DETAILED ACTION
Examiner’s note
Please note that the examiner of record has changed. Please address any subsequent correspondences to Georgiana Reglas, Examiner AU1651.
Status of claim rejections
The rejections of record under 35 USC 112(a) has been withdrawn in view of Applicant’s amendments in the response filed 06/30/2026. Note that the rejections have been recast against newly added claim 17.
The rejections under 35 USC 101 have been maintained and modified in view of Applicant’s amendments/arguments in the response filed 06/30/2026.
This Action is FINAL, as necessitated by Applicant’s amendments.
Election/Restrictions
The examiner notes that in response to the Restriction Requirement on 12/22/2025, Applicant elected Group I, claims 1-2, 6, 8-12, and 15-16, drawn to a tannase variant and a washing or cleaning agent comprising the tannase variant. It is noted in Applicant’s response to arguments filed 06/30/2026, Applicant has amended claim 1 to recite “a washing or cleaning agent” and withdrew claim 6 (which is drawn to a non-human host cell comprising the tannase variant according to claim 1). As such, claim 6 is no longer under consideration.
New Claim Objections, Necessitated by Applicant’s Amendments
Claim 2 is objected to because of the following informalities: claim 1, as amended, is drawn to “a washing or cleaning agent comprising a tannase variant”. Instant claim 2 recites “the tannase variant of claim 1”. For consistency, the claim should be amended to recite “the washing or cleaning agent of claim 1, wherein. . .” Appropriate correction is required.
New/Modified Claim Rejections - 35 USC § 112(a), Necessitated by Applicant’s Amendments
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 17 is rejected 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the inventor was in possession of the claimed genus. See, e.g., Ariad Pharm., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1340, 94 USPQ2d 1161, 1167 (Fed. Cir. 2010); University of California v. Eli Lilly & Co., 119 F.3d 1559, 43 USPQ2d 1398 (Fed. Cir. 1997) at 1406; Juno Therapeutics, Inc. v. Kite Pharma, Inc., 10 F.4th 1330, 1337, 2021 USPQ2d 893 (Fed. Cir. 2021) ("[T]he written description must lead a person of ordinary skill in the art to understand that the inventor possessed the entire scope of the claimed invention. Ariad, 598 F.3d at 1353–54 ('[T]he purpose of the written description requirement is to ensure that the scope of the right to exclude, as set forth in the claims, does not overreach the scope of the inventor's contribution to the field of art as described in the patent specification.' (internal quotation marks omitted).").
A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 USPQ2d 1780, 1790 (Fed. Cir. 2014). The issue is whether the skilled artisan would understand inventor to have invented, and been in possession of, the invention as claimed.
Newly added claim 17 recites “A washing or cleaning agent, comprising: a tannase variant with tannin-depleting activity with an amino acid sequence having a sequence identity of at least 85% to the amino acid sequence given in SEQ ID NO:1 over its entire length; and, at least one surfactant; wherein the concentration of the at least one tannase variant ranges from 0.005 to 15 wt% based on the active protein; wherein the agent has an improved cleaning performance compared to the same agent in the absence of the tannase variant on one more tannase-sensitive stains selected from: a bleachable stain, a tannin-containing stain, a tannin-derivative-containing stain, and combinations thereof.” Under broadest reasonable interpretation, the claim encompasses a cleaning agent having a tannase variant with an amino acid sequence having a sequence identity of at least 85% to the amino acid sequence given in SEQ ID NO:1, where the agent has an improved cleaning performance compared to the same agent in the absence of the tannase variant on one more tannase-sensitive stains selected from: a bleachable stain, a tannin-containing stain, a tannin-derivative-containing stain, and combinations thereof and the “improved cleaning performance” seems to be functional language derived from the use of the claimed tannase variant.
The instant specification does not provide adequate written description support for the full scope of the claimed genus of tannase variants defined by sequence identity threshold(s) and functional limitations (i.e., tannase variants having at least 85% identity to SEQ ID NO.1 and maintaining enzymatic activity in a washing or cleaning composition).
It was well known in the art before the effective filling date of the instant invention that tannase variants are defined by sequence identity, and their ability to retain enzymatic activity; and tannase enzyme activity is tied to specific structural features and catalytic residues.
As evidenced by Japanese Patent JP4370395B2 (2009; hereafter Masayuki, previously cited), teaches “a protein having tannase activity comprising an amino acid sequence in which one or more amino acids are added, deleted, or substituted in animo acid sequence by SEQ ID NO:1” (Paragraph 0010); which shows that variants of tannase enzymes are known by sequence variations within tannase proteins. Additionally, Masayuki teaches, “a tannase protein having an amino acid sequence having 65% or more sequence homology with the amino acid sequence represented by SEQ ID NO:1 and having tannase activity” (Paragraph 0010, 2), and “several known tannases generally have an optimum temperature around 40 deg C to 60 deg C and an optimum pH in a weakly acidic region around pH 5.0-5.5: (Paragraph 0004); which shows that tannase variants are known in the art by various sequence identities, exist across a range of sequence identities, enzymatic function depends on specific structural features, and tannase variants can tolerate sequence variation, but only if enzymatic activity is preserved. Masayuki teaches “a protein having physicochemical properties and tannase activity” (Paragraph 0011).
The instant specification does not reasonably convey that the Applicant was in possession of the claimed tannase variant genus at the time of filing because the specification does not identify representative species across the breadth of the genus, nor does the specification describe structural features common to the members of the tannase variant species that correlate with the enzymatic function used in the claimed washing or cleaning composition. An identity threshold of 85% encompasses an extremely large number of variant species (e.g., via encompassing substitutions, fragmentations, deletions, insertions, substitution mutagenesis, or combination thereof that maintain enzymatic function to improve cleaning performance on tannase-sensitive stains). The instant specification states “an amino acid sequence over a length of at least 200 to 511 contiguous amino acids, corresponds to the starting molecule” (Paragraph 0025). For example, the claimed tannase variant (i.e., tannase variant at least 85% amino acid sequence identity to SEQ ID NO:1) comprises 679 amino acids, and allowing variations to occur approximately 15% sequence variation of the amino acid sequence; substitutions would occur in approximately 102 amino acid positions; which would result in an extremely large number of potential variants i.e., permutations within the claimed identity range).
Additionally, it cannot be reasonably predicted which of the variants would retain the tannase enzymatic activity required for use in a washing or cleaning composition; and the instant specification does not identify motifs, domains, conserved regions, catalytic residues, or other structural features within the tannase sequence that must be maintained or conserved to preserve enzymatic activity for use in a washing or cleaning composition. Additionally, the specification does not provide characterization of conserved sequence elements, critical amino acid positions, or structure/function relationships for the claimed tannase variant genus to show full possession of the invention. It is noted that percent identity does not establish possession of the claimed tannase variant species that maintain the disclosed function (i.e., enzymatic activity used in a washing or cleaning composition).
The instant specification discloses “it is thus possible, for example, to delete individual amino acids at the termini or in the loops of the enzyme without the catalytic activity being lost or reduced as a result. Furthermore, such fragmentation or deletion, insertion or substitution mutagenesis can also be used, for example, to reduce the allergenicity of the enzymes concerned and thus to improve their usability overall. Advantageously, the enzymes retain their catalytic activity even after mutagenesis, i.e., their catalytic activity corresponds at least to that of the starting enzyme, i.e., in a preferred embodiment, the catalytic activity is at least 80%, preferably at least 90%, more preferably at least 100%, of the activity of the starting enzyme.” (Paragraph 0042). However, the specification does not disclose which tannase variants within the claimed percent identity range (at least 85%) would be expected to retain the recited functional properties (i.e., catalytic activity in a washing or cleaning composition) at any of the preferable functional activity thresholds.
The instant specification discloses “the variants are characterized in that they are obtainable as a starting molecule by single or multiple conservative amino acid substitutions” (Paragraph 0011), and “the starting molecule by fragmentation, deletion, insertion, or substitution mutagenesis, which comprises an amino acid sequence that corresponds to the starting molecule of a length” (Paragraph 0011). The specification discloses edits (e.g., P9T substitution, P9TH insertion, P9 deletion [Paragraph 0039]). It is noted that the specification discloses some ways the claimed tannase can be altered to form variants by providing descriptions of individual edits, and additional percentage identities; however, the specification does not clearly demonstrate possession of the full breadth of the claimed tannase variant genus because there is no sufficient disclosure of a representative number of tannase variant species across the breadth of the claimed identity range (i.e., at least 85% to SEQ ID NO:1) that demonstrate retention of the recited enzymatic functional properties that can be used in the claimed washing or cleaning composition; nor does the specification disclose structural limitations (e.g., conserved regions within the amino acid sequence that must be maintained to preserve enzymatic function) to demonstrate fully possession of the invention at the time of filing.
In the absence of such structural guidance and/or representative tannase variant species, the disclosure does not reasonably convey possession of the full scope of the claimed tannase variant genus because the specification does demonstrate possession of the full scope of a claimed genus, does not support the broad species claimed, and does not provide a representative number of species or structural features common to the tannase variant genus. Accordingly, the disclosure does not reasonably convey possession of the full scope of the claimed tannase variant genus at the time of filling.
Claim Rejections - 35 USC§ 101
35 U.S.C. 101 reads as follows:
Whoever invents or discovers any new and useful process, machine, manufacture, or composition of matter, or any new and useful improvement thereof, may obtain a patent therefor, subject to the conditions and requirements of this title.
Claims 1-2 and 9-12, and 15-17 are rejected under 35 U.S.C. 101 because the claimed invention is directed to a judicial exception (natural product) without significantly more. This judicial exception is not integrated into a practical application and the claims do not include additional elements that are sufficient to amount to significantly more than the judicial exception for the reasons set forth below.
Step 1 (Statutory Category): This part of the eligibility analysis evaluates whether the
claims fall within any statutory category. Here, the claims recite a washing or cleaning agent, comprising: a tannase variant with tannin-depleting activity with an amino acid sequence having a sequence identity of at least 85% or 95% to the amino acid sequence given in SEQ ID NO:1 over its entire length; and, at least one surfactant; wherein the concentration of the at least one tannase variant ranges from 0.005 to 15 wt% based on the active protein. This is a composition, therefore the claims fall within a statutory category of invention. [Step 1: YES]
Step 2A (Judicial Exceptions), Prong 1: This part of the eligibility analysis evaluates whether the claim recites a judicial exception. A claim “recites” a judicial exception when the exception is “set forth” or “described” in the claim (see MPEP 2106.04(II)). Because the claim recites a nature-based product limitation, the markedly different characteristics analysis is used to determine if the nature-based product limitations are a product of nature exception (see MPEP 2106.04(c)(I)). This analysis is performed by comparing the nature-based product limitations in the claims to its naturally occurring counterparts to determine if it has markedly different characteristics (see MPEP 2106.04(c)(II). The claim recites at least one judicial exception. Claims 1 and 17 broadly recite a composition of matter/ nature-based product (i.e., a tannase variant comprising an amino acid sequence having a sequence identity of at least 85% to the amino acid sequence given in SEQ ID No:1 over its entire length; wherein the amino acid sequence comprises a single or multiple conservative acid substitution(s), a fragmentation, a deletion, an insertion, substitution mutagenesis, or combinations thereof). The appropriate natural counterpart to the claimed enzyme is the same one as found in nature and a naturally occurring surfactant. Please note that the claims broadly encompass any de minimis amount of surfactant.
The instant specification identifies SEQ ID NO:1 as corresponding to a naturally occurring tannase enzyme. The instant specification recites, “The inventors surprisingly found that a tannase from Paenibacillus, in particular Paenibacillus pabuli, which has an identical amino acid sequence to the amino acid sequence indicated in SEQ ID NO:1 (Paragraph 0024). This constitutes an express admission that a tannase comprising the amino acid sequence of SEQ ID NO:1 represents a naturally occurring product.
Additionally, the instant specification recites, a tannase variant from Paenibacillus pabuli, identical to the amino acid sequence in SEQ ID NO:1, effects the removal of bleachable and/or tannin-containing stains cause in particular by fruits, fruit juices, nuts, legumes, tea, coffee, wine, cocoa, or chocolate, under standard washing conditions; this is surprising in particular insofar as tannase, in particular tannase from Paenibacillus, in particular Paenibacillus pabuli (Paragraph 0024). This constitutes an express admission that the amino acid sequence of SEQ ID NO:1 represents a naturally occurring product of nature with the known function (i.e., enzymatic activity for the removal of bleachable and/or tannin-containing stains); which is the same intended function of the instant invention. Therefore, the claimed tannase variant is not markedly different from its naturally-occurring counterpart in terms of structure and function.
As evidenced by German Patent DE1944904A1 (1971; hereafter “Wolf”, see Form 892), recites “a method for cleaning tableware contaminated with tea or other tannin-based residues in dishwashers and laundry contaminated with tea or other tannin-based residues in washing machines (i.e. rinsed in one or more cycles with an enzyme-containing washing-up liquid or washed with an enzyme-containing detergent); that enzyme is tannase or anueres-tanning agent or compounds derived therefore; that tannase or another tannin or any enzyme degrading therein is obtained from microorganisms” (Paragraph 0011, 0012, and 0013). Therefore, it is well established in the art that tannase enzymes are naturally occurring products of nature from microorganisms with the known intended function as an enzyme for the removal of bleachable/ and/or tannin-containing stains.
Krister Holmberg (Natural surfactants, Current Opinion in Colloid & Interface Science, Volume 6, Issue 2, 2001, Pages 148-159) evidences “naturally occurring surfactants such as amphiphiles produced by yeast or bacteria, amphiphiles containing a natural polar headgroup and amphiphiles containing a natural hydrophobic tail. Microorganisms produce both high molecular weight and low molecular weight surfactants.” (see abstract, see throughout). Holmberg also evidences that these surfactants are used to overcome solubility problems, as emulsifiers, as dispersants, to modify surfaces, etc. (see pg. 148, col 2).
In its totality, the claimed tannase variant and the surfactant are a natural combination that, absent evidence to the contrary, does not result in any markedly different characteristic with respect, to structure, function, etc.
Thus, the claim recites at least one judicial exception, a natural product. [Step 2A, Prong 1: YES]
Therefore, the analysis proceeds to Step 2A Prong 2.
Step 2A (Judicial Exceptions), Prong 2: This part of the eligibility analysis evaluates whether the claims as a whole integrate the recited judicial exception into a practical application of the exception. This evaluation is performed by (a) identifying whether there are any additional elements recited in the claims beyond the judicial exception, and (b) evaluating those additional elements individually and in combination to determine whether the claims as a whole integrate the exception into a practical application.
Further regarding claim 1, the claim recites “wherein the concentration of the at least one tannase variant ranges from 0.00005 to 15 wt.% based on the active protein.” However, the claim remains directed to a product of nature not markedly different from its naturally occurring counterpart (i.e., a tannase enzyme having the amino acid sequence identity of SEQ ID NO:1). The claim does not recite any additional elements beyond the tannase variant. Although the claim recites “a washing or cleaning agent”, the recited concentration range of 0.00005% to 15 wt.% of the active tannase variant defines the amount of the tannase variant present, and does not alter the structure or function of the tannase variant; nor provide any markedly different characteristics to its naturally occurring counterpart (i.e., a tannase enzyme comprising the amino acid sequence of SEQ ID NO:1). The recited concentration range is interpreted as a quantitative limitation of the tannase variant. The claimed tannase enzyme variant(s) performs catalytic activity (e.g., removal of tannin-containing stains) in the same way as it would in nature.
The claim also recites that the agent includes at least one surfactant. As discussed above, the addition of the surfactant does not amount to more than the judicial exception for the reasons set forth above.
Regarding Claim 2, which depends on Claim 1, and further recites the amino acid sequence comprises a single or multiple conservative acid substitution(s), a fragmentation, a deletion, an insertion, substitution mutagenesis, or combinations thereof. The instant specification recites, the tannase is a tannase which has tannin-depleting activity and comprises an amino sequence which is identical to the amino acid sequence indicated in SEQ ID NO:1 over its length at least 70% to 100%; and obtainable by single or multiple conservative amino acid substitution; obtainable by fragmentation, deletion, insertion, or substitution mutagenesis and comprise an amino acid sequence over a length of at least 200 to 511 contiguous amino acids, corresponds to the starting molecule (Paragraph 0025).
It is important to keep in mind that product of nature exceptions include both naturally occurring products and non-naturally occurring products that lack markedly different characteristics from any naturally occurring counterpart. See, e.g., Ambry Genetics, 774 F.3d at 760, 113 USPQ2d at 1244 ("Contrary to Myriad's argument, it makes no difference that the identified gene sequences are synthetically replicated. As the Supreme Court made clear, neither naturally occurring compositions of matter, nor synthetically created compositions that are structurally identical to the naturally occurring compositions, are patent eligible.").
While Claim 2 further recites variants comprising a single or multiple conservative acid substitution(s), a fragmentation, a deletion, an insertion, substitution mutagenesis, or combinations thereof, the claim does not specify a specific mutation to SEQ ID 1. Claim 2 therefore is broadly drawn to any naturally occurring mutant of SEQ ID 1.
Therefore, there is no adequate evidence/support within Applicant’s specification that its composition has any characteristics or properties that are different from the naturally-occurring counterpart(s) [including the natural compounds found therein- e.g. step 2Al(MPEP 2106.04 (a-c)]. Furthermore, the recited concentration range reflects optimization of tannase enzyme levels. Please note that modifying the concentration of the product/composition is not sufficient to remove the claimed composition from a judicial exception (see, e.g., Association for Molecular Pathology v. Myriad Genetics, Inc., 569 U.S._, 133 S. Ct.2107, 106 USPQ2d 1972 (2013)).
Regarding Claims 9-12, and 15-16, the claims are directed to “the washing or cleaning agent substantially free from boron-containing compounds” (Claim 9); “the washing or cleaning agent has a pH ranging from approximately 8 to approximately 9” (Claim 10); “the washing or cleaning agent is substantially free from phosphonate-containing compounds” (Claim 11); “the washing or cleaning agent is substantially free from phosphate-containing compounds” (Claim 12); “improved cleaning performance compared to agents without the tannase variant” (Claim 15); and “the agent has the improved cleaning performance at a temperature ranging from approximately 20°C to approximately 40°C” (Claim 16).
Therefore, Claims 9-13 and 15-16 are directed to intended optimization, field of use, and intended use of the naturally-occurring tannase variant (s), and do not integrate the judicial exception into a practical application or use markedly different from its naturally-occurring structure, function, or use (i.e., a tannase enzyme having the amino acid sequence identity of SEQ ID NO:1).
Therefore, the claimed composition is not deemed to be markedly different from what exists in nature in terms of structural and/or functional differences. In other words, the claims do not set forth a marked difference in terms of structural and/or or functional differences (properties and/or characteristics) as compared to the naturally-occurring counterpart(s) [see, e.g., Diamond v. Chakrabarty, 447 U.S. 303(1980)].
Step 2B (Significantly More): This part of the eligibility analysis evaluates whether the claims as a whole amount to significantly more than the recited exception, i.e., whether any additional element, or combination of additional elements, adds an inventive concept to the claim (MPEP 2106.05). This is based on an additional consideration of whether the elements in addition to the judicial exception add beyond what was well-understood, routine, and conventional to the claims. The recitation of the inclusion of a surfactant to the tannase enzyme was well-understood, routine, and conventional to the claims, as evidenced by Ghosh et al (US8466098B2), which discloses tannase enzymes used in washing and cleaning agents washing can be combined with, e.g., surfactants, builders, acids, alkaline substances, hydrotropes, solvents, thickening agents, bleaching agents, dyes, perfumes, corrosion inhibitors, sequestering agents, electrolytes, optical brighteners, anti-gray agents, silver corrosion inhibitors, color transfer inhibitors, foam inhibitors, abrasives, UV absorbers, solvents, antistatic agents, luster agents, and skin protectants (see col 10).
Additionally, there no adequate evidence/support within Applicant's specification that its claimed composition (as a whole) is markedly different by having a change in the composition's overall functional properties as compared to its/their naturally-occurring counterpart (i.e. a tannase enzyme comprising the amino acid sequence of SEQ ID NO:1) ; and/or no adequate evidence/support within Applicant's specification that its claimed composition/product is markedly different in terms of having a change in structure (by demonstrating "synergism") that produced an unexpected/synergistic functional effect as compared to its/their naturally-occurring counterpart(s). For example, the Applicant’s specification does not recite specific engineered structural modification (e.g., non-natural amino acid(s), a chimeric construct, a fusion protein, a defined alteration that produces new structural characteristics); a technological improvement; or a specific non-conventional application or use. Thus, the claims do not apply the naturally-occurring tannase variant(s) and surfactants in a different or meaningful technological manner other than the tannase variant itself; which is a judicial exception not integrated into a different practical application or use. [STEP 2B: NO]
In view of the above, the claims are considered to be directed to the judicial exception without integration into a practical application, or adding significantly more to the claim over the judicial exception. Therefore, the claims do not qualify as eligible subject matter under 35 USC § 101.
Examiner’s Note
The Applicant disclosed the sequence listing (see below).
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436
1150
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The closest prior art to the Applicant’s disclosed sequence is disclosed by Caixa et.al. 2016 (hereafter Caixa, previously cited), which is a sequence with 53.7% query match identity to the instant disclosed sequence (see referenced sequence below).
Caixa does not disclose the amino acid sequence having a sequence identity at least 85% to SEQ ID NO:1 over its entire length; nor enzymatic or catalytic function in a washing or cleaning composition.
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927
682
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The closest prior art to the Applicant’s disclosed sequence is disclosed by Caixa et.al. 2016 (hereafter Caixa, see Form 892), which is a sequence with 53.7% query match identity to the instant disclosed sequence (see referenced sequence below). Caixa does not disclose the amino acid sequence having a sequence identity at least 85% to SEQ ID NO:1 over its entire length; nor enzymatic or catalytic function in a washing or cleaning composition. Please note that while the sequence claimed is deemed to be free of the prior art, the claims are not allowable for the reasons set forth above.
Response to Arguments
Applicant's arguments filed 06/30/2026 have been fully considered but they are not persuasive.
On pg. 6-8 of the remarks, Applicant argues the amended claim materially changes the eligibility analysis because the claim is no longer directed to a tannase variant characterized only by sequence identity because the claim now requires the variant, at least one surfactant, and a defined concentration of the variant. Applicant argues that the claim is directed to a formulated detergent composition and not an isolated naturally occurring enzyme. Applicant argues that under Step 2A, Prong 1, the claim as a whole is not directed to a judicial exception, the claim positively recites that detergent context by requiring at least one surfactant which makes the composition a human-made washing or cleaning agent and not the variant in isolation. Applicant also argues that the claim incorporates the component into practical application under 2A Prong 2 because it is incorporated into a washing or cleaning agent and that the specification supports the formulation context and explains that washing or cleaning agents may include ingredients conventional to such agents. Applicant further urges the same as it relates to newly added claim 17.
In response, the examiner disagrees. First, as discussed above, the claim has been amended to require the tannase variant and a surfactant. As discussed above, it is well established in the art that tannase enzymes are naturally-occurring products of nature from microorganisms with the known intended function as an enzyme for the removal of bleachable and/or tannin-containing stains. Applicant’s specification explicitly states that the amino acid sequence of SEQ ID NO:1 represents a naturally occurring product of nature with the known function (i.e., enzymatic activity for the removal of bleachable/ and/or tannin-containing stains); which is the same intended function of the instant invention. Therefore, the claimed tannase variant is not markedly different from its naturally-occurring counterpart in terms of structure and function. The surfactant as claimed also encompasses naturally-occurring surfactants, such as the ones evidenced by Holmberg (see above). Furthermore, the claims as written encompass any de minimis amount of surfactant (including naturally occurring surfactants and the natural combination of surfactants does not amount ot more than the judicial exception for thereasons set forth above. Although the claim recites “a washing or cleaning agent”, the recited concentration range of 0.00005% to 15 wt.% of the active tannase variant defines the amount of the tannase variant present, and does not alter the structure or function of the tannase variant; nor provide any markedly different characteristics to its naturally occurring counterpart (i.e., a tannase enzyme comprising the amino acid sequence of SEQ ID NO:1). The recited concentration range is interpreted as a quantitative limitation of the tannase variant. The claimed tannase enzyme variant(s) performs catalytic activity (e.g., removal of tannin-containing stains) in the same way as it would in nature. As such, the rejections are maintained as set forth above.
Conclusion
NO CLAIMS ALLOWED.
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.
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/G.C.R./Examiner, Art Unit 1651
/THOMAS J. VISONE/Supervisory Patent Examiner, Art Unit 1672
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