Prosecution Insights
Last updated: April 19, 2026
Application No. 18/242,009

WASHING AND CLEANING AGENT COMPRISING TANNASE II

Non-Final OA §101§112
Filed
Sep 05, 2023
Examiner
ERHUNMWUNSEE, ENOSAKHARE NMN
Art Unit
1651
Tech Center
1600 — Biotechnology & Organic Chemistry
Assignee
Henkel AG & Co. KGaA
OA Round
1 (Non-Final)
Grant Probability
Favorable
1-2
OA Rounds
3y 2m
To Grant

Examiner Intelligence

Grants only 0% of cases
0%
Career Allow Rate
0 granted / 0 resolved
-60.0% vs TC avg
Minimal +0% lift
Without
With
+0.0%
Interview Lift
resolved cases with interview
Typical timeline
3y 2m
Avg Prosecution
2 currently pending
Career history
2
Total Applications
across all art units

Statute-Specific Performance

§101
16.7%
-23.3% vs TC avg
§103
33.3%
-6.7% vs TC avg
§102
8.3%
-31.7% vs TC avg
§112
33.3%
-6.7% vs TC avg
Black line = Tech Center average estimate • Based on career data from 0 resolved cases

Office Action

§101 §112
Notice of Pre-AIA or AIA Status The present application, filed on or after September 05, 2023 , is being examined under first inventor to file provisions of the AIA. Priority Acknowledgement is made of A pplicant’s claim for foreign priority under 35 U.S . C. 119 , from German Patent Application No. 10 2022 209 246.5 , filed on September 6, 2022. The certified copy has been filed with the present application on October 27, 2023. Restriction Election The response to the Restriction Requirement dated December 01, 2025 was received on December 22, 2025 . Applicant elected with traverse, Group I, claims 1 -2, 6, 8-12, and 15-16, drawn to a tannase variant and a washing or cleaning agent comprising at least one tannase variant. Claim 1 w as amended, Claims 2, 6, 8-12, and 15-16 are original claims. The traversal is o n the ground(s) that, “Applicant respectfully submits that there exists considerable overlapping subject matter in that, at the least, there is only a single independent claim from which all others depend. Thus, any field of search for one invention would necessarily overlap with the field of search for the other invention. Hence, it would not be a serious burden on the Examiner to examine both the method and apparatus claims presented in this case. Applicant further notes that in setting the restriction, the Office itself notes the interrelationships between Groups I and II, I and III, I and IV, II and III (both of which relate back to Group I), II and IV, and III and IV”. Applicant’s arguments have been fully considered but are not persuasive because as indicated in the Office A ction mailed on December 01, 2025, claims may be properly restricted if the claims are directed to patentably independent and distinct subject matter requiring different classifications, searches, or examinations. The restriction was determined based on whether the claims are drawn to independent and distinct inventions as defined under 35 U.S.C. 121, not on the mere presence of claim dependency or overlapping subject matter. Applicant’s assertion that examination of multiple invention groups would not impose a serious burden is also not persuasive. The burden concerns whether separate searches and examinations would be required, not whether the inventions share general subject matter. The record establishes that the groups require different prior art searches, and different patentability analyses ; which constitutes a serious examination burden . Accordingly, the traversal is not persuasive, and the restriction requirement is maintained. Claim Status Claims 1-2 , 6, 8-12, and 15-16 are pending and under examination. Drawings No drawings were filed with the present application. Information Disclosure Statement The IDS filed on September 05, 2023 is acknowledged and considered. Nucleotide and/or Amino Acid Sequence Disclosures The sequence listing filed electrotonically on September 5, 2023 and submitted via Patent Center is acknowledged and considered. Claim Interpretation Claims 1-2, 6, 8-12, and 15-16, drawn to 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 and a washing or cleaning agent comprising at least one tannase variant. 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 , 6 , 8-12, and 15-16 are rejected under 35 U.S.C.101 because the claimed invention is directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more. Claims 1-2, 6, 8-12, and 15-16 are directed to a natural phenomenon (i.e., a product of nature-e.g. step 1 (MPEP 2106.03)). The claims do not include additional elements that are sufficient to amount to significantly more than the judicial (i.e. do not recite additional elements/steps that integrate the exception into a practical application and/or do not recite additional elements that amount to significant more than the exception of the claimed naturally-occurring ingredients-e.g. step 2A2 (MPEP 2106.04(d) and 2B (MPEP 2106.5)) - i.e., as drafted, the cited claims read upon a product of nature for the following reasons: The Applicant’s Claims 1-2 , 6, 8-12, and 15-16 are drawn to 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 claimed composition is not markedly different from its naturally-occurring counterpart (i.e., a tannase enzyme having the amino acid sequence identity of SEQ ID NO:1 ) because there is no indication and/or sufficient evidence/support (i.e., no adequate evidence or support within Applicant’s specification that its claimed composition/product is markedly different by having a change in the composition’s overall functional properties as compared to its/their naturally-occurring counterpart (s) . 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 , i dentical to the amino acid sequence in SEQ ID NO:1 , effects the removal of bleachable and/or tannin-containing stains cause i n particular by fruits, fruit juices, nuts, legumes, tea, coffee, wine, cocoa, or chocolate, under standard washing conditions ; t his 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 t annase variant is not markedly different from its naturally- occurring counterpart in terms of structure and function. As evidenced by German Patent DE1944904A1 (1971; hereafter “Wo l f”, 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 therefo re; 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 . Regarding Claim 1 , defines the protein by sequence identity (i.e., a t annase variant having sequence identity of at least 85% to the amino acid sequence given in SEQ ID NO:1 over its entire length ) to its naturally-occurring counterpart (i.e., a tannase enzyme having the amino acid sequence identity of SEQ ID NO:1 ); which encompasses the exact naturally-occurring sequence (i.e., SEQ ID NO:1) , naturally-occurring homolog(s), and naturally-occurring variant(s). Hence , Claim 1 recites a product of nature . 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 a n amino sequence which is identical t o 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 lea st 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."). Hence, Claim 2 does not remove Claim 1 from being a product of nature because the claimed tannase variants(s) encompass the amino acid sequence of SEQ ID NO:1. The specification identifies SEQ ID NO:1 as a naturally occurring tannase enzyme (previously discussed); therefore, the claims encompass a naturally occurring product of nature. 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. Regarding Claim 6 , which depends on Claim 1 and recites a non-human host cell comprising the claimed tannase variant. Claim 6 doe s not remove Claim 1 from being a naturally -occurring product of nature (i.e., a tannase enzyme comprising the amino acid sequence of SEQ ID NO:1 ) because a ny non-human host comprising the tannase variant is still naturally- occurring (e.g., a tannase enzyme having the amino acid sequence identity of SEQ ID NO:1 ); which has been established is naturally-occurring . Regarding Claims 8 , which depends on Claim 1 (previously discussed) and recites a washing or cleaning agent comprising: at least one tannase variant according to claim 1 , wherein the concentration of the at least one tannase variant ranges from 0.00005 to 15 wt.% based on the active protein . Claim 8 does not remove Claim 1 from being a naturally -occurring product of (i.e., a tannase enzyme comprising the amino acid sequence of SEQ ID NO:1 ) because 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 only component expressly recited is the tannase variant itself, and no further ingredients, structural limitations, or formation components are recited by the claim. The recited “washing or cleaning agent” is interpreted as a description of intended use of the tannase variant . Further, 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. Therefore , since Claim 8 does not recite any additional elements it does not amount to significantly more than the naturally occurring product (i.e., a tannase enzyme comprising the amino acid sequence of SEQ ID NO: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) ] . Accordingly , Claim 8 remains directed to a product of nature (i.e., a tannase enzyme comprising the amino acid sequence of SEQ ID NO:1 ) and does not integrate the judicial exception into a practical application markedly different from its naturally-occurring structure or function . 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 which depend on Claim 8 (previously discussed) , do not remove Claim 8 from being a natural-occurring product of nature. Claims 9-13 and 15-16 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 ); “t he 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) ] . 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 do es 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) 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 . Thus, when the relevant factors are analyzed, they weigh against a significant difference between the claimed invention (i.e., a tannase variant at least 85% to the amino acid sequence given in SEQ ID No:1 over its entire length with functional enzymatic activity in a washing or cleaning agent ) and a judicial exception. Therefore, the claimed invention is not considered to be patent eligible subject matter. Claim Rejections - 35 USC§ 112 (a) 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. Claims 1-2. 6, 8-12, 15-16 are 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 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 limitation s (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, see Form 892), 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 o C to 6 0 o C and an optimum pH in a weakly acidic region around pH 5.0-5.5: (Paragraph 0004); which show s that tannase variants are known in the art by various sequence identities , exist across a range of sequence identit ies , enzymatic function depends on specific s tructural 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 a n 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 , P 9 deletion [ Paragraph 0039 ]) . It is noted that t he specification discloses some ways the claimed tannase can be altered to form variants by providing descriptions of individual edits , and additional percentage identit ies ; 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 funct ional 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) t o 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. Closest Prior Art The Applicant disclosed the sequence listing (see below ). 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. Conclusion No claim is allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to ENOSAKHARE ERHUNMWUNSEE whose telephone number is (571-272-1965). The examiner can normally be reached Monday-Friday 8:30 AM - 5 :00 PM. Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, MELENIE GORDON be reached on (571) 272-8037. 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. Visithttps://www.uspto.gov/patents/apply/patent-center for more information about Patent Center andhttps://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. /ENOSAKHARE ERHUNMWUNSEE/ Examiner, Art Unit 1651 /MELENIE L GORDON/ Supervisory Patent Examiner, Art Unit 1651
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Prosecution Timeline

Sep 05, 2023
Application Filed
Mar 26, 2026
Non-Final Rejection — §101, §112 (current)

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