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 .
Status of Claims
The Office Action is in response to the remarks and amendments filed on 2/17/2026. Claim 2 is cancelled. Accordingly, claims 1 and 3-20 are pending for consideration in this Office Action.
Claim Rejections - 35 USC § 103
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, 4, 7, 8, 10, 13, 14, 16 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Leoncavallo et al. (US8905255B2) in view of Haskins (US2899097A).
Regarding Claim 1, Leoncavallo teaches a bag holder for supporting a bioprocess bag during freezing [col. 5, lines 50-85], comprising:
a bag tray [pan 20, Figure 1] including:
a basin [depression 40, Figure 1], surrounded in part by a first side wall [side wall 42, Figure 1] and a second side wall [side wall 43, Figure 1];
a neck formed at one end of the basin [space 34, Figure 1], between the first side wall and the second side wall [where space 34 is centrally spaced on end 28, Figure 1; col. 4, lines 13-23], the neck having a height that is between a height of the bottom portion of the basin and a height of at least one of the first side wall or the second side wall [where space 34 interrupts the edge surfaces 30 and 31, Figure 5; col. 4, lines 13-23]; and
wherein the first side wall includes one or more first retaining features [pin 74, Figure 1], each of the first retaining features having a first shape [where pin 74 is a projection that tapers toward a distal end, Figure 1; col. 5, lines 40-49], where the first retaining feature comprise an upwards projection [where pin 74 is an upward projection, Figure 1; col. 5, lines 40-49],
the second side wall includes one or more second retaining features [socket 77, Figure 1], each of the second retaining features having a second shape [where socket 77 tapers toward a closed end, Figure 1; col. 5, lines 40-49],; and
the first shape and the second shape are such that the first shape and the second shape can be mechanically joined to one another [col. 5, lines 40-49],
where the bag tray [pan 20, Figure 1] is a first bag tray [first pan 20a, Figure 6; col. 5, lines 29-49], the bag holder further comprising a second bag tray [second pan 20b, Figure 6], the second bag tray identical to the first bag tray [col. 2, lines 28-43].
Leoncavallo does not teach where the first retaining features comprise an upwards projection with a tab extending outwards from a side of the upwards projection and wherein each of the second retaining features comprises an opening.
However, Haskins teaches a container [col. 1, lines 15-24] where the first retaining feature [finger 8 and hook 9, Figure 1] comprises an upwards projection [finger 8, Figure 1] with a tab [hook 9, Figure 1] extending outwards from a side of the upwards projection [where each finger has a lip or hook 9 at its free end that is out-turned; col. 1, lines 43-48] and wherein each of the second retaining features comprises an opening [hole or slot 10 in the other cup, Figure 1] where one of ordinary skill in the art would have been capable of applying the substitution of known elements, pin and hole, for another, hook and hole, and yield predictable results, i.e., preventing accidental disengagement [Haskins, col. 1, lines 19-24] while minimizing unique pieces for manufacturing [Haskins, col. 1, lines 36-42].
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Leoncavallo to have where the first retaining features comprise an upwards projection with a tab extending outwards from a side of the upwards projection and wherein each of the second retaining features comprises an opening in view of the teachings of Haskins where the substitution of elements for another would have yielded predictable results i.e. , preventing accidental disengagement [Haskins, col. 1, lines 19-24] while minimizing unique pieces for manufacturing [Haskins, col. 1, lines 36-42].
Regarding Claim 3, Leoncavallo, as modified, teaches the invention of claim 1 and further teaches where the first bag tray [first pan 20a, Figure 6] is configured to be joined to the second bag tray [second pan 20b, Figure 6] by engagement of the first retaining features of the first bag tray [pin 74a, Figure 6] with the second retaining features of the second bag tray [socket 76b, Figure 6] and engagement of the second retaining features of the first bag tray [socket 77 of pan 20a, Figure 6; col. 5, lines 38-49] with the first retaining features of the second bag tray [pin 75 of pan 20b, Figure 6; col. 5, lines 38-49].
Regarding Claim 4, Leoncavallo, as modified, teaches the invention of claim 3 and further teaches where when the first bag tray [first pan 20a, Figure 6] is joined to the second bag tray [second pan 20b, Figure 6], the bag holder includes an opening in communication with the neck of the first bag tray [opening 114, Figure 6; col.5 line 59 - col.6 line 3].
Regarding Claim 7, Leoncavallo, as modified, teaches the invention of claim 1 and further teaches where the basin [depression 40, Figure 1] includes a flat bottom surface [surface 44, Figure 1; col. 4, lines 24-38].
Regarding Claim 8, Leoncavallo, as modified, teaches the invention of claim 1 and further teaches where one or more bulkheads [lateral edges 22 and 24, Figure 5] around at least a portion of the basin [where lateral edges 22 and 24 are along portions of ends 26 and 28; col. 4 lines 13-23].
Regarding Claim 10, Leoncavallo, as modified, teaches the invention of claim 1 and further teaches where the first shape [where pin 74 is a projection that tapers toward a distal end, Figure 1; col. 5, lines 40-49] and the second shape [where pin 74 is a projection that tapers toward a distal end, Figure 1; col. 5, lines 40-49] are complementary to one another [col. 5, lines 40-49].
Regarding Claim 13, Leoncavallo teaches a method of manufacturing a bag holder for freezing of a bioprocess bag [col. 5, lines 50-85], comprising: forming [col. 15, lines 2-17] a first bag tray [first pan 20a, Figure 6], the first bag tray including:
a basin [pan 20, Figure 1], surrounded in part by a first side wall [side wall 42, Figure 1] and a second side wall [side wall 43, Figure 1];
a neck formed at one end of the basin [space 34, Figure 1], between the first side wall and the second side wall [where space 34 is centrally spaced on end 28, Figure 1; col. 4, lines 13-23], the neck having a height that is between a height of the bottom portion of the basin and a height of at least one of the first side wall or the second side wall [where space 34 interrupts the edge surfaces 30 and 31, Figure 5; col. 4, lines 13-23]; and
wherein the first side wall includes one or more first retaining features [pin 74, Figure 1], each of the first retaining features having a first shape [where pin 74 is a projection that tapers toward a distal end, Figure 1; col. 5, lines 40-49], wherein the first retaining features comprise an upwards projection [where pin 74 is an upward projection, Figure 1; col. 5, lines 40-49], the second side wall includes one or more second retaining features [socket 77, Figure 1], each of the second retaining features having a second shape [where socket 77 tapers toward a closed end, Figure 1; col. 5, lines 40-49], and the first shape and the second shape are such that the first shape and the second shape can be mechanically joined to one another [col. 5, lines 40-49]; and
forming [col. 15, lines 2-17] a second bag tray [second pan 20b, Figure 6] identical to the first [col. 2, lines 28-43].
Leoncavallo does not teach where the first retaining features comprise an upwards projection with a tab extending outwards from a side of the upwards projection and wherein each of the second retaining features comprises an opening.
However, Haskins teaches a container [col. 1, lines 15-24] where the first retaining feature [finger 8 and hook 9, Figure 1] comprises an upwards projection [finger 8, Figure 1] with a tab [hook 9, Figure 1] extending outwards from a side of the upwards projection [where each finger has a lip or hook 9 at its free end that is out-turned; col. 1, lines 43-48] and wherein each of the second retaining features comprises an opening [hole or slot 10 in the other cup, Figure 1] where one of ordinary skill in the art would have been capable of applying the substitution of known elements, pin and hole, for another, hook and hole, and yield predictable results, i.e., preventing accidental disengagement [Haskins, col. 1, lines 19-24] while minimizing unique pieces for manufacturing [Haskins, col. 1, lines 36-42].
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Leoncavallo to have where the first retaining features comprise an upwards projection with a tab extending outwards from a side of the upwards projection and wherein each of the second retaining features comprises an opening in view of the teachings of Haskins where the substitution of elements for another would have yielded predictable results i.e., preventing accidental disengagement [Haskins, col. 1, lines 19-24] while minimizing unique pieces for manufacturing [Haskins, col. 1, lines 36-42].
Regarding Claim 14, Leoncavallo teaches the method of claim 13 and further teaches where forming the first bag tray [first pan 20a, Figure 6] includes thermoforming or injection molding a material [col. 15, lines 2-17].
Regarding Claim 16, Leoncavallo teaches the method of claim 13 and further teaches wherein the basin [depression 40, Figure 1] includes a flat bottom surface [surface 44, Figure 1; col. 4, lines 24-38].
Regarding Claim 17, Leoncavallo teaches the method of claim 13 and further teaches where one or more bulkheads [lateral edges 22 and 24, Figure 5] around at least a portion of the basin [where lateral edges 22 and 24 are along portions of ends 26 and 28; col. 4 lines 13-23].
Claims 5 and 6 are rejected under 35 U.S.C. 103 as being unpatentable over Leoncavallo et al. (US8905255B2) in view of Haskins (US2899097A) and in further view of Tanaka et al. (US9441193B2).
Regarding Claim 5, Leoncavallo, as modified, teaches the invention of claim 1 and does not teach the invention further comprising a partial fill bar comprising a resilient material and configured to extend from the first side of the bag tray to the second side of the bag tray.
However, Tanaka teaches a bag tray [container table 12, Figure 2] for a bag-like cell culture container [culture container 11, Figure 1; col. 8, lines 22-33] where a partial fill bar [roller 13, Figure 2] comprising a resilient material [col. 10, lines 39-51] is configured to extend from the first side of the bag tray to the second side of the bag tray [where the length of the roller 13 is set to the width of the enclosure part 11-1, Figure; col.10, lines 1-19], where one of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element would perform the same function as it did separately and one of ordinary skills would have recognized that the results of the combination were predictable i.e., maintaining a constant density of fluid in the bag without damaging the contents [col. 2, lines 43-51]
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Leoncavallo to have where a partial fill bar comprising a resilient material is configured to extend from the first side of the bag tray to the second side of the bag tray in view of the teachings of Tanaka where the elements could have been combined by known methods with no change in their respective functions, and the combination would have yielded predictable results i.e., maintaining a constant density of fluid in the bag without damaging the contents [col. 2, lines 43-51]
Regarding Claim 6, Leoncavallo, as modified, teaches the invention of claim 5 and further teaches where the first side wall [side wall 242, Figure 16a] includes a plurality of the first retaining features [pin 274 and pin 276, Figure 16a] and the second side wall [side wall 243, Figure 16a] includes a plurality of the second retaining features [socket 277 and socket 275, Figure 16a].
Claims 11, 12, 15, 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Leoncavallo et al. (US8905255B2) in view of Haskins (US2899097A).and in further view of Pendlebury (US8992473B2).
Regarding Claim 11, Leoncavallo, as modified, teaches the invention of claim 1 and further teaches a second bag tray [second pan 20b, Figure 6], identical to the first bag tray [col. 2, lines 28-43], but does not teach a partial fill bar, wherein the first bag tray and the second bag tray are configured such that when the first bag tray is joined to the second bag tray, the partial fill bar can be retained between the first bag tray and the second bag tray such that the partial fill bar extends across the space defined by the basin of the first bag tray and the basin of the second bag tray from the first side wall of the first bag tray to the second side wall of the first bag tray.
However, Pendlebury teaches a delivery device for a container of frozen cells [col. 1, lines 49-67] having a partial fill bar [roller 69, Figure 3] where a first bag tray [lower part 76, Figure 3] and a second bag tray [top part 74, Figure 3] are configured such that when the first bag tray is joined to the second bag tray, the partial fill bar can be retained between the first bag tray and the second bag tray [where the roller 69 is mounted on the lower part 76 below the top part 74, Figure 10; col.5, lines 7-15] such that the partial fill bar extends across the space defined by the basin of the first bag tray and the basin of the second bag tray [pouch compartment 78, Figure 3] from the first side wall of the first bag tray to the second side wall of the first bag tray [where both sides of the roller 69 ride tracks inside lower part 76, Figure 10 and Figure 11; col. 5, lines 7-24 and lines 36-45] where one of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art i.e., reducing contamination by pressing the contents in the bag without needing to remove the bag from the tray.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Leoncavallo to have a partial fill bar where a first bag tray and a second bag tray are configured such that when the first bag tray is joined to the second bag tray, the partial fill bar can be retained between the first bag tray and the second bag tray such that the partial fill bar extends across the space defined by the basin of the first bag tray and the basin of the second bag tray from the first side wall of the first bag tray to the second side wall of the first bag tray in view of the teachings of Pendlebury where this known technique could have been applied to a known device that was ready for improvement and the results would have been predictable i.e., reducing contamination by pressing the contents in the bag without needing to remove the bag from the tray.
Regarding Claim 12, Leoncavallo, as modified, teaches the invention of claim 11, and does not teach where the first bag tray and the second bag tray are configured such that the partial fill bar can be slid in a direction extending from the neck to a back wall of the basin opposite the neck.
However, Pendlebury teaches a delivery device for a container of frozen cells [col. 1, lines 49-67] where a first bag tray [lower part 76, Figure 3] and a second bag tray [top part 74, Figure 3] are configured such that a partial fill bar [roller 69, Figure 3] can be slid [where each side of the roller 69 rides a track inside lower part 76, Figure 10 and Figure 11; col. 5, lines 7-24 and lines 36-45] in a direction extending from the neck [openings 70, Figure 11] to a back wall of the basin opposite the neck [at rear space 64 of rear section 62, Figure 3; col. 5, lines 7-19], where one of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art i.e., reducing contamination by distributing the contents in the bag without needing to remove the bag from the tray.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Leoncavallo to have where the first bag tray and the second bag tray are configured such that the partial fill bar can be slid in a direction extending from the neck to a back wall of the basin opposite the neck in view of the teachings of Pendlebury where this known technique could have been applied to a known device that was ready for improvement and the results would have been predictable i.e., reducing contamination by distributing the contents in the bag without needing to remove the bag from the tray.
Regarding Claim 15, Leoncavallo, as modified, teaches the method of claim 13, but does not teach where each of the first side wall and the second side wall are configured to accommodate a partial fill bar.
However, Pendlebury teaches a delivery device for a container of frozen cells [col. 1, lines 49-67] comprising a partial fill bar [roller 69, Figure 3] where each of the first side wall and the second side wall are configured to accommodate the partial fill bar [where the roller 69 rides a track along the sides of lower part 76, Figure 10 and Figure 11; col. 5, lines 7-24 and lines 36-45], where one of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art i.e., reducing contamination by distributing the contents in the bag without needing to remove the bag.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Leoncavallo to have where each of the first side wall and the second side wall are configured to accommodate a partial fill bar in view of the teachings of Pendlebury where this known technique could have been applied to a known device that was ready for improvement and the results would have been predictable i.e., reducing contamination by distributing the contents in the bag without needing to remove the bag.
Regarding Claim 19, Leoncavallo, as modified, teaches the method of claim 13 but does not teach the first bag tray and the second bag tray are configured such that when the first bag tray is joined to the second bag tray, a partial fill bar can be retained between the first bag tray and the second bag tray such that the partial fill bar extends across the space defined by the basin of the first bag tray and the basin of the second bag tray from the first side wall of the first bag tray to the second side wall of the first bag tray.
However, Pendlebury teaches a delivery device for a container of frozen cells [col. 1, lines 49-67] having a partial fill bar [roller 69, Figure 3] where a first bag tray [lower part 76, Figure 3] and a second bag tray [top part 74, Figure 3] are configured such that when the first bag tray is joined to the second bag tray, the partial fill bar can be retained between the first bag tray and the second bag tray [where the roller 69 is mounted on the lower part 76 below the top part 74, Figure 10; col.5, lines 7-15] such that the partial fill bar extends across the space defined by the basin of the first bag tray and the basin of the second bag tray [pouch compartment 78, Figure 3] from the first side wall of the first bag tray to the second side wall of the first bag tray [where both sides of the roller 69 ride tracks inside lower part 76, Figure 10 and Figure 11; col. 5, lines 7-24 and lines 36-45] where one of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art i.e., reducing contamination by pressing the contents in the bag without needing to remove the bag from the tray.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Leoncavallo to have a partial fill bar where a first bag tray and a second bag tray are configured such that when the first bag tray is joined to the second bag tray, the partial fill bar can be retained between the first bag tray and the second bag tray such that the partial fill bar extends across the space defined by the basin of the first bag tray and the basin of the second bag tray from the first side wall of the first bag tray to the second side wall of the first bag tray in view of the teachings of Pendlebury where this known technique could have been applied to a known device that was ready for improvement and the results would have been predictable i.e., reducing contamination by pressing the contents in the bag without removing the bag from the tray.
Regarding Claim 20, Leoncavallo, as modified, teaches the method of claim 19 but does not teach where the first bag tray and the second bag tray are configured such that the partial fill bar can be slid in a direction extending from the neck to a back wall of the basin opposite the neck.
However, Pendlebury teaches a delivery device for a container of frozen cells [col. 1, lines 49-67] where a first bag tray [lower part 76, Figure 3] and a second bag tray [top part 74, Figure 3] are configured such that a partial fill bar [roller 69, Figure 3] can be slid [where each side of the roller 69 rides a track inside lower part 76, Figure 10 and Figure 11; col. 5, lines 7-24 and lines 36-45] in a direction extending from the neck [openings 70, Figure 11] to a back wall of the basin opposite the neck [at rear space 64 of rear section 62, Figure 3; col. 5, lines 7-19], where one of ordinary skill in the art would have been capable of applying this known technique to a known device that was ready for improvement and the results would have been predictable to one of ordinary skill in the art i.e., reducing contamination by distributing the contents in the bag without needing to remove the bag from the tray.
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Leoncavallo to have where the first bag tray and the second bag tray are configured such that the partial fill bar can be slid in a direction extending from the neck to a back wall of the basin opposite the neck in view of the teachings of Pendlebury where this known technique could have been applied to a known device that was ready for improvement and the results would have been predictable i.e., reducing contamination by distributing the contents in the bag without needing to remove the bag from the tray.
Claims 9 and 18 are rejected under 35 U.S.C. 103 as being unpatentable over Leoncavallo et al. (US8905255B2) in view of Haskins (US2899097A) and in further view of Maeda et al. (JP6838906B2).
Regarding Claim 9, Leoncavallo, as modified, teaches the invention of claim 1 and does not teach where a metal insert forms a portion of the basin.
However, Maeda teaches a container for quick freezing of a liquid bag [0001] where a metal insert [second metal flat plate 7, Figure 1; 0021] forms a portion of the basin [bag housing part 3; 0025], where one of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element would perform the same function as it did separately and one of ordinary skills would have recognized that the results of the combination were predictable i.e., uniformly cooling the surface of the bag without damaging the bag [0019].
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the assembly of Leoncavallo where a metal insert forms a portion of the basin in view of the teachings of Maeda where the elements could have been combined by known methods with no change in their respective functions, and the combination would have yielded predictable results i.e., uniformly cooling the surface of the bag without damaging the bag [0019].
Regarding Claim 18, Leoncavallo, as modified, teaches the method of claim 13 and does not teach where forming the first bag tray includes providing a metal sheet, the metal sheet forming a portion of the basin.
However, Maeda teaches a container for quick freezing of a liquid bag [0001] where a metal insert [second metal flat plate 7, Figure 1; 0021] forms a portion of the basin [bag housing part 3; 0025], where one of ordinary skill in the art could have combined the elements as claimed by known methods and that in combination, each element would perform the same function as it did separately and one of ordinary skills would have recognized that the results of the combination were predictable i.e., uniformly cooling the surface of the bag without damaging the bag [0019].
Therefore, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the invention to modify the method of Leoncavallo where forming the first bag tray includes providing a metal sheet, the metal sheet forming a portion of the basin in view of the teachings of Maeda where the elements could have been combined by known methods with no change in their respective functions, and the combination would have yielded predictable results i.e., uniformly cooling the surface of the bag without damaging the bag [0019].
Response to Arguments
Applicant’s arguments 2/17/2026 pursuant rejections under 35 U.S.C. 103 with respect to claims 1 and 13 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.
Applicant does not separately argue the rejection of claims 3-12 except for their dependence upon claim 1 and claims 14-20 except for their dependence upon claim 13.
Accordingly, the rejections of record are considered proper and remain.
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.
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/KEONA LAUREN BANKS/Examiner, Art Unit 3763
/ELIZABETH J MARTIN/Primary Examiner, Art Unit 3763
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