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 .
Response to Amendment
The amendments made to claims 1, 4, 18, and 19 in the response filed 4/16/26 are acknowledged.
Claims 1-15 and 18-20 are still pending in the application and are examined below.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-15 and 18-20 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 (new reference Bremer has been provided to teach the newly added limitations regarding the tensile modulus of the adhesive).
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claim 18 is rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claim 18, the claim recites the limitation “wherein the first adhesive layer has a 100% tensile modulus of 1.5 N/mm2 or lower… wherein the first adhesive layer has a 100% tensile modulus of 2.5 N/mm2 or lower” in lines 11-13, making it unclear whether the first adhesive layer is claimed to be 1.5 or 2.5 N/mm2 or lower. Therefore, the scope of the claim is unclear. For purposes of compact prosecution and examination, the first adhesive layer is interpreted to have a 100% tensile modulus of 1.5 N/mm2 or lower.
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, 4, 5, 10, and 14 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zedalis et al. US 2009/0107513 A1 in view of Hoerner et al. US 6,020,070 further in view of Luo WO 2016/026256 A1 and Bremer US 2020/0085349 A1.
Regarding claim 1, Zedalis discloses a polyurethane condom ([0002], condom with lubricant; [0087], the condom may include a polyurethane film on each side of the elastomeric layer, making the condom a polyurethane condom), comprising: a first polyurethane film layer; and a second film layer, wherein the second film layer consists of a natural rubber or a polyisoprene resin ([0086], the elastomeric layer of the condom can be natural rubber latex; [0087], the elastomeric layer may comprise a film on one or both surfaces, and the film may be polyurethane).
Zedalis is silent on the condom having an adhesive layer; the adhesive layer on the first polyurethane film layer; and the second film layer on the adhesive layer; wherein the adhesive layer includes 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component, and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component.
However, Hoerner teaches a polyurethane condom having an adhesive layer Z (fig. 2 and col. 5, line 64-col. 6, line 5, the polymeric films are held together using bonding agent Z, and the device is well suited to the preparation of condoms; col. 5, line 44-54, bonding layer Z may be a variety of polymers, forming an adhesive layer; col. 5, lines 31-35, layers E may be polyurethane); the adhesive layer Z on the first polyurethane film layer E (fig. 2, the layer Z below the top layer E, which is a bonding layer as described in col. 5, line 44-54); and an analogous second film layer A on the adhesive layer Z (fig. 2 and col. 3, lines 25-30);
the following presents various interpretations of adhesive layer Z for the purposes of different dependent claims:
FOR THE PURPOSES OF CLAIMS 5, 10, and 13: wherein the adhesive layer Z includes 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component (col. 5, lines 48-63, layer Z can be polyvinyl acetate, which is a resin and a polar component; further, polymer Z can be in an aqueous dispersion of latex, which is a non-polar component; therefore, the polyvinyl acetate and latex must each be present in some quantity between 0 and 100% by weight), and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component (0% hybrid component).
FOR THE PURPOSES OF CLAIM 6: wherein the adhesive layer Z includes 0 to 100% by weight of a polar component (col. 5, lines 48-63, layer Z can be polyvinyl acetate, which is a resin and a polar component, in an organic solvent; thus, the adhesive layer Z in this case is interpreted to be comprised 100% of the polyvinyl acetate and solvent composition), 0 to 100% by weight of a non-polar component (0% non-polar component), and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component (0% hybrid component).
FOR THE PURPOSES OF CLAIM 11: wherein the adhesive layer Z includes 0 to 100% by weight of a polar component (0% polar component), 0 to 100% by weight of a non-polar component (0% non-polar component), and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component (col. 5, lines 48-63, layer Z can be polyvinyl acetate, which is a resin and a polar component; further, polymer Z can be in an aqueous dispersion of latex, which is a non-polar component; therefore, the polyvinyl acetate and latex form a hybrid polar and non-polar component making up 100% of the adhesive layer Z).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the condom of Zedalis with an adhesive layer; the adhesive layer on the first polyurethane film layer; and the second film layer on the adhesive layer; wherein the adhesive layer includes 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component, and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component, as taught by Hoerner, to more securely maintain the first and second layers of the condom together and prevent separation during use.
Zedalis in view of Hoerner is silent on the adhesive layer having a thickness of 0.1 to 30 microns.
However, Luo teaches a condom 1 comprising an adhesive layer 2 (fig. 2 and abstract), wherein the adhesive layer 2 has a thickness of 0.1 to 30 microns (abstract, adhesive film sheets 2 have a thickness of 0.001 mm to 0.1 cm, or 1-100 microns, which includes 1-30 microns).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the adhesive layer of Zedalis in view of Hoerner with a thickness of 0.1 to 30 microns, as taught by Luo, to form a light and unobtrusive part of the condom.
Zedalis in view of Hoerner further in view of Luo is silent on the adhesive layer having a 100% tensile modulus of 1.5 N/mm2 or lower.
However, Bremer teaches an adhesive layer used in adhesive systems for medical devices ([0002]) having a 100% tensile modulus of 1.5 N/mm2 or lower ([0063]-[0066], the multilayer composite adhesive system has a low effective Young’s modulus to deform well to the contours of the body; [0066], the effective elastic modulus of an individual layer of the adhesive system can be less than 100 kPa, or less than 0.1 N/mm2, which is less than 1.5 N/mm2; as illustrated in figs. 1A-C and [0070], the multilayer adhesive system 2800 includes adhesive layer 2830, which is an example of an individual layer of the adhesive system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the adhesive layer of Zedalis in view of Hoerner further in view of Luo to have a 100% tensile modulus of 1.5 N/mm2 or lower, as taught by Bremer, to increase the condom’s ability to deform to the contours of the body when worn.
Regarding claim 4, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Bremer further teaches the adhesive layer having a 100% tensile modulus of 1.2 N/mm2 or lower ([0066], the effective elastic modulus of an individual layer of the adhesive system can be less than 100 kPa, or less than 0.1 N/mm2, which is less than 1.2 N/mm2; as illustrated in figs. 1A-C and [0070], the multilayer adhesive system 2800 includes adhesive layer 2830, which is an example of an individual layer of the adhesive system), to increase the condom’s ability to deform to the contours of the body when worn.
Regarding claim 5, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Hoerner further teaches the polar component being selected from the group consisting of polyurethane resins, neoprene, polyvinyl acetate resins (col. 5, lines 48-49, polymer Z can be polyvinyl acetate, which is a resin), acrylonitrile-butadiene-styrene, vinyl acetate-ethylene copolymer resins, polyacrylates, polyvinyl chlorides, proteins, starches, celluloses, and epoxy resins, and any combinations thereof, to form the adhesive that securely attaches the first and second layers together to prevent separation during use.
Regarding claim 10, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Hoerner further teaches the non-polar component being selected from the group consisting of natural rubbers (col. 5, lines 61-63, latex), polyolefins, silicone resins, butyl rubbers, styrene-butadiene rubbers, ethylene-propylene-diene rubbers, polystyrenes, polyisoprenes, rosin resins, terpene resins, rosin resins and stretched forms thereof, and any combinations thereof, to form the adhesive that securely attaches the first and second layers together to prevent separation during use.
Regarding claim 14, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Hoerner further teaches at least one adhesive layer Z (fig. 2, the layer Z below the top layer E, which is a bonding layer as described in col. 5, line 44-54), to securely attach the first and second layers together to prevent separation during use.
Claim(s) 2 and 3 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zedalis et al. US 2009/0107513 A1 in view of Hoerner et al. US 6,020,070 further in view of Luo WO 2016/026256 A1, Bremer US 2020/0085349 A1, and Hill et al. US 2010/0229873 A1.
Regarding claim 2, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Zedalis in view of Hoerner further in view of Luo and Bremer is silent on a burst pressure of 1 kPa or more, and/or a burst volume of 5 L or more.
However, Hill teaches a condom with a burst pressure of 1 kPa or more ([0035]), and/or a burst volume of 5 L or more.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the condom of Zedalis in view of Hoerner further in view of Luo and Bremer with a burst pressure of 1 kPa or more, and/or a burst volume of 5 L or more, as taught by Hill, to meet the international condom standard ([0011]).
Regarding claim 3, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Zedalis in view of Hoerner further in view of Luo and Bremer is silent on the polyurethane condom having a thickness of 0.010 to 0.080 mm.
However, Hill teaches a condom with a thickness of 0.010 to 0.080 mm ([0023], thickness of 55 microns or less, which is 0.055 mm or less).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the polyurethane condom of Zedalis in view of Hoerner further in view of Luo and Bremer with a thickness of 0.010 to 0.080 mm, as taught by Hill, to provide a better experience for the user.
Claim(s) 6-9 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zedalis et al. US 2009/0107513 A1 in view of Hoerner et al. US 6,020,070 further in view of Luo WO 2016/026256 A1, Bremer US 2020/0085349 A1, and Maehama et al. WO 2010/095665 A1.
Regarding claim 6, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Hoerner further teaches the adhesive layer Z including 100% by weight of the polar component (as discussed above in claim 1, col. 5, lines 48-63, layer Z can be polyvinyl acetate, which is a resin and a polar component, in an organic solvent; thus, the adhesive layer Z in this case is interpreted to be comprised 100% of the polyvinyl acetate and solvent composition, which forms the polar component), to form the adhesive that securely attaches the first and second films together to prevent separation during use.
Zedalis in view of Hoerner further in view of Luo and Bremer is silent on the polar component being a polyurethane resin.
However, Maehama teaches an analogous resin composition used in adhesives (p. 2 of translation, polyurethane used in adhesives) being a polyurethane resin (p. 3, aqueous polyurethane resin composition).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have substituted the polyvinyl acetate resin of Zedalis in view of Hoerner further in view of Luo and Bremer with a polyurethane resin, as taught by Maehama, which exhibits excellent mechanical properties (p. 15).
Regarding claim 7, Zedalis in view of Hoerner further in view of Luo, Bremer, and Maehama discloses the claimed invention as discussed above.
Maehama further teaches the polyurethane resin being selected from the group consisting of anionic, cationic, nonionic, and amphoteric waterborne polyurethanes (p. 6, aqueous polyurethane resin with anionic hydrophilic group such as a carboxylic acid or sulfonic acid group), or solvent-based and solvent-free polyurethanes, and any combinations thereof, resulting in a composition that exhibits excellent mechanical properties (p. 15).
Regarding claim 8, Zedalis in view of Hoerner further in view of Luo, Bremer, and Maehama discloses the claimed invention as discussed above.
Maehama further teaches the polyurethane resin being selected from the group consisting of polyether-based, polyester-based, and polyether-polyester hybrid polyurethane resins, and any combinations thereof (p. 9-10, the polymer polyhydroxy compound includes polyester polyol, polyether polyol, or a mixture of both), resulting in a composition that exhibits excellent mechanical properties (p. 15).
Regarding claim 9, Zedalis in view of Hoerner further in view of Luo, Bremer, and Maehama discloses the claimed invention as discussed above.
Maehama further teaches the anionic waterborne polyurethane being a carboxylic acid-based polyurethane, a sulfonic acid-based polyurethane (p. 6, aqueous polyurethane resin with anionic hydrophilic group such as a carboxylic acid or sulfonic acid group), or a mixture of both, resulting in a composition that exhibits excellent mechanical properties (p. 15).
Claim(s) 11 and 12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zedalis et al. US 2009/0107513 A1 in view of Hoerner et al. US 6,020,070 further in view of Luo WO 2016/026256 A1, Bremer US 2020/0085349 A1, and Maruyama et al. US 4,567,221.
Regarding claims 11 and 12, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Zedalis in view of Hoerner further in view of Luo and Bremer is silent on the polar and non-polar hybrid component being selected from an organically modified polar or non-polar polymeric material, wherein the organic modification is selected from the group consisting of organosilicon modification, organofluorine modification, silane modification, acrylate copolymerization modification, vinyl modification, aromatic monomer modification, polyether modification, polyester modification, isocyanate modification, amination, carboxylation, hydroxylation, epoxidation, sulfonation, and polymerization modification, and any combinations thereof.
However, Maruyama teaches an analogous adhesive (col. 6, lines 53-59, modified polyvinyl acetate suitable for use as adhesive; as discussed above in claim 1, Hoerner discloses the polar component of the adhesive Z being polyvinyl acetate), the polar and non-polar hybrid component being selected from an organically modified polar or non-polar polymeric material (col. 2, line 10, modified PVA having a silyl group; thus, in combination, Hoerner’s polar and non-polar hybrid component Z comprises organically modified PVA as the polar component), wherein the organic modification is selected from the group consisting of organosilicon modification, organofluorine modification, silane modification, acrylate copolymerization modification, vinyl modification, aromatic monomer modification, polyether modification, polyester modification, isocyanate modification, amination, carboxylation, hydroxylation (col. 2, lines 42-46, modified PVA containing carboxyl or hydroxyl group by post-modification using silylating agent), epoxidation, sulfonation, and polymerization modification, and any combinations thereof.
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the polar and non-polar hybrid component of Zedalis in view of Hoerner further in view of Luo and Bremer to be selected from an organically modified polar or non-polar polymeric material, wherein the organic modification is selected from the group consisting of organosilicon modification, organofluorine modification, silane modification, acrylate copolymerization modification, vinyl modification, aromatic monomer modification, polyether modification, polyester modification, isocyanate modification, amination, carboxylation, hydroxylation, epoxidation, sulfonation, and polymerization modification, and any combinations thereof, as taught by Maruyama, to provide water resistance (col. 1, line 66-col. 2, line 1), making the adhesive more durable.
Claim(s) 13 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zedalis et al. US 2009/0107513 A1 in view of Hoerner et al. US 6,020,070 further in view of Luo WO 2016/026256 A1, Bremer US 2020/0085349 A1, and Karisson US 4,941,938.
Regarding claim 13, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Zedalis in view of Hoerner further in view of Luo and Bremer is silent on the adhesive layer including 50% by weight of the polar component and 50% by weight of the non-polar component.
However, Karisson teaches an analogous adhesive comprising polyvinyl acetate as an aqueous dispersion (col. 2, lines 38-48; analogous to Hoerner’s adhesive layer Z comprising polar polyvinyl acetate in nonpolar aqueous latex), wherein the composition comprises 50% by weight of polyvinyl acetate in the aqueous dispersion (col. 2, lines 46-48, 20-80% by weight of the dry content).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the polar component and non-polar component of Zedalis in view of Hoerner further in view of Luo and Bremer such that the adhesive layer includes 50% by weight of the polar component and 50% by weight of the non-polar component, as taught by Karisson, to form an adhesive appropriate for lamination where demands on strength under load are not particularly emphasized (col. 2, lines 49-54).
Claim(s) 15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zedalis et al. US 2009/0107513 A1 in view of Hoerner et al. US 6,020,070 further in view of Luo WO 2016/026256 A1, Bremer US 2020/0085349 A1, and Igarashi GB 2252528 A.
Regarding claim 15, Zedalis in view of Hoerner further in view of Luo and Bremer discloses the claimed invention as discussed above.
Zedalis in view of Hoerner further in view of Luo and Bremer is silent on the second film layer having a 100% tensile modulus of 1 N/mm2 or lower.
However, Igarashi teaches a dressing having a film layer 1 (abstract), wherein the film layer has a 100% tensile modulus of 1 N/mm2 or lower (p. 7, film 1 can have a 100% modulus of 10 kg/cm2, or about 0.98 N/mm2).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the second film layer of Zedalis in view of Hoerner further in view of Luo and Bremer to have a 100% modulus of 1 N/mm2 or lower, as taught by Igarashi, so that the condom is sufficiently flexible and comfortable to wear.
Claim(s) 18 is/are rejected under 35 U.S.C. 103 as being unpatentable over Zedalis et al. US 2009/0107513 A1 in view of Hoerner et al. US 6,020,070 further in view of Luo WO 2016/026256 A1, Bremer US 2020/0085349 A1, and Hill et al. US 2010/0229873 A1.
Regarding claim 18, Zedalis discloses a polyurethane condom ([0002], condom with lubricant; [0087], the condom may include a polyurethane film on each side of the elastomeric layer, making the condom a polyurethane condom), comprising: a first polyurethane film layer; a second film layer; and a third polyurethane film layer, the third polyurethane film layer having the same structure as that of the first polyurethane film layer ([0086], the elastomeric layer of the condom can be natural rubber latex, which is the second film layer; [0087], the elastomeric layer may comprise a film on both surfaces, and the films may be polyurethane, which are the first and third polyurethane film layers; since both polyurethane layers are films on opposite sides of the elastomeric layer, they can be considered as having the same structure as each other); wherein the second film layer consists of a natural rubber or a polyisoprene resin ([0086], the elastomeric layer of the condom can be natural rubber latex).
Zedalis is silent on a first adhesive layer on the first polyurethane film layer; the second film layer being on the first adhesive layer; a second adhesive layer on the second film layer, the second adhesive layer having the same structure as that of the first adhesive layer; wherein the first adhesive layer includes 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component, and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component.
However, Hoerner teaches a polyurethane condom (fig. 2 and col. 5, line 64-col. 6, line 5, the polymeric films are held together using bonding agent Z, and the device is well suited to the preparation of condoms; col. 5, line 44-54, bonding layer Z may be a variety of polymers, forming an adhesive layer; col. 5, lines 31-35, layers E may be polyurethane) having a first adhesive layer Z on the first polyurethane film layer E (fig. 2, the layer Z below the top layer E, which is a bonding layer as described in col. 5, line 44-54); an analogous second film layer A on the first adhesive layer Z (fig. 2 and col. 3, lines 25-30); a second adhesive layer Z on the second film layer A, the second adhesive layer Z having the same structure as that of the first adhesive layer Z (fig. 2, the layer Z below layer A, which is the same structure as that of the first adhesive layer, as indicated by the common reference Z); wherein the first adhesive layer Z includes 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component (col. 5, lines 48-63, layer Z can be polyvinyl acetate, which is a resin and a polar component; further, polymer Z can be in an aqueous dispersion of latex, which is a non-polar component; therefore, the polyvinyl acetate and latex must each be present in some quantity between 0 and 100% by weight), and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component (0% hybrid component).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the condom of Zedalis with a first adhesive layer on the first polyurethane film layer; the second film layer being on the first adhesive layer; a second adhesive layer on the second film layer, the second adhesive layer having the same structure as that of the first adhesive layer; wherein the first adhesive layer includes 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component, and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component, as taught by Hoerner, to more securely maintain the first, second, and third layers of the condom together and prevent separation during use.
Zedalis in view of Hoerner is silent on the first adhesive layer having a thickness of 0.1 to 30 microns.
However, Luo teaches a condom 1 comprising an adhesive layer 2 (fig. 2 and abstract), wherein the adhesive layer 2 has a thickness of 0.1 to 30 microns (abstract, adhesive film sheets 2 have a thickness of 0.001 mm to 0.1 cm, or 1-100 microns, which includes 1-30 microns).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the first adhesive layer of Zedalis in view of Hoerner with a thickness of 0.1 to 30 microns, as taught by Luo, to form a light and unobtrusive part of the condom.
Zedalis in view of Hoerner further in view of Luo is silent on the adhesive layer having a 100% tensile modulus of 1.5 N/mm2 or lower.
However, Bremer teaches an adhesive layer used in adhesive systems for medical devices ([0002]) having a 100% tensile modulus of 1.5 N/mm2 or lower ([0063]-[0066], the multilayer composite adhesive system has a low effective Young’s modulus to deform well to the contours of the body; [0066], the effective elastic modulus of an individual layer of the adhesive system can be less than 100 kPa, or less than 0.1 N/mm2, which is less than 1.5 N/mm2; as illustrated in figs. 1A-C and [0070], the multilayer adhesive system 2800 includes adhesive layer 2830, which is an example of an individual layer of the adhesive system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the adhesive layer of Zedalis in view of Hoerner further in view of Luo to have a 100% tensile modulus of 1.5 N/mm2 or lower, as taught by Bremer, to increase the condom’s ability to deform to the contours of the body when worn.
Zedalis in view of Hoerner further in view of Luo and Bremer is silent on the polyurethane condom having a thickness of 0.010 to 0.080 mm.
However, Hill teaches a condom with a thickness of 0.010 to 0.080 mm ([0023], thickness of 55 microns or less, which is 0.055 mm or less).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the polyurethane condom of Zedalis in view of Hoerner further in view of Luo and Bremer with a thickness of 0.010 to 0.080 mm, as taught by Hill, to provide a better experience for the user.
Claim(s) 19 and 20 is/are rejected under 35 U.S.C. 103 as being unpatentable over Yu et al. US 2005/0066414 A1 in view of Ra KR 20070110996A further in view of Hoerner et al. US 6,020,070, Luo WO 2016/026256 A1, and Bremer US 2020/0085349 A1.
Regarding claim 19, Yu discloses a method for preparing a polyurethane glove having an adhesive layer ([0001], easily donnable glove; [0079], the laminate layer may be polyurethane; [0080], after application of the first laminate layer, the former can be dipped in adhesive prior to application of the next laminate layer), comprising the steps of:
dipping in a polyurethane resin to form a first polyurethane film layer ([0079], ceramic former is dipped to form a laminate layer, where the laminate layer can be polyurethane, which is a resin);
dipping in an adhesive layer material to form the adhesive layer on the first polyurethane film layer ([0080], after application of the first laminate layer, the former may be immersed in an adhesive dip, which would form an adhesive layer);
dipping in a second film layer material to form a second film layer on the adhesive layer, wherein the second film layer consists of a natural rubber or a polyisoprene resin ([0080], another laminate layer is applied after the adhesive dip; [0079], the laminate material may be natural rubber latex);
dipping in a release agent to apply the release agent on the second film layer, followed by demolding to obtain the polyurethane condom having the adhesive layer ([0081], the glove is dipped in a silicon emulsion to improve removal from the former (i.e., demolding)).
Yu is silent on the method being a method for preparing a condom; each dipping step followed by drying; conducting electrical testing.
However, Ra teaches a method for preparing a glove or a condom (p. 2, making medical gloves and condoms); each dipping step followed by drying (p. 8, dipping/drying in latex is twice repeated to form a stable film for the condom; thus, Ra teaches the concept of drying after each dip); conducting electrical testing (p. 8-9, electrical testing is carried to inspect the condoms).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the method of Yu to be a method for preparing a condom; each dipping step followed by drying; conducting electrical testing, as taught by Ra, as condoms and gloves are known in the art to be interchangeably manufactured, since they are both elastic and sterile barrier articles; further, drying after each dip would allow each layer to fully form without blending into the next, creating a more stable barrier; lastly, conducting electrical testing would ensure integrity of each article.
Yu in view of Ra is silent on the adhesive layer including 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component, and 0 to 100% by weight of a material composed of polar and non-polar hybrid component.
However, Hoerner teaches a polyurethane condom having an adhesive layer Z (fig. 2 and col. 5, line 64-col. 6, line 5, the polymeric films are held together using bonding agent Z, and the device is well suited to the preparation of condoms; col. 5, line 44-54, bonding layer Z may be a variety of polymers, forming an adhesive layer; col. 5, lines 31-35, layers E may be polyurethane), wherein the adhesive layer Z includes 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component (col. 5, lines 48-63, layer Z can be polyvinyl acetate, which is a resin and a polar component; further, polymer Z can be in an aqueous dispersion of latex, which is a non-polar component; therefore, the polyvinyl acetate and latex must each be present in some quantity between 0 and 100% by weight), and 0 to 100% by weight of a material composed of a polar and non-polar hybrid component (0% hybrid component).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the adhesive layer of Yu in view of Ra to include 0 to 100% by weight of a polar component, 0 to 100% by weight of a non-polar component, and 0 to 100% by weight of a material composed of polar and non-polar hybrid component, as taught by Hoerner, to enable adequate adhesion to both polar and non-polar laminate materials.
Yu in view of Ra further in view of Hoerner is silent on the adhesive layer having a thickness of 0.1 to 30 microns.
However, Luo teaches a condom 1 comprising an adhesive layer 2 (fig. 2 and abstract), wherein the adhesive layer 2 has a thickness of 0.1 to 30 microns (abstract, adhesive film sheets 2 have a thickness of 0.001 mm to 0.1 cm, or 1-100 microns, which includes 1-30 microns).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have provided the adhesive layer of Yu in view of Ra further in view of Hoerner with a thickness of 0.1 to 30 microns, as taught by Luo, to form a light and unobtrusive part of the condom.
Yu in view of Ra further in view of Hoerner and Luo is silent on the adhesive layer having a 100% tensile modulus of 1.5 N/mm2 or lower.
However, Bremer teaches an adhesive layer used in adhesive systems for medical devices ([0002]) having a 100% tensile modulus of 1.5 N/mm2 or lower ([0063]-[0066], the multilayer composite adhesive system has a low effective Young’s modulus to deform well to the contours of the body; [0066], the effective elastic modulus of an individual layer of the adhesive system can be less than 100 kPa, or less than 0.1 N/mm2, which is less than 1.5 N/mm2; as illustrated in figs. 1A-C and [0070], the multilayer adhesive system 2800 includes adhesive layer 2830, which is an example of an individual layer of the adhesive system).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the invention to have modified the adhesive layer of Yu in view of Ra further in view of Hoerner and Luo to have a 100% tensile modulus of 1.5 N/mm2 or lower, as taught by Bremer, to increase the condom’s ability to deform to the contours of the body when worn.
Regarding claim 20, Yu in view of Ra further in view of Hoerner, Luo, and Bremer discloses the claimed invention as discussed above.
Yu in view of Ra further teach in combination the dipping in the polyurethane resin being carried out by dipping a mold (disclosed by Yu as discussed above in claim 19) composed of glass or a thermoplastic polymer in the polyurethane resin (p. 8 of Ra, the condom shaped mold is glass), to provide a durable mold for the repeated dipping process.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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/MICHELLE J LEE/ Primary Examiner, Art Unit 3786
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