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 § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1, 2, 6, 8, 9, 13-15, 17, 18, 21-23, 26, 27, 29-31, 36, and 37 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claim 1 recites in the preamble “a content of one or a plurality of containers” and in the main body of the claim “a container unit comprising a container carrier when the container carrier has or comprises one or more container receptacles”, it is unclear whether the claimed “container receptacles” of the main body of the claim are the same or different from the claimed “plurality of containers” recited in the preamble. Appropriate correction is required.
Claim 1 recites “the respective container”; however, it is unclear whether the aforementioned limitation refers to the earlier claimed “one container”. Appropriate correction is required.
Claim 2 recites “two extreme positions” which is unclear as the requisite degree of movement is not defined by the claim, and the specification does not provide a standard for ascertaining the requisite degree and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention.
Claim 8 recites “the gas flow generation unit comprises one or a plurality of movable gas flow generation members, wherein each of the gas flow generation members”; however, as the claim recites “one or a plurality of”, the later limitation of “wherein each of the gas flow generation members” is improper as the earlier limitation may be satisfied with only one gas flow generation unit, whereas the later limitation requires ONLY a plurality of gas flow generation members. Appropriate correction is required.
The remaining claims are rejected for at least the reason of their direct and/or indirect dependency from independent claim 1. 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 1-2, 6, 8-9, 13-15, 17-18, 21-23, 26-27, 29-31 and 36-37 are rejected under 35 U.S.C. 103 as being unpatentable over Cutting et al. (US 11,253,430)
With regard to claim 1, Cutting teaches in a first embodiment (FIGS. 3, 6) a thawing device (2) for thawing a content of one or a plurality of containers (5, FIG. 3) (“Freezing, storage, transport, and thawing are performed while the containers are arranged in a pallet 2.”), wherein the content comprises a frozen liquid (“In the context of the present disclosure, there are provided containers (such as bags or semi-rigid containers) containing biopharmaceutical product (denoted BP) which need to be shipped from one facility to another facility under the frozen form”) the thawing device (2) comprising: (a) a container unit (4, FIG. 6) comprising a container carrier (61, 62; FIG. 6), wherein the container carrier (61, 62) has or comprises one or more container receptacles (6; FIG. 6), each container receptacle (6) being suitable to receive one container (5) comprising with the frozen liquid (“Freezing, storage, transport, and thawing are performed while the containers are arranged in a pallet 2.”), wherein the content comprises a frozen liquid (“In the context of the present disclosure, there are provided containers (such as bags or semi-rigid containers) containing biopharmaceutical product (denoted BP) which need to be shipped from one facility to another facility under the frozen form”) and wherein the container unit (4) is movable (a shaker device 15 which is include in the base 11 of FIG. 3 produces “.n orbital reciprocating movement in the XY plane. The shaker device 15 can produce a to-and-fro movement in the vertical direction Z.”).
Cutting does not teach in the first embodiment (b) a gas flow generation unit, wherein the gas flow generation unit (7, FIG. 7) is operable to generate a gas flow along a gas flow path defined in the thawing device , wherein the thawing device, in the region of the container carrier, is configured to define a container region of the gas flow path, wherein, in the container region of the gas flow path, a section of the gas flow path extends along the exterior of the respective container when the respective container is arranged in the container receptacle. However, Cutting teaches in a second embodiment (FIG. 7) teaches the aforementioned limitation: b) a gas flow generation unit (7, FIG. 7), wherein the gas flow generation unit (7) is operable to generate a gas flow along a gas flow path (F1/F2/F3/F4; FIG. 7) defined in the thawing device (2)(“ Air/gas circulates in a channel along a flow shown by arrows F1,F2,F3,F4.”) , wherein the thawing device (2), in the region of the container carrier (61, 62), is configured to define a container region of the gas flow path (gas flows along F1, F2,F3, F4 through ports 33/34 around container units 4; FIGS. 6, 7), wherein, in the container region (61, 62) of the gas flow path (F1, F2, F3, F4), a section of the gas flow path extends along the exterior of the respective container (5) when the respective container (5) is arranged in the container receptacle (6). With regard to the limitation of “the container unit is movable relative to the gas flow generation unit, as the second embodiment does not explicitly illustrate the shaker device 15 illustrated in the first embodiment, it is submitted that the as the secondary embodiment (FIG. 7) is cited for its teachings related to the gas flow generation unit (7), and as the shaker device is situated in the base 11, the container unit (4) would be movable relative to the gas flow generation unit as claimed (see FIGS. 3 & 7).
Therefore, it would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art to modify the first embodiment in the Cutting reference, to include a gas flow generation unit, wherein the gas flow generation unit is operable to generate a gas flow along a gas flow path defined in the thawing device , wherein the thawing device, in the region of the container carrier, is configured to define a container region of the gas flow path, wherein, in the container region of the gas flow path, a section of the gas flow path extends along the exterior of the respective container when the respective container is arranged in the container receptacle, and wherein the container unit is movable relative to the gas flow generation unit, as suggested and taught by the second embodiment of Cutting, for the purpose of providing a predetermined cooling or thawing operation of the individual containers (see Cutting: “The stationary equipment 1 comprises a gas circulating unit 7 (not shown at FIG. 1 but illustrated at FIGS. 7 to 10). When it is under operation, the gas circulating unit causes a circulation of cold gas or warm gas (according to the respective need of freezing or thawing), from a pull/suck inlet 76 toward a blow outlet 77.”; “There may be further provided local gas guiding walls 45 at top and bottom sides of each container unit, as illustrated at FIG. 11. Such local gas guiding walls may be formed in the protective packaging 6. In other words, the packaging 6 can envelop substantially a gas passage provided along the flexible bag.”).
With regard to claim 2, Cutting teaches (a) the thawing device (2) is configured to move the container unit (4) between two extreme positions relative to the gas flow generation unit (7) in an oscillating manner (as taught above by the combined teachings of the first and second embodiments of Cutting: “In the context of the present disclosure, there are provided containers (such as bags or semi-rigid containers) containing biopharmaceutical product (denoted BP) which need to be shipped from one facility to another facility under the frozen form”) and wherein the container unit (4) is movable (a shaker device 15 which is include in the base 11 of FIG. 3 produces “.n orbital reciprocating movement in the XY plane. The shaker device 15 can produce a to-and-fro movement in the vertical direction Z.”) (b) the container carrier (61, 62) comprises a plurality of rows of container receptacles (see rows in FIG. 3 individually separated by support plates 22) and wherein each row of container receptacles (6) comprises a plurality of container receptacles (6) (see FIGS. 3 & 6); (c) between two vertically or laterally adjacent container receptacles (6) (see FIGS. 3 & 6), one section of the gas flow path (F1,F2,F3,F4) in the container region (61, 62) of the gas flow path is formed between the containers (5), when the containers are arranged in the two adjacent container receptacles; (“ Air/gas circulates in a channel along a flow shown by arrows F1,F2,F3,F4.”) , wherein the thawing device (2), in the region of the container carrier (61, 62), is configured to define a container region of the gas flow path (gas flows along F1, F2,F3, F4 through ports 33/34 around container units 4; FIGS. 6, 7), and/or (d) each container (5), when in the container receptacle (6), is sandwiched between two sections of the gas flow path (“ Air/gas circulates in a channel along a flow shown by arrows F1,F2,F3,F4.”) , wherein the thawing device (2), in the region of the container carrier (61, 62), is configured to define a container region of the gas flow path (gas flows along F1, F2,F3, F4 through ports 33/34 around container units 4; FIGS. 6, 7). Furthermore, with regard to the limitation of “a plurality of columns of container receptacles”, it is submitted that although Cutting does not explicitly teach “a plurality of columns”, it is submitted that such an adaptation would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art as an obvious duplication of parts as no new and unexpected results are produced by the aforementioned limitation (see MPEP 2144 VI.B – Duplication of Parts). As a final point, it should be stressed that the term “and/or” requires only one of items (a), (b), (c) or (d) to be identified in the prior art for a patentability analysis (however the Examiner provided teachings in the prior art for each of items (a), (b), (c), and (d).
With regard to claim 6, Cutting teaches the thawing device (2) further comprises a chassis (31, 32), wherein the container carrier (61, 62) (FIGS. 3 & 6) is connected to the chassis (31, 32) (FIGS. 3 & 6), and wherein the gas flow generation unit (7; FIG. 7) is fixedly connected to the chassis (31, 32) as detailed above via the asserted combination of the first and second embodiments of Cutting.
With regard to claim 8, Cutting teaches the gas flow generation unit (7) comprises one or a plurality of movable gas flow generation members (the limitation “one or a plurality” requires only ONE gas flow generate unit to be present for a patentability analysis), wherein each of the gas flow generation members (7) is operable to generate a gas flow which contributes to the total gas flow along the gas flow path (gas flow F1,F2,F3,F4; FIG. 7).
With regard to claim 9, with regard to the limitations: (a) the gas flow generation members are linearly arranged in a one-dimensional arrangement; (b) different gas flow generation members arc assigned to different columns of container receptacles; (c) the movable gas flow generation members are arranged to generate gas flows in parallel directions; (d) the gas flow generation members comprise fans; and/or (e) the thawing device further comprises one or more gas inlets and one or more gas outlets, the gas flow path extending from the gas inlets to the gas outlets and/or fluidly connecting the gas inlets and the gas outlets, and wherein the gas inlet of the thawing device is or the gas inlets of the thawing device are defined by the gas flow generation unit, as the claim utilizes the term “and/or” for items (a)-(e), the term “and/or” requires only one of items (a)-(e) to be analyzed in a patentability analysis, and the Examiner chose item (e) for their patentability analysis:. Cutting teaches ((e) the thawing device (2) further comprises one or more gas inlets (34; FIG. 7) and one or more gas outlets (33, FIG. 7), the gas flow path (F1,F2,F3,F4) extending from the gas inlets (34) to the gas outlets (33) and/or fluidly connecting the gas inlets (34) and the gas outlets (33), and wherein the gas inlet (79; FIG. 7) of the thawing device (2) is or the gas inlets of the thawing device are defined by the gas flow generation unit (7)).
With regard to claim 13, with regard to the limitation of the gas flow generation unit is configured to generate a gas flow with a gas flow velocity of greater than or equal to one of 1.0 m/s and of less than or equal to 8 m/s or of greater than or equal to 1.2 m/s and of less than or equal to 8 m/s, although Cutting does not teach the specific valuations with regard to the gas flow generation unit (7), it is submitted that such an adaptation would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art as a matter of routine experimentation to obtain a predetermined thawing of a given product contained within the subject device.
With regard to claim 14, with regard to the limitation of the gas flow generation unit is configured to provide a total gas displacement of greater than or equal to 9000 m³/h and less than or equal to 21000 m³/h, although Cutting does not teach the specific valuations with regard to the gas flow generation unit (7), it is submitted that such an adaptation would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art as a matter of routine experimentation to obtain a predetermined thawing of a given product contained within the subject device.
With regard to claim 15, Cutting teaches the gas flow generation unit (7) is configured to displace the gas along the gas flow path (F1,F2,F3,F4) towards the container region (61, 62) in a blowing mode of operation of the gas flow generation unit (7; FIG. 7) (“he gas circulating unit comprises a blower 71, and a heat exchanger 72.”).
With regard to claim 17, Cutting teaches the thawing device (2) comprises a chassis (31, 32), wherein the container carrier (61, 62) (FIGS. 3 & 6) is connected to the chassis (31, 32) (FIGS. 3 & 6), and wherein the container unit (4) is linearly movable relative to the chassis (31, 32) and/or the gas flow generation unit (7; FIG. 7) as detailed above via the asserted combination of the first and second embodiments of Cutting.
With regard to claim 18, with regard to the limitation of (a) the container unit is connected to the chassis such that movement of the container unit relative to the chassis is restricted to linear movement along a movement axis, wherein the container unit is movable along the movement axis in opposite directions, wherein the movement axis is fixed relative to the chassis and/or relative to the gas flow generation unit, and wherein the movement axis of the linear movement of the container unit is perpendicular to the gas flow path in the container region and/or perpendicular to the main longitudinal direction of extension of the containers; (b) the thawing device is configured such that a frequency of the oscillating movement of the container unit between the two extreme positions is less than or equal to 1.5 Hz and greater than or equal to 0.01 Hz; and/or (c) the container unit comprises a container gas duct, the container gas duct delimiting the gas flow path laterally or circumferentially in the container region, and wherein, in the container region, an exterior surface of a container in cooperation with the inner wall of the container gas duct delimits a section of the gas flow path, it is submitted that the term “and/or” requires only one of items (a)-(c) to be analyzed in a patentability analysis, and the Examiner chose item (b) for their patentability analysis:. with regard to limitation (b) the thawing device is configured such that a frequency of the oscillating movement of the container unit between the two extreme positions is less than or equal to 1.5 Hz and greater than or equal to 0.01 Hz, although Cutting does not teach the specific valuations with regard to the shaker device (15, FIG. 3), it is submitted that such an adaptation would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art as a matter of routine experimentation to obtain a predetermined thawing of a given product contained within the subject device.
With regard to claim 21, Cutting teaches in the region of the container unit (4), the gas flow path (F1,F2,F3,F4) defined in the thawing device (2) is restricted to the container unit (4) by the container gas duct (portion of 131/132; FIG. 7).
With regard to claim 22, Cutting teaches the thawing device (2) comprises a gas flow path adjuster (22, FIG. 3), and wherein the gas flow path adjuster (22) is arranged to define and/or to focus the gas flow path (F1,F2,F3,F4) in an intermediate region (region which includes 22) of the gas flow path (F1,F2,F3,F4) between the gas flow generation unit (7) and the container unit (4) (FIGS> 3 & 7).
With regard to claim 23, with regard to the limitation of (a) the gas flow path adjuster is configured to change the size and/or shape of the cross section of the gas flow path from a first size and/or shape at a first end of the gas flow path adjuster closer to the gas flow generation unit as seen along the gas flow path to a second size and/or shape at a second end of the gas flow path adjuster further away from the gas flow generation unit , and wherein the first end of the gas flow path adjuster is configured to receive the gas flow originating at the gas flow generation unit and the second end is configured to supply the gas flow towards the container unit; (b) the gas flow path adjuster is configured to adjust the cross section of the gas flow path to the cross section of the container carrier or the outer boundary of the container region of the gas flow path; and/or (c) the gas flow path adjuster has a continuous opening at the first end and/or a continuous opening at the second end, it is submitted that the term “and/or” requires only one of items (a)-(c) to be analyzed in a patentability analysis, and the Examiner chose item (b) for their patentability analysis:. with regard to limitation (b), Cutting teaches the gas flow path adjuster (22) is configured to adjust the cross section of the gas flow path (F1,F2,F3,F4) to the cross section of the container carrier (61,62) as illustrated in FIGS. 3 and 6.
With regard to claim 26, Cutting teaches the thawing device (2) comprises a gas flow divider, and wherein the gas flow divider (78, 79; FIG. 7) is arranged between the gas flow generation unit (7) and the container region (61, 62) as seen along the gas flow path (F1,F2,F3,F4) (FIGS. 3, 6, and 7).
With regard to claim 27, Cutting teaches: (a) the container unit( 4) comprises the gas flow divider (the outer sections along the outer perimeter of 5 divide the gas flow as illustrated in FIG. 6); and/or (b) the gas flow divider (78, 79)) is configured to direct incoming gas flow into the sections of the gas flow path (F1,F2,F3,F4) in the container region (61, 62) (FIGS. 3, 6, and 7). It must be stressed that the term “and/or” requires only one of items (a)-(b) to be analyzed in a patentability analysis, the Examiner chose to provide support for both of said items for their patentability analysis.
With regard to claim 29, Cutting teaches the sections (the outer sections along the outer perimeter of 5 divide the gas flow as illustrated in FIG. 6) are adjusted to the positions of the container receptacles (6) relative to the gas flow divider (the outer sections along the outer perimeter of 5 divide the gas flow as illustrated in FIG. 6), such that each container (5, FIG. 6) has at least one section of the gas flow path extending over opposite surfaces of the container (5) (FIG. 6 illustrates the upper and lower surfaces of container 5 each include a respective section as claimed)..
With regard to claim 30, Cutting teaches the gas flow path (F1,F2,F3,F4) is limited laterally by a flexible member (“flexible bag”: “According to one option, the container units may be formed as bag assemblies, each bag assembly comprising a single-use flexible bag and a protective packaging, each single-use flexible bag containing biopharmaceutical product (BP). The protective packaging can be any type of casing, shell or frame substantially surrounding at least the border of the bag. It is therefore possible to handle flexible bags conveniently and safely. The term ‘pouch’ can also be used instead of ‘bag’. ‘Vessel’ can also be sometimes used instead or ‘bag’ or ‘pouch’. The flexible bag (or pouch) is generally designed for a single use and is adapted to contain a biopharmaceutical fluid volume …According to one advantageous aspect, the container units, respectively the single-use flexible bags, extend substantially in the horizontal direction” ) in a region of the gas flow path (F1,F2,F3,F4) between the gas flow generation unit (7) and the container unit (4) (FIG. 6, 7).
With regard to claim 31, with regard to the limitation of (a) the region directly connects the gas flow path adjuster to the gas flow divider, wherein the flexible member is fixed to the gas flow path adjuster and to the gas flow divider, and wherein the flexible member allows movement of the gas flow divider relative to the gas flow path adjuster; (b) the thawing device is configured such that the thawing device is capable of thawing the content of 15 containers with a fill volume of more than 10L and/or less than 20L within a predetermined time, wherein the predetermined time is less than or equal to 20h and greater than or equal to 4h; (c) the thawing device is configured to thaw the frozen equivalent of 160L of liquid content; (d) the frozen content of the respective container is a medical liquid; and/or (e) the distance of the oscillating movement of the container unit from one extreme position to the other extreme position is greater than or equal to 2 cm and less than or equal to 6 cm, it is submitted that the term “and/or” requires only one of items (a)-(e) to be analyzed in a patentability analysis, the Examiner chose to provide support for item (e) for their patentability analysis: with regard to the limitation of the distance of the oscillating movement of the container unit from one extreme position to the other extreme position is greater than or equal to 2 cm and less than or equal to 6 cm, it is submitted that although Cutting does not teach the claimed valuations for the shaker device (15) which generated the claimed oscillating movement of the container unit (4) (FIGS. 3, 6, and 7) having the claimed “extreme positions”, it is submitted that such an adaptation would have been obvious before the effective date of the claimed invention to one of ordinary skill in the art as a matter of routine experimentation to obtain a predetermined thawing of a given product contained within the subject device.
With regard to claim 36, Cutting teaches a) one or more containers (5) comprising frozen with liquid, e.g. liquid for a thawing operation, (“In the context of the present disclosure, there are provided containers (such as bags or semi-rigid containers) containing biopharmaceutical product (denoted BP) which need to be shipped from one facility to another facility under the frozen form.”) and/or b) one or more dummy containers which are sized and shaped to be inserted into the one or more container receptacles; e.g. if the number of containers to be processed by the device in one operation cycle is less than the number of container receptacles available in the device. It is submitted that the term “and/or” requires only one of items (a)-(b) to be analyzed in a patentability analysis, the Examiner chose to provide support for item (a).
With regard to claim 37, Cutting teaches method for simultaneously thawing [[the]] frozen contents of a plurality of containers using the thawing device of claim 1 or a system of any one of the preceding claims comprising the following steps: (a) arranging the containers comprising the with frozen contents within the one or more container receptacles, (b) optionally arranging dummy containers in any empty container receptacle, (c) initiating gas flow generation via the gas flow generation unit for conducting an operation cycle, (d) moving the container unit relative to the gas flow generation unit during the operation cycle, and/or (e) [maintaining the gas flow and/or the container unit movement for a predetermined time. . It is submitted that the term “and/or” requires only one of items (a)-(e) to be analyzed in a patentability analysis, the Examiner chose to provide support for item (e): “maintaining the gas flow” (“Air/gas circulates in a channel along a flow shown by arrows F1,F2,F3,F4.”).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JOSEPH W ISKRA whose telephone number is (313) 446-4866. The examiner can normally be reached on M-F: 09:00-17:00 EST.
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/JOSEPH W ISKRA/Examiner, Art Unit 3761
/IBRAHIME A ABRAHAM/Supervisory Patent Examiner, Art Unit 3761
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