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 .
Election/Restriction
REQUIREMENT FOR UNITY OF INVENTION
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 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.
In accordance with 37 CFR 1.499, applicant is required, in reply to this action, to elect a single invention to which the claims must be restricted.
Group I, claim(s) 1-3,8, 17-18,25,30-31, and 114 drawn to a gas permeable cell culture device.
Group Ii, claims 115-124, drawn to a cell culture 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:
The groups lack unity of invention because the groups do not share the same or corresponding technical feature. Group I has the technical feature of a container, a fitting, and cell transfer conduit. Group II has the technical feature of a top end cap and a bottom end cap. Thus the groups do not share a corresponding special technical feature and there is a lack of unity.
Applicant is reminded that upon the cancelation of claims to a non-elected invention, the inventorship must be corrected in compliance with 37 CFR 1.48(a) if one or more of the currently named inventors is no longer an inventor of at least one claim remaining in the application. A request to correct inventorship under 37 CFR 1.48(a) must be accompanied by an application data sheet in accordance with 37 CFR 1.76 that identifies each inventor by his or her legal name and by the processing fee required under 37 CFR 1.17(i).
During a telephone conversation with Lei Xu on 7/30/2026 a provisional election was made with traverse to prosecute the invention of Group 1, claims 1-3,8,17-18,35,30-31 and 114. Affirmation of this election must be made by applicant in replying to this Office action. Claims 115-124 are withdrawn from further consideration by the examiner, 37 CFR 1.142(b), as being drawn to a non-elected invention.
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 1-3 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Vera et al. (US 8,956,860).
Regarding claim 1 Vera discloses a gas permeable cell culture device comprising: (See Vera Abstract Fig. 22A and Col. 30 Lines 10-35)
a container body defining an interior volume, the container body having a semi- permeable membrane defining one end of the interior volume; (See Vera Fig. 22A and Col. 30 Lines 10-35 wherein a container body has a semi-permeable, i.e. gas permeable, membrane 1006 at one end of an interior volume.)
a fitting defining an opposing end of the interior volume;(See Vera Fig. 22A and Col. 30 Lines 10-35 wherien a fitting, i.e. lid 1012, defines an opposing end of the interior volume.)
and a cell transfer conduit having:an open end positioned within the interior volume between the semi-permeable membrane and the fitting; and a radial portion disposed within the interior volume and between the open end and opposing end of the container body. (See Vera Fig. 22A and Col. 30 Lines 10-35 a cell transfer conduit 1002 with an open end is positioned in the interior volume between membrane and fitting and has a radial, i.e, bent, portion between the open end and opposing end of the container.)
Regarding claim 2 Vera discloses all the claim limitations as set forth above as well as the device wherein the interior volume is configured to include a headspace and at least a portion of the radial portion is disposed in the headspace. (See Vera Fig.22D wherein the interior volume has a headspace, i.e. portion above material 1024 and a portion of the radial portion is in the headspace.)
Regarding claim 3 Vera discloses all the claim limitations as set forth above as well as the device wherein the radial portion comprises a segment of the cell transfer conduit having a longitudinal axis with at least one finite radius of curvature. (See Vera Fig. 22A wherein the radial portion comprises a segment of the conduit having a longitudinal axis and has a finite radius of curvature.)
Regarding claim 25 Vera discloses all the claim limitations as set forth above as well as the
further comprising: a bottom fitting coupled to a bottom of the container, wherein the bottom fitting is adjacent to the semi-permeable membrane, and the bottom fitting is configured to be removably coupled to a tray, the tray being configured to receive a plurality of bottom fittings. (See Vera Fgi. 22A wherein a fitting, i.e. support, 1018 is adjacent the membrane and is fully configured to couple to a tray.)
It is noted that the claims do not positively require such a tray but merely a fitting which may be coupled to a tray.
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.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
And
Claims 8 and 30-31 are rejected under 35 U.S.C. 103 as being unpatentable over Vera et al. (US 8,956,860) as applied to claims above, and further in view of De et al. (US 2019/0048305).
Regarding claims 8,30,31 Vera discloses all the claim limitations as set forth above as well as the device as well as the use of other conduits but does not specifically disclose a gas inlet , an extraction conduit, and a feeding conduit.
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De et al. discloses a cell culture device having a separation membrane 206 at one and a fitting 219a and 219b at another and a cell transfer conduit 250. The device is also provided with a gas inlet conduit 244, through the fitting, an extraction conduit 228 extending into a headspace through the fitting, and a feeding conduit 224 extending into the headspace through the fitting and wherein a gas inlet conduit includes a radial portion between the membrane and the fitting, i.e. it bends as shown in Fig. 5C. (See De et al. Abstract and Figs. 4 and 5C)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a gas inlet, extraction, and feeding, conduits as described by De et al. in the device of Vera because such conduits allow for the perfusion and simultaneous feeding, removal, and transfer of materials into and out of a cell culture device so that cultures may be more efficiently maintained as would be desirable in the device of Vera.
Claims 17-18 and 114 are rejected under 35 U.S.C. 103 as being unpatentable over Vera et al. (US 8,956,860) as applied to claims above, and further in view of Knaus et al. (US 2014/0273077).
Regarding claim 17 Vera discloses all the claim limitations as set forth above as well as the device wherein a conduit 1008 passes through a horizontal top wall of the fitting but does not specifically disclose the cell transfer conduit passing through a vertical sidewall of the fitting.
Knaus disclose a cell culture device wherein a cell transfer conduit is placed perpendicular on a side wall from a vent though a horizontal top wall. (See Knaus Fig. 5.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a cell transfer conduit through a fitting sidewall and perpendicular to other conduits as described by Knaus in the device of Vera because doing so allows for more effective removal of cells without blocking other ports of the device as would be desirable in the device of Vera.
Furthermore such a modification would have required a mere rearrangement of parts which would have been obvious to one of ordinary skill in the art to optimize port spacing and because it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
Regarding claim 18 Vera discloses all the claim limitations as set forth above but does not disclose a separation membrane.
Knaus et al. discloses tubing sealed using a gasket, i.e. separation membrane, disclose between the fitting and interior volume of the container to maintain sterile conditions and the gasket has apertures configured to receive the tubing. (See Knaus [0102] wherein a tube extending through a fitting is sealed using a gasket, i.e. membrane, with apertures for the said tubes.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a gasket with tubing apertures as described by Knaus in the device of Vera because such a gasket allows sealing of the tubing and maintaining sterile conditions as would be desirable in the device of Vera.
Regarding claim 114 Vera discloses a gas permeable cell culture device comprising: (See Vera Abstract Fig. 22A and Col. 30 Lines 10-35)
a container body defining an interior volume, the container body having a semi- permeable membrane defining one end of the interior volume; (See Vera Fig. 22A and Col. 30 Lines 10-35 wherein a container body has a semi-permeable, i.e. gas permeable, membrane 1006 at one end of an interior volume.)
a fitting defining an opposing end of the interior volume and having a vertical wall;(See Vera Fig. 22A and Col. 30 Lines 10-35 wherien a fitting, i.e. lid 1012, defines an opposing end of the interior volume.)
and a cell transfer conduit having:an open end positioned within the interior volume between the semi-permeable membrane and the fitting; and a radial portion disposed within the interior volume and between the open end and opposing end of the container body. (See Vera Fig. 22A and Col. 30 Lines 10-35 a cell transfer conduit 1002 with an open end is positioned in the interior volume between membrane and fitting and has a radial, i.e, bent, portion between the open end and opposing end of the container.)
an interior portion extending from the fitting to the open end, the interior portion having an inner wall radially disposed about a longitudinal axis wherein no segment of the longitudinal axis of the interior portion has a radius of curvature; and a transfer portion in fluid communication with the radial portion and extending from the fitting. (See Vera Fig.22A wherein an interior portion has an inner wall radialy disposed about a longitudinal axis, i.e. it is a tube, and has a transfer portion from the fitting to 1004, at the top thereof in fluid communication and extending upwards from the fitting.
Vera does not explicitly disclose the cell transfer conduit passing through a vertical portion of the fitting or the radius of curvature that is less than 30 centimeters.
Knaus disclose a cell culture device wherein a cell transfer conduit is placed perpendicular on a side wall from a vent though a horizontal top wall. (See Knaus Fig. 5.)
It would have been obvious to one of ordinary skill in the art at the time of filing to provide a cell transfer conduit thorugh a sidewall of the fitting and perpendicular to other conduits as described by Knaus in the device of Vera because doing so allows for more effective removal of cells without blocking other ports of the device as would be desirable in the device of Vera.
Furthermore such a modification would have required a mere rearrangement of parts which would have been obvious to one of ordinary skill in the art to optimize port spacing and because it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
In regards to the length of the radius of curvature it is noted that such a modification would have required a mere change in size of the tubing which would have been obvious to one of ordinary skill in the art to optimize fitting in various sized cell culture devices and because A change in size (dimension) is generally recognized as being within the level of ordinary skill in the art. In re Rose, 220 F.2d 459, 105 USPQ 237 (CCPA 1955). Where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and the device having the claimed dimensions would not perform differently than the prior art device, the claimed device is not patentably distinct from the prior art device, Gardner v. TEC Systems, Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). It is well known in the art that the thinner the walls in heat exchange vessel the better the heat exchange efficiency and that many design parameters are taken into consideration when determining the thickness of the walls.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JONATHAN M HURST whose telephone number is (571)270-7065. The examiner can normally be reached on M-F 7AM-4PM.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached on 571-272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/JONATHAN M HURST/ Primary Examiner, Art Unit 1799
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