DETAILED ACTION
Objections and rejections raised in prior Office Actions are withdrawn unless restated below.
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 .
Claim Interpretation
Claim 16 is directed towards a product wherein embodiment alpha-amylase variants are not required to be made by any process nor from any specific “parent alpha-amylase” or any “parent” alpha-amylase at all. See MPEP 2113(I). For example, an embodiment of claim 16 can be made from solid phase peptide synthesis without involvement of DNA nor a living host cell. As such, the parent alpha-amylase recited in claim 16 does not define the scope of the embodiments of the claim 16 except for providing a reference for which a required improved performance is evaluated. In this regards, the “parent” alpha-amylase can be any second alpha-amylase including an alpha amylase that is itself an embodiment alpha-amylase variant of claim 16. For example, if an embodiment of claim 16 is identical to SEQ ID NO: 1 with substitution D118Q, the following (and many more) are all parent alpha-amylases:
-any of SEQ ID NO: 1-14.
-an alpha-amylase with 85% identity to any of SEQ ID NO: 1-14,
-an alpha-amylase with 99% identity to any of SEQ ID NO: 1-14.
The above discussion is to emphasize that a parent alpha-amylase is a broad genus of alpha-amylase for any one embodiment of claim 16 (and dependent claims). This interpretation of the claims is reinforced by claim 23 reciting that a parent alpha-amylase can have at least 85% identity to SEQ ID NOS: 1-14, which encompasses a very large number of individual parent species.
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.
Claims 16-29 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 16 recites “a modification at one or more positions corresponding to position 118 using SEQ ID NO: 1 for numbering.” However, claim 16 does not recite what reference is used for determining if a modification is present at position 118. Any embodiment requires at least 85% identity to one of SEQ ID NOS: 1-14 wherein it appears that any of SEQ ID NOS: 1-14 can be used as a reference for whether a modification is present. SEQ ID NO: 1 has a D amino acid at position 118 and SEQ ID NO: 3 has a L amino acid at position 118, wherein SEQ ID NOS: 1 and 3 have about 95% identity to one another. As such, for example, it is not clear if a polypeptide having about 86% identity to both of SEQ ID NOS: 1 and 3 with a L amino acid at position 118 is or is not an embodiment of claim 16, since a modification is present at position 118 relative to SEQ ID NO: 1 but not SEQ ID NO: 3. For this reason an ordinarily skilled artisan cannot determine how to avoid infringement of claim 16. It is noted that claim 17 is only considered to be further limiting to claim 16 since claim 17 defines the amino acid residues considered not to be a modification. The broadest reasonable interpretation of claims 16 and 17 includes the substitution D116L and any other substitution to an amino acid residue other than Asp.
Claims 20 and 24 recites a transitional phrase “comprises or consists of.” MPEP 2111.03 does not define the meaning of “comprises or consists of” and it is unclear if such phrases means “comprises” only or an unclear hybrid transitional phrase that somehow differs from the meaning of either “comprises” or “consists of.” Sine the effect or scope of “comprises or consists of” is not clear, an ordinarily skilled artisan cannot determine how to avoid infringement of these claims.
Claim 16 recites “Improvement Factor (IF) > 1.0, when compared to said parent alpha-amylase. The Claim Interpretation set forth above is interpreted above. As stated above, for any specific embodiment alpha-amylase variant of claim 16, a “parent alpha-amylase” is a broad genus of alpha-amylases for any one embodiment of claim 16 (and dependent claims). That is, if a specific embodiment of claim 16 is SEQ ID NO: 1 with modifications H1*+ G7A+R180*+S181*+ D118T+Y242F+E259G+N279S+G303R+E390A +G475K, a “parent alpha-amylase” can be any of SEQ ID NOS: 1-14 plus any number of additional polypeptides that can be a parent that can including 1000’s, 10,000’s or even more polypeptide that can be considered to be a parent alpha-amylase or “said parent polypeptide.” Since claim 16 recites IF>1.0, such claim terms is required to be definite. The specification, in Example 2, appears to define IF as:
Improvement Factor (IF)=[Specific Activity of Hybrid polypeptide]/[Specific Activity of parent polypeptide (alpha-amylase)]
The above is understood as stating that any particular embodiment has one value for IF. However, in order for there to be one value of IF, the ratio defining IF has to be calculated with a specific activity of a specific parent polypeptide such that one value of IF is calculable. However, as discussed, a parent alpha-amylase or polypeptide is a diverse genus of polypeptides since embodiments of the claims are not required to be made by any specific process or from any parent polypeptide at all. See MPEP 2113(I). For example, if a specific embodiment of claim 16 is SEQ ID NO: 1 with modifications H1*+ G7A+R180*+S181*+ D118T+Y242F+E259G+N279S+G303R+E390A +G475K, a different value of IF will be obtained for each of parent polypeptides of SEQ ID NOS: 1-14. Claim 23 includes parent-alpha amylases with at least 85% identity to any of SEQ ID NOS: 1-14 which covers alpha-amylase with a broad diversity of activities. That is, for any specific embodiment of claim 16 for an alpha-amylase variant, an unlimited number of IF values can be calculated since the identity of a parent alpha-amylase or polypeptide is arbitrary. For this reason, an ordinarily skilled artisan is unable to determine how to avoid infringement of IF>1.0 in the absence of any specific parent alpha-amylase or polypeptide required for calculating value of IF. Further, a value of IF is subject to different calculations depending upon the specific assay used to calculate “specific activity” of any alpha-amylase. Example 2 describes one example of calculating specific activity with a specific model detergent A. However, Example 2 is considered to only an exemplary and non-limiting manner of calculating specific activity. For this reason, IF has no specific meaning defined by the specification such that an ordinarily skilled artisan cannot determine how to avoid infringement.
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.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(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.
Claim(s) 16-20, 23, and 25-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Estell et al. (U.S. 2015/0087573 A1).
Estell, abstract, states:
Described are compositions and methods relating to variant alpha-amylases having altered biochemical properties and advantageous performance characteristics as compared to a reference alpha-amylase. The variants are suitable for use in various industrial applications such as starch conversion, ethanol production, laundry, dishwashing, pulp and paper production, textile desizing, and/or sweetener production.
“In one aspect, an isolated alpha-amylase variant is provided, wherein the variant is a mature form of alpha-amylase having amylase activity, and comprising a substitution at one or more positions selected from the group consisting of 1, 2, 3, 4, 5, 7, 15, 16, 17, 18, 19, 22, 25, 26, 28, 29, 30, 32, 35, 36, 37, 50, 51, 52, 53, 54, 55, 56, 59, 60, 70, 71, 72, 73, 75, 78, 83, 87, 90, 91, 93, 94, 95, 104, 105, 107, 108, 110, 112, 113, 116, 118, 125, 126, 128, 129, 130, 131, 134, 136, 138, 142, 144, 147, 149, 150, 152, 154, 156, 158, 160, 161, 162, 165, 166, 168, 169, 170, 172, 174, 177, 178, 182, 183, 185, 189, 192, 195, 197, 201, 202, 203, 207, 210, 214, 217, 221, 228, 234, 236, 237, 246, 250, 254, 255, 257, 264, 267, 269, 270, 272, 275, 279, 283, 284, 298, 301, 303, 305, 306, 310, 311, 314, 318, 319, 320, 322, 323, 336, 337, 338, 339, 340, 344, 359, 374, 375, 376, 377, 379, 381, 382, 393, 394, 399, 401, 407, 408, 419, 433, 436, 438, 444, 447, 448, 451, 453, 459, 465, 470, 475, 476, 483, and 484; wherein the positions correspond to amino acid residues in the amino acid sequence set forth in SEQ ID NO: 2.” Estell, para. [0009].
An alignment between recited SEQ ID NO: 12 and SEQ ID NO:2 of Estell is as follows:
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“According to the present disclosure any α-amylase, may be used as the parent (i.e., backbone) α-amylase. In a preferred embodiment the parent α-amylase is BASE (AmyTS23t) having the amino acid sequence shown in SEQ ID NO: 2.” Estell, para. [0168].
“In a further aspect, important mutations (including amino acid substitutions and deletions) with respect to obtaining variants exhibiting altered specific activity, in particular increased or decreased specific activity, especially at temperatures from 10-60° C., preferably 20-50° C., especially 30-40° C., include any of the mutations described herein. The specific activity may be determined as described in the “Methods” section below.” Estell, para. [0185].
Estell, in the claims, state:
1. An isolated alpha-amylase variant, wherein said variant is a mature form of alpha-amylase having amylase activity, and comprising a substitution at one or more positions selected from the group consisting of 1, 2, 3, 4, 5, 7, 15, 16, 17, 18, 19, 22, 25, 26, 28, 29, 30, 32, 35, 36, 37, 50, 51, 52, 53, 54, 55, 56, 59, 60, 70, 71, 72, 73, 75, 78, 83, 87, 90, 91, 93, 94, 95, 104, 105, 107, 108, 110, 112, 113, 116, 118, 125, 126, 128, 129, 130, 131, 134, 136, 138, 142, 144, 147, 149, 150, 152, 154, 156, 158, 160, 161, 162, 165, 166, 168, 169, 170, 172, 174, 177, 178, 182, 183, 185, 189, 192, 195, 197, 201, 202, 203, 207, 210, 214, 217, 221, 228, 234, 236, 237, 246, 250, 254, 255, 257, 264, 267, 269, 270, 272, 275, 279, 283, 284, 298, 301, 303, 305, 306, 310, 311, 314, 318, 319, 320, 322, 323, 336, 337, 338, 339, 340, 344, 359, 374, 375, 376, 377, 379, 381, 382, 393, 394, 399, 401, 407, 408, 419, 433, 436, 438, 444, 447, 448, 451, 453, 459, 465, 470, 475, 476, 483, and 484;
wherein the positions correspond to amino acid residues in the amino acid sequence set forth in SEQ ID NO: 2; and
wherein the substitution of the naturally-occurring amino acid residue at the one or more positions for a different amino acid residue produces an alpha-amylase variant having a performance index >1.0 for a measure of stability, and a performance index >1.0 for a measure of activity.
“As used herein, the term “performance index (PI)” refers to the ratio of performance of a variant to a parent or reference amylase.” Estell, para. [0113].
As such, a performance index of greater than >1.0 for a measure of activity is understood as description of an Improvement Factor (IF) > 1.0 for specific activity.
As such, Estell describes an alpha-amylase variant of parent enzyme that is identical to recited SEQ ID NO: 12 except for having a substitution to position 118 (Asp residue in recited SEQ ID NO: 12, SEQ ID NO: 2 of Estell, and corresponding to position 118 of recited SEQ ID NO: 1) including any additional substitutions as described to achieve “a performance index >1.0 for a measure of activity” which is understood to satisfy the claim limitation of improved wash performance determined by an Improvement Factor (IF) > 1.0 when compared to said parent alpha-amylase.
Regarding claim 19, Estell, claim 9, meets the features of claim 19.
Regarding claims 18 and 20, Estell, claim 1, indicates that substitution at position 118 can be to any residue. Table 7-1 indicates that substitution can specifically be D118T or D118Q, wherein Estell, claim 9, further indicate that deletion of positions 180 and 181 can be present in any embodiment of claim 1 of Estell.
Regarding claim 25, Estell, paras. [0200]-[0216], indicate that alpha-amylase variant embodiments are produced by introducing mutations into encoding DNA of a “parent” alpha-amylase and expressing the same in a suitable host cell to produce alpha-amylase variants. In embodiments wherein D118 is modified/substituted, the same meets the features of claim 25. Similarly, in embodiments wherein a substitution D118T/Q is combined with deletion of positions 180 and 181, the features of claim 26 are met.
Regarding claims 27-28, “Generally, the detergent composition may be in any convenient form, e.g., a bar, a tablet, a powder, a granule, a paste, or a liquid. A liquid detergent may be aqueous, typically containing up to about 70% water, and 0% to about 30% organic solvent. Compact detergent gels contained for example about 30% water or less.” Estell, para. [0285].
Claim(s) 16-17, 19, 23-24, and 27-29 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kaasgaard et al. (U.S. 2014/0141489 A1) (previously cited).
Kaasgaard, et al., abstract:
The present invention relates to variants of a parent alpha-amylase. The present invention also relates to polynucleotides encoding the variants; nucleic acid constructs, vectors, and host cells comprising the polynucleotides; and methods of using the variants.
Kaasgaard, in the claims, state:
1. An isolated variant of a parent alpha-amylase, comprising an alteration at two or more (several) positions corresponding to positions G304, W140, W189, D134, E260, F262, W284, W347, W439, W469, G476, and G477 of the mature polypeptide of SEQ ID NO: 1, wherein each alteration is independently a substitution, deletion or insertion, and wherein the variant has at least 80%, or at least 87%, but less than 100% sequence identity with the mature polypeptide of any of SEQ ID NOs 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12, and wherein the variant has alpha-amylase activity.
7. The variant according to claim 1, which comprises substitutions at two, three or four positions selected from the group consisting of G304R, W140YF, E260 GHIKNRTY and G476EK.
“In one embodiment, the variant further comprises one or more substitutions selected from the group consisting of T51IL, S52Q, N54K, G109A, E194D, N195F, V206Y, Y243F, G109A, G273DV, G337N, K72R, R181H, S303G and Y100I. In a preferred embodiment the one or more further substitutions are selected from the group consisting of N195F, V206Y, Y243F. Preferably, the variant comprises two or three of these substitutions. Hereby, variants are provided that have improved wash performance at low temperature as well as improved stability to Ca2+ depletion, compared to the parent alpha-amylase or compared to the alpha-amylase of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12.” Kaasgaard, para. [0164].
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An alignment between recited SEQ ID NO: 1 and SEQ ID NO: 1 of Kaasgaard is as follows:
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As seen in the alignment above, SEQ ID NO: 1 Kaasgaard has at least about 95% identity to recited SEQ ID NO: 1 wherein SEQ ID NO: 1 Kaasgaard has specific substitution D118L relative to recited SEQ ID NO: 1. Claim 16 does not require “a parent alpha-amylase” to have any specific identity such that SEQ ID NO: 1 of Kaasgaard is a parent alpha-amylase that further meets the requirements of claim 23.
Kaasgaard, as indicated above, teaches variant alpha-amylases having improved properties including “improved wash performance at low temperature as well as improved stability to Ca2+ depletion, compared to the parent alpha-amylase.” However, Kaasgaard does not specifically discuss an “Improvement Factor (IF)” as recited. The specification defines “Improvement Factor” as an increase in specific activity of an embodiment variant alpha-amylase relative to an undefined parent “alpha-amylase” and under undefined conditions for measuring such specific activity. However, it is apparent that a variant alpha-amylase that has “improved stability to Ca2+ depletion” will have improved specific activity relative to a “parent” alpha-amylase under conditions of Ca2+ depletion, since such parent alpha-amylase with less stability (i.e. greater fraction of enzyme being denatured or in an inactive state) necessarily has less specific activity. The specification also discusses “improved wash performance determined y an Improvement Factor (IF)>1.0” in general terms of any improvement is washing or stain removal. Specification, page 9. As such, the description of improved wash performance at low temperature and/or improved stability under Ca2+ depletion is a description that substituted embodiments of SEQ ID NO: 1 of Kaasgaard having over 85% identity to recited SEQ ID NO: 1 with substitution D118L inherently have an Improvement Factor (IF)>1 as recited relative to some parent alpha-amylase, wherein the numerical value of IF>1 is satisfied whenever an embodiment variant alpha-amylase has an improved wash performance relative to a parent alpha-amylase.
Regarding claims 27-29, Example 1B of Kaasgaard describes that it is appropriate to include any alpha-amylase disclosed in a heavy duty liquid detergent composition. “According to the invention, the above alpha-amylase variants may typically be a component in a cleaning composition, such as a detergent composition, e.g., a laundry detergent composition or a dishwashing detergent composition. Especially preferred is a liquid laundry detergent composition.” Kaasgaard, para. [0235].
Further regarding claims 24, Kaasgaard directly states making a the mutations described therein, to SEQ ID NO: 7 of Kaasgaard that is identical to recited SEQ ID NO: 3. Recited SEQ ID NO: 3 and SEQ ID NO: 7 of Kaasgaard have over 85% identity to recited SEQ ID NO: 1 and includes a substitution D118R relative to recited SEQ ID NO: 1. More specifically, Table 3 of Kaasgaard discloses several point mutations of SEQ ID NO: 7 of Kaasgaard (recited SEQ ID NO: 3) having maintaining a substitution D118R relative to recited SEQ ID NO: 1 having an improved wash performance relative to an alpha-amylase having recited SEQ ID NO: 3 (i.e. SEQ ID NO: 7). Such improved wash performance is understood as meeting the limitations of “Improvement Factor (IF)”>1 as recited in claim 16. For example, Kaasgaard expressly state making these same mutations to an alpha-amylase having any of SEQ ID NOS: 1-12 of Kaasgaard as indicated in claim 12 of Kaasgaard, which is indicated to result in improved wash performance relative to base sequences SEQ ID NOS: 1-12, wherein SEQ ID NO: 7 of Kaasgaard is recited SEQ ID NO: 3.
As discussed above, Kaasgaard does not use the specific claim terminology “Improvement Factor (IF)” as recited. The specification defines “Improvement Factor” as an increase in specific activity that increases wash performance of an embodiment variant alpha-amylase relative to an undefined parent “alpha-amylase” and under undefined conditions for measuring such specific activity. However, it is apparent that a variant alpha-amylase that has “improved stability to Ca2+ depletion” or “improved wash performance at low temperature” will have improved specific activity relative to a “parent” alpha-amylase under conditions of Ca2+ depletion or low temperature. As such, the description of improved stability to Ca2+ depletion or improved wash performance at low temperature is a description that substituted embodiments of SEQ ID NO: 7 of Kaasgaard having over 85% identity to recited SEQ ID NO: 1 with substitution D118R inherently have an Improvement Factor (IF)>1 as recited. It is noted that embodiments of claim 24 are not required to be made by any process involving any of recited SEQ ID NOS: 1, 2 or 3 nor to be made from any parent alpha-amylase; for example, embodiment variants can be made by solid-phase peptide synthesis. “[E]ven though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process." MPEP 2113(I).
Regarding claims 19 and 20, “The variants may further comprise an alteration at one or more (several) other positions. For example, the variants may comprise an alteration at a position corresponding to positions G182*+D183* or D183*+G184*.” Kaasgaard, para. [0166]. It is noted that positions 182-184 of SEQ ID NO: 1 of Kaasgaard correspond to positions 181-183 of recited SEQ ID NO: 1.
From Table 8, para. [0286] of Kaasgaard:
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Such a variant meets the features of claims 19, 20 and 26, wherein as discussed, a variant having improved stability under Ca2+ depleted conditions inherently has IF>1.0 as recited in claim 16.
Claim Rejections - 35 USC § 103
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.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claim(s) 16-20, 23, and 25-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Estell et al. (U.S. 2015/0087573 A1).
The rejection of claims 16-20, 23 and 25-29 under 35 U.S.C. 102(a)(1) as being anticipated by Estell et al. (U.S. 2015/0087573 A1) is incorporated herein by reference.
While the rejected claims are anticipated by Estell for the reasons stated above, in the event that is argued that Estell does not disclose an improved wash performance determined by an Improvement Factor (IF)>1.0 as compared with an undefined parent alpha-amylase and under undefined conditions, the following is noted.
“"[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims.” MPEP 2112(V). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP 2112.01.
Here, as discussed, Estell teaches a variant alpha-amylase identical to recited SEQ ID NO: 12 having a substitution at position 118 (according to numbering of recited SEQ ID NO: 1) being “an alpha-amylase variant having a performance index >1.0 for a measure of stability, and a performance index >1.0 for a measure of activity.” The same prior art variant alpha-amylase is at least substantially identical in structure as to the claimed alpha-amylase variants as to possess the recited characteristic of an Improvement Factor (IF)>1.0 as compared with an undefined parent alpha-amylase wherein an “Improvement Factor” as recited and a “performance index” as taught by Estell appear to be synonyms or substantially overlap in scope particular in view of an Improvement Factor (IF)>1.0 being an indefinite claim term as stated above under the rejections under 35 U.S.C. 112(b), which are incorporated herein by reference.
Similarly, as far as it may be argued that Estell does not anticipate such a variant alpha-amylase specifically including the substitution D118T/Q to SEQ ID NO: 2 of Estell, and/or the substitution D118T/Q to SEQ ID NO: 2 of Estell in combination with deletion of position 180 and 181 (i.e. R180 and S181), as discussed, claim 1 of Estell directly recites a substitution at position 118 wherein Table 7-1 exemplifies specific substitutions D181T and D181Q. As such, in forming embodiments of variant alpha-amylase variants wherein D118 is substituted, an ordinarily skilled artisan at time of filing would have been motivated to mutated to any amino acid exemplified by Estell including Thr or Gln. Further, claim 9 of Estell states that any embodiment variant alpha-amylase can include deletion of positions 180 and 181 (i.e. R180 and S181) such that an ordinarily skilled artisan at time of filing would have been motivated to deletion R180 and S181 in any embodiment of claim 1 of Estell since Estell directly teaches doing the same.
Claim(s) 16-17, 19, 23-24, and 27-29 is/are rejected under 35 U.S.C. 103 as being unpatentable over Kaasgaard et al. (U.S. 2014/0141489 A1).
While the rejected claims are anticipated by Kaasgaard for the reasons stated above, in the event that is argued that Kaasgaard does not disclose an improved wash performance determined by an Improvement Factor (IF)>1.0 as compared with an undefined parent alpha-amylase and under undefined conditions, the following is noted.
“"[T]he PTO can require an applicant to prove that the prior art products do not necessarily or inherently possess the characteristics of his [or her] claimed product. Whether the rejection is based on ‘inherency’ under 35 U.S.C. 102, on ‘prima facie obviousness’ under 35 U.S.C. 103, jointly or alternatively, the burden of proof is the same." In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433-34 (CCPA 1977) (footnote and citation omitted). The burden of proof is similar to that required with respect to product-by-process claims.” MPEP 2112(V). “Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established.” MPEP 2112.01.
Here, as discussed, Kaasgaard teaches a variant alpha-amylase at least 90% identical to recited SEQ ID NO: 1 having a substitution at position 118 (according to numbering of recited SEQ ID NO: 1) relative to SEQ ID NO: 1. The variant alpha-amylases are taught as having various improved properties related to stability in Ca2+ deficient and otherwise having improved wash performance. “Hereby, variants are provided that have improved wash performance at low temperature as well as improved stability to Ca2+ depletion, compared to the parent alpha-amylase or compared to the alpha-amylase of SEQ ID NO: 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 11 or 12.” Kaasgaard, para. [0164].
An alpha-amylase variant having “improved wash performance” being SEQ ID NO: 1 of Kaasgaard with the taught substitutions reviewed above or SEQ ID NO: 7 of Kaasgaard (identical to recited SEQ ID NO: 3) with the taught substitutions reviewed above or SEQ ID NO: 7 of Kaasgaard and having “improved was performance is at least substantially identical in structure as to the claimed alpha-amylase variants as to possess the recited characteristic of an Improvement Factor (IF)>1.0 as compared with an undefined parent alpha-amylase wherein an “Improvement Factor” as recited and a “performance index” as taught by Estell appear to be synonyms or substantially overlap in scope particular in view of an Improvement Factor (IF)>1.0 being an indefinite claim term as stated above under the rejections under 35 U.S.C. 112(b), which are incorporated herein by reference. That is, improved wash performance as set forth by Kaasgaard means that the performance of embodiment variant alpha-amylase is better than a related parent alpha-amylase as to have an IF>1.0 as recited in the claims.
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 16-29 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 2, 5-16 and 18 of copending Application No. 17/841,161 in view of Kaasgaard et al. (U.S. 2014/0141489 A1).
SEQ ID NO: 1 as recited and SEQ ID NO: 1 of the copending claims are identical.
Copending claims in part recite:
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Copending claim 9 anticipate claims 16-24. Claims 25 and 26 are anticipated by copending claim 15 and 16. Claim 26 is anticipated by copending claim 16.
Regarding claims 28 and 29, the rejections under 35 U.S.C. 102 over Kaasgaard et al. (U.S. 2014/0141489 A1) above are incorporated herein by reference. Kaasgaard teaches that it is well established in the prior art to incorporate a alpha-amylase with high sequence identity to SEQ ID NO: 1 of the copending claims into a liquid laundry detergent such that an ordinarily skilled artisan at the time of filing would have been motivated to formulate the cleaning compositions of the copending claims as a liquid laundry detergent.
This is a provisional nonstatutory double patenting rejection.
Response to arguments
Applicant argues:
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The Examiner disagrees for the reasons stated in the rejections above. It is noted that further rejections over Estell et al. are necessitated by applicant’s amendments. Similarly, the applicant makes no specific arguments regarding the rejections under 112(b) or for double patenting other than stating that asserted amendments overcome the rejections.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TODD M EPSTEIN whose telephone number is (571)272-5141. The examiner can normally be reached Mon-Fri 9:00a-5:30p.
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, Robert Mondesi can be reached at (408) 918-7584. 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.
/TODD M EPSTEIN/Primary Examiner, Art Unit 1652
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