DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 01/07/2026 has been entered.
Withdrawal of Rejections
The response and amendments filed on 01/07/2026 are acknowledged. Any previously applied minor objections and/or minor rejections (i.e., formal matters), not explicitly restated here for brevity, have been withdrawn necessitated by Applicant’s formality correction and/or amendments. For the purposes of clarity of the record, the reasons for the Examiner’s withdrawal, and/or maintaining, if applicable, of the substantive or essential claim rejections are detailed directly below and/or in the Examiner’s Response to Arguments section.
Briefly, the previous claim rejections under 35 U.S.C. 112(b) have been withdrawn necessitated by Applicant’s amendments. The previous claim rejection under 35 U.S.C. 103 for obviousness have been withdrawn necessitated by Applicant’s amendments; however, new grounds of rejection are set forth below.
The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Claim Rejections - 35 USC § 103, Obviousness
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 15, 53, 69, 135, 140, 144, 180, and 183-186 are rejected under 35 U.S.C. 103 as being unpatentable over Vejborg (WO 2019/086528; Date of Publication: May 9, 2019 – previously cited) in view of Brin (US 2019/0000935; Date of Publication: January 3, 2019 – previously cited).
Vejborg’s general disclosure relates to “cleaning compositions comprising enzymes
having hexoaminidase activity such as dispersins obtained from Staphylococcus” (see, e.g.,
Vejborg, pg. 1, lines 7-10). Furthermore, Vejborg discloses compositions that comprise one or
more polyols, one or more enzymes, one or more surfactant, and one or more polymer (see, e.g.,
Vejborg, pg. 1, line 34-38 & pg. 2, lines 1-3). Additionally, Vejborg discloses that the
hexoaminidase (i.e., DispersinB) can be formulated as a liquid enzyme formulation, wherein preservation agents and/or other stabilizers are included within the solvent system (see, e.g.,
Vejborg, pg. 8, lines 25-34).
Regarding claim 15 pertaining to DispersinB and polyols, Vejborg teaches liquid
compositions comprising dispersins, such as DispersinB, wherein the composition comprises
polyols for stability (see, e.g., Vejborg, “Description of the Related Art”, pg. 1 & “Liquid
Formulations”, pg. 9). Furthermore, Vejborg teaches that enzymes, such as dispersins, may be
stabilized using conventional stabilizing agents, such as polyols (see, e.g., Vejborg, “Liquid
formulations”, pg. 10, lines 4-7 & “Enzyme stabilizers/inhibitors”, pg. 23, lines 19-23).
Regarding claim 135 pertaining to the polymer, Vejborg teaches compositions comprising DispersinB and polyvinyl alcohol (see, e.g., Vejborg, “Liquid formulations”, pg. 9 & “Granular formulations”, pg. 11 & “Polymers”, pg. 20, line 25).
However, Vejborg does not teach: the polyol comprising one or more of isomalt at a concentration of 1% of the composition by weight or higher or maltitol at a concentration of 1% of the composition by weight or higher (claim 15); or wherein the polyol is isomalt (claim 53); or wherein the polyol is maltitol (claim 69);or wherein the polymer is poloxamer 407 (claim 140); or wherein the amount of isomalt is up to 20% of the composition by weight (claim 180); or wherein the amount of maltitol is up to 25% of the composition by weight (claim 183); or wherein the amount of maltitol is between 1% and 25% of the composition by weight (claim 184); or wherein the amount of maltitol is between 10% and 25% of the composition by weight (claim 185); or wherein the amount of maltitol is about 10% of the composition by weight (claim 186).
Brin’s general disclosure relates to the production of a biodegradable film composition
for the delivery of an active agent to a mucosal surface (see, e.g., Brin, [0002]). Furthermore,
Brin discloses the use of isomalt as a stabilizer within the composition (see, e.g., Brin, [0093],
[0100]) in order to stabilize the botulinum toxin within the compound, since botulinum toxin is
inherently fragile and labile (see, e.g., Brin, [0005]).
Regarding claims 15, 53, and 69 pertaining to isomalt or maltitol, Brin teaches the use of isomalt and maltitol within pharmaceutical film compositions (see, e.g., Brin, [0093]). Furthermore, Brin teaches that polyols, such as isomalt and maltitol, as used within the composition as a stabilizer (see, e.g., Brin, [0093]). Furthermore, Brin teaches that the term “polyol” is synonymous with “sugar alcohol” can be effective to increase dissolution of the film and/or act as a stabilizer (see, e.g., Brin, [0093]).
Regarding claim 140 pertaining to the polymer, Brin teaches that the polymer can be poloxamer 407 (see, e.g., Brin, [0081]). Moreover, Brin teaches that poloxamers are mucoadhesive and hydrophilic polymers (see, e.g., Brin, [0016]), and that these polymers are comprised within a film composition in order to make the film be bioadhesive/mucoadhesive and water-soluble (see, e.g., Brin, [0082]). Furthermore, Brin teaches “The hydrophilic polymer, in one embodiment, also provides mechanical strength to the film. It will be appreciated that one or more polymers or other ingredients may be used in the film formulation to provide a film having the desired properties including dissolution time, mechanical strength, and/or stability” (see, e.g., Brin, [0080]).
Regarding claim 144 pertaining to the preservative, Brin teaches that EDTA is used as a preservative within the film (see, e.g., Brin, [0108]).
Regarding claims 15, 180, and 183-186 pertaining to the amount of isomalt, Brin teaches the amount of polyol, such as isomalt or maltitol, is “added to the formulation is at least 0.5% (w/v), at least 1.0% (w/v), at least 2.0% (w/v), at least 3.0% (w/v), at least 4.0% (w/v), at least 5.0% (w/v), at least 6.0% (w/v), at least 7.0% (w/v), at least 8.0% (w/v), at least 9.0% (w/v), at least 10% (w/v), at least 15% (w/v), at least 20% (w/v), at least 25% (w/v), at least 30% (w/v), or at least 35% (w/v). In other aspects of this embodiment, the amount of polyol added to the formulation is at most 0.5% (w/v), at most 1.0% (w/v), at most 2.0% (w/v), at most 3.0% (w/v), at most 4.0% (w/v), at most 5.0% (w/v), at most 6.0% (w/v), at most 7.0% (w/v), at most 8.0% (w/v), at most 9.0% w/v), at most 10% (w/v), at most 15% w/v), at most 20% (w/v), at most 25% (w/v), at most 30% (w/v), or at most 35% (w/v)” (see, e.g., Brin, [0094]).
It would have been first obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising DispersinB and a polyol, as taught by Vejborg, wherein the polyol is isomalt or maltitol, as taught by Brin. One would have been motivated to do so because Brin teaches that one or more polyols is effective as a stabilizer within the composition (see, e.g., Brin, [0093], [0100]). Furthermore, Brin teaches that the term “polyol” is synonymous with “sugar alcohol (see, e.g., Brin, [0093]), and Vejborg teaches that the liquid composition comprises one or more sugar alcohols (see, e.g., Vejborg, “Summary of the Invention”, pg. 1, lines 34-36). Moreover, Vejborg teaches “The hexosaminidases e.g. dispersins in the liquid composition of the invention may be stabilized using conventional stabilizing agents, e.g. a polyol such as propylene glycol or glycerol, ethylene glycol, polyethylene glycol, sugar alcohols, sorbitol, mannitol, erythritol, dulcitol, inositol, xylitol and adonitol” (see, e.g., Vejborg, “Liquid Formulations”, pg. 9, lines 4-7). Therefore, based on the teachings of Vejborg and Brin, it would have been obvious to prepare a liquid composition comprising DispersinB and a polyol because the polyol acts as a stabilizer for DispersinB.
It would have been secondly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to prepare a composition comprising DispersinB and a polyol, as taught by Vejborg, wherein the composition also comprises poloxamer 407, as taught by Brin. One would have been motivated to do so because Brin teaches that poloxamers are mucoadhesive and hydrophilic polymers (see, e.g., Brin, [0016]), and that these polymers are comprised within a film composition in order to make the film be bioadhesive/mucoadhesive and water-soluble (see, e.g., Brin, [0082]). Furthermore, Brin teaches “The hydrophilic polymer, in one embodiment, also provides mechanical strength to the film. It will be appreciated that one or more polymers or other ingredients may be used in the film formulation to provide a film having the desired properties including dissolution time, mechanical strength, and/or stability” (see, e.g., Brin, [0080]). Furthermore, Vejborg teaches that the composition can include one or more polymer (see, e.g., Vejborg, pg. 2, line 3) and that “Films can also be of blended compositions comprising hydrolytically degradable and water soluble polymer blends such as polylactide and polyvinyl alcohol” (see, e.g., Vejborg, pg. 37, lines 27-29). Therefore, based on the teachings of Vejborg and Brin, it would have been obvious to produce a composition comprising DispersinB, a polyol, and poloxamer 407 because the poloxamer 407 would allow for the composition to be made into a film composition.
It would have been thirdly obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising DispersinB and a polyol, as taught by Vejborg, wherein the composition also comprises EDTA, as taught by Brin. One would have been motivated to do so because Brin teaches that EDTA can be used as a preservative within film compositions (see, e.g., Brin, [0108]). Furthermore, Vejborg teaches that EDTA can be used as a chelator within liquid detergent compositions (see, e.g., Vejborg, pg. 16, line 36). Therefore, based on the teachings of Vejborg and Brin, it would have been obvious to include EDTA in a film or liquid composition for preservation and/or chelation effects. One would have expected success because Vejborg and Brin both teach compositions comprising polyols for stabilizing protein compositions, as well as polymers for film compositions, and EDTA for film or liquid compositions.
Regarding claims 15 and 35’s recitation of “…to stabilize the DispersinB at an ambient or higher than ambient temperature…”, this is considered an outcome that occurs by following the method steps, as taught by Vejborg and Brin. Therefore, the prior art’s teachings of a method of producing a composition comprising a DispersinB and a polyol, such as isomalt or maltitol, would result in the outcome claimed.
Claims 187-189 are rejected under 35 U.S.C. 103 as being unpatentable over Vejborg and Brin as applied to claims 15, 53, 69, 135, 140, 144, 180, and 183-186 above, and further in view of Sawyer (US 2018/0310566; Date of Publication: November 1, 2018 – previously cited).
The teachings of Vejborg and Brin, herein referred to as modified-Vejborg-Brin, are
discussed above as it pertains to a method of producing a composition comprising DispersinB and a polyol.
However, modified-Vejborg-Brin does not teach: wherein the amount of poloxamer 407 is up to 10% of the composition by weight (claim 187); or wherein the amount of poloxamer 407 is between 4% and 6% of the composition by weight (claim 188); or wherein the amount of poloxamer 407 is about 5% of the composition by weight (claim 189).
Sawyer’s general disclosure relates to compositions for killing or inhibiting biofilm
formation on surfaces (see, e.g., Sawyer, abstract). Moreover, Sawyer teaches the use of
poloxamer 407 as a carrier agent for the composition in order to allow the composition to
effectively penetrate the biofilm (see, e.g., Sawyer, [0029], [0068]).
Regarding claims 187-189 pertaining to the amount of poloxamer, Sawyer teaches that
the composition comprises poloxamer 407 in a range of 0.2 to 75 wt%, wherein poloxamer 407
may more preferable be contained in an amount of 1.0 to 10 wt% with respect to the total weight
of the composition (see, e.g., Sawyer, [0110]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising DispersinB, a polyol, and poloxamer 407, as taught by modified-Vejborg-Brin, wherein the amount of poloxamer 407 is 0.2 to 75 wt% and more preferably within in an amount of 1.0 to 10 wt% with respect to the total weight of the composition, as taught by Sawyer. One would have been motivated to do so because Sawyer teaches that poloxamer 407 at these concentrations allows for poloxamer 407 to be used as thickening agents or carriers or gelling agents within the composition (see, e.g., Sawyer, [0110]). Furthermore, Sawyer teaches that poloxamers allow for the production of anhydrous, hydrophilic gel base carriers for wound dressings, wherein these anhydrous, hydrophilic gel base carriers absorb wound fluid and slowly release its water-soluble active microbial agent into the wound (see, e.g., Sawyer, [0098]). Moreover, modified-Vejborg-Brin teaches that poloxamers are mucoadhesive and hydrophilic polymers (see, e.g., Brin, [0016]), and that these polymers are comprised within a film composition in order to make the film be bioadhesive/mucoadhesive and water-soluble (see, e.g., Brin, [0082]). Furthermore, modified-Vejborg-Brin teaches “The hydrophilic polymer, in one embodiment, also provides mechanical strength to the film. It will be appreciated that one or more polymers or other ingredients may be used in the film formulation to provide a film having the desired properties including dissolution time, mechanical strength, and/or stability” (see, e.g., Brin, [0080]). Therefore, based on the teachings of modified-Vejborg-Brin and Sawyer, it would have been obvious to produce a composition comprising DispersinB, a polyol, and poloxamer 407, wherein the concentration of the poloxamer is 0.2 to 75 wt% and more preferably within in an amount of 1.0 to 10 wt% with respect to the total weight of the composition because this would allow for production of a hydrophilic film with mechanical strength and stability. One would have expected success because modified-Vejborg-Brin and Sawyer teach anti-biofilm compositions comprising poloxamer 407.
Claims 190 and 193 are rejected under 35 U.S.C. 103 as being unpatentable over Vejborg and Brin as applied to claims 15, 53, 69, 135, 140, 144, 180, and 183-186 above, and further in view of Leung (US 2014/0276493; Date of Publication: September 18, 2014 – previously cited).
The teachings of Vejborg and Brin, herein referred to as modified-Vejborg-Brin, are
discussed above as it pertains to a method of producing a composition comprising DispersinB and a polyol.
However, modified-Vejborg-Brin does not teach: wherein EDTA is up to 2.5% of the composition by weight (claim 190); or wherein the EDTA is about 0.1% of the composition by weight (claim 193).
Leung’s general disclosure relates to “biologically active solution compositions
comprising one or more sacrificial proteolytic enzyme substrates, one or more preservatives, and
one or more antimicrobial agents and methods of using the solution compositions to treat tissue
sites, in particular chronic wounds” (see, e.g., Leung, abstract). Furthermore, Leung teaches the
use of DispersinB as an antimicrobial agent for prevention or disruption of biofilm formation in
order to counter any bacterial protease activity that may hamper the healing environment, which
allows a tissue site to progress towards an optimal healing state (see, e.g., Leung, [0030],
[0042]). Moreover, Leung teaches that the composition can comprise DispersinB (see, e.g.,
Leung, [0030] & claim 7), polyols (see, e.g., Leung, [0019]), and EDTA (see, e.g., Leung,
[0006], [0012]). Leung discloses that the composition comprises EDTA, which is a preservative and chelator (see, e.g., Leung, [0006], [0012]). Furthermore, Leung teaches that EDTA may act synergistically with the antimicrobial agent (e.g., DispersinB) to kill microbes while preventing further biofilm formation (see, e.g., Leung, [0012]). Furthermore, Leung teaches that EDTA also acts as a stabilizer in the composition (see, e.g., Leung, [0034]).
Regarding claims 190 and 193 pertaining to the amount of EDTA, Leung teaches that
the “compositions may comprise about 0.01% to about 5%, 0.1% to 3%, 0.015% to 1%, 0.015%
to 0.5%, 0.01% to 0.1%, or 0.0225% to 0.1% w/v or about 0.015%, 0.225%, or 0.1% w/v” of
EDTA (see, e.g., Leung, [0029]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising DispersinB, a polyol, and EDTA, as taught by modified-Vejborg-Brin, wherein the amount of EDTA is about 0.01% to about 5% w/v, as taught by Leung. One would have been motivated to do so because Leung teaches compositions comprising DispersinB (see, e.g., Leung, [0030] & claim 7), polyols (see, e.g., Leung, [0019]), and EDTA (see, e.g., Leung, [0006], [0012]), wherein the amount of EDTA is about 0.01% to about 5% (see, e.g., Leung, [0029]) because EDTA can be used to act synergistically with the antimicrobial agent (e.g., DispersinB) to kill microbes while preventing further biofilm formation (see, e.g., Leung, [0012]). Furthermore, Leung teaches that EDTA also acts as a stabilizer in the composition (see, e.g., Leung, [0034]). Moreover, modified-Vejborg-Brin teaches that EDTA can be used as a preservative within film compositions (see, e.g., Brin, [0108]). Therefore, based on the teachings of modified-Vejborg-Brin and Leung, it would have been obvious to produce a composition comprising DispersinB, a polyol, and EDTA because the EDTA would act as a preservative and stabilizer, while also acting synergistically with DispersinB to kill microbes and prevent biofilm formation. One would have expected success because modified-Vejborg-Brin and Leung both teach compositions comprising DispersinB and EDTA for disruption of biofilms.
Claim 191 is rejected under 35 U.S.C. 103 as being unpatentable over Vejborg and Brin as applied to claims 15, 53, 69, 135, 140, 144, 180, and 183-186 above, and further in view of Doyle (US 2012/0148716; Date of Publication: June 14, 2012 – previously cited).
The teachings of Vejborg and Brin, herein referred to as modified-Vejborg-Brin, are
discussed above as it pertains to a method of producing a composition comprising DispersinB and a polyol.
However, modified-Vejborg-Brin does not teach: wherein the levulinic acid is about 1% of the composition by weight (claim 191).
Doyle’s general disclosure relates to “microbicide compositions for reducing a microbial
load of consumable food stuffs” (see, e.g., Doyle, [0002]). Moreover, Doyle discloses that the
antimicrobial compositions “can be used to remove biofilms from a solid surface” wherein the
biofilm is contacted with the antimicrobial composition in an aqueous composition (see, e.g.,
Doyle, [0094]). Furthermore, Doyle discloses the use of levulinic acid within the antimicrobial composition because Doyle found that levulinic acid, when used with a low concentration
surfactant, is effective in reducing viable microbe concentrations by greater than 2 log within 5
minutes of exposure (see, e.g., Doyle, [0055]). Moreover, Doyle discloses that levulinic acid can
be produced at low cost in high yield from renewable feedstocks (see, e.g., Doyle, [0057]).
Regarding claim 191 pertaining to the amount of levulinic acid, Doyle teaches that the
composition comprises 0.3% to 3% levulinic acid by weight per volume (see, e.g., Doyle, [0012]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising DispersinB and a polyol, as taught by modified-Vejborg-Brin, wherein the composition also comprises levulinic acid at an amount of 0.3% to 3% levulinic acid by weight per volume, as taught by Doyle. One would have been motivated to do so because Doyle teaches that levulinic acid, when used with a low concentration surfactant, is effective in reducing viable microbe concentrations by greater than 2 log within 5 minutes of exposure (see, e.g., Doyle, [0055]). Moreover, modified-Vejborg-Brin teaches that compositions comprising DispersinB are used for reducing or preventing biofilm formation caused by poly-N-acetylglucosamine-producing bacteria (see, e.g., Vejborg, pg. 1, lines 20-23). Therefore, based on the teachings of modified-Vejborg-Brin and Doyle, it would have been obvious to produce a composition comprising DispersinB and levulinic acid because both compounds reduce the concentration of viable microbes. One would have expected success because modified-Vejborg-Brin and Doyle both teach anti-biofilm compositions.
Claim 192 is rejected under 35 U.S.C. 103 as being unpatentable over Vejborg and Brin as applied to claims 15, 53, 69, 135, 140, 144, 180, and 183-186 above, and further in view of Mizuki (JP 2018/087161; Date of Publication: June 7, 2018 – previously cited).
The teachings of Vejborg and Brin, herein referred to as modified-Vejborg-Brin, are
discussed above as it pertains to a method of producing a composition comprising DispersinB and a polyol.
However, modified-Vejborg-Brin does not teach: wherein the anisic acid is about 0.1% of the composition by weight (claim 192).
Mizuki’s general disclosure relates to a denture cleaning solution for suppressing a
biofilm, wherein the composition also includes a biofilm inhibitor (see, e.g., Mizuki, English
Translation, “Description”, pg. 1). Additionally, Mizuki discloses that a composition comprising a polyglycerin monoalkyl ether, a chelating agent or salt, and optionally an anionic surfactant is
effective at significantly suppressing biofilms (see, e.g., Mizuki, English Translation,
“Description”, pg. 1). Furthermore, Mizuki teaches that the chelating agent used can be anisic
acid because the chelating agent can be used as a permeation imparting component that changes
the permeability of the cell membrane or biofilm surface of the microorganism, which further
allows the bactericidal agent to penetrate more into the cell (see, e.g., Mizuki, English
Translation, “Biofilm Inhibitor”, pg. 2).
Regarding claim 192 pertaining to the amount of anisic acid, Mizuki teaches “0.0001 to
30% by mass, preferably 0.001 to 10% by mass or 0.001 to 5% by mass with respect to the total
mass of the biofilm inhibitor of the present invention. More preferably 0.003 to 2% by mass, still
more preferably 0.005 to 1.5% by mass, particularly preferably 0.01 to 1.2% by mass, even more
preferably 0.1 to 0.6% by mass. It is appropriate that “If the chelating agent is 0.0001% by mass
or more, a sufficient biofilm suppressing effect can be imparted, and 30% by mass or less is
preferable from the viewpoint of stable blending and usability” (see, e.g., Mizuki, English
Translation, “Biofilm Inhibitor”, pg. 2).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to produce a composition comprising DispersinB and a polyol, as taught by modified-Vejborg-Brin, wherein the composition also comprises anisic acid at a concentration of 0.0001 to 30% by mass, preferably 0.001 to 10% by mass or 0.001 to 5% by mass with respect to the total mass of the biofilm inhibitor of the present invention, as taught by Mizuki. One would have been motivated to do so because Mizuki teaches that anisic acid “If the chelating agent is 0.0001% by mass or more, a sufficient biofilm suppressing effect can be imparted, and 30% by mass or less is preferable from the viewpoint of stable blending and usability” (see, e.g., Mizuki, English Translation, “Biofilm Inhibitor”, pg. 2). Furthermore, Mizuki teaches that the chelating agent used can be anisic acid because the chelating agent can be used as a permeation imparting component that changes the permeability of the cell membrane or biofilm surface of the microorganism, which further allows the bactericidal agent to penetrate more into the cell (see, e.g., Mizuki, English Translation, “Biofilm Inhibitor”, pg. 2). Moreover, modified-Vejborg-Brin teaches anti-biofilm compositions comprising EDTA as a chelating agent that also exhibits preservative effects (see, e.g., Brin, [0108]) (see, e.g., Vejborg, pg. 16, line 36). Therefore, based on the teachings of modified-Vejborg-Brin and Mizuki, it would have been obvious to produce a composition comprising DispersinB, a polyol, and anisic acid because the anisic acid acts as a chelator, which can change the permeability of bacterial cell membranes or biofilm surfaces allowing bactericidal agents to penetrate more into the cell. One would have expected success because modified-Vejborg-Brin and Mizuki both teach anti-biofilm compositions comprising chelating agents.
Examiner’s Response to Arguments
Applicant's arguments filed 01/07/2026 have been fully considered but they are not persuasive.
Applicant’s arguments with respect to claims 69 and 140 (remarks, pages 14-16) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Regarding Applicant’s argument that neither Brin nor Vejborg teach or suggest compositions comprising isomalt or maltitol and DispersinB, nor do Brin and Vejborg teach that polyols can stabilize DispersinB (remarks, page 11), this argument is not persuasive because, as discussed above, Vejborg teaches liquid compositions comprising dispersins, such as DispersinB, wherein the composition comprises polyols for stability (see, e.g., Vejborg, “Description of the Related Art”, pg. 1 & “Liquid Formulations”, pg. 9). Furthermore, Vejborg teaches that enzymes, such as dispersins, may be stabilized using conventional stabilizing agents, such as polyols (see, e.g., Vejborg, “Liquid formulations”, pg. 10, lines 4-7 & “Enzyme stabilizers/inhibitors”, pg. 23, lines 19-23). Furthermore, Brin teaches that polyols, such as isomalt and maltitol, as used within the composition as a stabilizer (see, e.g., Brin, [0093]). Additionally, Brin teaches that the concentration of the polyol is 0.5% to 35% (w/v) (see, e.g., Brin, [0094]).Therefore, based on the teachings of Vejborg and Brin, polyols, such as isomalt and maltitol, are used as stabilizers, and furthermore, Vejborg specifically teaches compositions comprising DispersinB which are stabilized by polyols, such as isomalt and maltitol. Moreover, this is motivation for one of ordinary skill in the art to produce a DispersinB composition comprising polyols since the polyols act as stabilizing agents. Based on these teachings, Applicant’s statement that Vejborg and Brin do not teach compositions comprising isomalt or maltitol and DispersinB, in general, and for stabilization, is incorrect.
Regarding Applicant’s statement that Vejborg and Brin do not teach the use of polyols within a composition with DispersinB for stabilization of DispersinB at higher than ambient temperatures (remarks, page 11), this argument is not persuasive because, as discussed above, the recitation of “…to stabilize the DispersinB at an ambient or higher than ambient temperature…”, is considered an inherent outcome that occurs by following the method steps, as taught by Vejborg and Brin. Therefore, the combined teachings of Vejborg and Brin, which teaches a method of producing a composition comprising a DispersinB and a polyol, such as isomalt or maltitol, wherein the isomalt or maltitol concentration is at 1% or more, would result in the outcome claimed.
Regarding Applicant’s argument that Vejborg and Brin, alone or combined do not recognize that isomalt or maltitol is effective at a stabilizer at a concentration of 1% or higher (remarks, page 12), this argument is not persuasive because, as discussed above, Vejborg teaches that enzymes, such as dispersins, may be stabilized using conventional stabilizing agents, such as polyols (see, e.g., Vejborg, “Liquid formulations”, pg. 10, lines 4-7 & “Enzyme stabilizers/inhibitors”, pg. 23, lines 19-23). Furthermore, Brin teaches that polyols, such as isomalt and maltitol, as used within the composition as a stabilizer (see, e.g., Brin, [0093]). Moreover, Brin teaches that the concentration of the polyol, which is used for stability, is 0.5% to 35% (w/v) (see, e.g., Brin, [0094]). Therefore, one of ordinary skill in the art would understand that 0.5% to 35% (w/v) of a polyol, such as isomalt or maltitol, would result in stabilization.
Regarding Applicant’s argument that Brin’s statement that all polyols have efficacy at all concentrations between 0.5% and 35% (w/v) is incorrect based on the data presented in the present application (remarks, pages 12-13), this argument is not persuasive for multiple reasons:
First, the broadest reasonable interpretation (BRI) of independent claim 15 is a method of preparing a composition comprising DispersinB and a polyol, wherein the polyol is isomalt or maltitol at a concentration of 1% of the composition by weight or higher. Based on the BRI of the instantly claimed invention, any concentration of isomalt or maltitol at or above 1% of the composition or higher would read upon the instantly claimed invention. Furthermore, Brin teaches that the concentration of the polyol, which is used for stability, is 0.5% to 35% (w/v) (see, e.g., Brin, [0094]). Therefore, Brin reads upon this limitation.
Secondly, Applicant’s arguments regarding the data presented in the present application, it is improper to import claim limitations from the specification (see, e.g., MPEP 2111.01(II). Therefore, Applicant’s argument that there are specific concentrations of polyols that are not effective at stabilization of DispersinB is not persuasive because, based on the BRI of the claimed invention, Applicant is claiming all concentrations of isomalt and maltitol at or above 1% (w/v). The Examiner cannot import the limitations pertaining to which concentration(s) of the polyols are effective into the instantly claimed invention.
Thirdly, Applicant’s argument pertaining to the data presented in the present application primarily relies concentrations on glycerol, mannitol, PEG, propylene glycol, xylitol, and erythritol that are not effective at stabilizing DispersinB; however, these polyols are not part of the instantly claimed invention. Therefore, Applicant’s arguments and data are not commensurate in scope with the instantly claimed invention.
Fourthly, Applicant’s arguments that Brin teaches away from the instantly claimed invention since 0.5% (w/v) of isomalt and maltitol is not effective at stabilizing DispersinB is not persuasive for multiple reasons. First, 0.5% maltitol and isomalt were not even tested for DispersinB stabilization in the instantly claimed invention (see, e.g., instant specification, Figures 10 and 12); therefore, Applicant has no evidence for stating that maltitol and isomalt concentrations an 0.5% are not effective at stabilizing DispersinB. Furthermore, MPEP 716.01(c) states that “Arguments presented by the applicant cannot take the place of evidence in the record. In re Schulze, 346 F.2d 600, 602, 145 USPQ 716, 718 (CCPA 1965) and In re De Blauwe, 736 F.2d 699, 705, 222 USPQ 191, 196 (Fed. Cir. 1984)”. Second, MPEP 2121.01(II) states "Even if a reference discloses an inoperative device, it is prior art for all that it teaches." Beckman Instruments v. LKB Produkter AB, 892 F.2d 1547, 1551, 13 USPQ2d 1301, 1304 (Fed. Cir. 1989). Therefore, "a non-enabling reference may qualify as prior art for the purpose of determining obviousness under 35 U.S.C. 103." Symbol Techs. Inc. v. Opticon Inc., 935 F.2d 1569, 1578, 19 USPQ2d 1241, 1247 (Fed. Cir. 1991). Therefore, the reference of Brin, even if not enabling, still reads on the instantly claimed invention because it teaches concentrations of polyols approaching or overlapping the instantly claimed invention (see, e.g., MPEP 2144.05(I)), and Vejborg and Brin teaches that these polyols are effective at stabilizing compositions (see, e.g., Vejborg, “Liquid formulations”, pg. 10, lines 4-7 & “Enzyme stabilizers/inhibitors”, pg. 23, lines 19-23) (see, e.g., Brin, [0093]).
Regarding Applicant’s argument that Brin to a clostridial toxin film disrupting composition and is a different issue than the present application (remarks, page 14), this argument is not persuasive because Brin was relied upon to teach the use of isomalt and maltitol at their respective concentrations for stabilizing active protein(s) within compositions. Vejborg was relied upon to teach compositions comprising DispersinB and polyols, wherein the polyol is used for stabilization (see, e.g., Vejborg, “Liquid formulations”, pg. 10, lines 4-7 & “Enzyme stabilizers/inhibitors”, pg. 23, lines 19-23). Therefore, Vejborg and Brin are analogous art because both teach compositions comprising polyols for stabilizing active proteins within compositions, which is applicable to the instantly claimed invention. Furthermore, it has been held that a prior art reference must either be in the field of the inventor’s endeavor or, if not, then be reasonably pertinent to the particular problem with which the inventor was concerned, in order to be relied upon as a basis for rejection of the claimed invention. See In re Oetiker, 977 F.2d 1443, 24 USPQ2d 1443 (Fed. Cir. 1992).
Regarding Applicant’s argument that Leung does not teach or suggest compositions comprising EDTA and DispersinB, nor does Leung contemplate or suggest the use of EDTA to promote stability of DispersinB (remarks, page 16), this argument is not persuasive for multiple reasons:
First, Applicant recites in their claims that EDTA is used as a preservation agent (see, e.g., instant application, claim 144); therefore, Applicant’s statement in the remarks that EDTA is used to enhance stability of DispersinB is not consistent with the instantly claimed invention. Moreover, modified-Vejborg-Brin teaches that EDTA is used as a preservative within the film composition (see, e.g., Brin, [0108]), and Leung was relied upon to further confirm that EDTA is used as a preservative (see, e.g., Leung, [0006], [0012]) and to teach the concentration of EDTA (see, e.g., Leung, [0029]). Therefore, modified-Vejborg-Brin and Leung read upon the instantly claimed invention.
Secondly, regarding Applicant’s argument that Leung does not teach the amount of EDTA needed in the composition, this argument is not persuasive because, as discussed above, Leung teaches that the “compositions may comprise about 0.01% to about 5%, 0.1% to 3%, 0.015% to 1%, 0.015% to 0.5%, 0.01% to 0.1%, or 0.0225% to 0.1% w/v or about 0.015%, 0.225%, or 0.1% w/v” of EDTA (see, e.g., Leung, [0029]).
Conclusion
Claims 15, 53, 69, 135, 140, 144, 180, and 183-193 are rejected.
No claims are allowed.
Correspondence Information
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/NATALIE IANNUZO/Examiner, Art Unit 1653
/SHARMILA G LANDAU/Supervisory Patent Examiner, Art Unit 1653
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