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 18-32 and 33 are currently pending in the instant patent application.
In response to a previous Office action, a Non-Final Rejection Office action (mailed on 03/25/2026), Applicants filed a response and an amendment on June 17, 2026, amending claims 18-24 is acknowledged.
Claims 29-33 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Applicants' arguments filed on June 17, April 7, 2006, have been fully considered and are deemed persuasive to overcome some of the rejections previously applied. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.
Claims 18-26 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 17205251.6, filed on 12/04/2017.
Withdrawn-Claim Objections
The previous objections Claims 19, and 20 is objected to in the recitation “variant comprises”, which should be changed to “variant further comprises”, is withdrawn in view of Applicant’s amendment to the claims and persuasive arguments.
The previous objections of 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to ”, which should be changed to “variant comprises substitutions selected from the group consisting of”, is withdrawn in view of Applicant’s amendment to the claims and persuasive arguments.
The previous objections of 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which should be changed to “variant -------- comprising substitutions to any of the following set of substitution ”, is withdrawn in view of Applicant’s amendment to the claims and persuasive arguments.
Withdrawn-Double Patenting Rejection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).
The previous rejection of Claim 18 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, is withdrawn, in view of Applicant’s amendment to the claims and persuasive arguments.
Withdrawn-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
The previous rejection of Claims 18-26 are rejected under 35 U.S.C. 112(a), as failing to comply with the written description requirement (WD), is withdrawn, in view of Applicant’s amendment to the claims and persuasive arguments.
Withdrawn-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, is withdrawn, in view of Applicant’s amendment to the claims and persuasive arguments.
New-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 18-20, and 21-26 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 Hansen et al. (method of reducing odor. WO 2017/001673 A1).
The Broadest Reasonable Interpretation (BRI) of claim 18, which are drawn to any variant of a parent lipase, wherein said variant has: a) at least 85% but less than 100% sequence identity with SEQ ID NO: 2, and comprises substitutions corresponding to F511 and H198N using the numbering of SEQ ID NO: 2.
Regarding claims 18, 25, 26, Hansen et al. teach a variant of parent lipase of the polypeptide of SEQ ID NO: 2 having the substitution mutations including F51 corresponding to substitutions at position F51I, and further teach mutations H198A, H198D, H198E, H198G, H198F, H198I, H198Q, H198L, H198N, H198S, H198T, H198V, or H198Y of the parent lipase corresponding to the parent lipase polypeptide of SEQ ID NO: 2, which is about 99.9% identical to SEQ ID NO: 2 instant application (see, sequence alignment as shown below, and part of the disclosure). Hansen et al. also teach a composition comprising said variant lipase. Hansen et al. also teach increased washing performance of detergent composition comprising said lipase variant, and reduction of odor or malodor (see, abstract, title, pg 1, 5, pg 40, 64, 89, 92-93, Example 2, 2.1, and claims 1-32).
RESULT 8
BDM62882
(NOTE: this sequence has 1 duplicate in the database searched.
See complete list at the end of this report)
ID BDM62882 standard; protein; 269 AA.
XX
AC BDM62882;
XX
DT 23-FEB-2017 (first entry)
XX
DE Humicola lanuginosa lipase variant #571.
XX
KW Lipase; enzyme engineering; enzyme production; lipid hydrolysis; mutein;
KW staining; surfactant.
XX
OS Thermomyces lanuginosus.
OS Synthetic.
XX
CC PN WO2017001673-A1.
XX
CC PD 05-JAN-2017.
XX
CC PF 01-JUL-2016; 2016WO-EP065542.
XX
PR 01-JUL-2015; 2015EP-00174788.
XX
CC PA (NOVO ) NOVOZYMES AS.
XX
CC PI Hansen CH, Liu Y, Kayser S, Nielsen VS;
XX
DR WPI; 2017-02152B/08.
XX
CC PT New lipase variant with reduced odor generation, useful for hydrolyzing a
CC PT lipase substrate and removing lipid stain material from a surface.
XX
CC PS Claim 11; Page; 121pp; English.
XX
CC The present invention relates to a novel lipase variant useful for
CC hydrolyzing a lipase substrate and removing lipid stain material from a
CC surface. The invention further claims: (1) a polynucleotide encoding the
CC lipase variant; (2) a nucleic acid construct comprising the
CC polynucleotide; (3) an expression vector comprising the polynucleotide;
CC (4) a host cell comprising the polynucleotide; (5) a method for producing
CC a lipase variant; and (6) a method for cleaning and reducing odor during
CC lipid stain removal. The lipase variant is used in a detergent
CC composition for cleaning a surface. The present sequence is a Humicola
CC lanuginosa lipase variant I255V, which is useful in the method for
CC hydrolyzing a lipase substrate and removing lipid stain material from a
CC surface. NOTE: The present sequence is created based on the information
CC given in claim 11 and SEQ ID NO:10 BDM62309.
XX
SQ Sequence 269 AA;
Query Match 99.9%; Score 1442; Length 269;
Best Local Similarity 99.6%;
Matches 268; Conservative 1; Mismatches 0; Indels 0; Gaps 0;
Qy 1 EVSQDLFNQFNLFAQYSAAAYCGKNNDAPAGTNITCTGNACPEVEKADATFLYSFEDSGV 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 EVSQDLFNQFNLFAQYSAAAYCGKNNDAPAGTNITCTGNACPEVEKADATFLYSFEDSGV 60
Qy 61 GDVTGFLALDNTNKLIVLSFRGSRSIENWIGNLNFDLKEINDICSGCRGHDGFTSSWRSV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 GDVTGFLALDNTNKLIVLSFRGSRSIENWIGNLNFDLKEINDICSGCRGHDGFTSSWRSV 120
Qy 121 ADTLRQKVEDAVREHPDYRVVFTGHSLGGALATVAGADLRGNGYDIDVFSYGAPRVGNRA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 ADTLRQKVEDAVREHPDYRVVFTGHSLGGALATVAGADLRGNGYDIDVFSYGAPRVGNRA 180
Qy 181 FAEFLTVQTGGTLYRITHTNDIVPRLPPREFGYSHSSPEYWIKSGTLVPVRRRDIVKIEG 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 FAEFLTVQTGGTLYRITHTNDIVPRLPPREFGYSHSSPEYWIKSGTLVPVRRRDIVKIEG 240
Qy 241 IDATGGNNQPNIPDIPAHLWYFGLIGTCL 269
||||||||||||||:||||||||||||||
Db 241 IDATGGNNQPNIPDVPAHLWYFGLIGTCL 269
PNG
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1108
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Greyscale
Claim 19-24 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, Hansen et al. anticipate claims 18-26 of the instant application as written.
Conclusion
Status of the claims:
Claims 18-26 are rejected.
Applicant's amendments (see, substantial amendment of claims 18-24), necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the date of this final action.
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.
Information regarding the status of an application may be obtained from the Patent Application Information Retrieval (PAIR) system. Status information for published applications may be obtained from either Private PAIR or Public PAIR. Status information for unpublished applications is available through Private PAIR only. For more information about the PAIR system, see http://pair-direct.uspto.gov. Should you have questions on access to the Private PAIR system, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free).
Iqbal H. Chowdhury, PhD.
Primary Patent Examiner
Art Unit 1656 (Recombinant Enzymes and Protein Crystallography)
US Patent and Trademark Office (USPTO)
Ph. (571)-272-8137 and Fax (571)-273-8137
/IQBAL H CHOWDHURY/
Primary Examiner, Art Unit 1656
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