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 .
Election/Restrictions
Applicant’s election of Group I (claims 1-12) in the reply filed on 5/14/2026 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)).
Claims 13-22 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to nonelected inventions, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5/14/2026.
Priority
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55.
Information Disclosure Statement
The information disclosure statements (IDS) filed on 10/3/2023 and 5/26/2026 are in compliance with 37 CFR 1.97. Accordingly, the information disclosure statements are being considered by the examiner.
Drawings
The drawings are objected to for the following reasons:
Ensure that the text is larger than 0.08 in. (37 CFR 1.52).
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. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. 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.
Specification
The lengthy specification has not been checked to the extent necessary to determine the presence of all possible minor errors. Applicant’s cooperation is requested in correcting any errors of which applicant may become aware in the specification.
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 following is a quotation of pre-AIA 35 U.S.C. 112, sixth paragraph:
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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph:
(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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph. The presumption that the claim limitation is not interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, 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) or pre-AIA 35 U.S.C. 112, sixth paragraph, except as otherwise indicated in an Office action.
This application includes one or more claim limitations that do not use the word “means,” but are nonetheless being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, because the claim limitation(s) uses a generic placeholder that is coupled with functional language without reciting sufficient structure to perform the recited function and the generic placeholder is not preceded by a structural modifier. Such claim limitation(s) is/are:
“a control system operable to selectively actuate respective ones of the plurality of valve actuators to provide a valve configuration within the membrane valve cassette to enable the base unit and the membrane valve cassette together to perform one of the predetermined set of bioprocessing operations” (claim 1, lines 8-11 in the specification);
interpreted as a controller on an equivalent thereof (pg. 13, lines 36-37).
“an attachment mechanism configured to removably attach the membrane valve cassette to the base unit” (claim 3, lines 2-3);
interpreted as a hollow cylindrical projection or an equivalent thereof (pg. 29, line 4 in the specification).
“a receiving mechanism configured to releasably engage the respective one of the plurality of valve actuators” (claim 11, lines 2-3);
interpreted as a cavity or an equivalent thereof (pg. 16, line 29 in the specification).
Because this/these claim limitation(s) is/are being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, it/they is/are being interpreted to cover the corresponding structure described in the specification as performing the claimed function, and equivalents thereof.
If applicant does not intend to have this/these limitation(s) interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph, applicant may: (1) amend the claim limitation(s) to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph (e.g., by reciting sufficient structure to perform the claimed function); or (2) present a sufficient showing that the claim limitation(s) recite(s) sufficient structure to perform the claimed function so as to avoid it/them being interpreted under 35 U.S.C. 112(f) or pre-AIA 35 U.S.C. 112, sixth paragraph.
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 9 and 10 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 9 recites the limitation "the membranes" in line 2. There is insufficient antecedent basis for this limitation in the claim.
The term “substantially” in claim 10 is a relative term which renders the claim indefinite. The term “substantially” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The specification appears to merely restate the claim language and does not provide a standard for ascertaining the requisite degree of the term “substantially”.
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 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Frigard et al. (WO 2018/0158273 A1) (US equivalent document 2020/009557 A1 will cited herein – cited in IDS; hereinafter referred to as Frigard).
Regarding claim 6, Frigard discloses a membrane valve cassette ([0001] bio-processing unit is a cassette; [0035] discloses a diaphragm valve, i.e., a membrane valve) for a reconfigurable bioprocessing system ([0001], “The invention further concerns a bio-processing system formed from plural bio-processing units”) according to claim 1, wherein the membrane valve cassette is configured to removably attach to a base unit of the reconfigurable bioprocessing system.
The limitation “for a reconfigurable bioprocessing system according to claim 1” is merely a recitation of a purpose or intended use of the invention and has been given an appropriate patentable weight (MPEP § 2111.02 II).
The limitation “configured to removably attach to a base unit of the reconfigurable bioprocessing system” is directed toward the intended manner of operating the claimed membrane valve cassette and does not differentiate the claimed membrane valve cassette from the prior art membrane valve cassette because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art membrane valve cassette would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 7, Frigard discloses the membrane valve cassette of claim 6, further comprising a plurality of conduits (Figs. 1 and 2 shows a plurality of conduits) and a plurality of valve interfaces (valve stems; [0025], “the front face 112f of plate 112 has exposed stems 182 of valves 180”), each of the plurality of valve interfaces configured to be actuated by a respective one of the plurality of valve actuators, each valve interface being actuatable between a first configuration in which fluid flow through one of the plurality of conduits is prevented and a second configuration in which fluid flow through the one or the plurality of conduits is enabled ([0025], “Valve stem 182 can be rotated to select one of the selection valve inlets 5 to 35 to import fluid”).
The limitation “each valve interface being actuatable between a first configuration in which fluid flow through one of the plurality of conduits is prevented and a second configuration in which fluid flow through the one or the plurality of conduits is enabled” is directed toward the intended manner of operating the claimed plurality of valve interfaces and does not differentiate the claimed plurality of valve interfaces from the prior art plurality of valve interfaces because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art plurality of valve interfaces would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 8, such claims are directed to the intended use of the apparatus. It has been held that the intended manner of operating the claimed apparatus does not differentiate the claimed apparatus from the prior art apparatus because all structural limitations are taught in the prior art apparatus (MPEP § 2114 II). The prior art plurality of valve interfaces would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 9, Frigard discloses the membrane valve cassette of claim 7, wherein at least two of the valve interfaces are operable at different depths or coplanar levels therein (Fig. 2 and 3 shows valve stems 182 at different depths).
The limitation with respect to the membranes is phrased in the alternative. Because at least one of the limitations, e.g., with respect to at least two of the valve interfaces, is rejected above, no further rejections are required at this time.
Regarding claim 10, Frigard discloses the membrane valve cassette of claim 9, further comprising at least one conduit therein that provides for fluid flow in a direction out of a plane substantially parallel to a surface of the membrane valve cassette (Fig. 1 and 1a shows that an outlet provides fluid flow parallel to a surface of the cassette).
The limitation “that interfaces with an outer mounting surface of a valve actuation unit” is directed toward the intended manner of operating the claimed membrane valve cassette and does not differentiate the claimed membrane valve cassette from the prior art membrane valve cassette because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art device would be able to would be fully capable of achieving every claimed intended use because Frigard teaches that the cassette is able to interface with external bioprocess components ([0025]).
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.
Claims 1-3 and 5 are rejected under 35 U.S.C. 103 as being unpatentable over Singh et al. (WO 2017/097604 A1) (US equivalent document 2021/0017482 A1 will be cited herein – see PTO-892; hereinafter referred to as Singh) in view of Gebauer et al. (US patent 10,451,591 B1) (WIPO application publication WO 2015/183871 A1 cited in IDS; hereinafter referred to as Gebauer).
Note: claim 3 contains limitations or language that has been interpreted according to Examiner’s understanding, see Claim Interpretation section above.
Regarding claim 1, Singh discloses a reconfigurable bioprocessing system (abstract, first unit) operable to perform a predetermined set of bioprocessing operations within the bioprocessing system ([0009], [0032] disclose use for chromatography systems and bioreactors), the bioprocessing system comprising: a base unit (Fig. 8, first unit); and
a control system ([0039] discloses a processor used for controlling flow; Fig. 8, processor 17).
Singh does not expressly teach or disclose a plurality of valve actuators, but does disclose a plurality of valves (abstract). The plurality of valves controlling flow through a disposable flow path ([0033]).
However, Gebauer in the art of biological liquid treatment discloses a remotely actuated valve (abstract), the valves containing actuators and used for controlling flow (Col. 4, lines 27-31) through single-use flow paths (Col 6, lines 33-35).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate the plurality of valve actuators taught by Gebauer as the plurality of Gebauer would predictably and beneficially control flow through the plurality of valves of Singh. Such a modification would have been within purview of one of ordinary skill in the art.
Singh does not expressly teach or disclose the processer being operable to selectively actuate respective ones of the plurality of valve actuators.
However, Gebauer teaches that a valve actuator can be controlled by a control unit, i.e., a processor, the control unit capable of changing modes (Col. 9, lines 28-33).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to configure the processor of Singh to control the plurality of valve actuators, as this modification was known in the art and the processor would predictably control the plurality of valve actuators as to selectively actuate respective ones of the plurality of valve actuators.
The limitation “operable to perform a predetermined set of bioprocessing operations within the bioprocessing system” is merely a recitation of a purpose or intended use of the invention and has been given an appropriate patentable weight (MPEP § 2111.02 II). would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitation “configured to releasably engage with a membrane valve cassette that is removably attachable to the base unit” is directed toward the intended manner of operating the claimed plurality of valve actuators and does not differentiate the claimed from the prior art plurality of valve actuators because all structural limitations are taught in the prior art (MPEP § 2114 II). The plurality of valves, and therefore the plurality of valve actuators, are compatible with detachable tubing, as taught by Singh ([0036]), and would be fully capable of achieving every claimed intended use.
The limitation “is actuatable to regulate fluid flow through the membrane valve cassette” is directed toward the intended manner of operating the claimed plurality of valve actuators and does not differentiate the claimed plurality of valve actuators from the prior art plurality of valve actuators because all structural limitations are taught in the prior art (MPEP § 2114 II). The plurality of valve actuators would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
The limitation “to provide a valve configuration within the membrane valve cassette to enable the base unit and the membrane valve cassette together to perform one of the predetermined set of bioprocessing operations” is directed toward the intended manner of operating the claimed control system and does not differentiate the claimed control system from the prior art control system because all structural limitations are taught in the prior art (MPEP § 2114 II). The control system taught by the prior art combination would be fully capable of achieving every claimed intended use because the prior art control system can selectively actuate respective ones of the plurality of valve actuators, as set forth above.
Regarding claim 2, the prior art combination discloses the bioprocessing system of claim 1, wherein the predetermined set of bioprocessing operations comprise one or more of: a chromatography operation, a mixing operation and/or a filtration operation, as set forth above ([0009]).
Regarding claim 3, the prior art combination teaches the bioprocessing system of claim 1.
The prior art combination is silent to the base unit further comprises an attachment mechanism configured to removably attach the membrane valve cassette to the base unit.
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However, Singh of the prior art combination discloses a hose barb coupling (Fig. 6, hose barb coupling 9 – see figure below) used for connecting components ([0036]).
Although Singh does not teach a base unit comprising an attachment mechanisms, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the device taught by the prior art combination to incorporate an attachment mechanism for the purpose of connecting components, as this method for improving the prior art combination device was known in the art. The inclusion of the attachment mechanisms would predictably provide a means of attaching to the base unit.
The limitation “configured to removably attach the membrane valve cassette to the base unit” is directed toward the intended manner of operating the claimed attachment mechanism and does not differentiate the claimed attachment mechanism from the prior art attachment mechanism because all structural limitations are taught in the prior art (MPEP § 2114 II). The attachment mechanism taught by Singh would be fully capable of achieving every claimed intended use because the prior art attachment mechanism is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Regarding claim 5, the prior art combination teaches the bioprocessing system of claim 1.
Singh discloses that the bioprocessing system further comprises a casing that houses the base unit wherein the casing comprises an elongate recess configured to accommodate a chromatography column (Fig. 2 shows all claimed limitations – see annotated figure below).
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The limitation “configured to accommodate a chromatography column” is directed toward the intended manner of operating the claimed elongated recess and does not differentiate the claimed elongated recess from the prior art elongated recess because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art elongated recess would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Claim 4 is rejected under 35 U.S.C. 103 as being unpatentable over Singh and Gebauer as applied to claim 1 above, and further in view of Burns et al. (US 2020/0238282 A1) (cited in IDS; hereinafter referred to as Burns).
Regarding claim 4, the prior art combination teaches the bioprocessing system of claim 1.
The prior art combination is silent to the base unit further comprises a plurality of linear actuators, wherein each of the plurality of valve actuators is configured to be independently actuated by a respective one of the plurality of linear actuators.
However, Burns in the art of fluid handling for a bioprocessing system discloses fluid control system including an actuator array, the actuator array including a plurality of linear actuators ([0046]). The linear actuators selectively actuate valves and controls fluid flow ([0046]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the prior art combination base unit to incorporate a plurality of linear actuators for the purpose of actuating valves and controlling fluid flow throughout the base unit.
The limitation “configured to be independently actuated by a respective one of the plurality of linear actuators” is directed toward the intended manner of operating the claimed plurality of linear actuators and does not differentiate the claimed plurality of linear actuators from the prior art plurality of linear actuators because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art plurality of linear actuators would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Claims 11 and 12 are rejected under 35 U.S.C. 103 as being unpatentable over Frigard in view of Gebauer.
Note: claim 11 contains limitations or language that has been interpreted according to Examiner’s understanding, see Claim Interpretation section above.
Regarding claim 11, Frigard discloses the membrane valve cassette of claim 7.
Frigard is silent to each of the plurality of valve interfaces comprising a respective resiliently deformable membrane comprising a receiving mechanism configured to releasably engage the respective one of the plurality of valve actuators.
However, Gebauer teaches that diaphragms, i.e., membranes, in diaphragm valve interfaces can be formed of thermoplastics or other pliant pressure responsive materials, i.e., materials that are resiliently deformable (Col. 7, lines 9-22) and that valve interfaces comprise a receiving mechanism (Figs. 10A-10B – see annotated figure below).
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It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the plurality of valve interfaces of Frigard such in the manner described by Gebauer with a reasonable expectation that it would readily control fluid flow. Such a modification to the plurality of valve interfaces would have been within purview of one of ordinary skill in the art.
The limitation “configured to releasably engage the respective one of the plurality of valve actuators” is directed toward the intended manner of operating the claimed receiving mechanism and does not differentiate the claimed receiving mechanism from the prior art receiving mechanism because all structural limitations are taught in the prior art (MPEP § 2114 II).
Regarding claim 12, the prior art combination teaches the membrane valve cassette of claim 11.
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Gebauer of the prior art combination teaches that the receiving mechanism comprises a cavity comprising an internal collar in an separate embodiment (Fig. 5, shows an internal collar surrounding a cavity – see annotated figure below) configured to releasably engage a corresponding portion of the respective one of the plurality of valve actuators to enable the push and pull forces to be exerted on the resiliently deformable membrane (Col. 7, lines 36-42).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to form the receiving mechanism with an internal collar with a reasonable expectation that it would be pneumatically operable. Such a modification would have been within purview of one of ordinary skill in the art.
The limitation “configured to releasably engage a corresponding portion of the respective one of the plurality of valve actuators to enable the push and pull forces to be exerted on the resiliently deformable membrane” is directed toward the intended manner of operating the claimed and does not differentiate the claimed internal collar from the prior art internal collar because all structural limitations are taught in the prior art (MPEP § 2114 II). The prior art device would be fully capable of achieving every claimed intended use because the prior art structure is substantially identical to the claimed structure absent clear evidence to the contrary and absent a showing of unexpected results (MPEP § 2112.01 I).
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure:
Karlin et al. (WO 2019/081684 A1) discloses a bioprocess system.
Rosengren et al. (WO 2019/057937 A2) discloses a valve unit for a chromatography apparatus.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ADRIAN J CARREON whose telephone number is (571)272-6818. The examiner can normally be reached Monday - Friday 8:30 AM - 5 PM.
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, 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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/A.J.C./ Examiner, Art Unit 1799
/William H. Beisner/ Primary Examiner, Art Unit 1799
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