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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/02/2025 has been entered.
Response to Arguments
Applicant's arguments filed 12/02/2025 have been fully considered but they are not persuasive. Applicant argues that none of the cited references teach “wherein the each of the hydrophobic particles is spherical. However, Aizenberg teaches that the hydrophobic particles are spherical (Fig 21B ¶[0203]) as set forth in the rejection below for claim 1. Furthermore, the particles taught by Aizenberg in ¶[0125][0136] comprise the same metal oxides claimed by Applicant in claim 12 and disclosed in page 4 ln 30-31 of the instant specification, and thus the particles taught by Aizenberg would necessarily have the same spherical properties as Applicant’s claimed particles.
Applicant further argues that the combination of Andersen/Aizenberg/Dubrow is improper because Dubrow teaches nanofibers rather than particles. However, the combination of Andersen/Aizenberg is not being modified by Dubrow to teach nanofibers, and is instead being used merely to teach regions having different hydrophobicity, as set forth in the rejection of claim 1 in order to include a continuous wickable flow-path for one or more fluid (Dubrow ¶[0010]).
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 1-3, 5, 8-9, 12-13, and 17-22 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (US 20050065485 A1) in view of Aizenberg (US 20150175814 A1), further in view of Dubrow (US 20060159916 A1).
Regarding Claim 1, Andersen discloses an ostomy pouch (Bag 1, Fig 1-2) having a pair of opposed side walls (front wall 2, rear wall 3, Fig 1-2), one of the side walls defining a stoma-receiving opening for, in use, receiving a part of a stoma (rear wall 3 has an inlet opening 4 to receive a stoma, Fig 1-2), one or both of the side walls being formed of a polymeric film (¶[0035-0036]) at least partially coated on an internal surface thereof with hydrophobic particles (Figs 1 and 2 show areas 6 and 7 disposed on the interior surface of walls 2 and 3, comprising a coating reducing the surface friction coefficient ¶[0042-0043]), wherein the first and second regions of the polymeric film are each coated with the hydrophobic particles (Fig 2 shows areas 6 and 7 disposed on the interior surface of wall 3, comprising a coating reducing the surface friction coefficient ¶[0042-0043]).
Andersen is silent whether the hydrophobic particles comprise: a metal oxide core; and a hydrocarbon chain having from 2 to 40 carbon atoms, wherein the hydrocarbon chain is chemically bound to the metal oxide core, wherein the hydrophobicity of the polymeric film is tuned at different regions across the internal surface such that a first region of the polymeric film has an associated first water contact angle measurement and a second region of the polymeric film has an associated second water contact angle measurement which differs from the first water contact angle measurement.
Aizenberg teaches a hydrophobic surface based on a metal containing compound, thus from the same field of endeavor, wherein the hydrophobic particles (arrangement 100, Fig 1; ¶ [0203], The hypothesis behind this observation is that the PPG micelles encapsulate the alumina particles when dispersed into the alumina sol-gel … The micelle-like structures are shown in FIG. 21A. A representation of hypothesized mechanism that leads to micelle formation is illustrated in FIG. 21B (the alumina particles are shown in gray) comprise: a metal oxide core (solid surface 110 including surface features 115 may comprise metal oxides, Fig 1 ¶[0020][0101]); and a hydrocarbon chain having from 2 to 40 carbon atoms (Liquid B 120 is bonded to solid surface 110 and may comprise hydrocarbon chains of up to 14 carbon atoms or more than 15 carbon atoms, Fig 1 ¶[0100]), wherein the hydrocarbon chain is chemically bound to the metal oxide core (solid surface 110 including surface features 115 may have a chemical affinity with liquid B 120, Fig 1 ¶[0109]), wherein each of the hydrophobic particles is spherical (Fig 21B ¶[0203] As a result of calcination at elevated temperatures, the PPG is removed and individual (or aggregated) particles fuse together within each micelle to form spherical structures. A representation of hypothesized mechanism that leads to micelle formation is illustrated in FIG. 21B (the alumina particles are shown in gray)) in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (¶[0159]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Andersen so that the hydrophobic particles comprise: a metal oxide core; and a hydrocarbon chain having from 2 to 40 carbon atoms, wherein the hydrocarbon chain is chemically bound to the metal oxide core, as taught by Aizenberg in order to create superhydrophobic surfaces, reducing pinning and sticking to the interior of the ostomy bag (as motivated by Aizenberg ¶[0159]).
Andersen/Aizenberg is silent whether the hydrophobicity of the polymeric film is tuned at different regions across the internal surface such that a first region of the polymeric film has an associated first water contact angle measurement and a second region of the polymeric film has an associated second water contact angle measurement which differs from the first water contact angle measurement.
However, Dubrow teaches surface coatings for medical devices (¶[0009]), thus from the same field of endeavor, wherein the hydrophobicity of the polymeric film is tuned at different regions across the internal surface such that a first region of the polymeric film has an associated first water contact angle measurement and a second region of the polymeric film has an associated second water contact angle measurement which differs from the first water contact angle measurement (¶[0010] the invention comprises a substrate which comprises a microarray comprising a first and at least a second region (each region comprising at least a first surface and a plurality of nanofibers attached to the first surface and one or more specific moiety attached to one or more member of the plurality of nanofibers). In such embodiments, the first region can comprise a different specific moiety than the second region (or indeed each separate region can comprise different moieties. The at least third region (whether or not it comprises a similar, greater, or lesser amount or density of nanofibers than the first and at least second regions) comprises a hydrophobicity/hydrophilicity polarity opposite to a hydrophobicity/hydrophilicity polarity of the nanofibers of the first and at least second regions, thus providing a barrier region between the first and second regions. Such substrates can also comprise wherein the third region comprises nanofibers having one or more hydrophobic or hydrophilic moiety (e.g., a moiety which in of itself is hydrophobic or hydrophilic or is lipophobic or lipophilic or is amphiphobic or amphiphilic or which confers such property upon the nanofibers). Other embodiments comprise wherein the property is super-hydrophobicity, super-lipophobicity or super-amphiphobicity.) in order to include a continuous wickable flow-path for one or more fluid (¶[0010]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Andersen/Aizenberg so that the hydrophobicity of the polymeric film is tuned at different regions across the internal surface such that a first region of the polymeric film has an associated first water contact angle measurement and a second region of the polymeric film has an associated second water contact angle measurement which differs from the first water contact angle measurement because it would have been obvious to try based on the teachings of Dubrow in order to include a continuous wickable flow-path for one or more fluid (¶[0010])
and because there are a finite number of possible solutions (1. The different regions of polymeric film have the same hydrophobicity; and 2. The different regions of polymeric film have a different hydrophobicity). One of ordinary skill would recognize the reasonable expectation of success of including a continuous wickable flow-path for one or more fluid (as motivated by Dubrow ¶[0010]).
.
Regarding Claim 2, Anderson/Aizenberg/Dubrow discloses that the side wall defining the stoma-receiving opening is formed of the polymeric film (rear wall 3 comprising inlet opening 4 to receive a stoma may be formed of a polymeric film, Fig 1-2 ¶[0035-0036]) and comprises a first region which at least partially surrounds or surrounds the stoma-receiving opening (area 7, Fig 2), wherein the first region is coated with the hydrophobic particles (Fig 2 shows area 7 disposed on the interior surface of wall 3, comprising a coating reducing the surface friction coefficient ¶[0042-0043]).
Regarding Claim 3, Anderson/Aizenberg/Dubrow discloses that the side wall opposing the side wall defining the stoma-receiving opening is formed of the polymeric film (front wall 2 is formed of a polymeric film, Fig 1-2 ¶[0035-0036]) and comprises a second region which substantially faces the stoma- receiving opening (area 6 faces inlet opening 4, Figs 1-2), wherein the second region is coated with the hydrophobic particles (Fig 2 shows area 6 disposed on the interior surface of wall 2, comprising a coating reducing the surface friction coefficient ¶[0042-0043]).
Regarding Claim 5, Anderson/Aizenberg/Dubrow discloses that the diameter of the second region is equal to the diameter of the first region (Anderson envisions that both areas 6 and 7 may cover the entire interior surfaces of walls 2 and 3, respectively, and thus the diameters of areas 6 and 7 would have equal diameters, Fig 2 ¶[0017-0018]).
Regarding Claim 8, Anderson/Aizenberg/Dubrow discloses that both side walls are formed of the polymeric film (walls 2 and 3 are formed of a polymeric film, Fig 1-2 ¶[0035-0036]) and the entire internal surfaces thereof are coated with the hydrophobic particles (Anderson envisions that both areas 6 and 7 may cover the entire interior surfaces of walls 2 and 3, respectively, Fig 2 ¶[0017-0018]).
Regarding Claim 9, Anderson/Dubrow is silent whether the average diameter of the hydrophobic particles is less than or equal to 200 nm; or wherein the average diameter of the hydrophobic particles is less than or equal to 50 nm; or wherein the average diameter of the hydrophobic particles is from 8 nm to 20 nm.
However, Aizenberg teaches a hydrophobic surface based on a metal containing compound, thus from the same field of endeavor, wherein the average diameter of the hydrophobic particles is less than or equal to 200 nm; or wherein the average diameter of the hydrophobic particles is less than or equal to 50 nm; or wherein the average diameter of the hydrophobic particles is from 8 nm to 20 nm (porous metal-containing layer has a thickness in the range of 10 nm-1000 µm, thus the hydrophobic particles may have a diameter of 10 nm-200 nm ¶[0015]) in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (¶[0159]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson/Dubrow so that the average diameter of the hydrophobic particles is less than or equal to 200 nm; or wherein the average diameter of the hydrophobic particles is less than or equal to 50 nm; or wherein the average diameter of the hydrophobic particles is from 8 nm to 20 nm as taught by Aizenberg in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (as motivated by Aizenberg ¶[0159]).
Regarding Claim 12, Anderson/Dubrow is silent whether the metal oxide core comprises one or a combination of aluminum oxide, iron oxide, zinc oxide, and silicon oxide.
However, Aizenberg teaches a hydrophobic surface based on a metal containing compound, thus from the same field of endeavor, wherein the metal oxide core comprises aluminum oxide, iron oxide, zinc oxide, and silicon oxide (¶[0125][0136]) in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (¶[0159]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to modify the device of Anderson/Dubrow so that the metal oxide core comprises aluminum oxide, as taught by Aizenberg in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (as motivated by Aizenberg ¶[0159]).
Regarding Claim 13, Anderson/Dubrow is silent whether the hydrocarbon chain is aliphatic.
However, Aizenberg teaches a hydrophobic surface based on a metal containing compound, thus from the same field of endeavor, wherein the hydrocarbon chain is aliphatic (possible hydrocarbon chains envisioned include various low molecular weight (up to C14) hydrocarbons (e.g. smokeless paraffin, Isopar.TM.) long-chain (C15 or higher) alkyl petroleum oils or "white oils" (e.g. paraffin oils, linear or branched paraffins, which would be aliphatic hydrocarbon chains ¶[0100]) in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (¶[0159]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson/Dubrow so that the hydrocarbon chain is aliphatic as taught by Aizenberg in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (as motivated by Aizenberg ¶[0159]).
Regarding Claim 17, Anderson/Dubrow is silent whether the hydrocarbon chain is covalently bound to the metal oxide core via a functional group.
However, Aizenberg teaches a hydrophobic surface based on a metal containing compound, thus from the same field of endeavor, wherein the hydrocarbon chain is covalently bound to the metal oxide core via a functional group (the surface nano-structure, which comprises the metal oxide core, is chemically functionalized to provide the desired chemical affinity to Liquid B, which comprises the hydrocarbon chain ¶[0100-0101][0126][0130-0131]) in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (¶[0159]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson/Dubrow so that the hydrocarbon chain is covalently bound to the metal oxide core via a functional group, as taught by Aizenberg in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (as motivated by Aizenberg ¶[0159]).
Regarding Claim 18, Anderson/Dubrow is silent whether the functional group comprises any one or a combination of hydroxide, carboxylate, phosphonate, phosphinate, thiolate and thiocarboxylate.
However, Aizenberg teaches a hydrophobic surface based on a metal containing compound, thus from the same field of endeavor, wherein the functional group comprises any one or a combination of hydroxide, carboxylate, phosphonate, phosphinate, thiolate and thiocarboxylate (the metal containing surface can be further functionalized for the appropriate compatibility with the lubricating liquid (e.g., using silane, thiol, carboxylate, phosphonate, phosphate, etc.) ¶[0133][0139]) in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (¶[0159]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson/Dubrow so that the functional group comprises any one or a combination of hydroxide, carboxylate, phosphonate, phosphinate, thiolate and thiocarboxylate, as taught by Aizenberg in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (as motivated by Aizenberg ¶[0159]).
Regarding Claim 19, Anderson/Dubrow is silent whether wherein the hydrophobic particles are free from fluorine.
However, Aizenberg teaches a hydrophobic surface based on a metal containing compound, thus from the same field of endeavor, wherein the hydrophobic particles are free from fluorine (while Aizenberg mentions particles that include fluorine (¶[0100]), hydrophobic particles free from fluorine are also envisioned ¶[0100][0125][0139]) in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (¶[0159]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson/Dubrow so that the hydrophobic particles are free from fluorine as taught by Aizenberg in order to create superhydrophobic surfaces, reducing pinning and sticking to the surface (as motivated by Aizenberg ¶[0159]).
Regarding Claims 20-21, Anderson/Aizenberg/Dubrow discloses that the polymeric film comprises a thermoplastic film (front and rear walls of bag 1 are heat sealable films, and thus are thermoplastic ¶[0036]), wherein the thermoplastic film comprises polyolefin, vinyl polymer or polyacetal film (films may be polyolefin films such as polyethylene or a coextrudate of polyethylene and polyvinylidene chloride, ¶[0036]).
Regarding Claim 22, Anderson/Aizenberg/Dubrow discloses that the thermoplastic film comprises a co-extruded bilayer film (films may be a coextrudate of polyethylene and polyvinylidene chloride, ¶[0036]).
Claims 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Andersen (US 20050065485 A1) in view of Aizenberg (US 20150175814 A1), in view of Dubrow (US 20060159916 A1)
further in view of Imai (US 20150175317 A1).
Regarding Claim 24-25, Anderson/Aizenberg/Dubrow is silent whether the hydrophobic particles and the polymeric film are secured to one another by an adhesive, wherein the mass ratio of the hydrophobic particles and the adhesive is from 1.0:1.0 to 2.0:1.0.
However, Imai teaches a hydrophobic cover material, thus from the same field of endeavor, wherein the hydrophobic particles (hydrophobic particles 5, Fig 2 ¶[0086-0088]) and the polymeric film (combination of base material layer 10, film 2, and sealant layer 2 is considered a multilayer film, Figs 1-2 ¶0067[0069][0082-0083]) are secured to one another by an adhesive (binder 6 adhesively fixes hydrophobic particles 5 to the sealant layer 3, Fig 2 ¶[0036]), wherein the mass ratio of the hydrophobic particles and the adhesive is from 1.0:1.0 to 2.0:1.0 (ratio of hydrophobic particles to binder may be 1.5:1 Tables 1-2, ¶[0041][0259]) in order to provide sufficient adhesion prevention properties and film strength (¶[0259]).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device of Anderson/Aizenberg/Dubrow so that he hydrophobic particles and the polymeric film are secured to one another by an adhesive, wherein the mass ratio of the hydrophobic particles and the adhesive is from 1.0:1.0 to 2.0:1.0, as taught by Imai in order to provide sufficient adhesion prevention properties and film strength (as motivated by Imai ¶[0259]).
Conclusion
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TIMOTHY LEE. FLYNN
Examiner
Art Unit 3781
/REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781