DETAILED CORRESPONDENCE
Status of the Application
The present application is being examined under the pre-AIA first to invent provisions.
Claim 1 is pending and is being examined on the merits.
Applicant’s claim listing, filed January 28, 2026, is acknowledged. This claim listing replaces all prior versions and listings of the claim.
Applicant’s submission of an English language translation of the foreign priority application, filed January 28, 2026, is acknowledged.
Applicant’s remarks and two declarations under 37 CFR 1.132 filed January 28, 2026 in response to the non-final rejection filed September 5, 2025 are acknowledged and have been fully considered.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claim Rejections - 35 USC § 102
The rejection of claim 1 under pre-AIA 35 U.S.C. 102(a) as being anticipated by Wieland et al. (WO 2011/032988 A1; cited on the IDS filed December 7, 2023; hereafter “Wieland”) is withdrawn in of applicant’s submission of an English language translation of the foreign priority application.
Claim Rejections - 35 USC § 103
The rejection of claim 1 under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Christianson et al. (WO 95/23221; cited on the IDS filed December 7, 2023; hereafter “Christianson”) in view of Gabriel et al. (U.S. Patent No. 5,877,141; cited on Form PTO-892 filed September 5, 2025; hereafter “Gabriel”) and as evidenced by U.S. Patent No. 5,340,735 (cited on Form PTO-892 filed September 5, 2025) is maintained for the reasons of record.
RESPONSE TO REMARKS: Beginning at p. 3 of the remarks, applicant argues neither Christianson nor Gabriel teaches or suggests formulating a detergent wherein a protease and a lipase in solution together, and neither reference (alone or in combination) teach the specific combination recited in claim 1 of (1) mixing (a) a protease comprising an amino acid sequence of SEQ ID NO: 2 and (b) a lipase and then (2) storing the liquid washing or cleaning agent for at least 4 weeks, wherein the protease and the lipase are in solution in the liquid washing or cleaning agent.
Applicant’s argument is not found persuasive. Examiner acknowledges that neither Christianson nor Gabriel alone teaches or suggests all limitations of the claims. However, the instant rejection is based on the combination of Christianson and Gabriel, which teach all claim limitations and provide motivation and a reasonable expectation of success to practice the claimed method.
Applicant argues one of ordinary skill in the art reading Christianson would not have combined a protease and another enzyme such as a lipase in a liquid dishwashing detergent and then stored the solution for at least 4 weeks (and would not have understood Christianson et al. as teaching to do so), as the protease would be expected to degrade both itself and the lipase under aqueous conditions, citing to paragraph [0007] of the specification, describing a disadvantage of liquid washing and cleaning agents comprising protease and lipase. According to applicant, Christianson only teaches a protease in combination with lipase in a solid, particulate form. Applicant argues a first declaration of Stefan Jenewein under 37 CFR 1.132 provides opinion evidence that Christianson does not teach a protease and a lipase in solution because the protease would have been expected to degrade itself and the lipase.
Applicant’s arguments and declarations under 37 CFR 1.132 are not found persuasive. Examiner acknowledges the recognized problem in the prior art of enzyme stability in liquid laundry detergents. However, the issue of enzyme stability in liquid laundry detergents had already been addressed by the use of enzyme stabilizers and protease-resistant detergent enzymes. For example, regarding enzyme stabilizers in liquid laundry detergents, Nielsen et al. (Computer Aided Chemical Engineering 23:149-163, 2007; cited on the attached Form PTO-892) discloses that several classes of enzymes including proteases and lipases are present in liquid laundry detergents and acknowledges “inherent stability problems” with enzymes in liquid laundry detergents (p. 149, Background). Nielsen et al. teaches boric acid has been known to have a stabilizing effect on enzymes in liquid detergents and has been included in liquid detergents for many years (p. 151, top). Nielsen et al. teaches boric acid enzyme stabilizers, e.g., 4-FPBA, that maintain 80% lipase activity in a liquid detergent comprising lipase and protease (p. 161). Similar results are disclosed by Nielsen et al. (US Patent No. 5,972,873; cited on the attached Form PTO-892).
Regarding protease-resistant detergent enzymes, Ruchi et al. (Bioresource Techonology 99:4796-4802, 2008; cited on the attached Form PTO-892) discloses that proteases and lipases are the key enzymatic constituents in detergent formulations (p. 4796, column 1) and protease and lipase are together required in detergent formulations (p. 4796, Abstract). Ruchi et al. discloses lipase is a protein that is likely to be hydrolyzed by protease and detergent lipases need to be protease resistant (sentence bridging pp. 4796-4797). Ruchi et al. teaches a lipase from a solvent-tolerant P. aeruginosa that is resistant to proteolysis (p. 4796, Abstract; p. 4798, column 2). Also, Rathi et al. (Process Biochemistry 37:187-192, 2001; cited on the attached Form PTO-892) discloses a lipase that is resistant to various commercial alkaline proteases (p. 187, Abstract), which, according to Rathi et al., is an added advantage when used in combination with proteases in detergent formulations (p. 191, column 2, top).
Given that protease, lipase, and boric acid as an enzyme stabilizer were well-known components of a liquid laundry detergent, and Christianson teaches protease and lipase as components of a detergent, teaches the preferred embodiment of a liquid detergent with an enzyme stabilizing system (p. 24, line 28 to p. 25, line 6), and teaches enzyme stabilizers such as boric acid in liquid detergents (p. 21, lines 22-26), one of ordinary skill in the art reading Christianson would recognize that Christianson is teaching a liquid laundry detergent comprising protease and lipase.
At p. 6 of the remarks, applicant argues there is no motivation in Gabriel to store a protease and lipase together in solution for 4 weeks because Gabriel teaches glycolic acid stabilizes protease but does not teach that the protease will not inactivate a lipase in a liquid detergent if stored for 4 weeks.
Applicant’s argument is not found persuasive. As described above, it was well-known in the prior art that protease and lipase together are components of a liquid laundry detergent and one of ordinary skill in the art would have recognized that Christianson is teaching a liquid laundry detergent comprising protease and lipase, and in view of the combined teachings Christianson and Gabriel, it would have been obvious to apply the method of Gabriel to the liquid detergent of Christianson.
Beginning at p. 6 of the remarks, applicant argues a second declaration of Stefan Jenewein under 37 CFR 1.132 provides experimental results showing the protease of SEQ ID NO: 2 with R99E mutation and a lipase exhibited higher protease and lipase activities than control after storage for 4 weeks, which are surprising and unexpected.
Applicant’s arguments and declarations under 37 CFR 1.132 are not found persuasive. According to MPEP 716.02(d), unexpected results must be commensurate in scope with the claimed invention. “Commensurate in scope” means that the evidence provides a reasonable basis for concluding that the untested embodiments encompassed by the claims would behave in the same manner as the tested embodiments. See In re Lindner, 457 F.2d 506, 508 (CCPA 1972). The results of the “second” declaration of Stefan Jenewein under 37 CFR 1.132 are based on storage at 37oC, 1% w/w protease, and 0.3% lipase (see p. 3, top) while claim 1 recites “wherein the liquid washing or cleaning agent exhibits increased storage stability of lipolytic activity after storage for 4 weeks at 30 oC and encompasses any amounts of the protease (a) and lipase (b). Also, the results of the “second” declaration of Stefan Jenewein under 37 CFR 1.132 are limited to a specific detergent composition and 4 specific lipases. However, given a broadest reasonable interpretation, the component(s) of the liquid washing or cleaning agent other than the protease (a) and lipase (b) is/are unlimited as is the lipase (b) and encompass enzyme stabilizers and protease inhibitors, e.g., 4-FPBA and peptide aldehydes, and protease-resistant lipases. While nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range (MPEP 716.02(d).I), there is no evidence of record that the untested embodiments encompassed by the claim would behave in the same manner as the tested embodiments. In this case, applicant’s results are not commensurate in scope with the claimed invention and consequently fail to rebut a prima facie case of obviousness.
Claim Rejections - 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 filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual 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/apply/applying-online/eterminal-disclaimer.
The rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 3, and 8 of U.S. Patent No. 9,163,226 B2 (cited on Form PTO-892 filed September 5, 2025) in view of Gabriel,
the rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claims 8 and 16 of U.S. Patent No. 10,093,888 B2 (cited on Form PTO-892 filed September 5, 2025) in view of Gabriel,
the provisional rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claim 1 of co-pending application 18/178,328 (reference application) in view of Gabriel, and
the provisional rejection of claim 1 on the ground of nonstatutory double patenting as being unpatentable over claim 15 of co-pending application 18/173,620 (reference application) in view of Gabriel
are maintained for the reasons of record.
RESPONSE TO REMARKS: Beginning at p. 7 of the remarks, applicant argues a second declaration of Stefan Jenewein under 37 CFR 1.132 provides experimental results showing the protease of SEQ ID NO: 2 with R99E mutation and a lipase exhibited higher protease and lipase activities than control after storage for 4 weeks, which are surprising and unexpected.
Applicant’s arguments and declarations under 37 CFR 1.132 are not found persuasive. As stated above, according to MPEP 716.02(d), unexpected results must be commensurate in scope with the claimed invention. “Commensurate in scope” means that the evidence provides a reasonable basis for concluding that the untested embodiments encompassed by the claims would behave in the same manner as the tested embodiments. See In re Lindner, 457 F.2d 506, 508 (CCPA 1972). The results of the “second” declaration of Stefan Jenewein under 37 CFR 1.132 are based on storage at 37oC, 1% w/w protease, and 0.3% lipase (see p. 3, top) while claim 1 recites “wherein the liquid washing or cleaning agent exhibits increased storage stability of lipolytic activity after storage for 4 weeks at 30 oC and encompasses any amounts of the protease (a) and lipase (b). Also, the results of the “second” declaration of Stefan Jenewein under 37 CFR 1.132 are limited to a specific detergent composition and 4 specific lipases. However, given a broadest reasonable interpretation, the component(s) of the liquid washing or cleaning agent other than the protease (a) and lipase (b) is/are unlimited as is the lipase (b) and encompass enzyme stabilizers and protease inhibitors, e.g., 4-FPBA and peptide aldehydes, and protease-resistant lipases. While nonobviousness of a broader claimed range can be supported by evidence based on unexpected results from testing a narrower range (MPEP 716.02(d).I), there is no evidence of record that the untested embodiments encompassed by the claim would behave in the same manner as the tested embodiments. In this case, applicant’s results are not commensurate in scope with the claimed invention and consequently fail to rebut a prima facie case of obviousness.
Conclusion
Status of the claims:
Claim 1 is pending in the application.
Claim 1 is rejected.
No claim is in condition for allowance.
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 DAVID J STEADMAN whose telephone number is (571)272-0942. The examiner can normally be reached Monday to Friday, 7:30 AM to 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MANJUNATH N. RAO can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/David Steadman/Primary Examiner, Art Unit 1656