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
This application is a divisional of 16/754,698, issued as US Patent No. 11,866,748, which is a 371 of PCT/EP2018/079047.
The amendment filed on May 5, 2025 has been entered.
Election/Restrictions
Applicant elected with traverse of Group I with a species election of (A) GH5 of SEQ ID NO:2 as the first mannanase and (B) GH26 of SEQ ID NO:7 as the second mannanase in the reply filed on August 20, 2024.
Claims 35-40 and 49 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected species and invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on August 20, 2024 and November 18, 2024.
It is noted that new claims 30-49 are amended claims based on previously presented claims 1-10, 15, 17-19, 22-24, 26, and 28-29.
Status of Claims
Claims 30-49 are pending.
Claims 35-40 and 49 are withdrawn.
Claims 30-34 and 41-48 are under examination.
Response to Amendments/Arguments
Claim Rejections - 35 USC § 112(b)
Applicant’s arguments, see Section I at page 7 of the Remarks, filed May 5, 2025, with respect to claim 3 have been fully considered and are persuasive. Claim 3 has been cancelled. Therefore, the rejection of claim 3 under 35 U.S.C. 112(b) has been withdrawn.
Applicant’s arguments, see Section II at page 7 of the Remarks, filed May 5, 2025, with respect to claim 23 have been fully considered and are persuasive. Claim 23 has been cancelled. Therefore, the rejection of claim 23 under 35 U.S.C. 112(b) has been withdrawn.
Claim Rejections - 35 USC § 102
Applicant’s arguments, see Section III at page 7 of the Remarks, filed May 5, 2025, with respect to claims 1, 22-24, and 29 have been fully considered and are persuasive. Newly amended claims require a second mannanase having at least 75% sequence identity to the mature polypeptide of SEQ ID NO:7, which is not taught by Adams (WO 2016/007929 – form PTO-1449). Therefore, the rejection of claims 1, 22-24, and 29 under 35 U.S.C. 102(a)(1) has been withdrawn.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 30-34 and 41-48 is/are rejected under 35 U.S.C. 103 as being unpatentable over Adams (WO 2016/007929 –form PTO-1449) and Lant (US 10,550,443 – cited previously on form PTO-892).
Regarding claims 30-34, Adams discloses a detergent composition comprising multiple mannanases, including (A) endo-β-mannanases such as a glycoside hydrolase family 5 mannanase or variants thereof and (B) a glycoside hydrolase family 26 mannanase or a variant thereof, and (C) surfactants, such as dodecylbenzene sulfonate (abstract, [002], [007], [0025], [00108], [0129]-[0130], [0139], [0146], [0160], and claims 27-32). Adams discloses a mature endo-β-mannanase of SEQ ID NO:78 (identified as the WO2015022428-0015 mannanase) having 100% sequence identity to the mannanase of SEQ ID NO:2 of the instant application ([0160] and [00347] and see the sequence alignment below). The instant specification states that the mannanase of SEQ ID NO:2 is the mature GH5 mannanase (page 4, line 15). Therefore, the mannanase of Adams is a GH5 mannanase. MPEP 2111 states that there is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference.
Regarding claim 41, Adams discloses using fragments of mannanase ([0088]-[0096]).
Regarding claims 41-43, Adams discloses an effective amount of any of the enzymes in the detergent composition as being at least 0.0001 to 1 weigh percent or more ([00126] and [00140]). Even though a ratio of 50:50 of the mannanases are not explicitly disclosed in Adams, it would have been well within the knowledge of one having ordinary skill in the art to use the mannanases in equal ratio at least 0.0001 to 1 weigh percent or more for each of the mannanase. Further, “[W]here 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.”, see MPEP 2144.
Regarding claim 45, Adams discloses a detergent composition comprising of an anionic surfactants, cationic surfactants, non-ionic surfactants, and amphoteric surfactants ([00129]-[00132], [00142], [0189], and claims 29-31).
Regarding claim 46, Adams discloses a detergent composition comprising an additional enzyme, such as a protease, amylase, or lipase ([00139]).
Regarding claim 47, the detergent composition of Adams is a laundry detergent or a hard surface cleaning composition ([007] and claim 33).
Regarding claim 48, the detergent composition of Adams is in the form of a liquid, gel, powder, granulate, paste or unit dose package ([007] and claim 34).
The difference between the claimed detergent composition and the detergent composition of Adams is that Adams does not disclose a detergent composition comprising a mannanase having at least 70-95% sequence identity to the mannanase of SEQ ID NO:7 of the instant application.
However, such mannanases were known in the art. Lant discloses a cleaning composition comprising a GH26 mannanase having at least 75-95% sequence identity to SEQ ID NO:30, wherein SEQ ID NO:30 has 100% sequence identity to the GH26 mannanase of SEQ ID NO:7 of the instant application (Column 7, lines 20-27, Column 10, lines 19-30, Column 10, line 60 through Column 11, line 3, and see the sequence alignment below).
Therefore, combining the teachings of Adams and Lant, it would have been obvious to one having ordinary skill in the art before the claimed invention was effectively filed to substitute the prior art mannanases with other known mannanases, such as the mannanase of Lant, at optimum ratios because one of ordinary skill in the art would have been able to carry out such a substitution, and the results were reasonably predictable. One of ordinary skill in the art would have had a reasonable expectation of success since Adams discloses a detergent composition comprising of multiple mannanases and Lant discloses a cleaning composition comprising a GH26 mannanase having 100% sequence identity to SEQ ID NO:7 of the instant application. The rationale to support a conclusion that the claims would have been obvious over the cited references is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art because (1) Adam discloses a device (detergent composition comprising of multiple mannanases including GH5 family mannanase and GH26 family mannanase) which differed from the claimed device by the substitution of some component (GH26 mannanase of SEQ ID NO:7) with other components; (2) the substituted component and its function was known in the art; and (3) one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable since both enzymes are mannanases. Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious. Also, the rationale to support that the claim would have been obvious is that all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination yielded nothing more than predictable results to one of ordinary skill in the art. See MPEP 2143.
Therefore, the above references render claims 30-34 and 41-48 prima facie obvious.
Applicant's arguments filed May 5, 2025 have been fully considered but they are not persuasive.
Applicant argues that the claims are not obvious because (A) Adams does not disclose or suggest a detergent composition comprising a first mannanase which is a glycoside hydrolase family 5 mannanase of SEQ ID NO: 2 and has at least 75% sequence identity to the mature polypeptide of SEQ ID NO: 2; and a second mannanase which is a glycoside hydrolase family 26 mannanase and has at least 75% sequence identity to the mature polypeptide of SEQ ID NO: 7 and (B) Lant does not disclose or suggest a detergent composition, comprising a first mannanase which is a glycoside hydrolase family 5 mannanase of SEQ ID NO: 2 and has at least 75% sequence identity to the mature polypeptide of SEQ ID NO: 2; and second mannanase which is a glycoside hydrolase family 26 mannanase and has at least 75% sequence identity to the mature polypeptide of SEQ ID NO: 7.
This is not found persuasive. In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In the instant case, Lant discloses GH family 26 mannanase having at least 75-95% sequence identity to the mature polypeptide of SEQ ID NO: 7 of the instant application. Adams discloses a detergent composition comprising multiple mannanases, including (A) endo-β-mannanases such as a glycoside hydrolase family 5 mannanase or variants thereof and (B) a glycoside hydrolase family 26 mannanase or a variant thereof, and (C) surfactants, such as dodecylbenzene sulfonate (abstract, [002], [007], [0025], [00108], [0129]-[0130], [0139], [0146], [0160], and claims 27-32). Therefore, it would have been obvious to one having ordinary skill in the art before the claimed invention was effectively filed to substitute the prior art mannanases with other known mannanases, such as the mannanase of Lant because one of ordinary skill in the art would have been able to carry out such a substitution, and the results were reasonably predictable.
Applicant argues that the claims are not obvious because there are a large number of family 5 and family 26 mannanases known in the art and there is no suggestion in Adams or Lant to combine the glycoside hydrolase family 5 mannanase of SEQ ID NO: 2 and the glycoside hydrolase family 26 mannanase of SEQ ID NO: 7.
This is not found persuasive. Express suggestion to substitute one equivalent for another need not be present to render such substitution obvious, see MPEP 2143. B. In the instant case, the rationale to support a conclusion that the claims would have been obvious over the cited references is that the substitution of one known element for another yields predictable results to one of ordinary skill in the art because (1) Adam discloses a device (detergent composition comprising of multiple mannanases including GH5 family mannanase and GH26 family mannanase) which differed from the claimed device by the substitution of some component (GH26 mannanase of SEQ ID NO:7) with other components; (2) the substituted component and its function was known in the art; and (3) one of ordinary skill in the art could have substituted one known element for another, and the results of the substitution would have been predictable since both enzymes are mannanases.
Applicant argues that the claims are not obvious because the specification demonstrates that there is a synergistic effect when using the combination of SEQ ID Nos: 2 and 7 in a detergent composition (Example 7, Table 4) and these results are not predicted by the prior art and therefore are surprising and unexpected.
This is not found persuasive. A greater than additive effect is not necessarily sufficient to overcome a prima facie case of obviousness because such an effect can either be expected or unexpected, MPEP 716.02(a). In the instant case, the increased washing performance the cleaning composition comprising two different mannanases is not unexpected because the two mannanases are different mannanases having different substrate specificity and their combined used can contribute to an enhanced cleaning across a broader temperature and/or substrate range. Further, Applicant’s assertion of unexpected results is not commensurate in scope with the instant claims. The results of Table 4 is limited to the combination of the mannanase of SEQ ID NO:2 and the mannanase of SEQ ID NO: 7 and the detergent composition of the instant claims comprise (1) a glycoside hydrolase family 5 mannanase having 75-95% sequence identity to SEQ ID NO:2 and (2) a glycoside hydrolase family 26 mannanase having 75-95 sequence identity to SEQ ID NO:7.
Hence the rejection is maintained.
Double Patenting
Applicant’s arguments, see Section V at page 8 of the Remarks, filed May 5, 2025, with respect to claims 1, 3, 17-19, 22-24, and 29 as being unpatentable over claims 1-19 of U.S. Patent No. 11,866,748 have been fully considered and are persuasive. Newly submitted claims 30-34 no longer recite a second GH26 mannanase of SEQ ID NO:4. An election of species requirement among the mannanases was issued in 16/754,698 (U.S. Patent No. 11,866,748) and the instant application was filed as a divisional application as a result of said requirement. Therefore, the nonstatutory double patenting rejection as being unpatentable over claims 1-19 of U.S. Patent No. 11,866,748 has been withdrawn.
Applicant’s arguments, see Section VII at page 9 of the Remarks, filed May 5, 2025, with respect to claims 1, 3, and 23 as being unpatentable over claims 1-12 and 14-16 of copending Application No. 17/782,279 have been fully considered and are persuasive. The claims of copending Application No. 17/782,279 have been amended to delete recitation of mannanases. Therefore, the provisional nonstatutory double patenting rejection as being unpatentable over copending Application No. 17/782,279 has been withdrawn.
Applicant’s arguments, see Section VIII at page 9 of the Remarks, filed May 5, 2025, with respect to claims 1, 3, and 23 as being unpatentable over claims 1-14 and 16-19 of copending Application No. 17/759,272 have been fully considered and are persuasive. The claims of copending Application No. 17/759,272 have been amended to delete recitation of mannanases. Therefore, the provisional nonstatutory double patenting rejection as being unpatentable over copending Application No. 17/759,272 has been withdrawn.
Conclusion
Claims 30-49 are pending.
Claims 35-40 and 49 are withdrawn.
Claims 30-34 and 41-48 are rejected.
THIS ACTION IS MADE FINAL. 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 nonprovisional extension fee (37 CFR 1.17(a)) 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 mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to YONG D PAK whose telephone number is (571)272-0935. The examiner can normally be reached M-Th: 5:30 am - 3:30 pm.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Robert Mondesi can be reached on 408-918-7584. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/YONG D PAK/Primary Examiner, Art Unit 1652
Sequence alignment of the mannanase of SEQ ID NO:2 of the instant application (“Qy”) and the mannanase of SEQ ID NO:78 of Adams (“Db”)
BCK93947
ID BCK93947 standard; protein; 300 AA.
XX
AC BCK93947;
XX
DT 10-MAR-2016 (first entry)
XX
DE Bacillus sp. mature endo-beta-mannanase protein, SEQ ID 78.
XX
KW Beta-1,4-mannan 4-mannanohydrolase; Beta-D-mannanase; Beta-mannanase B;
KW EC 3.2.1.78; Endo-1,4-beta-mannanase; Endo-beta-1,4-mannase;
KW Endo-beta-mannanase; Mannan endo-1,4-beta-mannosidase; beer; beverage;
KW enzyme production; feed-additive; feedstuff; fermentation; food;
KW food-additive; hydrolysis; surfactant; textile.
XX
OS Bacillus sp.
XX
CC PN WO2016007929-A2.
XX
CC PD 14-JAN-2016.
XX
CC PF 10-JUL-2015; 2015WO-US040057.
XX
PR 11-JUL-2014; 2014WO-CN082034.
XX
CC PA (DUPO ) DANISCO US INC.
XX
CC PI Adams CD, Ghirnikar R, Huang V, Jin L, Kolkman M, Qian Z;
XX
DR WPI; 2016-044569/10.
XX
CC PT New polypeptide useful in composition for cleaning textile fabrics, and
CC PT preparing food or feed composition and/or food or feed additive.
XX
CC PS Example 21; SEQ ID NO 78; 150pp; English.
XX
CC The present invention relates to a novel endo-beta-mannanase polypeptide,
CC useful in a composition as detergents for cleaning fabrics and hard
CC surfaces. The invention further provides: (1) a cleaning composition
CC comprising the above-mentioned polypeptide; (2) a method for hydrolyzing
CC a mannan substrate present in a soil or stain on a surface; (3) a method
CC for textile cleaning; (4) a nucleic acid encoding the above-mentioned
CC recombinant polypeptide; (5) an expression vector comprising the above-
CC mentioned nucleic acid operably linked to a regulatory sequence; (6) a
CC host cell comprising the above-mentioned expression vector; (7) a method
CC for producing an endo-beta-mannanase, by culturing the host cell in a
CC culture medium; (8) a method for hydrolyzing a polysaccharide; (9) a food
CC or a feed composition and/or a food additive comprising the above-
CC mentioned polypeptide; (10) a method for preparing the food or the feed
CC composition and/or the food or the feed additive; (11) a method for
CC providing a fermented beverage; and (12) a fermented beverage (e.g.,
CC beer). The polypeptide of the invention is useful in the preparation of
CC the food or the feed composition and/or the food or the feed additive
CC and/or a food or a feed stuff and/or a pet food. The present sequence
CC represents a Bacillus sp. mature endo-beta-mannanase protein, which is
CC used in a multiple sequence alignment using CLUSTAL W software, where the
CC enzyme is used in the composition as detergents for cleaning fabrics and
CC hard surfaces.
XX
SQ Sequence 300 AA;
Query Match 100.0%; Score 1616; DB 23; Length 300;
Best Local Similarity 100.0%;
Matches 298; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 ANSGFYVSGTTLYDANGNPFVMRGINHGHAWYKDQATTAIEGIANTGANTVRIVLSDGGQ 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 ANSGFYVSGTTLYDANGNPFVMRGINHGHAWYKDQATTAIEGIANTGANTVRIVLSDGGQ 60
Qy 61 WTKDDIHTVRNLISLAEDNHLVAVLEVHDATGYDSIASLNRAVDYWIEMRSALIGKEDTV 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 WTKDDIHTVRNLISLAEDNHLVAVLEVHDATGYDSIASLNRAVDYWIEMRSALIGKEDTV 120
Qy 121 IINIANEWFGSWEGDAWADGYKQAIPRLRNAGLNHTLMVDAAGWGQFPQSIHDYGREVFN 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 IINIANEWFGSWEGDAWADGYKQAIPRLRNAGLNHTLMVDAAGWGQFPQSIHDYGREVFN 180
Qy 181 ADPQRNTMFSIHMYEYAGGNASQVRTNIDRVLNQDLALVIGEFGHRHTNGDVDEATIMSY 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 ADPQRNTMFSIHMYEYAGGNASQVRTNIDRVLNQDLALVIGEFGHRHTNGDVDEATIMSY 240
Qy 241 SEQRGVGWLAWSWKGNGPEWEYLDLSNDWAGNNLTAWGNTIVNGPYGLRETSRLSTVF 298
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 SEQRGVGWLAWSWKGNGPEWEYLDLSNDWAGNNLTAWGNTIVNGPYGLRETSRLSTVF 298
Sequence alignment of the mannanase of SEQ ID NO:7of the instant application (“Qy”) and the mannanase of SEQ ID NO:30 of Lant (“Db”)
US-15-826-985-30
Sequence 30, US/15826985
Patent No. 10550443
GENERAL INFORMATION
APPLICANT: P&G
TITLE OF INVENTION: CLEANING COMPOSITIONS INCLUDING ENZYMES
FILE REFERENCE: CM04645MX
CURRENT APPLICATION NUMBER: US/15/826,985
CURRENT FILING DATE: 2017-11-30
NUMBER OF SEQ ID NOS: 32
SEQ ID NO 30
LENGTH: 312
TYPE: PRT
ORGANISM: Yunnania penicillata
Query Match 100.0%; Score 1704; Length 312;
Best Local Similarity 100.0%;
Matches 312; Conservative 0; Mismatches 0; Indels 0; Gaps 0;
Qy 1 APSTTPVNEKATDAAKNLLSYLVEQAANGVTLSGQQDLESAQWVSDNVGKWPAILGIDFM 60
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 1 APSTTPVNEKATDAAKNLLSYLVEQAANGVTLSGQQDLESAQWVSDNVGKWPAILGIDFM 60
Qy 61 DYSPSRVEYGAVGSTVPDAISYDSDGGIVTFCWHWGSPSGTYNTTDQPWWSNFYTEATAF 120
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 61 DYSPSRVEYGAVGSTVPDAISYDSDGGIVTFCWHWGSPSGTYNTTDQPWWSNFYTEATAF 120
Qy 121 DIAAAMDDPDSADYNLLVRDIDAISELLLQLQDLDIPILWRPLHEAEGGWFWWGAKGPEA 180
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 121 DIAAAMDDPDSADYNLLVRDIDAISELLLQLQDLDIPILWRPLHEAEGGWFWWGAKGPEA 180
Qy 181 CIALYRLMFDRMTNHHGLNNLLWVWNSVDPSWYPGNDVVDIVSADIYADAGDHSPQEETF 240
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 181 CIALYRLMFDRMTNHHGLNNLLWVWNSVDPSWYPGNDVVDIVSADIYADAGDHSPQEETF 240
Qy 241 ASLQSLTGDTKLVALGEVGNIPDPASTGGVADWAYWVTWNGDFIKGEDYNPLEYKKEVFS 300
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Db 241 ASLQSLTGDTKLVALGEVGNIPDPASTGGVADWAYWVTWNGDFIKGEDYNPLEYKKEVFS 300
Qy 301 AENIITRDEVDV 312
||||||||||||
Db 301 AENIITRDEVDV 312