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
Applicant amended claims 1, 6, 15, and 21; canceled claims 9-11; and added claims 23-25. Claims 1-8 and 12-25 are currently pending.
Response to Arguments
Applicant’s arguments, see page 7 of Applicant’s Remarks, filed 10/21/25, with respect to the rejection of claim 21 under 35 U.S.C. 112(b) as indefinite have been fully considered and are persuasive in light of the amendment to claim 21. Accordingly, the rejection has been withdrawn.
Applicant’s arguments, see pages 7-8 of Applicant’s Remarks, with respect to the rejections of claims 1-22 under 35 U.S.C. 103 as being unpatentable over Weikart in view of Groner and in further view of Dameron have been fully considered and are persuasive in light of the amendment to claim 1. Therefore, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
Claim Interpretation
Claim 1 recites “the oxygen barrier coating or layer being effective to reduce the ingress of oxygen into the lumen to less than 0.0005 cc/package/day at 25 °C, 60% relative humidity, and 0.21 bar” and then that the oxygen ingress rate may be optionally less than 0.0004 cc/package/day, optionally less than 0.0003 cc/package/day, optionally less than 0.0002 cc/package/day, and optionally less than 0.0001 cc/package/day, all at 25 °C, 60% humidity, and 0.21 bar. Because the claimed oxygen ingress rates of less than 0.0004, less than 0.0003, less than 0.0002, and less than 0.0001 are optional, they do not affect the scope of claim 1, and for the purpose of examination, claim 1 was interpreted as though it only recited the non-optional oxygen ingress rate of less than 0.0005 cc/package/day at 25 °C, 60% relative humidity, and 0.21 bar.
Claim 1 similarly recites “the water vapor barrier coating or layer being effective to reduce the ingress of water vapor into the lumen to less than 0.05 mg/package/day at 60 °C and 40% relative humidity” and then that the water vapor ingress rate may be optionally less than 0.04 mg/package/day, optionally less than 0.03 mg/package/day, optionally less than 0.02 mg/package/day, and optionally less than 0.01 mg/package/day, all at 60 °C and 40% relative humidity. Because the claimed water vapor ingress rates of less than 0.04, less than 0.03, 0.02, and less than 0.01 are optional, they do not affect the scope of claim 1, and for the purpose of examination, claim 1 was interpreted as though it only recited the non-optional water vapor ingress rate of less than 0.05 mg/package/day at 60 °C and 40% relative humidity.
Claim 16 similarly recites that “the lumen has a volume of 10 mL or less, optionally a volume of 5 mL or less, optionally a volume of 2 mL or less”. Because the volumes of 5 mL or less and 2 mL or less are optional, they do not affect the scope of claim 16, and for the purpose of examination, claim 16 was interpreted as though it only recited that the lumen has a volume of 10 mL or less.
Claim 22 similarly recites that “an FTIR absorbance spectrum of the pH protective coating has a ratio greater than 0.75” and then that the ratio may be optionally greater than 0.8, optionally greater than 0.85, or optionally greater than 0.9. Because the claims ratios greater than 0.8, greater than 0.85, and greater than 0.9 are optional, they do not affect the scope of claim 22, and for the purpose of examination, claim 22 was interpreted as though it only recited the non-optional ratio greater than 0.75.
The examiner would like to note that if the word “optionally” is removed from claims 1, 16, and/or 22, then claims 1, 16, and/or 22 may be rendered indefinite as including a narrow numerical range that falls within a broader range in the same claim, in accordance with the discussion in MPEP §2173.05(c)(I).
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 1-8, 12-22, and 24-25 are rejected under 35 U.S.C. 103 as being unpatentable over Weikart et al. (US 2015/0335823 A1) in view of Sparrow (Plastics Today, 02/13/2017: The medical case for cyclic block copolymers; hereinafter referred to as Sparrow), in further view of Groner et al. (Applied Physics Letters 88, 051907 (2006): Gas diffusion barriers on polymers using Al2O3 atomic layer deposition; hereinafter referred to as Groner), and in further view of Dameron et al. (J. Phys. Chem. C 2008, 112, 4573-4580: Gas Diffusion Barriers on Polymers Using Multilayers Fabricated by Al2O3 and Rapid SiO2 Atomic Layer Deposition; hereinafter referred to as Dameron).
Regarding claim 1, Weikart discloses a drug primary package (Figs. 1-7, feat. 12; ¶0154-0173) comprising: a vessel (12; ¶0157-0158) comprising a lumen (18) defined at least in part by a wall (14), the wall consisting essentially of a thermoplastic material (¶0159-0160), the wall having an interior surface facing the lumen (16) and an outer surface (syringe barrel wall 14 has an outer surface that is on the opposite side of the wall 14 from the interior surface 16); an oxygen barrier coating or layer supported by at least one of the interior surface and the outer surface of the wall, the oxygen barrier coating or layer being effective to reduce the ingress of oxygen into the lumen (Figs. 2-2A, feat. 30; ¶0177, 0188-0192, and 0243-0249: barrier coating 30 is supported on interior surface 16 via tie coating 838; ¶0191: barrier coating 30 prevents or reduces the ingress of an atmospheric gas containing both oxygen and water vapor and is therefore an oxygen barrier coating); a water vapor barrier coating or layer supported by at least one of the interior surface and the outer surface of the wall, the water vapor barrier coating or layer being effective to reduce the ingress of water vapor into the lumen (Figs. 2-2A, feat. 30; ¶0177, 0188-0192, and 0243-0249: barrier coating 30 is supported on interior surface 16 via tie coating 838; ¶0191: barrier coating 30 prevents or reduces the ingress of an atmospheric gas containing both oxygen and water vapor and is therefore a water vapor barrier coating; ¶0311-0321: A second coating or layer of the same material may be placed directly over the first coating or layer); and an injectable fluid drug stored in the lumen (Fig. 7, feat. 40; ¶0156-0158 and 0188).
Weikart does not disclose that the thermoplastic material making up the wall is a cyclic block copolymer (CBC). Weikart does not disclose the oxygen ingress rate that the oxygen barrier coating or layer allows or the water vapor ingress rate that the water vapor coating or layer allows. Weikart discloses that the coatings or layers within the vessel are applied by plasma enhanced chemical vapor deposition (PECVD) (¶0311-0321), which does not result in coatings or layers consisting essentially of a plurality of atomic monolayers of a pure element or compound, as discussed in ¶0446 of the present specification. Therefore, Weikart does not disclose that at least one of the oxygen barrier coating or layer and the water vapor barrier coating or layer consists essentially of a plurality of atomic monolayers of a pure element or compound.
Sparrow teaches that cyclic block copolymers (CBCs) have properties like low extractables and leachables, low moisture uptake, mechanical and barrier properties, sterilizability, and chemical resistance which make them advantageous materials for medical applications such as syringes, catheters, vials, and medical packaging, especially compared to cyclic olefin copolymers (Page 1). Therefore, it would have been prima facie obvious to one of ordinary skill in the art to modify the package disclosed by Weikart so that the wall consists essentially of a cyclic block copolymer (CBC) thermoplastic material in order to provide the wall with low extractable and leachable properties, low moisture uptake, mechanical and barrier properties, sterilizability, and chemical resistance as taught by Sparrow.
Groner teaches that atomic layer deposition (ALD) deposits smooth, conformal, and pinhole-free films which are suitable for creating the defect-free films needed for superior gas diffusion barriers (Page 051907-1, col. 1, line 1 – col. 2, line 10). As discussed in ¶0446 of the present specification, coatings applied by ALD consist of a plurality of monolayers of the deposited compound. Groner further teaches that ALD deposited Al2O3 films with thicknesses between 5 nm and 26 nm achieve oxygen transmission rates (OTR) less than 0.005 cc/m2/day, which are superior in performance to the OTR achieved by much thicker, >100 nm films of PECVD SiO2 (Page 051907-2, col. 1, lines 2-25). Groner further teaches that ALD deposited Al2O3 films with thicknesses between 5 nm and 26 nm achieve water vapor transmission rates (WVTR) between about 100 mg/m2/day and about 1 mg/m2/day, which are superior in performance to the WVTR achieved by much thicker, >100 nm films of PECVD SiO2 (Page 051907-2, col 2, lines 10-42). Therefore, Groner suggests that ALD Al2O3 coatings have better oxygen and water vapor barrier properties than PECVD SiO2 coatings due to the smooth, conformal, and pinhole-free films created by ALD.
Dameron teaches that single layer ALD Al2O3 gas diffusion barriers are subject to corrosion by water which may lead to barrier failure (Page 4576, col 1, line 60 – col. 2, line 21). Dameron further teaches that an ALD Al2O3 may be protected from this corrosion by the deposition of an ALD SiO2 layer, forming a bilayer of 26 nm Al2O3 and 60 nm SiO2, which also improves the gas barrier properties compared to the bare ALD Al2O3 films (Page 4573, Abstract; Page 4576, col. 2, line 22 – Page 4577, col. 2, line 15). Therefore, Dameron suggests that bilayers comprising 26 nm Al2O3 and 60 nm SiO2 deposited by ALD have better barrier properties than ALD Al2O3 films on their own.
Weikart discloses that the barrier coating or layer may be a PECVD SiO2 layer with a thickness between 2 nm and 1000 nm (¶0243-0249). As discussed above, Groner suggests that ALD Al2O3 coatings have better oxygen and water vapor barrier properties than PECVD SiO2 and Dameron suggests that a bilayer comprising 26 nm Al2O3 and 60 nm SiO2 deposited by ALD have better barrier properties than ALD Al2O3 films on their own. Therefore, modifying the package suggested by Weikart in view of Sparrow so that the barrier coating or layer comprising a bilayer comprising 26 nm Al2O3 and 60 nm SiO2 deposited by ALD would improve the gas barrier properties of the package as taught by Groner and Dameron. Because the bilayer comprises compounds deposited by ALD, each layer consists essentially of a plurality of atomic monolayers of each deposited compound. Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the drug primary package suggested by Weikart in view of Sparrow so that at least one of the oxygen barrier coating or layer and the water vapor barrier coating or layer consists essentially of a plurality of atomic monolayers of a pure element or compound in order to improve the gas barrier properties of the package as taught by Groner and Dameron.
Groner reports OTRs measured at 23 °C and 50% relative humidity, and therefore Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron do not explicitly disclose the claimed oxygen ingress rate of less than 0.0005 cc/package/day measured at 25 °C, 60% relative humidity, and 0.21 bar. Groner and Dameron report WVTRs measured at unknown temperatures and 100% relative humidity, and therefore Weikart in view of Groner and in further view of Dameron do not explicitly disclose the claimed water vapor ingress rate of less than 0.05 mg/package/day measured at 60 °C and 40% relative humidity. However the barrier in the package of Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron comprises 26 nm of Al2O3 deposited by ALD and 60 nm of SiO2 deposited by ALD, resulting in an 86 nm thick barrier. The barrier of the present application may similarly comprise a water vapor barrier layer comprising Al2O3 deposited by ALD and an oxygen barrier comprising SiO2 deposited by ALD, with a total thickness between 2 nm and 1000 nm, and achieve an oxygen ingress rate of less than 0.0005 cc/package/day at 25 °C, 60% relative humidity, and 0.21 bar and a water vapor ingress rate of less than 0.05 mg/package/day at 60 °C and 49% humidity (Present specification: ¶0013-0018). The barrier disclosed by Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron is structurally and compositionally identical to the barrier of the present application, and would therefore be expected to have the same properties. Please see MPEP §2112.01(II). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron inherently discloses that the oxygen barrier coating or layer is effective to reduce the ingress of oxygen into the lumen to less than 0.0005 cc/package/day at 25 °C, 60% relative humidity, and 0.21 bar and that the water vapor barrier coating or layer is effective to reduce the ingress of water vapor into the lumen to less than 0.05 mg/package/day at 60 °C and 40% relative humidity. Please see MPEP §2112.
Regarding claim 2, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 1. Weikart further discloses that the barrier coating (Fig. 2-2A, feat. 30) is supported on the interior surface (16) of the wall (14) via a tie coating (838). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests that at least one of the oxygen barrier coatings or layer or at least one of the water vapor barrier coatings or layer is supported by the interior surface of the wall.
Regarding claim 3, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 2. Weikart further discloses that the barrier coating (Fig. 2-2A, feat. 30) is between the interior surface (16) of the wall (14) and the lumen (18). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests that the water vapor barrier coating or layer and the oxygen barrier coating or layer are located between the interior surface of the wall and the lumen.
Regarding claim 4, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 3. Dameron further discloses that the SiO2 layer in the bilayer, which corresponds to the oxygen barrier layer, should be provided as a material barrier between fluid, such as the fluid drug stored in the lumen, and the Al2O3 layer in order to protect it from corrosion (Page 4573, Abstract; Page 4576, col. 2, line 22 – Page 4577, col. 2, line 15). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests that the water vapor coating or layer is located between the interior surface of the wall and the oxygen barrier coating or layer, and the oxygen barrier coating or layer is located between the water vapor coating or layer and the lumen.
Regarding claim 5, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 3. Weikart further discloses a pH protective coating or layer (Figs. 2-2A, feat. 34) in between the lumen (18) and barrier coating or layer (30) which increases the shelf-life of the vessel by preventing erosion due to high pH values (¶0179-0187, 0192, and 0250-0280). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests a pH protective coating or layer between the lumen and both the water vapor barrier coating or layer and the oxygen barrier coating or layer, the pH protective coating or layer being effective to increase the calculated shelf life of the vessel.
Regarding claim 6, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 5, and Weikart further discloses that the injectable fluid drug (Fig. 7, feat. 40) is in contact with the pH protective coating (Fig. 7, feat. 34; ¶0266-0267).
Regarding claims 7-8, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 1. Because Dameron teaches that both the Al2O3 and SiO2 layers in the bilayer gas barrier are deposited by ALD (Page 4576, col. 2, line 22 – Page 4577, col. 2, line 15), they consist essentially of a plurality of atomic monolayers pure Al2O3 and SiO2 respectively, as discussed in ¶0446 of the present specification. Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests that the oxygen barrier coating or layer consists essentially of a plurality of atomic monolayers of a pure element or compound, with respect to claim 7, and that the water vapor barrier coating or layer consists essentially of a plurality of atomic monolayers of a pure element or compound, with respect to claim 8.
Regarding claim 12, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 1. As discussed above, Dameron teaches a bilayer of ALD deposited Al2O3, which is a metal oxide, and ALD deposited SiO2 (Page 4576, col. 2, line 22 – Page 4577, col. 2, line 15). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests that the pure element or compound of at least one atomic monolayer is a metal oxide, a metal nitride, or an elemental metal.
Regarding claim 13, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 12. As discussed above, Dameron teaches a bilayer of ALD deposited Al2O3, which is a metal oxide, and ALD deposited SiO2 (Page 4576, col. 2, line 22 – Page 4577, col. 2, line 15). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests that the pure element or compound of at least one atomic monolayer is Al2O3, AlxTiyOz, HfO2, In2O3, MgO, SiO2, SrTiOx, Ta2O5, TiO2, Y2O3, ZnO, ZnO:Al, ZrO2, La2O3, or CeO2.
Regarding claim 14, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 5, and Weikart further discloses that the pH protective coating consists essentially of a PECVD coating of SiOxCy, in which x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 (¶0250-0251).
Regarding claim 15, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 14. Weikart further discloses that drugs with a pH between 5 and 9 may dissolve barrier coatings (¶0184-0186) and that pH protective coatings consisting essentially of a PECVD coating of SiOxCy, in which x if from about 0.5 to about 2.4 and y is from about 0.6 to about 3, may protect the barrier coating from dissolution for six months or more, thereby granting the package a shelf life of six months or more (¶0250-0251 and 0273). Weikart is silent with respect to the storage temperature at which the pH protective coating prevents dissolution of the barrier coating. However, as discussed above in the rejection of claim 14, the pH protective coating disclosed by Weikart is structurally and compositionally identical to the claimed pH protective coating, and would therefore be expected to have the same properties. Please see MPEP §2112.01(II). Therefore, Weikart inherently discloses that in which in the injectable fluid drug has a pH between 5 and 9, and the calculated shelf life of the vessel is more than six months at a storage temperature of 4°C. Please see MPEP §2112.
Regarding claim 16, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 1, and Weikart further discloses that the lumen has a volume of 10 mL or less (¶0118: the lumen may have a volume from 1 to 10 mL), optionally a volume of 5 mL or less, optionally a volume of 2 mL or less.
Regarding claim 17, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 1, and Weikart further discloses a lubricity coating or layer supported by the interior surface of the wall (¶0024, 0187, and 0284).
Regarding claim 18, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 17, and Weikart further discloses that the lubricity coating or layer consists essentially of SiOxCy, in which x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 (¶0024, 0186-0187, and 0284).
Regarding claim 19, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 18, and Weikart further discloses that the lubricity coating or layer is deposited by plasma enhanced chemical vapor deposition (PECVD) (¶0024, 0187, and 0284).
Regarding claim 20, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 17, and Weikart further discloses that the vessel is a syringe barrel (Figs 1-2A, feat. 14; ¶0154) and the lubricity coating or layer provides (i) a lower plunger sliding force, (ii) a lower plunger breakout force, or (iii) both (i) and (ii), when compared against the same syringe barrel but lacking the lubricity coating or layer (¶0024, 0187, and 0284).
Regarding claim 21, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 20. Weikart further discloses that the lubricity layer (Fig. 51, feat. 34; ¶0425-0435) should face the syringe lumen (18) in order to provide a reduced friction sliding surface for the syringe plunger (36; ¶0020-0024 and 0430-0435). Weikart further teaches that the lubricity layer may be adjacent to a pH protective layer, either due to being separate layers with a sharp transition or a single, graduated layer that transitions between the pH protective layer and the lubricity layer (¶0284). Because the lubricity layer should face the syringe lumen to provide a reduced friction sliding surface and is adjacent to a pH protective layer, it is located between the pH protective coating or layer and the lumen. Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron further suggests that the lubricity coating or layer is located between the pH protective coating or layer and the lumen.
Regarding claim 22, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the package of claim 5, and Weikart further discloses that an FTIR absorbance spectrum of the pH protective coating or layer has a ratio greater than 0.75, optionally greater than 0.8, optionally greater than 0.85, optionally greater than 0.9, between: the maximum amplitude of the Si-O-Si symmetrical stretch peak between about 1000 and 1040 cm-1, and the maximum amplitude of the Si-O-Si asymmetric stretch peak between about 1060 and about 1100 cm-1 (¶0147-0149 and 0268).
Regarding claims 24-25, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the drug primary package of claim 1, and Weikart further discloses that the drug primary package is a syringe (Figs. 1-7, feat. 12; ¶0154). Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron does not explicitly suggest the claimed particle contents under the claimed conditions. However, as discussed above with respect to claims 17-19, Weikart further discloses that the syringe may comprise a lubricity coating consisting essentially of SiOxCy (¶0024, 0187, and 0284). Weikart further discloses that the lubricity coating may be prepared using octamethylcyclotetrasiloxane (OMCTS) as the organosilicon precursor (¶0186-0187). The present specification discloses that such an OMCTS-based lubricity coating results in the claimed particle counts under the claimed conditions (Present specification: ¶0564-0572, especially ¶0566 and 0572). Because the lubricity coating on the syringe suggested by Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron is compositionally and structurally identical to the claimed lubricity coating of the present application, it would be expected to have the same properties, including the claimed particle counts under the claimed conditions. Please see MPEP §2112.01(II). Therefore, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron inherently discloses that the injectable fluid drug stored in the lumen comprises less than 50 particles having a size of more than 10 μm after the vessel has been rotated at 40°C for five minute, two weeks or four weeks after three freeze-thaw cycles from +5°C to -20°C with 1°C per minute, or after storage of the vessel at 5°C, 25°C and 60% relative humidity or 40°C and 75% relative humidity for three months, with respect to claim 24, and so that the injectable fluid drug stored in the lumen comprises less than 5 particles having a size of more than 25 μm after the vessel has been rotated at 40°C for five minute, two weeks or four weeks after three freeze-thaw cycles from +5°C to -20°C with 1°C per minute, or after storage of the vessel at 5°C, 25°C/60% relative humidity or 40°C/75% relative humidity for three months, with respect to claim 25. Please see MPEP §2112.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Weikart et al. (US 2015/0335823 A1) in view of Sparrow, in further view of Groner, in further view of Dameron, and in further view of Mackey et al. (US 2014/0228802 A1).
Regarding claim 23, Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron suggests the drug primary package of claim 1, and Weikart further discloses that the drug primary package is a syringe (Figs. 1-7, feat. 12; ¶0154). Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron is silent with respect to the syringe being configured to maintain container closure integrity (CCI) when cycled between -20 °C and 20 °C, in which during each cycle, the syringe is held at the lower temperature for about 24 hours and at the upper temperature for about 24 hours, and in which the syringe is subjected to three cycles.
Mackey teaches a syringe (Figs. 2-3, feat. 20; ¶0047-0061) comprising a barrel (45; ¶0048) including a reduced diameter portion (85) and a plunger (60) with front (50) and rear (55) o-rings which form a sliding gas-tight seal between the plunger and the barrel (¶0049-0051). The reduced diameter portion (85), o-rings (50, 55), and plunger (60) are configured to maintain a gas-tight seal throughout freezing and thawing cycles in an expected temperature range of -25 °C to 40 °C (¶0058-0061) in order to ensure seal integrity of the syringe during storage, shipping, thawing, and administering (¶0044-0046). Therefore, it would have been prima facie obvious to one of ordinary skill in the art prior to the effective filing date of the claimed invention to modify the syringe suggested by Weikart in view of Sparrow, in further view of Groner, and in further view of Dameron so that it has the barrel and sealing configuration taught by Mackey and is therefore configured to maintain container closure integrity (CCI) when cycled between -20 °C and 20 °C, in which during each cycle, the syringe is held at the lower temperature for about 24 hours and at the upper temperature for about 24 hours, and in which the syringe is subjected to three cycles in order for the syringe to maintain seal integrity during storage, shipping, thawing, and administering as taught by Mackey.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ARJUNA P CHATRATHI whose telephone number is (571)272-8063. The examiner can normally be reached M-F 8:30-5:00.
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/ARJUNA P CHATRATHI/Examiner, Art Unit 3781
/JESSICA ARBLE/Primary Examiner, Art Unit 3781