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 .
Claim Rejections - 35 USC § 102
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 the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claim(s) 1 – 20 is/are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as being anticipated by Fask et al. (US 2005/0082290 A1; hereinafter “Fask”).
Regarding claim 1, Fask teaches an apparatus (Abstract; paragraphs 74 and 80 – 83; figures 1 – 4) suitable for use in handling biological material, for directly introducing or removing material to, or from, a container (receptacle 12), comprising:
a body (container 10) comprising at least one resealable port (plug 38, of lid 14 acts as a resealable port over an aperture (bore 25) via self-sealing membrane 51) therein; and
a cover (lid 14) comprising an aperture (the opening occupied by bore 25 as shown in figure 2B) and wherein the cover is disposed over an upper side of the body (10), and wherein the cover (14) is moveable, the aperture of the cover is configured to expose at least part of the resealable port, when the aperture is disposed over the resealable port.
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Regarding claim 2, Fask teaches the apparatus according to claim 1, wherein the body (container 10) comprises an upper surface and a lower surface, the cover (lid 14) is disposed over the upper surface, and the at least one resealable port (plug 38) extending through the body from the upper surface to the lower surface (figures 1 and 2B).
Regarding claims 3 and 4, Fask teaches the apparatus according to claim 2, wherein the body comprises a plurality of longitudinal passageways extending from the upper surface to a recess formed in the lower surface, each longitudinal passageway comprising a resealable port and an annular recess comprising an annular resealable port (plurality of passageways (bores 212 and 214) in lid 210 can comprise resealable ports and are formed as a molded unitary member; figure 22; paragraph 93).
Regarding claim 5, Fask teaches the apparatus according to claim l, wherein the at least one resealable port is a hermetic seal (plug 38 is a solid self-sealing membrane that can function as a hermetic seal; paragraph 81).
Regarding claim 6, Fask teaches the apparatus according to claim 5, wherein the hermetic seal is a septum seal (self-sealing membrane 51 functions as a septum; paragraph 81).
Regarding claim 7, Fask teaches the apparatus according to claim 6, wherein the at least one septum seal and the body are co-molded (paragraphs 83 and 92).
Regarding claim 8, Fask teaches the apparatus according to claim 1, the cover further comprising a connector mechanism for connecting to a portion of a container, a bioreactor or a connector (a connector mechanism for a material transfer device can be attached via threads 182 for connecting to another container or bioreactor, etc.; paragraphs 81, 83 and 91).
Regarding claim 9, Fask teaches the apparatus according to claim 8, wherein the connector mechanism comprises a threaded portion configured to engage with a corresponding threaded portion of a container, a bioreactor or a connector (a connector mechanism for a material transfer device can be attached via threads 182 for connecting to another container or bioreactor, etc.; paragraphs 80, 83 and 91).
Regarding claim 10, Fask teaches the apparatus according to any preceding claim 1, wherein the cover (lid 14) comprises a centrally disposed opening at least partly surrounded by an upstanding wall (vertical ridges 24 or cylindrical wall 23 of lid 14 forming a centrally disposed opening underneath lid 14; figure 1; paragraph 72).
Regarding claim 11, Fask teaches the apparatus according to claim 10, wherein the body (container 10) comprises a central hub having a coupling element (threads 26), the central hub extending through the centrally disposed opening and the coupling element operably coupled to the upstanding wall (vertical ridges 24 or cylindrical wall 23 of lid 14 forming a centrally disposed opening underneath lid 14; figure 1; paragraph 72).
Regarding claim 12, Fask teaches the apparatus according to claim l, wherein the cover (lid 14) comprises a circumferential skirt (vertical ridges 24 or cylindrical wall 23 of lid 14 forming a centrally disposed opening underneath lid 14; figure 1; paragraph 72) that is configured and arranged to removably attach to a circumferential rim of the body (container 10) (figure 1).
Regarding claim 13, Fask teaches the apparatus according to any preceding claim 1, wherein the cover (lid 14) comprises a substantially circumferential rail (vertical ridges 24) that is configured and arranged to be received within a substantially circumferential groove (threads 26) of the body (container 10) (paragraph 72; figure 1).
Regarding claim 14, Fask teaches the apparatus according to claim 1, wherein the cover (lid 14) and the body (container 10) are rotatable with respect to one another (paragraph 72; figure 1).
Regarding claim 15, Fask teaches the apparatus according to claim l, wherein a lower surface of the body (container 10) includes a connector mechanism for connecting to a portion of a container, a bioreactor or a connector (e.g., a connector mechanism for a material transfer device can be attached via threads 182 for connecting to another container or bioreactor, etc.; paragraphs 80, 83 and 91).
Regarding claim 16, Fask teaches the apparatus according to claim 15, wherein the connector mechanism is a threaded portion configured to engage with a corresponding threaded portion of a container, a bioreactor or a connector, the threaded portion comprising an anti-rotational element configured and arranged to resist rotation of a container, a bioreactor or a connector, in use (e.g., a connector mechanism for a material transfer device can be attached via threads 182 for connecting to another container or bioreactor, etc.; paragraphs 80, 83 and 91).
Regarding claim 17, Fask teaches the apparatus according to claim 16, wherein the anti-rotational element comprises one or more trapezoidal threads of the threaded portion (e.g., threads 182 on the inside surface of cylindrical wall 175; figure 19F).
Regarding claim 18, Fask teaches the apparatus according to claim l, further comprising a detachable cover (plug cover 16; paragraph 74; figure 1) disposed over at least a portion of the at least one resealable port (plug 38, of lid 14 acts as a resealable port over an aperture (bore 25); figure 1).
Regarding claim 19, Fask teaches a system suitable for use in handling biological material (Abstract; paragraphs 74 and 80 – 83; figures 1 – 4) comprising:
an apparatus suitable for use in handling biological material, for directly introducing or removing material, or from, a container, the apparatus comprising:
a body (container 10) comprising at least one resealable port therein (plug 38 of lid 14 acts as a resealable port over an aperture (bore 25) via self-sealing membrane 51), and
a cover (lid 14) comprising an aperture (the opening occupied by bore 25 as shown in figure 2B) and wherein the cover is disposed over an upper side of claims the body, and wherein the cover is moveable, the aperture of the cover is configured to expose at least part of the resealable port, when the aperture is disposed over the resealable port; and
a container (receptacle 12), a bioreactor and/or a connector sealingly engaged with the at least one resealable port.
Regarding claim 20, Fask teaches a method of operating an apparatus suitable for use in handling biological material, for directly introducing or removing material to, or from, a container (Abstract; paragraphs 74 and 80 – 83; figures 1 – 4), comprising:
providing an apparatus suitable for use in handling biological material, for directly introducing or removing material, or from, a container, the apparatus comprising:
a body (container 10) comprising at least one resealable port therein (plug 38 of lid 14 acts as a resealable port over an aperture (bore 25) via self-sealing membrane 51), and
a cover (lid 14) comprising an aperture (the opening occupied by bore 25 as shown in figure 2B) and wherein the cover is disposed over an upper side of claims the body, and wherein the cover is moveable, the aperture of the cover is configured to expose at least part of the resealable port, when the aperture is disposed over the resealable port;
sealingly engaging a first container (receptacle 12) to the at least one resealable port at a lower surface of the body;
sealingly engaging a second container (e.g., a material transfer device; paragraphs 81 and 91) to the at least one resealable port at an upper surface of the body; providing fluid communication between the container and the bioreactor by providing a | fluid passageway through the at least one resealable port; and introducing material from the second container into the first container, or removing material from the first container into the second container.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIAN J. SINES whose telephone number is (571)272-1263. The examiner can normally be reached 9 AM-5 PM EST M-F.
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BRIAN J. SINES
Primary Patent Examiner
Art Unit 1796
/BRIAN J. SINES/Primary Examiner, Art Unit 1796