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 amendment of claims 1, 7, 8, 13, 15 and 16, in the paper of 8/5/2026, is acknowledged. Applicants' arguments filed on 7/29/2026, have been fully considered and are deemed to be persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. 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)).
Claim Objections
Claims 4 is objected to because of the following informalities:
Claim 4 recites “R40T” and “R40A” whereas claim 1 from which claim 4 depends recites “R040A/T”. It is suggested that applicants maintain consistency throughout the specification and claims (i.e. R040A/T; R040T and R040A)
Appropriate correction and/or comment 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.
Claims 2 and 3 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.
Claims 2 and 3 are indefinite in that they are each drawn to the variant lipolytic enzyme of claim 1 comprising an amino acid sequence which is less than 95% identical to the amino acid sequence of SEQ ID NO:2 (i.e. 75%, 80%, 90% etc…). It is indefinite in that it is unclear and confusing how this is possible since the variant of claim 1 must comprise at least 95% identity to the amino acid sequence of SEQ ID NO:2.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2 and 3 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claims 2 and 3 are each drawn to the variant lipolytic enzyme of claim 1 comprising an amino acid sequence which is less than 95% identical to the amino acid sequence of SEQ ID NO:2 (i.e. 75%, 80%, 90% etc…)(see also above rejection under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph). Claims 2 and 3 thus do not further limit claim 1, drawn that variant which comprises at least 95% identity to SEQ ID NO:2.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
Applicants have asked that this rejection be held in abeyance until appropriate to submit a terminal disclaimer.
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.
Applicants have asked that this rejection be held in abeyance until appropriate to submit a terminal disclaimer.
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.
Applicants have asked that this rejection be held in abeyance until appropriate to submit a terminal disclaimer.
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.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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.
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rgh
9/24/2026
/RICHARD G HUTSON/Primary Examiner, Art Unit 1652
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