Detailed Action
The present office action is in response to the reply filed on 29 Dec 2025.
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
Claims 1-4 and 9-11 of the pending application have been examined on the merits. Claims 5-8 are withdrawn (see “Response to Applicant Election” below).
Priority
Applicants identify the instant application, Serial #: 18/014,830, filed 06 Jan 2023, as a National Stage Entry of International Patent Application #: PCT/JP2020/026826, filed 09 Jul 2020.
Information Disclosure Statement
The information disclosure statement(s) (IDS) submitted on 06 Jan 2023, 21 Feb 2024, and 24 Apr 2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Response to Applicant Election
Applicant’s election with traverse of Group I, claims 1-4 and 9-11, in the reply filed on 18 Dec 2025 is acknowledged. Applicant filed a supplemental response on 29 Dec 2025 withdrawing the traversal of the election. The election is thus treated as an election without traverse.
Claims 5-8 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 29 Dec 2025.
Claim Interpretation
Claim 1 states, “A combined pharmaceutical preparation for treating a terminal non-small cell lung cancer patient or terminal non-small cell lung cancer patient with brain metastasis…” The phrase “for treating a terminal non-small cell lung cancer patient or terminal non-small cell lung cancer patient with brain metastasis” is construed as an intended use and is of no significance to the claim construction.
Claim Warning
Applicant is advised that should claim 4 be found allowable, claim 9 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. Applicant is further advised that should claim 11 be found allowable, claim 10 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(b)
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.
Claim 4 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.
Regarding claim 4, the phrase "such as" 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).
Claim Rejections - 35 USC § 112(d)
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 2 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 2 adds limitations to the preamble phrase “for treating a terminal non-small cell lung cancer patient or terminal non-small cell lung cancer patient with brain metastasis.” However, because that preamble phrase is not significant to the claim construction and does not add meaningful limitations to the independent claim (see above), claim 2 does not add any substantial limitations to claim 1. 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.
Claim(s) 1-4 and 9-11 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by U.S. 10,293,019, hereinafter ‘019.
The instant claims are drawn to a combined pharmaceutical preparation comprising ubenimex (10 mg/day) and afatinib (20 mg/day) (claims 1 and 2). The claims further limit the preparation to a kit or combined preparation (claim 3) in an oral administration form (claims 4 and 9) where the oral administration form is a capsule, tablet, or granule (claims 10 and 11).
'019 teaches treating a patient with a composition of Bestatin (10 mg/day) and Giotrif (20 mg/day) (column 13, lines 34-53). '019 identifies Bestatin as the tradename of ubenimex (column 5, lines 19-24) and further identifies Giotrif as the tradename of afatinib (column 7, lines 18-19). '019 teaches that a combination product can comprise a pharmaceutical composition of ubenimex and another anticancer agent and may be distributed in the form of a single package in a form suitable for combination administration of the ubenimex and another anticancer agent (column 7, lines 26-40). '019 teaches that dosage forms suitable for oral administration include tablets, pills, capsules, and granules (column 6, lines 22-34). Thus ‘019 anticipates the instant claims.
Conclusion
No claim is allowed.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Jonathan D. Mahlum whose telephone number is (703)756-4691. The examiner can normally be reached 8:30 AM - 5:00 PM ET, M-F.
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/J.D.M./Examiner, Art Unit 1625 /Andrew D Kosar/Supervisory Patent Examiner, Art Unit 1625