`
`The present response adds claim 190. Claims 1-182, 184, 186, 187, 189 and 190 remain
`
`pending in the captioned case. Claims 4-32, 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`117, 124, 125, 131, 140-142, 144-154, 157, 159-168, 170-172 and 174-182 remain withdrawn.
`
`Further examination and reconsideration of the presently claimed application are respectfully
`
`requested.
`
`Specific support for added claim 190 may be found at the specification as filed, with
`
`particular support found at 1111 [0548] and [0554] and in the sequence listing. Accordingly, this
`
`added claim constitutes no new matter.
`
`The Examiner has noted in the present Office Action dated November 08, 2010 that
`
`reference was made in the amendment and response by Applicants dated 10/28/ 10 to “claim 190
`
`is added herein” and no claim 190 was added. The reference to “claim 190” was an
`
`unintentional typographical error at page 33 (1St paragraph), as only claim 189 was added, and
`
`added claim 189 was correctly referred to at pages 33 (211d paragraph) of the response dated
`
`10/28/10.
`
`M31
`
`The Office Action dated November 08, 2010 only grants priority to the claims to the
`
`instant application filed on 10/01/2008 as the “as the elected species ‘lysozyme’ was only
`
`disclosed in US Provisional Application No.: 60/976,676 filed on 10/01/2007 and the limitation
`
`in the amended claim 1
`
`‘... wherein the antimicrobial peptide comprises a peptide sequence of
`
`SEQ ID NO: 40 has been disclosed for the first time in the instant application filed on
`
`10/01/2008.’” The Examiner’s reply to Applicants’ arguments made at page 33 of the response
`
`dated 10/28/ 10, states that the paragraph notations were not present in the original specification
`
`of US Patent Application 10/665,345. Applicants apologize for not providing the citation of the
`
`page and line numbers in the specification of US Patent Application No. 10/655,345, and
`
`erroneously citing the paragraphs of corresponding Patent application publication no.
`
`20040109853 (“USPGPUB 20040109853”). The Examiner further states that Applicants
`
`REMARKS for the response dated 10/28/ 10 were “incorrect and misleading.” Applicants
`
`provide evidence in the passages below that any errors in correct citation of text in the
`
`32
`
`
`
`REMARKS of the response dated 10/28/ 10 arose without deceptive intent on part of Applicants.
`
`Applicants have attached a copy of the specification of US Patent Application No 10/655,345
`
`(“US 10/655,354”) as Exhibit A for the convenience of the Examiner in referring to the citations
`
`made herein. Applicants will provide additional clarification in the remarks below regarding the
`
`REMARKS of the response dated 10/28/ 10 in support of the priority claim to US Patent
`
`Application 10/665,345 regarding a coatings with an enzyme, lysozyme, and that this assertion
`
`of priority is based on the disclosures of US Patent Application 10/665,345 as filed, and that
`
`these citation of passages were made without deceptive intent.
`
`The Examiner reviewed the cited paragraphs in USPGPUB 20040109853 and found
`
`1] [0273] is drawn to a method of cell lysis using lysozyme in host cells expressing the
`
`polypeptide of interest and does not recite “A coating composition comprising lysozyme.” The
`
`text of interest of 1] [0273] USPGPUB 20040109853 is found in US 10/655,354 at page 82, lines
`
`16-18 and states: “Examples of a biological cell disruption method include contacting the cell
`
`with one or more enzymes (e.g., lysozyme) that weaken, damage, and/or permeabilize a cell
`
`membrane, cell wall or combination thereof.”
`
`Applicants noted at page 33 of the response dated 10/28/ 10 that: “However, the instant
`
`application is a Continuation in Part of US Patent Application 10/655,345 filed on 09/04/2003,
`
`which discloses the enzyme, lysozyme, at paragraph [0273].”
`
`Applicants maintain that this assertion is factually based and not misleading, as this text
`
`does disclose lysozyme as an example of enzymes, specifically ones that have the ability to
`
`“weaken, damage, and/or permeabilize a cell membrane, cell wall or combination thereof” The
`
`Examiner states in the present Office action that this text does not recite “A coating composition
`
`comprising lysozyme.” That the specific sentence disclosing lysozyme does not recite “a
`
`coating” in it is immaterial in light of the teachings of US 10/655,354 that explicitly disclose a
`
`coating with an enzyme, that “enzyme” encompasses any enzyme, and that lysozyme is disclosed
`
`as an enzyme. In particular, 1] [0120] ofUSPGPUB 20040109853, found in US 10/655,354 at
`
`page 35, lines 7-11, states: “The selection of a biomolecule for use in the present invention
`
`depends on the desired property that is to be conferred to a composition of the present invention.
`
`A preferred biomolecule of the present invention comprise an enzyme, as enzymatic activity is a
`
`preferred property to be conferred to a biomolecule composition, coating and/or paint in the
`
`present invention.”
`
`33
`
`
`
`The Examiner argues that fl “[0127] is drawn to coating compositions comprising
`
`‘oxidoreductase’ and not ‘lysozyme’; and paragraph [0130] is drawn to coating compositions
`9”
`comprising ‘ligase’ and not ‘lysozyme. Applicants state at page 33 of the response dated
`
`10/28/10 that: “That the composition of the claims comprises an enzyme is disclosed throughout
`
`the specification of US Patent Application 10/655,345, such as at paragraphs [0120] and [0127]
`
`t_0 [0132].” (Emphasis added).
`
`Paragraphs [0127] to [0132] of USPGPUB 20040109853, found in US 10/655,354 at
`
`page 37, line 20 to page 38, line 36, describe various enzymes (z'.e., an oxidoreductase, a
`
`transferase, a hydrolase, a lyase, an isomerase, a ligase) that encompass the major categories of
`
`enzymes by activity and the Enzyme Commission classification system (e. g., EC 1, EC 2, EC 3,
`
`EC 4, EC 5, EC 6); and further lists the sub-genera of enzymes by their activity substrate(s) and
`
`according to the Enzyme Commission numbering system (z'.e., EC 1.1, EC 1.2, EC 1.3, EC 1.4,
`
`EC 1.5, EC 1.6, EC 1.7, EC 1.8,EC 1.9, EC 1.10, EC 1.11, EC 1.12, EC 1.13,EC 1.14, EC 1.15,EC
`
`1.16, EC 1.17, EC 1.18, EC 1.19, EC 1.20, EC 1.21, EC 1.97, EC 2.1, EC 2.2, EC 2.3, EC 2.4, EC
`
`2.5, EC 2.6, EC 2.7, EC 2.8, EC 2.9, EC 3.1, EC 3.2, EC 3.3, EC 3.4, EC 3.5, EC 3.6, EC 3.7, EC
`
`3.8, EC 3.9, EC 3.10, EC 3.11, EC 3.12, EC 3.13, EC 4.1, EC 4.2, EC 4.3, EC 4.4, EC 4.5, EC 4.6,
`
`EC 4.99, EC 5.1, EC 5.2, EC 5.3, EC 5.4, EC 5.5, EC 5.99, EC 6.1, EC 6.2, EC 6.3, EC 6.4, EC 6.5).
`
`These paragraphs were cited by Applicants as support of the inclusive breadth of the enzyme to
`
`be incorporated into a coating as taught in US 10/655,354 to the use of any enzyme, as these
`
`examples of enzymes genera and sub-genera specified by the disclosed EC Commission numbers
`
`encompass virtually all known enzyme species.
`
`Further submitted herein as support that “enzyme” encompasses various enzymes,
`
`Applicants draw the Examiner’s attention to paragraph [0125] of USPGPUB 20040109853, also
`
`found in US 10/655,354 at page 37, lines 1-9:
`
`“In some embodiments, enzymes may be described by the classification system of
`The International Union of Biochemistry and Molecular Biology (“IUBMB”). The
`IUBMB classifies enzymes by the type of reaction catalyzed and enumerates each
`sub-class by a designated enzyme commission number (“EC”). The IUBMB
`classification of various enzymes may be obtained using the computerized database
`at http://www.chem.qmw.ac.uk/iubmb/enzyme/. Based on these broad categories, an
`enzyme may comprise an oxidoreductase (EC 1), a transferase (EC 2), a hydrolase
`(EC 3), a lyase (EC 4), an isomerase (EC 5), a ligase (EC 6), or a combination
`thereof.”
`
`34
`
`
`
`Additionally evidenced herein, claims 1, 2, 8, 10, and 11 at page 262, lines 3-7, 24-25,
`
`and 31-36 of US 10/655,354 as filed on 09/04/2003 specify coatings with the various enzymes of
`
`the major enzyme categories, as well as various active biomolecules (i.e., peptide, polypeptide,
`
`protein), as shown below:
`
`1.
`
`A coating comprising a biomolecule composition, wherein the
`
`biomolecule composition comprises an active biomolecule.
`
`2.
`
`The coating of claim 1, wherein the active biomolecule comprises a
`
`proteinaceous molecule.
`
`8.
`
`The coating of claim 2, wherein the proteinaceous molecule comprises a
`
`peptide, a polypeptide, a protein, or a combination thereof.
`
`10.
`
`The coating of claim 8, wherein the proteinaceous molecule comprises an
`
`enzyme.
`
`11.
`
`The coating of claim 10, wherein the enzyme comprises an oxidoreductase, a
`
`transferase, a hydrolase, a lyase, an isomerase, a ligase, or a combination thereof.
`
`Moreover, attached hereto is Exhibit B, a copy of the EC classification web-pages for
`
`enzymes under EC 3 (i.e., hydrolases) wherein enzymes of EC 3.2 (i.e., glycosylases) are a sub-
`
`type, and wherein lysozyme is sub-classified under the further sub-category of EC 3.2.1 (i.e.,
`
`glycosidases), specifically as EC 3.2.1.17 (i.e., lysozyme), further demonstrating that lysozyme
`
`is an enzyme, and more particularly, an enzyme within the categories of enzymes described and
`
`originally claimed in coatings as noted above.
`
`Further, as 1] [0120] ofUSPGPUB 20040109853, found in US 10/655,354 at page 35,
`
`lines 7-11 states:
`
`The selection of a biomolecule for use in the present invention depends on the
`desired property that is to be conferred to a composition of the present invention
`enzymatic activity is a preferred property to be conferred to a biomolecule
`composition, coating and/or paint in the present invention.
`
`And the selection of biomolecules including enzymes with different activities for
`
`incorporation into coatings is further described at 1111 [0034]-[0035] of USPGPUB 20040109853,
`
`found in US 10/655,354 at page 16, lines 28-42:
`
`In certain embodiments, the active biomolecule comprises a combination of active
`biomolecules. The combination of biomolecules may be of the same type, such as a
`
`35
`
`
`
`combination of enzymes. The combination may be of different biomolecules or may
`be of different types of biomolecules such as a receptor ligand and an enzyme, a
`receptor and an antibody, an enzyme and a combination of antibodies, etc. All
`iterations of active biomolecules may be selected to confer to a coating a
`combination of bioactivities as desired. In general embodiments, a composition of
`the present invention may comprise 1 to 100 or more different selected biomolecules
`of interest, including all intermediate ranges and combinations thereof
`
`In some embodiments, the proteinaceous molecule comprises an enzyme. In
`particular embodiments, the enzyme comprises an oxidoreductase, a transferase, a
`hydrolase, a lyase, an isomerase, a ligase, or a combination thereof”
`
`And, as previously noted, 11 [0273] USPGPUB 20040109853, found in US 10/655,354 at
`
`page 82, lines 16-18 states: “Examples of a biological cell disruption method include contacting
`
`the cell with one or more enzymes (e.g., lysozyme) that weaken, damage, and/or permeabilize a
`
`cell membrane, cell wall or combination thereof.”
`
`The disclosures of US 10/655,354 clearly include the description that one or more
`
`biomolecules including enzyme(s) are selected to confer property(s) to a coating; the disclosure
`
`of lysozyme as an enzyme; the description of a property of enzymes that include lysozyme to
`
`“weaken, damage, and/or permeabilize a cell membrane, cell wall or a combination thereof’; and
`
`the description of incorporation of enzymes that would include lysozyme in that genus of
`
`enzymes, additionally supported by the Exhibit B of enzymes according to EC classification of
`
`which lysozyme is also classified, as would be known in the art of enzymes. These disclosures
`
`amply demonstrate that the inclusion of the lysozyme as an enzyme into a coating; as well as
`
`conferring to a coating an enzymatic property, with “weaken, damage, and/or permeabilize a cell
`
`membrane, cell wall or a combination thereof’ being taught as a property of lysozyme and other
`
`enzymes; was encompassed by the disclosures of US 10/655,354.
`
`Applicants respectfully request that priority for at least "lysozyme" be corrected to at
`
`least the filing date of 09/04/2003 for US Patent Application 10/655,345.
`
`Withdrawn Claim Re'ections Under 35 U.S.C. 112 First Para ra h and
`
`102 and 103
`
`Applicants respectfully acknowledge and appreciate the withdrawal of previous
`
`rejections under 35 § U.S.C. 112 first paragraph, and 35 § 102 and 103.
`
`36
`
`
`
`Objection to the Specification
`
`Claims 2 and 189 was objected to for reciting non-elected subject-matter, and the
`
`Examiner has directed that “appropriate correction is required.” Applicants maintain that a claim
`
`may containing elected subject matter may also contain non-elected subject matter during
`
`examination (see MPEP § 803.02).
`
`Applicants respectfully request that this objection be withdrawn.
`
`Double Patenting Rejection
`
`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 and 189 are provisionally rejected
`
`under the judicially created doctrine of obviousness-type double patenting as being unpatentable
`
`over claims 1-98 of McDaniel et al., (US Application No.: 12/696,651). Applicants will file a
`
`terminal disclaimer to obviate the rejection upon receiving notice that some or all of the claims
`
`in the captioned application are allowed.
`
`Section 1031a) Rejections
`
`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, 186, 187 and 189 were rejected under 35
`
`U.S.C. § 103(a) as being anticipated by McDaniel et al., (Prog. Org. Coatings., 2006, Vol. 55:
`
`182-188), Bonaventura et al. (US Patent No.: 5,998,200), Sherba et al., (US Patent No.:
`
`5,069,717), Dalla Riva Toma, JM., (US Patent No.: 6,054,504) and in view of Edwards D., (US
`
`Patent No.: 6,020,312). Applicants respectfully traverse this rejection. To establish a prima
`
`facie obviousness of a claimed invention, all claim limitations must be taught or suggested by the
`
`prior art. In re Royka, 490 F.2d 981, 180 U.S.P.Q. 580 (C.C.P.A. 1974), MPEP 2143.03.
`
`Obviousness cannot be established by combining or modifying the teachings of the prior art to
`
`produce the claimed invention, absent some teaching or suggestion or incentive to do so. In re
`
`Bond, 910 F. 2d 81,834, 15 USPQ2d 1566, 1568 (Fed. Cir. 1990).
`
`The Examiner cites McDaniel et al. “as disclosing active enzymes and other bioactive
`
`molecules sequestered in paint and coatings including lysozyme and antimicrobial peptides
`
`(Abstract, page 187, column 2, and first paragraph).” The Examiner fiarther argues at page 12 of
`
`the instant Office Action that:
`
`37
`
`
`
`McDaniel et al., provides Teaching, Suggestion and Motivation for preparing
`enzyme based additives for paint and coatings, and as proof of principle has
`shown active enzymes and other active biomolecules sequestered in paints and
`coatings and have reported the design and characterization of biological additives
`for latex coatings which impart catalytic detoxification or biodefensive
`capabilities to surfaces (Abstact, page 182 and entire document).
`
`The Examiner cites the above characterization of McDaniel et al., for providing
`
`“Teaching, Suggestion and Motivation” as part of a “string of continuity” at pages 15 and 16 in
`
`combining this reference with Bonaventural et al., which is said to teach “antifouling
`
`compositions and methods for preventing fouling that comprises affixing biologically active
`
`chemical to a surface intended for use (coating composition or paint), wherein the chemical is
`
`an enzyme, said enzyme is a lysozyme (Abstract, Table III) and preparation of said coating
`
`compositions by immobilization in polyurethane (column 19, Example V; claims, columns 36-
`
`38);” Sherba et al. which is said to teach “a synergistic antialgal compositions comprising
`
`small molecules that have antialgal activity and lysozyme enzyme (Abstract), said
`
`compositions in the form antifouling compositions and use of said compositions in construction
`
`produces such as stucco, roof mastics, wall mastics and masonry coatings (column 4, lines 27-
`
`30),” and Dalla Riva Toma, JM., which is said to “clearly suggest various biostatic compositions
`
`comprising biostatic agents and methods for conjugating said biostatic agents to various
`
`functional groups of hydrophilic polymers, said functional group capable of reacting with and
`
`covalently bonding to an antimicrobial agent without effectively reducing antimicrobial property
`
`(Abstract); said hydrophilic polymer can be, but not limited to a polyurethane, a maleic
`
`anhydride, a polyol, a polyamine, an acrylate, an ethylene oxide or modified forms of said
`
`polymers (column 3, line 29-34) and suitable solvents (column 3, lines 45-50) and claims
`
`(columns 12-18),” Edwards D., disclose the isolation and structure of an antifungal peptide
`
`having 100% sequence homology to SEQ ID NO: 40 of the instant invention (see provided
`
`sequence alignment), said reference also teaches the use of said peptide in various compositions
`
`as an antimicrobial agent (Abstract) in the form of coating mixture comprising a noninterfering
`
`carrier and an effective quantity of the antimicrobial composition (columns 7 and 10), method
`
`for encapsulation of said antimicrobial peptide (column 27-28).”
`
`38
`
`
`
`Applicants submit that, as described above in the remarks for the priority claim of the
`
`instant application, the instant application is a Continuation in Part of US Patent Application
`
`10/655,345 filed on 09/04/2003, which discloses coatings and paints comprising enzyme(s),
`
`which includes lysozyme as it is a disclosed enzyme. Further, as demonstrated in the cited
`
`passages of US Patent Application 10/655,345 in the remarks for the priority claim, US Patent
`
`Application 10.655,345 teaches paints and coatings with, various active biomolecules, including
`
`proteinaceous molecules, peptides, proteins, polypeptides, antibodies, and receptors (see the
`
`remarks above regarding cited passages of 1111 [0034]-[0035] of USPGPUB 20040109853, found
`
`in US 10/655,354 at page 16, lines 28-42; and claims 1, 2, 8, 10, and 11 at page 262, lines 3-7,
`
`24-25, and 31-36 of US 10/655,354). As the filing date of 09/04/2003 for US Patent Application
`
`10/655,345 predates that of McDaniel et al., the combinability of McDaniel et al. with
`
`Bonaventura et al., Sherba et al., and Dalla Riva Toma, JM., in view of Edwards D. fails, and the
`
`“Teaching, Suggestion and Motivation” argued as provided by McDaniel et al. is removed from
`
`the rej ection’s “string of continuity” in combining the teachings of McDaniel et al., Bonaventura
`
`et al., Sherba et al., and Dalla Riva Toma, JM., in view of Edwards D.
`
`Applicants respectfully note the Examiner's acknowledgement at p. 9 of the Action that
`
`McDaniel et al., Bonaventura et al., Sherba et al., and Dalla Riva Toma, JM "are silent regarding
`
`said coating compositions comprising an antimicrobial peptide having the peptide sequence of
`
`SEQ ID NO:40." Applicants also note that Edwards D. is also silent regarding lysozyme or any
`
`enzyme being suitable in the compositions it describes, and thus does not teach, suggest, or
`
`provide any motivation to a skilled artisan to combine the compositions and peptides of Edwards
`
`D. with the lysozyme or compositions described in the other cited references.
`
`In this context, even if the teachings of McDaniel et al., were available for combination
`
`with the teachings of McDaniel et al., Bonaventura et al., Sherba et al., and Dalla Riva Toma, JM
`
`in view of Edwards D., these references do not provide a skilled artisan any motivation to
`
`combine their compositions with the peptide of Edwards, nor does any of these references alone
`
`or in combination with the teachings of Edwards provides a reasonable expectation of success
`
`in achieving antimicrobial activity if such a combination was made. The Examiner
`
`characterizes, at page 14 of the instant Office Action, Applicants’ previous arguments made in
`
`the response dated 10/2 8/ 1 0 as directed to the references individually, though Applicants
`
`respectfully submit that the arguments made at, for example, pages 58-59 of the response dated
`
`39
`
`
`
`10/28/10, as well as the present arguments made herein, address the combination of teachings of
`
`the cited references in demonstrating non-obviousness of the invention of the independent
`
`claims.
`
`Applicants find that Bonaventura et al., does not teach, suggest, or provide any
`
`motivation for combining an antimicrobial peptide of the present claims in any of its
`
`compositions. Applicants find that Sherba et al. does not teach, suggest, or provide any
`
`motivation for combining an antimicrobial peptide of the present claims in any of its
`
`compositions, and that the "small molecules" relate to a chemical agent, not a peptide of the
`
`present claims. Applicants find that Dalla Riva Toma, JM. does not teach, suggest, or provide
`
`any motivation for combining an antimicrobial peptide or an enzyme of the present claims in any
`
`of its compositions. Applicants find none of these references teach or suggest any antimicrobial
`
`peptide, let alone an antimicrobial peptide of the present claims. The compositions of
`
`Bonaventura et al., and Sherba et al, though arguably related via having anti-fouling or antialgal
`
`properties, are generally directed toward marine/water contacting materials (see Bonaventura et
`
`al., column 2 lines 39-63; and Sherba et al. column 2, lines 1-13) are distinctly different than the
`
`compositions of Dalla Riva Toma, JM' that is directed to compositions for a medical device (see
`
`column 9, lines 1-7; and column 1, lines 12-16).
`
`The Examiner argues for the obviousness to combine the above cited references with the
`
`teachings of Edwards D. at the bridging paragraph, page 9 to 10, stating:
`
`Hence, it would have been obvious to a person of ordinary skill in the art to
`combine the teaching in the cited references to generate a coating compositions or
`paints comprising: i) polypeptides having enzymatic activities like lipase,
`lysozyme, libiase, esterase, hydrolase. .. and ii) antimicrobial peptide having
`antimicrobial activity against any microorganism and iii) said antimicrobial
`polypeptide comprising the sequence of SEQ ID No: 40. Motivation to do so
`derives from the fact that coating compositions or paints comprising non-toxic
`antimicrobial/antifouling agents such as enzyme and antimicrobial peptides have
`wide use in various industrial applications. The expectation of success is high,
`because methods and design for producing coating compositions or paints
`comprising: i) polypeptides having enzymatic activities like lipase, lysozyme,
`libiase, esterase, hydrolase. .. and ii) antimicrobial peptide having antimicrobial
`activity against any microorganism were well known in the art (McDaniel et al.,
`Bonaventura et al., Sherba et al., and Dalla Riva Toma, JM.,) and iii) the structure
`of the key antimicrobial peptide comprising the sequence of SEQ ID NO: 40 is
`also well known in the art (Edwards D.).
`
`40
`
`
`
`Edwards D. is argued at page 9 of the instant Office action as teaching the “use of said
`
`peptide. . .as an antimicrobial agent. . .in the form of a coating mixture comprising a
`
`noninterfering carrier and an effective quantity of the antimicrobial composition.” Applicants
`
`note that the term “coating mixture” of Edwards D. refers to a carrier for use on plants or animals
`
`(Edwards D. columns 7 and 10). As stated at Edwards D., column 10, lines 40-44: “The method
`
`comprises coating plant part of organ with the peptide compositions of the invention in a coating
`
`mixture comprising a noninterfering carrier and an effective quantity of the antimicrobial
`
`composition.” (Emphasis added)
`
`The applicability of the peptides taught by Edwards D. is only to limited materials for use
`
`on plants and animals, and moreover, this applicability is further limited to particular types of
`
`carriers, as evidenced by the Edwards D. teaching away from other carrier materials that may
`
`interfere with the peptide, as described in column 7 of Edwards D., shown below:
`
`"The antibiotic compositions of the invention may also comprise a carrier. In
`certain instances, the carrier will be one suitable for pharmaceutical applications.
`In other instances, the carrier will be one suitable for use in applying the
`antibiotic compositions onto plants. In either instance, the carrier selected
`must be a carrier whose chemical and/or physical characteristics do not
`significantly interfere with the antibiotic activity of the peptide composition.
`It is known, for instance that certain microsphere carriers may be effectively
`utilized with proteinaceous compositions in order to deliver these compositions to
`a site of preferred activity such as onto a topical surface of a plant or animal.
`Liposomes have been similarly utilized to deliver labile antibiotics by injection or
`inhalation to internal sites within an organism. Saline solutions, pharmaceutically
`acceptable buffers and solvents and the like may also be utilized as carriers for the
`peptide compositions of the invention." (Emphasis added)
`
`These teachings of Edwards D are in direct opposition to the Examiner’s assertion of the
`
`combinability of the teaching of Edwards D with the other cited references with any reasonable
`
`expectation of success, let alone an expectation of “high” success as asserted by the Examiner.
`
`The Examiner’s describes the rational for this rejection as described at points 1-3 at page 21 of
`
`the instant action:
`
`(1) Combining prior art elements according to known method to yield predicable
`results.
`
`(2) Simple substitution of one known element for another to obtain predictable
`results.
`
`(3) “Obvious to try’ — choosing from a finite number of identified, predictable
`solution, with a reasonable expectation of success. (Offle Action, pg. 21)
`
`41
`
`
`
`The teachings of Edwards D. above clearly demonstrates that this rational does not
`
`succeed in making the claimed invention obvious, as the peptides Edward D. in the coatings in
`
`the other cited references would not produce a predictable result of no change to the function of
`
`antimicrobial activity in such coatings with any reasonable expectation of success, in light of the
`
`suitability of the peptides to limited types the materials due to the interference of certain carriers,
`
`as taught by Edward D. Further, the teachings of Bonaventura et al., and Sherba et al. to
`
`enzymes and/or lysozyme; and Dalla Riva Toma, JM. to biostatic agents, in compositions and/or
`
`coatings, either alone as separate references or in combination with each other and Edwards D.
`
`and/ or McDaniel et al. does not overcome these deficiencies to make the combination of a
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`peptide with an enzyme in a coating would produce a reasonable expectation of success, by a
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`predictable result of no change to the function of antimicrobial activity. In particular, it is known
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`in the art of coating compositions that the efficacy and duration of antimicrobial activity within
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`coatings is highly dependent on the compatibility of antimicrobial agents within the coating
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`media, as evidenced by US. Patent 3,988,294 to Hill (hereinafter "Hill") submitted as Exhibit C,
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`previously provided to the Examiner in the Information Disclosure Statement dated 11/04/2010
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`as US. Patent Number Citation 2. Applicants cite the teaching Hill that underscores that there is
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`not such an expectation for success in incorporating a fungicide in a coating such as a paint, and
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`notes that expectation of success is quite low.
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`The fungicide must be compatible with the paint medium and retain its activity
`during normal container storage life. Many fungicides lose their fiangicidal
`activity prior to application of the paint as a protective or decorative coating.
`Loss of activity during storage in the container is of particular concern in the case
`of latex paint because of its alkalinity and water content. Furthermore, many
`fungicides decompose in aqueous alkaline systems. .
`. .Therefore, the fact that a
`particular chemical compound may be known to possess fiangicidal activity does
`not necessarily mean that it will be effective in inhibiting fungal growth on
`exterior coating surfaces for long periods of time. In fact, most known fungicides
`are not useful in paint for one or more of the above-mentioned reasons (Hill - col.
`1, lines 43-68).
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`Applicants submit that without such an expectation of success, as was understood to
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`those of skill in the art, the combination of the references cited in the rejection are fail to meet
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`the teaching, suggestion, and motivation rational argued by the Examiner.
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`Further, in direct contrast to these teachings by Edwards D. and Hill, the instant
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`application demonstrates that the combination of an antimicrobial enzyme and an antimicrobial
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`42
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`
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`peptide not only demonstrate activity in a coating, but produces greater antimicrobial effects in a
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`coating composition than the activities of an antimicrobial enzyme or an antimicrobial peptide
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`by themselves as described at 11[0416] and demonstrated at example 14. As noted in the
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`M.P.E.P. 11 716.02(a):
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`A greater than expected result is an evidentiary factor pertinent to the legal
`conclusion of obviousness
`of the claims at issue.’ In re Corkz'll, 711 F.2d 1496,
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`226 USPQ 1005 (Fed. Cir. 1985). In Corkhill, the claimed combination showed
`an additive result when a diminished result would have been expected. This result
`was persuasive of nonobviousness even though the result was equal to that of one
`component alone. Evidence of a greater than expected result may also be shown
`by demonstrating an effect which is greater than the sum of each of the effects
`taken separately (i.e., demonstrating “synergism”). Merck & C0. Inc. v. Biocraft
`Laboratories Inc., 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493
`US. 975 (1989).
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`For at least the reasons set forth above, none of cited art, taken alone or in combination,
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`teaches or suggests the limitations of the independent claims 1, 155-182, 184, 186, and 189
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`specifically a peptide composition of SEQ ID no. 40 or a fianctionally equivalent conservative amino
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`acid substituted peptide sequence in combination with an antimicrobial enzyme, in the specified
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`coating compositions of these independent claims. As such, independent claims 1, 155-182, 184 and
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`186 are patentably distinct over the cited art. For at least the same reasons, claims dependent from
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`these independent claims are also patentably distinct over the cited art as well. Accordingly,
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`removal ofthe 35 U.S.C. § 103(a) rejection ofclaims 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 186-189 is
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`respectfully requested.
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`CONCLUSION
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`The present amendment and response is believed to be a complete response to the issues
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`raised in the final Office Action mailed November 08, 2010. If the Examiner has any questions,
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`comments or suggestions, the undersigned attorney earnestly requests a telephone conference.
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`The Commissioner is authorized to charge any fees which may be required, or credit any
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`overpayment, to deposit account no. 50-3268.
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`43
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`Respectfully submitted,
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`/C. Steven McDaniel/
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`C. Steven McDaniel
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`Reg. No. 33,962
`Attorney for Applicant
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`Customer No. 13598
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`Date: May 91 2011
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`44
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