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 with traverse of the invention of Group I, claims 33-53, 55, and 58, and the species of D204C/E253C in the reply filed on 08/27/2025 is acknowledged. The traversal is on the ground(s) that claim 57 has been amended to recite only subject matter that falls within Group I. This argument is found persuasive in light of the amendment of 08/27/2025.
The requirement is still deemed proper and is therefore made FINAL.
Claim Status
The amendment of 08/27/2025 has been entered. Claims 33-58 are pending in this US patent application. Claims 54 and 56 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, and claims 38, 49, 50, and 52-53 are withdrawn as being directed to nonelected species, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 08/27/2025.
Claims 33-37, 39-48, 51, 55, and 57-58 are currently under examination and were examined on their merits.
Information Disclosure Statement
The information disclosure statements filed in this application on 04/27/2023 and 01/08/2024 have been received and considered.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 33-37, 39-48, 51, 55, and 57-58 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are drawn to esterases having at least 80% identity to the sequence of SEQ ID NO.: 1 that further include at least one of a wide range of specific amino acid substitutions in a large number of positions in the protein sequence. Given that SEQ ID NO.: 1 is 261 amino acids long, the claims encompass proteins with as many as 52 amino acids altered in comparison with the sequence of SEQ ID NO.: 1. The claims also recite that the claimed esterases have polyester degrading activity and exhibit an increased thermostability and/or increased degrading activity compared to the esterase of SEQ ID NO.: 1. No correlation between the structure of SEQ ID NO.: 1 and the recited functional characteristics is disclosed. Applicant’s specification has listed four variants that exhibit the recited functional characteristics (see Tables 1-4 on pages 31-36 of the instant specification as filed). However, Applicant’s claimed genus of proteins is vastly larger than four, potentially encompassing any variant of SEQ ID NO.: 1 that has anywhere from 1-52 amino acids mutated to any other amino acid, which is a group containing many thousands of amino acid sequences. In light of the large number of potential sequences and the lack of disclosure of structural characteristics that lead to the sequences having the recited functional characteristics, along with the disclosure of only four sequences that actually exhibit the recited functional characteristics, the Examiner has determined that Applicant has not demonstrated possession of the entire genus recited in instant claim 33.
Therefore, claims 33-37, 39-48, 51, 55, and 57-58 are rejected under 35 U.S.C. 112, first paragraph, as failing to meet the written description requirement.
Election/Restrictions
Applicant’s elected species of an esterase of SEQ ID NO.: 1 with D204C/E253C mutations is free of the prior art. The closest prior art to the claimed invention is found in the teachings of Degering, discussed below. However, this reference does not teach the specific D204C/E253C variant or the improved properties displayed by this variant as shown in Tables 1-4 of the instant specification. As such, the Examiner has selected another esterase that falls within the scope of instant claim 33, a protein of SEQ ID NO.: 1 with an L90I mutation, for examination with respect to the prior art. In light of the Examiner’s selection, claims 35-50 are withdrawn from examination at this time as being directed to nonelected species. Claims 33-34, 51, 55, and 57-58 are currently under examination with respect to the prior art.
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 33-34, 51, 55, and 57-58 are rejected under 35 U.S.C. 103 as being unpatentable over US patent application 2015/0290840 filed by Boisart et al., published 10/15/2015, in view of UniProt accession no. H6WX58, published 04/18/2012 (cited on the IDS filed 04/27/2023; hereafter ‘UniProt’), and international patent application publication WO 2019/168811 filed by Beckham et al., published 09/06/2019 (cited on the IDS filed 04/27/2023).
Boisart teaches degrading plastic materials with enzymes, including degrading polylactic acid-containing plastics with esterase from Thermobifida halotolerans (see entire document, including paragraphs 0053-0055; cf. claims 33, 55, and 57; the Examiner notes that instant SEQ ID NO.: 1 is an esterase from Thermobifida halotolerans and that polylactic acid is a polyester). A surfactant such as Tween may be added to the reaction mixture with the plastic and the enzyme (paragraph 0074; cf. claim 58). The enzymes may be modified to improve stability or activity (paragraph 0058; cf. claims 33 and 51).
However, Boisart does not teach that the Thermobifida halotolerans enzyme has the sequence of instant SEQ ID NO.: 1 or the L90I mutation.
UniProt teaches that SEQ ID NO.: 1 is an esterase from Thermobifida halotolerans (see entire document, including page 1).
Beckham teaches the use of enzymes to degrade polymers (see entire document, including page 2, lines 17-18). The enzymes may be at least about 70% identical to the sequences in Beckham’s application (page 12, lines 15-18; cf. claims 33-34; the Examiner notes that Beckham’s SEQ ID NO.: 24 is 78.2% identical to instant SEQ ID NO.: 1). The polypeptides may contain one or more variant residues, including conservative substitutions, such as the replacement of leucine with isoleucine (page 12, lines 3-10; cf. claims 33-34).
While Boisart does not teach that the Thermobifida halotolerans enzyme has the sequence of instant SEQ ID NO.: 1, it would have been obvious to one of ordinary skill in the art in view of Boisart to use any esterase from Thermobifida halotolerans in Boisart’s method, including the Thermobifida halotolerans esterase of UniProt. While Boisart and UniProt do not teach the inclusion of an L90I mutation in the sequence of the esterase enzyme used to degrade polylactic acid-containing materials, it would have been obvious to one of ordinary skill in the art to do so because Beckham teaches that leucines can be conservatively substituted with isoleucine in enzymes used to degrade polymers. One of ordinary skill in the art would have a reasonable expectation that substituting any leucine residue in the esterase used in the method rendered obvious by Boisart and UniProt, including L90, with isoleucine would successfully result in the production of an esterase that is capable of performing the PLA degrading functions taught by Boisart.
Therefore, claims 33-34, 51, 55, and 57-58 are rendered obvious by Boisart in view of UniProt and Beckham and are rejected under 35 U.S.C. 103.
The Supreme Court has acknowledged:
When a work is available in one field of endeavor, design incentives and other market forces can prompt variations of it, either in the same field or a different one. If a person of ordinary skill can implement a predictable variation…103 likely bars its patentability…if a technique has been used to improve one device, and a person of ordinary skill in the art would recognize that it would improve similar devices in the same way, using the technique is obvious unless its actual application is beyond that person’s skill. A court must ask whether the improvement is more than the predictable use of prior-art elements according to their established functions……the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results (see KSR International Co. v. Teleflex Inc., 82 USPQ2d 1385 U.S. 2007) (emphasis added).
From the teachings of the references, it is apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Erin M. Bowers, whose telephone number is (571)272-2897. The examiner can normally be reached Monday-Friday, 7:30-5:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sharmila Landau, can be reached at (571)272-0614. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Erin M. Bowers/Primary Examiner, Art Unit 1653 12/31/2025