvement of”, etc. See MPEP 606.
A new title is required that is clearly indicative of the invention to which the claims are directed.
The following title is suggested: -- PHARMACEUTICAL COMPOSITION COMPRISING [[NOVEL]] SD911 COMPOUND AS ACTIVE INGREDIENT FOR PREVENTION OR TREATMENT OF TRANSPLANT REJECTION -- .
Claim Objections
Claim 1 is objected to as the placement of the illustration of formula 1 should be before the period of claim 1. It is recommended to place the illustration of formula 1 after the phrase “represented by Chemical Formula I” within line 3 of the claim.
Claims 2-14 and 16 are similarly objected to as these claims refer back to claim 1 but do not remedy the rationale underpinning the basis for objecting to claim 1.
Claim 14 is objected to as it is missing a -- comprising -- . Revising to the following will help render moot the objection: -- A method for improving immunosuppression after transplantation comprising administering a composition comprising the compound or the pharmaceutically acceptable salt thereof of claim 1 as an active ingredient. --
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 4 and 16 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.
The claim 4 contains the word “includes”. This renders the metes and bounds of claim 4 undefined (hence rendering claim 4 indefinite under 35 USC 112(b)). The artisan does not know if the limitation(s) following “includes” are merely exemplary or are required limitations of the claim.
Claim 16 is rejected as indefinite under 35 USC 112(b) since the claim is drawn to a method of administering a compound to a subject. However, it is impossible to administer one (emphasis) compound (“a compound”). Medicinals are always administered as “pharmaceutical compositions comprising a compound”. The claim 16 is indefinite since it is unclear how to administer one compound to a subject.
It is recommended to cancel claim 16 since adding -- a pharmaceutical composition comprising a compound -- risks making claim 16 a duplicate of claim 1.
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.
Claim 1 is provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 1-14 of co-pending Application No. 17/794,823 (reference application). The reference amended claims of 18 November 2025 and the instant amended claims of 12 October 2023 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, a reference claim 14 drawn to “a method for preventing or treating transplant rejection or transplant rejection disease, comprising administering a pharmaceutical composition comprising a compound of formula 1:
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, or a pharmaceutically acceptable salt thereof”, anticipates instant claim 1, drawn to a method for treating a transplant rejection comprising administering a pharmaceutical composition comprising a compound of formula 1:
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, or a pharmaceutically acceptable salt thereof.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of obviousness-type nonstatutory double patenting as being unpatentable over claims 1-14 of co-pending Application No. 17/794,823 (reference application). The reference amended claims of 18 November 2025 and the instant amended claims of 12 October 2023 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims render obvious the instant claims. For example, reference claim 14, drawn to “a method for preventing or treating transplant rejection or transplant rejection disease, comprising administering a pharmaceutical composition comprising a compound of formula 1:
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, or a pharmaceutically acceptable salt thereof, teaches the instant claim 1, drawn to a method for treating a transplant rejection comprising administering a pharmaceutical composition comprising a compound of formula 1:
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, or a pharmaceutically acceptable salt thereof.
Moreover, reference claim 10, drawn to a pharmaceutical composition (with the intended use of) for treating transplantation rejection or transplantation rejection disease comprising the compound of reference claim 1:
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, teaches a method of use of said compound to treat transplantation rejection, according to instant claim 1. The intended use of reference claim 10, and the method of reference claim 14, provide the motivation to use said reference claims’ 1 and 10 compound in a method to treat transplantation rejection (thus teaching instant claim 1).
From that, it follows that reference claim 11, defining the transplantation rejection as one of an alternative list selected from the group consisting of cells, blood, tissues, and organs, teaches instant claim 2, drawn to same.
From that, reference claim 12, teaches instant claim 3.
From that the GVHD of reference claim 13 teaches instant claim 4, drawn to same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-4 are provisionally rejected on the ground of anticipatory nonstatutory double patenting as being unpatentable over claims 5-8 of co-pending Application No. 19/688,477 (reference application). The reference original claims of 26 May 2026 and the instant amended claims of 12 October 2023 were used to write this rejection.
Although the claims at issue are not identical, they are not patentably distinct from each other because the reference claims anticipate the instant claims. For example, a reference claim 5 drawn to “a method for preventing or treating transplant rejection or transplant rejection disease, comprising administering a pharmaceutical composition comprising a compound of formula 1:
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, or a pharmaceutically acceptable salt thereof”, anticipates instant claim 1, drawn to a method for treating a transplant rejection comprising administering a pharmaceutical composition comprising a compound of formula 1:
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, or a pharmaceutically acceptable salt thereof.
Reference claim 6, defining the transplantation rejection as one of an alternative list selected from the group consisting of cells, blood, tissues, and organs, teaches instant claim 2, drawn to same.
Reference claim 7 anticipates instant claim 3.
The GVHD of reference claim 8 anticipates instant claim 4, drawn to same.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
Claims 5-14 are objected to for various informalities (see “Claim Objections” section, above).
Claims 1-4 and 16 are not presently allowable as written.
Claim 1 is free of the prior art.
There is no known prior art reference that either teaches or anticipates use of the instant claim 1 compound to treat transplant rejection, according to the instant claims.
The reference YANG (WO 2021149971 A1, Applicant-provided reference and included in IDS of 12 October 2023), discloses the compound:
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(para [23]), and its use to treat transplant rejection (paragraph [28]).
However, YANG cannot be a 35 USC 102(a)(1) or 35 USC 102(a)(2) reference since it is not 1) by another and 2) it is published within the grace period (April 5, 2021-April 6, 2022).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOHN S KENYON whose telephone number is (571)270-1567. The examiner can normally be reached Monday-Friday 10a-6p.
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 D 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.
/JOHN S KENYON/Primary Patent Examiner, Art Unit 1625
Prosecution Insights