DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Status of the Claims
Claims 2, 4, 10-11, and 13-15 have been canceled.
Claims 16-24 have been added.
Claims 1, 3, 6-9, 12, and 16-24 are currently pending.
Election/Restrictions
Applicant’s election without traverse of Group I, Claims 1, 3, 6-9, and 16-24, and of species fructan degrading enzyme having SEQ ID NO: 18, fructan degrading enzyme having fructan (2,1)-fructosidase activity (EC 3.2.1.153), at least one surfactant, and a nuclease polypeptide having SEQ ID NO: 19, in the reply filed on 12/2/2025 is acknowledged.
Claims 3, 12 and 16-22 have been withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to nonelected inventions and species, there being no allowable generic or linking claims.
Claims 1, 6-9 and 23-24 are being examined in this application, insofar as they read on the elected species of fructan degrading enzyme having SEQ ID NO: 18, fructan degrading enzyme having fructan (2,1)-fructosidase activity (EC 3.2.1.153), at least one surfactant, and a nuclease polypeptide having SEQ ID NO: 19.
Non-compliant Claim Amendment
According to MPEP 714 37 CFR 1.121, each amendment document that includes a change to an existing claim, cancellation of an existing claim or addition of a new claim, must include a complete listing of all claims ever presented. In the instant case, claim 5 was in the original claim set filed on 09/20/2022, but missing in the claim amendments filed on 12/02/2025. In order to be fully responsive to the instant Office action, applicant must submit claim amendment that is in compliance with 37 CFR 1.121.
Claim Objections
Claims 23-24 are objected to because of the following informalities:
Claim 23, line 1, the recitation of “A cleaning composition of claim 1” is suggested to read “The cleaning composition of claim 1”.
Claim 24, line 1, the recitation of “A cleaning composition of claim 8” is suggested to read “The cleaning composition of claim 8”. In addition, the recitation of “nuclease polypeptide” is suggested to read “the at least one nuclease polypeptide”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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, 6-9 and 23-24 are rejected under 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 pre-AIA the inventor(s), at the time the application was filed, had possession of the claimed invention.
The claims are directed to a cleaning composition comprising a GH32 fructan degrading enzyme and at least one detergent component, wherein the fructan degrading enzyme comprises a GH32 domain and wherein the fructan degrading enzyme has at least 80% sequence identity to SEQ ID NO: 18.
To fulfill the written description requirements set forth under 35 USC § 112, first paragraph, the specification must describe at least a substantial number of the members of the claimed genus, or alternatively describe a representative member of the claimed genus, which shares a particularly defining feature common to at least a substantial number of the members of the claimed genus, which would enable the skilled artisan to immediately recognize and distinguish its members from others, so as to reasonably convey to the skilled artisan that Applicant has possession of the claimed invention. Applicants have not described the genus of claimed fructan degrading enzyme such that the specification might reasonably convey to the skilled artisan that Applicants had possession of the claimed invention at the time the application was filed.
With the written description of a genus, however, merely drawing a fence around a perceived genus is not a description of the genus. One needs to show that one has truly invented the genus, i.e., that one has conceived and described sufficient representative species encompassing the breadth of the genus. Otherwise, one has only a research plan, leaving it to others to explore the unknown contours of the claimed genus. See Ariad, 598 F.3d at 1353 (The written description requirement guards against claims that "merely recite a description of the problem to be solved while claiming all solutions to it and . . . cover any compound later actually invented and determined to fall within the claim's functional boundaries."). Abbvie Deutschland GmbH & Co. v. Janssen Biotech, Inc., 759 F.3d 1285, 1300, 111 U.S.P.Q.2d 1780, 1790, 2014 BL 183329, 12 (Fed. Cir. 2014). Furthermore, the written description provision of 35 USC § 112 is severable from its enablement provision; and adequate written description requires more than a mere statement that it is part of the invention and reference to a potential method for isolating it. The nucleic acid [product] itself is required. See Fiers v. Revel, 25 USPQ2d 1601, 1606 (CAFC 1993) and Amgen Inc. v. Chugai Pharmaceutical Co. Ltd., 18 USPQ2d 1016. Possession may be shown in a variety of ways including description of an actual reduction to practice, or by showing the invention was 'ready for patenting' such as by disclosure of drawings or structural chemical formulas that show that the invention was complete, or by describing distinguishing identifying characteristics sufficient to show that the applicant was in possession of the claimed invention" (Id. at 1104). Moreover, because the claims encompass a genus of variant species, an adequate written description of the claimed invention must include sufficient description of at least a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics sufficient to show that Applicant was in possession of the claimed genus. To satisfy the written description requirement, an applicant must convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention, and that the invention, in that context, is whatever is now claimed. Vas-Cath, Inc. v. Mahurkar, 935 F.2d 1555, 1563-64, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991) and MPEP 2163.02.
However, factual evidence of an actual reduction to practice has not been disclosed by Applicant in the specification; nor has Applicant shown the invention was "ready for patenting" by disclosure of drawings or structural chemical formulas that show that the invention was complete; nor has Applicant described distinguishing identifying characteristics sufficient to show that Applicant were in possession of the claimed invention at the time the application was filed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus'" (Id. at 1106); accordingly, it follows that an adequate written description of a genus cannot be achieved in the absence of a disclosure of at least one species within the genus. The scope of the claim includes numerous structural variants, and the genus is highly variant because a significant number of structural differences between genus members is permitted.
One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
Devos (Proteins: Structure, Function and Genetics. 2000;41:98-107.) teaches that the results obtained by analyzing a significant number of true sequence similarities, derived directly from structural alignments, point to the complexity of function prediction. Different aspects of protein function, including (i) enzymatic function classification, (ii) functional annotations in the form of key words, (iii) classes of cellular function, and conservation of binding sites can only be reliably transferred between similar sequences to a modest degree. The reason for this difficulty is a combination of the unavoidable database inaccuracies and plasticity of proteins (Abstract, p.98) and the analysis poses interesting questions about the reliability of current function prediction exercises and the intrinsic limitation of protein function prediction (col.1 para 3, p.99) and conclude that "Despite widespread use of database searching techniques followed by function inference as standard procedures in Bioinformatics, the results presented here illustrate that transfer of function between similar sequences involves more difficulties than commonly believed. Our data show that even true pair-wise sequence relations, identified by their structural similarity, correspond in many cases to different functions (col.2 para 2, p.105).
Because the art is unpredictable, in accordance with the Written Description Guidelines, the recitations of “the fructan degrading enzyme has at least 80% sequence identity to SEQ ID NO: 18” (claim 1) and “a polypeptide having a sequence identity to SEQ ID NO: … of at least 60%; and … a fragment of the polypeptide …” (claim 9) with any changes (and any combination of changes) or the recitations just that the fructan degrading enzyme comprises SEQ ID NO: 18 (claim 23) and nuclease polypeptide comprises SEQ ID NO: 19 (claim 24) are not adequate. The scope of the claim includes numerous structural variants and the genus is highly variant because a significant number of structural differences between genus members is permitted. The specification does not describe any members of the claimed genus by complete structure. One of skill in the art would reasonably conclude that the disclosure fails to provide a representative number of species to describe the genus, and thus, that the applicant was not in possession of the claimed genus. The claimed subject matter is not supported by an adequate written description because a representative number of species has not been described.
There are no drawings or structural formulas disclosed of any of these fragments or variants of the claimed polynucleotides. There is no teaching in the specification regarding which 20% of the structure can be varied and still produce a polypeptide which has one or more of the recited enzymatic activities. Although the disclosure of SEQ ID NO: 18 combined with the knowledge in the art, may put one in possession of peptides that are at least 80% identical to SEQ ID NO: 18, the level of skill and knowledge in the art is such that one of ordinary skill would not be able to identify without further testing which of those peptides would have the required functional activities. Based on the lack of knowledge and predictability in the art, those of ordinary skill in the art would not conclude that the applicant was in possession of the claimed genus of polypeptides.
Applicant is referred to the revised guidelines concerning compliance with the written description requirement of U.S.C. 112, first paragraph, published in the Official Gazette and also available at www.uspto.gov.
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 35 U.S.C. 112 (pre-AIA ), first paragraph:
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, 6-9 and 23-24 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for a cleaning composition comprising a GH32 fructan degrading enzyme and at least one detergent component, wherein the fructan degrading enzyme having amino acid sequence of SEQ ID NO: 18, but does not reasonably provide enablement for a cleaning composition comprising a GH32 fructan degrading enzyme and at least one detergent component, wherein the fructan degrading enzyme comprises a GH32 domain and wherein the fructan degrading enzyme has at least 80% sequence identity to SEQ ID NO: 18 instantly claimed. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the invention commensurate in scope with these claims.
There are many factors to be considered when determining whether there is sufficient evidence to support a determination that a disclosure does not satisfy the enablement requirement and whether any necessary experimentation is undue. These factors include, but are not limited to: (a) breadth of the claims; (b) nature of the invention; (c) state of the prior art; (d) level of one of ordinary skill in the art; (e) level of predictability in the art; (f) amount of direction provided by the inventor; (g) existence of working examples; and (h) quantity of experimentation needed to make or use the invention based on the content of the disclosure. (See Ex parte Forman 230 USPQ 546 (Bd. Pat. App. & Inter. 1986) and In re Wands, 8 USPQ2d 1400 (Fed. Cir. 1988).
The above factors, regarding the present invention, are summarized as follows:
The breadth of the claims – The breadth of the claims is drawn to a cleaning composition comprising fructan degrading enzyme having amino acid sequence of SEQ ID NO: 18 and at least one detergent component.
The Nature of the invention – The nature of the invention is drawn to a cleaning composition comprising fructan degrading enzyme having amino acid sequence of SEQ ID NO: 18 and at least one detergent component.
The state of the prior art / The predictability or lack thereof in the art – Whisstock (Quarterly Reviews of Biophysics. 2003;36(3):307-340.) highlights the difficulties associated with “Prediction of protein function from protein sequence and structure”: “To reason from sequence and structure to function is to step onto much shakier ground”, closely related proteins can change function, either through divergence to a related function or by recruitment for a very different function, in such cases, assignment of function on the basis of homology, in the absence of direct experimental evidence, will give the wrong answer (p.309 para 4), it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. Given three sequences, it is possible to decide which of the three possible pairs is most closely related. Given three structures, methods are also available to measure and compare similarity of the pairs. However, in many cases, given three protein functions, it would be more difficult to choose the pair with most similar function, although it is possible to define metrics for quantitative comparisons of different protein sequences and structures, this is more difficult for proteins of different functions (p.312 para 5), in families of closely related proteins, mutations usually conserve function but modulate specificity i.e., mutations tend to leave the backbone conformation of the pocket unchanged but to affect the shape and charge of its lining, altering specificity (p.313 para 4), although the hope is that highly similar proteins will share similar functions, substitutions of a single, critically placed amino acid in an active-site residue may be sufficient to alter a protein's role fundamentally (p.323 para 1). This finding is reinforced in the following scientific teachings for specific proteins in the art that suggest, even highly structurally homologous polypeptides do not necessarily share the same function and many functionally similar proteins will have little or no structural homology to disclosed proteins.
The relative skill of those in the art – The relative skill of those in the art is high, with a typical practitioner possessing commensurate degree level, as well as several years of professional experience.
The amount of direction or guidance present – The specification states that substitutions, additions, or deletions, may be made to the defined sequences; however, the specification provides no guidance as which amino acids may be changed without causing a detrimental effect to the enzyme and with the added enzymatic function requirement.
The presence or absence of working examples – The working examples present in the instant specification are directed to wash assay using fructan degrading enzymes with and without DNase, wherein the fructan degrading enzymes include enzyme SEQ ID NO: 18 (Example 1), fructanase activity assay including using of enzyme SEQ ID NO: 18 (Example 2), and construction of clades and phylogenetic trees (Example 3).
The quantity of experimentation needed – While it is known that many amino acid substitutions are possible in any given protein, the position within the protein’s sequence where amino acid substitutions can be made with a reasonable expectation of success are limited. Other positions are critical to the protein’s structure/function relationship, e.g., such as various positions or regions directly involved in binding, catalysis in providing the correct three-dimensional spatial orientation of binding and catalytic sites. These regions can tolerate only very little or no substitutions. Selective point mutation to one key residue could eliminate the function of the polypeptide. It could eliminate its functional properties. If the range of decreased binding ability after single point mutation of a protein antigen varies, one could expect point mutations in the protein antigen to cause varying degrees of loss of protection/function, depending on the relative importance to the binding interaction of the altered residue. Alternatively, the combined effects of multiple changes in an antigenic determinant could again result in loss of function. A protein having multiple point mutations, or accumulated point mutations at key residues could create a new antigen that is precipitously or progressively unrecognizable. As stated above, Applicants have not shown the particular substitution and the result it produces. Applicants have provided no guidance to enable one of ordinary skill in the art how to determine, without undue experimentation, the effects of different amino substitutions and the nature and extent of the changes that can be made. It is expensive and time consuming to make amino acid substitutions at more than one position, in a particular region of the protein, in view of the many fold possibilities for change in structure and the uncertainty as to what utility will be possessed.
A conclusion of lack of enablement means that, based on the evidence regarding each of the above factors, the specification, at the time the application was filed, would not have taught one skilled in the art how to make and/or use the full scope of the claimed invention without undue experimentation. {In re Wright, 999 F.2d 1557, 1562, 27 USPQ2d 1510, 1513 (Fed. Cir. 1993)}.
Genentech Inc. v. Novo Nordisk A/S (CAFC) 42 USPQ2d 1001 clearly states: “Patent protection is granted in return for an enabling disclosure of an invention, not for vague intimations of general ideas that may or may not be workable. See Brenner v. Manson, 383 U.S. 519, 536, 148 USPQ 689, 696 (1966) (stating, in context of the utility requirement, that "a patent is not a hunting license. It is not a reward for the search, but compensation for its successful conclusion.") Tossing out the mere germ of an idea does not constitute enabling disclosure. While every aspect of a generic claim certainly need not have been carried out by an inventor, or exemplified in the specification, reasonable detail must be provided in order to enable members of the public to understand and carry out the invention.”
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 1, 6-9 and 23-24 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 pre-AIA the applicant regards as the invention.
Claim 1 recites “a GH32 fructan degrading enzyme … comprises a GH32 domain and … has at least 80% sequence identity to SEQ ID NO: 18”. The recited enzyme is vague and indefinite as it is unclear what specific structure is required to meet the scope of the invention. In addition, claim 1 also recites “a cleaning composition” comprising the enzyme. It is unclear what specific structure of the enzyme is required to meet the recited functional property – a cleaning composition.
Claim 6 recites “(EC …)”. It is unclear what the parenthetical information is conveying. Further, parenthesis is reserved for reference characters and information within parenthesis has no effect on the scope of the claims. See MPEP 608.01(m).
Claim 9 is dependent from claim 8, and claim 8 recites “at least one nuclease polypeptide”. Claim 9 recites “the nuclease” on line 1, it is unclear what / which nuclease claim 9 refers to, since there can be more than one nuclease. Applicant is suggested to amend claim 9 to recite “the at least one nuclease” to overcome this rejection.
Claim 23, line 1-2, the recitation of “comprises or consists of” is indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. In the instance case, claim 23 recites the broad recitation “comprises”, and the claim also recites “consists of” which is the narrower statement of the range/limitation. Claim 23 is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
Claim 24, line 1-2, the recitation of “comprises or consists of” is indefinite. A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. In the instance case, claim 24 recites the broad recitation “comprises”, and the claim also recites “consists of” which is the narrower statement of the range/limitation. Claim 24 is considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claim.
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, 6-9 and 23-24 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 and 23 are directed to fructan degrading enzyme having at least 80% sequence identity to SEQ ID NO: 18 and at least one detergent component. As disclosed in the instant specification, the claimed fructan degrading enzyme and at least one detergent component (for example, water), are naturally occurring. There is no indication in the instant specification that the claimed fructan degrading enzyme and at least one detergent component have any characteristics that are different from the naturally occurring fructan degrading enzyme and at least one detergent component, respectively. Thus, the claimed fructan degrading enzyme and at least one detergent component do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Accordingly, claims 1 and 23 are directed to an exception. Claim 6 recites “wherein” clause, which would not materially change the fructan degrading enzyme from its natural state. Claim 7 recites at least one surfactant. It was well-known in the art that surfactants can be naturally occurring, for example, glucosides. Claims 8-9 and 24 recite nuclease polypeptides. As disclosed in the instant specification, the claimed nuclease polypeptides are naturally occurring. There is no indication in the instant specification that the claimed nuclease polypeptides have any characteristics that are different from the naturally occurring nuclease polypeptides. Thus, the claimed nuclease polypeptides do not have markedly different characteristics from their natural counterparts in their natural state, and are “product of nature” exceptions. Therefore, claims 1, 6-9 and 23-24 do not qualify as eligible subject matter, and should be rejected under 35 U.S.C. § 101.
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 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 of this title, 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.
Claims 1, 6-9 and 24 are rejected under 35 U.S.C. 103 as being unpatentable over Berka et al (US 2010/0064393 A1; 3/11/2010.) in view of Gjermansen et al (WO 2017/059802 A1; 4/13/2017.).
The instant claims recite a cleaning composition comprising a GH32 fructan degrading enzyme and at least one detergent component, wherein the fructan degrading enzyme comprises a GH32 domain and wherein the fructan degrading enzyme has at least 80% sequence identity to SEQ ID NO: 18.
Berka teaches a biological substance comprises an amino acid sequence having SEQ ID NO: 8168 (the fructan degrading enzyme has at least 80% sequence identity to SEQ ID NO: 18) (para 0084-0085, also see Search results filed on 01/29/2026; 20260129_162406_us-17-913-103-18.rag; Result 5 – screen shot below), wherein the proteases from Bacillus licheniformis are used in the detergent industry (para 0008). Since Berka’s SEQ ID NO: 8168 read on the claimed fructan degrading enzyme, Berka’s SEQ ID NO: 8168 has fructan (2,1)-fructosidase activity.
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Berka does not teach at least one detergent component (claim 1), at least one surfactant (claim 7), and the claimed nuclease polypeptide having DNase or RNase activity (claims 8-9 and 24).
However, Berka does teach the claimed fructan degrading enzyme is used in the detergent industry. Gjermansen teaches a detergent (Abstract) / cleaning (p.3 line 33) composition comprising a polypeptide shown in SEQ ID NO: 21 (100% identical to SEQ ID NO: 19) (p.4 line 14, also see Search results filed on 01/29/2026; 20260129_162406_us-17-913-103-19.rag; Result 1 – screen shot below). The composition comprises detergent adjunct ingredient including surfactants, builders, enzymes, and etc. (p.13 line 12-18 & 30-35).
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Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate at least one detergent component, at least one surfactant, and the claimed nuclease polypeptide having DNase or RNase activity, since Berka discloses that the claimed fructan degrading enzyme is used in the detergent industry, and Gjermansen discloses that detergent components, surfactants, and the claimed nuclease polypeptide having DNase or RNase activity are incorporate into a detergent / cleaning composition. Furthermore, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the claimed fructan degrading enzyme with detergent components, surfactants, and the claimed nuclease polypeptide having DNase or RNase activity for the same purpose – obtaining a detergent / cleaning composition. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate at least one detergent component, at least one surfactant, and the claimed nuclease polypeptide having DNase or RNase activity, with a reasonable expectation for successfully obtaining a cleaning composition.
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 claims at issue 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); and 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 a nonstatutory double patenting ground provided the reference application or patent either is shown to be commonly owned with this application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The USPTO internet Web site contains terminal disclaimer forms which may be used. Please visit http://www.uspto.gov/forms/. The filing date of the application will determine what form 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 http://www.uspto.gov/patents/process/file/efs/guidance/eTD-info-I.jsp.
Claims 1, 6-9 and 23-24 are provisionally rejected on the ground of nonstatutory obviousness-type double patenting as being unpatentable over claims 17-25 and 29 of co-pending Application No. 18/042,251 (referred to as the ‘251 application) in view of Gjermansen et al (WO 2017/059802 A1; 4/13/2017.).
Claims 17-25 and 29 of the ‘251 application recite an oral care composition comprising a GH32 fructan degrading enzyme and denture cleaning solution (at least one detergent component), wherein the fructan degrading enzyme comprises a GH32 domain and wherein the fructan degrading enzyme has amino acid sequence of SEQ ID NO: 2 (100% identical to SEQ ID NO: 18). The enzyme has fructan (2,1)-fructosidase activity.
‘251 application does not teach at least one surfactant (claim 7), and the claimed nuclease polypeptide having DNase or RNase activity (claims 8-9 and 24).
Gjermansen teaches a composition formulated as a dental paste, a liquid dentifrice, a mouthwash (Claim 67), comprising detergent adjunct ingredient including surfactants, builders, enzymes, and etc. (p.13 line 12-18 & 30-35), and a polypeptide shown in SEQ ID NO: 21 (100% identical to SEQ ID NO: 19) (p.4 line 14, also see Search results filed on 01/29/2026; 20260129_162406_us-17-913-103-19.rag; Result 1).
Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to incorporate at least one surfactant, and the claimed nuclease polypeptide having DNase or RNase activity, since ‘251 application discloses an oral care composition comprises the claimed fructan degrading enzyme, and Gjermansen discloses an oral care composition comprises surfactants and the claimed nuclease polypeptide having DNase or RNase activity. Thus, before the effective filing date of the claimed invention, it would have been obvious to one of ordinary skill in the art to combine the claimed fructan degrading enzyme with detergent components, surfactants, and the claimed nuclease polypeptide having DNase or RNase activity for the same purpose – obtaining an oral care composition. Moreover, before the effective filing date of the claimed invention, one of ordinary skill in the art would have been motivated by the cited reference and routine practice to incorporate at least one surfactant, and the claimed nuclease polypeptide having DNase or RNase activity, with a reasonable expectation for successfully obtaining an oral care composition.
This is a provisional obviousness-type double patenting rejection because the patentably indistinct claims have not in fact been patented.
Conclusion
No claims are allowed.
Contact Information
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LYNN Y FAN whose telephone number is (571)270-3541. The examiner can normally be reached on M-F 7am-4pm.
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/Lynn Y Fan/
Primary Examiner, Art Unit 1759