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 .
Drawings
The drawings are objected to as failing to comply with 37 CFR 1.84(p)(5) because they do not include the reference sign 26 mentioned in the description.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Claim Interpretation
The following is a quotation of 35 U.S.C. 112(f):
(f) Element in Claim for a Combination. – An element in a claim for a combination may be expressed as a means or step for performing a specified function without the recital of structure, material, or acts in support thereof, and such claim shall be construed to cover the corresponding structure, material, or acts described in the specification and equivalents thereof.
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art. The broadest reasonable interpretation of a claim element (also commonly referred to as a claim limitation) is limited by the description in the specification when 35 U.S.C. 112(f) is invoked.
As explained in MPEP § 2181, subsection I, claim limitations that meet the following three-prong test will be interpreted under 35 U.S.C. 112(f):
(A) the claim limitation uses the term “means” or “step” or a term used as a substitute for “means” that is a generic placeholder (also called a nonce term or a non-structural term having no specific structural meaning) for performing the claimed function;
(B) the term “means” or “step” or the generic placeholder is modified by functional language, typically, but not always linked by the transition word “for” (e.g., “means for”) or another linking word or phrase, such as “configured to” or “so that”; and
(C) the term “means” or “step” or the generic placeholder is not modified by sufficient structure, material, or acts for performing the claimed function.
Use of the word “means” (or “step”) in a claim with functional language creates a rebuttable presumption that the claim limitation is to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites sufficient structure, material, or acts to entirely perform the recited function.
Absence of the word “means” (or “step”) in a claim creates a rebuttable presumption that the claim limitation is not to be treated in accordance with 35 U.S.C. 112(f). The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) is rebutted when the claim limitation recites function without reciting sufficient structure, material or acts to entirely perform the recited function.
Claim limitations in this application that use the word “means” (or “step”) are being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action. Conversely, claim limitations in this application that do not use the word “means” (or “step”) are not being interpreted under 35 U.S.C. 112(f), except as otherwise indicated in an Office action.
Limitations interpreted under 35 U.S.C. 112(f) include:
“transfer means” which reads on a fluidic network comprising any combination of mechanisms (e.g., pumps, conduits, filters, probes, valves and/or sensors) configured to regulate fluid flow
“fluid driver means” which reads on a pump or any known functional equivalent
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 1, 13 and 15 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 4649118) in view of Griffin (US 20240279585).
With respect to claim 1, Anderson discloses a fluid sampling system for biotechnological applications comprising a bioreactor chamber and a transfer means. The transfer means is configured to transfer controlled amounts of fluid culture medium from the bioreactor to a target container. Anderson teaches that the transfer means includes a perfusion probe with a fluid-tight probe housing (Figure 2:35) surrounding an internal probe volume, an inlet probe aperture, and an outlet probe aperture. A fluid filtering element (Figure 2:48) is sealingly connected to the fluid-tight probe housing and forms a cover over the inlet probe aperture. The fluid filtering element is formed as a monolithic platelet with a primary face in contact with the culture medium in the bioreactor chamber and a secondary face opposed thereto and in contact with the internal probe volume. The fluid filtering element includes a plurality of pores that extend between the primary and second faces, such that the pores are configured as an array of microchannels. Column 1, lines 12-32, column 3, line 36 to column 4, lines 4 and column 6, lines 17-33 state that the pores (“microchannels”) are intended to permit the passage of expended medium and cell byproducts while blocking cells, and that the “filter 48 may be of a commercially known type, preferably being formed of a rigid screen covered by an outer mesh, membrane, fabric or the like having a desired pore or opening size for the culture process that is to be carried out”. Accordingly, those of ordinary skill would have found it obvious to consider pore openings/diameters of 0.2 to 64 microns.
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A fluid driver means configured as a pump drives the fluid culture medium from the bioreactor chamber through the perfusion probe to yield filtered culture medium. The filtered culture medium moves through a connection line (Figure 1:36) to the target container, which may be a waste, processing, collection and/or detection container. This is described in column 4, line 38 to column 5, line 2. Anderson, however, does not teach that the connection line is in communication with a fluid receptacle disposed on a weight measuring station.
Griffin discloses a fluid sampling system for biotechnological applications comprising a bioreactor chamber (Figure 3:410) in communication with a transfer means (Figure 3:414) and a fluid receptacle (Figure 3:472a-d). Paragraphs [0031], [0161], [0178] and [0263] state that fluid receptacles may function as reagent, collection and waste containers, and each may be disposed on a weight measuring station configured to acquire a weight signal corresponding to a momentary weight of that fluid receptacle.
Before the effective filing date of the claimed invention, it would have been obvious to provide the Anderson system with a fluid receptacle disposed on a weight measuring station. Griffin teaches that load cells are useful because they automatically detect variations in the fluid volume of a particular receptacle and thereby allow one to efficiently respond to the changing requirements of a cell culture reactor (“pump control may be based on a weight measurement of the bioreactor vessels (using the feedback from the load cells 760). For example, the configuration of the system enables instantaneous pump calibration based on load cell readings, allowing the system to automatically accommodate changes in the tube/pump performance over time. Further, this method can be used for closed loop control on a mass (volume) rate of change when emptying or filling a bioreactor vessel”).
With respect to claim 13, Anderson and Griffin disclose the combination as described above. Anderson discloses a corresponding method in which a bioreactor is loaded with a fluid culture medium and cells. Filtered culture is transferred to a target container. Griffin shows how it is known in the art to first send the filtered culture medium to an intervening fluid receptacle to acquire a weight signal corresponding to a momentary weight of the fluid receptacle.
With respect to claim 15, Anderson and Griffin disclose the combination as described above. Griffin further teaches in at last paragraphs [0118], [0119], [0122] and [0215] that culture media may be directed to multiple sample collection stations and/or a harvesting station to obtain an expanded population of target cells.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 4649118) in view of Griffin (US 20240279585) as applied to claim 1, and further in view of Lehtonen (US 20150314246).
Anderson and Griffin disclose the combination as described above. Although Griffin discloses the provision of a weight measuring station, Griffin does not specify a bending beam load cell.
Lehtonen discloses an automated solution dispenser comprising at least one fluid receptacle containing a biological fluid and/or reagent. Lehtonen teaches in paragraphs [0024], [0128]-[0131] and [0166] that an amount of dosed fluid is continuously recorded by measuring the changing weight of the fluid receptacle and the receiving container using bending beam load cells.
Before the effective filing date of the claimed invention, it would have been obvious to use known load cells, such as bending beam load cells, when weighing the fluid receptacle in the modified Anderson system. Lehtonen expressly states that it is well within the ability of one of ordinary skill to “us[e] any suitable scales, weight sensors, or load cells known in the art” to measure volume change in a fluid receptacle. Lehtonen directly mentions bending beam load cells as a mechanical load cell suited for operations involving metering and dispensing.
Claims 4 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 4649118) in view of Griffin (US 20240279585) as applied to claim 1, and further in view of Lee (US 20100236340) and Yardimci (US 7871462).
Anderson and Griffin disclose the combination as described above, but do not expressly state that the fluid receptacle includes a fluid entrance connector located in an upper region, a fluid exit connector located in a bottom region and a gas pressure compensation port. Although peristaltic pumps are considered to be bidirectional (based on the direction of rotation), the references do not expressly state that the fluid receptacle is in communication with a bidirectional fluid pump and a monodirectional fluid pump.
Lee discloses a fluid sampling system comprising a bioreactor chamber (Figure 1:20) and a transfer means (Figure 1:22). The transfer means is in communication with a plurality of gas pressure compensation ports (Figure 1:32,34), a plurality of fluid receptacles (Figure 1:B-1 to B-5) and a bidirectional fluid pump (Figure 1:30). This is described in paragraphs [0017]-[0022].
Yardimci discloses a fluid-tight fluid receptacle chamber (Figure 3:50c) comprising a fluid entrance connector (Figure 3:62) located in an upper region of the receptacle chamber, a fluid exit connector (Figure 3:64) located in a bottom region of the receptacle chamber, and a gas pressure compensation port (Figure 3:70) located in the upper region of the receptacle chamber. This is taught in column 9, line 64 to column 10, line 24.
Before the effective filing date of the claimed invention, it would have been obvious to transfer fluid from the Anderson bioreactor into and out of a fluid receptacle having fluid and gas entrance and exit connectors using bidirectional and monodirectional pumps. Lee and Yardimci show that these features are known in the art and characterized by a predictable operation. Lee teaches that bidirectional pumps are useful for driving a fluid repeatedly into and out of a fluid receptacle to enable sample collection and disposal. Yardimci and Lee each show how venting and gas removal is accomplished using a gas pressure compensation port.
In the alternative, the terms “monodirectional” and “bidirectional” describe how the claimed pump is to be used, and therefore represent intended use recitations that do not describe the structure of the claimed apparatus. It is well established that apparatus claims cover what a device is, not what a device does. A claim containing a recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus if the prior art apparatus teaches all the structural limitations of the claim. See MPEP 2114.
Claims 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 4649118) in view of Griffin (US 20240279585) as applied to claim 1, and further in view of Shor (US 20160108356).
Anderson and Griffin disclose the combination as described above. Although Anderson appears to show that the filtering element includes a frame that supports the filter medium (i.e., the monolithic platelet), Anderson does not does not expressly teach a core region defined by a plurality of array segments.
Shor discloses a fluid sampling system for biotechnological applications comprising a bioreactor chamber and a transfer means. The transfer means is configured to transfer controlled amounts of fluid culture medium from the bioreactor to a target container. Shor teaches that the transfer means includes a perfusion probe with a fluid-tight probe housing and a fluid filtering element (Figure 2:204). The fluid filtering element includes a plurality of pores that extend between the primary and second faces, such that the pores are configured as an array of microchannels.
A fluid driver means configured as a pump drives the fluid culture medium from the bioreactor chamber through the perfusion probe to yield filtered culture medium. The filtered culture medium moves through a connection line (Figure 1A:122) to the target container, which may be a waste, processing, collection and/or detection container. Shor shows in Fig. 2 that the filtering element comprises a frame region with a first thickness and a core region with a second thickness, such that core region is divided into a plurality of array segments using a separation rib structure.
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Before the effective filing of the claimed invention, it would have been obvious to ensure that the Anderson fluid filtering element includes a frame region, a core region, and a plurality of array segments separated by separation ribs. Shor shows how this filtering element configuration is effective for filtering cell culture fluid and separating cells from waste and biproducts (“The filter may keep the larger, i.e., healthier cells in the vessel, while unhealthy or damaged cells and debris which are generally smaller pass through the filter, and go out of the vessel, forming a concentrated mixture of culture and healthy cells in the vessel”). It is prima facie obvious to apply a known technique (here, the filter design of Shor) to a known device ready for improvement to yield predictable results. See MPEP 2143.
Claim 16 is rejected under 35 U.S.C. 103 as being unpatentable over Anderson (US 4649118) in view of Griffin (US 20240279585) and Lehtonen (US 20150314246) as applied to claim 2, and further in view of Lee (US 20100236340) and Yardimci (US 7871462).
Anderson, Griffin and Lehtonen disclose the combination as described above, but do not expressly state that the fluid receptacle includes a fluid entrance connector located in an upper region, a fluid exit connector located in a bottom region and a gas pressure compensation port.
Lee discloses a fluid sampling system comprising a bioreactor chamber (Figure 1:20) and a transfer means (Figure 1:22). The transfer means is in communication with a plurality of gas pressure compensation ports (Figure 1:32,34), a plurality of fluid receptacles (Figure 1:B-1 to B-5) and a fluid pump (Figure 1:30). This is described in paragraphs [0017]-[0022].
Yardimci discloses a fluid-tight fluid receptacle chamber (Figure 3:50c) comprising a fluid entrance connector (Figure 3:62) located in an upper region of the receptacle chamber, a fluid exit connector (Figure 3:64) located in a bottom region of the receptacle chamber, and a gas pressure compensation port (Figure 3:70) located in the upper region of the receptacle chamber. This is taught in column 9, line 64 to column 10, line 24.
Before the effective filing date of the claimed invention, it would have been obvious to transfer fluid from the Anderson bioreactor into and out of a fluid receptacle having fluid and gas entrance and exit connectors. Lee and Yardimci show that these features are known in the art and characterized by a predictable operation to enable fluid transfer and venting and gas removal. Yardimci specifically shows how inlet and outlet ports to and from the fluid receptacle may be arranged to encourage the downward flow of liquid and the upward flow of air to promote effective degassing of the culture liquid.
Allowable Subject Matter
Claims 3, 6, 9-12, 14 and 17-20 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.
Although the prior art may independently disclose across different references certain aspects of the claimed system and method, there is no teaching or suggestion in the art that would lead one of ordinary skill to combine separate elements from various fields of endeavor to arrive at Applicant’s invention. The particulars of the weight measuring station set forth in claim 3, the fluid driver means of set forth in claim 6, and the filter composition of claims 9 and 20 do not appear to be known in the context of Applicant’s claimed invention.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure. The Biksacky (US 20090241698) and Timmins (US 20220154127) references teach the state of the art regarding fluid sampling systems and methods.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to NATHAN ANDREW BOWERS whose telephone number is (571)272-8613. The examiner can normally be reached M-F 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (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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/NATHAN A BOWERS/ Primary Examiner, Art Unit 1799