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 .
DETAILED ACTION
Application Status
This application is a 371 of PCT/EP2021/079924, filed on 04/14/2023.
Claims 18-26, 27-32 and 33 are currently pending in the instant patent application.
The preliminary amendment filed on 12/21/2025, canceling claims 1-17 and adding new claims 18-26, 27-32 and 33 is acknowledged.
Election/Restriction
Applicant's election with traverse of Group I, claim(s) 1-9, drawn to a variant of a parent lipase which variant has lipase activity, has at least
Since, Applicants canceled all the previous version claims and added new claims 18-26, 27-32 and 33, and new claims 18-26 correspond to Group I, and claims 27-28, drawn to method of use of lipase variant of Group II, and claims 29-33, drawn to a polynucleotide encoding the lipase variant , vector, and process of producing the polypeptide in a host cell of Group III.
Arguments: The traversal is on the ground(s) that there would be no burden of search for the co-examination of the claims of Groups I-III, and further stated that the claims of Group I are linked to group II and III through the lipase variant.
Response: This is not found persuasive because as discussed previously- A variant of a parent lipase which variant has lipase activity, has at least F51I in SEQ ID NO: 2, of Group I, a polynucleotide encoding a variant of claim 1, a nucleic acid construct comprising the polynucleotide of claim 18, and a process for producing lipase variant in a host cell of Group III, are each patentably distinct product, and comprises a chemically unrelated structure capable of separate manufacture, use and effect. are each chemically distinct entities. The only shared technical feature of these groups I-II and III is that they all relate to a lipase variant, which is a variant of a parent lipase has lipase activity, has at least 80% but less than 100% sequence identity with SEQ ID NO: 2 and comprises: the substitution mutation F51I in SEQ ID NO: 2. However, this shared technical feature is not a “special technical feature” as defined by PCT Rule 13.2 as it does not define a contribution over the art. Borch et al. (WO 2018/001959A1, publication 01/04/2018) teach a lipase variant having 99.3% identity to SEQ ID NO 2 of the instant application (see, whole document, in particular abstract, pg 42, and claims 1-17), Thus, a variant of a parent lipase has lipase activity, has at least 80% but less than 100% sequence identity with SEQ ID NO: 2 and comprises mutation F51I in SEQ ID NO:2, and method of use thereof does not make contribution over the prior art and lack unity of invention. Besides, 37 CFR 1.475 does not provide for multiple products and/or methods within a single application. Therefore, inventions of Group I - III lack unity of invention.
The requirement is still deemed proper and is therefore made FINAL.
Claims 27-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 18-25 and 26 are present for examination.
Priority
Acknowledgement is made of applicants claim for foreign priority under 35 U.S.C. 119(a)-(d) to a foreign patent application EPO 21189683.2, filed on 08/04/2021, and EPO 20204541.5, filed on 10/29/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 04/14/2023 is acknowledged. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is considered by the examiner. The signed copy of 1449 is enclosed herewith.
Drawings
There is no drawing with this patent application.
Claim Objections
Claims 19, and 20 is objected to in the recitation “variant comprises”, which should be changed to “variant further comprises”. Appropriate correction is required.
Claim 19 is objected to in the recitation “variant comprises substitutions selected from the group corresponding to ”, which should be changed to “variant comprises substitutions selected from the group consisting of”. Appropriate correction is required.
Claim 20 is objected to in the recitation “variant -------- comprising substitutions corresponding to any of the following set of substitution ”, which should be changed to “variant -------- comprising substitutions to any of the following set of substitution ”. Appropriate correction is required.
Claim 24 is objected to RP(wash); as abbreviations should not be used without at least once fully setting forth what they are used for. Appropriate correction is required.
Claim 23 is objected to RP(odor); as abbreviations should not be used without at least once fully setting forth what they are used for. Appropriate correction is required.
Double Patenting Rejection
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. See 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.130(b).
Effective January 1, 1994, a registered attorney or agent of record may sign a terminal disclaimer. A terminal disclaimer signed by the assignee must fully comply with 37 CFR 3.73(b).
Claim 18 is rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over at least claims 1-3 of U. S. Patent 12559736 B2. Although the conflicting claims are not identical, they are not patentably distinct from each other because claims 18 of the instant application disclose a variant of a parent lipase which variant has lipase activity, has at least 80% but less than 100% sequence identity with SEQ ID NO: 2, and comprises the substitution corresponding to F51I (Phe51Iso) in SEQ ID NO: 2,
Claims 1-3 of US patent 12559736 B2 disclose a variant of a parent lipase, wherein said variant has: a) at least 90% but less than 100% sequence identity with SEQ ID NO: 2,b) lipase activity; c) substitutions corresponding to G91A, N92D, and D961 in the region located from position G82 to position 1100 of SEQ ID NO: 2; and d) substitutions corresponding to T231 R and N233R of SEQ ID NO: 2, wherein the variant of claim 1, further comprising one or more additional substitutions corresponding to S83T; R84N; 186L,P; 190V; L93F; N94E; D96V,H,L; K981,Q; or 1100Y of SEQ ID NO: 2, wherein the variant further comprises one or more additional substitutions corresponding to Q4E, R; D27R; G38A; K46Q; T50K; F511, V; S54T, E56R, Q; T72R; K74E; D111A; R118F; G163K; G212R; Y220F; R232Q; K237V; T244E; D254A,G,L,S,T; 1255G,L,T,V; P256G,L,N,R,S,T,Y; L264A,P; and/or L269V in SEQ ID NO: 2.
The above indicated claims 1-3 of the reference patents while not totally identical to the instant claim(s) 1, is indeed a product claim of a variant of a parent lipase, wherein said variant has: a) at least 90% but less than 100% sequence identity with SEQ ID NO: 2,b) lipase activity; c) substitutions corresponding to G91A, N92D, and D961 in the region located from position G82 to position 1100 of SEQ ID NO: 2; and d) substitutions corresponding to T231 R and N233R of SEQ ID NO: 2, wherein the variant of claim 1, further comprising one or more additional substitutions corresponding to S83T; R84N; 186L,P; 190V; L93F; N94E; D96V,H,L; K981,Q; or 1100Y of SEQ ID NO: 2, wherein the variant further comprises one or more additional substitutions corresponding to Q4E, R; D27R; G38A; K46Q; T50K; F511, V; S54T, E56R, Q; T72R; K74E; D111A; R118F; G163K; G212R; Y220F; R232Q; K237V; T244E; D254A,G,L,S,T; 1255G,L,T,V; P256G,L,N,R,S,T,Y; L264A,P; and/or L269V in SEQ ID NO: 2 as claimed in claim 1, which is drawn to a variant of a parent lipase which variant has lipase activity, has at least 80% but less than 100% sequence identity with SEQ ID NO: 2, and comprises the substitution corresponding to F51I (Phe51Iso) in SEQ ID NO: 2 as claimed in the instant claim 1. The portion of the claims and the specification in the reference patent US 12559736 B2, while drawn to the actual product as claim in claim 18 in the instant application, includes several embodiments that would anticipate the invention claimed in the instant application. Claims of the instant application listed above cannot be considered patentably distinct over claims 1-3 of the reference patents when there are specifically recited embodiments that would either anticipate to claim 18 of the instant application or alternatively render them obvious. Alternatively, claim 18 cannot be considered patentably distinct over claims 1-3 of the reference patent US 12559736 B2 when there is specifically disclosed embodiment in the reference patent that falls within the scope of claim 18 of the instant application, i.e. there is substantially overlapping scope between the claimed invention and the teachings of the reference. One having ordinary skill in the art would have been motivated to do this because that embodiment is disclosed in the reference patent as being a preferred embodiment within the claims 1-3 of US patent US 12559736 B2.
Claim Rejections - 35 USC § 112(a)
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
A. Written Description
Claims 18-26 are rejected under 35 U.S.C. 112(a), 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.
Claims 18 and 26 are directed to a variant of a parent lipase, wherein said variant has: a) at least 80% but less than 100% sequence identity with SEQ ID NO: 2, and comprises a substitution corresponding to F51I in SEQ ID NO: 2, and a composition comprising said variant of claim 18.
The Court of Appeals for the Federal Circuit has held that a “written description of an invention involving a chemical genus, like a description of a chemical species, ‘requires a precise definition, such as by structure, formula [or] chemical name,’ of the claimed subject matter sufficient to distinguish it from other materials.” University of California v. Eli Lilly and Co., 1997 U.S. App. LEXIS 18221, at *23, quoting Fiers v. Revel, 25 USPQ2d 1601, 1606 (Fed. Cir. 1993). To fully describe a genus of genetic material, which is a chemical compound, applicants must (1) fully describe at least one species of the claimed genus sufficient to represent said genus whereby a skilled artisan, in view of the prior art, could predict the structure of other species encompassed by the claimed genus and (2) identify the common characteristics of the claimed molecules, e.g., structure, physical and/or chemical characteristics, functional characteristics when coupled with a known or disclosed correlation between function and structure, or a combination of these (paraphrased from Enzo Biochemical).
Thus, Claims 18 and 26, are drawn to any variant of a parent lipase, wherein said variant has: a) at least 80% but less than 100% sequence identity (for claim 18), and comprises a substitution corresponding to F51I in SEQ ID NO: 2, i.e., 20% non-identity to SEQ ID NO: 2, that encompasses many variant lipase enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, i.e. No Structure-Function correlation, which is required to fulfill the Written Description (WD) requirement.
As discussed in the written description guidelines the Written Description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus. A representative number of species means that the species, which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Furthermore, the genus of polypeptides required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides are adequately described by the disclosure of the structures of prior art. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight 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, it is difficult to state criteria for successful prediction of function, since function is a vague concept. 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. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and completely eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Furthermore, the genus of polynucleotide encoding polypeptides or variants required in the claimed invention is an extremely large structurally and functionally variable genus. While the argument can be made that the recited genus of polypeptides are adequately described by the disclosure of the structures of prior art, i.e., lipase variant enzymes. However, the art clearly teaches the “Practical Limits of Function Prediction”: Whisstock et al., (2003) highlight 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, it is difficult to state criteria for successful prediction of function, since function is in principle a fuzzy concept. 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. For example, proteins having similar structure have different activities (structure does not always correlate to function); Witkowski et al., (1999) teaches that one conservative amino acid substitution transforms a -ketoacyl synthase into a malonyl decarboxylase and completely eliminates -ketoacyl synthase activity. Similarly, the art also teaches that functionally similar molecules have different structures; Kisselev L., (2002) teach that polypeptide release factors in prokaryotes and eukaryotes have same function but different structures.
Claims are drawn to very broadly any variant of a parent lipase, wherein said variant has: a) at least 80% but less than 100% sequence identity (for claim 18), and comprises a substitution corresponding to F51I in SEQ ID NO: 2, i.e., 20% non-identity to SEQ ID NO: 2, that encompasses many variant lipase enzymes derived from many unknown sources and many mutants, variants, and fragments thereof, which can have wide variety of unknown structures, which can have wide variety of unknown structures, whose structures are not fully described in the specification. No information, beyond the characterization of variant lipases enzymes has been provided, which would indicate that applicants had possession of the claimed genus. The specification does not contain sufficient disclosure of the structure with function of all the variant lipase enzymes, within the scope of the claimed genus. The genus of polypeptides claimed is a large variable genus including many mutants, variant and fragments thereof, which can have wide variety of structures. Therefore, many structurally unrelated enzymes (variant lipase) within the scope of these claims. The specification discloses the structure of only few representative species of the claimed genus, which is insufficient to put one of skill in the art in possession of the attributes and features of all species within the claimed genus. Therefore, one skilled in the art cannot reasonably conclude that applicant had possession of the claimed invention at the time the instant application was filed.
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.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless -
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 18-26 are rejected under 35 U.S.C. 102(a)(1/2) based upon a public use or sale or other public availability of the invention as anticipated by Borch et al. (Lipase variants and composition comprising surfactant and lipase variant. WO 2018/001959 A1.
The Broadest Reasonable Interpretation (BRI) of claims 1 and 5-6, which are drawn to any variant of a parent lipase, wherein said variant has: a) at least 80% but less than 100% sequence identity (for claim 1) with a substitution F51I in SEQ ID NO: 2.
Regarding claims 18-26, Borch et al. teach a variant of parent lipase of the polypeptide of SEQ ID NO: 2 having the substitution mutations F51 corresponding to substitutions at position F51I, and further teach mutations E1 C, V2Y, D27R, N33K, N33Q, G38A, F51V, E56K, L69R, D96E, D96L, K98I, K98Q, D1 11A, G163K, V176L, H198S, E210K, Y220F, L227G, T231R, N233R, N233C, K237C, D254S, and P256T corresponding to the parent lipase polypeptide of SEQ ID NO: 2, which is about 99.3% identical to SEQ ID NO: 2 instant application (see, sequence alignment as shown below). Borch et al. also teach polynucleotide sequence encoding the polypeptide comprising said lipase variant, which is at least 90% identity and less than 10% identity to SEQ ID NO: 1 of the instant application, and a composition comprising said variant lipase. Borch et al. also teach increased washing performance of detergent composition comprising said lipase variant, and reduction of malodor (see, abstract, title, pg 1, 5, pg 41-42, 71, 73, and claims 1-16)
Claim 23-25 are included in this rejection because- According to MPEP 2112.01- when structure recited in the reference is substantially identical to that of the claims, claimed properties, or functions are presumed to be inherent.
2112.01 Composition, Product, and Apparatus Claims [R-07.2015]
I. PRODUCT AND APPARATUS CLAIMS — WHEN THE STRUCTURE RECITED IN THE REFERENCE IS SUBSTANTIALLY IDENTICAL TO THAT OF THE CLAIMS, CLAIMED PROPERTIES OR FUNCTIONS ARE PRESUMED TO BE INHERENT
Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). Therefore, the prima facie case can be rebutted by evidence showing that the prior art products do not necessarily possess the characteristics of the claimed product. In re Best, 562 F.2d at 1255, 195 USPQ at 433. See also Titanium Metals Corp.v. Banner, 778 F.2d 775, 227 USPQ 773 (Fed. Cir. 1985) (Claims were directed to a titanium alloy containing 0.2-0.4% Mo and 0.6-0.9% Ni having corrosion resistance. A Russian article disclosed a titanium alloy containing 0.25% Mo and 0.75% Ni but was silent as to corrosion resistance. The Federal Circuit held that the claim was anticipated because the percentages of Mo and Ni were squarely within the claimed ranges. The court went on to say that it was immaterial what properties the alloys had or who discovered the properties because the composition is the same and thus must necessarily exhibit the properties.).
Therefore, Borch et al. anticipate claims 18-26 of the instant application as written.
The relevance arts is : US11891591B2.
Conclusion
Status of the claims:
Claims 18-26 are rejected.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to IQBAL H CHOWDHURY whose telephone number is (571)272-8137. The examiner can normally be reached on M-F, at 9:00-5:00 PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Manjunath N. Rao, can be reached on 571-272-0939. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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Iqbal H. Chowdhury, Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656