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 .
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.
Claim(s) 1-13 and 16-20 are rejected under 35 U.S.C. 103 as being unpatentable over McGlothlin et al. U.S. Publication No. (2006/0173137 A1) in view of Lewis et al. U.S. Publication No. (2015/0202651 A1).
With respect to claim 1, McGlothlin et al. substantially discloses a condom formed from a composition (abstract, “Natural rubber and/or synthetic polyisoprene film products having enhanced tear strength and tensile strength crosslinked) and [0051 thin-walled rubber film products in accordance with this invention are primarily contemplated for direct or indirect contact with living tissue... Examples of these articles are. medical gloves, condoms] prepared by a method comprising:
providing a polymer latex dispersion and adding thereto a plurality of compounding ingredients effective to form a compounding formulation (abstract; and [0094, in a preferred embodiment of the present invention, the natural rubber or cis-1,4-polyisoprene rubber is in the form of a latex. Latices of natural rubber or cis-1,4-polyisoprene are formed by methods known to those skilled in the art of rubber compounding and processing. These methods include either emulsification of an organic solution of the polymer in an aqueous medium] and [0105, in a first embodiment, the temperature of the compounding ingredients may be significantly reduced prior to mixing (e.g., from a temperature from about 32° F. to 75° F.), and the compounded latex may then be stored] and
subjecting the compounding formulation to conditions sufficient to crosslink the polymer latex to a defined cure state and thus provide the composition from which the condom is formed [0114, the technique used for curing in the present invention can be any technique for obtaining complete crosslinking of the polynitrile oxide crosslinking agent with the rubber compound. Curing can take place in a convection oven, forced convection oven, steam chamber, or molten media bath. Additionally, infrared heating or microwave heating techniques may be used, or the film product can remain at room temperature until curing is completed. Thin-walled dip-molded or cast rubber film products can be cured].
McGlothlin et al. substantially discloses the invention as claimed except the method further comprises combining synthetic spider silk with the polymer latex dispersion prior to forming the compounding formulation or combining the synthetic spider silk with the compounding formulation prior to achieving the defined cure state.
Lewis et al. however teaches in an invention relating to film formations, Lewis teaches combining synthetic spider silk with a polymer before a cured state (abstract, “Methods for forming useful films using recombinant spider silk protein are discussed. In one embodiment, the method involves dissolving silk protein in a sufficient quantity to form a film suspended in a solvent... membrane material); in [0209, “50 mg of goat generated M4 (MaSp1 in Nephila clavipes) powder was placed into a 3 mL Wheaton glass vial with PTFE seal inside a plastic lid. Included in the dope solution was-1 mL Nanopure water froma Thermo Fisher brand Barnstead. The plastic lid was then tightened onto the vial in order to prevent leaking. The vial and contents were then microwaved in a 1.6 kW GE household microwave oven for 1 minute. The dope solution was then poured, 200 uL a band, onto 4 bands of Sylgard 182 slicone elastomer Polydimethylsioxane (PDMS) 5:1 base: curing agent measuring 30 times 7 mm and allowed to dehydrate. After drying, the film was cut to 3.5x13 mm and weighed to determine thickness].
In view of the teachings of Lewis et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of McGlothlin et al. by incorporating synthetic spider silk with the polymer latex dispersion prior to form the compounding formulation or combine the synthetic spider silk with the compounding formulation prior to achieving the defined cure state by routine experimentation to optimize the strength of condoms Lewis et al. [0263], “the film product completely capable of full integration into the vast industries discussed herein. As is further evident from the data presented herein, stretching of the films results in increased beta sheet with orientation in direction of the stretch. This attribute explains the substantial increase in the strength of the films”].
With respect to claim 2, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. McGlothlin et al. further discloses the polymer latex comprises natural rubber latex [0037].
With respect to claim 3, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. McGlothlin et al. further discloses the plurality of compounding ingredients are selected from the group consisting of stabilizers [0099], surfactants [0099, anionic surfactants such as salts of alcohol sulfates are known to be useful as mechanical stabilizers and wetting agents in many anionic latexes. Cationic latices, on the hand, typically require cationic or non-ionic surfactants such as quaternary ammonium salts. In one embodiment of the present invention, the rubber may be compounded with a sufficient amount of an anionic surfactant, such as DARVAN.RTM. WAQ (sodium alkyl sulfate) or DARVAN.RTM. SMO surfactant (DARVAN is a registered trademark of Vanderbilt Company, R. T., Inc.). Preferably, the surfactant is in an amount ranging between about 0.2 phr to about 2.0 phr], curing agents [0197], catalysts [0093 Ziegler catalyst consisting of isobutylaluminum and titanium tetrachloride, or alkali metal catalysts such as finely divided lithium metal or organolithium compounds], accelerators [0031 vulcanization accelerators], and antioxidants [0097, Antioxidants, antiozonants, and other additives may be utilized in the film products of the invention. Antioxidants and antiozonants may be included to protect against environmental aging. Preferred antioxidants are hindered phenolic compounds, e.g., 4-{[4,6-bis(octylthio)-s-triazin-2-yl]amino}-2,6-di-t-butyl-phenol, 2,4-bis[(octylthio)methyl]-o-cresol, and polymerized 1,2-dihydro-2,2,4-trimethylquinoline].
With respect to claim 4, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed but did not explicitly disclose the synthetic spider silk is combined with the polymer latex dispersion before addition of any curing agents. McGlothlin et al. however, teaches and fairly suggests in [0100, the rubber compound used in the present invention may be treated with a coagulant prior to curing]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method in like manner, the synthetic spider silk is combined with the polymer latex dispersion before addition of any curing agents in order to prevent premature reaction of the polynitrile oxide with the rubber compound, i.e., prior to the formation of a wet or dry gel of the rubber article. This will prevent the rubber compound from excessive pre-vulcanizing (pre-curing). The inhibition of pre-vulcanization can be done in a number of different ways [0104] of McGlothlin et al.
With respect to claim 5, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed but did not explicitly disclose the synthetic spider silk is combined with the polymer latex dispersion before addition of any catalysts. McGlothlin et al. however, teaches and fairly suggests in [0100, the rubber compound used in the present invention may be treated with a coagulant prior to curing]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method in like manner, the synthetic spider silk is combined with the polymer latex dispersion before addition of any catalysts in order to prevent premature reaction of the polynitrile oxide with the rubber compound, i.e., prior to the formation of a wet or dry gel of the rubber article. This will prevent the rubber compound from excessive pre-vulcanizing (pre-curing). The inhibition of pre-vulcanization can be done in a number of different ways [0104] of McGlothlin et al.
With respect to claim 6, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed but did not explicitly disclose the synthetic spider silk is combined with the polymer latex dispersion before addition of any accelerators. McGlothlin et al. however, teaches and fairly suggests in [0100, the rubber compound used in the present invention may be treated with a coagulant prior to curing]. Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method in like manner, the synthetic spider silk is combined with the polymer latex dispersion before addition of any accelerators in order to prevent premature reaction of the polynitrile oxide with the rubber compound, i.e., prior to the formation of a wet or dry gel of the rubber article. This will prevent the rubber compound from excessive pre-vulcanizing (pre-curing). The inhibition of pre-vulcanization can be done in a number of different ways [0104] of McGlothlin et al.
With respect to claim 7, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. Lewis et al. further teaches the synthetic spider silk is combined with the polymer latex dispersion before completing forming the compounding formulation [Abstract, the method involves dissolving silk protein in a sufficient quantity to form a film suspended in a solvent].
With respect to claim 8, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. Lewis et al. further teaches the conditions sufficient to crosslink the polymer latex to a defined cure state include heating the compounding formulation above room temperature for a defined length of time (Abstract) and [0075].
With respect to claim 9, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. Lewis et al. further teaches the synthetic spider silk is combined with the compounding formulation prior to heating the compounding formulation above room temperature (Abstract, the method involves dissolving silk protein in a sufficient quantity to form a film suspended in a solvent. The solution is then mixed with a compound selected from water, acids, imidazole crosslinking agents, antibiotics, nanoparticles, surfactants and combinations thereof. Solubilisation of the protein in the solution is effected by microwave exposure).
With respect to claim 10, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. Lewis et al. further teaches the synthetic spider silk is combined with the compounding formulation prior to completion of the defined length of time (Abstract, the method involves dissolving silk protein in a sufficient quantity to form a film suspended in a solvent. The solution is then mixed with a compound selected from water, acids, imidazole crosslinking agents, antibiotics, nanoparticles, surfactants and combinations thereof and Solubilisation of the protein in the solution is effected by microwave exposure) and [0075].
With respect to claim 11, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. McGlothlin et al. further discloses the conditions sufficient to crosslink the polymer latex to a defined cure state include holding the compounding formulation at one or more temperatures for a total length of time sufficient to achieve the defined cure state [0114] and [0138].
With respect to claim 12, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. Lewis et al. further teaches the synthetic spider silk is combined with the compounding formulation prior to completion of the defined length of time (Abstract) and [0075].
With respect to claim 13, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. Lewis et al. further teaches the synthetic spider silk is provided as a dispersion [0083].
With respect to claim 16, McGlothlin et al. substantially discloses a condom(abstract, “Natural rubberand/or synthetic polyisoprene film products having enhanced tear strength and tensile strength crosslinked) and [0051, “thin walled rubber film products in accordance with this invention are primarily | contemplated for direct or indirect contact with living tissue... Examples of these articles are medical gloves, condoms"] comprising: at least one layer of a film formed from a compounded polymer latex composition that has been crosslinked to a defined cure state (abstract) and [0094, “In a preferred embodiment of the present invention, the naturalrubberor.cis-1,4-polyisoprenerubberis in the form of a latex. Latices of natural rubber or cis-1,4-polyisoprene are formed by methods known to those skilled in the art of rubber compounding and processing. These methods include either emulsification of an organic solution of the polymer in an aqueous medium) and [0105, “In a first embodiment, the temperature of the compounding ingredients may be significantly reduced prior to mixing (e.g., from a temperature - from about 32° F. to 75° F], and the compounded latex may then be stored”; [0114], “The technique used for curing in the present invention can be any technique for obtaining complete crosslinking of the polynitrile oxide crosslinking agent with the rubber compound. Curing can take place in a convection oven, forced convection oven, steam chamber, or molten media bath. Additionally, infrared heating or microwave heating techniques may be used, or the film product can remain at room temperature until curing is completed. Thin-walled dip-molded or cast rubber film products can be cured”].
McGlothlin et al. substantially discloses the invention as claimed except a synthetic spider silk incorporated therein wherein the synthetic spider silk is effective to impart improved properties to the condom by having been added to the compounded polymer latex composition before reaching the defined cure state.
Lewis et al., however, teaches in an invention relating to film formations, combining synthetic spider silk with a polymer before a cured state (Abstract, “Methods for forming useful films using recombinant spider silk protein are discussed. In one embodiment, the method involves dissolving silk protein in a sufficient quantity to form a film suspended in a solvent... membrane material) and [0209, “50 mg of goat generated M4 (MaSp1 in Nephila clavipes) powder was placed into a 3 mL Wheaton glass vial with PTFE seal inside a plastic lid. Included in the dope solution was 1 mL: Nanopure water from a Thermo Fisher brand Barnstead. The plastic lid was then tightened onto the vial in order to prevent leaking. The vial and contents were then microwaved in a 1.6 kW GE household microwave oven for 1 minute. The dope solution was then poured, 200 uL a band, onto 4 bands of Sylgard 182 slicone elastomer Polydimethylsioxane (PDMS) 5:1 base: curing agent measuring 30x7 mm and allowed to dehydrate. After drying, the film was cut to 3.5x13 mm and weighed to determine thickness].
In view of the teachings of Lewis et al., it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to modify the method of McGlothlin et al. by incorporating a synthetic spider silk effective to impart improved properties to the condom by having been added to the compounded polymer latex composition before reaching the defined cure state by routine experimentation to optimize the strength of condoms, Lewis et al. [0263, “the film product completely capable of full integration into the vast industries : discussed herein. As is further evident from the data presented herein, stretching of the films results in increased beta sheet with orientation in direction of the stretch. This attribute explains the substantial increase in the strength of the films’].
With respect to claim 17, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. McGlothlin et al. further discloses the compounded polymer latex composition comprises natural rubber latex [0037].
With respect to claim 18, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. McGlothlin et al. further discloses the plurality of compounding ingredients are selected from the group consisting of stabilizers [0099], surfactants [0099, anionic surfactants such as salts of alcohol sulfates are known to be useful as mechanical stabilizers and wetting agents in many anionic latexes. Cationic latices, on the hand, typically require cationic or non-ionic surfactants such as quaternary ammonium salts. In one embodiment of the present invention, the rubber may be compounded with a sufficient amount of an anionic surfactant, such as DARVAN.RTM. WAQ (sodium alkyl sulfate) or DARVAN.RTM. SMO surfactant (DARVAN is a registered trademark of Vanderbilt Company, R. T., Inc.). Preferably, the surfactant is in an amount ranging between about 0.2 phr to about 2.0 phr], curing agents [0197], catalysts [0093 Ziegler catalyst consisting of isobutylaluminum and titanium tetrachloride, or alkali metal catalysts such as finely divided lithium metal or organolithium compounds], accelerators [0031 vulcanization accelerators], and antioxidants [0097, Antioxidants, antiozonants, and other additives may be utilized in the film products of the invention. Antioxidants and antiozonants may be included to protect against environmental aging. Preferred antioxidants are hindered phenolic compounds, e.g., 4-{[4,6-bis(octylthio)-s-triazin-2-yl]amino}-2,6-di-t-butyl-phenol, 2,4-bis[(octylthio)methyl]-o-cresol, and polymerized 1,2-dihydro-2,2,4-trimethylquinoline].
With respect to claim 19, the combination of McGlothlin et al./Lewis et al. discloses the synthetic spider silk is effective to impart improved properties to the condom Lewis et al. discloses in [0263, “the film product completely capable of full integration into the vast industries: discussed herein. As is further evident from the data presented herein, stretching of the films results in increased beta sheet with orientation in direction of the stretch. This attribute explains the substantial increase in the strength of the films’] by having been added to the compounded polymer latex composition before subjecting the compounded polymer latex composition to crosslinking conditions [0104] of McGlothlin et al.
With respect to claim 20, the combination of McGlothlin et al./Lewis et al. substantially discloses the invention as claimed. Lewis et al. further teaches the synthetic spider silk added to the compounded polymer latex composition is provided as a dispersion [0083].
Allowable Subject Matter
Claims 14-15 and 21-22 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Reasons for Allowance
The following is an examiner’s statement of reasons for allowance:
The closest prior art drawn to the combination of McGlothlin et al./Lewis et al. fail to show or make obvious the claimed combinations of elements particularly the limitations as set forth in dependent claims 14-15 and 21-22 which recite features not taught or suggested by the prior art drawn to McGlothlin et al./Lewis et al., in combination with the other elements (or steps) of the apparatus and method recited in the claims.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to OPHELIA ALTHEA HAWTHORNE whose telephone number is (571)270-3860. The examiner can normally be reached M-F 8:00 AM-5:00 PM, EST.
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/OPHELIA A HAWTHORNE/Primary Examiner, Art Unit 3786