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 elected Group 1, without traverse, in the reply filed on 3/825/2026.
Claims 22-24, 28, and 31 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Accordingly, claims 1-5, 8-9, 11, 13, 16-19, 21, and 32 have been examined on the merits.
Priority
The instant application is a national stage entry of PCT/US2022/071562 filed on 4/05/2022, which claims priority benefit of U.S. Provisional Application No. 63/171429 filed on 4/06/2021 under 35 U.S.C. 119(e).
Foreign priority under 35 U.S.C. 119(a)-(d) is also claimed based on application JP2021-055393 filed in Japan on 3/29/2021. Certified copy of the foreign priority document has not been submitted. Should applicant desire to obtain the benefit of foreign priority under 35 U.S.C. 119(a)-(d) prior to declaration of an interference, a certified English translation of the foreign application must also be submitted in reply to this action. 37 CFR 41.154(b) and 41.202(e).
Information Disclosure Statement
The information disclosure statements (IDSs) submitted on 9/29/2023, 5/16/2025, and 4/09/2026 are in compliance with the provisions of 37 C.F.R. 1.97. All references cited in these IDSs have been fully considered.
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)(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.
The applied reference has a common assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claims 1-3, 9, 11, 13, 16, and 18 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Choi et al. (Pub. No. US 2021/0308237 A1).
Choi et al. discloses a recombinant L-asparaginase with no immunological cross-reactivity to E. coli-derived asparaginase, a pharmaceutical composition comprising the recombinant L-asparaginase, as well as a method of using said recombinant L-asparaginase for treatment of a disease treatable by asparagine depletion in a human subject (par. [0006]-[0007], [0256]).
In an embodiment, the recombinant L-asparaginase is not lyophilized (par. [0019]). In other embodiments, it is not conjugated with a PEG moiety, nor with a proline- or alanine-containing peptide (par. [0008], [0021]).
Choi et al. reads on the instant application as follows:
Regarding claim 1: the pharmaceutical composition being provided in the form of a solution and preferably not lyophilized is equivalent to “An aqueous, non-lyophilized formulation”.
The pharmaceutical composition containing recombinant L-asparaginase meets the requirement that the claimed formulation comprises “(i) an L-asparaginase”.
The embodiment of the recombinant L-asparaginase being a tetramer composed of four monomers is the same as “wherein the L-asparaginase comprises four monomer units”
Each of the four monomers comprising the amino acid sequence of SEQ ID NO: 1 (par. [0114]), which is 100% identical to applicant’s SEQ ID NO: 1 (see sequence-to-sequence alignment below), satisfies “wherein each monomer unit has an amino acid sequence that is at least about 70% identical to SEQ ID NO: 1”.
Query Match 100.0%; Score 1644; DB 1; Length 327;
Best Local Similarity 100.0%;
Matches 327; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ADKLPNIVILATGGTIAGSAATGTQTTGYKAGALGVDTLINAVPEVKKLANVKGEQFSNM 60
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Db 1 ADKLPNIVILATGGTIAGSAATGTQTTGYKAGALGVDTLINAVPEVKKLANVKGEQFSNM 60
Qy 61 ASENMTGDVVLKLSQRVNELLARDDVDGVVITHGTDTVEESAYFLHLTVKSDKPVVFVAA 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 ASENMTGDVVLKLSQRVNELLARDDVDGVVITHGTDTVEESAYFLHLTVKSDKPVVFVAA 120
Qy 121 MRPATAISADGPMNLLEAVRVAGDKQSRGRGVMVVLNDRIGSARYITKTNASTLDTFKAN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 MRPATAISADGPMNLLEAVRVAGDKQSRGRGVMVVLNDRIGSARYITKTNASTLDTFKAN 180
Qy 181 EEGYLGVIIGNRIYYQNRIDKLHTTRSVFDVRGLTSLPKVDILYGYQDDPEYLYDAAIQH 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 EEGYLGVIIGNRIYYQNRIDKLHTTRSVFDVRGLTSLPKVDILYGYQDDPEYLYDAAIQH 240
Qy 241 GVKGIVYAGMGAGSVSVRGIAGMRKAMEKGVVVIRSTRTGNGIVPPDEELPGLVSDSLNP 300
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Db 241 GVKGIVYAGMGAGSVSVRGIAGMRKAMEKGVVVIRSTRTGNGIVPPDEELPGLVSDSLNP 300
Qy 301 AHARILLMLALTRTSDPKVIQEYFHTY 327
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Db 301 AHARILLMLALTRTSDPKVIQEYFHTY 327
The pharmaceutical composition also comprising pharmaceutically acceptable carriers and/or excipients including sugars like sucrose and buffers like Hank’s solution (par. [0257]) corresponds to “(ii) one or more stabilizers, or one or more buffers, or any combination thereof”.
Regarding claim 2: trehalose is a disaccharide and therefore fulfills “wherein the one or more stabilizers comprise one or more disaccharides, one or more sorbitols, one or more amino acids, or any combination thereof”.
Regarding claim 3: trehalose is identical to “wherein the one or more disaccharides comprise trehalose…”.
Regarding claim 9: the recombinant L-asparaginase being not conjugated with a PEG moiety, nor with a proline- or alanine-containing peptide (par. [0008], [0021]) is the same as “wherein the L-asparaginase is non-PEGylated and non-PASylated”.
Regarding claims 11 and 13: an example of a suitable buffer is Hank’s solution, which contains sodium phosphate, thereby satisfying “wherein: a) the one or more buffers comprise a phosphate buffer, an acetate buffer, or any combination thereof; b) the one or more buffers are present at a concentration of between about 0.5 mM and 50 mM; or c) a combination thereof” and “wherein the one or more buffers comprise sodium phosphate”.
Regarding claim 16: the pharmaceutical solution can contain saline solution, which comprises sodium chloride and thus fulfills “wherein the formulation further comprises sodium chloride”.
Regarding claim 18: the pharmaceutical solution comprising excipients (par. [0257]) is akin to “wherein the formulation further comprises one or more excipients”
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MICHELLE F PAGUIO FRISING whose telephone number is (571)272-6224. The examiner can normally be reached Monday-Friday, 8:00 a.m. - 4:00 p.m..
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, Melenie L. Gordon can be reached at (571) 272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Michelle F. Paguio Frising/Primary Examiner, Art Unit 1651
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