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
An amendment was filed on 01/13/2026. Claims 1, 19, 22, and 24 have been added, and new claims 32-35 have been added. Claims 1-8, 10-11, 13-14, 18-20, 22-24, and 26-35 are pending with claims 28-31 still being restricted per the requirement sent on 07/14/2025. Claims 1-8, 10-11, 13-14, 18-20, 22-24, 26-27, and 32-35 are being examined on the merits.
Response to Arguments
Applicant’s arguments with respect to claim(s) 1-8, 10-11, 13-14, 18-20, 22-24, 26-35 have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument. Notably, newly cited Biesecker (US 5197602) is utilized as a primary reference.
Claim Objections
Claim 27 is objected to because of the following informalities:
Claim 27 recites at least one trademark/trade name (i.e., Forane, Ultane, etc.), which renders the claim indefinite. However, because the list of drugs has instances that are not trademarked, examiner recommends merely removing the trademarked drugs.
Appropriate correction is required.
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 1-4, 32-33, and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Biesecker (US 5197602) in view of Cohen (US 5318183), and further in view of Bantug (US 20190152650).
Regarding claim 1, Biesecker discloses a vial (abstract) comprising
an external base and an external sidewall extending up from the external base (fig. 1, outer container 10 with container bottom 14 and container wall 18), the external sidewall narrowing at an upper section of the vial to form a neck (fig. 1, neck portion 22), the neck leading to a rim surrounding an opening providing access to a product compartment (fig. 1, neck 22 leading to a rim near opening into interior 40 of container insert 12), the external base, the external sidewall, the neck and the rim together defining an outer profile of the vial (fig. 1, outer container 10 defining outer profile), the outer profile being symmetrical about a central axis (fig. 1 shows outer container 10 as symmetrical), the vial further comprising an internal sidewall (38) that is spaced radially inward relative to the external sidewall such that a void exists between the internal sidewall and the external sidewall (fig. 3, insert 12 with wall 38 forming a void between it and wall 18), the internal sidewall extending downward to an internal base (fig. 2, insert 12 with bottom 34), the internal sidewall and internal base forming an enclosure that defines the product compartment (fig. 2, insert 12 for holding medicament), the vial comprising contents in frozen form stored in the product compartment (col. 7, lines 50-54 describes pills which are in solid form/frozen form), the product compartment having a fixed volume that remains unchanged during storage and during extraction of the contents (fig. 4 shows insert 12 as solid without a means of altering the volume), the product compartment terminating at a floor that is intersected at its geometric center by the central axis, there being no portion of the product compartment positioned below the floor (fig. 4 fully shows insert 12 as a fully enclosed volume with no portion of product compartment below bottom 34).
Biesecker does not teach wherein the product compartment is conical, frustoconical, or substantially conical in profile.
However, Cohen teaches a means of storing medicament (abstract) with a similar product compartment that is frustoconical in profile (fig. 1 shows an interior tube 30, with a taper shown in fig. 2 to make the profile frustoconical for tube 40, col. 2, lines 26-44).
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 Biesecker such that the product compartment is frustoconical, as taught by Cohen, for the purpose of providing a suitable structure that allows for rapid insertion of the insert into the container (see Cohen, col. 2, lines 26-44).
Moreover, if the interpretation of pills being in solid form and therefore being frozen is not clearly envisioned by the applicant, Bantug teaches wherein the contents are in cryogenically frozen form (paragraph 0011).
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 Biesecker such that the contents are in cryogenically frozen form, as taught by Bantug, for the purpose of providing a suitable means of insuring molecular integrity of certain products (see Bantug, paragraph 0003).
Regarding claim 2, Biesecker discloses the vial being round about the central axis (fig. 1 shows outer container 10 as cylindrical), the internal sidewall extending from an internal portion of the neck, downward to the internal base, the internal sidewall having an inner diameter no greater than the inner diameter of the neck (fig. 3 shows insert 12 starting from internal of neck 22 and having no greater diameter than inner diameter of neck 22, fig. 4 shows insert 12 extending into its internal base).
Regarding claim 3, Biesecker discloses wherein the vial is made from a thermoplastic material and is formed by injection molding (col. 5, lines 64-68 and col. 6, lines 1-10 describe thermoplastic material and injection-blow moldable material ).
Regarding claim 4, Biesecker is silent to wherein the outer profile has dimensions that comply with ISO 8362-7:2006.
However, because ISO 8362-7:2006 is a standard format for mass production, 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 Denning such that the outer profile has dimensions that comply with ISO 8362-7:2006, for the purpose of providing a suitable standard set of measurements for mass production as standard practice.
Regarding claim 32, Biesecker does not teach the device comprising contents in cryogenically frozen form, prior to being converted to the product in the liquid state, stored in the product compartment.
However, Bantug teaches a vial sleeve assembly (abstract) wherein contents are cryogenically frozen (paragraph 0011), and are liquid prior to freezing (paragraph 0140)
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 Biesecker such that the contents are in cryogenically frozen form, prior to being converted to the product in the liquid state, stored in the product compartment, as taught by Bantug, for the purpose of providing a suitable means of insuring molecular integrity of certain products (see Bantug, paragraph 0003).
Regarding claim 33, Biesecker does not teach wherein the contents are in cryogenically frozen form.
However, Bantug teaches wherein the contents are in cryogenically frozen form (paragraph 0011).
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 Biesecker such that the contents are in cryogenically frozen form, as taught by Bantug, for the purpose of providing a suitable means of insuring molecular integrity of certain products (see Bantug, paragraph 0003).
Regarding claim 35, Biesecker discloses the internal base being located proximal to a plane defined by the external base (fig. 4, bottom of insert 12 proximal to the plane defining the bottom of outer container 10).
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Cohen and Bantug, and further in view of Charan (US 20070116649).
Regarding claim 5, Biesecker does not teach wherein the vial is provided as a member selected as an ISO standard 6R format.
However, Charan teaches wherein vials at the ISO standard 6R format are well known in the art (paragraph 0150).
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 Denning such that the vial is provided as a member selected as an ISO standard 6R format, as taught by Charan, for the purpose of providing a suitable structure that conforms to a desired standard for mass production.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Cohen and Bantug, and further in view of Denning (US 20130261591).
Regarding claim 6, Biesecker does not teach wherein the product compartment is in fluid communication with a stopper cavity located directly above the product compartment, the stopper cavity being defined by a portion of the vial located inward of the neck and the rim.
However, Denning teaches discloses wherein the product compartment is in fluid communication with a stopper cavity located directly above the product compartment (see annotated fig. 3 below), the stopper cavity being defined by a portion of the vial located inward of the neck and the rim (see annotated fig. 3 below), the stopper cavity being configured and sized to receive a portion of a stopper to seal the vial (fig. 3, stopper 28 received within the stopper cavity as defined below).
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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 Biesecker such that the product compartment is in fluid communication with a stopper cavity located directly above the product compartment, the stopper cavity being defined by a portion of the vial located inward of the neck and the rim, as taught by Denning, for the purpose of providing a suitable structure that allows for a seal for liquid material that allows for extraction via a syringe (see Denning, paragraph 0022).
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over Denning in view of Cohen and Bantug, and further in view of Weikart (US 20140251859).
Regarding claim 7, Biesecker does not teach wherein the vial is made from an olefin polymer or copolymer.
However, Weikart teaches that cyclic olefin copolymer is a well-known material used in making vials (paragraph 0238, “A cyclic olefin copolymer (COC) resin was injection molded to form a batch of 5 ml vials.”).
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 Biesecker such that the vial is made from an olefin copolymer, as taught by Weikart, 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 for holding a medicament. In re Leshin, 125 USPQ 416.
Claim 8 is rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Cohen, Bantug, and Weikart, and further in view of Weitzel (US 20110022023).
Regarding claim 8, Biesecker, as modified by Weikart, discloses wherein the vial is made from cyclic olefin copolymer (see Weikart, paragraph 0238), but is silent to wherein the product compartment is configured to store precisely 0.50 mL of product, the vial having an outer profile with standard dimensions of an ISO standard 2mL vial.
However, it would have been obvious to modify the device disclosed in Denning in view of Weikart such that the vial has an outer profile with standard dimensions of an ISO standard 2 mL vial, for the purpose of providing a suitable structure that follows a standard for mass production.
Moreover, Weitzel teaches wherein single dose vials of a medicament, such as a vaccine, are at 0.5 ml (paragraph 0002, “single dose vials containing substantially a single dose (e.g. 0.5 ml volume) of a given vaccine are used”).
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 Denning in view of Weikart such that the product compartment is configured to store precisely 0.50 mL of product, as taught by Weitzel, for the purpose of providing a suitable volume that is capable of serving a specific desired dose of a medicament (see Weitzel, paragraph 0002).
Claims 10-11 and 13-14 are rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Cohen and Bantug, and further in view of Baltazar (WO 2019191269, published 10/03/2019).
Regarding claim 10, Biesecker discloses the vial comprising:
an external vial surface that includes an outer surface of the external sidewall, an outer surface of the neck and an outer surface of the rim (fig. 1, outer container 10)
an internal surface that includes an inside of the produce compartment and any other surface in fluid communication therewith (fig. 2, container insert 12 has an internal surface), and
an external product compartment surface that includes an outer surface of the product compartment (fig. 2, container insert 12 has an external surface).
Biesecker does not teach wherein at least a portion of at least one of the external vial surface, the internal surface and the external product compartment comprises at least one plasma enhanced chemical vapor deposition (PECVD) coating or layer disposed thereon.
However, Baltazar teaches at least one PECVD coating disposed on the internal surface of a container (fig. 2A, water barrier coating 300 on the wall 214 of container, as well as a tri layer comprising layers 286, 288, and 289, paragraph 0068. Paragraph 0032 also describes both sets being a PECVD coating).
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 Biesecker such that at least a portion of at least one of the external vial surface, the internal surface and the external product compartment comprises at least one plasma enhanced chemical vapor deposition (PECVD) coating or layer disposed thereon, as taught by Baltazar, for the purpose of providing a suitable structure that increases shelf life by increasing water barrier and oxygen barrier efficacy (see Baltazar, paragraph 0007).
Regarding claim 11, Biesecker does not teach a PECVD water barrier coating or layer deposited onto at least a portion of at least of the external vial surface, the internal surface and the external product compartment surface, the PECVD water barrier coating or layer having a water contact angle of from larger than 80 degrees to less than 180 degrees.
However, Baltazar teaches wherein the PECVD coating comprises a water barrier coating (300) with a water contact angle larger than 80 degrees and less than 180 degrees (fig. 2A, water barrier layer 300, paragraph 0059).
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 Biesecker such that it includes a PECVD water barrier coating or layer deposited onto at least a portion of at least of the external vial surface, the internal surface and the external product compartment surface, the PECVD water barrier coating or layer having a water contact angle of from larger than 80 degrees to less than 180 degrees, as taught by Baltazar, for the purpose of providing a suitable structure that increases useful shelf life by improving water barrier efficacy (see Baltazar, paragraph 0007).
Regarding claim 13, Biesecker does not teach wherein the vial comprises a PECVD tri-layer coating set deposited onto the internal surface.
However, Baltazar teaches wherein the fluid container comprises a PECVD tri-layer coating set deposited onto the internal surface (fig. 2A, internal wall of wall 214 coated with a trilayer comprising tie coating 289, barrier coating 288, and pH protective coating 286 as part of layer set 285, paragraph 0068).
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 Biesecker such that the vial comprises a PECVD tri-layer coating set deposited onto the internal surface, as taught by Baltazar, for the purpose of providing a suitable structure that increases useful shelf life by adding an oxygen barrier (see Baltazar, paragraph 0007)
Regarding claim 14, Biesecker does not teach (a) the PECVD water barrier coating or layer deposited onto the internal surface and a PECVD tri-layer coating set deposited atop the PECVD water barrier coating or layer, or (b) the PECVD tri-layer coating set deposited onto the internal surface and the PECVD water barrier coating or layer deposited atop the PECVD tri-layer coating set.
However, Baltazar teaches wherein a PECVD tri-layer coating layer (286, 288, 289) is deposited onto the internal surface (fig. 2A, tri-layer comprising pH protective coating, gas barrier coating layer described in paragraph 0062, and tie layer 289 described in paragraph 0063), with the PECVD water barrier coating (300) on top of the PECVD tri-layer (fig. 2A, water barrier layer 300 on top of the trilayer of 286, 288, and 289, paragraph 0068).Fig. 2B also shows the water barrier coating or layer is underneath the tri-layer coating.
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 Biesecker such that it comprises (a) the PECVD water barrier coating or layer deposited onto the internal surface and a PECVD tri-layer coating set deposited atop the PECVD water barrier coating or layer, or (b) the PECVD tri-layer coating set deposited onto the internal surface and the PECVD water barrier coating or layer deposited atop the PECVD tri-layer coating set, as taught by Baltazar, for the purpose of providing a suitable structure that increases shelf life by increasing water barrier and oxygen barrier efficacy (see Baltazar, paragraph 0007).
Claim 18 is rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Cohen and Bantug, and further in view of Howard (US 4746017)
Regarding claim 18, Biesecker does not teach a plurality of ribs running axially between the internal sidewall and external sidewall so as to occupy a portion of the void, thereby bridging the internal sidewall with the external sidewall so as to reinforce the external sidewall
However, Howard teaches a vial for holding medication (abstract) comprising a plurality of ribs (32) running axially between the internal sidewall and external sidewall so as to occupy a portion of the void (fig. 3, ribs 32 engage with outer surface of vial 18 within), thereby bridging the internal sidewall with the external sidewall so as to reinforce the external sidewall (fig. 3, if ribs 32 engage with the outer surface of vial 18, they also reinforce the external sidewall. The ribs also occupy and create an air space between body 12 and vial 18, col. 2, lines 47-58).
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 Denning such that it comprises a plurality of ribs running axially between the internal sidewall and external sidewall so as to occupy a portion of the void, thereby bridging the internal sidewall with the external sidewall so as to reinforce the external sidewall, as taught by Howard, for the purpose of providing a suitable structure that can hold the internal structure more snugly in position with the outer vial while still providing an air space to act as further cushioning (see Howard, col. 2, lines 47-58).
Claims 19-20 are rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Brodner (US 20030071040).
Regarding claim 19, Biesecker discloses an external base and an external sidewall extending up from the external base (fig. 1, outer container 10 with container bottom 14 and container wall 18), the external sidewall narrowing at an upper section of the vial to form a neck (fig. 1, neck portion 22), the neck leading to a rim surrounding an opening providing access to a product compartment (fig. 1, neck 22 leading to a rim near opening into interior 40 of container insert 12), the external base, the external sidewall, the neck and the rim together defining an outer profile of the vial (fig. 1, outer container 10 defining outer profile), the outer profile being symmetrical about a central axis (fig. 1 shows outer container 10 as symmetrical), the vial further comprising an internal sidewall (38) that is spaced radially inward relative to the external sidewall such that a void exists between the internal sidewall and the external sidewall (fig. 3, insert 12 with wall 38 forming a void between it and wall 18), the internal sidewall extending downward to an internal base (fig. 2, insert 12 with bottom 34), the internal sidewall and internal base forming an enclosure that defines the product compartment (fig. 2, insert 12 for holding medicament),
the product compartment having a fixed volume (fig. 4 shows insert 12 as solid without a means of altering the volume), the product compartment terminating at an immovable floor located at the central axis (fig. 4, bottom of insert 12 is immovable), the floor being configured to allow product in a liquid state to pool and thereby facilitate extraction of all drug product from the product compartment (fig. 4, bottom 34 is solid to let liquid pool, also see col. 7, lines 50-52).
Biesecker does not teach the vial comprising a bottom cap assembled to an underside of the vial
However, Brodner teaches means of holding material (abstract) that comprises a bottom cap (200) assembled to an underside of the vial (fig. 4, bottom plug 200 at the bottom of jar 100)
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 Biesecker such that the vial comprises a bottom cap assembled to an underside of the vial, as taught by Brodner, for the purpose of providing a suitable structure that covers the bottom of the vial (see Brodner, paragraph 0015), thus granting more protection to the internal components.
Regarding claim 20, Biesecker does not teach wherein the bottom cap provides a seating surface configured to stabilize the vial when standing upon a resting surface, wherein the bottom cap is assembled to an inner surface of the external sidewall at a location adjacent to the external base.
However, Brodner teaches wherein the bottom cap (200) provides a seating surface configured to stabilize the vial when standing upon a resting surface (fig. 2, bottom plug 200 configured to stabilize vial as a flat surface), wherein the bottom cap is assembled to an inner surface of the external sidewall at a location adjacent to the external base (fig. 4, bottom plug 200 has a central lip portion 205 that engages with internal face of external wall)
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 Biesecker such that the bottom cap provides a seating surface configured to stabilize the vial when standing upon a resting surface, wherein the bottom cap is assembled to an inner surface of the external sidewall at a location adjacent to the external base, as taught by Brodner, for the purpose of providing a suitable structure that covers the bottom of the vial (see Brodner, paragraph 0015), thus granting more protection to the internal components.
Claim 23 is rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Brodner, and further in view of Fowles (US 6022339)
Regarding claim 23, Biesecker, as modified by Brodner, does not teach wherein the bottom cap includes a plurality of openings configured to allow sterilization gas to migrate into the void during a sterilization procedure
However, Fowles teaches a sealing member (61) that comprises a central opening for steam sterilization past the sealing member and into a hollow chamber (col. 11, lines 24-56, “The central opening would also allow for steam sterilization past the sealing member 61”).
The seal member of Fowles is considered pertinent prior art because it pertains to a seal for a hollow chamber. 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 Denning in view of Brodner such that the bottom cap includes an opening configured to allow sterilization gas to migrate into the void during a sterilization procedure, as taught by Fowles, for the purpose of providing a suitable structure that allows for steam to enter the internal components for sterilization (see Fowles, col. 11, lines 24-56).
Denning, as modified by Fowles, does not teach a plurality of openings.
However, 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 Denning in view of Brodner and Fowles such that the bottom cap has a plurality of openings for sterilization, for the purpose of providing a suitable structure that lets more steam enter the system faster for sterilization (see Fowles, col. 11, lines 24-56), and since it has been held that a duplication of parts involves routine skill in the art. In re Harza, 274 F.2d 669, 124 USPQ 378 (CCPA 1960).
Claims 24 and 26-27 are rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Brodner and further in view of Tsakas (US 20170258683).
Regarding claim 24, Biesecker discloses the vial comprising contents in liquid form stored in the product compartment (col. 7, lines 50-54), the vial further comprising a cap or stopper to fully or partially close the opening (col. 8, lines 16-24, “After the material to be packaged is deposited into the container insert 12 the outer container is then sealed with a cap or the like”), but does not teach contents in a frozen or lyophilized form, prior to being converted to the product in the liquid state.
However, Tsakas teaches wherein the sample solution is lyophilized, wherein a liquid solvent is frozen and heated in vacuum such that the solvent sublimes (paragraph 0003 and 0039).
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 Biesecker such that the contents are in a frozen or lyophilized form, prior to being converted to the product in the liquid state, as taught by Tsakas, for the purpose of providing a suitable structure that allows for safe storage of certain biological agents (see Tsakas, paragraphs 0002-0003).
Regarding claim 26, Biesecker does not teach wherein the contents comprise biologic drugs.
However, Tsakas teaches wherein biologic drugs in vials are well known in the art (paragraph 0002, “examples of such active biological agents include proteins, enzymes, nucleic acid sequences, and vaccines”).
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 Biesecker such that the contents comprise biologic drugs, as taught by Tsakas, for the purpose of providing antibiotics, treatments for HIV, etc. (see Tsakas, paragraph 0002).
Regarding claim 27, Biesecker is silent to wherein the contents are drug contents or diagnostic tests that are at least one member selected from drug classes, which includes vaccines.
However, Tsakas teaches wherein vials containing drug classes including antibiotics are well known in the art (paragraph 0002).
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 Biesecker to include antibiotics, as taught by Tsakas, for the purpose of providing a suitable drug used to treat specific illnesses.
Claim 34 is rejected under 35 U.S.C. 103 as being unpatentable over Biesecker in view of Cohen, and further in view of Brodner.
Regarding claim 34, Biesecker does not teach the device comprising a bottom cap assembled to an underside of the vial, wherein the internal base engages the bottom cap.
However, Brodner teaches a means for storing fluid (abstract) wherein the device comprises a bottom cap (200) assembled to an underside of the vial (fig. 1, bottom plug 200 at the bottom of the container 100), wherein the internal base (135) engages the bottom cap (fig. 1, bottom plug 200 engaging with closed bottom end 135 of inner wall structure 105).
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 Biesecker such that it comprises a bottom cap assembled to an underside of the vial, wherein the internal base engages the bottom cap, as taught by Brodner, for the purpose of providing a suitable structure that covers the bottom of the vial (see Brodner, paragraph 0015), thus granting more protection to the internal components.
Allowable Subject Matter
Claim 22 is allowed.
The following is an examiner’s statement of reasons for allowance:
Regarding claim 22, Biesecker, as modified by Brodner, discloses most of the structure of claim 22 as recited in claim 19, but does not teach wherein the bottom cap comprises a thru-hole into which the internal base protrudes and with which the internal base engages.
While Fowles teaches a motivation to place a thru-hole at the bottom cap to allow for steam sterilization of a hollow chamber, it does not fairly teach the internal base of Denning protruding into the thru hole and engaging with the thru-hole.
Cohen ‘762 (US 20050270762) discloses an axially-extending projection fitting into a bottom base. However, not only does the bottom cap not have a thu hole, this projection is meant to engage and rupture ampules within the compartment for a chemiluminescent material, and as such does not appear to be pertinent to the invention of Biesecker.
The prior art of record does not teach wherein the bottom cap comprises a thru-hole into which the internal base protrudes and with which the internal base engages. For these reasons, claim 22 is allowable.
Any comments considered necessary by applicant must be submitted no later than the payment of the issue fee and, to avoid processing delays, should preferably accompany the issue fee. Such submissions should be clearly labeled “Comments on Statement of Reasons for Allowance.”
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 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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/Brandon W. Levy/Examiner, Art Unit 3781 /REBECCA E EISENBERG/Supervisory Patent Examiner, Art Unit 3781