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 statements (IDS) submitted on 04/02/2024 and 09/19/2025 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Claim Rejections - 35 USC § 102
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 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, 6, 11-15, 17, and 18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Corti et al. (US PGPub 2021/0187456, hereinafter Corti).
Regarding claim 1, Corti discloses mixer base assembly, comprising:
a body (figure 1, body 550) having:
an upper end (end 571) including a mating face (face 575) for mixing vessel connection (see figures 10A and 11A);
a lower end (end 572) including a cavity (cavity 557);
a fluid mixing chamber (chamber 530) having a bottom wall (wall 531)
a rounded side wall and a flat side wall (see figure 1, at least one round and one flat side wall are present among walls 551A-D), wherein the rounded side wall at a first part is the only wall encasing the fluid mixing chamber and at a second part joins with the flat side wall to encase the mixing chamber (walls 551A-D include at least one first part with a rounded side wall that joins a flat side wall at a second part);
an inlet port (port 501) arranged in the rounded side wall or the flat side wall (wall 551A);
an outlet port (port 502) arranged in the rounded side wall or the flat side wall (wall 551C);
at least one probe port (ports 518 and 519) arranged in the rounded side wall or the flat side wall (wall 551C); and,
an impeller seat (seat 615) arranged in the cavity in the lower end of the body; and,
an impeller (impeller 650) arranged in the impeller seat.
Regarding claim 2, Corti discloses an alignment marker on the rounded side wall (figure 1, indent seen in wall 551D near where item 551D is indicated) or the flat side wall configured to denote if the mixer base assembly is in a proper orientation for connection with the mixing vessel and/or a seat on a housing containing a drive system configured to drive the impeller (figure 13A). As can be seen in figure 1, the indent on wall 551D is aligned with a screw hole for attaching the mixer base to the drive system housing. Because they screw holes must be aligned for this attachment, the indent acts as the claimed alignment marker.
Regarding claim 3, Corti discloses the alignment marker is a protrusion or notch (figure 1, indent seen in wall 551D near where item 551D is indicated would be such a notch) in the side rounded side wall or the flat side wall.
Regarding claim 6, Corti discloses the impeller is a levitating magnetic impeller comprising a magnet, a base, and at least two blades (paragraph 0003).
Regarding claim 11, Corti discloses the bottom wall of the mixing chamber slopes downwardly in a direction from the inlet port toward the outlet port (paragraph 0023).
Regarding claim 12, Corti discloses the probe port (figure 1, ports 518 and 519) is positioned to position a probe into the fluid mixing chamber at a desired angle (paragraph 0023).
Regarding claim 13, Corti discloses at least one probe (figure 1, probes 818 and 819) insertable into the at least one probe port.
Regarding claim 14, Corti discloses the probe measures at least one of pH, conductivity, temperature, or dissolved oxygen (paragraph 0038).
Regarding claim 15, Corti discloses the mixing vessel is a flexible bag (paragraphs 0043 and 0044).
Regarding claim 17, Corti discloses the body is mated with the flexible bag (paragraphs 0042 and 0043).
Regarding claim 18, Corti discloses the mixer base assembly has a hold-up volume of less than 20 mL (paragraphs 0037 and 0052).
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.
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Corti et al. (US PGPub 2021/0187456, hereinafter Corti).
Regarding claim 5, although Corti does not explicitly disclose the inlet and/or outlet ports being disposed on the rounded wall, the movement of these ports to the rounded wall would have had no effect on the operation of the device and produced only the expected result of allowing material to enter and/or exit the device. It is well-settled that the mere rearrangement of parts of a device is of no significance unless the operation of the device is modified or an unexpected result is produced. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Thus, to one of ordinary skill in the art before the effective filing date of the claimed invention, it would have been obvious to have positioned the inlet and/or outlet ports on the rounded wall because such a rearrangement of parts would have provided only the predictable result of allowing fluid to enter and/or exit the device.
Regarding claim 16, Corti discloses the mixing vessel is a flexible bag (paragraphs 0016 and 0017), but does not explicitly disclose a working volume of at least 5 liters. However, it has been held that, where the only difference between the prior art and the claims was 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, there is no evidence that a mixing vessel having the recited working volume would perform differently from mixing vessels having other volumes, 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 device of Corti with the instantly claimed volume.
Claim 7-10 are rejected under 35 U.S.C. 103 as being unpatentable over Corti et al. (US PGPub 2021/0187456, hereinafter Corti) in view of Terentiev et al. (US PGPub 2006/0131765, hereinafter Terentiev).
Regarding claim 7, Corti discloses the levitating magnetic impeller comprises a central cavity, wherein the impeller seat comprises a shaft protruding through the central cavity of the levitating magnetic impeller (paragraph 0031, “the impeller comprising a base 652 including a magnet and having a central vertical opening 653 (for the spindle 610, providing an axis about which the impeller rotates)”), but is silent to a shaft cap as recited. Terentiev teaches a magnetic impeller (figure 1, element 18) having a central cavity (see element 18), wherein the impeller seat comprises a shaft (figure 1C, post 20) protruding through the central cavity of the levitating magnetic impeller, and a shaft cap (portion 20a) configured to prevent the levitating magnetic impeller from becoming dislodged from the shaft (paragraph 0037, “portion 20a for capturing the fluid-agitating element 18 and assisting in holding it thereon”). 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 Corti with the shaft cap of Terentiev for the purpose of holding the magnetic impeller on the shaft, as stated by Terentiev.
Regarding claim 8, Corti is silent to the shaft cap. Terentiev is relied upon, as above, to teach the shaft cap, and further to teach the shaft cap having a greater diameter than the central cavity of the levitating magnetic impeller (see figures 1, 1b, and 2). 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 Corti with the shaft cap of Terentiev for the purpose of holding the magnetic impeller on the shaft, as stated by Terentiev.
Regarding claim 9, Corti discloses the levitating magnetic impeller is configured to rotate around the shaft (paragraph 0031, “spindle 610, providing an axis about which the impeller rotates”).
Regarding claim 10, the heat staking of the shaft cap is considered to be a product-by-process limitation. It is well-settled that product-by-process limitations are not limited by the recited steps, only by the structure implied by the steps. See MPEP 2113. In this case, the heat staking of the shaft cap forms the structure of the cap being attached to the shaft. The combination of Corti and Terentiev above renders obvious a shaft cap attached to a shaft (as seen in figure 1c of Terentiev), and thus the product-by-process limitation is met.
Claims 5 and 16 are rejected under 35 U.S.C. 103 as being unpatentable over Corti et al. (US PGPub 2021/0187456, hereinafter Corti).
Regarding claim 5, although Corti does not explicitly disclose the inlet and/or outlet ports being disposed on the rounded wall, the movement of these ports to the rounded wall would have had no effect on the operation of the device and produced only the expected result of allowing material to enter and/or exit the device. It is well-settled that the mere rearrangement of parts of a device is of no significance unless the operation of the device is modified or an unexpected result is produced. See In re Japikse, 181 F.2d 1019, 86 USPQ 70 (CCPA 1950). Thus, to one of ordinary skill in the art before the effective filing date of the claimed invention, it would have been obvious to have positioned the inlet and/or outlet ports on the rounded wall because such a rearrangement of parts would have provided only the predictable result of allowing fluid to enter and/or exit the device.
Regarding claim 16, Corti discloses the mixing vessel is a flexible bag (paragraphs 0016 and 0017), but does not explicitly disclose a working volume of at least 5 liters. However, it has been held that, where the only difference between the prior art and the claims was 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, there is no evidence that a mixing vessel having the recited working volume would perform differently from mixing vessels having other volumes, 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 device of Corti with the instantly claimed volume.
Claim 19 and 20 are rejected under 35 U.S.C. 103 as being unpatentable over Corti et al. (US PGPub 2021/0187456, hereinafter Corti) in view of Watkins et al. (US 10059914, hereinafter Watkins).
Regarding claim 19, Corti is silent to flexible tubing as recited. Watkins teaches a mixer base assembly having an inlet and an outlet (claim 2) wherein the inlet and outlet port are mated in fluid connection with flexible tubing (column 4, line 49-column 5, line 7). The cited text indicates that inlets and outlets of the device are connected to TPE tubing, a known form of flexible tubing. 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 Corti with the tubing of Watkins for the purpose of connecting the inlets and outlets of the device to sources of fluids and/or collection or additional processing devices.
Regarding claim 20, Corti discloses sampling from the device, and specifically sampling from the outlet port (paragraph 0035). This, in combination with the flexible tubing of Watkins would indicate that samples could be taken from the tubing attached to the outlet port using a known tubing junction. 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 Corti with sampling within the tubing taught by Watkins for the purpose of ensuring the mixture being outputted by the device has a desired composition.
Allowable Subject Matter
Claim 4 is 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.
Claim 4 is deemed allowable because it recites a specific configuration of the alignment marker 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 mixing systems having a mixer base assembly and a mixer drive system.
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
