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 .
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.
Information Disclosure Statement
The information disclosure statement dated 11/11/2022 has been considered and made of record.
Claim Objections
Claims 2, 5 and 7 are objected to because of the following informalities:
In claim 2, at line 1, “aconductive” should be “a conductive”.
In claim 5, at line 1, “asolid” should be “a solid”.
In claim 7, at line 2, “isconnected” should be “is connected”.
Appropriate correction is required.
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, 6-8, 11, 12, 25-27, 29, 32-34 and 36 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ossart (WO 2011/045547 and corresponding English language machine translation).
With respect to claim 1, the reference of Ossart discloses:
A system for bioprocessing (Figs. 2-4), comprising:
a bioprocessing vessel (bioreactor)(30) formed of a material insulative to a liquid medium when present therein (page 7, last paragraph, of the translation);
at least one sensor (4, 1, 2)(probe) for sensing a parameter of the bioprocessing vessel and generating a signal indicative of the parameter; and
at least one conductor ((electrode) (3) and (wire or cable)(10)) adapted to provide electrical communication between the liquid medium in the bioprocessing vessel and an external structure ((measurement mass)(7) or (earth (ground))(31)) to achieve equipotential for reducing noise in the signal produced by the at least one sensor (putting the culture medium to the mass or to earth) (page 3, last three paragraphs of the translation).
With respect to claim 2, the reference of Ossart discloses that the at least one conductor is a pin (electrode) (3) or wire (cable)(10) connecting the liquid medium with the external structure.
With respect to claim 3, the reference of Ossart discloses that the at least one sensor includes a body (support)(5) connected to the insulative material of the bioprocessing vessel, the body further including a conductive portion (electrode)(3) adapted to contact the liquid medium, the at least one conductor (wire or cable)(10) adapted to electrically communicate with the conductive portion of the body.
With respect to claim 6, the bioprocessing vessel includes a port (opening) (page 8, second paragraph, of the translation) for receiving the sensor.
With respect to claim 7, the sensor is connected to a controller (6) for monitoring one or more operating parameters.
With respect to claim 8, the parameter can be biomass/cell density (page 3, last three paragraphs of the translation).
With respect to claim 11, the external structure comprises a ground connection (earth)(31) or a controller (6, 7).
With respect to claim 12, the bioprocessing vessel is a bioreactor (30).
With respect to claim 25, the reference of Ossart discloses:
An apparatus (Figs. 3 and 4) for use in connection with bioprocessing including a liquid medium (biological medium)(page 7, last paragraph, of the translation) and an external structure ((measurement mass)(7) or (earth (ground))(31)), comprising:
a sensor (4, 1, 2)(probe) for contacting the liquid medium, the sensor having a conductive material (electrode)(3) in electrical communication with the liquid medium; and
a conductor (cable or wire (10) connecting the electrode (3) to the measurement mass (7) or ground (31)) adapted to provide electrical communication between the liquid medium via the conductive material of the sensor and the external structure to achieve equipotential (putting the culture medium to the mass or to earth)(page 3, last three paragraphs of the translation).
With respect to claim 26, the reference of Ossart discloses that the sensor can be a tubular body (Figs. 4-6) that includes electrode (3).
With respect to claim 27, the reference of Ossart discloses that the conductor is a cable or wire (10).
With respect to claim 29, the reference of Ossart discloses the sensor includes a probe structure (support)(5) which is in contact with conductive material (electrode)(3).
With respect to claim 32, the reference of Ossart discloses:
A method of improving measurement of one or more process parameters (biomass quantity) by at least one sensor (probe)(4) associated with a bioprocessing vessel (bioreactor) (30) formed of a material insulative to a liquid medium (page 7, last paragraph, of the translation), comprising:
providing electrical communication between the liquid medium (biological medium)(page 7, last paragraph, of the translation) in the bioprocessing vessel (bioreactor)(30) and an external structure ((measurement mass)(7) or (earth (ground))(31)) to achieve equipotential for reducing noise in a signal produced by the at least one sensor (putting the culture medium to the mass or to earth) (page 3, last three paragraphs of the translation).
With respect to claim 33, the providing step includes providing a conductor ((electrode) (3) and (wire or cable)(10)) in electrical communication with the liquid medium (biological medium) and the external structure ((measurement mass)(7) or (earth (ground))(31)).
With respect to claim 34, the providing step includes providing a conductor (wire or cable)(10) with a conductive portion (electrode)(3) of the at least one sensor.
With respect to claim 36, the method includes a step of culturing cells in the bioprocessing vessel (page 7, paragraph 4, to page 8, paragraph 5, of the translation).
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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 4, 5 and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Ossart (WO 2011/045547 and corresponding English language machine translation) in view of Lin (CN 201353627 and corresponding English language machine translation).
The reference of Ossart has been discussed above with respect to claims 1, 3, 25 and 26.
While the electrical connection or circuit between the liquid medium in the bioprocessing vessel and the external structure includes a sensor (4) and wire or cable (10) using a connector (9), claims 4, 5 and 28 differ by reciting that the electrical circuit includes the use of a conductive liquid.
The reference of Lin discloses that it is known in the art to provide a connector structure (Figs. 1-7) that includes a conductive liquid (c, 3).
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to employ a connector structure as disclosed by the reference of Lin in the device of the primary reference for the known and expected result of employing an art recognized electrical connection device while providing the advantages of the connector device of Lin which employ a conductive liquid (page 3, second paragraph, of the translation of Lin).
Claims 9, 10 and 35 are rejected under 35 U.S.C. 103 as being unpatentable over Ossart (WO 2011/045547 and corresponding English language machine translation) in view of Shulgin et al. (SU 1096617 and corresponding English language machine translation).
The reference of Ossart has been discussed above with respect to claims 1, 3, 25 and 26.
Claims 9, 10 and 35 differ by reciting that the system further includes a plurality of conductors for detecting a level of the liquid within the bioprocessing vessel.
The reference of Shulgin et al. discloses that it is known in the art to provide a bioprocessing vessel (fermenter) (Lone Figure) with a plurality of conductors (level sensors)(1, 2 and 3) to detect the level of medium within the bioprocessing vessel.
In view of this teaching and in the absence of a showing of unexpected results, it would have been obvious to one of ordinary skill in the art to provide the system of the primary reference with a plurality of conductors for the known and expected result of providing an art recognized means for monitoring the level of the culture medium within the bioprocessing vessel.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
The reference of Ossart (US 2003/0070942) is drawn to prior art that discloses a sensor structure for use in a bioprocessing vessel.
The reference of Arekapudi et al. (US 5,056,363) is drawn to prior art that discloses a temperature and level sensor.
The reference of Selker et al. (US 2008/0032389) is drawn to prior art that discusses the dielectric nature of disposable bioreactors.
The reference of Kjar et al. (US 2015/0198549) is drawn to prior at the discloses the use of a ground probe (Fig. 7) with a bioprocessing vessel.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to WILLIAM H BEISNER whose telephone number is (571)272-1269. The examiner can normally be reached on Mon-Fri from 8am to 5pm.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, MICHAEL A MARCHESCHI, can be reached at telephone number (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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/William H. Beisner/
Primary Examiner
Art Unit 1799
WHB