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 .
DETAILED ACTION
Applicant’s response filed on 05/11/2026 is duly acknowledged.
Claims 2-37 were previously canceled by applicants.
Claims 1 and 38-64 (as amended) are currently pending in this application.
Election/Restrictions
Applicant’s election without traverse of Group I (Claims 1, 38-45, 50, 51, 53, 61 and 62; directed to “An esterase variant…”) in the reply filed on 05/11/2026 (see REM, p.1) is duly acknowledged.
Claims 46-49, 52, 54-60, 63 and 64 (drawn to non-elected inventions of Groups II-IV) have been withdrawn from further considerations.
Claims 1, 38-45, 50, 51, 53, 61 and 62 (elected invention of Group I, without traverse; directed to “An esterase variant…”) have been examined on their merits in this office action hereinafter.
Priority
This application is a 371 of PCT/EP2022/082014 (filed on 11/15/2022), which claims foreign priority from an European application EP 21306589.9 (filed on 11/16/2021).
Objection to Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code (see page 7, 1st paragraph, line 15, for instance). Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01.
Appropriate correction is required.
NOTE: 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.
Claim Rejections - 35 USC § 103
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.
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.
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.
Claims 1, 38-45, 50, 51, 53, 61 and 62 (as amended/presented) are rejected under 35 U.S.C. 103 as being unpatentable over Duquesne et al (WO 2019/021118 A1; FOR cited in applicant’s IDS dated 05/16/2024).
Claim 1 (as amended) is reproduced hereinbelow:
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Duquesne et al (Jan. 2020) disclose an esterase enzyme 100% identical to the SEQ ID NO: 1 (see Duquesne et al, p. 2, lines 5-11; reference to G9BY57 in SwissProt; see also applicant’s instant specification, p. 2, lines 4-11, for instance); wherein (regarding instant Claim 1) they also disclose multiple variants of said esterase enzyme (wherein amino acid residue positions are numbered with reference to the same SEQ ID NO: 1), including comprising a variant S212T (disclosed as variant S212F/T/I/L; see Duquesne et al, p. 12, line 25; p. 50, claims 8-9, for instance); wherein said variant/substitution mutants show improved polyester polyethylene terephthalate (PET) degrading activity (see p. 39, Table 1, for instance) and thermostability (see p. 45, Table 3) at a broad pH ranges between pH 5 to 11 (see Duquesne et al, p. 23, lines 14-15, for instance).
Duquesne et al also disclose (regarding instant claims 38-39, 41-43 partially) various other variants of the esterase enzyme, including amino acid substitutions, and/or combinations thereof at positions S13 (Serine 13), D158 (Aspartic acid 158; see p. 12, last paragraph); F208 (Phenylalanine 208, such as F208I/W), D203 (Aspartate 203, such as D203C), S248 (such as S248C), and V170 (Valine 170, such as V170I; see p. 2, Summary of the Invention, lines 14-15; p. 10, lines 11-12, and last paragraph, for instance). Regarding instant claims 44-45, Duquesne et al disclose the esterase variant comprising at least one amino acid residue selected from S130, D175 or H207, and combination thereof, as in the esterase having the amino acid sequence as set forth in SEQ ID NO: 1 (see p. 10, lines 16-19, for instance).
Regarding instant claim 51, Duquesne et al disclose a nucleic acid encoding an esterase according to claim 1, an expression cassette or vector comprising said nucleic acid, or a host cell comprising said nucleic acid, expression cassette or vector (see section “Nucleic acids, expression cassette, vector, host cell” in its entirety starting on p. 23; and section “Production of esterase” starting on p. 27). They also disclose a composition (regarding instant claim 53) comprising an esterase variant according to instant claim 1 (see section “Composition” starting on p. 28). Regarding instant claim 61, Duquesne et al disclose a polyester containing material comprising at least one polyester (such as for degrading PET) and at least one esterase according to claim 1 (see p. 30, entire section of “Uses of esterase”, for instance). Regarding instant claim 62, Duquesne et al disclose a detergent composition comprising at least one esterase according to claim 1, used as an additive in order to reduce pilling and greying effects during textile cleaning (see p. 34, lines 24-27, for instance).
Although, Duquesne et al do not explicitly disclose the specific combination(s) of substitutions at positions as recited in instant claims 38, 39 and 41-43, given the detailed procedures and mutagenesis techniques disclosed, such combinations of mutations, with the same goal of increasing polyester degrading activity and/or thermostability of the same esterase enzyme, it would have been obvious to an artisan in the art to combine the mutations and screen them for better serving variant enzyme, with a reasonable expectation of success. Since, all the methods as well as genetic manipulation techniques required for making such mutant combinations at specific amino acid residues/positions have been already taught by the cited prior art reference using the same expression cassette/vector (such as pET26b-LCC-His; see Example 1 on p. 35, section “Construction”, for instance; see also applicant’s disclosure SPEC, p.55, Example 1, section “Construction”) and the same esterase enzyme, an artisan in the art would have fully contemplated screening for such combinations of desired variants for achieving the same goal of obtaining better, efficient version of the esterase mutants that can be effectively expressed and purified, and possess superior enzymatic activity in terms of degrading variety of polyester materials and are also more thermostable (such that they can be used in various applications disclosed, such as in detergent compositions, for instance), unless evidence/data provided on record to the contrary for the entire scope of the invention as currently claimed (see instant claims 1, 41-43, in particular). Therefore, the invention as generically claimed fails to distinguish itself over the teachings and/or suggestions from the cited prior art reference of Duquesne et al, as specifically discussed above. It is noted to applicants that the scope of the showing must be commensurate with the scope of claims to consider evidence probative of unexpected results, for example. In re Dill, 202 USPQ 805 (CCPA, 1979), In re Lindner 173 USPQ 356 (CCPA 1972), In re Hyson, 172 USPQ 399 (CCPA 1972), In re Boesch, 205 USPQ 215, (CCPA 1980), In re Grasselli, 218 USPQ 769 (Fed. Cir. 1983), In re Clemens, 206 USPQ 289 (CCPA 1980). It should be clear that the probative value of the data is not commensurate in scope with the degree of protection sought by the claim (see instant claims 1 and 41-43, in particular).
Thus, the claim as a whole would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date of the invention as currently claimed.
As per MPEP 2111.01, during examination, the claims must be interpreted as broadly as their terms reasonably allow. In re American Academy of Science Tech Center, F.3d, 2004 WL 1067528 (Fed. Cir. May 13, 2004)(The USPTO uses a different standard for construing claims than that used by district courts; during examination the USPTO must give claims their broadest reasonable interpretation.). This means that the words of the claim must be given their plain meaning unless applicant has provided a clear definition in the specification. In re Zletz, 893 F.2d 319, 321, 13 USPQ2d 1320, 1322 (Fed. Cir. 1989).
Conclusion
NO claims are currently allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to SATYENDRA K. SINGH whose telephone number is (571)272-8790. The examiner can normally be reached M-F 8:00- 5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, LOUISE W HUMPHREY can be reached at 571-272-5543. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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SATYENDRA K. SINGH
Primary Examiner
Art Unit 1657
/SATYENDRA K SINGH/Primary Examiner, Art Unit 1657
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