DETAILED CORRESPONDENCE
Status of the Application
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Claims 1-8, 11-15, and 17-21 are pending in the application.
Applicant’s amendment to the claims, filed May 13, 2026, is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s amendment to the specification, filed May 13, 2026, is acknowledged.
Applicant’s remarks filed May 13, 2026 in response to the non-final rejection filed February 13, 2026 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.
Restriction/Election
In response to a requirement for restriction/election filed November 20, 2025, applicant elected without traverse the invention of Group I, claims 1-8, 11-14, and 17-21, species A1), protease comprises threonine or serine at position 3 (3T or 3S), species B2), protease comprises amino acid substitutions S3T, V4I, and V205I, and species C10), protease comprises amino acid sequence of SEQ ID NO: 4, in the reply filed January 20, 2026.
Claim 15 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 1-8, 11-14, and 17-21 are being examined on the merits with claims 3, 5, and 7 being examined only to the extent the claims read on the elected subject matter set forth above.
Specification/Informalities
The objection to the specification is withdrawn in view of applicant’s amendment to the specification to include sequence identifiers.
Claim Objections
The objections to claims 1, 13, and 14 are withdrawn in view of the amendment to claim 1 to recite “80% sequence identity” and the amendments to claims 13 and 14 to recite “A detergent composition” and “The detergent composition,” respectively.
Claim Rejections - 35 USC § 112(b)
The rejection of claims 2-5 and 19 under 35 U.S.C. 112(b) as being indefinite in the recitation of “which comprises compared to SEQ ID NO: 1 the amino acid substitution R101E or R101D according to the numbering of SEQ ID NO: 2” in claim 2, “wherein the protease comprises compared to SEQ ID NO: 1 the amino acid substitution R101E or R101D and the amino acid substitutions S3T, V4I, and V205I according to the numbering of SEQ ID NO: 2” in claim 4, the recitation of “wherein the protease comprises compared to SEQ ID NO: 1 the amino acid substitution R101E or R101D…according to the numbering of SEQ ID NO: 2” in claim 5, and “wherein the additional mutation at position 217 according to the numbering of SEQ ID NO: 2 is L217Q…” because SEQ ID NO: 2 has serine and not arginine at position 101, has isoleucine and not valine at position 205, and has tyrosine and not leucine at position 217 is withdrawn in view of applicant’s clarifying remarks that the substitutions are with respect to the sequence of SEQ ID NO: 1.
The rejection of claim 7 for reciting the protease comprises the amino acid sequence of SEQ ID NO: 4 (i.e., part c) of claim 7), which has only one additional negative charge as compared to the sequence of amino acids 96 to 102 of SEQ ID NO: 1, while claim 1 requires “at least two additional negative charges…” as compared to the sequence of amino acids 96 to 102 of SEQ ID NO: 1 is withdrawn in view of applicant’s clarifying remarks regarding the phrase “two additional charges.”
The rejection of claims 20 and 21 under 35 U.S.C. 112(b) as being indefinite for reciting polar amino acids such as serine (abbreviated as “Ser”) for R1, R2, and R3 is withdrawn in view of applicant’s amendments to claims 20 and 21 to delete polar amino acids.
Claim Rejections - 35 USC § 102/103
Claims 1-8, 11-14, and 17-21 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Jenewein et al. (WO 2018/069158 A1; cited on Form PTO-892 filed November 20, 2025; hereafter “Jenewein”). This rejection has been modified from its previous version in order to address applicant’s amendment to the claims.
As amended, the claims are drawn to a composition comprising
a) a protease
a1) comprising an amino acid sequence which is at least 80% identical to SEQ ID NO: 1 and
a2) wherein the amino acid sequence of the protease comprises compared to SEQ ID NO: 1 at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2;
b) a protease inhibitor selected from the group consisting of peptide aldehyde, peptide aldehyde hydrosulfite adduct, and combinations thereof; and
c) at least one second enzyme different from the protease (a),
wherein the composition comprises increased residual activity of the second enzyme when compared to a composition comprising a protease not having at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2.
Regarding claim 1, Jenewein teaches an aqueous solution comprising a protease and one or more natural inhibitors of said protease, wherein the protease comprises an amino acid sequence which is at least 80% identical to SEQ ID NO: 1 and which comprises compared to SEQ ID NO: 1 at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2 (p. 3, lines 13-17). Instant SEQ ID NO: 1 is identical to SEQ ID NO: 1 of Jenewein (see Appendix B at p. 17 of the Office action filed February 13, 2026 for sequence alignment). Jenewein teaches the aqueous solution can comprise one or more stabilizing agents, preferably a protease inhibitor (p. 23, lines 7-15) including a peptide aldehyde (p. 24, line 17). Jenewein teaches the aqueous solution comprises one or more detergent enzymes other than the disclosed protease (p. 22, lines 42-43).
Jenewein does not explicitly teach the aqueous solution comprises increased residual activity of the one or more detergent enzymes other than the disclosed protease when compared to the aqueous solution without the protease. However, according to MPEP 2112.01, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent and since the aqueous solution of Jenewein is substantially identical to the composition of claim 1, it is presumed that the aqueous solution of Jenewein exhibits increased residual activity of the one or more detergent enzymes other than the disclosed protease.
Regarding claims 2-5, Jenewein teaches the protease comprises the amino acid substitution R101E or R101D and the amino acid substitutions S3T, V4I, and V205I according to the numbering of SEQ ID NO: 2 (p. 4, lines 26-28; p. 16, lines 42-43).
Regarding claims 6 and 19, Jenewein teaches the protease has an additional mutation at position 217 according to the numbering of SEQ ID NO: 2, preferably L217Q, L217D, L217E, or L217G (p. 19, lines 19-20).
Regarding claim 7, Jenewein teaches that in a preferred embodiment, the protease comprises the amino acid sequence of SEQ ID NO: 4 (p. 19, lines 22 and 36). Instant SEQ ID NO: 4 is identical to SEQ ID NO: 4 of Jenewein (see Appendix C at p. 18 of the Office action filed February 13, 2026 for sequence alignment).
Regarding claim 8, Jenewein teaches the aqueous solution can comprise one or more stabilizing agents, preferably a protease inhibitor (p. 23, lines 7-15), which include a peptide aldehyde specially designed for the protease active site (p. 23, lines 10-15; p. 24, lines 17-19).
Regarding claim 11, Jenewein teaches the aqueous solution comprises one or more detergent components, which include surfactants (p. 22, lines 30-32).
Regarding claim 12, Jenewein teaches the one or more enzymes different from the disclosed protease include, e.g., protease, amylase, and lipase (p. 23, lines 2-3).
Regarding claim 13, Jenewein teaches the aqueous solution is a detergent composition (p. 28, lines 4-5).
Regarding claim 14, Jenewein teaches the detergent composition is for laundry (p. 11, lines 35-36) and Jenewein’s detergent composition for laundry is considered to be “a laundry detergent composition” in claim 14.
Regarding claims 17, 20, and 21, Jenewein teaches the peptide aldehyde comprises 3 amino acid residues, the N-terminal of the peptide aldehyde is protected by an N-terminal protection group, and discloses the amino acids of the peptide aldehyde, which include non-polar amino acids such as Val (p. 24, lines 18-38).
Regarding claim 18, Jenewein teaches the N-terminal protection group of the peptide aldehyde includes benzyloxycarbonyl (p. 24, lines 21-23).
Therefore, Jenewein anticipates claims 1-8, 11-14, and 17-21 as written.
Alternatively, in view of the cited teachings of Jenewein, the composition of claims 1-8, 11-14, and 17-21 would have been obvious to one of ordinary skill in the art before the effective filing date. One would have been motivated and expected success to make the composition of claims 1-8, 11-14, and 17-21 because of the explicit teachings of Jenewein set forth above.
Therefore, claims 1-8, 11-14, and 17-21 are anticipated by or, in the alternative, are obvious in view of Jenewein.
RESPONSE TO REMARKS: Applicant argues that only through improper hindsight reasoning in view of the instant disclosure could one of ordinary skill in the art have made specific selections of Jenewein to arrive at the claimed invention because no preference is given in Jenewein for the components recited in the instantly claimed composition.
Applicant’s arguments are fully considered but are not found persuasive. In response to applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See MPEP 2145.X.A. In this case, the rejection relies only on teachings of Jenewein, which anticipate, or in the alternative, render obvious claims 1-8, 11-14, and 17-21, and do not include knowledge gleaned only from the applicant’s disclosure.
Applicant argues Examples 1 and 2 of the instant specification demonstrate an unexpected stabilizing effect of a second enzyme.
Applicant’s arguments and allegation of an unexpected result are fully considered but are not found persuasive. To the extent the rejection is made under 35 U.S.C. 102(a)(1), Jenewein anticipates claims 1-8, 11-14, and 17-21 and evidence of unexpected results cannot overcome a 35 U.S.C. 102 rejection (see MPEP 2131.04). To the extent the rejection is made under 35 U.S.C. 103, applicant’s results are not compared with the closest prior art as required by MPEP 716.02(e), which is considered to be the reference of Jenewein. Also, applicant’s results are based on the specific compositions disclosed in Examples 1 and 2 of the instant specification, while at least claim 1 generally recites a protease a1) comprising an amino acid sequence which is at least 80% identical to SEQ ID NO: 1 and a2) wherein the amino acid sequence of the protease comprises compared to SEQ ID NO: 1 at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2, generally recites a protease inhibitor selected from the group consisting of peptide aldehyde, peptide aldehyde hydrosulfite adduct, and combinations thereof, and generally recites at least one second enzyme different from the protease (a), which are not commensurate in scope with the claimed invention as required by MPEP 716.02(d). “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). 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), and there is no evidence of record that the untested embodiments encompassed by the claims would behave in the same manner as the tested embodiment(s).
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.
Claims 1-8, 11-14, and 17-21 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 9, and 16 of copending Application No. 18/245,849 (reference application) in view of Branner et al. (WO 1991/000345; cited on the IDS filed March 21, 2023; hereafter “Branner”) and Jenewein. Although the claims at issue are not identical, they are not patentably distinct from each other. This rejection has been modified from its previous version in order to address applicant’s amendment to the claims.
Regarding instant claims 1, 8, 11, 13, 17, 18, 20, and 21, claim 1 of the reference application recites a liquid composition, comprising
component (a): at least one peptide aldehyde, and
component (b): at least two organic solvents, wherein one organic solvent is 1,2-propane diol and at least one further organic solvent is selected from the group consisting of diols other than 1,2-propane diol in a weight ratio of 1,2-propane diol: at least one diol other than 1,2-propane diol of 25:1 to 1:4;
claim 6 of the reference application recites the composition according to claim 1, wherein the composition additionally comprises
component (c): at least one hydrolase comprising as a catalytic triad the amino acids aspartate, histidine and serine;
claim 9 of the reference application recites a liquid detergent formulation comprising the liquid composition according to claim 1 and at least one detergent component selected from the group consisting of surfactants and non-phosphate based builders; and
claim 16 of the reference application recites the liquid composition according to claim 1, wherein the at least one peptide aldehyde is a tripeptide aldehyde selected from the group consisting of compounds according to formula (PA)
PNG
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228
759
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wherein
R1 and R2 are groups such that NH-CHR1-CO and/or NH-CHR2-CO are non-polar amino acids;
R3 is a group such that NH-CHR3-CO is an L or D-amino acid residue of Tyr, Phe, Val, Ala or Leu;
and
the N-terminal protection group Z is selected from the group consisting of benzyloxycarbonyl (Cbz), p-methoxybenzyl carbonyl (MOZ), benzyl (Bn), benzoyl (Bz), p-methoxybenzyl (PMB), p-methoxyphenyl (PMP), formyl, acetyl (Ac), methyloxy, alkoxycarbonyl, methoxycarbonyl, fluorenylmethyloxycarbonyl (Fmoc), and tert-butyloxycarbonyl (Boc).
The differences between instant claims 1, 8, 11, 13, 17, 18, 20, and 21 and the claims of the reference application are
the claims of the reference application do not recite the protease of part a) of instant claim 1,
the claims of the reference application do not recite the at least one second enzyme of part c) of instant claim 1, and
the claims of the reference application do not recite wherein the composition comprises increased residual activity of the second enzyme when compared to a composition comprising a protease not having at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2.
Branner teaches subtilisin proteases comprise a catalytic triad of Asp – His – Ser (p. 21, lines 12-14).
Jenewein teaches a modified subtilisin protease that is resistant against natural protease inhibitors in stains, the protease comprising an amino acid sequence which is at least 80% identical to SEQ ID NO: 1 and which comprises compared to SEQ ID NO: 1 at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2 (p. 3, lines 6-17). Instant SEQ ID NO: 1 is identical to SEQ ID NO: 1 of Jenewein (see Appendix B at p. 17 of the Office action filed February 13, 2026 for sequence alignment).
Jenewein teaches a detergent composition comprising one or more detergent enzymes other than the disclosed modified subtilisin protease (p. 22, lines 42-43).
In view of teachings of Branner and Jenewein, it would have been obvious to one of ordinary skill in the art for the at least one hydrolase comprising as a catalytic triad the amino acids aspartate, histidine and serine of the claims of the reference application to be the modified subtilisin protease of Jenewein and for the detergent composition of the claims of the reference application to comprise one or more detergent enzymes other than the recited hydrolase. One would have been motivated and expected success for the at least one hydrolase comprising as a catalytic triad the amino acids aspartate, histidine and serine of the claims of the reference application to be the modified subtilisin protease of Jenewein because claim 6 of the reference application recites the composition additionally comprises component (c): at least one hydrolase comprising as a catalytic triad the amino acids aspartate, histidine and serine, Branner teaches subtilisin proteases comprise a catalytic triad of Asp – His – Ser, and Jenewein teaches a modified subtilisin protease that is resistant against natural protease inhibitors in stains. One would have been motivated and expected success for the detergent composition of the claims of the reference application to comprise one or more detergent enzymes other than the recited hydrolase because the claims of the reference application recite a detergent composition and Jenewein teaches a detergent composition comprises one or more detergent enzymes other than a protease.
Branner and Jenewein do not teach or suggest the composition comprises increased residual activity of the second enzyme when compared to a composition comprising a protease not having at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2. However, according to MPEP 2112.01, when the structure recited in the reference is substantially identical to that of the claims, claimed properties or functions are presumed to be inherent and since the liquid composition of the claims of the reference application as modified according to Branner and Jenewein is substantially identical to the composition of claim 1, it is presumed that the liquid composition of the claims of the reference application as modified according to Branner and Jenewein exhibits increased residual activity of the one or more detergent enzymes other than the disclosed protease.
Regarding instant claims 2-5, Jenewein teaches the modified subtilisin protease comprises the amino acid substitution R101E or R101D and the amino acid substitutions S3T, V4I, and V205I according to the numbering of SEQ ID NO: 2 (p. 4, lines 26-28; p. 16, lines 42-43).
Regarding claims 6 and 19, Jenewein teaches the protease has an additional mutation at position 217 according to the numbering of SEQ ID NO: 2, preferably L217Q, L217D, L217E, or L217G (p. 19, lines 19-20).
Regarding claim 7, Jenewein teaches that in a preferred embodiment, the protease comprises the amino acid sequence of SEQ ID NO: 4 (p. 19, lines 22 and 36). Instant SEQ ID NO: 4 is identical to SEQ ID NO: 4 of Jenewein (see Appendix C at p. 18 of the Office action filed February 13, 2026 for sequence alignment).
Regarding claim 12, Jenewein teaches the one or more enzymes different from the disclosed protease include, e.g., protease, amylase, and lipase (p. 23, lines 2-3).
Regarding claim 14, Jenewein teaches a detergent composition can be used for laundry (p. 11, lines 35-36).
Therefore, claims 1-8, 11-14, and 17-21 of this application are unpatentable over claims 1, 6, 9, and 16 of the reference application. This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
RESPONSE TO REMARKS: Applicant argues that only through improper hindsight reasoning in view of the instant disclosure could one of ordinary skill in the art have made specific selections from the claims of the reference application and the cited prior art to arrive at the claimed invention because no preference is given in the claims of the reference application and the cited prior art for the components recited in the instantly claimed composition.
Applicant’s arguments are fully considered but are not found persuasive. In response to applicant’s argument that the examiner’s conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant’s disclosure, such a reconstruction is proper. See MPEP 2145.X.A. In this case, the rejection relies only on the claims of the reference application and teachings of Branner and Jenewein and does not include knowledge gleaned only from the applicant’s disclosure.
Applicant argues Examples 1 and 2 of the instant specification demonstrate an unexpected stabilizing effect of a second enzyme.
Applicant’s arguments and allegation of unexpected results are fully considered but are not found persuasive. Applicant’s results are not compared with the closest prior art as required by MPEP 716.02(e), which is the reference of Jenewein. Also, applicant’s results are based on the specific compositions disclosed in Examples 1 and 2 of the instant specification, while at least claim 1 generally recites a protease a1) comprising an amino acid sequence which is at least 80% identical to SEQ ID NO: 1 and a2) wherein the amino acid sequence of the protease comprises compared to SEQ ID NO: 1 at least two additional negative charges in the loop region of residues 98 to 104 according to the numbering of SEQ ID NO: 2, generally recites a protease inhibitor selected from the group consisting of peptide aldehyde, peptide aldehyde hydrosulfite adduct, and combinations thereof, and generally recites at least one second enzyme different from the protease (a), which are not commensurate in scope with the claimed invention as required by MPEP 716.02(d). “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). 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), and there is no evidence of record that the untested embodiments encompassed by the claims would behave in the same manner as the tested embodiment(s).
Conclusion
Status of the claims:
Claims 1-8, 11-15, and 17-21 are pending.
Claim 15 is withdrawn from consideration.
Claims 1-8, 11-14, and 17-21 are 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
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