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 .
DETAILED ACTION
Claims 1 and 15-16, and 18-31 are pending. Claims 15 and 19-22 are withdrawn.
Response to Amendment
Applicant amended claim 18 and canceled claim 17.
The objection to the specification is withdrawn in view of the amendment.
The rejections of claim 17 under 35 U.S.C. 112(d), 35 U.S.C. 103 and on the ground of nonstatutory double patenting are withdrawn in view of the amendment.
New Rejection Necessitated by the Amendment
Claim Rejections - 35 USC § 112
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.
Claim 18 is 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. The limitation “wherein the composition provides at least one hand skin care benefit selected from corneocyte removal, reduced transepidermal water loss, an improved hand skin barrier, and improved hand skin water retention” states the purpose or intended use of the composition but does not further limit the structure of the composition. Applicant may consider adding these limitations at the end of claim 1. 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.
Maintained Rejections
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.
Claims 1, 16, 18, and 23-31 are rejected under 35 U.S.C. 103 as being unpatentable over Christensen (WO 2016001449 A1, published 07/01/2016, of record in Office Correspondence mailed on 09/20/2024, hereinafter “Christensen”). See the sequence alignment, Appendix B, in Office Correspondence mailed on 09/20/2024.
Regarding claims 1 and 23-25, Christensen teaches subtilase variants suitable for use in detergent compositions such as hand dish washing compositions (Abstract, page 4 line 17). Christensen teaches SEQ ID NO: 1 and 2 which are 100% identical to instant SEQ ID NO: 1 and 2 (See Appendix B page 1). Christensen teaches the liquid detergent may be aqueous, typically containing at least 20% and up to about 70% water by weight (page 158 lines 3-4). Christensen teaches SEQ ID NO:1 variant S9E+N43R+N76D+L262E (page 104 line 14). Christensen further teaches the variant can comprise one or more of the substitutions selected from the group consisting of S9E, N43R, N76D, V205I, Q206L, Y209W, S259D, N261W and L262E (page 13 lines 20-35 through page 14 lines 1-4). Christensen teaches each of the above single mutations increases the stability compared to the parent subtilase, and introducing any of the above substitutions in a subtilase parent provides increased stability.
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the variant taught by Christensen by adding the substitutions V205I, Q206L, Y209W, S259D, and N261W in the SEQ ID NO:1 variant S9E+N43R+N76D+L262E and adjusting the water content, as suggested by Christensen. One of ordinary skill in the art would be motivated to do so in order to increase the stability of the variant as taught by Christensen and form an effective detergent composition. Since Christensen teaches the desire to form a variant subtilase with increased stability, there is a reasonable expectation of success.
Regarding claims 16 and 29, Christensen teaches the subtilase variant in the detergent composition is in an amount of 0.1 mg to 10 mg per 1L of composition (i.e., 0.01% to 1%), which falls within the instant limitation of from about 0.001% w/w to about 4% w/w (page 142 lines 31-34).
Regarding claim 18, the limitation ““wherein the composition provides at least one hand skin care benefit selected from corneocyte removal, reduced transepidermal water loss, an improved hand skin barrier, and improved hand skin water retention” is an intended use limitation and does not add any compositional or structural limitations to the claimed composition. Applicant discloses that the parent protease SEQ ID NO: 1 is capable of the removal of corneocyte (Specification Table 1).
Regarding claims 26-28, Christensen teaches the composition is formulated to have a pH from about 6 to about 8 (page 167 lines 21-22) and teaches the composition at pH 7 (Table 3)
Regarding claims 30 and 31, Christensen teaches the subtilase variant in the detergent composition is in an amount 0.05%-5% of enzyme protein by weight of the composition (page 143 line 5), or 0.1%-5% of enzyme protein by weight of the composition (page 143 line 8). One of ordinary skill in the art would be motivated to modify the amount of the enzyme in the composition depending on the intended use of the composition, like for use in automatic dishwash, for use in laundry granulation, or for use in laundry liquid.
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, 16, 18, and 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of U.S. Patent No. 12,012,573 in view of Christensen as evidenced by Appendix B (Appendix B, sequence alignment, 2024, of record in Office Correspondence mailed on 09/20/2024, hereinafter “Appendix B”).
Regarding instant claims 1 and 23-25, patent claim 1 recites a cleaning composition comprising a protease variant having at least 90% sequence identity to SEQ ID NO: 24 and comprising the substitutions S9E, N43R, N76D, V205I, Q206L, Y209W, S259D, N261W and L262E, wherein position numbers are based on the numbering of SEQ ID NO: 25. SEQ ID NO: 24 and 25 are 100% identical to instant SEQ ID NO: 1 and 2 (See Appendix B page 2). Patent claim 1 does not recite composition comprising from 30% to 90% by weight of an aqueous liquid carrier.
However, Christensen teaches subtilase variants suitable for use in detergent compositions such as hand dish washing compositions and teaches the liquid detergent may be aqueous, typically containing at least 20% and up to about 70% water by weight (page 158 lines 3-4). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by adjusting the water content, as suggested by Christensen. One of ordinary skill in the art would be motivated to do so in order form an effective detergent composition.
Regarding instant claim 18, the limitation “provides at least one hand skin care benefit selected from corneocyte removal, reduced transepidermal water loss, an improved hand skin barrier, and improved hand skin water retention” is a recitation of intended use and is not considered to contribute to the patentability of the claimed composition as explained above.
Regarding instant claims 16 and 29-31, patent claim 1 does not recite an amount of the protease in the composition. However, Christensen teaches the subtilase variant in the detergent composition is in an amount of 0.1 mg to 10 mg per 1L of composition (i.e., 0.01% to 1%). Christensen teaches the subtilase variant in the detergent composition is in an amount 0.05%-5% of enzyme protein by weight of the composition (page 143 line 5), or 0.1 %-5% of enzyme protein by weight of the composition (page 143 line 8). One of ordinary skill in the art would be motivated to modify the amount of the enzyme in the composition depending on the intended use of the composition, like for use in automatic dishwash, for use in laundry granulation, or for use in laundry liquid.
Regarding claims 26-28, patent claim 1 does not recite a pH. However, Christensen teaches the composition is formulated to have a pH from about 6 to about 8 (page 167 lines 21-22) and teaches the composition at pH 7 (Table 3). One of ordinary skill in the art would be motivated to adjust the pH in order to optimize the activity of the enzyme.
Claims 1, 16, 18, and 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 14, and 22 of U.S. Patent No. 10,683,491 in view of Christensen and as evidenced by Appendix B.
Regarding instant claims 1 and 23-25, patent claim 22 recites a detergent composition comprising a variant of claim 1. Claim 1 recites a subtilase variant comprising the substitutions X9E+X206L+X262E. Patent claim 14 recites the substitution S9E+N43R+N76D+ V205I+Q206L+ Y209W +S259D+N261W+L262E (column 99). Patent SEQ ID NO: 1 and 2 are 100% identical to instant SEQ ID NO: 1 and 2 (See Appendix B page 3). Patent claim 1 does not recite composition comprising from 30% to 90% by weight of an aqueous liquid carrier. However, Christensen teaches subtilase variants suitable for use in detergent compositions such as hand dish washing compositions and teaches the liquid detergent may be aqueous containing at least 20% and up to about 70% water by weight (page 158 lines 3-4). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by adjusting the water content, as suggested by Christensen. One of ordinary skill in the art would be motivated to do so in order form an effective detergent composition.
Regarding instant claim 18, the limitation “provides at least one hand skin care benefit selected from corneocyte removal, reduced transepidermal water loss, an improved hand skin barrier, and improved hand skin water retention” is a recitation of intended use and is not considered to contribute to the patentability of the claimed composition as explained above.
Regarding instant claims 16 and 29-31, patent claim 1 does not recite an amount of the protease in the composition. However, Christensen teaches the subtilase variant in the detergent composition is in an amount of 0.1 mg to 10 mg per 1L of composition (i.e., 0.01% to 1%). Christensen teaches the subtilase variant in the detergent composition is in an amount 0.05%-5% of enzyme protein by weight of the composition (page 143 line 5), or 0.1 %-5% of enzyme protein by weight of the composition (page 143 line 8). One of ordinary skill in the art would be motivated to modify the amount of the enzyme in the composition depending on the intended use of the composition, like for use in automatic dishwash, for use in laundry granulation, or for use in laundry liquid.
Regarding claims 26-28, patent claim 1 does not recite a pH. However, Christensen teaches the composition is formulated to have a pH from about 6 to about 8 (page 167 lines 21-22) and teaches the composition at pH 7 (Table 3). One of ordinary skill in the art would be motivated to adjust the pH in order to optimize the activity of the enzyme.
Claims 1, 16, 18, and 23-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, and 6 of U.S. Patent No. 10,550,381 in view of Christensen and as evidenced by Appendix B.
Regarding instant claims 1 and 23-25, patent claim 6 recites a detergent composition comprising a variant of claim 1. Claim 1 recites a subtilase variant wherein the amino acid sequence of the variant subtilase has at least 90% but less than 100% sequence identity to the amino acid sequence of SEQ ID NO: 1, and wherein the subtilase variant comprises the substitutions X9E, X76D, and X262E, wherein each position corresponds to the position of the polypeptide of SEQ ID NO: 2. Patent SEQ ID NO: 1 and 2 are 100% identical to instant SEQ ID NO: 1 and 2 (See Appendix B page 4). Patent claim 2 recites subtilase variant further comprises one or more of the substitutions selected from the group consisting of X43A, X43C, X43L, X43R, X43W, X72A, X72V, X78D, X104F, X114V, X115T, X115W, X120I , X120T, X120V, X129D, X147W, X149C, X149N, X158E, X160D, X160P, X161C, X161E, X163A, X163D, X182C, X182E, X185C, X185E, X188C, X188D, X188E, X191N, X204D, X204V, X205I , X206C, X206E, X206I , X206K, X206L, X206T, X206V, X206W, X209W, X212A, X212D, X212G, X212N, X216I, X216T, X216V, X217C, X217M, X218T, X222C, X222R, X225A, X255C, X255E, X256A, X256C, X256D, X256V, X256Y, X259D, X260E, X260P, X261C, X261E, X261L, X261M, X261 V, X261 W, X261 Y, and X261F.
Patent claim 1 does not recite composition comprising from 30% to 90% by weight of an aqueous liquid carrier. However, Christensen teaches subtilase variants suitable for use in detergent compositions such as hand dish washing compositions and teaches the liquid detergent may be aqueous containing at least 20% and up to about 70% water by weight (page 158 lines 3-4). It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the composition recited in patent claim 1 by adjusting the water content, as suggested by Christensen. One of ordinary skill in the art would be motivated to do so in order form an effective detergent composition.
Regarding instant claim 18, the limitation “provides at least one hand skin care benefit selected from corneocyte removal, reduced transepidermal water loss, an improved hand skin barrier, and improved hand skin water retention” is a recitation of intended use and is not considered to contribute to the patentability of the claimed composition as explained above.
Regarding instant claims 16 and 29-31, patent claim 1 does not recite an amount of the protease in the composition. However, Christensen teaches the subtilase variant in the detergent composition is in an amount of 0.1 mg to 10 mg per 1L of composition (i.e., 0.01% to 1%). Christensen teaches the subtilase variant in the detergent composition is in an amount 0.05%-5% of enzyme protein by weight of the composition (page 143 line 5), or 0.1 %-5% of enzyme protein by weight of the composition (page 143 line 8). One of ordinary skill in the art would be motivated to modify the amount of the enzyme in the composition depending on the intended use of the composition, like for use in automatic dishwash, for use in laundry granulation, or for use in laundry liquid.
Regarding claims 26-28, patent claim 1 does not recite a pH. However, Christensen teaches the composition is formulated to have a pH from about 6 to about 8 (page 167 lines 21-22) and teaches the composition at pH 7 (Table 3). One of ordinary skill in the art would be motivated to adjust the pH in order to optimize the activity of the enzyme.
Response to Arguments
Applicant's arguments filed 05/29/2026 have been fully considered but they are not persuasive.
Applicant argues that the claimed protease is a variant of SEQ ID NO: 1 comprising the nine specifically recited substitutions. Applicant argues the recited variant is specific and that Christensen does not suggest such a particular combination of substitutions but suggests substitutions at many additional positions.
In response to the argument, Christensen’s teachings render the claimed variant obvious. Christensen teaches SEQ ID NO:1 with S9E+N43R+N76D+L262E substitutions (page 104 line 14) and S9E+N43R+N76D+Q206L+Y209W+S256D (page 106 line 1). Christensen further teaches the variant can comprise one or more of the substitutions selected from the group consisting of S9E, N43R, N76D, V205I, Q206L, Y209W, S259D, N261W and L262E (page 13 lines 20-35 through page 14 lines 1-4). Christensen teaches each of the above single mutations increases the stability compared to the parent subtilase, and introducing any of the above substitutions in a subtilase parent provides increased stability. Instant claim 1 recite “the protease comprises..”. Thus, the claim does not exclude the presence of other substitutions and does not limit the variant to consist only of SEQ ID NO: 1 and the claimed substitutions.
Applicant argues that Christensen is directed to stability effects and not to the claimed effects of corneocyte removal, reduced transepidermal water loss, an improved hand skin barrier, and improved hand skin water retention. Applicant argues an unexpected result and that the composition provides demonstrable skin-related functional benefits, which are not predictable from stability improvements and not necessarily inherent to protease function generally.
In response to the argument, claim 18 recites the variant protease has a corneocyte removal benefit. The claim does not limit the percentage of corneocyte removal. Any corneocyte removal will read on the claim. Applicant discloses that the parent protease SEQ ID NO: 1 has the corneocyte removal feature (Specification Table 1). Christensen teaches the substitutions affect the stability and teaches the variants have protease activity. Thus, it is understood that the variants taught in Christensen retain the protease activity of the parent SEQ ID NO: 1. Furthermore, increasing protease stability leads to higher product yield because it extends the enzyme's active lifespan, allowing it to process more substrate before degrading, as evidenced by Hoekstra (Improving Protease Stability in Liquid Detergents by Protein Engineering." Sofw Journal (2019)). Hoekstra reports that an engineered protease with higher stability has an increase in activity compared to less stable protease (Fig. 2).
Applicant requests that the double patenting issue be deferred.
A request to defer or to hold a rejection in abeyance is not a proper response to a rejection. Rather, a request to hold a matter in abeyance may only be made in response to an OBJECTION or REQUIREMENTS AS TO FORM (see 37 CFR 1.111(b) and MPEP §714.02). Thus, the double patenting rejections of record have been maintained as no response to these rejections has been filled by applicant at this time.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 MARY A CRUM whose telephone number is (571)272-1661. The examiner can normally be reached M-F 8:00-5:00 CT with alternate Fridays off.
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/MARY A CRUM/Examiner, Art Unit 1657
/THANE UNDERDAHL/Primary Examiner, Art Unit 1699
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