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 .
Response to Election/Restriction filed on September 18, 2025 is acknowledged.
Claims 31-54 are pending in this application.
Applicant has not filed a Power of Attorney (POA) for this application. Applicant is required to file a POA in response to this office action.
Information Disclosure Statement
5. It is noted that Applicant has not filed an information disclosure statementunder § 1.97(c). Applicant is reminded of 37 CFR § 1.56, which details Applicant’s dutyto disclose all information known to be material to patentability.
Restriction
6. Applicant’s election without traverse of Group 1 (claims 31-53) and elected plitidepsin as the species of a fully defined compound of formula I, and rheumatoid arthritis as the species of an autoimmune condition in the reply filed on September 18, 2025 is acknowledged. Restriction is deemed to be proper and is made FINAL in this office action. Claim 54 is withdrawn from consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected invention, there being no allowable generic or linking claim. Applicant indicates claims 31-38, 40-41, 44, 46, 48, 50 and 52 read on the elected species. A search was conducted on the elected species, and prior art was found. Claims 39, 42-43, 45, 47, 49 and 51 are withdrawn from further consideration as being drawn to nonelected species. During the search, a prior art was found on the nonelected species, Didemnin B, thus, claim 53 is rejoined herein. Claims 31-38, 40-41, 44, 46, 48, 50 and 52-53 are examined on the merits in this office action.
Objections
7. The abstract is objected to for the following minor informality:
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words. It is important that the abstract not exceed 150 words in length since the space provided for the abstract on the computer tape used by the printer is limited. The form and legal phraseology often used in patent claims, such as "means" and "said," should be avoided. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, "The disclosure concerns," "The disclosure defined by this invention," "The disclosure describes," etc.
In the instant case, the abstract recites, “The present invention relates to the use of compounds...” at line 1 of the abstract. Applicant should correct these informalities. See MPEP 608.01(b). For example, the abstract is recommended to be amended to recite, “Compounds for the treatment of autoimmune conditions…are described.”
8. The drawings are objected to because the Y axis label is missing from FIG. 7a, 7b and 7c. Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Please note, the specification has not been checked to the extent necessary to determine the presence of all possible error. Applicant's cooperation is required in correcting any errors of which applicant may become aware in the specification. MPEP § 608.01.
9. Claim 40 is objected to for the following minor informality: claim 40 recites, “A The method of claim 1…” Applicant is required to delete the article “A” from the preamble of the claim.
10. Claim 52 is objected to for the following minor informality: claim 52 contains the acronym “PLD”, and an acronym in the first instance of claims should be expanded upon/spelled out with the acronym indicated in parentheses, i.e., Plitidepsin (PLD). The abbreviations can be used thereafter.
Rejections
U.S.C. 112(b)
11. 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.
12. Claims 32-38, 40-41, 44, 46, 48, 50 and 52-53 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.
13. Claims 32-38, 40-41, 44, 46, 48, 50 and 52-53 depend from cancelled claim 1, therefore the metes and bounds of the claims are unclear. Claims cannot depend from a cancelled claim.
14. Regarding claim 36, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
15. Regarding claim 38, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
16. Regarding claim 40, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
17. Regarding claim 41, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
18. Regarding claim 46, the phrase "preferably" renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
U.S.C. 102
19. 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.
20. 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)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(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.
21. Claim(s) 31 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Rinehart et al (US Patent No. 6156724).
22. Rinehart et al teach a compound of instant formula I
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(see Didemnin B). Rinehart et al teach treating rheumatoid arthritis with the compound Didemnin B (see column 4, lines 50-60, for example; claims 1-2), meeting the limitation of instant claim 31. Since Rinehart et al teach all of the active method steps, i.e., the same patient population and the same compound, Rinehart et al anticipates instant claim 31.
23. Claim(s) 31 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Nixon et al (US 2019/0192682) or Nixon et al (US 2019/0328901) as evidenced by Trinidad-Calderon et al (Molecules, 2023, 28(670): 1-30).
24. Nixon et al teach “additional cytotoxins that can be conjugated to antibodies, antigen-binding fragments thereof, and ligands that recognize and bind CD45…for use in directly treating cancer, autoimmune condition, or for conditioning a patient…dehydrodidemnin B…” (see paragraph [0579] for ‘682 and paragraph [0577] for ‘’901). As evidenced by Trinidad-Calderon et al., dehydrodidemnin B is commonly known as plitidepsin (the elected species)…dehydrodidemnin B is recognized as a part of the latest generation of didemnins, which exert no toxicity while exhibiting enhanced therapeutic and cancer-targeting effects compared with didemnin B (see p. 5, “2.1.5. Dehydrodidemnin B”). Since Nixon et al teach that the plitidepsin compound can be conjugated to antibodies, antigen-binding fragments thereof, and ligands for use in directly treating cancer, autoimmune conditions, Nixon et al as evidenced by Trinidad-Calderon et al., teach all of the active method steps, meeting the limitation of instant claim 31.
U.S.C. 103
25. 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.
26. 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.
27. 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.
28. 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.
29. Claim(s) 31 is/are rejected under 35 U.S.C. 103 as being unpatentable over Rinehart et al (US Patent No. 6156724) in view of Nixon et al (US 2019/0192682) or Nixon et al (US 2019/0328901) as evidenced by Trinidad-Calderon et al (Molecules, 2023, 28(670): 1-30).
30. Rinehart et al teach a compound of instant formula I
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(see Didemnin B). Rinehart et al teach treating rheumatoid arthritis with the compound Didemnin B (see column 4, lines 50-60, for example; claims 1-2), meeting the limitation of instant claim 31. Since Rinehart et al teach all of the active method steps, i.e., the same patient population and the same compound, Rinehart et al anticipates instant claim 31. The difference between the reference and instant claim is that the reference does not teach the elected species, Plitidepsin.
31. However, Nixon et al teach “additional cytotoxins that can be conjugated to antibodies, antigen-binding fragments thereof, and ligands that recognize and bind CD45…for use in directly treating cancer, autoimmune condition, or for conditioning a patient…dehydrodidemnin B…” (see paragraph [0579] for ‘682 and paragraph [0577 for ‘’901). As evidenced by Trinidad-Calderon et al., dehydrodidemnin B is commonly known as plitidepsin (the elected species)…dehydrodidemnin B is recognized as a part of the latest generation of didemnins, which exert no toxicity while exhibiting enhanced therapeutic and cancer-targeting effects compared with didemnin B (see p. 5, “2.1.5. Dehydrodidemnin B”).
32. Therefore, it would have been obvious to one of ordinary skill in the art to combine the teachings of Rinehart et al and Nixon et al, as evidenced by Trinidad-Calderon et al., since the references all teach method of treating autoimmune diseases. One of ordinary skill in the art would be motivated to combine with a reasonable expectation of success, since Nixon et al teach that dehydrodidemnin B (additional cytotoxins) that can be conjugated to antibodies, antigen-binding fragments thereof, and ligands that recognize and bind CD45…for use in directly treating cancer, autoimmune condition, and as evidenced by Trinidad-Calderon et al teach that dehydrodidemnin B is commonly known as plitidepsin (the elected species). Additionally, Trinidad-Calderon et al teach that dehydrodidemnin B is recognized as a part of the latest generation of didemnins. Therefore, one of ordinary skill in the art would be motivated to try since dehydrodidemnin B (plitidepsin) is the latest generation of didemnins. Thus, one of ordinary skill in art would have a reasonable expectation that plitidepsin (dehydrodidemnin B) that is used to treat autoimmune disease would be successful in treating a species of an autoimmune diseases, i.e., rheumatoid arthritis. Therefore, the combined art is prima facie obvious over instant claim 31.
CONCLUSION
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JULIE HA whose telephone number is (571)272-5982. The examiner can normally be reached Monday-Thursday 5:00 am- 6:30 pm EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LIANKO GARYU can be reached at 571-270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JULIE HA/Primary Examiner, Art Unit 1654
12/03/2025