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 .
Status of Claims
Claims 1-12 are pending and will be examined on the merits.
Priority
Acknowledgment is made of applicant’s claim for foreign priority under 35 U.S.C. 119 (a)-(d). The certified copy has been filed in parent Application No. PCT/JP2022/021320, filed on 05/25/2022. However, the certified copy is not in English, and therefore it cannot be determined if the foreign priority document discloses the invention as currently claimed. Therefore, the effective filing date of this application is 05/25/2022.
Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
Information Disclosure Statement
The Information Disclosure Statements filed on 12/13/2023, 1/2/2024, 8/5/2025, and 11/10/2025 have been considered. Signed copies are enclosed.
Claim Interpretation
Regarding claims 1, 4, 6, and 8, the recitation of “to be administered in combination with…” in the preamble of the claim is considered to be an intended use of the claimed invention and thus does not hold patentable weight. For more information, see MPEP 2111.02(II).
Claim Objections
Applicant is advised that should claims 1-3 be found allowable, claims 6-12 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
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 10-12 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.
Claim 10 is drawn to a medicament comprising ubenimex as an active ingredient, wherein the medicament is administered in combination with an immune checkpoint inhibitor to be used for treatment of a malignant tumor. The limitations of the claim that are drawn to the administration of the invention (a medicament) are a combination of products (ubenimex) and processes (administered in combination to, to be used for). A single claim cannot be drawn to both product and process, as the metes and bounds of the claim are unclear. See MPEP 2173.02 for more information. Appropriate correction is required.
Claims 11 and 12 inherit this rejection, as they are dependent on claim 10.
Claim 5 is 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.
Claim 5 is dependent on claim 4, which is drawn to an antitumor agent comprising an immune checkpoint inhibitor antibody as an active ingredient. Claim 5 is drawn to a dosage parameter of ubenimex, which is not a component of the anti-tumor agent of claim 4. It is unclear as to if the antitumor agent of claim 4 requires ubenimex, if claim 5 is simply limiting a dose that could be used in connection with the antitumor agent of claim 4, or another scenario. Appropriate correction is required.
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.
Claim 5 is 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. Claim 4, on which claim 5 is dependent, is drawn to an antitumor agent comprising an immune checkpoint inhibitor antibody as an active ingredient. Claim 5 is drawn to a dosage parameter of ubenimex, which is not a component of the anti-tumor agent of claim 4. 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 § 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)(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.
Claims 1-3 and 6-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Abe et al., Cancer Immunol Immunother 1989; 28(1):29-33.
Claim 1 is drawn to an antitumor agent comprising ubenimex as an active ingredient. Claims 2 and 3 further limit the dosage and the frequency of administration of the agent of claim 1. Claims 6, 8, and 10 are drawn to a medicament comprising ubenimex as an active ingredient, and claims 7, 9, and 11 are drawn to a dosage parameter of ubenimex. Claim 12 is drawn to the daily administration of the medicament of claim 10.
Abe et al. discuss the serum pharmacokinetics of bestatin. While Abe et al. does not use the word ubenimex, the instant specification discloses, in paragraph [0014], that bestatin is another name for ubenimex capsules and therefore bestatin and ubenimex are art recognized synonyms. Thus, Abe et al. disclose an antitumor agent comprising ubenimex as the active ingredient, meeting the limitations of claims 1, 6, 8, and 10. Moreover, Abe et al. thoroughly explains the pharmacokinetics of ubenimex, and shows the dosing administered reaches an AUC of over 10 ug●hr/mL (see figure 2). Finally, regarding the daily administration limitation of claims 3 and 12, Abe et al. recites in the abstract bestatin, or ubenimex, requires daily administration for therapeutic activity.
Therefore, Abe et al. anticipates instant claims 1-3 and 6-12.
Claims 4 and 5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by WO 2021/123202 A1, 2021, Sigl et al.
Claim 4 is drawn to an antitumor agent comprising an anti-PD1 antibody, an anti-PDL1 antibody, or an anti-CTLA4 antibody as an active ingredient. Sigl et al. disclose an pharmaceutical composition comprising an anti-PD1 antibody for use in the treatment of cancer (abstract, whole document). Furthermore, Sigl et al. disclose, on pg 14, that composition can further comprise ubenimex. Therefore, Sigl et al. anticipates instant claims 4 and 5.
Claims 4 and 5 are rejected under 35 U.S.C. 102(a)(1) and (a)(2) as being anticipated by Alt et al., WO 2018/204303.
Claim 4 is drawn to an antitumor agent comprising an anti-PD1 antibody, an anti-PDL1 antibody, or an anti-CTLA4 antibody as an active ingredient. Alt et al. disclose an antibody that specifically binds a PD1 polypeptide (paragraph [0005]), also referred to as an anti-PD1 antibody (abstract, whole document). Furthermore, Alt et al. disclose, on pg 47-48, that the method can further comprise administering ubenimex. Therefore, Alt et al. anticipates instant claims 4 and 5.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Sekine et al, Int J Cancer: 94, 485-491 (2001) – discloses a mechanism of action for ubenimex against cancer cells, wherein it has an augmenting effect on antibody action against cancer cells.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Amelia C Stephens whose telephone number is (571)272-1006. The examiner can normally be reached M-F 8-5 EST.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Daniel E Kolker can be reached at (571) 272-3181. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/AMELIA STEPHENS/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645