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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 09/10/25 has been entered.
Response to Amendment
Applicant amended claims 1-3, 5-6, 10, 12-13, 15, and 30. Claims 1-3, 5-6, 10, 12-13, 15-20, and 25-30 are currently pending, with claims 17-20, 25, and 27-29 being withdrawn from consideration.
Response to Arguments
Applicant’s arguments, see pages 12-15 of Applicant’s Remarks, filed 09/10/25, with respect to the rejections of claims 1-3, 5, 12, and 16 under 35 U.S.C. 102(a)(1) as anticipated by Weikart, of claims 6, 13, and 30 under 35 U.S.C. 103 as being obvious over Weikart, of claim 10 in further view of Geise, and of claim 15 in further view of Breaux have been fully considered and are persuasive in light of the amendments to the claims. Therefore, the rejections have been withdrawn. However, upon further search and consideration, new grounds of rejection have been made as indicated below.
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.
Claims 1-3, 5-6, 10, 12-13, 16, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Shippert (US 2009/0287190 A1) in view of Weikart et al. (US 2015/0290080 A1).
Regarding claim 1, Shippert discloses a system (Figs. 21 and 23, feats. 2100; ¶0125-0136) comprising: a series of vessels (Fig. 21, feat. 2112; ¶0126; Fig. 23, feat. 2308; ¶0136) or connectors (Fig. 21, feat. 2144; ¶0127; Fig. 23, feat. 2312; ¶0136) capable of use in the manufacture, packaging, or delivery of a biopharmaceutical product (Fig. 23, feat. 2304; ¶0018-0020 and 0136-0138: the system is used for the collection and reinjection of fat, or adipose tissue, which includes cells, and is therefore a biopharmaceutical product as discussed in ¶0004-0005 of the present specification), wherein each of said vessels in the series is connected to at least one of another vessel in the series (Fig. 23, feats. 2112 and 2308) through one or more connectors (Fig. 23, feat. 2312); wherein each of said vessels or connectors in the series comprises walls defining inner cavities, wherein the walls of each of said vessels or connectors in the series have inner surfaces facing the cavities (Figs. 21 and 23, feats. 2112, 2144, 2308, and 2312), the inner surfaces of at least two of the vessels or connectors in the series being characterized by a common surface residing thereon in substantially all areas where the inner surface would, absent the common surface, come in contact with the biopharmaceutical product (¶0132: various surfaces of the system, such as the interior of tubing 2144 and collection vessel 2112, may comprise a silicone coating to present a smoother surface which reduces damage to the cells and facilitates tissue transport).
Shippert does not disclose that the common surface has the claimed composition.
Weikart teaches a coating system (Figs. 1-4, feat. 285; ¶0042-0054) for vessels and connectors for storing, transporting, or delivering biopharmaceuticals (¶0034-0035). The coating system comprises a tie coating (Fig. 2, feat. 289; ¶0043) comprising SiOxCy or SiNxCy, wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 (¶0055-0064), a barrier coating (Fig. 2, feat. 288) comprising SiOx, wherein x is from 1.5 to 2.9 and the barrier coating is from 2 to 1000 nm thick (¶0065-0071) and a pH protective coating comprising SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 (¶0072-0088). The tie coating (Figs. 1-4, feat. 289) is disposed on the wall of the vessel or connector (214), the barrier coating (288) is disposed on the tie coating, and the pH protective coating (286) is disposed on the barrier coating such that the tie, barrier, and pH protective coatings are on the inner surfaces of the walls of the vessels or connectors and the pH protective coating is the innermost coating (Figs. 3-4, feat. 286) which interfaces with the biopharmaceutical material (Figs. 3-4, feat. 218). The pH protective coating may be made from polysiloxane precursors (¶0102-0103), and may therefore be a silicone material, similar to the coating disclosed by Shippert (Shippert: ¶0132). Weikart teaches that such a coating system advantageously provides enhanced gas barrier properties due to the inclusion of a barrier coating comprising SiOx (¶0009-0011 and 0065) and isolates the biopharmaceutical material from the materials of the vessels and connectors (¶0006-0011). Modifying the system of vessels and connectors disclosed by Shippert so that they comprise the coating system taught by Weikart, and not just the silicone coating disclosed by Shippert, would enhance the gas barrier properties in the system and protect the adipose tissue from the materials of the vessels and connectors as taught by Weikart. 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 system disclosed by Shippert so that the common surface on said at least two of the vessels or connectors in the series comprises: a tie coating or layer, a barrier coating or layer; optionally, a pH protective coating or layer; wherein the tie coating or layer comprises SiOxCy or SiNxCy, wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the walls of the vessels or connectors and having an inner surface facing the cavities; wherein the barrier coating or layer comprises SiOx, wherein x is from 1.5 to 2.9, the barrier coating or layer being from 2 to 1000 nm thick, the barrier coating or layer having an outer surface facing the inner surface of the tie coating or layer and having an inner surface facing the cavities; and wherein the pH protective coating or layer comprises SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating or layer having an outer surface facing the inner surface of the barrier coating or layer and having an inner surface facing the cavities in order to provide enhanced gas barrier properties to the system and protect the adipose tissue from the materials of the vessels and connectors as taught by Weikart.
Regarding claims 2-3, Shippert in view of Weikart suggests the system of claim 1. Shippert further discloses that the coated collection vessel (Shippert: Fig. 23, feat. 2112; ¶0132) may be a bag (Shippert: ¶0126), such as a media bag or a transfer bag. While Shippert does not explicitly teach that the syringe (Shippert: Fig. 23, feat. 2308; ¶0136) is coated, Shippert teaches that providing the same silicone coating on multiple surfaces in the system presents a smoother surface which reduces damage to the cells and facilitates tissue transport (Shippert: ¶0132). Weikart further teaches that coated vessels include at least syringes (Weikart: ¶0034-0035), and as discussed above, that the coating system provides an enhanced gas barrier and biopharmaceutical material isolation (¶0006-0001 and 0065). 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 system suggested by Shippert in view of Weikart so that the vessels or connectors in the series are a media or transfer bag and a syringe to reduce damage to the biopharmaceutical product and facilitate transport, as taught by Shippert, and provide the system with enhanced gas barrier and biopharmaceutical material isolation properties, as taught by Weikart. Therefore, Shippert in view of Weikart further suggests that the vessels or connectors in the series are independently selected from the group consisting of one or more of the following: 384 well plates; 96 well plates; bioreactors; blood sample collection tubes; bottles; bulk storage vessels; cannulas; capture columns; cartridges; catheters; cell bank vials; cell separators; cell vials; centrifugal pumps; centrifuge tubes; chromatography columns; chromatography vials; clarifiers; closures; container closure systems; cryopreservation vessels; culture bottles; delivery containers; diafiltration equipment; dispensing units, ELISA plates; elution bags; evacuated blood sample collection tubes; fill/finish equipment; filtration equipment; freeze dryer equipment; harvest vessels; shakers; in-process analysis instruments; intermediate columns; intravenous (IV) bags; media bags; media bottles; media vessels; membrane chromatography columns; microplates; microtiter plates; microwell plates; mixing bags; monitoring devices; multiple-use bioreactors; package filling apparatus; pumps; petri dishes; pipette tips; plates; plungers; polish columns; pre-filled syringes; pre-filled syringe with luer lock fittings; primary packaging; production bioreactors; production fermenters; roller bottles; sample collection tubes; sampling vessels; seed fermenters; separators; shake flasks; single-use bioreactors; slides; spinner flasks; staked needle pre-filled syringes; storage bags; sterilizers; stock culture vials; storage containers; tanks; terminal reactors; transfer bags; ultrafiltration/diafiltration equipment; ultrafiltration equipment; upstream bioreactors; valves; vials; viral filtration equipment; viral inactivation vessels; and wave bioreactors, with respect to claim 2, and that the vessels or connectors in the series are independently selected form the group consisting of bioreactors, pumps, cell bank vials, harvest vessels, stock culture vials, fermenters, shake flasks, flasks, shakers, columns, separators, bags, beakers, tanks, cylinders, bulk storage units or containers, single use bags, roller bottles, storage tubes, sampling vessels, syringes, dispensing units, pipette tips, slides, vials and intravenous (IV) bags, with respect to claim 3.
Regarding claim 5, Shippert in view of Weikart suggests the system of claim 1. Shippert discloses that the system (Shippert: Figs. 21 and 23, feats. 2100) comprises a series of vessels comprising a bag (Shippert: Figs. 21 and 23, feat. 2112; ¶0126), which is useful for holding a bulk amount of a biopharmaceutical product, and a syringe (Shippert: Fig. 23, feat. 2308; ¶0136), which is useful for administering the biopharmaceutical product to a patient (Shippert: ¶0136-0138: the syringe is used for reinjecting the adipose tissue). As discussed above, Shippert explicitly teaches that the bag comprises a coating and that providing the same silicone coating on multiple surfaces in the system presents a smoother surface which reduces damage to the cells and facilitates tissue transport (Shippert: ¶0132), but does not explicitly disclose that the syringe is coated. As discussed above, Weikart further teaches that coated vessels include at least syringes (Weikart: ¶0034-0035), and as discussed above, that the coating system provides an enhanced gas barrier and biopharmaceutical material isolation (¶0006-0001 and 0065). 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 system suggested by Shippert in view of Weikart so that the series comprises: (a) a first vessel useful for holding a bulk amount of the biopharmaceutical product; and (b) a second vessel useful for administering a composition comprising at least a portion of said biopharmaceutical product to a subject in need thereof, wherein the first and second vessels are characterized by a common surface residing on the inner surface of their respective walls in substantially all areas where the inner surfaces would, absent the common surface, come in contact with the biopharmaceutical product in order to reduce damage to the biopharmaceutical product and facilitate transport, as taught by Shippert, and provide an enhanced gas barrier and biopharmaceutical material isolation, as taught by Weikart.
Regarding claim 6, Shippert in view of Weikart suggests the system of claim 1, and Shippert further discloses that the connectors in the series are independently selected from the group consisting of tubes, tubings (Figs. 21 and 23, feats. 2144 and 2312; ¶0127, 0132, and 0136), valves, and pipes.
Regarding claim 10, Shippert in view of Weikart suggests the system of claim 5. Shippert further teaches an alternate system embodiment (Figs. 10-11, feat. 1000; ¶0083-0087) comprising a tissue collection and processing vessels (1004 and 1008; ¶0083-0084) similar to the collection vessel of the previously cited embodiment (Figs. 21 and 23, feat. 2112). Shippert further teaches that the system may be expanded with additional tissue collection and processing vessels (Fig. 12, feats. 1004 and 1008) in order to allow the system to collect and process a higher volume of tissue (¶0088), and therefore biopharmaceutical material. 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 system suggested by Shippert in view of Weikart to include an additional vessel useful in the production of a bulk amount of the biopharmaceutical produce in the system in order to allow the system to process a higher volume of biopharmaceutical material as taught by Shippert. As discussed above with respect to claim 5, Shippert teaches that different vessels in the system having the same silicone coating reduces damage to the cells and facilitates tissue transport, and Weikart teaches that the claimed coating system provides an enhanced gas barrier and isolation properties. Therefore, Shippert in view of Weikart further suggests that the system comprises one or more vessels useful in the production of said bulk amount of the biopharmaceutical product, wherein the inner surface of the walls of at least one of said one or more vessels is characterized by a surface residing thereon in substantially all the areas that would, absent the surface, come into contact with the biopharmaceutical product during its production, that is selected from the group of surfaces that are common or not common to that of the first and second vessels.
Regarding claim 12, Shippert discloses a system (Figs. 21 and 23, feats. 2100; ¶0125-0136) comprising: a series of vessels (Fig. 21, feat. 2112; ¶0126; Fig. 23, feat. 2308; ¶0136) or connectors (Fig. 21, feat. 2144; ¶0127; Fig. 23, feat. 2312; ¶0136), wherein each of said vessels in the series is connected to at least one of another vessel in the series (Fig. 23, feats. 2112 and 2308) through one or more connectors (Fig. 23, feat. 2312); wherein each of said vessels or connectors in the series comprises walls defining inner cavities, wherein the walls of each of said vessels or connectors in the series have inner surfaces facing the cavities (Figs. 21 and 23, feats. 2112, 2144, 2308, and 2312), the inner surfaces of at least two of the vessels or connectors in the series being characterized by a common surface residing thereon in substantially all areas where the inner surface would, absent the common surface, come in contact with the biopharmaceutical product (¶0132: various surfaces of the system, such as the interior of tubing 2144 and collection vessel 2112, may comprise a silicone coating to present a smoother surface which reduces damage to the cells and facilitates tissue transport).
Shippert discloses vessels including at least a bag (Figs. 21 and 23, feat. 2112; ¶0126) and a syringe (Fig. 23, feat. 2308; ¶0136) and connectors including tubing (Figs. 21 and 23, feats. 2144 and 2312) for storing, transporting, and/or delivering a biopharmaceutical product, but is silent with respect to whether or not the vessels or connectors are capable of use in assessing the quality, purity, and/or integrity of the biopharmaceutical product. The present specification indicates that vessels which are useful in assessing the quality, purity, and integrity of a biopharmaceutical product enable that product to be tested, but does not otherwise particularly limit what kind of vessels are capable of use in assessing quality, purity, and integrity of a product (present specification: ¶0055-0057). Because the bag (Figs. 21 and 23, feat. 2112) of Shippert holds the biopharmaceutical product, it is capable of holding the biopharmaceutical product until it is tested, and is therefore capable of use for assessing the quality, purity, and integrity of a product. Furthermore, because the syringe (Fig. 23, feat. 2308) of Shippert is capable of transferring the biopharmaceutical product from the bag to another vessel for testing, it is also capable of use for assessing the quality, purity, and integrity of a product. Therefore, Shippert discloses a series of vessels which are inherently capable of use in assessing one or more of the following characteristics: quality, purity, and integrity of a biopharmaceutical product. Please see MPEP §2112.
Shippert does not disclose that the common surface has the claimed composition.
Weikart teaches a coating system (Figs. 1-4, feat. 285; ¶0042-0054) for vessels and connectors for storing, transporting, or delivering biopharmaceuticals (¶0034-0035). The coating system comprises a tie coating (Fig. 2, feat. 289; ¶0043) comprising SiOxCy or SiNxCy, wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 (¶0055-0064), a barrier coating (Fig. 2, feat. 288) comprising SiOx, wherein x is from 1.5 to 2.9 and the barrier coating is from 2 to 1000 nm thick (¶0065-0071) and a pH protective coating comprising SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3 (¶0072-0088). The tie coating (Figs. 1-4, feat. 289) is disposed on the wall of the vessel or connector (214), the barrier coating (288) is disposed on the tie coating, and the pH protective coating (286) is disposed on the barrier coating such that the tie, barrier, and pH protective coatings are on the inner surfaces of the walls of the vessels or connectors and the pH protective coating is the innermost coating (Figs. 3-4, feat. 286) which interfaces with the biopharmaceutical material (Figs. 3-4, feat. 218). The pH protective coating may be made from polysiloxane precursors (¶0102-0103), and may therefore be a silicone material, similar to the coating disclosed by Shippert (Shippert: ¶0132). Weikart teaches that such a coating system advantageously provides enhanced gas barrier properties due to the inclusion of a barrier coating comprising SiOx (¶0009-0011 and 0065) and isolates the biopharmaceutical material from the materials of the vessels and connectors (¶0006-0011). Modifying the system of vessels and connectors disclosed by Shippert so that they comprise the coating system taught by Weikart, and not just the silicone coating disclosed by Shippert, would enhance the gas barrier properties in the system and protect the adipose tissue from the materials of the vessels and connectors as taught by Weikart. 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 system disclosed by Shippert so that the common surface on said at least two of the vessels or connectors in the series comprises: a tie coating or layer, a barrier coating or layer; optionally, a pH protective coating or layer; wherein the tie coating or layer comprises SiOxCy or SiNxCy, wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the tie coating or layer having an outer surface facing the walls of the vessels or connectors and having an inner surface facing the cavities; wherein the barrier coating or layer comprises SiOx, wherein x is from 1.5 to 2.9, the barrier coating or layer being from 2 to 1000 nm thick, the barrier coating or layer having an outer surface facing the inner surface of the tie coating or layer and having an inner surface facing the cavities; and wherein the pH protective coating or layer comprises SiOxCy or SiNxCy wherein x is from about 0.5 to about 2.4 and y is from about 0.6 to about 3, the pH protective coating or layer having an outer surface facing the inner surface of the barrier coating or layer and having an inner surface facing the cavities in order to provide enhanced gas barrier properties to the system and protect the adipose tissue from the materials of the vessels and connectors as taught by Weikart.
Regarding claim 13, Shippert in view of Weikart suggests the system of claim 5. As discussed above, Shippert teaches that the tubing, or connectors, connecting to the vessels may be provided with the same silicone coating in order to present a smooth surface which reduces damage to cells and facilitates tissue transport (Shippert: ¶0132). Therefore, Shippert in view of Weikart further suggests that the common surface of the first vessel and the second vessel is optionally identical to the surface residing on the inner surface of the walls of the one or more connectors in the series, in substantially all areas where said inner surface would, absent the surface, come in contact with the biopharmaceutical product.
Regarding claim 16, Shippert in view of Weikart suggests the system of claim 1. Shippert teaches that the system is used for the collection and reinjection of fat, or adipose tissue (¶0018-0020), which is a harvested cell formulation because it is harvested from a patient. Therefore, Shippert in view of Weikart further suggests that the biopharmaceutical product is selected from the group consisting of one of more of the following: an antibody, a bulk biopharmaceutical formulation, a cell culture formulation, a cell suspension, a culture fluid, a biopharmaceutical product, a biopharmaceutical substance, a biopharmaceutical formulation, an expression vector / host formulation, a harvested cell formulation, a host cell composition, a host cell contaminant, a mobile phase, a monoclonal antibody formulation, a product stream, a seed train composition, a stationary phase, a peptide or protein formulation, and a nucleic acid formulation.
Regarding claim 30, Shippert in view of Weikart discloses the system of claim 12. Shippert further teaches that the connectors (Figs. 21 and 23, feats. 2144 and 2312) for transferring the biopharmaceutical product in and out of vessels (Figs. 21 and 23, feat. 2112 and 2308) may have the same coating as the vessels in order to present a smoother surface which reduces damage to the cells and facilitates tissue transport (¶0132). Therefore, Shippert in view of Weikart further suggests that the inner surface of the walls of the one or more connectors in the series is characterized by a surface, residing thereon in substantially all the areas that would, absent the surface, come into contact with the biopharmaceutical product during its production, that is common to the surface residing on the inner surface of the walls of at least one of the vessels in the series in substantially all the areas that would, absent the surface, come into contact with the biopharmaceutical product during its production.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Shippert (US 2009/0287190 A1) in view of Weikart et al. (US 2015/0290080 A1) and in further view of Breaux et al. (US 2016/0074862 A1).
Regarding claim 15, Shippert in view of Weikart suggests the system of claim 12, but does not disclose that each vessel is selected from a group consisting of microplates, microtiter plates, microwell plates, and petri dishes.
Breaux teaches laboratory ware articles (Fig. 1, feat. 20; ¶0021), which include microplates and microwell plates (¶0024-0032) and may be used for in vitro testing (¶0002-0004), coated with an identical surface with identical coatings or layers to that taught by Weikart (Fig. 9; ¶0076 and 0089-0094) in order to advantageously improve the interactions between the laboratory ware articles and biopharmaceutical products held within by reducing non-specific peptide binding, metal contamination, and improving solvent resistance (¶0071-0075). 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 system suggested by Shippert in view of Weikart so that each vessel is selected from a group consisting of microplates, microtiter plates, microwell plates, and petri dishes in order to improve the interactions between the laboratory ware articles used in in vitro testing and the biopharmaceutical product as taught by Breaux.
Conclusion
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
/SARAH AL HASHIMI/Supervisory Patent Examiner, Art Unit 3781