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 .
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/19/2023 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
Claim 15 is objected to because of the following informalities: the claim recites a figure reference number “2a” in its third line. Figure reference numbers in claims should be presented in parenthesis. Appropriate correction is required.
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.
Claims 5, 9, 11, and 14 are 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.
Claims 5, 9, 11, and 14 all use the term “preferably” (claim 5, line 2; claim 9, line 3; claim 11, line 2; claim 14, lines 2 and 4). This term renders the claims indefinite because it is not clear if the limitations following the term are required by the claim or merely optional. For examination on the merits, any limitation that is recited to be preferable will be interpreted as optional, but the claims must be clarified.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
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.
Claims 1-5, 7, 10-12, and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Bernard et al. (US PGPub 2011/0158037, hereinafter Bernard) in view of Isailovic (US PGPub 2015/0151261, hereinafter Isailovic) and Terentiev (US PGPub 2007/0263484, hereinafter Terentiev).
Regarding claim 1, Bernard discloses an apparatus having a single-use bag filled with a liquid of a biopharmaceutical composition, the apparatus being capable of mixing the biopharmaceutical composition and comprising:
the bag (figure 1C and 1D, container 2) made of flexible plastic material (paragraph 0038), provided with a bottom wall, a top wall and a sidewall extending from the bottom wall to the top wall so that the bag delimits an interior volume (see figures 1C and 1D);
a tank (figures 1A and 1B, container 8) provided with a base that is rectangular, the tank comprising a side wall that is rigid and provided with four panels extending upwardly from the base, in order to delimit a receiving compartment (see figures 1A and 1B);
a stirring device (means 14) located in the interior volume and adapted to be driven from below (see position of means 14 in figure 1), at the opposite from the top wall;
wherein the bag is placed inside the tank and arranged above the base and between the four panels, in the receiving compartment (paragraph 0067),
wherein the bag, in an unfolded configuration of the bag due to the liquid present inside the bag, has a parallelepiped configuration (see figure 1) and is:
extending vertically, parallel to a central axis of the tank that intersects an upper opening of the tank (see figures 1 and 2),
provided with a rectangular cross-section being in correspondence with rectangular distribution of the four panels (see figures 1 and 2), and
satisfies V2>1500L where V2 is the capacity of the bag (paragraph 0065).
Bernard is silent to a bag having a tubular sidewall that is provided with four rounded corners as recited. Isailovic teaches a single use mixing device having a tubular sidewall with four rounded corners (figure 6, container 1100), and Terentiev teaches a bag that includes rounded corners that area spaced apart from a sidewall of a tank (see figure 18). To one of ordinary skill in the art before the effective filing date of the claimed invention, it would have been obvious to have provided the apparatus of Bernard with the sidewall of Isailovic and Terentiev because Isailovic specifically indicates that different shapes of bags can be used with such an invention (paragraph 0047).
With regard to the relationship of 0.1 < 4r/p < 0.45; where p is an inner perimeter at said base to delimit the receiving compartment, r is a curvature radius as measured at any one of the four rounded corners, the Examiner has found that the specification contains no disclosure of any unexpected results arising therefrom, and that as such the parameters are arbitrary and therefore obvious. Such unsupported limitations cannot be a basis for patentability, because where patentability is said to be based upon particular chosen parameters or upon another variable recited in a claim, the applicant must show that the chosen parameters/variables are critical. See In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990) and MPEP 2144.05(III).
With respect to the limitation of relationship, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the combination of Bernard, Isailovic, and Terentiev with the dimensions recited in the instant claims, which are now considered at most an optimum choice, lacking any disclosed criticality.
Regarding claim 2, Bernard discloses the bag (figure 1C and 1D, container 2) is in contact with each of the four panels (container 8), the four panels being that are vertical panels, and wherein contact between the bag and each of the four vertical panels is obtained at four respective rectangular contact areas which extend each upwardly from the base (see figures 1 and 2).
Regarding claim 3, Bernard does not explicitly disclose the height as recited. However, it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In this case, a bag having the claimed height would operate no differently from the bag of Bernard, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the bag of Bernard with the recited height.
Regarding claim 4, Bernard discloses the bag has a longitudinal extension and comprises four plastic sheets and four longitudinal seams (see figures 1C and 1D) so that two of the four plastic sheets are gussets (gussets 4), each of the four longitudinal seams including two longitudinal sheet margins distributed in two adjacent plastic sheets that are part of the bag (see figures 1C and 1D).
Regarding claim 5, Bernard discloses the two gussets are identical sheets (see gussets 4 in figure 1C), preferably made of a multilayer plastic film (paragraph 0038). It is noted that the multilayer plastic film is considered to be an optional limitation (see rejections under 35 USC 112(b) above).
Regarding claim 7, Bernard discloses the inner perimeter of said bas is identical in circumference delimited by the four panels (see figures 1A-1D), and wherein the sidewall has a given height in said parallelepiped configuration (see figure 1C), with each of the seams having an elongated portion that is extending vertically and protruding outwardly from the sidewall of the bag (see figures 1C and 1D).
Bernard is silent to the seams being kept upright without any contact with the seams and the panels. Isailovic teaches a single use mixing device having a tubular sidewall with four rounded corners (figure 6, container 1100), and Terentiev teaches a bag that includes rounded corners that area spaced apart from a sidewall of a tank (see figure 18). In both configurations, the seams would be positioned at junctions between the panels but would not touch the panels as recited. To one of ordinary skill in the art before the effective filing date of the claimed invention, it would have been obvious to have provided the apparatus of Bernard with the sidewall of Isailovic and Terentiev because Isailovic specifically indicates that different shapes of bags can be used with such an invention (paragraph 0047).
Regarding claim 10, Bernard discloses the stirring device (figure 1C, means 14) is configured to rotate around a vertical axis (see rotation arrow in figures 1E-1H), and wherein the bag comprises an opening in the top wall suitable for introduction of powder into the interior volume from above (means of introduction 3).
Regarding claim 11, Bernard discloses a stirring device comprising only a single impeller (figure 1C, means 14). It is noted that the figures of Bernard appear to show a Rushton impeller, but this limitation is considered to be optional. With regard to the spacing height, Bernard does not explicitly disclose the height as recited. However, it has been held that where the only difference between the prior art and the claims is a recitation of relative dimensions of the claimed device, and a device having the claimed relative dimensions would not perform differently than the prior art device, the claimed device was not patentably distinct from the prior art device. See Gardner v. TEC Syst., Inc., 725 F.2d 1338, 220 USPQ 777 (Fed. Cir. 1984), cert. denied, 469 U.S. 830, 225 USPQ 232 (1984). In this case, a bag having the claimed spacing height would operate no differently from the bag of Bernard, and thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the bag of Bernard with the recited spacing height.
Regarding claim 12, Bernard discloses contact between the bag and each of the four vertical panels is obtained at four respective rectangular contact areas which extend upwardly from the base (see figures 1A-1D). As can clearly be seen in the figures, the rectangular profile of the bag of Bernard would fit into the rectangular profile of the tank of Bernard as recited, meeting the claim.
Regarding claim 17, Bernard discloses a method for mixing in single-use bioreactors, using a bag specifically designed to contain a biopharmaceutical composition (paragraph 0009), wherein the bag (figure 1C and 1D, container 2) is made of flexible plastic material (paragraph 0038) and is a 3D-bag adapted to have a paralellapiped configuration such that it is provided with a bottom wall, a top wall and a sidewall extending from the bottom wall to the top wall (see figures 1C and 1D) the method comprising:
opening a front opening to a receiving compartment of a tank (figures 1A and 1B, container 8), the tank comprising a base that is rectangular, the tank comprising a side wall that is rigid and provided with four panels extending upwardly from the base, in order to delimit a receiving compartment (see figures 1A and 1B);
placing the bag inside the tank and arranged above the base and between the four panels, in the receiving compartment (paragraph 0067),
while the front opening is open, connecting a stirring device (means 14) which extends inside the bag to a drive unit arranged below the receiving compartment, the stirring device being configured to be driven from below (see position of means 14 in figure 1), at the opposite from the top wall;
lifting the top end of the bag to start unfolding two opposite gussets of the bag (paragraph 0038); and
simultaneously filling the bag with liquid and further unvolding the bag to reach parallelepiped configuration of the bag (paragraphs 0038 and 0024);
wherein the bag, once placed inside the tank and unfolded according to the unfolded configuration (see figure 1) is:
extending vertically, parallel to a central axis of the tank that intersects an upper opening of the tank (see figures 1 and 2),
provided with a rectangular cross-section being in correspondence with rectangular distribution of the four panels (see figures 1 and 2), and
satisfies V2>1500L where V2 is the capacity of the bag (paragraph 0065).
Bernard is silent to a bag having a tubular sidewall that is provided with four rounded corners as recited. Isailovic teaches a single use mixing device having a tubular sidewall with four rounded corners (figure 6, container 1100), and Terentiev teaches a bag that includes rounded corners that area spaced apart from a sidewall of a tank (see figure 18). To one of ordinary skill in the art before the effective filing date of the claimed invention, it would have been obvious to have provided the apparatus of Bernard with the sidewall of Isailovic and Terentiev because Isailovic specifically indicates that different shapes of bags can be used with such an invention (paragraph 0047).
With regard to the relationship of 0.1 < 4r/p < 0.45; where p is an inner perimeter at said base to delimit the receiving compartment, r is a curvature radius as measured at any one of the four rounded corners, the Examiner has found that the specification contains no disclosure of any unexpected results arising therefrom, and that as such the parameters are arbitrary and therefore obvious. Such unsupported limitations cannot be a basis for patentability, because where patentability is said to be based upon particular chosen parameters or upon another variable recited in a claim, the applicant must show that the chosen parameters/variables are critical. See In re Woodruff, 919 F.2d 1575, 1578, 16 USPQ2d 1934, 1936 (Fed. Cir. 1990) and MPEP 2144.05(III).
With respect to the limitation of relationship, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the combination of Bernard, Isailovic, and Terentiev with the dimensions recited in the instant claims, which are now considered at most an optimum choice, lacking any disclosed criticality.
Allowable Subject Matter
Claims 6, 8, 9, and 13-16 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 and to overcome the rejections under 35 USC 112(b) of claims 9 and 14.
Claim 6 is deemed to contain allowable subject matter because it recites specific structure of end seals not reasonably disclosed, taught, or suggested by the prior art of record.
Claim 13 is deemed to contain allowable subject matter because it recites specific structure of a linking element and bracket not reasonably disclosed, taught, or suggested by the prior art of record.
Claim 15 is deemed to contain allowable subject matter because it recites specific structure of a fastening element not reasonably disclosed, taught, or suggested by the prior art of record.
Claim 16 is deemed to contain allowable subject matter because it recites specific structure of vertically elongated spacers not reasonably disclosed, taught, or suggested by the prior art of record.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The cited prior art generally discloses disposable bags for mixing contained within rigid frames or containers.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARC C HOWELL whose telephone number is (571)272-9834. The examiner can normally be reached Monday-Friday 8-5.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Claire Wang can be reached at 571-270-1051. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MARC C HOWELL/Primary Examiner, Art Unit 1774
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