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
All outstanding objections and rejections, except for those maintained below, are withdrawn in light of applicant’s amendment filed on 5/11/2026.
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior office action.
The new grounds of rejection set forth below are necessitated by applicant’s amendment filed on 5/11/2026. In particular, claim 1 has been amended to incorporate now-canceled claims 3 and 5. This combination of limitations was not present in the original claims. Thus, the following action is properly made final.
Claim Rejections - 35 USC § 102
Claims 8, 9, 12, and 13 rejected under 35 U.S.C. 102(a)(2) as being anticipated by Kodemura (US 2021/0388199).
With respect to claims 8, 9, and 13, Kodemura discloses a latex of a styrene-based block copolymer for use in condoms (paragraph 0097) and exemplifies compositions comprising styrene-isoprene-styrene triblock copolymer (Examples 1-4). The dip-molded product of Example 2 has tensile strength of 30 MPa, 500% tensile stress of 1.4 MPa, tear strength of 34 N/m, and elongation of 1110%. Kodemura teaches that the SIS of Example 2 is pre-crosslinked with a radical polymerization peroxide initiator (paragraph 0127), i.e., the block copolymer is crosslinked to form the latex. Kodemura teaches adding additional crosslinking agents such as sulfur to the latex (paragraph 0081), which is different from the peroxide polymerization initiator used to crosslink the styrene-based block copolymer to form the pre-crosslinking SIS.
With respect to claim 12, Kodemura teaches that the dip molded film has excellent uniformity of film thickness (paragraph 0096).
Claim Rejections - 35 USC § 102/103
Claims 10 and 24-30 are rejected under 35 U.S.C. 102(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Kodemura (US 2021/0388199).
With respect to claim 10, the discussion with respect to Kodemura in paragraph 5 above is incorporated here by reference.
Kodemura teaches that its dip molded articles have high strength (abstract; Table 1; paragraph 0117) but fails to disclose the Young’s modulus of the dip molded articles at 1 Hz and 21.5 Hz. Even so, Kodemura discloses a SIS polymer latex dip molded article having claimed tensile strength, tensile modulus, tear strength, and elongation at break. It is therefore inherent that, e.g., Example 2, has claimed Young’s modulus properties since such properties are evidently dependent upon the nature of the composition used. Case law holds that a material and its properties are inseparable. In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990).
Alternatively, Young’s modulus is representative of tensile properties at low strain (Young’s modulus). Because the SIS is viscoelastic, the dip molded articles made therefrom are expected to exhibit higher Young’s modulus at higher 21.5 Hz compared to at 1 Hz. Because the dip molded article is elastomeric, the Young’s modulus at 1 Hz is expected to be low, i.e., less than 1 MPa.
Given that Kodemura discloses mechanical properties of tensile strength, tensile modulus, tear strength, and elongation at break that are within the claimed ranges and further given that Young’s modulus is representative of mechanical properties at low strain, it would have been obvious to one of ordinary skill in the art to expect or to prepare an elastomeric article having Young’s modulus at 1 and 21.5 Hz of less than 1 MPa and greater than 1 MPa, respectively.
With respect to claims 24 and 26-30, Kodemura discloses a latex of a styrene-based block copolymer for use in condoms (paragraph 0097) and exemplifies compositions comprising styrene-isoprene-styrene triblock copolymer (Examples 1-4). The dip-molded product of Example 2 has tensile strength of 30 MPa, 500% tensile stress of 1.4 MPa, tear strength of 34 N/m, and elongation of 1110%. Kodemura teaches that the SIS of Example 2 is pre-crosslinked (paragraph 0127).
Kodemura does not disclose that the pre-crosslinking is performed under conditions to provide a composition having relaxed modulus of 0.50-0.61 MPa or at specific times and temperatures. Even so, these process limitations are in a product claim. Case law holds that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
Alternatively, in the event any differences can be shown for the product of the product-by-process claims, as opposed to the product taught by Kodemura, such differences would have been obvious to one of ordinary skill in the art as a routine modification of the product in the absence of a showing of unexpected results.
With respect to claim 25, Kodemura teaches that the dip molded film has excellent uniformity of film thickness (paragraph 0096).
Claim Rejections - 35 USC § 103
Claims 1, 2, 4, 6, 7, 11, and 14-23 are rejected under 35 U.S.C. 103 as being unpatentable over Kodemura (US 2021/0388199) in view of De Jong (US 2016/0263780).
With respect to claims 1, 2, and 7, Kodemura discloses a latex of a styrene-based block copolymer for use in dip molded condoms (paragraph 0097) and exemplifies compositions comprising styrene-isoprene-styrene triblock copolymer (Examples 1-4). The dip molded product of Example 2 has tensile strength of 30 MPa, 500% tensile stress of 1.4 MPa, tear strength of 34 N/m, and elongation of 1110%. Kodemura discloses that the composition to prepare the dip molded article includes sulfur as crosslinking agent (i.e., sulfur donor) (paragraph 0081) and a crosslinking accelerator (paragraph 0082).
Kodemura discloses adding a surfactant (paragraph 0050) but fails to disclose that the surfactant is an amphoteric surfactant.
De Jong discloses dipped articles such as condoms prepared from a styrenic block copolymer latex (abstract; paragraphs 0013-0015). The examples include styrene-isoprene block copolymers which are formed into latex with Manawet 172 as surfactant (paragraphs 0031-0032). Manawet 172 is the same amphoteric surfactant used in the examples of the instant specification (Table 1).
Given that Kodemura is open to the use of surfactants and further given that a dip-formed articles comprising styrene-isoprene block copolymer latex with an amphoteric surfactant, it would have been obvious to one of ordinary skill in the art to utilize an amphoteric surfactant in the Kodemura’s composition for dip molding condoms. Case law holds that the selection of a known material based on its suitability for its intended use supports prima facie obviousness. Sinclair & Carroll Co vs. Interchemical Corp., 325 US 327, 65 USPQ 297 (1045).
With respect to claim 4, Kodemura teaches that its dip molded articles have high strength (abstract; Table 1; paragraph 0117) but fails to disclose the Young’s modulus of the dip molded articles at 1 Hz and 21.5 Hz.
Even so, Kodemura discloses a SIS polymer latex dip molded article having claimed tensile strength, tensile modulus, tear strength, and elongation at break. Young’s modulus is representative of tensile properties at low strain (Young’s modulus). Because the SIS is viscoelastic, the dip molded articles made therefrom are expected to exhibit higher Young’s modulus at higher 21.5 Hz compared to at 1 Hz. Because the dip molded article is elastomeric, the Young’s modulus at 1 Hz is expected to be low, i.e., less than 1 MPa.
Given that Kodemura discloses mechanical properties of tensile strength, tensile modulus, tear strength, and elongation at break that are within the claimed ranges and further given that Young’s modulus is representative of mechanical properties at low strain, it would have been obvious to one of ordinary skill in the art to expect or to prepare an elastomeric article having Young’s modulus at 1 and 21.5 Hz of less than 1 MPa and greater than 1 MPa, respectively.
With respect to claim 6, Kodemura teaches that the dip molded film has excellent uniformity of film thickness (paragraph 0096).
With respect to claim 11, the discussion with respect to Kodemura in paragraph 5 above is incorporated here by reference.
Kodemura discloses that the composition to prepare the dip molded article includes sulfur as crosslinking agent (i.e., sulfur donor) (paragraph 0081) and a crosslinking accelerator (paragraph 0082).
Kodemura discloses adding a surfactant (paragraph 0050) but fails to disclose that the surfactant is an amphoteric surfactant.
De Jong discloses dipped articles such as condoms prepared from a styrenic block copolymer latex (abstract; paragraphs 0013-0015). The examples include styrene-isoprene block copolymers which are formed into latex with Manawet 172 as surfactant (paragraphs 0031-0032). Manawet 172 is the same amphoteric surfactant used in the examples of the instant specification (Table 1).
Given that Kodemura is open to the use of surfactants and further given that a dip-formed articles comprising styrene-isoprene block copolymer latex with an amphoteric surfactant, it would have been obvious to one of ordinary skill in the art to utilize a suitable amphoteric surfactant in the Kodemura’s composition for dip molding condoms. Case law holds that the selection of a known material based on its suitability for its intended use supports prima facie obviousness. Sinclair & Carroll Co vs. Interchemical Corp., 325 US 327, 65 USPQ 297 (1045).
With respect to claims 14-22, Kodemura discloses a latex of a styrene-based block copolymer for use in condoms (paragraph 0097) and exemplifies compositions comprising styrene-isoprene-styrene triblock copolymer (Examples 1-4). The dip-molded product of Example 2 has tensile strength of 30 MPa, 500% tensile stress of 1.4 MPa, tear strength of 34 N/m, and elongation of 1110%. Kodemura teaches that the SIS of Example 2 is pre-crosslinked (paragraph 0127).
Kodemura discloses that the composition to prepare the dip molded article includes sulfur as crosslinking agent (i.e., sulfur donor) (paragraph 0081) and a crosslinking accelerator (paragraph 0082).
Kodemura discloses adding a surfactant (paragraph 0050) but fails to disclose that the surfactant is an amphoteric surfactant.
De Jong discloses dipped articles such as condoms prepared from a styrenic block copolymer latex (abstract; paragraphs 0013-0015). The examples include styrene-isoprene block copolymers which are formed into latex with Manawet 172 as surfactant (paragraphs 0031-0032). Manawet 172 is the same amphoteric surfactant used in the examples of the instant specification (Table 1).
Given that Kodemura is open to the use of surfactants and further given that a dip-formed articles comprising styrene-isoprene block copolymer latex with an amphoteric surfactant, it would have been obvious to one of ordinary skill in the art to utilize a suitable amphoteric surfactant in the Kodemura’s composition for dip molding condoms. Case law holds that the selection of a known material based on its suitability for its intended use supports prima facie obviousness. Sinclair & Carroll Co vs. Interchemical Corp., 325 US 327, 65 USPQ 297 (1045).
Kodemura does not disclose that the pre-crosslinking is performed under conditions to provide a composition having relaxed modulus of 0.50-0.61 MPa or at specific times and temperatures. Even so, these process limitations are in a product claim. Case law holds that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985).
With respect to claim 23, Kodemura teaches that the dip molded film has excellent uniformity of film thickness (paragraph 0096).
Double Patenting
Claims 1, 2, 4, and 6-30 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 and 6-10 of U.S. Patent No. 12,528,936.
The rejection is adequately set forth in paragraph 6 of Office action mailed on 2/12/2026 and is incorporated here by reference.
Claims 14, 20, 22, and 24 are rejected on the ground of nonstatutory double patenting as being unpatentable over claim 14 of U.S. Patent No. 12,509,572.
The rejection is adequately set forth in paragraph 7 of Office action mailed on 2/12/2026 and is incorporated here by reference.
Response to Arguments
Applicant's arguments filed 5/11/2026 have been fully considered but they are not persuasive. Specifically, applicant argues that Kodemura does not disclose a composition that is prevulcanized.
Kodemura teaches that the styrene-based block copolymer latex is produced by crosslinking a latex of styrene-based block copolymer “prior to” crosslinking as a raw material (paragraph 0025). Also, Kodemura teaches adding additional crosslinking agents such as sulfur to the latex (paragraph 0081), which is different from the peroxide polymerization initiator used to crosslink the styrene-based block copolymer to form the pre-crosslinking SIS. Therefore, Example 2 of Kodemura clearly teaches a precrosslinked SIS derived from the SIS and peroxide initiator (paragraph 0127).
Also, the limitation of “is prevulcanized and cured” is a process limitation in a product-by-process. Case law holds that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” See In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). Based on the properties of tensile strength and modulus taught by Kodumura, the composition of Kodumura anticipates claim 8 as being the same.
Applicant also argues that the terminal disclaimers overcome the obviousness-type double patenting rejections of record.
The terminal disclaimers filed on 5/11/2026 have been disapproved because they are not signed by an attorney of record
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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/VICKEY NERANGIS/Primary Examiner, Art Unit 1763
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