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 07/30/2025 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, 6, 7, 11-14, 17, 18, and 20 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 a bioprocess mixer system, comprising:
a mixer base assembly (figure 1) comprising:
a body (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 plurality of side walls (walls 551A-D), the plurality of side walls comprising a rounded side wall and a flat side wall (see figure 1, at least one round and one flat side wall are present);
an inlet port (port 501) arranged in one of the one or more side walls;
an outlet port (port 502) arranged in one of the one or more side walls;
at least one probe port (ports 518 and 519) arranged in one of the one or more side walls; and,
a fluid mixing chamber (chamber 530) having a bottom wall (wall 531);
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; and
a mixer drive system comprising:
a drive system (figure 13A, system 2500) configured to drive the impeller (via motor 2000); and
a housing (housing 2300) containing the drive system, the housing comprising a locking mechanism (paragraph 0050) configured to lock the mixer base assembly into an aligned position when connected to the housing (openings for screws can be seen in figures 4A and 8, screws can be seen in figures 9A and 11A, openings in the base assembly can be seen in figures 13A and 13C).
Regarding claim 6, Corti discloses a probe support holder (figure 1, adapters 818B and 819B) configured to hold a probe in the probe port at a predetermined angle.
Regarding claim 7, Corti discloses the probe support holder (figure 1, adapters 818B and 819B) is mounted to an enclosure body configured to encase the mixing vessel positioned above the mixer drive system (see figures 1 and 11A).
Regarding claim 11, Corti discloses a method for mixing a fluid, the method comprising:
a mixer base assembly (figure 1) comprising:
a body (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 plurality of side walls (walls 551A-D), the plurality of side walls comprising a rounded side wall and a flat side wall (see figure 1, at least one round and one flat side wall are present);
an inlet port (port 501) arranged in one of the one or more side walls;
an outlet port (port 502) arranged in one of the one or more side walls;
at least one probe port (ports 518 and 519) arranged in one of the one or more side walls; and,
a fluid mixing chamber (chamber 530) having a bottom wall (wall 531);
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; and
a mixer drive system comprising:
a drive system (figure 13A, system 2500) configured to drive the impeller (via motor 2000); and
a housing (housing 2300) containing the drive system, the housing comprising a locking mechanism (paragraph 0050) configured to lock the mixer base assembly into an aligned position when connected to the housing (openings for screws can be seen in figures 4A and 8, screws can be seen in figures 9A and 11A, openings in the base assembly can be seen in figures 13A and 13C); and
introducing fluid into the fluid mixing chamber (paragraph 0004); and
rotating the impeller to mix the fluid in the fluid mixing chamber (paragraph 0004).
Regarding claim 12, Corti discloses measuring the pH and/or conductivity of the fluid in the fluid mixing chamber (paragraph 0025).
Regarding claim 13, Corti discloses sampling the fluid in the fluid mixing chamber by removing a sample of the fluid by a sample port (figure 1, sample port 507) in fluid connection with the outlet port (port 502; as can be seen in figure 1, the sample port and the outlet port are fluidly connected via chamber 530).
Regarding claim 14, Corti discloses connecting the mixer base assembly to the mixer drive system comprises locking the mixer base assembly to the mixer drive system (openings for screws can be seen in figures 4A and 8, screws can be seen in figures 9A and 11A, openings in the base assembly can be seen in figures 13A and 13C).
Regarding claim 17, Corti discloses draining the fluid from the fluid mixing chamber via the outlet port (paragraph 0032), wherein the fluid mixing chamber has a hold-up volume of less than 30 mL (paragraphs 0037 and 0052).
Regarding claim 18, Corti discloses the mixer base assembly is connected to the mixing vessel (paragraph 0053).
Regarding claim 20, Corti discloses inserting a probe (figure 1, probes 818A, 819A) into a probe support holder (adapters 818B, 819B) mounted to an enclosure body configured to encase the mixing vessel positioned above the mixer drive system (see figure 1).
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 2 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Corti et al. (US PGPub 2021/0187456, hereinafter Corti) in view of Hajianpour (US 6042262, hereinafter Hajianpour).
Regarding claim 2, Corti is silent to a rotating ring lock as recited. Hajianpour teaches a mixing device wherein a mixer base assembly (figure 1, mixing section 12) is locked to a housing (drive base 14) using a rotating ring lock (locking ring 148). 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 rotating ring lock of Hajianpour for the purpose of releasably attaching the mixer base assembly to the drive housing.
Regarding claim 15, Corti is silent to a rotating ring lock as recited. Hajianpour teaches a mixing device wherein a mixer base assembly (figure 1, mixing section 12) is locked to a housing (drive base 14) using a rotating ring lock (locking ring 148). 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 rotating ring lock of Hajianpour for the purpose of releasably attaching the mixer base assembly to the drive housing.
Claim 16 is 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 16, Corti is silent to heating the fluid in the fluid mixing chamber. Watkins teaches a mixing method in which the fluid within a mixing chamber is heated (column 6, lines 31-34). To one of ordinary skill in the art before the effective filing date of the claimed invention, it would have been obvious to have heated the fluid within the mixing chamber of Corti for the purpose of maintaining a desired setpoint temperature, which Watkins indicates is important for a bioprocess mixing device (column 6, lines 31-34).
Claim 19 is rejected under 35 U.S.C. 103 as being unpatentable over Corti et al. (US PGPub 2021/0187456, hereinafter Corti).
Regarding claim 19, 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.
Allowable Subject Matter
Claims 3-5 and 8-10 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.
Claim 3 is deemed allowable because it recites a specific configuration of the ring lock not reasonably disclosed, taught, or suggested by the prior art of record.
Claim 8 is deemed allowable because it recites a specific configuration of the probe support holder 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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/MARC C HOWELL/Primary Examiner, Art Unit 1774
