DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Priority
This application is a Continuation (Bypass Application) of International Application PCT/US2021/072100, filed 10/29/2021. Applicant’s claim for the benefit of a prior-filed applications EP20204794.0, EP20204795.7, and EP20204791.6, each filed 10/29/2020, under 35 U.S.C. 119(e) or under 35 U.S.C. 120, 121, 365(c), or 386(c) is acknowledged. Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 7/3/2023; 4/10/2024; 6/24/2024; 12/11/2024; 9/3/2025; and 3/14/2026 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 1-19), in the reply filed on 1/16/2026 is acknowledged. Applicant’s amendment in response to the Election of Species requirement is acknowledged. Although Applicant did not specifically point out the elected sequences, from the submitted response, it is evident that Applicant elected a composition comprising at least an alginate lyase enzyme having an amino acid sequence with at least 60% sequence identity to SEQ ID NO: 1. Amended claim 8 recites that the composition comprises at least a first alginate lyase enzyme having 60% similarity to SEQ ID NO: 1 and a second alginate lyase enzyme having 60% similarity to SEQ ID NO: 5. The previous election of species is thus moot, due to the amendments.
Applicant’s amendment to the claims is acknowledged. This listing of the claims replaces all prior versions and listings of the claims. Claims 6 and 7 have been canceled. Claim 20 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention.
Claims 1-5 and 8-19 are pending and have been examined on the merits.
Specification (Abstract)
Applicant is reminded of the proper content of an abstract of the disclosure.
A patent abstract is a concise statement of the technical disclosure of the patent and should include that which is new in the art to which the invention pertains. The abstract should not refer to purported merits or speculative applications of the invention and should not compare the invention with the prior art.
If the patent is of a basic nature, the entire technical disclosure may be new in the art, and the abstract should be directed to the entire disclosure. If the patent is in the nature of an improvement in an old apparatus, process, product, or composition, the abstract should include the technical disclosure of the improvement. The abstract should also mention by way of example any preferred modifications or alternatives.
Where applicable, the abstract should include the following: (1) if a machine or apparatus, its organization and operation; (2) if an article, its method of making; (3) if a chemical compound, its identity and use; (4) if a mixture, its ingredients; (5) if a process, the steps.
Extensive mechanical and design details of an apparatus should not be included in the abstract. The abstract should be in narrative form and generally limited to a single paragraph within the range of 50 to 150 words in length.
See MPEP § 608.01(b) for guidelines for the preparation of patent abstracts.
The abstract of the disclosure is objected to because the claims are drawn to particular composition including a specific alginate lyase, having specific activities that are not highlighted in the current Abstract. See above, (3) “if a chemical compound, its identity and use;”. The abstract should provide enough information regarding that which is new in the art to which the invention pertains.
It is suggested to at least include a more detailed description of the claimed mixture in the Abstract, that more precisely reflects the invention, particularly that “the detergent composition comprises from 0.00005% to 5% wt alginate lyase enzyme and a cleaning adjunct” and that “the alginate lyase enzyme has activity towards poly(beta-D-mannuronate) (polyM) and activity towards poly(alpha-L-guluronate) (polyG)”.
A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claims 1 and 19 is objected to because of the following informalities:
Claim 1 should recite, in line 1, “comprising an alginate lyase enzyme”.
Claim 19 recites “comprising additional enzyme, comprising” and recites a group of enzymes to be selected from. For proper grammar and precision, this phrase should instead say: “comprising at least one additional enzyme, wherein the at least one additional enzyme comprises”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
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 1-5 and 8-19 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
As used herein, the term “about” in claims 1-5, 8, 14-18 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree or a special definition for “about”, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
MPEP § 2173.05(b).III.A. discusses that: “In determining the range encompassed by the term "about" one must consider the context of the term as it is used in the specification and claims of the application. Ortho-McNeil Pharm., Inc. v. Caraco Pharm. Labs., Ltd., 476 F.3d 1321, 1326, 81 USPQ2d 1427, 1432 (Fed. Cir. 2007) ... However, in another case, the court held that claims reciting "at least about" were invalid for indefiniteness where there was close prior art and there was nothing in the specification, prosecution history, or the prior art to provide any indication as to what range of specific activity is covered by the term about. Amgen, Inc. v. Chugai Pharmaceutical Co., 927 F.2d 1200, 18 USPQ2d 1016 (Fed. Cir. 1991).”
Claim 1 recites the phrase “at least about” in reference to the sequence identity of the alginate lyase enzyme amino acid sequence. The resulting claim is indefinite because the limit for the actual sequence identity requirement is undefined. Is a sequence of 55% identity within the claimed limitation? Is a sequence of 59.5% within the claimed limitation? Because there is no defined meaning of the amount of variance allowed by “about” in the instant specification, there is no way to determine the metes and bounds of the claimed subject matter.
To overcome this rejection, is recommended to amend the language to “wherein the alginate lyase enzyme comprises an amino acid sequence having at least 60% sequence identity to SEQ ID NO: 1”, or phrasing similar. This applies to each claim wherein “at least about” is recited, including claims 2-5, 8, and 14-15.
Also, claims 16-18 each recite the phrase “from about ... to about ...” in reference to a weight % or weight ratio of the composition surfactant components. As discussed above, there is no clear or standard definition for “about” that can be applied to the context of the instant claims. Because the claimed composition is defined by the ingredients and the amounts thereof, the metes and bounds of the claimed composition cannot be determined in this case and the claims are indefinite. It is recommended to amend the claim language to recite: “from ... to ... ”.
Claim 12 recites “wherein the alginate lyase enzyme provides activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity).”. The metes and bounds of the claimed subject matter cannot be determined because it is unclear if the claim requires a single enzyme (i.e. one amino acid sequence) that has both the polyM and polyG activities, or if the claim requires that the “alginate lyase enzyme” component includes two or more enzyme sequences (i.e. a plurality of enzymes) each having one of the two activities. The claim is indefinite because one of ordinary skill in the art would not be reasonable appraised of the required subject matter of the claim. Clarification of the language is requested.
Further, the use of the second parenthetical terms in claim 12 is not clear regarding the limitation on the claimed enzyme activity. Is the parenthesis merely intended to be an abbreviation (i.e. (polyM) for “poly(beta-D-mannuronate)? For the sake of clarity and precision, it is recommended to remove the recitation of the parenthetical “(polyM activity)” and “(polyG activity)” from the claim, as the abbreviations are not necessary nor used in any other claim.
All other claims depend directly or indirectly from the rejected claims and are, therefore, also rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, for the reasons set forth above.
Claim Rejections - 35 USC § 112(a) - Written Description
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 1-5 and 8-19 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 claims 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 inventors, at the time the application was filed, had possession of the claimed invention.
Claim 1 recites: the alginate lyase enzyme comprises at least about 60% sequence identity to SEQ ID NO: 1. Claim 2 limits the sequence identity to 70%, and claim 3 limits the identity to 80%. Further, claims 4 and 5 recite that the alginate lyase is selected from (i) alginate lyases having at least about 60% or 70%, respectively, identity to SEQ ID NO: 1 and (ii) alginate lyases having at least about 60% or 70%, respectively, identity to SEQ ID NO: 5. Claim 8 requires that the alginate lyase enzyme comprises two or more alginate lyase enzymes at least one of which has at least about 60% sequence identity to SEQ ID NO: 1 and the other of which has at least about 60% sequence identity to SEQ ID NO: 5.
None of the other dependent claims further limit the structure of the alginate lyase(s).
The claims thus encompass any and all alginate lyase enzymes having at least the minimal sequence identity to the recites sequences (SEQ ID NO:1 and/or SEQ ID NO:5). This includes various derivates and mutants thereof. When considering that SEQ ID NO: 1 has 288 amino acids, then for a sequence to have at least 60% identity, up to 116 of the amino acids can be mutated (288-(0.6*288)). This would amount to at least 2.16x10148 (i.e. 19^116) possible variants that fulfill this claim limitation. For 80% this would be about 7.74x1072 (i.e. 19^57), and thus an enormous number of possible sequence variants with the required similarity.
Regarding SEQ ID NO: 5, for a sequence with at least 60% identity, up to 99 of the amino acids can be mutated (248-(0.6*248)). This would amount to at least 3.95x10126 (i.e. 19^99) possible variants that fulfill this claim limitation. 70% identity to SEQ ID NO:5 would still allow for over 4.24x1094 different variations.
Thus, according to the B.R.I. of the claim, when viewed in light of the specification, there exists an extremely large number of structures and sequences within the claimed scope.
Comparatively, the specification only recites a small number of species of this broad genus that meets all of the recited structural limitations. In the Test Examples, on pages 31-32, a test using “Ariel liquid plus 1ppm wash concentration alginate lyase (SEQ ID NO: 1 and SEQ ID NO: 5 variants)” is disclosed, and has success in the stain removing assay. There are no other working examples or specific embodiments of sequences related to SEQ ID NOs: 1 and 5.
MPEP § 2163.(II)(A)(3)(a) states that 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 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 Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406.
The specification fails to reasonably describe the full genus of the claimed invention by providing identifying characteristics or properties other than the requisite activity of being an alginate lyase, or the functional properties of acting upon the substrates poly(beta-D-mannuronate) (polyM) and/or poly(alpha-L-guluronate) (polyG).
There is no known or disclosed relationship between the sequence and function that is sufficient to fulfill the written description requirement. The specification describes various bioinformatic tools and algorithms for determining sequence identity (e.g. on pages 3-5), however this cannot be considered an adequate description of a correlation between a recognized sequence motif and desired function when the number of claimed sequence variants are many magnitudes greater than a trillion. See MPEP § 2163.(II)(A)(3)(a)(ii).
Essentially, the specification only provides only one example of the claimed genus (e.g. the combination of SEQ ID NO: 1 and SEQ ID NO: 5 shown in the Table spanning pages 31-32), which cannot be considered a sufficient description of a representative number of species by actual reduction to practice of the full breadth of the vast genus. There are other examples (i.e. some using the non-elected SEQ ID NOs: 6 and 7), however just four divergent enzymes cannot be said to represent the enormous quantity of possible enzymes sequences having even at least 80% similarity to SEQ ID NO: 1 alone, much less those of 60% to SEQ ID NOs: 1 or 5.
There is no evidence that, at the time of filing, the Applicant possessed additional representative species of this near-infinite genus beyond the variants provided in the Examples.
Thus, the disclosure fails to provide adequate written description to support the entirety of the broad genus claim to the full complement of alginate lyase enzymes having at least 80% identity to SEQ ID NO: 1, as in claim 3 (or to 70% or 60%).
Claims 1-5 and 8-19 are rejected under 35 U.S.C. § 112(a) because the claimed subject matter is not described in the specification in such a way as to reasonably convey to a skilled artisan that the inventor, or a joint inventor, had possession of the claimed invention.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-5 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bettiol et al. (US Pat No. 6,486,112, cited on IDS filed 7/3/2023; hereafter “Bettiol”) in view of Huang et al. (J. Ind. Microbiol. Biotechnol. 40:113-122, 2013; cited on IDS filed 7/3/2023; hereafter “Huang”) and as evidenced by UniProt Database Accession Number G9CHX6, (Alginate lyase, alg2A, from Flavobacterium sp. S20. First Entry Feb. 2012; hereafter “UniProt G9CHX6”).
Bettiol et al. pertains to laundry detergent compositions comprising a saccharide gum degrading enzyme and methods for removing polysaccharides from fabric (Abstract, Claim 1).
Bettiol teaches that suitable enzymes usable in the laundry detergent includes poly(α-L guluronate)lyases, also called Alginase II (E.C. 4.2.2.11) (Col 4, line 45 - Col 5, line 4).
Bettiol teaches that the performance of the laundry detergent compositions of the present invention is enhanced by the addition of selected surfactants (Col 2, line 66 - Col 3, line 2), and teaches that the surfactant can comprise a nonionic, an anionic, and/or a cationic surfactant (Col 25, lines 37 - 67). Bettiol teaches multiple nonionic, anionic, and cationic surfactants which are known to the art, and recognized properties thereof, that may be selected from for the detergent (e.g. all of Cols 26 - 32).
Regarding claims 14 and 15, Bettiol teaches enzymes are normally incorporated in the detergent composition at levels from 0.0001% to 2% of pure enzyme by weight of the detergent composition (Col 37, lines 11-16) and the surfactant is can be at a level of from 0.1% to 60% by weight (Col 25, lines 38-59). Bettiol teaches an anionic surfactant is typically present from about 1% to about 40%, preferably from about 3% to about 20% by weight of the laundry detergent composition (Col 29, lines 34-37). When the surfactant is present at 0.1% by weight and enzyme is present at 0.0001% by weight, the weight ratio of surfactant to enzyme would amount to 1,000:1, which is within the ratios of claims 14 and 15. Any of the higher amounts of surfactant would be greater than this ratio. Thus, the ranges of the instant claims are taught by the disclosure of Bettiol.
Regarding claims 16-18, Bettiol teaches the laundry detergent compositions of the present invention will comprise a nonionic, an anionic and/or a cationic surfactant, which includes the combination of nonionic and anionic surfactants. Bettiol teaches the anionic surfactant is typically present from about 1% to about 40%, preferably from about 3% to about 20% by weight (Col 29, lines 34-37) and semi-polar nonionic surfactant is typically present from 0.2% to about 15%, preferably from about 1% to about 10% by weight, which are within the ranges of claim 16 (Col 41, lines 50-53). In a composition where anionic surfactant is present at 1% by weight and nonionic surfactant is present at 0.2%, the weight ratio of anionic surfactant to nonionic surfactant amounts to 5:1, which is within the ratios recited in claims 17 and 18.
Regarding claim 19, Bettiol teaches the detergent compositions comprise a mannanase (column 5, lines 44-46).
However, Bettiol does not teach an alginate lyase having at least 60% sequence identity to the amino acid sequence of SEQ ID NO:1, as required in the instant claim 1, nor does Bettiol teach that the alginate lyase is obtained from a Flavobacterium sp., as in claims 9-10, nor that the enzyme is from polysaccharide lyase family 7, as in claim 11.
Huang teaches characterization of a new alginate lyase from Flavobacterium sp. S20 (Title, Abstract), referred to as “Alg2A” (pg. 113, Abstract). Huang teaches that the Alg2A enzyme belongs to polysaccharide lyase family 7 (pg. 116, right col, top paragraph). Huang teaches Alg2A has a substrate preference for poly-α-L-guluronate (polyG) (pg. 113, Abstract) and alginate lyases with a substrate preference for polyG are classified as poly-α-L-guluronate lyase having EC 4.2.2.11 (pg. 114, left col). Huang teaches that Alg2A has high enzymatic capability and may be a useful enzyme for large scale preparation of alginate oligosaccharides, with high stability and favorable kinetics (pg. 113, right col; Figs. 2 and 4).
Regarding claim 12, Huang teaches that Alg2A depolymerizes both poly-α-L-guluronate (polyG) and poly-β-D-mannuronate (polyM) (pg. 117, right col 2; pg. 119, Fig. 3).
Huang does not explicitly teach the amino acid sequence of Alg2A. However, evidentiary reference UniProt G9CHX6 is provided herein to demonstrate that the amino acid sequence of Alg2A from Flavobacterium sp. S20, as identified in Huang, is identical to instant SEQ ID NO: 1 (see Appendix below for sequence alignment(s)).
Therefore, to one of ordinary skill in the art, before the effective filing date of the instant invention, it would have been prima facie obvious to combine the teachings of Bettiol and Huang, to arrive at the instantly claimed invention of a detergent having a surfactant (i.e. the adjunct) and an alginate lyase enzyme, wherein the alginate lyase enzyme comprises an amino acid sequence that is identical to or highly similar to that of SEQ ID NO:1.
One would have been motivated to provide Alg2A as taught in Huang for the poly(α-L guluronate) lyase used in the detergent composition of Bettiol because Bettiol teaches that a poly (α-L guluronate) lyase belongs to the same class of EC 4.2.2.11 (e.g. a PolyG alginate lyase), and Huang teaches that Alg2A has favorable enzymatic properties (i.e. high turnover and improved efficiency) and Huang suggests that this enzyme for large scale preparation of alginate oligosaccharides, e.g. the breakdown of alginates including poly(α-L guluronate).
The selection of enzymes having the preferred activity described in Bettiol, for preparing a detergent composition as taught therein, from among those enzymes known to the art, would have been a matter of judicial selection and optimization to one having ordinary skill in the art.
Claims 1-5 and 9-13 would have thus been obvious over Bettiol in view of Huang.
Regarding claims 14 and 15, Bettiol teaches composition having the ratios that fall within the limitations recited in claims 14 and 15. Thus, the ranges of the instant claims are taught by the disclosure of Bettiol. Regarding claims 16-18, Bettiol teaches laundry detergent compositions within a range wherein the anionic surfactant is present at 1% by weight and nonionic surfactant is present at 0.2%, thus the weight ratio of anionic surfactant to nonionic surfactant amounts to 5:1, within the limitations recited in claims 16-18. MPEP § 2144.05 describes that the determination of suitable or effective concentration of a known composition (or performing a known method) can be determined by one of ordinary skill in the art through the use of routine or manipulative experimentation to obtain optimal results, as these are variable parameters attainable within the art. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus these claims are obvious in view of the combined teachings of the cited art.
Regarding claim 19, Bettiol teaches the laundry detergent compositions comprise a mannanase (EC 3.2.1.78) which are known useful enzymes which are capable of cleaving glycosidic bonds in mannans, glucomannans, galactomannans and galacto-gluco-mannans. Bettiol teaches detergents which comprise mixtures of enzymes. Thus, the selection of a mannanase to add to the alginate lyase would have been prima facie obvious in view of Bettiol, as each have similar saccharide degradation activities useful to a detergent composition.
From the teachings of the cited references, it is apparent that there would have been a reasonable expectation of success in combining the teachings of Huang and Bettiol to arrive at the claimed invention because a Alg2A enzyme having 100% identity to that of the instantly recited SEQ ID NO:1 is known in the art and recognized as having alginate lyase activity according to Huang, and Huang teaches this enzyme successfully degrades alginate.
Therefore, the inventions of claims 1-5 and 9-19 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Claims 1-5 and 9-19 are rejected under 35 U.S.C. 103 as being unpatentable over Bettiol et al. (US Pat No. 6,486,112) in view of Huang et al. (J. Ind. Microbiol. Biotechnol. 40:113-122, 2013) and UniProt G9CHX6, as applied to claims 1-5 and 9-19 above, and further in view of Thomas et al. (“Comparative characterization of two marine alginate lyases from Zobellia galactanivorans reveals distinct modes of action and exquisite adaptation to their natural substrate.” The Journal of biological chemistry vol. 288,32 (2013): 23021-37. doi:10.1074/jbc.M113.467217, cited on IDS filed 7/3/2023) and UniProt Database Accession Number G0LAE1 (Alginate lyase, family PL7, from Zobellia galactanivorans. First Entry October 2011; hereafter “UniProt G0LAE1”).
The combined teachings of Bettiol and Huang (with supporting evidence from UniProt G9CHX6) make obvious the claimed detergent composition having a cleaning adjunct, e.g. a surfactant) and an alginate lyase enzyme comprising at least 60% sequence identity to that of SEQ ID NO: 1. An alginate lyase enzyme having 100% identity to SEQ ID NO:1 is disclosed in UniProt G9CHX6 which corresponds to Alg2A taught in Huang.
However, the combination of Bettiol, Huang, and UniProt G9CHX6 does not teach that the enzyme composition comprises a second enzyme having at least 60% identity to that of the amino acid sequence of SEQ ID NO: 5, as recited in the instant claim 8.
Thomas et al. pertains to the characterization of two marine alginate lyases from Zobellia galactanivorans, including AlyA1- an endolytic guluronate lyase of the PL7 family (Title, Abstract, pg. 23022, left col). Thomas teaches that AlyA1 is an alginate lyase acting via a β-elimination mechanism and that this enzyme preferentially cleaves between two guluronate units of the polysaccharide chain (pg. 23026- 23027; Fig. 5). Thomas also teaches: “bacteria have evolved diverse strategies to efficiently assimilate the polysaccharides available in their habitat. In general, polysaccharide degrading organisms will produce several enzymes that together, synergistically or by complementary actions, will break down the complex polymers into smaller mono- and oligosaccharide building units (pg. 23032, right col, last paragraph).
Thomas does not explicitly disclose the sequence of AlyA1 from Zobellia galactanivorans, however, the sequence is provided by UniProt G0LAE1, which contains a sequence that is 100% identical to that of SEQ ID NO: 5 required of claim 8.
Thus, to one of ordinary skill in the art, before the effective filing date of the instant invention, it would have been prima facie obvious to modify the composition rendered obvious by the teachings of Bettiol, Huang, and UniProt G9CHX6, by adding a second alginate enzyme, including that of AlyA1 taught in Thomas to arrive at the instantly claimed invention of a detergent having a surfactant and at least two distinct alginate lyase enzymes, wherein the first sequence is SEQ ID NO: 1, and wherein the second alginate lyase enzyme comprises an amino acid sequence with high similarity to SEQ ID NO:5 (as evidenced by UniProt G0LAE1).
One would have been motivated to provide multiple alginate lyase enzymes because Thomas teaches that, in nature, alginate-degrading organisms often produce several enzymes that together, synergistically or by complementary actions, that break down the complex polymers into smaller mono- and oligosaccharide building units. One having ordinary skill would have been motivated to provide synergistic or complementary alginate lyases for the composition having desired alginate degradation abilities.
Predictably, including a second enzyme would result in an improved composition in which the robustness of the enzyme activity and stability of the composition is improved (e.g. the activity is more robust across a wider range of temperatures, pH, and substrates).
MPEP § 2144.06 describes that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)... In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023) (That the two claimed types of active agents, GABA-a agonists and ARBs, were known to be useful for the same purpose—alleviating hypertension—alone can serve as a motivation to combine).” In the instant case, both AlyA1 of Thomas and Alg2A of Huang belong to EC 4.2.2.11 (e.g. both are PolyG alginate lyases), thus predictably, the combination of the two enzymes in the same composition would predictably result in a similar composition with activity towards poly(alpha-L-guluronate).
The selection of enzymes having the preferred activity for preparing a detergent composition as taught therein, from among those enzymes known to the art, would have thus been a matter of judicial selection and optimization to one having ordinary skill in the art.
Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955). Thus these claims are obvious in view of the combined teachings of the cited art.
From the teachings of Huang, Bettiol, and Thomas, it is apparent that there would have been a reasonable expectation of success in providing these enzymes because alginate lyases having 100% identity to that of the instantly recited SEQ ID NOs: 1 and 5 are known in the art and recognized as having a desirable activity (e.g. poly(α-L guluronate)lyase activity) according to Bettiol for a detergent or cleaning composition.
Therefore, the invention of claim 8 would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date, as evidenced by the cited references, especially in the absence of evidence to the contrary.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-5 and 8-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-18 of copending Application No. 18/297,302 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the reference application claims anticipate or make obvious each of the instant claims.
Claim 1 of the reference application recites a detergent composition comprising about 0.00005 wt% to about 5 wt% of an alginate lyase enzyme and from about 1 to about 60 wt% anionic surfactant, and claim 6 recites that the alginate lyase enzyme is from polysaccharide lyase family 7, wherein the alginate lyase enzyme comprises an amino acid sequence having about 60% to about 100%, sequence identity to SEQ ID NO: 1, which is identical to the instant sequence. Thus claim 6 of the reference application makes obvious, if not anticipates, the instant invention of claims 1-3, 11 (requiring that the alginate lyase enzyme is from polysaccharide lyase family 7), and 13 (requiring that the adjunct is a surfactant).
Regarding the instant claims 4 and 5, claim 7 of the ’302 application recites that the alginate lyase enzyme comprises an amino acid sequence having about 60% to about 100% sequence identity to SEQ ID NO: 1 or about 60% to about 100% sequence identity to SEQ ID NO: 5. The sequences in the ’302 application are identical to the instantly claimed sequences.
Regarding claim 8, claim 12 of the reference application recites that the alginate lyase enzyme comprises two or more alginate lyase enzymes, and claim 7 recites that the composition can comprise enzymes comprising sequences having about 60% to about 100% sequence identity to SEQ ID NO: 1 or about 60% to about 100% sequence identity to SEQ ID NO: 5. Thus, the claimed combination of two alginate lyase enzymes having similarity to SEQ ID NO: 1 and SEQ ID NO: 5 would have been prima facie obvious over the subject matter of the reference claims.
Regarding the instant claims 9 and 10, claims 4 and 5 of the reference application recites that the alginate lyase enzyme is obtainable from Flavobacterium sp, Sphingomonas sp, or Zobellia galactanivorans.
Regarding claim 12, claim 11 of the reference application discloses that the alginate lyase enzyme has depolymerase activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity).
Regarding claims 14 and 15, claims 9 and 10 of the reference application recite that an anionic surfactant is present in an amount such that a weight ratio of surfactant to the alginate lyase enzyme protein is at least about 500:1 (claim 9), or at least about 1000:1 (claim 10).
Regarding claim 16, claim 13 of the ’302 application recites that the detergent composition additionally comprises nonionic surfactant in an amount from about 1 to about 30 wt% of the detergent composition.
Regarding claims 17 and 18, claim 14 of the reference application recites that a weight ratio of the anionic surfactant to the nonionic surfactant is from 30:1 to 1:2, and claim 15 of the reference application recites that the weight ratio of the anionic surfactant to the nonionic surfactant is from 20:1 to 2:3.
Regarding the instant claim 19, claim 18 of the reference application recites that the composition further comprises at least one additional enzyme selected from the group consisting of amylase, nuclease, hexosaminidase, mannanase, xanthan lyase, and xanthanase.
Thus, all of the claimed subject matter of the instant claims would have been anticipated (or otherwise rendered obvious) by the recited subject matter of the ’302 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 8-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 and 15 of copending Application No. 18/301,513 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the reference application claims anticipate or make obvious the subject matter recited in the instant claims.
Claim 1 of the reference application recites a detergent composition comprising about 0.00005 wt% to about 5 wt% of an alginate lyase enzyme and from about 1 to about 60 wt% anionic surfactant, wherein the alginate lyase enzyme provides activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity).
Claim 9 of the ’513 application recites that the alginate lyase enzyme comprises an amino acid sequence having about 60% to about 100% sequence identity to SEQ ID NO: 1, or about 60% to about 100% sequence identity to SEQ ID NO: 5. The sequences in the ’513 application are identical to the instantly claimed sequences.
Thus the subject matter of claim 9 from the reference application anticipates, or at least makes obvious, the instant invention of claims 1-5, 12, and 13.
Regarding claim 8, claim 4 of the reference application recites that the “alginate lyase enzyme” comprises two or more alginate lyase enzymes which in combination provide polyM and polyG activity and claim 9 recites that the composition can comprise enzymes comprising sequences having about 60% to about 100% sequence identity to SEQ ID NO: 1 or about 60% to about 100% sequence identity to SEQ ID NO: 5. Thus, the claimed combination of two alginate lyase enzymes having similarity to SEQ ID NO: 1 and SEQ ID NO: 5 would have been prima facie obvious over the subject matter of the reference claims.
Regarding the instant claims 9 and 10, claims 7 and 8 of the reference application recites that the alginate lyase enzyme is obtainable from Flavobacterium sp, Sphingomonas sp, or Zobellia galactanivorans.
Regarding instant claim 11, the alginate lyase having SEQ ID NO:1 recited in the reference claims is identical to that in the instant claims, and thus, it must also be from polysaccharide lyase family 7.
Regarding claims 14 and 15, claim 10 of the reference application recites that an anionic surfactant is present in an amount such that a weight ratio of surfactant to the alginate lyase enzyme protein is at least about 500:1, as recited in instant claim 14. Because this is an open ended limitation (i.e. only limiting a minimal amount), the ranges of both claims 14 and 15 (at least 1000:1) are fully encompassed by the reference claim. Further, determining the suitable amount or concentration of a composition’s components is considered routine optimization to one of ordinary skill. Thus, instant claim 15 is also found obvious over reference claim 10.
Regarding claim 16, claim 11 of the ’513 application recites that the detergent composition additionally comprises nonionic surfactant in an amount from about 1 to about 30 wt% of the detergent composition.
Regarding claims 17 and 18, claim 12 of the reference application recites that a weight ratio of the anionic surfactant to the nonionic surfactant is from 30:1 to 1:2, and claim 13 of the reference application recites that the weight ratio of the anionic surfactant to the nonionic surfactant is from 20:1 to 2:3.
Regarding the instant claim 19, claim 15 of the reference application recites that the composition further comprises at least one additional enzyme selected from the group consisting of amylase, nuclease, hexosaminidase, mannanase, xanthan lyase, and xanthanase.
Thus, all of the claimed subject matter of the instant claims would have been anticipated (or otherwise rendered obvious) by the recited subject matter of the ’513 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 9-11, and 13-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-17 of copending Application No. 18/297,366 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the reference application claims anticipate or make obvious each of the instant claims.
Claim 1 of the reference application recites a detergent composition comprising from 0.00005 wt% to 5 wt% alginate lyase enzyme by weight of the composition and from about 1 to about 60 wt% anionic surfactant, wherein the alginate lyase enzyme comprises from 98% to 100%, sequence identity to the polypeptide of SEQ ID NO: 1, which the same as the instant sequence.
Thus claim 1 of the reference application makes obvious, if not anticipates, the instant invention of claims 1-5 and 13 (requiring that the adjunct is a surfactant).
Regarding the instant claims 9 and 10, claims 4 and 5 of the reference application recites that the alginate lyase enzyme is obtainable from Flavobacterium sp, Sphingomonas sp, or Zobellia galactanivorans.
Regarding claim 11, requiring that the alginate lyase enzyme is from polysaccharide lyase family 7, the alginate lyase recited in the reference claim 1 is identical to that of the instant claims, and thus, it must also be of the same from polysaccharide lyase family 7. This is evidenced from the disclosure of the reference application (pg. 4 of the specification).
Regarding claims 14 and 15, claims 9 and 10 of the reference application recite that an anionic surfactant is present in an amount such that a weight ratio of surfactant to the alginate lyase enzyme protein is at least about 500:1 (claim 9), or at least about 1000:1 (claim 10).
Regarding claim 16, claim 12 of the ’366 application recites that the detergent composition additionally comprises nonionic surfactant in an amount from about 1 to about 30 wt% of the detergent composition.
Regarding claims 17 and 18, claim 13 of the ’366 application recites that a weight ratio of the anionic surfactant to the nonionic surfactant is from 30:1 to 1:2, and claim 14 of the reference application recites that the weight ratio of the anionic surfactant to the nonionic surfactant is from 20:1 to 2:3.
Regarding the instant claim 19, claim 17 of the reference application recites that the composition further comprises at least one additional enzyme comprising one or more of an amylase, a mannanase, a xanthan lyase, and a xanthanase.
Thus, the claimed subject matter of the instant claims would have been anticipated or otherwise rendered obvious by the recited subject matter of the ’366 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 9-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-7 and 9-17 of copending Application No. 18/297,366 (reference application) in view of Huang et al. (J. Ind. Microbiol. Biotechnol. 40:113-122, 2013; cited on IDS filed 7/3/2023; “Huang”), as evidenced by UniProt Database Accession Number G9CHX6, (Alginate lyase, alg2A, from Flavobacterium sp. S20. Feb. 2012; “UniProt G9CHX6”).
Claims 1-5, 9-11, and 13-19 have been found unpatentable over reference application 18/297,366 for all of the reasons described above.
However, claim 12 recites that the alginate lyase enzyme has depolymerase activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity), which is not explicitly recited in the subject matter of the ’366 application.
The teachings of Huang et al. include all of those set forth above. Huang teaches an alginate lyase from Flavobacterium sp. S20 (Title, Abstract), referred to as “Alg2A” (pg. 113, Abstract). Huang teaches that the Alg2A enzyme belongs to polysaccharide lyase family 7 (pg. 116, right col, top paragraph). Huang teaches Alg2A has a preference for poly-α-L-guluronate (polyG) (pg. 113, Abstract) but also teaches that Alg2A depolymerizes both poly-α-L-guluronate (polyG) and poly-β-D-mannuronate (polyM) (pg. 117, right col 2; pg. 119, Fig. 3). In other words, Alg2A can act upon both substrates, but has a preference for poly-α-L-guluronate. As discussed above, Huang does not explicitly teach the amino acid sequence of Alg2A.
However, evidentiary reference UniProt G9CHX6 is provided herein to demonstrate that the amino acid sequence of Alg2A from Flavobacterium sp. S20, as identified in Huang, is identical to instant SEQ ID NO: 1 (see Appendix below for sequence alignment(s)).
Therefore, to one having ordinary skill in the art, it would have been prima facie obvious that the alginate lyase belonging to the PL7 family having the sequence of SEQ ID NO: 1, as disclosed in the claims of the reference application, comprises both depolymerization activity towards both poly-α-L-guluronate (polyG) and poly-β-D-mannuronate (polyM), as required in the instant claim. As this is clearly the same sequence disclosed in the reference claim the providing of the alginate lyase having this sequence fulfills the limitation inherently.
Claim 12 is thus rejected on the grounds of nonstatutory double patenting over the claims of the ‘366 application in view of the evidentiary teachings of Huang and UniProt G9CHX6.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 8-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of copending Application No. 18/301,463 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the reference application claims anticipate or make obvious each of the instant claims.
Claim 1 of the reference application recites a detergent composition comprising about 0.00005 wt% to about 5 wt% of an alginate lyase enzyme and from about 1 to about 60 wt% anionic surfactant, and claim 5 recites that the alginate lyase enzyme comprises an amino acid sequence having about 60% to about 100%, sequence identity to SEQ ID NO: 1 and/or about 60% to about 100% sequence identity to SEQ ID NO: 5. The sequences in the ’463 application are identical to the instantly claimed sequences. Thus the subject matter recited in claim 5 of the reference application anticipates the instant invention of claims 1-5 and 13.
Regarding the instant claims 9 and 10, claims 3 and 4 of the reference application recites that the alginate lyase enzyme is obtainable from Flavobacterium sp, Sphingomonas sp, or Zobellia galactanivorans.
Regarding instant claim 11, the alginate lyase having SEQ ID NO:1 recited in the reference claims is identical to that in the instant claims, and thus, it must also be from polysaccharide lyase family 7.
Regarding claim 12, claim 10 of the reference application discloses that the alginate lyase enzyme has depolymerase activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity).
Regarding claims 14 and 15, claims 8 and 9 of the reference application recite that an anionic surfactant is present in an amount such that a weight ratio of surfactant to the alginate lyase enzyme protein is at least about 500:1 (claim 9), or at least about 1000:1 (claim 10).
Regarding claim 16, claim 13 of the ’463 application recites that the detergent composition additionally comprises nonionic surfactant in an amount from about 1 to about 30 wt% of the detergent composition.
Regarding claims 17 and 18, claim 14 of the reference application recites that a weight ratio of the anionic surfactant to the nonionic surfactant is from 30:1 to 1:2, and claim 15 of the reference application recites that the weight ratio of the anionic surfactant to the nonionic surfactant is from 20:1 to 2:3.
Regarding the instant claim 19, claim 17 of the reference application recites that the composition further comprises at least one additional enzyme comprising an amylase, a hexosaminidase, a mannanase, a xanthan lyase, and a xanthanase.
Regarding claim 8, the reference claims do not explicitly state a composition having two different enzymes, including that of SEQ ID NO: 1 and SEQ ID NO: 5. However, claims 5 and 6 recite that the composition can comprise enzymes comprising sequences having about 60% to about 100% sequence identity to SEQ ID NO: 1, about 60% to about 100% sequence identity to SEQ ID NO: 5, or mixture thereof. Thus, the claimed combination of two alginate lyase enzymes having similarity to SEQ ID NO: 1 and SEQ ID NO: 5 would have been prima facie obvious over the subject matter of the reference claims, which includes combinations of multiple alginate enzymes, including those of SEQ ID NO: 1 and SEQ ID NO: 5.
MPEP § 2144.06 describes that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)... In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023). In this case both enzymes have the same known activity, the degradation of alginate containing polysaccharides and thus the composition of claim 8 would have been obvious in view of the claims of the ’463 application.
Thus, all of the claimed subject matter of the instant claims would have been anticipated or otherwise obvious to one of ordinary skill by the recited subject matter of the ’463 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 8-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-9 of copending Application No. 18/739,532 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the reference application claims anticipate or make obvious each of the instant claims.
Claim 1 of the reference application recites a detergent composition comprising about 0.00005 to about 5 wt% alginate lyase enzyme and Bacillus spores, while claim 6 recites a composition further comprising surfactant present in an amount such that the weight ratio of surfactant to active alginate lyase enzyme protein is at least about 500:1. Claim 4 recites that the alginate lyase enzyme comprises: an alginate lyase selected from alginate lyase having at least about 80%, sequence identity to one or more of SEQ ID NO: 1 and/or an alginate lyase having at least about 80%, or mixtures thereof. The sequences of the reference application are identical to those of the instant application.
Thus, claims 1-5 and 13 of the instant application are found obvious over the disclosed composition of claims 4 and 6 of the ’532 application.
Regarding claim 8, the reference claims do not explicitly state a composition having two different enzymes, including that of SEQ ID NO: 1 and SEQ ID NO: 5. However, claim 4 of the ‘532 application recites that the composition can comprise enzymes comprising sequences having at least 80% sequence identity to SEQ ID NO: 1, at least 80% sequence identity to SEQ ID NO: 5, or mixtures thereof. Thus, the claimed combination of two alginate lyase enzymes having similarity to SEQ ID NO: 1 and SEQ ID NO: 5 would have been prima facie obvious over the subject matter of the reference claims, which includes combinations of multiple alginate enzymes, including those of SEQ ID NO: 1 and SEQ ID NO: 5.
MPEP § 2144.06 describes that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)... In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023). In this case both enzymes have the same known activity, the degradation of alginate containing polysaccharides and thus the composition of claim 8 would have been obvious in view of the claims of the ’532 application.
Regarding the instant claims 9 and 10, claim 3 of the reference application recites the detergent composition according to claim 1, wherein the alginate lyase enzyme is obtainable from Flavobacterium sp, Sphingomonas sp, Zobellia galactanivorans, preferably Flavobacterium sp..
Regarding instant claim 11, the alginate lyase having SEQ ID NO:1 recited in the reference claims is identical to that in the instant claims, and thus, it must also be from polysaccharide lyase family 7 as identical compositions have identical properties.
Regarding claim 12, the reference application claims do not explicitly state that the alginate lyase enzyme has depolymerase activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity). However, the exact same enzyme sequences are recited in the instant claims as that in the composition of the reference application. Because identical enzymes have identical properties, the instant subject matter is considered anticipated by the recitation of the identical enzyme having the amino acid sequence of SEQ ID NO: 1 in the reference claims.
Regarding claims 14 and 15, the reference application claims recite that an anionic surfactant is present in an amount such that a weight ratio of surfactant to the alginate lyase enzyme protein is at least about 500:1 (claim 6). Because this is an open ended limitation (i.e. only limiting a minimal amount), the ranges of both claims 14 and 15 (at least 1000:1) are fully encompassed by the claimed range. Further, determining the suitable amount or concentration of a composition’s components is considered routine optimization to one of ordinary skill. Thus, instant claim 15 is also found obvious over the claims of the ‘532 application.
Regarding claim 16, claim 8 of the ’532 application recites that the detergent composition additionally comprises nonionic surfactant in an amount from about 1 to about 30 wt% of the detergent composition.
Regarding claims 17 and 18, claim 9 of the reference application recites that a weight ratio of the anionic surfactant to the nonionic surfactant is from about 30:1 to about 1:2.
The instant claim 18 recites that the weight ratio of the anionic surfactant to the nonionic surfactant is from 20:1 to 2:3, which is not recited explicitly in the reference claims. However, it is noted that this range is narrower than that of claim 17 and is fully encompassed within the reference claim range of ratios from about 30:1 to about 1:2.
MPEP § 2144.05 discusses the obviousness of overlapping and similar ranges, amounts, and proportions, and states “In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)... [A] prior art reference that discloses a range encompassing a somewhat narrower claimed range is sufficient to establish a prima facie case of obviousness." In re Peterson, 315 F.3d 1325, 1330, 65 USPQ2d 1379, 1382-83 (Fed. Cir. 2003)”. In the instant case, arriving at the claimed slightly narrower range would have been well within the level of ordinary experiment and routine optimization of concentrations, and the claim limitation is found obvious over the recited ratio in claim 9 of the reference application.
Regarding the instant claim 19, claim 7 of the reference application recites that the composition further comprises an additional enzyme selected from amylase, protease, nuclease enzyme, hexosaminidase enzyme, endo-β-1,3-glucanase enzyme, and mixtures thereof.
Thus, all of the claimed subject matter of the instant claims would have been anticipated or otherwise obvious to one of ordinary skill by the recited subject matter of the ’532 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5 and 8-19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of copending Application No. 18/932,665 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the reference application claims anticipate or make obvious each of the instant claims.
Claim 1 of the reference application recites a detergent composition comprising about 0.00005 wt% to about 5 wt% of an alginate lyase enzyme while claim 6 recites a composition further comprising a surfactant present in an amount such that the weight ratio of surfactant to active alginate lyase enzyme protein is at least about 500:1. Further, claim 5 of the reference application recites that the alginate lyase enzyme comprises an amino acid sequence having at least 60% sequence identity to SEQ ID NO: 1 (up to 100%); at least 60% sequence identity sequence identity to SEQ ID NO: 5 (up to 100%), and/or mixtures thereof. The sequences in the ’665 application are identical to the instantly claimed sequences.
Thus, claims 1-5 and 13 of the instant application are found obvious over the disclosed composition of claims 5 and 6 of the ’665 application.
Regarding claim 8, the reference claims do not explicitly state a composition having two different enzymes, including that of SEQ ID NO: 1 and SEQ ID NO: 5. However, claim 5 encompasses composition having at least 60% sequence identity to SEQ ID NO: 1, at least 60% sequence identity to SEQ ID NO: 5, and mixtures thereof. Thus, the claimed combination of two alginate lyase enzymes having similarity to SEQ ID NO: 1 and SEQ ID NO: 5 would have been prima facie obvious over the subject matter of the reference claims, which includes combinations of multiple alginate enzymes, including those of SEQ ID NO: 1 and SEQ ID NO: 5.
MPEP § 2144.06 describes that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)... In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023). In this case both enzymes have the same known activity, the degradation of alginate containing polysaccharides and thus the composition of claim 8 would have been obvious in view of the claims of the ’532 application.
Regarding the instant claims 9 and 10, claim 4 of the reference application recites a detergent composition wherein the alginate lyase enzyme is obtainable from Flavobacterium sp, Sphingomonas sp, Zobellia galactanivorans, preferably Flavobacterium sp..
Regarding instant claim 11, the alginate lyase having SEQ ID NO:1 recited in the reference claims is identical to that in the instant claims, and thus, it must also be from polysaccharide lyase family 7 as identical compositions have identical properties.
Regarding claim 12, claim 7 of the reference application discloses that the alginate lyase enzyme has depolymerase activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity).
Regarding claims 14 and 15, the reference application claims recite that an anionic surfactant is present in an amount such that a weight ratio of surfactant to the alginate lyase enzyme protein is at least about 500:1 (in claim 6). Because this is an open ended limitation (i.e. only limiting a minimal amount), the ranges of claims 14 and 15 (at least 1000:1) are fully encompassed by the claimed range.
Further, determining the suitable amount or concentration of a composition’s components is considered routine optimization to one of ordinary skill. Thus, instant claim 15 is found obvious over the claims of the ‘665 application.
Regarding claim 16, claim 9 of the ’665 application recites that the detergent composition additionally comprises nonionic surfactant in an amount from about 1 to about 30 wt% of the detergent composition.
Regarding claims 17 and 18, claim 10 of the reference application recites that a weight ratio of the anionic surfactant to the nonionic surfactant is from 30:1 to 1:2, and claim 11 of the reference application recites that the weight ratio of the anionic surfactant to the nonionic surfactant is from 20:1 to 2:3.
Regarding the instant claim 19, claim 14 of the reference application recites that the composition further comprises an additional enzyme selected from amylase, nuclease, hexosaminidase, mannanase, xanthan lyase, xanthanase, and mixtures thereof.
Thus, all of the claimed subject matter of the instant claims would have been anticipated or otherwise obvious to one of ordinary skill by the recited subject matter of the ’665 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claims 1-5, 8-13, 16, and 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of copending Application No. 18/932,669 (reference application).
Although the claims at issue are not identical, they are not patentably distinct from each other because the subject matter of the reference application claims anticipate or make obvious each of the instant claims.
Claim 1 of the reference application recites a washing machine-cleaning composition comprising (a) at least two enzymes selected from (i) alginate lyase enzyme: (ii) Pel-ase enzyme: (iii) Psl-ase enzyme: (iv) endo-β-1,3-glucanase enzyme: and (v) endo-β-1,3(4)-glucanase enzyme: and (b) a cleaning adjunct, and claim 7 of the ‘669 application recites that the alginate lyase enzyme comprises an amino acid sequence having at least 60% sequence identity to SEQ ID NO: 1 (up to 100% sequence identity); at least 60% sequence identity sequence identity to SEQ ID NO: 5 (up to 100% sequence identity), and/or mixtures thereof. The sequences in the ’669 application are identical to the instantly claimed sequences.
Thus, claims 1-5 of the instant application are found obvious over, if not anticipated by, the disclosed composition of claims 1 and 7 of the ’669 application.
Regarding claim 8, the reference claims do not explicitly state a composition having two different enzymes, including that of SEQ ID NO: 1 and SEQ ID NO: 5. However, claim 7 encompasses composition having at least 60% sequence identity to SEQ ID NO: 1, at least 60% sequence identity to SEQ ID NO: 5, and mixtures thereof. The claimed combination of two alginate lyase enzymes having the sequences of SEQ ID NO: 1 and SEQ ID NO: 5 would have been obvious over the subject matter of the reference claims, which includes combinations of multiple alginate enzymes, including those of SEQ ID NO: 1 and SEQ ID NO: 5.
MPEP § 2144.06 describes that it is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. “[T]he idea of combining them flows logically from their having been individually taught in the prior art." In re Kerkhoven, 626 F.2d 846, 850, 205 USPQ 1069, 1072 (CCPA 1980) (citations omitted)... In re Couvaras, 70 F.4th 1374, 1378-79, 2023 USPQ2d 697 (Fed. Cir. 2023). In this case both enzymes have the same known activity, the degradation of alginate containing polysaccharides and thus the composition of claim 8 would have been obvious in view of the claims of the ’532 application.
Regarding the instant claims 9 and 10, claims 5 and 6 of the reference application recite a detergent composition wherein the alginate lyase enzyme is obtainable from Flavobacterium sp, Sphingomonas sp, Zobellia galactanivorans, or just Flavobacterium sp. (claim 6).
Regarding instant claim 11, the alginate lyase having SEQ ID NO:1 recited in the reference claims is identical to that in the instant claims, and thus, it must also be from polysaccharide lyase family 7 as identical compositions have identical properties.
Regarding claim 12, the reference application claims do not explicitly state that the alginate lyase enzyme has depolymerase activity towards poly(beta-D-mannuronate) (polyM activity) and activity towards poly(alpha-L-guluronate) (polyG activity). However, the exact same enzyme sequences are recited in the instant claims as that in the composition of the reference application. Because identical enzymes have identical properties, the instant subject matter is considered anticipated by the recitation of the identical enzyme having the amino acid sequence of SEQ ID NO: 1 in the reference claims.
Regarding claim 13, claim 2 of the ’669 application recites that the composition further comprises a surfactant.
Regarding claim 16, claim 9 of the ’669 application recites that the detergent composition additionally comprises a nonionic surfactant at a weight percentage of from about 0.5% to about 30 wt% of the composition.
Regarding the instant claim 19, claim 10 of the ’669 application recites that the composition further comprises an additional enzyme comprising at least one of: amylase, nuclease, mannanase, xanthan lyase, xanthanase, and mixtures thereof.
Thus, the claimed subject matter of the instant claims would have been anticipated or otherwise obvious to one of ordinary skill by the recited subject matter of the ’669 application.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Citation of Pertinent Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
Barnett et al. (US PGPub No. 20100080788) discloses alginate lyase compositions (Title, Abstract) and a method for dissolving an alginate based biomaterial, comprising administering a composition comprising an alginate lyase (claim 1). The alginate lyase compositions taught in Barnett include bacterial alginate lyases derived from a Flavobacterium ([0086]). Table 1 in Barnett discloses some additional alginate lyases and exemplary sources ([0187]).
Yan et al. (CN 110607266 A) (published 12/24/2019) discloses a flavobacterium (with strain/deposit number CGMCC No.17354) and applications thereof for producing an alginate lyase (Abstract). Yan et al. teaches that the produced alginate lyase can degrade alginate composed of guluronic acid (G) and mannuronic acid (M) (e.g. the translated paragraphs of “BACKGROUND” and “summary of the invention”).
Conclusion
No claims are allowed.
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/A.T.M./Examiner, Art Unit 1655
/ANAND U DESAI/Supervisory Patent Examiner, Art Unit 1655
Appendix A: Sequence alignment of SEQ ID NO: 1 and G9CHX6 (Alg2A from Flavobacterium sp. S20)
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Appendix B: Sequence alignment of SEQ ID NO: 1 and G0LAE1 (AlyA1 from Zobellia galactanivorans)
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