`
`UNITED STATES PATENT AND TRADEMARK OFFICE
`
`UNITED STATES DEPARTMENT OF COMMERCE
`United States Patent and Trademark Office
`Address: COMMISSIONER FOR PATENTS
`P.O. Box 1450
`Alexandria1 Virginia 22313- 1450
`wwwnsptogov
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`APPLICATION NO.
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`
`
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` F ING DATE
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`FIRST NAMED INVENTOR
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`ATTORNEY DOCKET NO.
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`
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`
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`CONF {MATION NO.
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`12/243,755
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`10/01/2008
`
`C. Steven McDaniel
`
`5842—02001
`
`1750
`
`”90
`WW
`CStevenMcDaniel —
`c/0 Daffer McDaniel, LLP
`RAGHU, GANAPATHIRAM
`130' BOX 684908
`ART UNIT
`PAPER NUMBER
`Austin, TX 78768-4908
`652
`
`—1
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`MAIL DATE
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`04/28/2010
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`DELIVERY MODE
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`PAPER
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`Please find below and/or attached an Office communication concerning this application or proceeding.
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`The time period for reply, if any, is set in the attached communication.
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`PTOL—90A (Rev. 04/07)
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`
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`
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`Office Action Summary
`
`Application No.
`
`Applicant(s)
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`12/243,755
`
`MCDANIEL ET AL.
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`Examiner
`
`GANAPATHIRAMA RAGHU
`
`Art Unit
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`1652 -
`
`-- The MAILING DA TE of this communication appears on the cover sheet with the correspondence address --
`Period for Reply
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`A SHORTENED STATUTORY PERIOD FOR REPLY IS SET TO EXPIRE 3 MONTH(S) OR THIRTY (30) DAYS,
`WHICHEVER IS LONGER, FROM THE MAILING DATE OF THIS COMMUNICATION.
`Extensions of time may be available under the provisions of 37 CFR 1.136(a).
`In no event however may a reply be timely filed
`after SIX (6) MONTHS from the mailing date of this communication.
`If NO period for reply is specified above, the maximum statutory period will apply and will expire SIX (6) MONTHS from the mailing date of this communication.
`-
`- Failure to reply within the set or extended period for reply will, by statute, cause the application to become ABANDONED (35 U.S.C. § 133).
`Any reply received by the Office later than three months after the mailing date of this communication, even if timely filed, may reduce any
`earned patent term adjustment. See 37 CFR 1.704(b).
`
`Status
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`1)IXI Responsive to communication(s) filed on 10 December 2009.
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`2a)I:I This action is FINAL.
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`2b)IZI This action is non-final.
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`3)I:I Since this application is in condition for allowance except for formal matters, prosecution as to the merits is
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`closed in accordance with the practice under EX parte Quayle, 1935 CD. 11, 453 O.G. 213.
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`Disposition of Claims
`
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`4)IZI Claim(s) 1-182 184 186 and 187 is/are pending in the application.
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`4a) Of the above Claim(s) See Continuation Sheet is/are withdrawn from consideration.
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`5)I:I Claim(s)
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`is/are allowed.
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`6)IXI Claim(s) See Continuation Sheet is/are rejected.
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`7)I:I Claim(s) _ is/are objected to.
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`8)I:I Claim(s) _ are subject to restriction and/or election requirement.
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`Application Papers
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`9)IXI The specification is objected to by the Examiner.
`
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`10)I:I The drawing(s) filed on
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`is/are: a)I:I accepted or b)I:I objected to by the Examiner.
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`Applicant may not request that any objection to the drawing(s) be held in abeyance. See 37 CFR 1.85(a).
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`Replacement drawing sheet(s) including the correction is required if the drawing(s) is objected to. See 37 CFR 1.121(d).
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`11)I:I The oath or declaration is objected to by the Examiner. Note the attached Office Action or form PTO-152.
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`Priority under 35 U.S.C. § 119
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`12)I:I Acknowledgment is made of a claim for foreign priority under 35 U.S.C. § 119(a)—(d) or (f).
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`a)I:I All
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`b)I:I Some * c)I:I None of:
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`1.I:I Certified copies of the priority documents have been received.
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`2.I:I Certified copies of the priority documents have been received in Application No.
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`
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`3.I:I Copies of the certified copies of the priority documents have been received in this National Stage
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`application from the International Bureau (PCT Rule 17.2(a)).
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`* See the attached detailed Office action for a list of the certified copies not received.
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`Attachment(s)
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`4) D Interview Summary (PTO-413)
`1) E Notice of References Cited (PTO-892)
`Paper No(s)/Mai| Date. _
`2) D Notice of Draftsperson‘s Patent Drawing Review (PTO-948)
`5) I:I Notice of Informal Patent Application
`3) IZI Information Disclosure Statement(s) (PTO/SB/08)
`
`
`Paper No(s)/Mai| Date 10/22/09' 05/06/09' 12/30/08' 12/30/08.
`6) X Other: SEQ ALIGN.
`U.S. Patent and Trademark Office
`
`PTOL-326 (Rev. 08-06)
`
`Office Action Summary
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`Part of Paper No./Mai| Date 20100425
`
`
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`Continuation Sheet (PTOL-326)
`
`Application No. 12/243,755
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`Continuation of Disposition of Claims: Claims withdrawn from consideration are 4-34,36-64,69,74,76,83-93,96,99-104,109-
`112,116,117,124,125,131,140-142,144-154,157,159-168,170-172 and 174-182.
`
`Continuation of Disposition of Claims: Claims rejected are 1-3,35,65-68,70-73,75,77-82,94,95,97,98,105-108,113-115,118—
`123,126-130,132-139,143,155,156,158,169,173,184 and 186-188.
`
`
`
`Application/Control Number: 12/243,755
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`Page 2
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`Art Unit: 1652
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`Detailed Action
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`Election/Restrictions
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`Please note that the instant application/case has been transferred to examiner
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`Ganapathirama Raghu, Art Unit 1652, whose telephone number is (571)-272-4533 and
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`all further enquiries regarding this application should be directed to said examiner.
`
`Applicants’ election of Group | without traverse, directed to claims 1-3, 35, 65-
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`68, 70,-73, 75, 77-82, 94, 95, 97, 98, 105-108, 113-115, 118-123, 126-130, 132-139,
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`143, 155, 156, 158, 169, 173, 184 and 186-188 with the recited elected species in the
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`reply filed on 12/10/09 is acknowledged.
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`Claims 1-182, 184 and 186-188 are pending in this application, claims 4-34, 36-
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`64, 69, 74, 76, 83-93, 96, 99-104, 109-112, 116, 117, 124, 125, 131, 140-142, 144-154,
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`157, 159-168, 170-172 and 174-182 are withdrawn from further consideration pursuant
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`to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable
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`generic or linking claim. Thus, claims 1-3, 35, 65-68, 70,-73, 75, 77-82, 94, 95, 97, 98,
`
`105-108, 113-115, 118-123, 126-130, 132-139, 143, 155, 156, 158, 169, 173, 184 and
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`186-188 with the recited elected species in the reply filed on 12/10/09 are now under
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`consideration for examination.
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`Acknowledgment is made of a claim for domestic priority under 35 U.S.C. 119(e)
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`Priority
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`to the US Provisional Application No.: 60/976,676 filed on 10/01/2007 and 60/409,102
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`filed on 09/09/2002. Applicants’ claim for the benefit of a prior-filed application under 35
`
`U.S.C. 120, 121, or 365(c) is acknowledged. This application is a CIP of 10/655,345
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`filed on 09/04/2003. However, please note that the instant claims are only granted the
`
`
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`Application/Control Number: 12/243,755
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`Page 3
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`Art Unit: 1652
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`priority date of US Provisional Application No.: 60/976,676 filed on 10/01/2007, as the
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`elected species “lysozyme” was only disclosed in US Provisional Application No.:
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`60/976 676 filed on 10/01/2007.
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`The information disclosure statements (IDS) submitted on 10/22/09, 05/06/09,
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`Information Disclosure Statement
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`12/30/08 and 12/30/08 are in compliance with the provisions of 37 CFR 1.97.
`
`Accordingly, the examiner has considered and initialed the IDS statements.
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`Specification-Objection
`The disclosure is objected to because it contains an embedded hyperlink and/or
`
`other form of browser-executable code. The specification contains hyperlinks to various
`
`site domains, for example on page 75, paragraph [0430]. Applicants are required to
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`scrutinize the application thoroughly and delete the embedded hyperlinks and/or other
`
`form of browser-executable code. See MPEP § 608.01. 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.
`A nonstatutory obviousness-type 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 USPQZd 1226
`(Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQZd 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) or 1.321(d) may be used to
`overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided
`the conflicting application or patent either is shown to be commonly owned with this application, or claims
`an invention made as a result of activities undertaken within the scope of a joint research agreement.
`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).
`
`
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`Application/Control Number: 12/243,755
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`Page 4
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`Art Unit: 1652
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`Claims 1-3, 35, 65-68, 70,-73, 75, 77-82, 94, 95, 97, 98, 105-108, 113-115, 118-
`
`123, 126-130, 132-139, 143, 155, 156, 158, 169, 173, 184 and 186-188 with the recited
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`elected species are provisionally rejected under the judicially created doctrine of
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`obviousness-type double patenting as being unpatentable over claims 1-98 of McDaniel
`
`et al., (US Application No.: 12/696,651). An obviousness-type double patenting rejection
`
`is appropriate where the conflicting claims are not identical, but an examined application
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`claims are not patentably distinct from the reference claims, because the examined
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`claims are either anticipated by, or would have been obvious over reference claims.
`
`See, e.g., In re Berg, 140 F.3d 1428,46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman,
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`11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir.1993); In re Longi 759 F.2d 887,225 USPQ
`
`645 (Fed. Cir. 1985). Although the conflicting claims are not
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`identical,
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`they are not
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`patentably distinct from each other. Claims 1-3, 35, 65-68, 70,-73, 75, 77-82, 94, 95, 97,
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`98, 105-108, 113-115, 118-123, 126-130, 132-139, 143, 155, 156, 158, 169, 173, 184
`
`and 186-188 of the instant application are directed to a coating composition comprising
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`an active enzyme and an antimicrobial peptide, wherein the antimicrobial enzyme
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`comprises a lysozyme and the antimicrobial peptide having the sequence of SEQ ID
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`NO: 40. Claims 1-98 of McDaniel et al., (US Application No.: 12/696,651) are also
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`directed to a coating composition comprising an active enzyme and an antimicrobial
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`peptide, wherein the antimicrobial enzyme comprises a lysozyme and the antimicrobial
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`peptide having the sequence of SEQ ID NO: 40, said SEQ ID NO: 40 of the reference
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`McDaniel et al., (US Application No.: 12/696,651) has 100% sequence identity to SEQ
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`ID NO: 40 of the instant application (see provided sequence alignment). The co-pending
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`
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`Application/Control Number: 12/243,755
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`Page 5
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`Art Unit: 1652
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`claims 1-98 of
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`the reference application McDaniel et al.,
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`(US Application No.:
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`12/696,651), therefore encompass coating compositions which overlaps with the genus
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`of instant claims. This is a provisional obviousness-type double patenting rejections,
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`because the conflicting claims have not in fact been patented.
`
`Claim Rejections: 35 USC § 112-First Paragraph
`The following is a quotation of the first paragraph of 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.
`
`Written Description
`Claims 1-3, 35, 65-68, 70,-73, 75, 77-82, 94, 95, 97, 98, 105-108, 113-115, 118-
`
`123, 126-130, 132-139, 143, 155, 156, 158, 169, 173, 184 and 186-187 with the recited
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`elected species are rejected under 35 U.S.C. 112, first paragraph, as failing to comply
`
`with the written description requirement. The claim(s) contains subject matter which was
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`not described in the specification in such a way as to reasonably convey to one skilled
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`in the relevant art
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`that
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`the inventor(s), at
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`the time the application was filed, had
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`possession of the claimed invention.
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`Claims 1-3, 35, 65-68, 70,-73, 75, 77-82, 94, 95, 97, 98, 105-108, 113-115, 118-
`
`123, 126-130, 132-139, 143, 155, 156, 158, 169, 173, 184 and 186-187 with the recited
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`elected species, as interpreted, are directed to a genus of coating compositions or
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`paints comprising: i) any protein, having any structure and having enzymatic activities
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`like lipase, lysozyme, libiase, esterase, hydrolase... from any source including variants,
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`mutants and recombinants of undefined structure and ii) any antimicrobial peptide from
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`any source including variants, mutants and recombinants of undefined structure having
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`
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`Application/Control Number: 12/243,755
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`Page 6
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`Art Unit: 1652
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`antimicrobial
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`activity
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`against
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`any undefined microorganism and
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`said
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`coating
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`composition or paint having the recited functional limitations.
`
`the Court of
`ln University of California v. Eli Lilly & Co., 43 USPQ2d 1938,
`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”. As indicated in MPEP § 2163, 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 that Applicant was in
`possession of the claimed genus. In addition, MPEP § 2163 states that 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.
`
`In the instant case the scope of the instant claims encompass a genus of
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`structures/ encoding polypeptides of interest in said genus of coating compositions or
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`paints with recited functional
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`limitations and there is no structure associated with
`
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`function with regard to the members of the genus Le, a genus of coating compositions
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`or paints comprising: i) any protein, having any structure and having enzymatic activities
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`like lipase, lysozyme, libiase, esterase, hydrolase... from any source including variants,
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`mutants and recombinants of undefined structure and ii) any antimicrobial peptide from
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`any source including variants, mutants and recombinants of undefined structure having
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`antimicrobial
`
`activity
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`against
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`any undefined microorganism and
`
`said
`
`coating
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`composition or paint having the recited functional
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`limitations. Furthermore,
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`the
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`specification teaches in Examples 1-6 and 22 a few well characterized coating
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`compositions and paints comprising a few well characterized enzymes like known
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`
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`Application/Control Number: 12/243,755
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`Page 7
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`Art Unit: 1652
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`lipases and lysozyme as taught in the prior art and mere citation of polypeptides having
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`the desired activity from prior art and said paint further comprising an anti-microbial
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`polypeptide of SEQ ID NO: 40 having anti-fungal activity (as taught in prior art).
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`As interpreted above, the scope of the instant claims encompass a genus of
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`structures/ encoding polypeptides of interest in said genus of coating compositions or
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`paints with recited functional
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`limitations and there is no structure associated with
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`function with regard to the members of the genus. Examiner finds support for the
`
`interpretation of
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`instant claims in the following teachings cited below, as instant
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`invention requires the activity of many polypeptides in said coating compositions and
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`paints and therefore structure with associated function is necessary. The art clearly
`
`teaches the “Practical Limits of Function Prediction”: |. Devos et al., (Proteins: Structure,
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`Function and Genetics, 2000, Vol. 41: 98—1071,
`
`teach that the results obtained by
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`analyzing a significant number of true sequence similarities, derived directly from
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`structural alignments, point to the complexity of function prediction. Different aspects of
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`protein function, including (i) enzymatic function classification, (ii) functional annotations
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`in the form of key words, (iii) classes of cellular function, and (iv) conservation of binding
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`sites can only be reliably transferred between similar sequences to a modest degree.
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`The reason for this difficulty is a combination of the unavoidable database inaccuracies
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`and plasticity of proteins (Abstract, page 98) and the analysis poses interesting
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`questions about the reliability of current function prediction exercises and the intrinsic
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`limitation of protein function prediction (Column 1, paragraph 3, page 99) and conclude
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`that “Despite widespread use of database searching techniques followed by function
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`
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`Application/Control Number: 12/243,755
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`Page 8
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`Art Unit: 1652
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`inference as standard procedures in Bioinformatics, the results presented here illustrate
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`that
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`transfer of function between similar sequences involves more difficulties than
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`commonly believed. Our data show that even true pair-wise sequence relations,
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`identified by their structural similarity, correspond in many cases to different functions
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`(column 2, paragraph 2, page 105). Applicants are also respectfully directed to the
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`problems associated EC Classification in the section “Transferring the EC Classification
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`enzyme to Non-Enzyme Comparisons”; pages 101-102 and Fig. 2a)-b), highlighting the
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`structural and functional heterogeneity based on EC Classification numbers.
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`||. Whisstock et al., (Quarterly Reviews of Biophysics 2003, Vol. 36 (3): 307-340,
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`M also highlight the difficulties associated with “Prediction of protein function from
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`protein sequence and structure”; “To reason from sequence and structure to function is
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`to step onto much shakier ground”, closely related proteins can change function, either
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`through divergence to a related function or by recruitment for a very different function, in
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`such cases, assignment of function on the basis of homology, in the absence of direct
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`experimental evidence, will give the wrong answer (page 309, paragraph 4), it is difficult
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`to state criteria for successful prediction of function, since function is in principle a fuzzy
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`mpg. Given three sequences,
`
`it
`
`is possible to decide which of the three possible
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`pairs is most closely related. Given three structures, methods are also available to
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`measure and compare similarity of the pairs. However,
`
`in many cases, given three
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`protein functions, it would be more difficult to choose the pair with most similar function,
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`although it is possible to define metrics for quantitative comparisons of different protein
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`sequences and structures, this is more difficult for proteins of different functions (page
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`
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`Application/Control Number: 12/243,755
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`Page 9
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`Art Unit: 1652
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`312, paragraph 5),
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`in families of closely related proteins, mutations usually conserve
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`function but modulate specificity i.e., mutations
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`tend to leave the backbone
`
`conformation of the pocket unchanged but to affect the shape and charge of its lining,
`
`altering specificity (page 313, paragraph 4), although the hope is that highly similar
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`proteins will share similar functions, substitutions of a single, critically placed amino acid
`
`in an active-site residue may be sufficient to alter a protein’s role fundamentally (page
`
`323, paragraph 1).
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`III. This finding is reinforced in the following scientific teachings: as taught by the
`
`art, 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, Witkowski et al., (Biochemistry 38:11643-
`
`11650, 1999), teaches that one conservative amino acid substitution transforms a [3-
`
`ketoacyl synthase into a malonyl decarboxylase and completely eliminates Biketoacyl
`
`synthase activity. Seffernick et al., (J. Bacteriol. 183(8): 2405-2410, 2001), teaches that
`
`two naturally occurring Pseudomonas enzymes having 98% amino acid sequence
`
`identity catalyze two different reactions: deamination and dehalogenation,
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`therefore
`
`having different function. Broun et al., (Science 282:1315-1317, 1998), teaches that as
`
`few as four amino acid substitutions can convert an oleate 12-desaturase into a
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`hydrolase and as few as six amino acid substitutions can transform a hydrolase to a
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`desaturase. The art also teaches that functionally similar molecules have different
`
`structures; Kisselev L., (Structure, 2002, Vol. 10: 8-9) teach that polypeptide release
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`factors in prokaryotes and eukaryotes have same function but different structures.
`
`
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`Application/Control Number: 12/243,755
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`Page 10
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`Art Unit: 1652
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`Due to the fact that the specification only discloses few structures,
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`i.e.,
`
`the
`
`specification teaches in Examples 1-6 and 22 a few well characterizes coating
`
`compositions and paints comprising a few well characterized enzymes like known
`
`lipases and lysozyme as taught in the prior art and mere citation of polypeptides having
`
`the desired activity from prior art and said paint further comprising an anti-microbial
`
`polypeptide of SEQ ID NO: 40 having anti-fungal activity (as taught in prior art), and the
`
`lack of description of any additional species/variants/mutants from any source by any
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`relevant, identifying characteristics or properties or structure-function correlation, one of
`
`skill
`
`in the art would not
`
`recognize from the disclosure that applicants’ were in
`
`possession of the claimed invention.
`
`Applicants’ are 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 wwwusptogov.
`
`Enablement
`
`Claims 1-3, 35, 65-68, 70,-73, 75, 77-82, 94, 95, 97, 98, 105-108, 113-115, 118-
`
`123, 126-130, 132-139, 143, 155, 156, 158, 169, 173, 184 and 186-187 with the recited
`
`elected species are rejected under 35 U.S.C. 112,
`
`first paragraph, because the
`
`specification, while being enabling for: specification teaches in Examples 1-6 and 22 a
`
`few well characterized coating compositions and paints comprising a few well
`
`characterized enzymes like known lipases and lysozyme as taught in the prior art and
`
`mere citation of polypeptides having the desired activity from prior art and said paint
`
`further comprising an anti-microbial polypeptide of SEQ ID NO: 40 having anti-fungal
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`activity (as taught in prior art, for details see 103(a) rejection below), the specification
`
`
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`Application/Control Number: 12/243,755
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`Page 11
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`Art Unit: 1652
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`does not reasonably provide enablement
`
`for any coating compositions or paints
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`comprising:
`
`i) any protein, having any structure and having enzymatic activities like
`
`lipase,
`
`lysozyme,
`
`libiase, esterase, hydrolase...
`
`from any source including variants,
`
`mutants and recombinants of undefined structure and ii) any antimicrobial peptide from
`
`any source including variants, mutants and recombinants of undefined structure having
`
`antimicrobial
`
`activity
`
`against
`
`any undefined microorganism and
`
`said
`
`coating
`
`composition or paint having the recited functional limitations. The specification does not
`
`enable any person skilled in the art to which it pertains, or with which it is most nearly
`
`connected, to use the invention commensurate in scope with the claims.
`
`Factors to be considered in determining whether undue experimentation is
`
`required are summarized in In re Wands (858 F.2d 731, 8 USPQ 2nd 1400 (Fed. Cir.
`
`1988)) as follows:
`
`(1) the quantity of experimentation necessary, (2) the amount of
`
`direction or guidance presented, (3) the presence or absence of working examples, (4)
`
`the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in
`
`the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the
`
`claim(s).
`
`Claims 1-3, 35, 65-68, 70,-73, 75, 77-82, 94, 95, 97, 98, 105-108, 113-115, 118-
`
`123, 126-130, 132-139, 143, 155, 156, 158, 169, 173, 184 and 186-187, encompass
`
`any coating compositions or paints comprising: i) any protein, having any structure and
`
`having enzymatic activities like lipase,
`
`lysozyme,
`
`libiase, esterase, hydrolase... from
`
`any source including variants, mutants and recombinants of undefined structure and ii)
`
`any antimicrobial peptide from any source including variants, mutants and recombinants
`
`
`
`Application/Control Number: 12/243,755
`
`Page 12
`
`Art Unit: 1652
`
`of
`
`undefined
`
`structure
`
`having
`
`antimicrobial
`
`activity
`
`against
`
`any
`
`undefined
`
`microorganism and said coating composition or paint having the recited functional
`
`limitations. The scope of the claims is not commensurate with the enablement provided
`
`by the disclosure with regard to extremely large number of polypeptides of unknown
`
`structure with the recited enzyme activities in a genus of coating compositions or paints
`
`comprising said enzymes and said compositions further comprising a genus of
`
`antimicrobial
`
`polypeptides
`
`of undefined
`
`structure
`
`having
`
`activity
`
`against
`
`any
`
`microorganism, as broadly encompassed by the claims. As interpreted the instant
`
`claims encompass: i) any protein, having any structure and having enzymatic activities
`
`like lipase, lysozyme, libiase, esterase, hydrolase... from any source including variants,
`
`mutants and recombinants of undefined structure and ii) any antimicrobial peptide from
`
`any source including variants, mutants and recombinants of undefined structure having
`
`antimicrobial
`
`activity
`
`against
`
`any undefined microorganism and
`
`said
`
`coating
`
`composition or paint having the recited functional
`
`limitations, predictability of which
`
`changes can be tolerated in a protein's amino acid sequence and obtain the desired
`
`activity requires knowledge and guidance with regard to which amino acids in the
`
`protein's sequence,
`
`if any, are tolerant of modification and which are conserved (i.e.
`
`eXpectedly intolerant to modification), and detailed knowledge of the ways in which the
`
`encoded proteins' structure relates to its function. Especially in the instant case
`
`guidance is required for how changes in the structure of the enzymes disclosed in the
`
`instant application affect the desired activities in said genus of coating compositions or
`
`paints.
`
`In this case the disclosure is limited to a few well characterized polypeptides,
`
`
`
`Application/Control Number: 12/243,755
`
`Page 13
`
`Art Unit: 1652
`
`i.e., specification teaches in Examples 1-6 and 22 a few well characterized coating
`
`compositions and paints comprising a few well characterized enzymes like known
`
`lipases and lysozyme as taught in the prior art and mere citation of polypeptides having
`
`the desired activity from prior art and said paint further comprising an anti-microbial
`
`polypeptide of SEQ ID NO: 40 having anti-fungal activity (for details see 103(a) rejection
`
`below).
`
`In view of the broad breadth of the claims,
`
`the amount of experimentation
`
`required to obtain polypeptides with desired biochemical properties and suitable coating
`
`compositions or paints, the lack of guidance, working examples, and unpredictability of
`
`the art in predicting function from a polypeptide primary structure (e.g., see Whisstock et
`
`al., Q Rev Biophys. 2003 Aug; 36(3): 307-340) and use of said polypetides and
`
`antimicrobial polyp[etides in said coating compositions or paints, the claimed invention
`
`would require undue experimentation. As such, the specification fails to teach one of
`
`ordinary skill how to make and use the full scope of: i) any protein, having any structure
`
`and having enzymatic activities like lipase,
`
`lysozyme,
`
`libiase, esterase, hydrolase...
`
`from any source including variants, mutants and recombinants of undefined structure
`
`and ii) any antimicrobial peptide from any source including variants, mutants and
`
`recombinants of undefined structure having antimicrobial activity against any undefined
`
`microorganism and said coating composition or paint having the recited functional
`
`limitations, as encompassed by these claims.
`
`While enzyme isolation techniques, recombinant and mutagenesis techniques
`
`are known, it is n_ot routine in the art to screen for any number of proteins to find those
`
`with enzymatic activities like lipase, lysozyme, libiase, esterase, hydrolase... from any
`
`
`
`Application/Control Number: 12/243,755
`
`Page 14
`
`Art Unit: 1652
`
`source including variants, mutants and recombinants of undefined structure and ii) any
`
`antimicrobial peptide from any source including variants, mutants and recombinants of
`
`undefined structure having antimicrobial activity against any undefined microorganism
`
`or for multiple substitutions or multiple modifications as required by the instant claims.
`
`The specific amino acid positions within a protein's sequence where amino acid
`
`modifications can be made with a reasonable expectation of success in obtaining the
`
`desired activity/utility are limited in any protein and the result of such modifications is
`
`unpredictable (e.g., see Whisstock et al., Q Rev Biophys. 2003 Aug; 36(3): 307-340). In
`
`addition, one skilled in the art would expect any tolerance to modification for a given
`
`protein to diminish even further with additional modification, e.g. multiple substitutions or
`
`deletions.
`
`As argued by the examiner, since what applicants have disclosed, remotely
`
`provides information on the structure-function correlation of the enzymes needed in
`
`enzymatic activities like lipase,
`
`lysozyme,
`
`libiase, esterase, hydrolase...
`
`from any
`
`source including variants, mutants and recombinants of undefined structure and ii) any
`
`antimicrobial peptide from any source including variants, mutants and recombinants of
`
`undefined structure having antimicrobial activity against any undefined microorganism
`
`and the broadest
`
`interpretation of claims encompasses a genus of polypeptides
`
`including varaints and mutants with any structure and clearly constitutes undue
`
`experimentation, as it would involve making and testing many parent sequences
`
`including the mutants, variants
`
`and recombinants of
`
`said parent
`
`sequences.
`
`Furthermore, a variant polypeptide of a parent sequence although having the same
`
`
`
`Application/Control Number: 12/243,755
`
`Page 15
`
`Art Unit: 1652
`
`functional annotation (classified in the same class based on structural similarity), said
`
`variant polypeptide biochemical characteristics i.e., the substrate stereo-specificity, the
`
`kinetics of the reaction and the product generated may be significantly different from the
`
`parent sequence and its ability to catalyze the desired reaction in any given coating
`
`composition or paint may vary. It is also noted that the art teaches several examples of
`
`how even small changes in structure can lead to changes in function. For example,
`
`Witkowski et al.
`
`(Biochemistry, 1999, Vol. 38: 11643-116150)
`
`teaches that w
`
`conservative amino acid substitution transforms a Bketoacyl synthase into a malonyl
`
`decarboxylase and completely eliminates Bketoacyl synthase activity. Seffernick et al.
`
`(J. Bacteriol., 2001, Vol. 183 (8): 2405-2410) teaches that
`
`two naturally occurring
`
`
`Pseudomonas enzymes having 98% amino acid sequence identity catalyze two
`
`different reactions: deamination and dehalogenation, therefore having different function.
`
`Thus given this unpredictability in the art, the specification fails to enable the skilled
`
`artisan to know which of the large number of possible sequences including their
`
`mutants, variants and recombinants have the desired characteristics i.e., the substrate
`
`stereo-specificity, enzyme kinetics and product specificity and their use in any coating
`
`composition or paint. Moreover, it would be undue experimentation for a skilled artisan,
`
`as the skilled artisan would be required to make and test an essentially unlimited
`
`number of mutants, variants and recombinants. The
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