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 .
Election/Restrictions
Claim 9 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 03/30/2023.
Claim 9 was previously withdrawn as belonging to a non-elected group of invention (Group I) in the reply filed 03/30/2023. Therefore, claim 9, which currently holds the claim status of (Original) and not (withdrawn) is hereby withdrawn from further consideration.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 15-18, 21, and 25 are rejected under 35 U.S.C. 103 as being unpatentable over Gosse et al. (US-20050020718-A1) (previously cited) in view of Pfeiffer et al. (US 20170292005 A1) (newly cited), Song (US-20050037048-A1) (previously cited), Meng et al. (US 20190175794 A1) (previously cited) and Wang (US-20010007884-A1) (previously cited), as evidenced by Palamoll 652 (Palamoll 652, August 2022, BASF, Pages 1-3 ) and DuPont Duolite AP143-1083 Resin (DuPont Duolite AP143/1083 Resin, February 2023, Dupont, Pages 1-6).
Regarding claim 15, Gosse teaches a medical device comprising an alkaline resistant halogenated polymer (polyvinyl chloride) comprising a halogenated polymer incorporating a polymeric plasticizer and may include multiple different plasticizers such as adipate esters (Gosse, Abstract, Par. 0001, and 0011-0015). Gosse teaches the halogenated polymer incorporates diesters of cyclohexanoic acid which removes free-radical growth (Gosse, Par. 0131-0033 and 0181-0184). Polyvinyl chloride satisfies the limitation of being alkaline resistant as it is listed as an alkaline resistant polymer by the instant claim 16 and the instant specification Par. 010 and 017. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01, I. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id, MPEP 2112.01, II. Gosse teaches the medical device comprises a polymeric stabilizer (Gosse, Par. 0052-0060).
Gosse is silent regarding the polymeric plasticizer comprising a polyadipate.
Pfeiffer teaches a medical device comprising a material which comprises PVC and a polymeric plasticizer that is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0029-0034, 0052-0054, 0130-0132, 0148, and 0235-0237), which is a polyadipate and an ester of adipate that has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Pages 1-2). This is further the same plasticizer used by the instant invention which is stated to be a polyadipate by the instant specification Par. 025-026 and Table 1.
Gosse and Pfeiffer are analogous art as they both teach medical devices comprising PVC plasticized with an adipate ester. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the Palamoll 652 plasticizer taught by Pfeiffer in the medical device of Gosse. This would allow for plasticized PVC with good flexibility (Pfeiffer, Par. 0004, 0008, and 0148).
Modified Gosse is silent regarding the halogenated polymer incorporating a free radical inhibitor, wherein the free radical inhibitor is incorporated into the halogenated polymer at a concentration between about 0.01 parts per hundred resin to about 1 parts per hundred resin.
Song teaches a medical device comprising a halogenated polymer (polyvinyl chloride) which incorporates a phenolic free radical inhibitor (see antioxidants that terminate a free radical) such as hydroquinone or BHT (Song, Abstract, Par. 0001, 0009, 0023-0024, and 0039). Song further teaches examples utilizing a phenolic free radical inhibitor (BHT) in an amount of 0.005 per 100 g total weight and 0.6-0.7 g resin (Song, Par. 0050 and 0052-0053) and thus teaches examples utilizing 0.71-0.83 parts phenolic free radical inhibitor per hundred resin, which lies within the claimed range of about 0.01 to about 1 parts per hundred resin and therefore satisfies the claimed range, see MPEP 2131.03.
Modified Gosse and Song are analogous art as they both teach medical devices comprising polyvinyl chloride which aims to inhibit free radical growth. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Song and incorporated Song’s free radical inhibitor with the polyvinyl chloride of modified Gosse. This would allow for reduced free radical growth, resistance to damaging oxidation effects, and extended shelf life (Song, Par. 0013-0014, 0023-0024).
Modified Gosse is silent regarding the polymeric stabilizer comprising an ion exchange resin or an ionomer.
Meng teaches a medical device such as a catheter wherein the medical device comprises polyvinyl chloride and an ion exchange resin such as Duolite AP143/1083 resin (Meng, Abstract, Par. 0007-0008, 0016), which is an ion exchange resin comprising divinylbenzene as evidenced by Dupont Duolite AP143/1083 Resin (DuPont Duolite AP143/1083 Resin, Pages 1-3). The ion exchange resin comprising divinylbenzene is the same as the instant invention per the instant claim 21, and therefore satisfies the limitation of a stabilizer.
Modified Gosse and Meng are analogous art as they both teach medical devices comprising PVC. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included Meng’s ion exchange resin in the medical device of modified Gosse. This would allow for the carrying and controllable release of drugs in the medical device (Meng, Par. 0007-0008 and 0016).
Modified Gosse is silent regarding the medical device being sterile.
Wang teaches a medical device comprising polyvinyl chloride and a polymeric stabilizer, wherein the medical devices are sterilized by radiation (Wang, Par. 0003-0004 and claim 5).
Modified Gosse and Wang are analogous art as they both teach medical devices comprising polyvinyl chloride. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Wang and sterilized the halogenated polymer of modified Gosse with radiation. This would allow for a sterilized medical device that reduces degradation and yellowing caused from sterilization radiation and extends the life of the medical device (Wang, Par. 0003-0004).
Regarding claim 16, modified Gosse teaches the halogenated polymer comprises polyvinyl chloride (Gosse, Abstract, Par. 0001 and 0011-0015).
Regarding claim 17, modified Gosse teaches the polyadipate is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0052-0054, 0130-0132, and 0148), which has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Page 1). This is further the same plasticizer used by the instant invention which is a polypropylene adipate as stated by the instant specification Par. 025-026 and Table 1, satisfying the claimed limitation.
Regarding claim 18, modified Gosse teaches the alkaline resistant halogenated polymer is sterilized by radiation (Wang, Par. 0003-0004 and claim 5).
Regarding claim 21, modified Gosse teaches the ion exchange resin is Duolite AP143/1083 resin (Meng, Abstract, Par. 0007-0008, 0016), which is an ion exchange resin comprising divinylbenzene as evidenced by Dupont Duolite AP143/1083 Resin (DuPont Duolite AP143/1083 Resin, Pages 1-3).
Regarding claim 25, modified Gosse teaches the polyadipate is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0052-0054, 0130-0132, and 0148), which has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Page 1). This is further the same plasticizer used by the instant invention which is stated to be a polyadipate comprising hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol and 1,2-propanediol, isononyl ester by the instant specification Par. 025-026 and Table 1, satisfying the claimed limitation.
Claims 15-18, and 22-25 are rejected under 35 U.S.C. 103 as being unpatentable over Gosse et al. in view of Pfeiffer et al., Song, Lundquist et al. (US 20100267872 A1) (previously cited) and Wang, as evidenced by Palamoll 652.
Regarding claim 15, Gosse teaches a medical device comprising an alkaline resistant halogenated polymer (polyvinyl chloride) comprising a halogenated polymer incorporating a polymeric plasticizer and may include multiple different plasticizers such as adipate esters (Gosse, Abstract, Par. 0001, and 0011-0015). Gosse teaches the halogenated polymer incorporates diesters of cyclohexanoic acid which removes free-radical growth (Gosse, Par. 0131-0033 and 0181-0184). Polyvinyl chloride satisfies the limitation of being alkaline resistant as it is listed as an alkaline resistant polymer by the instant claim 16 and the instant specification Par. 010 and 017. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01, I. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id, MPEP 2112.01, II. Gosse teaches the medical device comprises a polymeric stabilizer (Gosse, Par. 0052-0060).
Gosse is silent regarding the polymeric plasticizer comprising a polyadipate.
Pfeiffer teaches a medical device comprising a material which comprises PVC and a polymeric plasticizer that is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0029-0034, 0052-0054, 0130-0132, 0148, and 0235-0237), which is a polyadipate and an ester of adipate that has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Pages 1-2). This is further the same plasticizer used by the instant invention which is stated to be a polyadipate by the instant specification Par. 025-026 and Table 1.
Gosse and Pfeiffer are analogous art as they both teach medical devices comprising PVC plasticized with an adipate ester. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the Palamoll 652 plasticizer taught by Pfeiffer in the medical device of Gosse. This would allow for plasticized PVC with good flexibility (Pfeiffer, Par. 0004, 0008, and 0148).
Modified Gosse is silent regarding the halogenated polymer incorporating a free radical inhibitor, wherein the free radical inhibitor is incorporated into the halogenated polymer at a concentration between about 0.01 parts per hundred resin to about 1 parts per hundred resin.
Song teaches a medical device comprising a halogenated polymer (polyvinyl chloride) which incorporates a phenolic free radical inhibitor (see antioxidants that terminate a free radical) such as hydroquinone or BHT (Song, Abstract, Par. 0001, 0009, 0023-0024, and 0039). Song further teaches examples utilizing a phenolic free radical inhibitor (BHT) in an amount of 0.005 per 100 g total weight and 0.6-0.7 g resin (Song, Par. 0050 and 0052-0053) and thus teaches examples utilizing 0.71-0.83 parts phenolic free radical inhibitor per hundred resin, which lies within the claimed range of about 0.01 to about 1 parts per hundred resin and therefore satisfies the claimed range, see MPEP 2131.03.
Modified Gosse and Song are analogous art as they both teach medical devices comprising polyvinyl chloride which aims to inhibit free radical growth. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Song and incorporated Song’s free radical inhibitor with the polyvinyl chloride of modified Gosse. This would allow for reduced free radical growth, resistance to damaging oxidation effects, and extended shelf life (Song, Par. 0013-0014, 0023-0024).
Modified Gosse is silent regarding the polymeric stabilizer comprising an ion exchange resin or an ionomer.
Lundquist teaches stabilizing polyvinyl chloride by using a stabilizer that comprises a metal salt of an organic polymer (polyacrylic acid) (Lundquist, Abstract, Par. 0016, 0018, 0026-0027, and claim 6). Lundquist's metal salt of an organic polymer satisfies the claimed ionomer as the instant specification states that metal salts of organic polymers are ionomers.
Modified Gosse and Lundquist are analogous art as they both teach stabilizing PVC. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Lundquist’s metal salt as the stabilizer of modified Gosse. This would allow for a stabilized PVC composition (Lundquist, Par. 0016, 0018, and 0026-0027).
Modified Gosse is silent regarding the medical device being sterile.
Wang teaches a medical device comprising polyvinyl chloride and a polymeric stabilizer, wherein the medical devices are sterilized by radiation (Wang, Par. 0003-0004 and claim 5).
Modified Gosse and Wang are analogous art as they both teach medical devices comprising polyvinyl chloride. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Wang and sterilized the halogenated polymer of modified Gosse with radiation. This would allow for a sterilized medical device that reduces degradation and yellowing caused from sterilization radiation and extends the life of the medical device (Wang, Par. 0003-0004).
Regarding claim 16, modified Gosse teaches the halogenated polymer comprises polyvinyl chloride (Gosse, Abstract, Par. 0001 and 0011-0015).
Regarding claim 17, modified Gosse teaches the polyadipate is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0052-0054, 0130-0132, and 0148), which has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Page 1). This is further the same plasticizer used by the instant invention which is a polypropylene adipate as stated by the instant specification Par. 025-026 and Table 1, satisfying the claimed limitation.
Regarding claim 18, modified Gosse teaches the alkaline resistant halogenated polymer is sterilized by radiation (Wang, Par. 0003-0004 and claim 5).
Regarding claims 22-24, modified Gosse teaches that the ionomer is comprises a metal salt of an organic polymer, wherein the organic polymer comprises an acrylic acid containing polymer and the metal is a metal cation that is potassium (Lundquist, Par. 0026-0027 and Claim 6).
Regarding claim 25, modified Gosse teaches the polyadipate is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0052-0054, 0130-0132, and 0148), which has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Page 1). This is further the same plasticizer used by the instant invention which is stated to be a polyadipate comprising hexanedioic acid, polymer with 2,2-dimethyl-1,3-propanediol and 1,2-propanediol, isononyl ester by the instant specification Par. 025-026 and Table 1, satisfying the claimed limitation.
Claims 19-20 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gosse et al. in view of Pfeiffer et al., Song, Meng et al., and Wang as applied to claim 15 above, and further in view of Choo et al. (US-20070293441-A1) (previously cited).
Regarding claims 19-20 and 26, modified Gosse teaches all of the elements of the claimed invention as stated above for claim 15. Modified Gosse is silent regarding the alkaline resistant halogenated polymer being in contact with a high alkaline pharmaceutical formulation having a pH greater than 7 as required by claim 19, a pH in the range of 8 to 14 as required by claim 20, or a pH in the range of 9 to 14 as required by claim 26.
Choo teaches a sterilized medical system formed from polyvinyl chloride (Choo, Par. 0004, 0085, and Figs. 1-4). Choo teaches the polyvinyl chloride is in contact with a high alkaline pharmaceutical formulation (dialysis solution) having a pH of about 1 to 11 (Choo, Par. 0008-0012 and 0063), which overlaps the claimed ranges of greater than 7, 8 to 14, and 9 to 14 and therefore, establishes a prima facie case of obviousness over the claimed ranges, see MPEP 2144.05, I.
Modified Gosse and Choo are analogous art as they both teach medical devices comprising polyvinyl chloride. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Choo and used the medical device of modified Gosse for dialysis solutions having a pH in the claimed range. This would allow for a medical device for dialysis solutions with improved stability to UV light, improved low temperature properties, and improved processability (Choo, Par. 0004 and 0008-0012; Gosse, Abstract).
Claims 19-20 and 26 are rejected under 35 U.S.C. 103 as being unpatentable over Gosse et al. in view of Pfeiffer et al., Song, Lundquist et al., and Wang as applied to claim 15 above, and further in view of Choo et al.
Regarding claims 19-20 and 26, modified Gosse teaches all of the elements of the claimed invention as stated above for claim 15. Modified Gosse is silent regarding the alkaline resistant halogenated polymer being in contact with a high alkaline pharmaceutical formulation having a pH greater than 7 as required by claim 19, a pH in the range of 8 to 14 as required by claim 20, or a pH in the range of 9 to 14 as required by claim 26.
Choo teaches a sterilized medical system formed from polyvinyl chloride (Choo, Par. 0004, 0085, and Figs. 1-4). Choo teaches the polyvinyl chloride is in contact with a high alkaline pharmaceutical formulation (dialysis solution) having a pH of about 1 to 11 (Choo, Par. 0008-0012 and 0063), which overlaps the claimed ranges of greater than 7, 8 to 14, and 9 to 14 and therefore, establishes a prima facie case of obviousness over the claimed ranges, see MPEP 2144.05, I.
Modified Gosse and Choo are analogous art as they both teach medical devices comprising polyvinyl chloride. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Choo and used the medical device of modified Gosse for dialysis solutions having a pH in the claimed range. This would allow for a medical device for dialysis solutions with improved stability to UV light, improved low temperature properties, and improved processability (Choo, Par. 0004 and 0008-0012; Gosse, Abstract).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gosse et al. in view of Pfeiffer et al., Dave et al. (US 20110129628 A1) (newly cited), Meng et al. and Wang, as evidenced by Palamoll 652 and DuPont Duolite AP143-1083 Resin.
Regarding claim 27, Gosse teaches a medical device comprising an alkaline resistant halogenated polymer (polyvinyl chloride) comprising a halogenated polymer incorporating a polymeric plasticizer and may include multiple different plasticizers such as adipate esters (Gosse, Abstract, Par. 0001, and 0011-0015). Gosse teaches the halogenated polymer incorporates diesters of cyclohexanoic acid which removes free-radical growth (Gosse, Par. 0131-0033 and 0181-0184). Polyvinyl chloride satisfies the limitation of being alkaline resistant as it is listed as an alkaline resistant polymer by the instant claim 16 and the instant specification Par. 010 and 017. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01, I. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id, MPEP 2112.01, II. Gosse teaches the medical device comprises a polymeric stabilizer (Gosse, Par. 0052-0060).
Gosse is silent regarding the polymeric plasticizer comprising a polyadipate.
Pfeiffer teaches a medical device comprising a material which comprises PVC and a polymeric plasticizer that is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0029-0034, 0052-0054, 0130-0132, 0148, and 0235-0237), which is a polyadipate and an ester of adipate that has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Pages 1-2). This is further the same plasticizer used by the instant invention which is stated to be a polyadipate by the instant specification Par. 025-026 and Table 1.
Gosse and Pfeiffer are analogous art as they both teach medical devices comprising PVC plasticized with an adipate ester. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the Palamoll 652 plasticizer taught by Pfeiffer in the medical device of Gosse. This would allow for plasticized PVC with good flexibility (Pfeiffer, Par. 0004, 0008, and 0148).
Modified Gosse is silent regarding the halogenated polymer incorporating a free radical inhibitor, wherein the free radical inhibitor is incorporated into the halogenated polymer at less than 0.1 parts per hundred resin.
Dave teaches a PVC composition comprising plasticizers and a free-radical inhibitor (antioxidant) that is a hydroquinone (Dave, Abstract, Par. 0073, 0114, 0125, and 0139-0141), in an amount of 0.01 to 10 parts by weight per 100 parts resin (PVC), which overlaps the claimed range of less than 0.1 and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I.
Modified Gosse and Dave are analogous art as they both teach PVC compositions comprising plasticizers. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Dave and incorporated Dave’s free radical inhibitor (antioxidant) with the polyvinyl chloride of modified Gosse. This would allow for antioxidative properties of the PVC (Dave, Par. 0114).
Modified Gosse is silent regarding the polymeric stabilizer comprising an ion exchange resin or an ionomer.
Meng teaches a medical device such as a catheter wherein the medical device comprises polyvinyl chloride and an ion exchange resin such as Duolite AP143/1083 resin (Meng, Abstract, Par. 0007-0008, 0016), which is an ion exchange resin comprising divinylbenzene as evidenced by Dupont Duolite AP143/1083 Resin (DuPont Duolite AP143/1083 Resin, Pages 1-3). The ion exchange resin comprising divinylbenzene is the same as the instant invention per the instant claim 21, and therefore satisfies the limitation of a stabilizer.
Modified Gosse and Meng are analogous art as they both teach medical devices comprising PVC. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have included Meng’s ion exchange resin in the medical device of modified Gosse. This would allow for the carrying and controllable release of drugs in the medical device (Meng, Par. 0007-0008 and 0016).
Modified Gosse is silent regarding the medical device being sterile.
Wang teaches a medical device comprising polyvinyl chloride and a polymeric stabilizer, wherein the medical devices are sterilized by radiation (Wang, Par. 0003-0004 and claim 5).
Modified Gosse and Wang are analogous art as they both teach medical devices comprising polyvinyl chloride. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Wang and sterilized the halogenated polymer of modified Gosse with radiation. This would allow for a sterilized medical device that reduces degradation and yellowing caused from sterilization radiation and extends the life of the medical device (Wang, Par. 0003-0004).
Claim 27 is rejected under 35 U.S.C. 103 as being unpatentable over Gosse et al. in view of Pfeiffer et al., Dave et al., Lundquist et al. and Wang, as evidenced by Palamoll 652.
Regarding claim 27, Gosse teaches a medical device comprising an alkaline resistant halogenated polymer (polyvinyl chloride) comprising a halogenated polymer incorporating a polymeric plasticizer and may include multiple different plasticizers such as adipate esters (Gosse, Abstract, Par. 0001, and 0011-0015). Gosse teaches the halogenated polymer incorporates diesters of cyclohexanoic acid which removes free-radical growth (Gosse, Par. 0131-0033 and 0181-0184). Polyvinyl chloride satisfies the limitation of being alkaline resistant as it is listed as an alkaline resistant polymer by the instant claim 16 and the instant specification Par. 010 and 017. Where the claimed and prior art products are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977), see MPEP 2112.01, I. "Products of identical chemical composition can not have mutually exclusive properties." In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990). A chemical composition and its properties are inseparable. Therefore, if the prior art teaches the identical chemical structure, the properties applicant discloses and/or claims are necessarily present. Id, MPEP 2112.01, II. Gosse teaches the medical device comprises a polymeric stabilizer (Gosse, Par. 0052-0060).
Gosse is silent regarding the polymeric plasticizer comprising a polyadipate.
Pfeiffer teaches a medical device comprising a material which comprises PVC and a polymeric plasticizer that is Palamoll 652 (Pfeiffer, Par. 0008, 0026, 0029-0034, 0052-0054, 0130-0132, 0148, and 0235-0237), which is a polyadipate and an ester of adipate that has a CAS number of 208945-13-5 as evidenced by Palamoll 652 (Palamoll 652, Pages 1-2). This is further the same plasticizer used by the instant invention which is stated to be a polyadipate by the instant specification Par. 025-026 and Table 1.
Gosse and Pfeiffer are analogous art as they both teach medical devices comprising PVC plasticized with an adipate ester. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the Palamoll 652 plasticizer taught by Pfeiffer in the medical device of Gosse. This would allow for plasticized PVC with good flexibility (Pfeiffer, Par. 0004, 0008, and 0148).
Modified Gosse is silent regarding the halogenated polymer incorporating a free radical inhibitor, wherein the free radical inhibitor is incorporated into the halogenated polymer at less than 0.1 parts per hundred resin.
Dave teaches a PVC composition comprising plasticizers and a free-radical inhibitor (antioxidant) that is a hydroquinone (Dave, Abstract, Par. 0073, 0114, 0125, and 0139-0141), in an amount of 0.01 to 10 parts by weight per 100 parts resin (PVC), which overlaps the claimed range of less than 0.1 and therefore establishes a prima facie case of obviousness over the claimed range, see MPEP 2144.05, I.
Modified Gosse and Dave are analogous art as they both teach PVC compositions comprising plasticizers. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Dave and incorporated Dave’s free radical inhibitor (antioxidant) with the polyvinyl chloride of modified Gosse. This would allow for antioxidative properties of the PVC (Dave, Par. 0114).
Modified Gosse is silent regarding the polymeric stabilizer comprising an ion exchange resin or an ionomer.
Lundquist teaches stabilizing polyvinyl chloride by using a stabilizer that comprises a metal salt of an organic polymer (polyacrylic acid) (Lundquist, Abstract, Par. 0016, 0018, 0026-0027, and claim 6). Lundquist's metal salt of an organic polymer satisfies the claimed ionomer as the instant specification states that metal salts of organic polymers are ionomers.
Modified Gosse and Lundquist are analogous art as they both teach stabilizing PVC. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used Lundquist’s metal salt as the stabilizer of modified Gosse. This would allow for a stabilized PVC composition (Lundquist, Par. 0016, 0018, and 0026-0027).
Modified Gosse is silent regarding the medical device being sterile.
Wang teaches a medical device comprising polyvinyl chloride and a polymeric stabilizer, wherein the medical devices are sterilized by radiation (Wang, Par. 0003-0004 and claim 5).
Modified Gosse and Wang are analogous art as they both teach medical devices comprising polyvinyl chloride. It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the teachings of Wang and sterilized the halogenated polymer of modified Gosse with radiation. This would allow for a sterilized medical device that reduces degradation and yellowing caused from sterilization radiation and extends the life of the medical device (Wang, Par. 0003-0004).
Response to Arguments
Applicant’s remarks and amendments filed 29 November 2025 have been fully considered.
On pages 6-7 of the remarks, Applicant first argues that the prior art of record does not teach that the polymeric plasticizer is a polyadipate as required by newly amended claim 15. This is found moot.
The grounds of rejection have been updated in view of the present claim amendments. Newly cited Pfeiffer is not relied upon to teach the limitation of the polymeric plasticizer comprising a polyadipate as stated above.
Secondly, on page 8 of the remarks, Applicant argues that Song does not teach an amount of free radical inhibitor of less than 0.1 parts per hundred resin as required by new claim 27. This is found moot.
New grounds of rejection have been made for newly added claim 27. In the grounds of rejection to claim 27, previously cited Song is not relied upon. Instead, newly cited Dave is relied upon to teach the amount of free radical inhibitor.
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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/THOMAS J KESSLER/Examiner, Art Unit 1782