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 claim 1 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
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.
Claim 11 is 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 11 recites “wherein the plurality of grooves are disposed in which the plurality of grooves extend in directions nonparallel to each other on the culture chamber side surface of the first vessel wall and the first vessel wall side surface of the intermediate culture wall facing each other, and in directions nonparallel to each other on the culture chamber side surface of the second vessel wall and the second vessel wall side surface of the intermediate culture wall” (emphasis added). However, claim 10, from which claim 11 depends, recites “wherein the plurality of grooves are linearly disposed in parallel” (emphasis added) which can reasonably be interpreted as meaning that all grooves extend in directions parallel to each other, and this subject matter would appear to contradict the subject matter claimed in claim 11. Therefore, the subject matter in base claim 10 renders claim 11 indefinite.
Claim Rejections - 35 USC § 102
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.
Claims 1-5, 8, and 12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fuller et al. (US Patent 7,560,274).
Regarding claim 1, Fuller et al. discloses a bag-shaped adherent cell culture vessel (Abstract, col. 7 lines 44-47) made of flexible packaging material (col. 7 lines 1-47), comprising:
a vessel body portion having a first vessel wall and a second vessel wall (formed by two membranes welded together) (col. 10 line 36-col. 11 line 2) (Figs 1-3, sheets 1-2 of 10); and
one or more injecting/ejecting ports (23) (col. 10 line 36-col. 11 line 2) (Figs 1-3, sheets 1-2 of 10), wherein:
the vessel body portion has an intermediate culture wall (36) between the first vessel wall and the second vessel wall (col. 10 line 61-col. 11 line 2) (Fig. 3, sheet 2 of 10), and a flow passage communicating between the respective culture chambers is disposed (each pore in the intermediate culture wall forms such a passage, see col. 6 lines 5-32); and
a whole or a part of a culture chamber side surface of the first vessel wall, a whole or a part of a first vessel wall side surface of the intermediate culture wall, a whole or a part of a culture chamber side surface of the second vessel wall, and a whole or a part of a second vessel wall side surface of the intermediate culture wall are formed by being provided with surface treatment that allows adherent cells to adhere to the culture chamber side surface of the first vessel wall, the first vessel wall side surface of the intermediate culture wall, the culture chamber side surface of the second vessel wall, and the second vessel wall side surface of the intermediate culture wall (col. 3 lines 23-47, col. 6 lines 5-32, col. 10 line 36-col. 11 line 2) (Fig. 3, sheet 2 of 10).
Regarding claim 2, Fuller et al. discloses wherein a plurality of the intermediate culture walls (36) are disposed between the first vessel wall and the second vessel wall (col. 10 line 61-col. 11 line 2) (Fig. 3, sheet 2 of 10), a culture chamber is disposed between the intermediate culture walls (col. 6 lines 5-32, col. 10 line 61-col. 11 line 2) (Fig. 3, sheet 2 of 10), and a flow passage communicating between the respective culture chambers is disposed (each pore in the intermediate culture wall forms such a passage, see col. 6 lines 5-32).
Regarding claim 3, Fuller et al. discloses wherein the flow passage is a hole (called pore) passing through the intermediate culture wall (col. 6 lines 5-32).
Regarding claim 4, Fuller et al. discloses wherein the first vessel wall and the second vessel wall have a bulging shape that bulges outward at a peripheral edge region of a culture chamber (col. 10 line 36-col. 11 line 2) (Figs 1-3, sheets 1-2 of 10).
Regarding claim 5, Fuller et al. discloses wherein the intermediate culture wall (36) has a bulging shape that bulges outward in a peripheral edge region of a culture chamber (col. 6 lines 5-32, col. 10 line 61-col. 11 line 2) (Fig. 3, sheet 2 of 10).
Regarding claim 8, Fuller et al. discloses wherein a plurality of grooves composed of mountain-shaped portions and trough-shaped portions are disposed in a region of each of the surfaces on which surface treatment is performed (col. 3 lines 23-47, col. 6 lines 5-32, col. 10 line 36-col. 11 line 2) (Figs. 1-3, sheets 1-2 of 10).
Regarding claim 12, Fuller et al. discloses wherein a plurality of the injecting/ejecting ports are disposed to be opposed in a peripheral edge region of a culture chamber (col. 10 lines 50-60) (Figs. 2-3, sheets 1-2 of 10).
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.
Claim 6 is rejected under 35 U.S.C. 103 as being unpatentable over Fuller et al. (US Patent 7,560,274).
Regarding claim 6, Fuller et al. discloses the bag-shaped vessel formed of first and second vessel walls, as set forth above, wherein each of the first and second vessel walls and the intermediate culture wall are membranes (col. 10 line 61-col. 11 line 2).
Fuller et al. does not expressly teach wherein a thickness of the first vessel wall, the second vessel wall, and the intermediate culture wall is 1 mm or less.
However, Fuller et al. discloses elsewhere that a membrane having a thickness of 0.25 mm can be used to fabricate a cell culture vessel (col. 11 lines 40-51). Fuller et al. further discloses that bag-shaped vessels are valued in the cell culture art for their flexibility and disposability and because they take up less space (col. 7 lines 1-12).
It has been held that where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation, when the particular parameter is recognized as a result-effective variable (MPEP §2144.05). Fuller et al. discloses general condition for the thickness of a membrane and the skilled artisan would understand that adjusting the thickness of the first vessel wall, second vessel wall, and intermediate culture wall would affect the flexibility, disposability, and ease of storage of the vessel. 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 discover an optimum or workable range for the thickness of each of the first vessel wall, the second vessel wall, and the intermediate culture wall through routine experimentation.
Claims 9-10 are rejected under 35 U.S.C. 103 as being unpatentable over Fuller et al. (US Patent 7,560,274) in view of O'Connell et al. (US Patent 5,272,084) (already of record).
Regarding claim 9, Fuller et al. discloses the plurality of grooves disposed in a region of each of the surfaces on which surface treatment is performed, as set forth above. Fuller et al. further discloses wherein the surface treatment is performed to increase surface area and enhance cell adhesion (Abstract, col. 3 lines 24-47).
Fuller et al. does not expressly teach wherein the plurality of grooves have V-shaped cross section perpendicular to a direction in which each of the plurality of grooves extends, and an inclined angle of side surface of the V shape in each of the plurality of grooves is 80 degrees or less.
O’Connell et al. discloses a cell culture vessel (Abstract) comprising a vessel wall fabricated to comprise on an inner surface thereof a plurality of grooves composed of mountain-shaped portions (“peaks”) and trough-shaped portions (“valleys”) (col. 3 lines 16-52) (Figs. 1-4, sheets 1-2 of 3) wherein the plurality of grooves have a V-shaped cross section perpendicular to a direction in which each of the plurality of grooves extends (col. 3 lines 16-52) (Figs. 1-4, sheets 1-2 of 3) and an inclined angle of side surfaces of the V shape in each of the plurality of grooves is about 70 degrees (O’Connell et al. discloses wherein the top angle alpha of each triangular peak is about 40 degrees, see col. 4 lines 16-40 and Fig. 4, and therefore the inclined angle of a corresponding side surface is =
180
-
40
2
= 70). O’Connell et al. discloses that such a groove shape promotes cell adhesion (col. 5 lines 44-50) and that the particular angle discussed above is “particularly suitable for a variety of cell lines” (col. 5 lines 19-22).
It has been held that changes in shape are considered a matter of choice which a person of ordinary skill in the art would find prima facie obvious absent persuasive evidence that the particular shape configuration is significant (MPEP §2144.04). 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 each of the plurality of grooves disclosed by Fuller et al. to have a V-shaped cross section perpendicular to a direction in which each of the plurality of grooves extends, as O’Connell discloses that it was known in the art to use such a shape to promote adhesion of adherent cells. Additionally, the skilled artisan would have been motivated to modify the grooves disclosed by Fuller et al. to have an inclined angle of side surfaces of about 70 degrees (falls within the claim range), as O’Connell discloses that such a configuration is suitable for a variety of cell lines.
Regarding claim 10, Fuller et al. discloses the plurality of grooves disposed in a region of each of the surfaces on which surface treatment is performed, as set forth above. Fuller et al. further discloses wherein the surface treatment is performed to increase surface area and enhance cell adhesion (Abstract, col. 3 lines 24-47).
Fuller et al. does not expressly teach wherein the plurality of grooves are linearly disposed in parallel, and a top end portion of each of the mountain-shaped portions is linear.
O’Connell et al. discloses a cell culture vessel (Abstract) comprising a vessel wall fabricated to comprise on an inner surface thereof a plurality of grooves composed of mountain-shaped portions (“peaks”) and trough-shaped portions (“valleys”) (col. 3 lines 16-52) (Figs. 1-4, sheets 1-2 of 3) wherein the plurality of grooves are linearly disposed in parallel (“continuous parallel raised ridges”) (col. 3 lines 16-19) (Figs. 1-2, sheet 1 of 3) and a top end portion of each of the mountain-shaped portions is linear (e.g., each peak has a same height and a straight line can be drawn across a top end portion of each of the mountain-shaped portion, see col. 4 lines 16-29 and Figs. 1-4). O’Connell et al. discloses that such a groove shape promotes cell adhesion (col. 5 lines 44-50), and further discloses that disposing the grooves linearly as discussed above allows “bridging” between cultured cells which provides a more in-vivo like culture (col. 3 lines 16-38).
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 plurality of grooves disclosed by Fuller et al. to be linearly disposed in parallel wherein a top end portion of each of the mountain-shaped portions is linear, as O’Connell et al. discloses that such a groove configuration provides a more in-vivo like environment, and the skilled artisan would have been motivated to enhance in-vivo conditions for the cell culture.
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Fuller et al. (US Patent 7,560,274) in view of O'Connell et al. (US Patent 5,272,084) (already of record), as applied to claim 10, above, and in further view of Tai et al. (US Patent Application Publication 2018/0016533) (already of record).
Regarding claim 11, Fuller et al. discloses grooves on each of the culture chamber side surface of the first vessel wall and the first vessel wall side surface of the intermediate culture wall, wherein these sides face each other, and on the culture chamber side surface of the second vessel wall and the second vessel wall side surface of the intermediate culture wall, wherein these sides face each other, as set forth above (see also Fig. 3). Furthermore, Fuller et al. in view of O’Connell et al. teaches wherein the plurality of grooves are disposed in parallel, as set forth above.
The prior art combination is silent as to wherein the plurality of grooves are disposed in which the plurality of grooves extend in directions nonparallel to each other on the culture chamber side surface of the first vessel wall and the first vessel wall side surface of the intermediate culture wall facing each other, and in directions nonparallel to each other on the culture chamber side surface of the second vessel wall and the second vessel wall side surface of the intermediate culture wall.
Nonetheless, disposing the grooves taught by the prior art combination such that they extend in directions nonparallel to one another on the surfaces facing one another represents a mere rearrangement of the grooves, and it has been held that rearrangement of parts of a prior art device is a prima facie obvious design modification (MPEP 2144.04).
Furthermore, Tai et al. discloses that it is desirable to prevent a cell culture bag from collapsing and the facing sides thereof from sticking together (Abstract).
Therefore, the prior art supplies a teaching that would lead one of ordinary skill in the art to seek to prevent collapse and/or sides sticking together of the bag-shaped cell culture vessel taught by Fuller et al. in view of O’Connell et al., and the skilled artisan would recognize that two facing surfaces including grooves parallel to one another would be likely to stick together owing to the mating between parallel grooves on each side. Thus, the skilled artisan would have found it obvious to arrange the grooves to extend in directions nonparallel to one another on the surfaces facing one another to avoid mating and prevent the sides from sticking together.
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 HOLLY KIPOUROS whose telephone number is (571)272-0658. The examiner can normally be reached M-F 8.30-5PM.
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/HOLLY KIPOUROS/Primary Examiner, Art Unit 1799