DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Response to Arguments
Applicant’s arguments with respect to the previous prior art rejection of claim 15 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claim.
The previous rejection of claim 16 under 35 U.S.C. 112(b) has been withdrawn in view of the amendments to the claim.
The previous nonstatutory double patenting rejection of claims 15-17, 21-26 and 29 has been withdrawn in view of the claim amendments.
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 15-17, 21-28, and 30 are rejected under 35 U.S.C. 103 as being unpatentable over Akers et al. (US Patent 6,673,598) in view of Rozga et al. (US Patent 6,207,448).
Regarding claim 15, Akers et al. discloses a bag (Abstract) comprising:
one or more polymer films having edges bonded together to form edges around an undivided interior compartment of the bag (col. 2 lines 22-27, col. 5 line 65-col. 6 line 12) (see undivided interior shown in Fig. 12, sheet 7 of 13);
a first port (29) formed in an exterior surface of the bag (col. 8 lines 54-64) (Fig. 12, sheet 7 of 13);
a first liquid-permeable tube (one of plurality of perfusion tubes 22b) (col. 8 lines 4-30) extending into and in fluid communication with the interior compartment of the bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the first tube being operatively coupled to the first port and extending into the interior compartment (col. 8 lines 21-64) (Figs. 12 and 18, sheets 7 and 9 of 13), the first tube having a free end (23) terminating in the interior compartment (col. 8 lines 21-30) (Fig. 12, sheet 7 of 13);
a second port (41) formed in an exterior surface of the bag (col. 9 lines 38-48) (Fig. 12, sheet 7 of 13);
a second liquid-permeable tube (another one of plurality of perfusion tubes 22b) (col. 8 lines 4-30) extending into and in fluid communication with the interior compartment of the bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the second tube being operatively coupled to the second port (fluid is perfused through the second tube 22b into the interior of the bag and is thereafter operable to flow out of the outlet 41, see col. 8 lines 4-30 and col. 9 line 38-col. 10 line 25, thus fulfilling the limitation of the second tube being operatively coupled to the second port as these two elements are operatively connected so as to allow fluid flow) and extending into the interior compartment bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the second tube having a free end (23) terminating in the interior compartment (col. 8 lines 21-30) (Fig. 12, sheet 7 of 13); and
a third port (92) formed in an exterior surface of the bag (col. 4 lines 57-60) (Fig. 3, sheet 3 of 12), the third port being in communication with the interior compartment of the bag (col. 7 lines 43-55).
Akers et al. discloses wherein the first tube has perforations that allow perfusion media to be introduced from the first tube into the interior of the bag (col. 8 lines 21-30), and further discloses that during operation cells are retained in the interior compartment of the bag for culturing purposes (col. 14 lines 3-16).
However, Akers et al. is silent as to wherein the first tube has an average pore size of no more than 50 microns.
Rozga et al. discloses a cell culture device (Abstract) comprising a housing defining an inner compartment wherein cells are cultured (col. 2 line 67-col. 3 line 30), the inner compartment having therein a wall (28) provided with a plurality of perforations (30) (col. 3 lines 38-40). The perforations have a size of about 5 microns or larger and this size allows perfusion media to pass through while preventing biological components from passing through (col. 4 lines 7-13).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the first tube disclosed by Akers et al. to have an average pore size of about 5 microns or larger, based on the teachings of Rozga et al., in order to provide perforations that allow perfusion media to pass through but prevent the passage of cells, in order to achieve the goals envisioned by Akers et al. as discussed above.
It has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (no more than 50 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 16, Akers et al. discloses a cell culture system (Abstract, col. 4 line 13-col. 5 line 40) comprising a bag (Abstract) comprising:
one or more polymer films having edges bonded together to form edges around an undivided interior compartment of the bag (col. 2 lines 22-27, col. 5 line 65-col. 6 line 12) (see undivided interior shown in Fig. 12, sheet 7 of 13);
a first port (29) formed in an exterior surface of the bag (col. 8 lines 54-64) (Fig. 12, sheet 7 of 13);
a first liquid-permeable tube (one of plurality of perfusion tubes 22b) (col. 8 lines 4-30) extending into and in fluid communication with the interior compartment of the bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the first tube being operatively coupled to the first port and extending into the interior compartment (col. 8 lines 21-64) (Figs. 12 and 18, sheets 7 and 9 of 13), the first tube having a free end (23) terminating in the interior compartment (col. 8 lines 21-30) (Fig. 12, sheet 7 of 13);
a second port (41) formed in an exterior surface of the bag (col. 9 lines 38-48) (Fig. 12, sheet 7 of 13);
a second liquid-permeable tube (another one of plurality of perfusion tubes 22b) (col. 8 lines 4-30) extending into and in fluid communication with the interior compartment of the bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the second tube being operatively coupled to the second port (fluid is perfused through the second tube 22b into the interior of the bag and is thereafter operable to flow out of the outlet 41, see col. 8 lines 4-30 and col. 9 line 38-col. 10 line 25, thus fulfilling the limitation of the second tube being operatively coupled to the second port as these two elements are operatively connected so as to allow fluid flow) and extending into the interior compartment bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the second tube having a free end (23) terminating in the interior compartment (col. 8 lines 21-30) (Fig. 12, sheet 7 of 13); and
a third port (92) formed in an exterior surface of the bag (col. 4 lines 57-60) (Fig. 3, sheet 3 of 12), the third port being in communication with the interior compartment of the bag (col. 7 lines 43-55);
wherein the bag is oriented on a support (col. 4 line 65-col. 5 line 40) such that the first and second liquid-permeable tubes are elevated relative to a majority of a bottom surface of the bag (see Figs. 1-3 and Fig. 12, sheets 1-3 and 7 of 13; first and second liquid-permeable tubes 22b are elevated relative to a majority of a bottom surface of the bag).
Akers et al. discloses wherein the first tube has perforations that allow perfusion media to be introduced from the first tube into the interior of the bag (col. 8 lines 21-30), and further discloses that during operation cells are retained in the interior compartment of the bag for culturing purposes (col. 14 lines 3-16).
However, Akers et al. is silent as to wherein the first tube has an average pore size of no more than 50 microns.
Rozga et al. discloses a cell culture device (Abstract) comprising a housing defining an inner compartment wherein cells are cultured (col. 2 line 67-col. 3 line 30), the inner compartment having therein a wall (28) provided with a plurality of perforations (30) (col. 3 lines 38-40). The perforations have a size of about 5 microns or larger and this size allows perfusion media to pass through while preventing biological components from passing through (col. 4 lines 7-13).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the first tube disclosed by Akers et al. to have an average pore size of about 5 microns or larger, based on the teachings of Rozga et al., in order to provide perforations that allow perfusion media to pass through but prevent the passage of cells, in order to achieve the goals envisioned by Akers et al. as discussed above.
It has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (no more than 50 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 17, Akers et al. discloses a cell culture system (Abstract, col. 4 line 13-col. 5 line 40) comprising a bag (Abstract) comprising:
one or more polymer films having edges bonded together to form edges around an undivided interior compartment of the bag (col. 2 lines 22-27, col. 5 line 65-col. 6 line 12) (see undivided interior shown in Fig. 12, sheet 7 of 13);
a first port (29) formed in an exterior surface of the bag (col. 8 lines 54-64) (Fig. 12, sheet 7 of 13);
a first liquid-permeable tube (one of plurality of perfusion tubes 22b) (col. 8 lines 4-30) extending into and in fluid communication with the interior compartment of the bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the first tube being operatively coupled to the first port and extending into the interior compartment (col. 8 lines 21-64) (Figs. 12 and 18, sheets 7 and 9 of 13), the first tube having a free end (23) terminating in the interior compartment (col. 8 lines 21-30) (Fig. 12, sheet 7 of 13);
a second port (41) formed in an exterior surface of the bag (col. 9 lines 38-48) (Fig. 12, sheet 7 of 13);
a second liquid-permeable tube (another one of plurality of perfusion tubes 22b) (col. 8 lines 4-30) extending into and in fluid communication with the interior compartment of the bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the second tube being operatively coupled to the second port (fluid is perfused through the second tube 22b into the interior of the bag and is thereafter operable to flow out of the outlet 41, see col. 8 lines 4-30 and col. 9 line 38-col. 10 line 25, thus fulfilling the limitation of the second tube being operatively coupled to the second port as these two elements are operatively connected so as to allow fluid flow) and extending into the interior compartment bag (col. 8 lines 45-55) (Fig. 12, sheet 1 of 13), the second tube having a free end (23) terminating in the interior compartment (col. 8 lines 21-30) (Fig. 12, sheet 7 of 13); and
a third port (92) formed in an exterior surface of the bag (col. 4 lines 57-60) (Fig. 3, sheet 3 of 12), the third port being in communication with the interior compartment of the bag (col. 7 lines 43-55);
wherein the bag is oriented on a support (col. 4 line 65-col. 5 line 40) such that the first liquid permeable-tube is elevated relative to the second liquid-permeable tube (see Figs. 1-3 and Fig. 12, sheets 1-3 and 7 of 13; a first liquid-permeable tube 22b is elevated relative to a second liquid-permeable tube 22b).
Akers et al. discloses wherein the first tube has perforations that allow perfusion media to be introduced from the first tube into the interior of the bag (col. 8 lines 21-30), and further discloses that during operation cells are retained in the interior compartment of the bag for culturing purposes (col. 14 lines 3-16).
However, Akers et al. is silent as to wherein the first tube has an average pore size of no more than 50 microns.
Rozga et al. discloses a cell culture device (Abstract) comprising a housing defining an inner compartment wherein cells are cultured (col. 2 line 67-col. 3 line 30), the inner compartment having therein a wall (28) provided with a plurality of perforations (30) (col. 3 lines 38-40). The perforations have a size of about 5 microns or larger and this size allows perfusion media to pass through while preventing biological components from passing through (col. 4 lines 7-13).
It would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the first tube disclosed by Akers et al. to have an average pore size of about 5 microns or larger, based on the teachings of Rozga et al., in order to provide perforations that allow perfusion media to pass through but prevent the passage of cells, in order to achieve the goals envisioned by Akers et al. as discussed above.
It has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (no more than 50 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 21, Akers et al. in view of Rozga et al. teaches wherein the first tube has an average pore size of about 5 microns or larger, as set forth in the rejection of claim 15, above.
The prior art combination does not expressly teach an average pore size of less than 20 µm.
Nonetheless, it has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (less than 20 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 22, Akers et al. in view of Rozga et al. teaches wherein the first tube has an average pore size of about 5 microns or larger, as set forth in the rejection of claim 15, above.
The prior art combination does not expressly teach an average pore size of less than 10 µm.
Nonetheless, it has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (less than 10 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 23, Akers et al. in view of Rozga et al. teaches wherein the first tube has an average pore size of about 5 microns or larger, as set forth in the rejection of claim 15, above.
The prior art combination does not expressly teach an average pore size of less than 5 µm.
Nonetheless, it has been held that in the case where a claimed range touches the prior art range, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that touches the claim range (less than 5 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 24, Akers et al. in view of Rozga et al. teaches wherein the first tube has an average pore size of about 5 microns or larger, as set forth in the rejection of claim 15, above.
The prior art combination does not expressly teach an average pore size of at least 400 nm.
Nonetheless, it has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (less than 10 microns but at least 400 nm), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 25, Akers et al. in view of Rozga et al. teaches wherein the first tube has an average pore size of about 5 microns or larger, as set forth in the rejection of claim 15, above.
The prior art combination does not expressly teach an average pore size of at least 1000 nm.
Nonetheless, it has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (less than 10 microns but at least 1000 nm), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 26, Akers et al. discloses wherein the one or more polymer films include a first polymer film and a second polymer film (col. 2 lines 22-27, col. 5 line 65-col. 6 line 12), having edges bonded together to form edges around an undivided interior compartment of the bag (col. 6 lines 34-39) (Figs. 12 and 16, sheet 7 of 13).
Regarding claim 27, Akers et al. discloses the second tube, as set forth above.
Akers et al. is silent as to wherein the second tube has an average pore size of less than 50 µm.
However, Akers et al. discloses wherein the second tube is of the same configuration as the first tube and is configured to deliver perfusion media into the internal compartment via perforations (first and second tubes are elements of the plurality of tubes 22b, as discussed in the rejection of claim 15, above; see also col. 8 lines 4-30). Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the second tube to have an average pore size of about 5 microns or larger, based on the teachings of Rozga et al., for the same rationale applied in the rejection of claim 15, above.
It has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (less than 50 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 28, Akers et al. discloses the second tube, as set forth above.
Akers et al. is silent as to wherein the second tube has an average pore size of less than 20 µm.
However, Akers et al. discloses wherein the second tube is of the same configuration as the first tube and is configured to deliver perfusion media into the internal compartment via perforations (first and second tubes are elements of the plurality of tubes 22b, as discussed in the rejection of claim 15, above; see also col. 8 lines 4-30). Therefore, it would have been obvious to one of ordinary skill in the art at the time before the effective filing date of the claimed invention to modify the second tube to have an average pore size of about 5 microns or larger, based on the teachings of Rozga et al., for the same rationale applied in the rejection of claim 15, above.
It has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (less than 20 microns), and therefore the claim does not introduce a patentable distinction over the prior art.
Regarding claim 30, Akers et al. in view of Rozga et al. teaches wherein the first tube has an average pore size of about 5 microns or larger, as set forth in the rejection of claim 15, above.
The prior art combination does not expressly teach an average pore size in the range of 10 to 50 microns
Nonetheless, it has been held that in the case where a claimed range overlaps or lies inside a range disclosed by the prior art, a prima facie case of obviousness exists (MPEP §2144.05). In this case, the prior art teaches a range (about 5 microns or larger) that overlaps the claim range (10 to 50 microns) and therefore the claim does not introduce a patentable distinction over the prior art.
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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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799