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 Arguments
Applicant's arguments filed 02/17/2026 have been fully considered but they are not fully persuasive.
In response to the applicant’s arguments with respect to Laurence in view of Niedospial and Fazi, notably wherein the taken teachings from paragraph 0038 refer to the composition of a plunger rod, the examiner notes that this was a typographical error, wherein paragraph 0050 describes the metal seal 116 as aluminum. As such the error has been corrected in the rejections below.
Moreover, while Laurance in view of Fazi does not explicitly state the coefficient of thermal expansion, it has been held that wherein the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01. In this instance, because the device of Laurence in view of Niedospial and Fazi comprises all of the same materials as the claimed invention, it would necessarily have the quality that after the cooling of the pharmaceutical container, the shrinkage of the metal-containing cap is greater than or equal to the combined shrinkage of the glass container and the stopper such that the compression is maintained on the upper sealing surface such that a helium leakage rate of the pharmaceutical container is less than or equal to 1.4x10-6 cm3/s at the temperature.
In response to the applicant’s arguments that Fazi does not teach the use of cryogenic temperatures, such that they would be an improvement for the goal of Laurance, the examiner respectfully disagrees.
Fazi is considered pertinent prior art because it pertains to a seal made of a mixture of aluminum and copper. Because the composition of the seal is identical to the seal as claimed, a prima facie case of anticipation or obviousness is established to fulfil the claim limitation. See MPEP 2112.01.
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, 5-10 and 13-14, 18-23 are rejected under 35 U.S.C. 103 as being unpatentable over Laurence (WO 2021162984) in view of Niedospial (US 5895383), and further in view of Fazi (US 20140263319). Astlett Rubber Inc.: Synthetic Rubber (hereinafter Astlett) is used as extrinsic evidence for claims 5 and 18.
Regarding claim 1, Laurence discloses a sealed pharmaceutical container (abstract) comprising:
a shoulder (fig. 14 shows vial 110, which has a shoulder better shown in fig. 9B underneath the neck);
a neck extending from the shoulder (fig. 14 shows neck of vial 110);
a flange extending from the neck (fig. 14, collar 145 as the flange), the flange comprising:
an underside surface extending from the neck (fig. 14, collar 145 has underside in which seal 116 is crimped);
an outer surface extending from the underside surface, the outer surface defining an outer diameter of the flange (fig. 14, outer surface is denoted as the vertical sidewalls of collar 145); and
an upper sealing surface extending between the outer surface and an inner surface defining an opening in the sealed pharmaceutical container (fig. 14, upper sealing surface of collar 145 denoted as top horizontal walls between the defined outer surface and the walls defining an opening), and
a sealing assembly comprising:
a stopper (142) including a sealing portion extending over the upper sealing surface of the flange and covering the opening (fig. 14, stopper 142 has a portion going over the collar 145 and covers the opening of the vial 110), and an insertion portion extending into the opening and in contact with the inner surface of the flange (fig. 14, stopper 142 goes into the opening of vial 110 and contacts the inner walls), the stopper having a first CTE (paragraph 0030, “Generally, the systems according to the various embodiments of the present invention include a container closure comprising an elastomeric body and a material having a coefficient of thermal expansion that is less than the coefficient of thermal expansion of the elastomeric body”, with embodiments such as figure 8B describing the vial stopper 82 as an elastomeric body in paragraph 0048); and
a filler member (147) encased within the stopper and having a second CTE, the second CTE being lower than the first CTE (fig. 14, material 146 within bore 148 of stopper 142, paragraph 0053 describes material 147 with a negative coefficient of thermal expansion, and paragraph 0030 describes a material with a lesser CTE than the elastomeric body).
wherein the filler member comprises a first material, the first material including at least one of glass, a crystalline material, a polymer, and a metal (paragraph 0039, describing the second material with a negative coefficient of thermal expansion including silicates, titanium-based alloys, alloys containing zirconium, etc.), and
a metal-containing cap (116) extending over the sealing portion of the stopper (fig. 14) and along the outer surface of the flange to contact the underside surface of the flange, thereby compressing the sealing portion of the stopper (“The annular lip 118 abuts the underside of the annual collar 15 and assists in maintaining an axial force onto the top surface of the stopper 112”)
Laurence discloses wherein the metal-containing cap is constructed of aluminum (paragraph 0050), but does not teach wherein the second material includes at least one of butyl rubber, nitrile rubber, fluoro rubber, butyl silicone rubber, and polyacrylate elastomer, wherein the metal-containing cap is constructed of a metallic alloy comprising at least two of Zinc, Aluminum, Magnesium, and Copper, wherein a shrinkage of the metal-containing cap is greater than or equal to a combined shrinkage of the pharmaceutical container and the stopper such that the sealing assembly maintains a helium leakage rate of the sealed pharmaceutical container.
However, Niedospial teaches an elastomeric stopper for a container (abstract) that cites the use of an inert chlorobutyl rubber coating the stopper (col. 1, lines 15-34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Laurence such that the first material is coated with a second material, the second material including a butyl rubber, as taught by Niedospial, for the purpose of providing a suitable structure that insulates the stopper form the contents of the container to prevent contact and possible chemical reactions therebetween (see Niedospial, col. 1, lines 15-34)
Laurence does not teach wherein a shrinkage of the metal-containing cap is greater than or equal to a combined shrinkage of the pharmaceutical container and the stopper such that the sealing assembly maintains a helium leakage rate of the sealed pharmaceutical container at least than or equal to 1.4x10-6 cm3/s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to -450C.
However, Fazi teaches a pharmaceutical container (abstract) wherein a collar used in place of a standard vial cap (paragraph 0002) can be made of a combination of copper and aluminum (paragraph 0031, “the collar or portions thereof may be composed of a metal or metal alloy such as, but not limited to, aluminum, steel, copper, brass, and the like and combinations thereof”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Laurence such that the metal-containing cap is constructed of a metallic allow comprising at least two of aluminum and copper, as taught by Fazi, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (in this instance as a cap for a medicament container). In re Leshin, 125 USPQ 416.
Laurence, as modified by Fazi, is silent to wherein a shrinkage of the metal-containing cap is greater than or equal to a combined shrinkage of the pharmaceutical container and the stopper such that the sealing assembly maintains a helium leakage rate of the sealed pharmaceutical container at less than or equal to 1.4x10-6 cm3/s as the sealed pharmaceutical container is cooled to a temperature of less than or equal to -45 0C.
However, it has been held that wherein the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01. In this instance, because the device of Laurence in view of Niedospial and Fazi comprises all of the same materials as the claimed invention, it would necessarily have the quality that after the cooling of the pharmaceutical container, the shrinkage of the metal-containing cap is greater than or equal to the combined shrinkage of the glass container and the stopper such that the compression is maintained on the upper sealing surface such that a helium leakage rate of the pharmaceutical container is less than or equal to 1.4x10-6 cm3/s at the temperature.
Regarding claim 3, Laurence discloses wherein the first material includes at least one of oxide, halide, nitride, and chalcogen (paragraph 0039 describes the material being a silicate, which are oxides).
Regarding claim 5, Laurence, as modified by Niedospial, discloses wherein the second material has a thermal glass transition temperature between -200 0C to 300 0C (see Niedospial, col. 1, lines 15-34 utilizing chlorobutyl rubber, with a thermal glass transition temperature of -65 0C, see Astlett).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Laurence such that the second material has a thermal glass transition temperature between -200 0C to 300 0C, as taught by Niedospial, for the purpose of providing a suitable structure that insulates the stopper from the contents of the container to prevent contact and possible chemical reactions therebetween (col. 1, lines 15-34).
Regarding claim 6, Laurence does not teach wherein the filler member includes a filler body having a body diameter greater than an opening diameter of the opening of the sealed pharmaceutical container.
However, another embodiment of Laurence teaches the user of a ring-shaped insert (114) above the flange portion and with a diameter greater than an opening diameter of the opening of the sealed pharmaceutical container (fig. 11, ring-shaped insert 114, paragraph 0050).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in fig. 14 of Laurence either to additionally include ring-shaped filler member to the stopper, or to modify the filler member of the embodiment in fig. 14 such that it has a body diameter greater than an opening diameter of the opening of the sealed pharmaceutical container, as suggested by fig. 11 of Laurence, for the purpose of providing a suitable structure that allows for a vertical compressive force in addition to a horizontal compressive force (see Laurence, fig. 11 demonstrates material 114 comprising downwards), thus creating a further improved seal.
Regarding claim 7, Laurence discloses wherein a body channel is formed extending through an upper surface of the filler body and a lower surface of the filler body (fig. 14, bore 148 within stopper 142 is also defined through openings in the upper and lower surfaces of the material 147).
Regarding claim 8, Laurence discloses wherein the filler member includes a filler protrusion extending at least partially through the opening of the pharmaceutical container and parallel to the inner surface of the pharmaceutical container (see annotated fig. 14 below).
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Regarding claim 9, Laurence discloses wherein a protrusion channel is formed extending through an upper surface of the filler protrusion and a lower surface of the protrusion (fig. 14, bore 148 also defined by filler protrusion), the body and the protrusion form a one-piece monolithic structure (fig. 14, body of material 147 as one piece between body and protrusion underneath), and the protrusion channel and the body channel are coaxial with one another (fig. 14, body and protrusion are coaxial).
Regarding claim 10, Laurence discloses wherein the filler member includes a filler protrusion extending at least partially through the opening of the pharmaceutical container and parallel to the inner surface of the pharmaceutical container (see annotated fig. 14 above), the filler protrusion having a protrusion diameter less than an opening diameter of the opening of the sealed pharmaceutical container (fig. 14 above has the filler protrusion as defined have a lesser diameter than the opening of the vial 110).
Regarding claim 13, Laurence discloses wherein the flange (which is a part of the vial) is constructed of a composition having a coefficient of thermal expansion that is greater than or equal to 0-70 x 10-7/K (paragraph 0038 describes the vial being made of common materials such as polypropylene, which is demonstrated to have a coefficient of thermal expansion of 100 x 10-6/K, or 1 x 10-4/K).
Regarding claim 14, Laurence discloses a method of sealing a pharmaceutical container, the method comprising:
providing a pharmaceutical container (110) comprising a shoulder, a neck extending from the shoulder and a flange extending from the neck (fig. 14 shows vial 10, which has a shoulder better shown in fig. 9B underneath the neck, fig. 14 shows the neck and collar 145 as the flange), the flange comprising:
an underside surface extending from the neck (fig. 14, collar 145 has underside in which seal 116 is crimped);
an outer surface extending from the underside surface, the outer surface defining an outer diameter of the flange (fig. 14, outer surface is denoted as the vertical sidewalls of collar 145); and
an upper sealing surface extending between the outer surface to an inner surface of the pharmaceutical container that defines an opening (fig. 14, upper sealing surface of collar 145 denoted as top horizontal walls between the defined outer surface and the walls defining an opening);
inserting a pharmaceutical composition into the pharmaceutical container (the pharmaceutical composition is implied to be placed in the container before adding a stopper as best understood by one of ordinary skill in the art); and
providing a stopper (142) including a sealing portion extending over the upper sealing surface of the flange and covering the opening (fig. 14, stopper 142 has a portion going over the collar 145 and covers the opening of the vial 110), and an insertion portion extending into the opening and in contact with the inner surface of the flange (fig. 14, stopper 142 goes into the opening of vial 110 and contacts the inner walls), the stopper having a first CTE (paragraph 0030, “Generally, the systems according to the various embodiments of the present invention include a container closure comprising an elastomeric body and a material having a coefficient of thermal expansion that is less than the coefficient of thermal expansion of the elastomeric body”, with embodiments such as figure 8B describing the vial stopper 82 as an elastomeric body in paragraph 0048), a filler member (147) encased within the stopper and having a second CTE, the second CTE being lower than the first CTE (fig. 14, material 146 within bore 148 of stopper 142, paragraph 0053 describes material 147 with a negative coefficient of thermal expansion, and paragraph 0030 describes a material with a lesser CTE than the elastomeric body)
wherein the filler member comprises a first material, the first material including at least one of glass, a crystalline material, a polymer, and a metal (paragraph 0039, describing the second material with a negative coefficient of thermal expansion including silicates, titanium-based alloys, alloys containing zirconium, etc.)
crimping a metal-containing cap (116) over the sealing portion of the stopper and along the outer surface of the flange to contact the underside surface of the flange, thereby compressing the sealing portion of the stopper (fig. 14, metal seal 116 over the stopper and compresses said stopper, paragraph 0050), and
cooling the pharmaceutical container to a temperature of less than or equal to -20 0C (paragraph 0038 describes the material utilized in the invention having desired properties at cryogenic temperatures defined as less than -150 0C).
but does not teach wherein the first material is coated with a second material, the second material including at least one of butyl rubber, nitrile rubber, fluoro rubber, butyl silicone rubber, and polyacrylate elastomer, wherein the metal-containing cap is constructed of a metallic alloy comprising at least two of Zn, Al, Mg, and Cu, wherein, after the cooling of the pharmaceutical container, the shrinkage of the metal-containing cap is greater than or equal to the combined shrinkage of the glass container and the stopper such that the compression is maintained on the upper sealing surface such that a helium leakage rate of the pharmaceutical container is less than or equal to 1.4x106 cm3/s at the temperature.
However, Niedospial teaches an elastomeric stopper for a container (abstract) that cites the use of an inert chlorobutyl rubber coating the stopper (col. 1, lines 15-34).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Laurence such that the first material is coated with a second material, the second material, the second material including a butyl rubber, as taught by Niedospial, for the purpose of providing a suitable structure that insulates the stopper from the contents of the container to prevent contact and possible chemical reactions therebetween (col. 1, lines 15-34).
Laurence, as modified by Niedospial, discloses wherein the metal-containing cap is constructed of aluminum (see Laurence, paragraph 0050) does not teach wherein the metal-containing cap is constructed of a metallic alloy comprising at least two of Zn, Al, Mg, and Cu, wherein, after the cooling of the pharmaceutical container, the shrinkage of the metal-containing cap is greater than or equal to the combined shrinkage of the glass container and the stopper such that the compression is maintained on the upper sealing surface such that a helium leakage rate of the pharmaceutical container is less than or equal to 1.4x106 cm3/s at the temperature.
However, Fazi teaches a pharmaceutical container (abstract) wherein a collar used in place of a standard vial cap (paragraph 0002) can be made of a combination of copper and aluminum (paragraph 0031, “the collar or portions thereof may be composed of a metal or metal alloy such as, but not limited to, aluminum, steel, copper, brass, and the like and combinations thereof”).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method disclosed in Laurence such that the metal-containing cap is constructed of a metallic allow comprising at least two of aluminum and copper, as taught by Fazi, since it has been held to be within the general skill of a worker in the art to select a known material on the basis of its suitability for the intended use (in this instance as a cap for a medicament container). In re Leshin, 125 USPQ 416.
Laurence, as modified by Niedospial and Fazi, does not teach wherein, after the cooling of the pharmaceutical container, the shrinkage of the metal-containing cap is greater than or equal to the combined shrinkage of the glass container and the stopper such that the compression is maintained on the upper sealing surface such that a helium leakage rate of the pharmaceutical container is less than or equal to 1.4x106 cm3/s at the temperature.
However, it has been held that wherein the claimed and prior art products are identical or substantially identical in structure or composition, a prima facie case of either anticipation or obviousness has been established. See MPEP 2112.01. In this instance, because the device of Laurence in view of Niedospial and Fazi comprises all of the same materials as the claimed invention, it would necessarily have the quality that after the cooling of the pharmaceutical container, the shrinkage of the metal-containing cap is greater than or equal to the combined shrinkage of the glass container and the stopper such that the compression is maintained on the upper sealing surface such that a helium leakage rate of the pharmaceutical container is less than or equal to 1.4x106 cm3/s at the temperature.
Regarding claim 18, Laurence, as modified by Niedospial, discloses wherein the second material has a thermal glass transition temperature between -200 0C to 300 0C (see Niedospial, col. 1, lines 15-34 utilizing chlorobutyl rubber, with a thermal glass transition temperature of -65 0C, see Astlett).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Laurence such that the second material has a thermal glass transition temperature between -200 0C to 300 0C, as taught by Niedospial, for the purpose of providing a suitable structure that insulates the stopper from the contents of the container to prevent contact and possible chemical reactions therebetween (col. 1, lines 15-34).
Regarding claim 19, the embodiment of fig. 14 of Laurence discloses wherein the filler member includes a filler body (see annotated fig. 14 below), but does not teach wherein the filler body has a body diameter equal to or greater than an opening diameter of the opening of the sealed pharmaceutical container.
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However, another embodiment of Laurence teaches the user of a ring-shaped insert (114) above the flange portion and with a diameter greater than an opening diameter of the opening of the sealed pharmaceutical container (fig. 11, ring-shaped insert 114, paragraph 0050).
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Laurence either to additionally include ring-shaped filler member to the stopper, or to modify the filler member of the embodiment in fig. 14 such that it has a body diameter greater than an opening diameter of the opening of the sealed pharmaceutical container, as suggested by fig. 11 of Laurence, for the purpose of providing a suitable structure that allows for a vertical compressive force in addition to a horizontal compressive force (see Laurence, fig. 11 demonstrates material 114 comprising downwards), thus creating a further improved seal.
Regarding claim 20, Laurence discloses wherein a body channel is formed extending through an upper surface of the body and a lower surface of the body (fig. 14, bore 148 within stopper 142 is also defined through openings in the upper and lower surfaces of the material 147).
Regarding claim 21, Laurence discloses wherein the filler member includes a filler protrusion extending at least partially through the opening of the pharmaceutical container and parallel to the inner surface of the pharmaceutical container (see annotated fig. 14 below).
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Regarding claim 22, Laurence discloses wherein a protrusion channel is formed extending through an upper surface of the protrusion and a lower surface of the protrusion (fig. 14, bore 148 also defined by filler protrusion), the body and the protrusion form a one-piece monolithic structure (fig. 14, body of material 147 as one piece between body and protrusion underneath), and the protrusion channel and the body channel are coaxial with one another (fig. 14, body and protrusion are coaxial).
Regarding claim 23, Laurence discloses wherein the filler member includes a filler protrusion extending at least partially through the opening of the pharmaceutical container and parallel to the inner surface of the pharmaceutical container (see annotated fig. 14 above), the filler protrusion having a protrusion diameter less than an opening diameter of the opening of the pharmaceutical container (fig. 14 above has the filler protrusion as defined have a lesser diameter than the opening of the vial 110).
Claim 12 is rejected under 35 U.S.C. 103 as being unpatentable over Laurence in view of Niedospial and Fazi, and further in view of Wadsworth (US 4084718).
Regarding claim 12, Laurence does not teach wherein the upper sealing surface is an inclined sealing surface extending at an angle relative to a plane extending through an end of the opening such that a distance between the inclined sealing surface and the plane increases with decreasing radial distance from the outer surface.
However, Wadsworth teaches a stopper in a vial (abstract) wherein an end surface (13) is an inclined sealing surface extending at an angle relative to a plane extending through an end of the opening (fig. 1, circular junction 13 as an inclined sealing surface for stopper 21, inclined at an angle relative to a horizontal plane at an end of the opening), such that a distance between the inclined sealing surface and the plane increases with decreasing radial distance from the outer surface (fig. 1, circular junction 13 slopes downwards and the distance increases with decreasing distance from the outer surface vertical walls)
Therefore, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device disclosed in Laurence such that wherein the upper sealing surface is an inclined sealing surface extending at an angle relative to a plane extending through an end of the opening such that a distance between the inclined sealing surface and the plane increases with decreasing radial distance from the outer surface, as taught by Wadsworth, for the purpose of providing a suitable structure that creates a fluid tight seal against the sealing surface while leaving the center of the septum stress-free to withstand multiple punctures (see Wadsworth, col. 2, lines 59-68 and col. 3, lines 1-10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRANDON W LEVY whose telephone number is (571)272-7582. The examiner can normally be reached M-F 7:30AM- 4:00 PM.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Rebecca Eisenberg can be reached on 5712705879. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/Brandon W. Levy/Examiner, Art Unit 3781