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 .
Applicant’s cancellation of claim 14, amendment of claims 1, 6, and 15, in the paper of 3/4/2026, is acknowledged. Claims 1-13, 15-17 are still at issue and are present for examination.
Election/Restrictions
Applicant's election with traverse of the invention of the following species:
Species Group 1: R040A/T.
Species Group 2: PEV304, i.e.: R40A-T64V-S70E-T117L-T177N-I178L-F180P-Y182A-R190L-S205G-F207T-S212D- F226L-A236P-Y239I-L249P-S252I-E254Q-L258F.
Species Group 3: improved stability.
Species Group 4: polyethylene terephthalate (PET).
Species Group 5: cellulase.
in the paper of 3/24/2026, is acknowledged.
Applicant’s election of the above species in the reply filed on 3/24/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Information Disclosure Statement
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609 A(1) states, "the list may not be incorporated into the specification but must be submitted in a separate paper."
There are currently no information disclosure statements in the application file.
Claim Objections
Claims 8, 13, 15 and 16 are objected to because of the following informalities:
Claim 13 recites “comprises at least at least one additional enzyme” which should be “comprises at least one additional enzyme”.
Claims 8, 15 and 16 recite “a variant lipolytic enzyme” which for consistency should be “the variant lipolytic enzyme”.
Appropriate correction and/or comment is required.
Specification
The disclosure is objected to because of the following informalities:
The use of the terms: Triton (page 24, line 4), TWEEN (page 24) which is a trade name or a mark used in commerce, has been noted in this application. The term should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 7 are 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.
Claim 7 is indefinite in the recitation “The lipolytic enzyme of claim 1, wherein the variant has” in that there is not literal antecedent basis for “The lipolytic enzyme” and “the variant” in claim 1. It is suggested that the recitation be amended to ““The variant lipolytic enzyme of claim 1, wherein the variant lipolytic enzyme has”.
Appropriate correction and/or comment is required.
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.
Claim(s) 1-13, 15-17 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
Claim(s) 1-13, 15-17 are directed to all possible variant lipolytic enzymes comprising an amino acid sequence having a mere 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-1178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution ofany identifying structural characteristics or properties, for which no predictability of structure is apparent.
Regarding the level of skill and knowledge in the art of amino acid mutation, the reference of Singh et al. (Curr. Protein Pept. Sci. 18:1-11, 2017; cited on the attached Form PTO-892) reviews various protein engineering methods and discloses that despite the availability of an ever-growing database of protein structures and highly sophisticated computational algorithms, protein engineering is still limited by the incomplete understanding of protein functions, folding, flexibility, and conformational changes (see p. 7, column 1, top). Also, the unpredictability associated with amino acid mutations is exemplified by the reference of Zhang et al. (Structure 26:1474-1485, 2018; cited on the attached Form PTO-892), which discloses that even a mutation of a surface residue that was predicted to be benign caused significant structural changes and unexpected effects on the function of a polypeptide (p. 1475, column 1).
Given this lack of additional representative species as encompassed by the claims, Applicants have failed to sufficiently describe the claimed invention, in such full, clear, concise, and exact terms that a skilled artisan would recognize Applicants were in possession of the claimed invention.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
Claim(s) 1-13, 15-17 are rejected under 35 U.S.C. 112, first paragraph, because the specification, while being enabling for that variant lipolytic enzymes comprising an amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-1178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution of, does not reasonably provide enablement for all possible variant lipolytic enzymes comprising an amino acid sequence having a mere 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-1178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution of. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
Factors to be considered in determining whether undue experimentation is required, are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir. 1988)) as follows: (1) the quantity of experimentation necessary, (2) the amount of direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claim(s).
Claim(s) 1-13, 15-17 are so broad as to encompass all possible variant lipolytic enzymes comprising an amino acid sequence having a mere 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-1178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution ofT064V-T117L-T177N/R-1178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution of
While recombinant and mutagenesis techniques are known, it is not routine in the art to screen for multiple substitutions or multiple modifications, as encompassed by the instant claims, and the positions within a protein's sequence where amino acid modifications can be made with a reasonable expectation of success in obtaining the desired activity/utility are limited in any protein and the result of such modifications is unpredictable. In addition, one skilled in the art would expect any tolerance to modification for a given protein to diminish with each further and additional modification, e.g. multiple substitutions.
The specification does not support the broad scope of the claims which encompass any possible variant lipolytic enzyme comprising an amino acid sequence having a mere 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-1178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution ofthe specification does not establish: (A) regions of the variant lipolytic enzymes which may be modified effecting the esterase activity; (B) the general tolerance of enzymes of the esterase group to modification and extent of such tolerance; (C) a rational and predictable scheme for modifying any amino acid residue of an enzyme of the esterase group with an expectation of obtaining the desired biological function; and (D) the specification provides insufficient guidance as to which of the essentially infinite possible choices is likely to be successful. Because of this lack of guidance, the extended experimentation that would be required to determine which substitutions would be acceptable to retain the required esterase activities and the fact that the relationship between the sequence of a peptide and its tertiary structure (i.e. its activity) are not well understood and are not predictable (e.g., see Ngo et al. in The Protein Folding Problem and Tertiary Structure Prediction, 1994, Merz et al. (ed.), Birkhauser, Boston, MA, pp. 433 and 492-495; Franceus et al., J. Ind. Microbiol. Biotechnol. Vol 44, pp 687-695, 2017), it would require undue experimentation for one skilled in the art to arrive at the majority of those variant lipolytic enzymes of the claimed genus.
Thus, applicants have not provided sufficient guidance to enable one of ordinary skill in the art to make and use the claimed invention in a manner reasonably correlated with the scope of the claims broadly including any variant lipolytic enzymes comprising an amino acid sequence having a mere 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-1178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution ofthe variant has esterase activity, polynucleotides encoding said variant lipolytic enzyme and methods of use of said variant lipolytic enzyme, polynucleotides encoding and methods of use. The scope of the claims must bear a reasonable correlation with the scope of enablement (In re Fisher, 166 USPQ 19 24 (CCPA 1970)). Without sufficient guidance, determination of those variant lipolytic enzymes having the desired biological characteristics is unpredictable and the experimentation left to those skilled in the art is unnecessarily, and improperly, extensive and undue. See In re Wands 858 F.2d 731, 8 USPQ2nd 1400 (Fed. Cir, 1988).
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1-13, 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of copending Application No. 18/571,886 (reference application).. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-16 of copending Application No. 18/571,886 (reference application) drawn to a cleaning composition, comprising
at least one variant lipolytic enzyme, wherein said variant lipolytic enzyme comprises an amino acid sequence having at least 70% identity to the full length amino acid sequence of SEQ ID NO:2, comprising the substitutions T064V-T117L-T177N/R-I178L-F180P-Y182A-R190L-S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution selected from the group consisting of V014S, R040A/T, G059Y, G061D, A066D, S070E, Q161H, G175A/E, F207L/T, V210I, Q227H, A236P, S244E, E254Q, and R256K, wherein the positions are numbered by reference to the amino acid sequence of SEQ ID NO:2, and wherein the variant has polyesterase activity anticipate/make obvious instant claims 1-13, 15-17 drawn to variant lipolytic enzyme comprising an amino acid sequence having at least 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-I178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution of RO40A/T, wherein the positions are numbered by reference to the amino acid sequence of SEQ ID NO: 2, and wherein the variant has esterase activity and methods of use of said variant lipolytic enzyme.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of copending Application No. 18/571,882 (reference application).. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-19 of copending Application No. 18/571,882 (reference application) drawn to a cleaning or fabric conditioning composition, comprising (a) at least one variant lipolytic enzyme, wherein said variant lipolytic enzyme comprises an amino acid sequence having at least 70% identity to the full length amino acid sequence of SEQ ID NO:2, comprising the substitutions T064V-T117L-T177N/R-I178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution selected from the group consisting of V014S, R040A/T, G059Y, G061 D, A066D, S070E, Q161 H, G175A/E, F207L/T, V210I, Q227H, A236P, S244E, E254Q, and R256K, wherein the positions are numbered by reference to the amino acid sequence of SEQ ID NO:2, and wherein the variant has esterase activity; and (b) at least one additional ingredient selected from the group consisting of performance polymers, complexing agents, surfactants, and combinations thereof. anticipate/make obvious instant claims 1-13, 15-17 drawn to variant lipolytic enzyme comprising an amino acid sequence having at least 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-I178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution of RO40A/T, wherein the positions are numbered by reference to the amino acid sequence of SEQ ID NO: 2, and wherein the variant has esterase activity and methods of use of said variant lipolytic enzyme.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-13, 15-17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of copending Application No. 18/571,816 (reference application).. Although the claims at issue are not identical, they are not patentably distinct from each other because claims 1-15 of copending Application No. 18/571,816 (reference application) drawn to a cleaning composition comprising (a) a variant lipolytic enzyme, wherein said variant lipolytic enzyme comprises an amino acid sequence having at least 70% identity to the full length amino acid sequence of SEQ ID NO:2, comprising the substitutions T064V-T117L-T177N/R-I178L-F180P-Y182A-R190L-S205G- S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution selected from the group consisting of V014S, R040A/T, G059Y, G061 D, A066D, S070E, Q161 H, G175A/E, F207L/T, V210I, Q227H, A236P, S244E, E254Q, and R256K, wherein the positions are numbered by reference to the amino acid sequence of SEQ ID NO:2, and wherein the variant has polyesterase activity; (b) at least one surfactant, preferably in an amount of 2 to 30 wt.%, more preferably 4 to 20 wt.%; (c) optionally at least one further enzyme, preferably in an amount of 0.001 to 1 wt.%, more preferably 0.005 to 0.5 wt.%; (d) optionally at least one performance polymer, preferably in an amount of 0.05 to 5 wt.%, more preferably 0.05 to 0.5 wt.%; and (e) optionally at least one organic solvent, preferably in an amount of 0.1 to 10 wt.%, more preferably 0.1 to 5 wt.% anticipate/make obvious instant claims 1-13, 15-17 drawn to variant lipolytic enzyme comprising an amino acid sequence having at least 70% identity to the full length amino acid sequence of SEQ ID NO: 2, comprising the substitutions T064V-T117L-T177N/R-I178L-F180P-Y182A-R190L- S205G-S212D-F226L-Y239I-L249P-S252I-L258F, and further comprising at least one additional substitution of RO40A/T, wherein the positions are numbered by reference to the amino acid sequence of SEQ ID NO: 2, and wherein the variant has esterase activity and methods of use of said variant lipolytic enzyme.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Closest Prior Art.
WO 03/076580 teaches site saturation mutagenesis of Pseudomonas mendocina lipase (Example 1) leading to variants with improved hydrolytic activity on polyester in poly(ethyleneterephthalate) fibers as compared to the wild type enzyme of SEQ ID NO:2.
WO 01/34899 teach assays of hydrolytic activity of P. mendocina lipase variants on long chain polyester polymer fibers or diethyl terephthalate; Examples 1A-C).
Remarks
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to RICHARD G HUTSON whose telephone number is (571)272-0930. The examiner can normally be reached 6-3 EST Mon-Fri.
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, Robert Mondesi can be reached at (408) 918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
rgh
5/22/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
Prosecution Insights