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 claims 1-12 have been considered but are moot in view of a new grounds of rejection necessitated by the amendments to the claims.
The claim amendments have overcome the previously presented rejections under 35 U.S.C. 112(b).
Election/Restrictions
Newly submitted claims 23-25 are directed to an invention that lacks unity with the invention originally claimed for the following reasons:
As provided in 37 CFR 1.475(a), a national stage application shall relate to one invention only or to a group of inventions so linked as to form a single general inventive concept (“requirement of unity of invention”). Where a group of inventions is claimed in a national stage application, the requirement of unity of invention shall be fulfilled only when there is a technical relationship among those inventions involving one or more of the same or corresponding special technical features. The expression “special technical features” shall mean those technical features that define a contribution which each of the claimed inventions, considered as a whole, makes over the prior art.
The determination whether a group of inventions is so linked as to form a single general inventive concept shall be made without regard to whether the inventions are claimed in separate claims or as alternatives within a single claim. See 37 CFR 1.475(e).
When Claims Are Directed to Multiple Categories of Inventions:
As provided in 37 CFR 1.475 (b), a national stage application containing claims to different categories of invention will be considered to have unity of invention if the claims are drawn only to one of the following combinations of categories:
(1) A product and a process specially adapted for the manufacture of said product; or
(2) A product and a process of use of said product; or
(3) A product, a process specially adapted for the manufacture of the said product, and a use of the said product; or
(4) A process and an apparatus or means specifically designed for carrying out the said process; or
(5) A product, a process specially adapted for the manufacture of the said product, and an apparatus or means specifically designed for carrying out the said process.
Otherwise, unity of invention might not be present. See 37 CFR 1.475 (c).
Restriction is required under 35 U.S.C. 121 and 372.
This application now contains the following inventions or groups of inventions which are not so linked as to form a single general inventive concept under PCT Rule 13.1:
Group I, claim(s) 1-22, drawn to a culture apparatus.
Group II, claim(s) 23-25, drawn to a culturing method.
The groups of inventions listed above do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features for the following reasons:
Groups I and II lack unity of invention because even though the inventions of these groups require the technical feature of a culture container configured to hold a liquid therein, and an outer wall covering a periphery of the culture container, wherein the culture container comprises a membrane material, the membrane material having an inner surface configured to be in contact with the liquid, and an outer surface opposite to the inner surface and configured to be in contact with a gas, the membrane material being gas-permeable such that the gas is transferable into the liquid, the outer wall forming, between the outer wall and the culture container, a space for containing the gas, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Lacey (US Patent Application Publication 2019/0127674). Lacey discloses a culture container (100) configured to hold a liquid therein (para. 40, 44, 46) and an outer wall (120) covering a periphery of the culture container (para. 48), wherein the culture container comprises a membrane material (thin polymeric gas permeable material, see Abstract; reads on a membrane material), the membrane material having an inner surface configured to be in contact with the liquid (para. 44), and an outer surface opposite to the inner surface and configured to be in contact with a gas (para. 41), the membrane material being gas-permeable such that the gas is transferable into the liquid (para. 41), the outer wall forming, between the outer wall and the culture container, a space for containing the gas (a space is formed between the outer wall 120 and the culture container 100, e.g., after the container 100 is inserted into the outer wall 120 but before the container 100 is fully expanded, see para. 48-50 and Fig. 1a, and this space is fully capable of containing a gas as the outer wall is a gas-impermeable material such as glass, see para. 49).
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits.
Accordingly, claims 23-25 are withdrawn from consideration as being directed to a nonelected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
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, 7, 9-10, and 21 are rejected under 35 U.S.C. 103 as being unpatentable over Lacey (US Patent Application Publication 2019/0127674) in view of Nishii et al. (JP 2010075081 A) (machine translation).
Regarding claim 1, Lacey discloses a culture container (100) configured to hold a liquid therein (para. 40, 44, 46), comprising:
a membrane material (thin polymeric gas permeable liner material, see Abstract; reads on a membrane material),
wherein the membrane material has an inner surface configured to be in contact with the liquid (para. 44, 46), and an outer surface that is opposite to the inner surface and is configured to be in contact with a gas (para. 41),
the membrane material is gas-permeable such that the gas is transferable into the liquid (Abstract, para. 41), and
the membrane material comprises one or more polymeric materials such as polytetrafluoroethylene (PTFE) (para. 14), and
wherein the membrane material forms a side and a bottom of the culture container (para. 40) (Fig. 1, sheet 1 of 6).
Lacey is silent as to wherein the membrane material is a laminate comprising a plurality of porous membranes laminated together or a laminate comprising a plurality of nonwoven fabrics laminated together.
Nishii et al. discloses a membrane material for a cell culture device wherein the membrane material is configured to contact cultured cells (para. 47-49). Specifically, Nishii et al. discloses wherein the membrane material is a laminate comprises a PTFE porous membrane laminated together with a polyethylene porous membrane (para. 47), and further discloses wherein this particular laminate has improved strength and good gas permeability (para. 36-37).
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 membrane material disclosed by Lacey to comprise a laminate comprising a PTFE porous membrane laminated together with a polyethylene porous membrane (reads on a plurality of porous membranes laminated together), based on the teachings of Nishii et al., as the skilled artisan would have been motivated to use a material recognized in the art to have good strength and gas permeability to provide for a reliable cell culture process with good gas exchange.
Regarding claim 3, Lacey in view of Nishii et al. teaches wherein the membrane material comprises PTFE (reads on a fluororesin), as set forth above.
Regarding claim 7, Lacey discloses a culture apparatus (Abstract), comprising:
a container (100) configured to hold a liquid therein (para. 40, 44, 46); and
an outer wall (120) covering a periphery of the culture container (para. 48);
wherein the culture container comprises a membrane material (thin polymeric gas permeable liner material, see Abstract; reads on a membrane material),
the membrane material has an inner surface configured to be in contact with the liquid (para. 44, 46), and an outer surface that is opposite to the inner surface and is configured to be in contact with a gas (para. 41),
the membrane material is gas-permeable such that the gas is transferable into the liquid (Abstract, para. 41),
the membrane material comprises one or more polymeric materials such as polytetrafluoroethylene (PTFE) (para. 14),
the outer wall forms, between the outer wall and the culture container, a space for containing the gas (a space is formed between the outer wall 120 and the culture container 100, e.g., after the container 100 is inserted into the outer wall 120 but before the container 100 is fully expanded, see para. 48-50 and Fig. 1a, and this space is fully capable of containing a gas as the outer wall is a gas-impermeable material such as glass, see para. 49), and
wherein the membrane material forms a side and a bottom of the culture container (para. 40) (Fig. 1, sheet 1 of 6).
Lacey is silent as to wherein the membrane material is a laminate comprising a plurality of porous membranes laminated together or a laminate comprising a plurality of nonwoven fabrics laminated together.
Nishii et al. discloses a membrane material for a cell culture device wherein the membrane material is configured to contact cultured cells (para. 47-49). Specifically, Nishii et al. discloses wherein the membrane material is a laminate comprises a PTFE porous membrane laminated together with a polyethylene porous membrane (para. 47), and further discloses wherein this particular laminate has improved strength and good gas permeability (para. 36-37).
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 membrane material disclosed by Lacey to comprise a laminate comprising a PTFE porous membrane laminated together with a polyethylene porous membrane (reads on a plurality of porous membranes laminated together), based on the teachings of Nishii et al., as the skilled artisan would have been motivated to use a material recognized in the art to have good strength and gas permeability to provide for a reliable cell culture process with good gas exchange.
Regarding claim 9, Lacey in view of Nishii et al. teaches wherein the membrane material comprises PTFE (reads on a fluororesin), as set forth above.
Regarding claim 10, Lacey in view of Nishii et al. teaches wherein the membrane material comprises PTFE, as set forth above.
Regarding claim 21, Lacey discloses wherein the outer wall includes an opening through which the gas can be introduced into the space (the neck 122 forms an opening that would be fully capable of introducing the gas, see para. 48-50).
Claims 15 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Lacey (US Patent Application Publication 2019/0127674) in view of Nishii et al. (JP 2010075081 A) (machine translation), as applied to claims 1 and 7, respectively, above, and in further view of Park et al. (US Patent Application Publication 2020/0172695).
Regarding claim 15, Lacey discloses wherein the culture container is configured to hold a liquid therein, and Lacey in view of Nishii et al. teaches wherein the culture container is formed from a membrane material comprising porous PTFE, as set forth above.
The prior art combination is silent as to wherein the culture container has a water pressure resistance of 300 kPa or more.
Park et al. discloses a porous PTFE membrane material (Abstract, para. 51) having a water pressure resistance of 10 to 300 kPa (para. 21) to prevent water penetration (para. 7).
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 claim range (300 kPa or more) overlaps the range disclosed by the prior art (10 to 300 kPa), and as such 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 form the culture container to have a water pressure resistance of 300 kPa, as the prior art embodied by Park et al. discloses that it was known in the art to form a membrane material having an overlapping range for the water pressure resistance in order to prevent water penetration.
Regarding claim 19, the rejection of claim 15, above, forms the basis of the rejection of claim 19.
Claim 22 is rejected under 35 U.S.C. 103 as being unpatentable over Lacey (US Patent Application Publication 2019/0127674) in view of Nishii et al. (JP 2010075081 A) (machine translation), as applied to claim 7, above, and in further view of Simon (US Patent Application Publication 2010/0055790).
Regarding claim 22, Lacey discloses wherein the culture container is formed of a gas-permeable membrane material and wherein the culture container is received within the outer wall such that a space is formed between the outer wall and the culture container, as set forth above.
Lacey is silent as to a spacer configured to maintain a predetermined distance between the culture container and the outer wall in the space.
Simon discloses an apparatus comprising a gas-permeable culture container (100) (para. 48) and an outer wall (300) for receiving the culture container (para. 56), the apparatus further comprising a spacer configured to maintain a predetermined distance between the culture container and the outer wall in a space formed therebetween (para. 57) (Fig. 3G, sheet 5 of 14), thereby promoting gas exchange.
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 apparatus disclosed by Lacey to comprise a spacer configured to maintain a predetermined distance between the culture container and the outer wall in the space, based on the teachings of Simon, in order to promote gas exchange.
Allowable Subject Matter
Claims 2, 8, 13-14, 16-18, and 20 are objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
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