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 16-18 and 20-29 are pending in this application.
Applicant’s amendment to the claims filed 02/24/2026 is acknowledged. This listing of the claims replaces all prior versions and listings of the claims.
Applicant’s remarks filed on 02/24/2026 in response to the non-final rejection mailed on 12/04/2025 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.
Election
The elected subject matter is
Group I, corresponding to claims 16-18 and 20-25, drawn to the technical feature of an alpha-amylase variant of a parent alpha-amylase polypeptide comprises a modification in one or more position corresponding to position: 1, 2, 7, 9, 11, 16, 19, 25, 37, 43, 48, 54, 56, 58, 59, 60, 63, 81, 84, 86, 90, 98, 104, 109, 111, 113, 116, 118, 125, 127, 130, 132, 133, 134, 135, 136, 139, 142, 144, 149, 158, 160, 163, 167, 169, 170, 171, 172, 173, 174, 175, 176, 178, 181, 182, 186, 187, 195, 202, 203, 204, 206, 209, 210, 212, T227, 235, 238, 246, 256, 259, 264, 265, 266, 267, 269, 270, 272, 273, 274, 275, 276, 284, 286, 291, 293, 295, 298, 299, 302, 303, 304, 306, 310, 311, 314, 315, 317, 319, 320, 323, 328, 337, 339, 345, 357, 365, 377, 375, 385, 391, 395, 400, 406, 408, 410, 431, 435, 439, 444, 445, 458, 465, 466, 469, 473, 476 and 481, using SEQ ID NO: 1 for numbering and wherein each modification is independently a substitution, insertion, or deletion, and wherein said variant has at least 59% but less than 100% sequence identity to the polypeptide of SEQ ID NOs: 1-17 and wherein said variant has alpha-amylase activity, and a composition thereof,
the modification of position 365, and
the variant alpha-amylase comprising the substitutions N195F and Q365S,
elected with traverse in the reply filed 04/09/2024.
Claim 18 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected species, there being no allowable generic or linking claim.
Claims 26-29 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim.
Claims 16-17 and 20-25 are being examined on the merits only to the extent they read on the elected subject matter.
Claim Rejections - 35 USC § 102
The rejection of claims 16-17 and 23-25 under 35 U.S.C. 102(a)(1) as being anticipated by Novozymes (WO 2016/180748; cited on the IDS submitted 09/02/2021; herein NOVO2) is withdrawn in view of the amendment to claim 16 to no longer recite SEQ ID NO: 14 as one of the sequences with which the claimed alpha-amylase variant shares at least 95% but less than 100% identity.
Claims 16-17 and 23-25 are newly rejected under 35 U.S.C. 102(a)(1) as being anticipated by Novozymes (WO 2017/114891; cited on the attached Form PTO-892; herein NOVO3).
The instant rejection is newly stated and necessitated by claim amendment.
As amended, the claims are drawn to an alpha-amylase variant of a parent alpha-amylase polypeptide, wherein said variant comprises substitutions corresponding to G109A, N195F and Q365S using SEQ ID NO: 1 for numbering, wherein the amino acid sequence of said variant has at least 95% but less than 100% sequence identity to the polypeptide of any one of SEQ ID NOs: 1-13 and 15-17, and wherein said variant has alpha-amylase activity.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 16, NOVO3 discloses a variant alpha-amylase which shares 99.8% sequence identity with SEQ ID NO: 17 and contains the mutations G109A, N195F and Q365S using SEQ ID NO: 1 for numbering [see Appendices A and B], as the variant is disclosed as “SEQ ID NO: 1 + G109A” in Table 9 [p 64], wherein SEQ ID NO: 1 of NOVO3 is shares 100% sequence identity with SEQ ID NO: 17 of the instant application [see Appendix C]. As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claim, the variant alpha-amylase of NOVO3 is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in the claim is not considered to be a structural limitation of the claimed alpha-amylase variant polypeptide, the disclosure of NOVO3 satisfies the all of the structural limitations of the claim.
Regarding claim 17, as the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents”.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
For these reasons, NOVO3 anticipates claims 16-17 and 23-25.
Response to Remarks: Beginning on page 6 of the response to rejections under 35 USC 102; Applicant contends that claim 16 as amended to exclude the art used for the 102 rejection.
Applicant’s remarks are considered and found not convincing. The amended claims recite a polypeptide that is anticipated by NOVO3 as discussed in the new rejection necessitated by claim amendment set forth above.
Double Patenting
The double patenting and provisional double patenting rejections corresponding to rejections A.-H. set forth in the previous Office action (see pp. 9-23) are withdrawn in view of the amendment to claim 16 to no longer recite SEQ ID NO: 14 as one of the sequences with which the claimed alpha-amylase variant shares at least 95% but less than 100% identity.
A. Claims 16-17 and 23-25 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 17 of U.S. Patent No. 10,428,321 (cited on the Form PTO-892 mailed 05/02/2024; hereafter referred to as “patent”) in view of NOVO3.
The instant rejection is newly stated and necessitated by claim amendment.
Regarding instant claim 16, claim 17 of the patent recites a detergent composition comprising an alpha-amylase of claim 1 of the patent.
The claims of the patent do not recite the sequence requirements of the variant alpha-amylase of the instant claims.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 16, NOVO3 discloses a variant alpha-amylase which shares 99.8% sequence identity with SEQ ID NO: 17 and contains the mutations G109A, N195F and Q365S using SEQ ID NO: 1 for numbering [see Appendices A and B], as the variant is disclosed as “SEQ ID NO: 1 + G109A” in Table 9 [p 64], wherein SEQ ID NO: 1 of NOVO3 is shares 100% sequence identity with SEQ ID NO: 17 of the instant application [see Appendix C]. As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in the claim is not considered to be a structural limitation of the claimed polypeptide, the disclosure of NOVO3 satisfies the all of the structural limitations of the claim.
In view of NOVO3, it would have been obvious to one of skill in the art before the effective filing date to modify the claims of the patent by using the variant of NOVO3, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that both the variant of the patent and the variant of NOVO3 are alpha-amylases with amylase activity, and as such both are capable of being incorporated into a composition as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the variant of the patent with the variant of NOVO3, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the patent and NOVO3 discuss variant alpha-amylases with amylase activity.
Regarding claim 17, as the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents”.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
B. Claims 16-17 and 23-25 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 10 of U.S. Patent No. 8,435,577 (cited on the Form PTO-892 mailed 05/02/2024; hereafter referred to as “patent”) in view of NOVO3.
The instant rejection is newly stated and necessitated by claim amendment.
Regarding instant claim 16, claim 1 of the patent recites an alpha-amylase and claim 10 the patent recites a detergent composition comprising the alpha-amylase.
The claims of the patent do not recite the sequence requirements of the variant alpha-amylase of the instant claims.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 16, NOVO3 discloses a variant alpha-amylase which shares 99.8% sequence identity with SEQ ID NO: 17 and contains the mutations G109A, N195F and Q365S using SEQ ID NO: 1 for numbering [see Appendices A and B], as the variant is disclosed as “SEQ ID NO: 1 + G109A” in Table 9 [p 64], wherein SEQ ID NO: 1 of NOVO3 is shares 100% sequence identity with SEQ ID NO: 17 of the instant application [see Appendix C]. As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in the claim is not considered to be a structural limitation of the claimed polypeptide, the disclosure of NOVO3 satisfies the all of the structural limitations of the claim.
In view of NOVO3, it would have been obvious to one of skill in the art before the effective filing date to modify the claims of the patent by using the variant of NOVO3, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that both the variant of the patent and the variant of NOVO3 are alpha-amylases with amylase activity, and as such both are capable of being incorporated into a composition as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the variant of the patent with the variant of NOVO3, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the patent and NOVO3 discuss variant alpha-amylases with amylase activity.
Regarding claim 17, As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents”.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
C. Claims 16-17 and 23-25 are newly rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 38 of U.S. Patent No. 12,473,540 (cited on the attached Form PTO-892; herein “patent”) in view of NOVO3.
The instant rejection is newly stated and necessitated by claim amendment.
Regarding instant claim 16, claim 1 of the patent recites a polypeptide with alpha-amylase activity, and claim 38 of the patent recites a detergent composition comprising the polypeptide.
The claims of the patent do not recite the sequence requirements of the variant alpha-amylase of the instant claims.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 16, NOVO3 discloses a variant alpha-amylase which shares 99.8% sequence identity with SEQ ID NO: 17 and contains the mutations G109A, N195F and Q365S using SEQ ID NO: 1 for numbering [see Appendices A and B], as the variant is disclosed as “SEQ ID NO: 1 + G109A” in Table 9 [p 64], wherein SEQ ID NO: 1 of NOVO3 is shares 100% sequence identity with SEQ ID NO: 17 of the instant application [see Appendix C]. As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in the claim is not considered to be a structural limitation of the claimed polypeptide, the disclosure of NOVO3 satisfies the all of the structural limitations of the claim.
In view of NOVO3, it would have been obvious to one of skill in the art before the effective filing date to modify the claims of the patent by using the variant of NOVO3, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that both the variant of the patent and the variant of NOVO3 are alpha-amylases with amylase activity, and as such both are capable of being incorporated into a composition as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the variant of the patent with the variant of NOVO3, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the patent and NOVO3 discuss variant alpha-amylases with amylase activity.
Regarding claim 17, As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents”.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
D. Claims 16-17 and 23-25 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 23 of co-pending Application No. 18/774233 (herein “reference application”) in view of NOVO3.
The instant rejection is newly stated and necessitated by claim amendment.
Regarding instant claim 16, claim 23 of the reference application recites a variant alpha-amylase with alpha-amylase activity.
The claims of the reference application do not recite the sequence requirements of the variant alpha-amylase of the instant claims.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 16, NOVO3 discloses a variant alpha-amylase which shares 99.8% sequence identity with SEQ ID NO: 17 and contains the mutations G109A, N195F and Q365S using SEQ ID NO: 1 for numbering [see Appendices A and B], as the variant is disclosed as “SEQ ID NO: 1 + G109A” in Table 9 [p 64], wherein SEQ ID NO: 1 of NOVO3 is shares 100% sequence identity with SEQ ID NO: 17 of the instant application [see Appendix C]. As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in the claim is not considered to be a structural limitation of the claimed polypeptide, the disclosure of NOVO3 satisfies the all of the structural limitations of the claim.
In view of NOVO3, it would have been obvious to one of skill in the art before the effective filing date to modify the claims of the reference application by using the variant of NOVO3, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that both the variant of the reference application and the variant of NOVO3 are alpha-amylases with amylase activity, and as such both are capable of being incorporated into a composition as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the variant of the reference application with the variant of NOVO3, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the reference application and NOVO3 discuss variant alpha-amylases with amylase activity.
Regarding claim 17, As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents”.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
E. Claims 16-17 and 23-25 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 1 of co-pending Application No. 17/841161 (herein “reference application”) in view of NOVO3.
The instant rejection is newly stated and necessitated by claim amendment.
Regarding instant claim 16, claim 1 of the reference application recites a cleaning composition comprising a variant alpha-amylase with alpha-amylase activity.
The claims of the reference application do not recite the sequence requirements of the variant alpha-amylase of the instant claims.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 16, NOVO3 discloses a variant alpha-amylase which shares 99.8% sequence identity with SEQ ID NO: 17 and contains the mutations G109A, N195F and Q365S using SEQ ID NO: 1 for numbering [see Appendices A and B], as the variant is disclosed as “SEQ ID NO: 1 + G109A” in Table 9 [p 64], wherein SEQ ID NO: 1 of NOVO3 is shares 100% sequence identity with SEQ ID NO: 17 of the instant application [see Appendix C]. As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in the claim is not considered to be a structural limitation of the claimed polypeptide, the disclosure of NOVO3 satisfies the all of the structural limitations of the claim.
In view of NOVO3, it would have been obvious to one of skill in the art before the effective filing date to modify the claims of the reference application by using the variant of NOVO3, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that both the variant of the reference application and the variant of NOVO3 are alpha-amylases with amylase activity, and as such both are capable of being incorporated into a composition as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the variant of the reference application with the variant of NOVO3, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the reference application and NOVO3 discuss variant alpha-amylases with amylase activity.
Regarding claim 17, As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents”.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
F. Claims 16-17 and 23-25 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 16 of co-pending Application No. 17/781512 (herein “reference application”) in view of NOVO3. The instant rejection is newly stated and necessitated by claim amendment.
Regarding instant claim 16, claim 16 of the reference application recites an alpha-amylase variant.
The claims of the reference application do not recite the sequence requirements of the variant alpha-amylase of the instant claims.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 16, NOVO3 discloses a variant alpha-amylase which shares 99.8% sequence identity with SEQ ID NO: 17 and contains the mutations G109A, N195F and Q365S using SEQ ID NO: 1 for numbering [see Appendices A and B], as the variant is disclosed as “SEQ ID NO: 1 + G109A” in Table 9 [p 64], wherein SEQ ID NO: 1 of NOVO3 is shares 100% sequence identity with SEQ ID NO: 17 of the instant application [see Appendix C]. As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in the claim is not considered to be a structural limitation of the claimed polypeptide, the disclosure of NOVO3 satisfies the all of the structural limitations of the claim.
In view of NOVO3, it would have been obvious to one of skill in the art before the effective filing date to modify the claims of the reference application by using the variant of NOVO3, since the simple substitution of one known element for another results in a predictable result. One of ordinary skill in the art would have recognized that both the variant of the reference application and the variant of NOVO3 are alpha-amylases with amylase activity, and as such both are capable of being incorporated into a composition as described by the patent. Thus it would have been obvious to one of ordinary skill in the art to replace the variant of the reference application with the variant of NOVO3, as one of ordinary skill in the art would have been able to carry out such a substitution with a reasonable expectation of success because both the reference application and NOVO3 discuss variant alpha-amylases with amylase activity.
Regarding claim 17, As the sequence of the variant alpha-amylase of NOVO3 is encompassed by the claims, the variant alpha-amylase of NOVO3 is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents”.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
G. Claims 16-17 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of co-pending Application No. 18/864972 (herein “reference application”). Although the claims at issue are not identical, they are not patentably distinct from each for the following reasons.
The instant rejection is newly stated and necessitated by claim amendment.
Regarding instant claims 16-17, claim 2 of the reference application recites a polypeptide comprising any of SEQ ID NOs: 1-91, 183-72144, 72147 and 72149, wherein SEQ ID NO: 33488 shares greater than 95% identity with SEQ ID NO: 1 of the instant application and has the substitutions G109A, N195F and Q365S [see Appendix D]. As the sequence of the polypeptide of the reference application is encompassed by the claims, the polypeptide of the reference application is presumed to have the recited alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure. As the sequence of a parent polypeptide as recited in instant claim 16 is not considered to be a structural limitation of the instantly claimed polypeptide, the polypeptide of the reference application satisfies the all of the structural limitations of instant claim 16. Furthermore, as the sequence of the reference application is encompassed by the claims, the polypeptide of the reference application is presumed to have the recited Improvement Factor (IF) of >1.0 for a measure of wash performance when compared to said parent polypeptide having alpha-amylase activity according to MPEP 2112.01.I, as the function is presumed to be inherent from the structure.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 23-25 are newly provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claim 2 of co-pending Application No. 18/864972 as applied to claims 16-17, and further in view of NOVO3.
The instant rejection is newly stated and necessitated by claim amendment.
The claims of the reference application as applied to instant claims 16-17 are discussed above. The claims of the reference application do not recite a composition comprising the variant alpha-amylase of the instant claims.
NOVO3 relates to enzyme variants [title], particularly alpha-amylase variants [p 1, ln 10] that have enhanced wash performance and are incorporated into detergent compositions for domestic and industrial cleaning processes such as laundry cleaning and dishwashing [p 2, lns 1-12].
Regarding claim 23, NOVO3 discloses a composition comprising the variant [p 39, ln 10] and further components such as oxidizing agents, bleach activators, and bulking agents [p 39, ln 27-31], which is considered to correspond to an active component according to the specification at [p 319, number 61] which discloses “wherein one or more additional active component is selected from the group consisting of … oxidizing agents, bleach activators … bulking agents].
In view of NOVO3, it would have been obvious to one of skill in the art before the effective filing date to modify the claims of the reference application by incorporating the polypeptide of the reference application into a composition as disclosed by NOVO3 to arrive at the claimed invention. One of ordinary skill in the art would have been motivated to incorporate the polypeptide of the reference application into a composition because NOVO3 discloses alpha-amylase variants are used in laundry compositions, and the polypeptide of the reference application is presumed to have alpha-amylase activity based on its amino acid sequence features. One of ordinary skill in the art would have had a reasonable expectation of success because the reference application and NOVO3 relate to alpha-amylases.
Regarding claims 24-25, NOVO3 discloses the composition is a liquid or powder automatic dishwashing detergent composition [p 39, ln 33-34].
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Remarks: Beginning on page 6 of the response to double patenting rejections; Applicant contends the amended claims overcome all double patenting rejections.
Applicant’s remarks are considered and found not convincing. The amendments to the claims necessitated new rejections as set forth in the section above.
Conclusion
Status of the Application:
Claims 16-18 and 20-29 are pending.
Claims 18 and 26-29 are withdrawn.
Claims 16-17 and 23-25 are rejected.
Claims 20-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
No claim is in condition for allowance.
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 JOSEPH SPANGLER whose telephone number is (571)270-0314. The examiner can normally be reached M-F 7:30 am - 4:30 pm.
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, Manjunath Rao can be reached at (571) 272-0939. 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.
/JOSEPH R SPANGLER/
Examiner
Art Unit 1656
/David Steadman/Primary Examiner, Art Unit 1656
APPENDIX A
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602
586
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Alignment of SEQ ID NO: 17 with the alpha-amylase of WO 2017/114891, wherein * denotes positions 109, 195 and 365 relative to SEQ ID NO: 1 for numbering.
APPENDIX B
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163
633
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Alignment of SEQ ID NO: 1 with SEQ ID NO: 17 to indicate the location of position 365 of SEQ ID NO: 1 relative to SEQ ID NO: 17.
APPENDIX C
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311
639
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Alignment of SEQ ID NO: 17 with SEQ ID NO: 1 of WO 2017/114891, wherein * denotes position 109 and the location of the mutation G109A.
APPENDIX D
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749
575
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Alignment of SEQ ID NO: 1 with SEQ ID NO: 33488 of co-pending Application 18/864972, wherein * denotes positions 109, 195 and 365.
Prosecution Insights