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 3/31/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Election/Restrictions
Applicant’s election of group II (claims 6-9 and 17) in the reply filed on 5/1/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
Claim Status
Claims 6-9 and 17 are pending and being examined.
Claim Objections
Claim 6 is objected to because of the following informalities: claim 6 reads “the admission line)” in line 8 should read “the admission line)” without the parenthesis; and claim 6 reads “the gaseous medium from the liqoid” should read “the gaseous medium from the liquid”. 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 6-9 and 17 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.
Claim 6 recites the limitation "at least one liquid outlet" in lines 6 and 13. The limitation is unclear as to which liquid outlet the Applicant is referring to. Specifically, the "at least one liquid outlet" in line 6 is comprised by the device and the "at least one liquid outlet" in line 13 is comprised by the liquid utilization system. The Examiner suggest reciting either “an additional at least one liquid outlet” or “a different at least one liquid outlet”. The limitation is unclear as to whether the "at least one liquid outlet" of the device and the liquid utilization system is the same. For purpose of prosecution, the Examiner interprets separate liquid outlets. Claims 7-9 and 17 are rejected by virtue of dependency on claim 1.
Claim 8 recites the limitation “a liquid inlet” in line 2. The limitation is unclear as to which liquid inlet the Applicant is referring to. Specifically, is there an additional liquid inlet that is separate from the “at least one liquid inlet” recited in claim 6. The limitation is unclear as to which structure is connected to the liquid inlet. The Examiner suggest reciting “an additional” or “a different” inlet. Claim 9 is rejected by virtue of dependency on claim 8.
Claim 9 recites the “a recirculation module configured to connect the additional reservoir to the liquid inlet of the liquid utilization system, to the admission line and to the emission line”. The limitation is unclear as to what the recirculation module is connecting. Specifically, the additional reservoir comprises a liquid inlet that is connected to the liquid outlet of the liquid utilization system as recited in claim 8. Thus, it is unclear as to how the recirculation module connects the additional reservoir to the admission line and the emission line as well. If the additional reservoir is connected to the liquid outlet of the liquid utilization, then why would it be recirculated into the admission and emission line that is configured to provide and withdraw gases. The “additional reservoir” would not receive gaseous medium to be recirculated.
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 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.
Claim(s) 6-8 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Niazi et al (US 20170198246 A1; hereinafter “Niazi”; already of record in IDS filed on 3/31/2023).
Regarding claim 6, Niazi teaches an assembly (Niazi; Abstract), comprising:
a device comprising:
a liquid reservoir (Niazi; Fig. 1; para [17]; container is filled with a pre-determined volume of culture medium) provided with at least one gas inlet (Niazi; Fig. 1; para [12]; at least one inert gas inlet 4b in the top surface); at least one gas outlet (Niazi; Fig. 1; para [12]; at least one gas outlet 10 in the top surface); and at least one liquid outlet (Niazi; Fig. 1; para [44]; The supporting platform further provides holes in its surface to allow passage of the liquid outlet of the container and connection to the capture column);
an admission line configured to provide a gaseous medium into the liquid reservoir, the admission line being connected to the at least one gas inlet and comprising at least one control valve (Niazi; Fig. 1 para [12]; the gas inlet 5 is connected to a source of a nutritive gas and a source of an inert gas…gas inlet control valve 8; examiner interprets the admission line as the inlet which connects 4a and 4b into the system); and
the emission line configured to withdraw the gaseous medium from the liquid reservoir, the emission line being connected to the at least one gas outlet and comprising at least one valve (Niazi; Fig. 1; para [12]; at least one gas outlet in the top surface comprising a one-way valve and a variable-speed vent fan; Examiner interprets the emission line as the pathway prior to the valve); and
a liquid utilization system comprising at least one liquid inlet and at least one liquid outlet (Niazi; para [12]; The container is additionally coupled to a capture column connected to the liquid outlet of the container, wherein the capture column comprises a product binding medium),
wherein the liquid outlet of the device is connected to the liquid inlet of the liquid utilization system, the device being configured for providing a liquid medium with a controlled flow rate and with a controlled concentration of a dissolved gas to the liquid utilization system (Niazi; para [12]; The container is additionally coupled to a capture column connected to the liquid outlet of the container, wherein the capture column comprises a product binding medium, a control valve located between the liquid outlet and the capture column, and a solution inlet having a control valve to enter solutions to wash and elute bound product in the capture column).
Regarding claim 7, Niazi teaches the assembly of claim 6, wherein the liquid utilization system is a cell culture system (Niazi; para [15-16]; The culture medium flows out of the container and into the capture column under gravity flow. The bioreactor of the present invention allows instant capture of expressed product as the culture medium can flow through a capture column).
Regarding claim 8, Niazi teaches the assembly of claim 6, comprising: an additional reservoir connected to a pressure controller and comprising a liquid inlet connected to the liquid outlet of the liquid utilization system; and/or a flow restrictor configured for modifying the hydraulic resistance for the liquid medium downstream of the liquid reservoir (Niazi; para [13]; a control valve located between the liquid outlet and the capture column, and a solution inlet having a control valve to enter solutions to wash and elute bound product in the capture column). The Examiner notes that the “additional reservoir” and/or the “flow restrictor” is required. For purpose of examination, the Examiner interprets that the assembly comprises only the flow restrictor.
Regarding claim 17, Niazi teaches the assembly of claim 6, wherein the liquid utilization system is selected from the group consisting of a microfluidic cell culture system, a millifluidic cell culture system, and a nanofluidic cell culture system (Niazi; para [13]; The perforated pouches may be made of nylon membrane consisting of pores ranging in size between 5 and 50 microns). The Examiner interprets the pouches as the “microfluidic cell culture system” as the pores if micropores and fluid passes through each layer.
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 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.
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.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Niazi in view of Galliher et al (US 20090035856 A1; hereinafter “Galliher”).
Regarding claim 9, Niazi teaches the assembly of claim 8, with the liquid utilization system.
Niazi does not teach the assembly further comprising a recirculation module configured to connect the additional reservoir to the liquid inlet of the liquid utilization system, to the admission line and to the emission line.
However, Galliher teaches an analogous art of a system comprising bioreactors for harvesting cells (Galliher; Fig. 3; Abstract) comprising a recirculation module (Galliher; Fig. 2; para [60]; an outlet of apparatus 66 may be connected to an inlet of apparatus 68 via connection 73 (e.g., a tube or other fluid transfer device) and an outlet of apparatus 68 may be connected to an inlet of apparatus 66 via connection 80). It would have been obvious to one of ordinary skill in the art to have modified the assembly of Niazi to comprise the recirculation module as taught by Galliher, because Galliher teaches that combining substantially homogeneously mixed liquids with a liquid recycling system, e.g., a system where an outlet of a first apparatus is connected to an inlet of a second apparatus, and an outlet of the second apparatus is connected to an inlet of the first apparatus) the systems of the invention may have increased efficiency (Galliher; para [44]). The examiner notes that the limitation “configured to connect the additional reservoir to the liquid inlet of the liquid utilization system, to the admission line and to the emission line” is interpreted as intended use and/or functional language. The Courts have held that the manner in which a claimed apparatus is intended to be employed does not differentiate an apparatus claim from the prior art, if the prior art apparatus teaches all of the structural limitations of the claim. See Ex parte Masham, 2 USPQ2d 1647 (BPAI 1987). A functional recitation of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. See MPEP § 2114. The recirculation module disclosed by Galliher teaches all of the structural limitations of the claim and thus is configured for and capable of performing the intended use and/or function language of connecting the additional reservoir to the liquid inlet of the liquid utilization system, to the admission line and to the emission line Further, the “additional reservoir” is not a positively recited limitation and not a required element of the claimed system. Therefore, the modification to Niazi in view of Galliher would be capable of the intended function.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Curtis Mayes can be reached at (571) 272-1234. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/MATTHEW D KRCHA/Primary Examiner, Art Unit 1796
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