Attorney Docket No.: 11357-US-CNT
`
`PATENT
`
`IN THE UNITED STATES PATENT AND TRADEMARK OFFICE
`
`In re Application of: Hendriksen et al.
`
`Confirmation No: 3014
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`Serial No.: 15/433,642
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`Group Art Unit: 1791
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`Filed: February 15, 2017
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`Examiner: Elizabeth Gwartney
`
`For: Method for Producing a Dairy Product
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`SUPPLEMENTAL PRELIMINARY AMENDMENT
`
`Commissioner for Patents
`P.O. Box 1450
`Alexandria, VA 22313-1450
`
`Sir:
`
`Prior to examination, please amend the above-identified application as follows:
`
`Amendments to the claims are reflected in the listing of claims, which begins on page 2 of
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`this document.
`
`Remarks and arguments begin on page 4 of this document.
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`

`

`LISTING OF THE CLAIMS:
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`Claims 2, 4, 6, 8, 10-20, and 22-26 are canceled. Claims 27-40 are added. The following is
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`the status of the claims of the above-captioned application, as amended.
`
`1-26.
`
`(Canceled).
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`27.
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`(New). A polypeptide having transgalactosylating activity, which is a truncated polypeptide
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`consisting of the amino acid sequence of amino acids 28-979 of SEQ ID NO: 1 or is a fragment
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`thereof having transgalactosylating activity.
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`28.
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`(New). The polypeptide of claim 27, wherein the truncated polypeptide consists of the amino
`
`acid sequence of amino acids 28-979 of SEQ ID NO: 1.
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`29.
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`(New). The polypeptide of claim 27, wherein the truncated polypeptide consists of the amino
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`acid sequence of a fragment of amino acids 28-979 of SEQ ID NO: 1.
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`30.
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`(New). A nucleic acid encoding the polypeptide according to claim 27.
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`31.
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`(New). A cell capable of expressing the polypeptide according to claim 27.
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`32.
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`(New). A method of expressing a polypeptide, the method comprising obtaining a cell
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`according to claim 31 and expressing the polypeptide from the cell.
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`33.
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`(New). The method of claim 32, the method further comprising purifying the polypeptide.
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`34.
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`(New). A composition comprising the polypeptide of claim 27.
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`35.
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`(New). The composition of claim 34, which is a food composition.
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`36.
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`(New). The composition of claim 35, which is a dairy product.
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`37.
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`(New). A method for producing a food product, comprising treating a substrate comprising
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`lactose with the polypeptide of claim 27.
`
`2
`
`

`

`38.
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`(New). A method for producing a dairy product, comprising treating a milk-based substrate
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`comprising lactose with the polypeptide of claim 27.
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`39.
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`(New). A method for producing galacto-oligosaccharides, comprising contacting
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`the
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`polypeptide of claim 27 with a milk-based substrate comprising lactose.
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`40.
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`(New). A method for producing galacto-oligosaccharides, comprising contacting
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`the
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`polypeptide of claim 33 with a milk-based substrate comprising lactose.
`
`3
`
`

`

`REMARKS
`
`Claims 2, 4, 6, 8, 10-20, and 22-26 are canceled. Claims 27-40 are added and therefore are
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`now pending in the present application. Support for the amendment appears throughout the
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`specification as filed, e.g., page 17, lines 27-29. There is no new matter added, and entry of the
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`amendment is respectfully requested.
`
`I.
`
`Applicants' Suggestion for an Interference
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`Applicants hereby suggest and request that the United States Patent and Trademark Office
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`declare an interference between the above-captioned application and U.S. Application No.
`
`14/405,072 ("the '072 application"). Claim 1 of the '072 application, as amended on February 15,
`
`2018 reads as follows:
`
`A polypeptide having transgalactosylating activity selected from the group
`1.
`consisting of:
`a truncated polypeptide consisting of an amino acid sequence having
`a.
`at least 98% sequence identity with SEQ ID NO: 1, wherein the polypeptide has a
`ratio of transgalactosylation activity above 150%, and
`b.
`a truncated polypeptide consisting of an amino acid sequence having
`at least 98% sequence identity with SEQ ID NO: 2, wherein the polypeptide has a
`ratio of transgalactosylation activity above 150%.
`
`As explained at page 6, lines 24-27 of the '072 application, SEQ ID NO: 1 (also named
`
`BIF _917) is an 887 amino acid C-terminally truncated fragment of SEQ ID NO: 22 (i.e., amino
`
`acids 1-887 of SEQ ID NO: 22) and SEQ ID NO: 2 (also named BIF _995) is a 965 amino acid C(cid:173)
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`terminally truncated fragment of SEQ ID NO: 22 (i.e., amino acids 1-965 of SEQ ID NO: 22). SEQ
`
`ID NO: 22 is the amino acid sequence of an extracellular lactase from Bifidobacterium bifidum
`
`DSM20215.
`
`Moreover, Example 1 of the '072 application describes an experiment to determine the
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`ratio of transgalactosylation activity of eight different C-terminally truncated variants. The results
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`are presented in Figure 3, and show that truncation variants having a length of 1241 amino acid
`
`residues or less have a ratio of transgalactosylation activity above 100% and truncation variants
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`having a length of more than 1241 amino acid residues have a ratio of transgalactosylation activity
`
`below 100%. The truncation variants BIF-917 and BIF-995 (SEQ ID NOs: 1 and 2, respectively)
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`have the highest ratio of transgalactosylation activity around 250%.
`
`The amino acid sequence of amino acids 28-979 of SEQ ID NO: 1 of the present application
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`is a 952 amino acid C-terminally truncated polypeptide of a Bifidobacterium bifidum lactase.
`
`Applicants submit herewith an alignment of the sequence of amino acids 28-979 of SEQ ID NO:
`
`4
`
`

`

`1 of the present application (denoted as "NZ11357 _SEQ1_28to979") and SEQ ID Nos: 1 and 2
`
`of the '072 application (denoted as SEQID_ 1_DUPONT and SEQID_2_DUPONT, respectively).
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`The alignment shows the sequence of amino acids 28-979 of SEQ ID NO: 1 of the present
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`application is almost identical to SEQ ID Nos: 1 and 2 of the '072 application, and the sequence of
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`amino acids 28-979 of SEQ ID NO: 1 of the present application is longer than SEQ ID NO: 1 and
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`shorter than SEQ ID NO: 2 of the '072 application.
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`Moreover, based on the results disclosed in the '072 application, a person of ordinary skill
`
`in the art would expect that this 952 amino acid C-terminally truncated polypeptide has a ratio of
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`transgalactosylation activity above 150%. Applicants therefore respectfully submit that the claims of
`
`the present application and the '072 application are directed to the same patentable invention and
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`an interference should be declared.
`
`II.
`
`Conclusion
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`The Examiner is hereby invited to contact the undersigned by telephone if there are any
`
`questions concerning this amendment or application.
`
`All required fees were charged to Novozymes North America, lnc.'s Deposit Account No.
`
`50-1701 at the time of electronic filing. The USPTO is authorized to charge this Deposit Account
`
`should any additional fees be due.
`
`Date: February 22, 2018
`
`Respectfully submitted,
`
`/Elias Lambiris, Reg. # 33728/
`Elias J. Lambiris, Reg. No. 33,728
`Novozymes North America, Inc.
`77 Perry Chapel Church Road
`Franklinton, NC 27525
`(919) 494-3405
`
`5
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`

`

`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_UJPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_UJPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_UJPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_UJPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_UJPONT
`NZ11357 SEQl 28to979
`
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`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_D'JPONT
`NZ11357 SEQl 28to979
`
`SEQID_l_D'JPONT
`SEQID_2_UJPONT
`NZ11357 SEQl 28to979
`
`************************************************
`
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`K'TGNKPT .LP 3 D\/E.VRYS DGT S DP(..)N\71 1t''JDA\1 SD TJQ I.A.KP.GS FS \/l~ .. GT\lAGQ K- -- -- - - -
`
`