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 .
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-5 and 16-20) and amino acid sequence of SEQ ID NO: 2 in the reply filed on 8/18/2026 is acknowledged.
The requirement is still deemed proper and is therefore made FINAL.
Status of Application, Amendments, And/Or Claims
Claims 1-20 are pending.
Claims 6-15 are withdrawn for being drawn to non-elected inventions (i.e., Groups II-IV).
Claims 1-5 and 16-20 are under examination to the extent they read elected species (i.e., SEQ ID NO: 2).
Information Disclosure Statement
The Information Disclosure Statement filed on 9/14/2026 has been considered. The crossed-out reference #3 is duplicate of reference #2.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Claim Rejections - 35 USC § 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-5 and 16-20 are rejected under 35 U.S.C. 101 because the claimed invention is directed to non-statutory subject matter. The claim(s) does/do not fall within at least one of the four categories of patent eligible subject matter because the instantly claimed recombinant protein (Lipocalin) comprising amino acid sequence of SEQ ID NO: 2 (claims 1-5) and a drug comprising Lipocalin protein comprising amino acid sequence of SEQ ID NO: 2 of claim 1 is a product of nature. The claimed lipocalin of SEQ ID NO: 2 is disclosed by Pan H. Sun E and Zhang Y. (see "Characteristic and Complete Genome Sequencing of A Novel Member of Infective Endocarditis Causative Bacteria: Bergeyella cardium QL-PH.";
Submitted (APR-2018) to the EMBL/GenBank/DDBJ databases).
It is noted to applicant that claims 1-5 and 16-20 are drawn to a product with an intended use for cell death.
Claim Rejections - 35 USC § 102/103
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 –
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.
Claim(s) 1-5 and 16-20 is/are rejected under 35 U.S.C. 102(a) (1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Pan et al. (submitted (Apr 2018) and integrated 07-Oct -2020).
The instantly claimed invention is broadly drawn to a recombinant protein (Lipocalin) having amino acid sequence of SEQ ID NO:2 for inducing cell death, wherein a cell is selected from the group consisting of tumor cell or a normal immune cell, wherein the cell death comprises vacuolization cell death, or a drug comprising the recombinant protein according to claims 1-5.
Pan et al. teach that the instantly claimed Lipocalin is 100% identical to the amino acid sequence of PS51257 (proteomes: UP000463318) (see sequence alignment below).
Search Result 20261007_us-18-412-867-2.rag
RESULT 1
A0A6P1QX68_9FLAO
ID A0A6P1QX68_9FLAO Unreviewed; 156 AA.
AC A0A6P1QX68;
DT 07-OCT-2020, integrated into UniProtKB/TrEMBL.
DT 07-OCT-2020, sequence version 1.
DT 02-APR-2025, entry version 10.
DE SubName: Full=Uncharacterized protein {ECO:0000313|EMBL:QHN65593.1};
GN ORFNames=DBX24_06710 {ECO:0000313|EMBL:QHN65593.1};
OS Bergeyella cardium.
OC Bacteria; Pseudomonadati; Bacteroidota; Flavobacteriia; Flavobacteriales;
PNG
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926
834
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Greyscale
Therefore, the instantly claimed invention is implicitly or explicitly anticipated by the prior art of record.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to GYAN CHANDRA whose telephone number is (571)272-2922. The examiner can normally be reached Mon-Friday 8:30AM-5:00P.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Vanessa Ford can be reached at 571-272-0857. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/GYAN CHANDRA/Primary Examiner, Art Unit 1674
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