DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 04/14/2026 has been entered. Claims 1-2 have been amended. Claim 12 is cancelled. Claims 1-11 and 13-15 are pending. Claims 7-9 and 11 are withdrawn. Claims 1-6, 10 and 13-15 are under examination.
Claim Rejections Withdrawn
The rejection of claims 1-6, 10, and 13-15 under 35 U.S.C. 112(b) is withdrawn in view of the cancellation of the claims.
The rejection of claims 1-6, 10, and 13-15 under 35 U.S.C. 112(a) as failing to comply with the written description requirement is withdrawn upon further consideration of the amended claims.
The rejection of claims 1-6, 10, and 13-15 under 35 U.S.C. 112(a) scope of enablement is withdrawn upon further consideration of the amended claims.
New Claim Rejections
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 3-5 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 3 recites:
The protease according to claim 1, wherein the
(1) amino acid substitutions occur at 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E; and
(a) one or more further amino acid substitutions occur at 131H and 189T;
(b) 89A and 131H;
(c) 89A and 189T; or
(d) 89A, 131H and 189T.
Claim 3 as written is confusing. Do the amino acid substitutions occur at 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E or the amino acid substitutions are 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E?
When the claim recites that “the amino acid substitutions occur at 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E”, these residues do not occur at those positions. In addition, claims 4 and 5 which depend on claim 3 recite that “the amino acid substitutions are 9T, 130D, 133A, 144K, 217M, 224A, 252T, and 271E” and “the amino acid substitutions are 9T, 130V, 133A, 144K, 217M, 224A, 252T, and 271E”, respectively.
If the amino acid substitutions are occurring at 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E”, then claims 4 and claim 5 are inconsistent because claims 4 and 5 respectively recite that “the amino acid substitutions are 9T, 130D, 133A, 144K, 217M, 224A, 252T, and 271E” and “the amino acid substitutions are 9T, 130V, 133A, 144K, 217M, 224A, 252T, and 271E.
For the similar reasons, the recitation of claim 3 (a) that one or more further amino acid substitutions occur at 131H and 189T makes claim 4 and claim inconsistent because claim 4 recites that the amino acid substitution are 131H and 189T.
Is Claim 3 parts (b)-(d) part of the “one or more further amino acid substitutions”? Only claim 3 part (a) recites “one or more further amino acid substitutions” and so this limitation is not applicable to Claim 3 parts (b)-(d) as written.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 2, 4 and 5 are rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Claim 1 requires an amino acid substitution at position 224. However, in claim 2, part b, the amino acid substitution at position 224 is part of “the one or more further amino acid substitutions” which means that amino acid substitution at position 224 may or may not be present. For this reason, claim 2 fails to further limit the subject matter of claim 1 and also fails to include all the limitations of claim 1.
In claims 4 and 5, the 224A amino acid substitution which is recited in claim 3 is not recited as part of the substitutions in claim 4 and claim 5.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1, 2, 6, 10 and 13 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Fernandez et al. WO 2019048495 03-14-2019 cited in IDS.
35 U.S.C. 102(a)(1): Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
35 U.S.C. 102(a)(2): The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1: Fernandez et al disclose a protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 224, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 131 and 166.
See disclosure of:
In various embodiments of the invention, the protease comprises an amino acid sequence which corresponds to the amino acid sequence given in SEQ ID NO: 1 over its total length to at least 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%. , 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 90.5%, 91%, 91, 5%, 92%, 92.5%, 93%, 93.5%, 94%, 94.5%, 95%, 95.5%, 96%, 96.5%, 97%, 97.5% , 98%, 98.5% and 98.8% are identical, and in each case based on the numbering according to SEQ ID NO: 1 has the above-indicated amino acid substitutions.
Surprisingly, it has now been found that a protease from Bacillus pumilus or a sufficiently similar protease (based on the sequence identity), the amino acid substitutions at least one of the positions of the position 271 and optionally 9, in each case based on the numbering according to SEQ ID NO: 1, and optionally at least one of the positions corresponding to the positions 18, 29, 48, 61, 92, 101, 130, 131, 133, 137, 144, 149, 156, 162, 166, 172, 192, 217 , 224, 252 or 265, each based on the numbering according to SEQ ID NO: 1, is improved in terms of proteolytic activity under standard washing conditions compared to the wild-type form and / or reference mutants and therefore particularly for use in washing or Cleaning agents is suitable.
Fernandez et al disclose that the protease has the amino acid substitutions 9T, 130D, 133A 144K, 252T and 271E; and
(2) at least one of the positions corresponding to positions 62, 99, 133, 137, 149, 156, 162, 166, 172, 192, 199, 217, 224 or 265, at least one other
See embodiments throughout Fernandez et al.
Claim 2: Fernandez et al disclose the protease according to claim 1, wherein the protease has (1)the amino acid substitutions 9T, 130D, 133A 144K, 217M, 252T and 271E; and (2) 224A:
In various embodiments, the protease at the position corresponding to position 271 has an amino acid substitution, especially the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to positions 62, 99, 133, 137, 149, 156, 162, 166, 172, 192, 199, 217, 224 or 265, at least one, for example 1, 2, 3 , 4, 5, 6, 7, 8, 9, 10, 11, 12 or 13, for example 1, 2, 3 or 4, further amino acid substitution (s), these preferably are selected from: 62S, 99Y, 133R, 133K, 133A, 137K, 1491, 156G, 156Y, 162S, 166M, 172G, 172P, 192V, 199M, 217M, 224A and 265A. Such proteases are disclosed, for example, in Example 1 and thus the subject of the invention. Particularly preferred are those proteases which, at the position corresponding to position 271, have an amino acid substitution, in particular the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to the positions 62, 133, 137, 162, 192, 217 or 265, at least one, for example 1, 2, 3, 4, 5, 6 or 7, for example 1, 2, 3 or 4 further amino acid substitutions, these being preferably selected from: 62S, 133R, 133K, 133A, 137K, 162S, 192V, 217M and 224A.
Claim 6: Fernandez et al disclose the protease according to claim 1, further comprising: one or more conservative amino acid substitutions created by a substitution mutagenesis:
All these facts are also applicable to the method of producing a protease according to the invention. Accordingly, a method according to the invention further comprises one or more of the following method steps: a) introduction of a single or multiple conservative amino acid substitution into the protease, wherein the protease
(a) at the position corresponding to position 271, an amino acid substitution, in particular the amino acid substitution 271 E; and
(b1) at least one of the positions corresponding to positions 18, 61, 92, 99, 137, 149, 156, 159, 162, 166, 172, 192, 199, 217 or 265, at least one more amino acid substitution; and or
(b2) at the position corresponding to position 9, an amino acid substitution, in particular selected from 9T, 9H, 9S and 9A, preferably 9T, and at least one position corresponding to the positions 29, 48, 101, 130, 131, 133 , 144, 217, 224 and 252, in particular 130, 133, 144, 217 and 252, another amino acid substitution, for example A29G, A48V, D101E, N130D, N130S, N130H, G131D, G131N, G131S, G131 K, T133K, T133R, T133Y, N144K, N144L, N144A, S224A, S224T or N252S; b) altering the amino acid sequence by fragmentation, deletion, insertion or substitution mutagenesis in such a way that the protease has an amino acid sequence which is over a length of at least 200, 210, 220, 230, 240, 250, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273 or 274 of the parent amino acid, wherein the protease
(a) at the position corresponding to position 271, an amino acid substitution, in particular the amino acid substitution 271 E; and (b1) at least one of the positions corresponding to positions 18, 61, 92, 99, 137, 149, 156, 159, 162, 166, 172, 192, 199, 217 or 265, at least one more amino acid substitution; and or
(b2) at the position corresponding to position 9, an amino acid substitution, in particular selected from 9T, 9H, 9S and 9A, preferably 9T, and at least one position corresponding to the positions 29, 48, 101, 130, 131, 133 , 144, 217, 224 and 252, in particular 130, 133, 144, 217 and 252, another amino acid substitution, for example A29G, A48V, D101E, N130D, N130S, N130H, G131D, G131N, G131S, G131 K, T133K, T133R, T133Y, N144K, N144L, N144A, S224A, S224T or N252S.
All embodiments also apply to the inventive method. In particular, each of the aforementioned proteases may additionally comprise an amino acid substitution at position 216 and / or 217 in the count according to SEQ ID NO: 1, in particular 216C and / or 217M. However, in various embodiments, it may be preferred that the protease has no substitution at position 216.
Claim 10: Fernandez et al disclose a composition, comprising: a washing or cleaning agent, the washing or cleaning agent containing at least one protease according to claim 1: Another object of the invention is an agent which is characterized in that it contains a protease according to the invention as described above. Preferably, the agent is as a washing or cleaning agent.
Claim 13: Fernandez et al disclose the protease according to claim 1, wherein the amino acid substitutions are 9T, 130D, 133A, 144K, 217M, 224A, 252T, and 271E corresponding to the amino acid substitutions at positions 9, 130, 133, 144, 217, 224, 252, and 272, respectively:
In various embodiments, the protease at the position corresponding to position 271 has an amino acid substitution, especially the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to positions 62, 99, 133, 137, 149, 156, 162, 166, 172, 192, 199, 217, 224 or 265, at least one, for example 1, 2, 3 , 4, 5, 6, 7, 8, 9, 10, 11, 12 or 13, for example 1, 2, 3 or 4, further amino acid substitution (s), these preferably are selected from: 62S, 99Y, 133R, 133K, 133A, 137K, 1491, 156G, 156Y, 162S, 166M, 172G, 172P, 192V, 199M, 217M, 224A and 265A. Such proteases are disclosed, for example, in Example 1 and thus the subject of the invention. Particularly preferred are those proteases which, at the position corresponding to position 271, have an amino acid substitution, in particular the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to the positions 62, 133, 137, 162, 192, 217 or 265, at least one, for example 1, 2, 3, 4, 5, 6 or 7, for example 1, 2, 3 or 4 further amino acid substitutions, these being preferably selected from: 62S, 133R, 133K, 133A, 137K, 162S, 192V, 217M and 224A.
Claim(s) 1, 2, 6, 10 and 13 is/are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Mussmann et al. US 11,739,310 published 8/29/23 filed 9/5/2018.
35 U.S.C. 102(a)(2): The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1: Fernandez et al disclose a protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 224, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 131 and 166.
See disclosure of:
In various embodiments of the invention, the protease comprises an amino acid sequence which corresponds to the amino acid sequence given in SEQ ID NO: 1 over its total length to at least 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%. , 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 90.5%, 91%, 91, 5%, 92%, 92.5%, 93%, 93.5%, 94%, 94.5%, 95%, 95.5%, 96%, 96.5%, 97%, 97.5% , 98%, 98.5% and 98.8% are identical, and in each case based on the numbering according to SEQ ID NO: 1 has the above-indicated amino acid substitutions.
Surprisingly, it has now been found that a protease from Bacillus pumilus or a sufficiently similar protease (based on the sequence identity), the amino acid substitutions at least one of the positions of the position 271 and optionally 9, in each case based on the numbering according to SEQ ID NO: 1, and optionally at least one of the positions corresponding to the positions 18, 29, 48, 61, 92, 101, 130, 131, 133, 137, 144, 149, 156, 162, 166, 172, 192, 217 , 224, 252 or 265, each based on the numbering according to SEQ ID NO: 1, is improved in terms of proteolytic activity under standard washing conditions compared to the wild-type form and / or reference mutants and therefore particularly for use in washing or Cleaning agents is suitable.
Fernandez et al disclose that the protease has the amino acid substitutions 9T, 130D, 133A 144K, 252T and 271E; and
(2) at least one of the positions corresponding to positions 62, 99, 133, 137, 149, 156, 162, 166, 172, 192, 199, 217, 224 or 265, at least one other
See embodiments throughout Fernandez et al.
Claim 2: Fernandez et al disclose the protease according to claim 1, wherein the protease has (1)the amino acid substitutions 9T, 130D, 133A 144K, 217M, 252T and 271E; and (2) 224A:
In various embodiments, the protease at the position corresponding to position 271 has an amino acid substitution, especially the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to positions 62, 99, 133, 137, 149, 156, 162, 166, 172, 192, 199, 217, 224 or 265, at least one, for example 1, 2, 3 , 4, 5, 6, 7, 8, 9, 10, 11, 12 or 13, for example 1, 2, 3 or 4, further amino acid substitution (s), these preferably are selected from: 62S, 99Y, 133R, 133K, 133A, 137K, 1491, 156G, 156Y, 162S, 166M, 172G, 172P, 192V, 199M, 217M, 224A and 265A. Such proteases are disclosed, for example, in Example 1 and thus the subject of the invention. Particularly preferred are those proteases which, at the position corresponding to position 271, have an amino acid substitution, in particular the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to the positions 62, 133, 137, 162, 192, 217 or 265, at least one, for example 1, 2, 3, 4, 5, 6 or 7, for example 1, 2, 3 or 4 further amino acid substitutions, these being preferably selected from: 62S, 133R, 133K, 133A, 137K, 162S, 192V, 217M and 224A.
Claim 6: Fernandez et al disclose the protease according to claim 1, further comprising: one or more conservative amino acid substitutions created by a substitution mutagenesis:
All these facts are also applicable to the method of producing a protease according to the invention. Accordingly, a method according to the invention further comprises one or more of the following method steps: a) introduction of a single or multiple conservative amino acid substitution into the protease, wherein the protease
(a) at the position corresponding to position 271, an amino acid substitution, in particular the amino acid substitution 271 E; and
(b1) at least one of the positions corresponding to positions 18, 61, 92, 99, 137, 149, 156, 159, 162, 166, 172, 192, 199, 217 or 265, at least one more amino acid substitution; and or
(b2) at the position corresponding to position 9, an amino acid substitution, in particular selected from 9T, 9H, 9S and 9A, preferably 9T, and at least one position corresponding to the positions 29, 48, 101, 130, 131, 133 , 144, 217, 224 and 252, in particular 130, 133, 144, 217 and 252, another amino acid substitution, for example A29G, A48V, D101E, N130D, N130S, N130H, G131D, G131N, G131S, G131 K, T133K, T133R, T133Y, N144K, N144L, N144A, S224A, S224T or N252S; b) altering the amino acid sequence by fragmentation, deletion, insertion or substitution mutagenesis in such a way that the protease has an amino acid sequence which is over a length of at least 200, 210, 220, 230, 240, 250, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273 or 274 of the parent amino acid, wherein the protease
(a) at the position corresponding to position 271, an amino acid substitution, in particular the amino acid substitution 271 E; and (b1) at least one of the positions corresponding to positions 18, 61, 92, 99, 137, 149, 156, 159, 162, 166, 172, 192, 199, 217 or 265, at least one more amino acid substitution; and or
(b2) at the position corresponding to position 9, an amino acid substitution, in particular selected from 9T, 9H, 9S and 9A, preferably 9T, and at least one position corresponding to the positions 29, 48, 101, 130, 131, 133 , 144, 217, 224 and 252, in particular 130, 133, 144, 217 and 252, another amino acid substitution, for example A29G, A48V, D101E, N130D, N130S, N130H, G131D, G131N, G131S, G131 K, T133K, T133R, T133Y, N144K, N144L, N144A, S224A, S224T or N252S.
All embodiments also apply to the inventive method. In particular, each of the aforementioned proteases may additionally comprise an amino acid substitution at position 216 and / or 217 in the count according to SEQ ID NO: 1, in particular 216C and / or 217M. However, in various embodiments, it may be preferred that the protease has no substitution at position 216.
Claim 10: Fernandez et al disclose a composition, comprising: a washing or cleaning agent, the washing or cleaning agent containing at least one protease according to claim 1: Another object of the invention is an agent which is characterized in that it contains a protease according to the invention as described above. Preferably, the agent is as a washing or cleaning agent.
Claim 13: Fernandez et al disclose the protease according to claim 1, wherein the amino acid substitutions are 9T, 130D, 133A, 144K, 217M, 224A, 252T, and 271E corresponding to the amino acid substitutions at positions 9, 130, 133, 144, 217, 224, 252, and 272, respectively:
In various embodiments, the protease at the position corresponding to position 271 has an amino acid substitution, especially the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to positions 62, 99, 133, 137, 149, 156, 162, 166, 172, 192, 199, 217, 224 or 265, at least one, for example 1, 2, 3 , 4, 5, 6, 7, 8, 9, 10, 11, 12 or 13, for example 1, 2, 3 or 4, further amino acid substitution (s), these preferably are selected from: 62S, 99Y, 133R, 133K, 133A, 137K, 1491, 156G, 156Y, 162S, 166M, 172G, 172P, 192V, 199M, 217M, 224A and 265A. Such proteases are disclosed, for example, in Example 1 and thus the subject of the invention. Particularly preferred are those proteases which, at the position corresponding to position 271, have an amino acid substitution, in particular the amino acid substitution 271 E; and at the positions corresponding to positions 9, 130, 144 and 252, the amino acid substitutions 9T, 130D, 144K and 252T; and optionally at one or more of the positions corresponding to the positions 62, 133, 137, 162, 192, 217 or 265, at least one, for example 1, 2, 3, 4, 5, 6 or 7, for example 1, 2, 3 or 4 further amino acid substitutions, these being preferably selected from: 62S, 133R, 133K, 133A, 137K, 162S, 192V, 217M and 224A.
Claim(s) 1-6, 10 and 13-15 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Mussmann et al. WO2020/221579 11/5/2020 filed 4/14/2020 with priority to DE102019111057.2 filed 04/29/2019.
35 U.S.C. 102(a)(1):Applicant cannot rely upon the certified copy of the foreign priority application to overcome this rejection because a translation of said application has not been made of record in accordance with 37 CFR 1.55. When an English language translation of a non-English language foreign application is required, the translation must be that of the certified copy (of the foreign application as filed) submitted together with a statement that the translation of the certified copy is accurate. See MPEP §§ 215 and 216.
35 U.S.C. 102(a)(2): The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1-6, 10 and 13-15: Fernandez et al disclose a protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 224, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 131 and 166.
In various embodiments of the invention, the protease comprises an amino acid sequence which is at least 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77% of the total length of the amino acid sequence given in SEQ ID NO: 1 , 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 90.5%, 91%, 91, 5%, 92%, 92.5%, 93%, 93.5%, 94%, 94.5%, 95%, 95.5%, 96%, 96.5%, 97%, 97.5%, 98%, 98.5% and 98.8% identical and, based in each case on the numbering according to SEQ ID NO: 1, has the amino acid substitutions indicated above. In connection with the present invention, the feature that a protease has the specified substitutions means that it contains one (of the specified) substitution (s) at the respective position, i.e. at least the specified positions are not otherwise mutated or, for example, by fragmentation of the protease , are deleted.
In various embodiments, the protease has amino acid substitutions, especially those at positions corresponding to positions 9, 144, 252 and 271
Amino acid substitutions selected from 9T, 144K, 252T and 271 E as defined above; and at one or more of the positions corresponding to positions 53, 120, 131, 149, 159, 162, 166, 172, 189, 192, 211, 215, 217, 224 and 274, at least one, for example 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11, for example 1, 2, 3, 4, 5 or 6 further amino acid substitution (s), these being preferably selected from: 53T, 120N, 131 H , 1491, 159S, 162E, 162S, 166M, 172E, 189T, 192V, 211 N, 215A, 217M, 224A and 274C. In addition, a protease according to the invention in various further embodiments additionally has at least one further amino acid substitution at the positions which correspond to positions 130 and 133, these being preferably selected from: 130D, 130Q, 130T, 130V, 130R and 133A. Such proteases are disclosed, for example, as mutants 2-23 in Example 1 and are thus the subject of the invention.
Claim(s) 1-6, 10 and 13-15 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Mussmann et al. US 2022/0204960 6/30/2022 cited in IDS 4/14/2020 with priority to DE102019111057.2 filed 04/29/2019.
35 U.S.C. 102(a)(2): The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1-6, 10 and 13-15: Fernandez et al disclose a protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 224, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 131, 189 and 166, 211.
In various embodiments of the invention, the protease comprises an amino acid sequence which is at least 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77% of the total length of the amino acid sequence given in SEQ ID NO: 1 , 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 90.5%, 91%, 91, 5%, 92%, 92.5%, 93%, 93.5%, 94%, 94.5%, 95%, 95.5%, 96%, 96.5%, 97%, 97.5%, 98%, 98.5% and 98.8% identical and, based in each case on the numbering according to SEQ ID NO: 1, has the amino acid substitutions indicated above. In connection with the present invention, the feature that a protease has the specified substitutions means that it contains one (of the specified) substitution (s) at the respective position, i.e. at least the specified positions are not otherwise mutated or, for example, by fragmentation of the protease , are deleted.
In various embodiments, the protease has amino acid substitutions, especially those at positions corresponding to positions 9, 144, 252 and 271
Amino acid substitutions selected from 9T, 144K, 252T and 271 E as defined above; and at one or more of the positions corresponding to positions 53, 120, 131, 149, 159, 162, 166, 172, 189, 192, 211, 215, 217, 224 and 274, at least one, for example 1, 2, 3, 4, 5, 6, 7, 8, 9, 10 or 11, for example 1, 2, 3, 4, 5 or 6 further amino acid substitution (s), these being preferably selected from: 53T, 120N, 131 H , 1491, 159S, 162E, 162S, 166M, 172E, 189T, 192V, 211 N, 215A, 217M, 224A and 274C. In addition, a protease according to the invention in various further embodiments additionally has at least one further amino acid substitution at the positions which correspond to positions 130 and 133, these being preferably selected from: 130D, 130Q, 130T, 130V, 130R and 133A. Such proteases are disclosed, for example, as mutants 2-23 in Example 1 and are thus the subject of the invention.
Claim(s) 1-6, 10 and 13-15 is/are rejected under 35 U.S.C. 102 (a)(2) as being anticipated by Mussmann et al. US 2022/0154110 5/19/2022 4/14/2020 with priority to DE102019111047.5 filed 04/29/2019.
35 U.S.C. 102(a)(2): The applied reference has a common inventor with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Claim 1-6, 10 and 13-15: Fernandez et al disclose a protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 224, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 131, 211, 166.
Mussmann et al [0025]: In various embodiments, the protease comprises an amino acid sequence which, over its entire length, is at least 70%, 71%, 72%, 73%, 74%, 75%, 76%, 77%, 78%, 79%, 80%, 81%, 82%, 83%, 84%, 85%, 86%, 87%, 88%, 89%, 90%, 90.5%, 91%, 91.5%, 92%, 92.5%, 93%, 93.5%, 94%, 94.5%, 95%, 95.5%, 96%, 96.5%, 97%, 97.5%, 98%, 98.5% and 98.8% identical to the amino acid sequence given in SEQ ID NO:1, and has the amino acid substitutions given above in each case based on the numbering according to SEQ ID NO:1. In the context, the feature whereby a protease has the given substitutions means that it contains one (of the given) substitution(s) at the relevant position, i.e. at least the given positions are not otherwise mutated or deleted, for example by fragmentation of the protease.
Mussmann et al[0046]: All of these aspects are also applicable to the methods for producing a protease. Accordingly, a method further comprises one or more of the following method steps:
a) introducing one-time or multiple conservative amino acid substitution into the protease, the protease comprising amino acid substitutions, preferably the amino acid substitutions selected from 9T, 144K, 252T and 271E at the positions corresponding to positions 9, 144, 252 and 271; and having at least one further amino acid substitution at least one of the positions corresponding to positions 18, 38, 48, 89, 101, 131, 145, 147, 149, 162, 166, 172, 189, 192, 205, 211, 215, 217, 218, 224 and 274;
b) altering the amino acid sequence by fragmentation or deletion, insertion or substitution mutagenesis such that the protease comprises an amino acid sequence which matches the starting molecule over a length of at least 200, 210, 220, 230, 240, 250, 260, 261, 262, 263, 264, 265, 266, 267, 268, 269, 270, 271, 272, 273 or 274 contiguous amino acids, the protease having the substitutions 9T, 144K, 252T and 271E at the positions corresponding to positions 9, 144, 252 and 271; and at least one further amino acid substitution at least one of the positions corresponding to positions 18, 38, 48, 89, 101, 131, 145, 147, 149, 162, 166, 172, 189, 192, 205, 211, 215, 217, 218, 224 and 274.
Mussmann at [0049]: In various further embodiments, a protease also has at least one additional amino acid substitution at the positions corresponding to positions 130 and 133. In various embodiments, the at least one additional amino acid substitution is selected from 130D, 130Q, 130T, 130V and 133A.
[0019] In various other embodiments, a protease is characterized in that
e) the amino acid substitution at the position corresponding to position 131 is selected from 131H and 131D; and/or
i) the amino acid substitution at the position corresponding to position 211 is selected from 211N; and/or
k) the amino acid substitution at the position corresponding to position 89 is selected from 89A; and/or
n) the amino acid substitution at the position corresponding to position 189 is selected from 189T; and/or
q) the amino acid substitution at the position corresponding to position 217 is selected from 217M; and/or
r) the amino acid substitution at the position corresponding to position 166 is selected from 166M; and/or
t) the amino acid substitution at the position corresponding to position 224 is selected from 224A; and/or
Mussmann et al disclose claim 10, a washing or cleaning agent containing at least one protease according to claim 1. See paragraphs 21-23 and 29-30.
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 1-6, 10 and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12398386 (‘386). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘386 disclose:
Claim 1: A protease comprising: an amino acid sequence having at least 70% sequence identity with the amino acid sequence given in SEQ ID NO:1 (SEQ ID NO: 1 of the ‘386 patent claims is 100% identical to instant SEQ ID NO: 1) over its entire length encoding a protease with proteolytic activity (as evidenced by the protease exhibiting improved washing performance when compared to the protease of SEQ ID NO: 1 and the ‘386 specification at paragraph 10-11 discloses that the protease of the ‘386 claims encodes a protease with proteolytic activity); wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 6, 89, 131, 166, 189, 211 and 224.
Thus, the protease of the ‘386 claims renders prima facie obvious:
A protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1, (a) amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217,224, 252, and 271; and, (b) one or more further amino acid substitutions at the positions corresponding to positions 6, 89, 131, 166, 189, and 211.
This is because at least 70% sequence identity given the sequence of SEQ ID NO: 1 renders prima facie obvious at least at least 80% sequence identity to SEQ ID NO: 1. In addition, “one or more further amino acid substitutions at the positions corresponding to positions 6, 89, 131, 166, 189, 211 and 224” of the ‘386 claims renders prima facie obvious instant claim 1 part (a) amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217,224, 252, and 271. The ‘386 claims disclose all the other positions amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217 252, and 271 in instant claim 1 part a.
Claim 2: The ‘386 claims disclose the protease has (1) the amino acid substitutions 9T, 130D/V, 133A, 144K, 217M, 252T, 271E; and
,(2) the one or more further amino acid substitutions selected from 6W/F, 89A, 89G, 131H, 131Y, 131F, 189T, 189L, 189 I, 211N, 211Q, 224A, and 224G.
Claim 3. The 386 claims disclose protease according to claim1, wherein the (1)amino acid substitutions occur at 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E; and(a) one or more further amino acid substitutions occur at 131H and 189T; (b) 89A and 131H;(c) 89A and 189T; or (d) 89A, 131H and 189T. See claim 2-5 of the ‘386 claims.
Claim 4: The ’386 claims disclose the protease according to claim 3, wherein the amino acid substitutions are 9T, 130D, 133A, 144K, 217M, 252T, and 271E; and, wherein the one or more further amino acid substitutions are:(a) 131H and 189T; (b) 89A and 131H;(c) 89A and 189T; or (d) 89A, 131H and 189T. See claims 2-5 of the ‘386 claims.
Claim 5: The ‘386 claims disclose the protease according to claim 3, wherein the amino acid substitutions are 9T, 130V, 133A, 144K, 217M, 252T, and 271E; and, wherein the one or more further amino acid substitutions are:(a) 131H and 189T;(b) 89A and 131H;(c) 89A and 189T; or (d) 89A, 131H and 189T. See claims 2-5 of the ‘386 claims.
Claim 6: The ‘386 claims disclose the protease according to claim 1, further comprising: one or more conservative amino acid substitutions created by at least one of: fragmentation, deletion, insertion mutagenesis, substitution mutagenesis, and combinations thereof. See claim 6 of the ‘386 claims.
Claim 10: The ‘386 claims disclose a composition, comprising: a washing or cleaning agent, the washing or cleaning agent containing at least one protease according to claim 1.
Claim 13: The ‘386 claims disclose the protease according to claim 1, wherein the amino acid substitutions are 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E corresponding to the amino acid substitutions at positions 9, 130, 133, 144, 217, 224, 252, and 272, respectively. See claims 2-5 of the ‘386 claims.
Claim 14: The ‘386 claims disclose the protease according to claim 1, wherein the one or more further amino acid substitutions are selected from 89A/G, 131H/Y/F, and 189T/L/I corresponding to positions 89, 131, and 189, respectively. See claims 2-5 of the ‘386 claims.
Claim 15: The ‘386 claims disclose the protease according to claim 1, wherein the one or more further amino acid substitutions are selected from 89A, 131H, and 189T corresponding to positions 89, 131, and 189, respectively. See claims 2-5 of the ‘386 claims.
Claims 1-6, 10 and 13-15 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 12492360 (‘360). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘360 disclose:
Claim 1: A protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 (SEQ ID NO: 1 of the ‘360 patent claims is 100% identical to instant SEQ ID NO: 1) over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 224, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 6, 89, 131, 166, 189 and 211.
Thus, the protease of the ‘360 claims renders prima facie obvious the instant protease of claim 1:
Claim 2: The ‘360 claims disclose the protease has (1) the amino acid substitutions 9T, 130D/V, 133A, 144K, 217M, 252T, 271E; and
(2) the one or more further amino acid substitutions selected from 6W/F, 89A, 131H, 131Y, 131F, 189T, 189L, 189 I, 211N, 211Q, 224A, and 224G.
Claim 3. The ‘360 claims disclose protease according to claim1, wherein the (1)amino acid substitutions occur at 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E; and(a) one or more further amino acid substitutions occur at 131H and 189T; (b) 89A and 131H;(c) 89A and 189T; or (d) 89A, 131H and 189T. See claim 2-3 of the ‘360 claims.
Claim 4: The ’360 claims disclose the protease according to claim 3, wherein the amino acid substitutions are 9T, 130D, 133A, 144K, 217M, 252T, and 271E; and, wherein the one or more further amino acid substitutions are:(a) 131H and 189T; (b) 89A and 131H;(c) 89A and 189T; or (d) 89A, 131H and 189T. See claims 2-3 of the ‘360 claims.
Claim 5: The ‘360 claims disclose the protease according to claim 3, wherein the amino acid substitutions are 9T, 130V, 133A, 144K, 217M, 252T, and 271E; and, wherein the one or more further amino acid substitutions are:(a) 131H and 189T;(b) 89A and 131H;(c) 89A and 189T; or (d) 89A, 131H and 189T. See claims 2-3 of the ‘360 claims.
Claim 6: The ‘360 claims disclose the protease according to claim 1, further comprising: one or more conservative amino acid substitutions created by at least one substitution mutagenesis. See claim 1-3 of the ‘360 claims.
Claim 10: The ‘360 claims disclose a composition, comprising: a washing or cleaning agent, the washing or cleaning agent containing at least one protease according to claim 1.
Claim 13: The ‘360 claims disclose the protease according to claim 1, wherein the amino acid substitutions are 9T, 130D/V, 133A, 144K, 217M, 224A, 252T, and 271E corresponding to the amino acid substitutions at positions 9, 130, 133, 144, 217, 224, 252, and 272, respectively. See claims 2-3 of the ‘360 claims.
Claim 14: The ‘360 claims disclose the protease according to claim 1, wherein the one or more further amino acid substitutions are selected from 89A, 131H/Y/F, and 189T/L/I corresponding to positions 89, 131, and 189, respectively. See claims 1-3 of the ‘360 claims.
Claim 15: The ‘386 claims disclose the protease according to claim 1, wherein the one or more further amino acid substitutions are selected from 89A, 131H, and 189T corresponding to positions 89, 131, and 189, respectively. See claims 1-3 of the ‘360 claims.
Claims 1, 6 and 10 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11739310 (‘310). Although the claims at issue are not identical, they are not patentably distinct from each other because the ‘310 disclose:
Claim 1: A protease comprising: an amino acid sequence having at least 70% sequence identity with the amino acid sequence given in SEQ ID NO:1 (SEQ ID NO: 1 of the ‘310 patent claims is 100% identical to instant SEQ ID NO: 1) over its entire length encoding a protease with proteolytic activity (as evidenced by the ‘310 specification); wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1,
amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 252, and 271; and
one or more further amino acid substitutions at the positions corresponding to positions 131, 166, and 224.
Thus, the protease of the ‘310 claims renders prima facie obvious:
A protease comprising: an amino acid sequence having at least 80% sequence identity with the amino acid sequence given in SEQ ID NO:1 over its entire length encoding a protease with proteolytic activity; wherein the protease has, in each case based on the numbering according to SEQ ID NO: 1, amino acid substitutions at the positions corresponding to positions 9, 130, 133, 144, 217, 252, and 271; and one or more further amino acid substitutions at the positions corresponding to positions 131, 166, and 224.
This is because at least 70% sequence identity given the sequence of SEQ ID NO: 1 renders prima facie obvious at least at least 80% sequence identity to SEQ ID NO: 1.
Claim 6. The ‘310 claims disclose the protease according to claim 1, further comprising: one or more conservative amino acid substitutions created substitution mutagenesis,.
Claim 10: The ‘310 claims disclose a composition, comprising: a washing or cleaning agent, the washing or cleaning agent containing at least one protease according to claim 1-the ‘310 claims the protease is the washing or cleaning agent.
Status of Claims
Claims 7-9 and 11 are withdrawn. Claims 1-6, 10 and 13-15 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OLUWATOSIN A OGUNBIYI whose telephone number is (571)272-9939. The examiner can normally be reached IFP.
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, Michael Allen can be reached at 5712703497. 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.
/OLUWATOSIN A OGUNBIYI/Primary Examiner, Art Unit 1645
Prosecution Insights