DETAILED ACTION
Notice of AIA Status
The present application, filed on 5/25/23, is being examined under the first inventor to file provisions of the AIA .
Status of Claims
Claims 1-11 and 20 are rejected.
Claims 1-11 and 20 are objected to.
Claims 12-19 are withdrawn.
Election/Restriction
Applicant's election with traverse of Invention I (claims 1-11 and 20) in the reply filed on 2/19/26 is acknowledged. The traversal is on the grounds that the technical features shared between the claimed inventions are special technical feature. This is not found persuasive because the groups of inventions do not relate to a single general inventive concept under PCT Rule 13.1 because, under PCT Rule 13.2, they lack the same or corresponding special technical features because even though the inventions of these groups require the technical feature of “a fluidic channel permitting a fluid to flow”, this technical feature is not a special technical feature as it does not make a contribution over the prior art in view of Nankervis (US20140051167) which teaches a fluidic channel permitting a fluid to flow (see [0067], which recites “Fluid flows into cell growth chamber 600 through IC inlet port 601A, through hollow fibers in cell growth chamber 600, and exits via IC outlet port 601B. Pressure sensor 610 measures the pressure of media leaving cell growth chamber 601.”).
The requirement is still deemed proper and is therefore made FINAL.
Claims 12-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 2/19/26.
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) 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.
Claim 1 recites “a first sensing device”. The corresponding structure described in the specification as performing the claimed function is one of electrochemical instrument 978, electrochemical instrument 980, or one of fluorescence instrument 988, fluorescence instrument (see [0112]-[0123] of the instant specification) and equivalents thereof.
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 Objections
Claims 1-11 and 20 are objected to because of the following informalities:
Claim 1 recites “A sensing chamber for a bioprocessing system, comprising …”. For the sake of clarity, consider rephrasing to ‘A sensing chamber for a bioprocessing system, the sensing chamber comprising …’.
Claim 1 recites “at least one fluidic channel …. with the fluidic channel … into the fluidic channel … with the fluidic channel … wherein the at least one fluidic channel …” For the sake of uniformity in claim terminology, consider rephrasing to ‘a fluidic channel …. with the fluidic channel … into the fluidic channel … with the fluidic channel … wherein the at least one fluidic channel … into the at least one fluidic channel … with the at least one fluidic channel … wherein the at least one fluidic channel …’.
Claim 1 recites “sensing of a plurality of parameters of the fluid with at least a first sensing device and a second sensing device”. For the sake of clarity, consider rephrasing to ‘sensing of a plurality of parameters of the fluid with at least one of a first sensing device and a second sensing device’.
Claim 7 recites “at least one of dissolved oxygen, pH, carbon dioxide and/or analytes”. For the sake of clarity, consider rephrasing to ‘at least one of dissolved oxygen, pH, carbon dioxide and an analyte’ or ‘ or an analyte or a combination thereof”. For the sake of clarity, consider rephrasing to ‘at least one of dissolved oxygen, pH, carbon dioxide and an analyte’.
Claim 8 recites “at least one of optical density sensing, turbidimetry, digital holographic microscopy, light dynamic scattering and/or optical interferometry.” For the sake of clarity, consider rephrasing to ‘at least one of optical density sensing, turbidimetry, digital holographic microscopy, light dynamic scattering and optical interferometry’.
Claim 10 recites “at least one of the electrochemical monitoring includes at least one of electrical impedance spectroscopy, galvanometry, amperometry and/or polarography” For the sake of clarity, consider rephrasing to ‘at least one of the electrochemical monitoring includes at least one of electrical impedance spectroscopy, galvanometry, amperometry and polarography’.
Claim 20 recites “A disposable kit for a bioprocessing system, comprising: …”. For the sake of clarity, consider rephrasing to ‘A disposable kit for a bioprocessing system, the disposable kit comprising: …’.
Claims dependent on an objected base claim are objected because a claim in dependent form is construed to incorporate by reference all the limitations of the claim to which it refers.
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.
Claim 10 is rejected under 35 U.S.C. 112(b) 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 10 recites “the electrochemical monitoring”. There is insufficient antecedent basis for the electrochemical monitoring in the claim branch having claim 10. Consider amending claim dependency such that claim 10 depends from claim 9.
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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1-5 and 7-9 are rejected under 35 U.S.C. 102(a)(2) as being anticipated by Maikov (US20230358675).
With respect to claim 1, Maikov teaches a sensing chamber (monitoring system 100 in [0083]) for a bioprocessing system, comprising:
a front plate (cover top 12 in [0121]);
a back plate (element 16 in Fig. 7) (see [0120], which recites “the monitoring system includes a housing 11 having a generally box-like geometry”);
at least one fluidic channel (fluid path in [00128]) intermediate the front plate (cover top 12) and the back plate (element 16) (see Figs 7-8);
a first port (fluid inlet 26 in [0159]) in fluid communication with the fluidic channel (fluid path) and permitting a flow of fluid into the fluidic channel (fluid path); and
a second port (outlet 28 in [0131]) in fluid communication with the fluidic channel (fluid path) and permitting a flow of fluid out of the fluidic channel (fluid path);
wherein the at least one fluidic channel (fluid path) includes a plurality of segments permitting sensing of a plurality of parameters of the fluid with at least a first sensing device (electro-chemical sensing unit in [0046]) which recites “the housing can include at least one examination chamber disposed along the fluid path. The examination chamber can be separate and distinct from the examination tube, and includes the at least one electrode sensing unit (electro-chemical sensing unit) for allowing electrical or electrochemical measurement of the fluid passing/accommodated within the examination chamber”) and a second sensing device (optical sensing unit in [0040], which recites “one examination tube configured to be disposed within the body along the fluid path and having at least one at least partially transparent portion for allowing optical measurement of the fluid passing within the examination tube by the at least one optical sensing unit”);
wherein the first sensing device (electro-chemical sensing unit) is configured to sense at least one parameter of the fluid using a first sensing technique (see [0058], which recites “data indicative of measurements obtained in one or more sensing sessions performed on the fluid by at least one electro-optical sensing unit and at least one optical sensing unit, said data indicative of the measurements comprising measured fluid quality data indicative of multiple parameters of the fluid”) (see [0046]) which recites “the housing can include at least one examination chamber disposed along the fluid path. The examination chamber can be separate and distinct from the examination tube, and includes the at least one electrode sensing unit (electro-chemical sensing unit) for allowing electrical or electrochemical measurement of the fluid passing/accommodated within the examination chamber”) and the second sensing device (optical sensing unit) is configured to sense at least one parameter of the fluid using a second sensing technique (see [0087], which recites “optical sensing unit is configured to illuminate a region of the fluid and detect light returned from the illuminated region (transmission and/or reflection and/or scattering). The detected light is thus indicative of the optical response of the fluid to the illumination (e.g. absorbance, fluorescence and scattering of light) indicative of material-related parameters of the fluid contents”) (see [0040], which recites “one examination tube configured to be disposed within the body along the fluid path and having at least one at least partially transparent portion for allowing optical measurement of the fluid passing within the examination tube by the at least one optical sensing unit”) (the first sensing device is interpreted being a claimed element of the sensing chamber, the second sensing device is interpreted being a claimed element of the sensing chamber);
wherein the first sensing technique is different from the second sensing technique (optical measurement is different from electro-chemical measurement, see [0085], which recites “The sensing system 112 includes multiple (generally at least two) sensing units of different types configured to measure multiple parameters of the fluid”).
With respect to Claim 2, Maikov teaches the sensing chamber of claim 1, wherein:
the first sensing technique is an electrochemical sensing process (see [0046]) and the second sensing technique is an optical sensing process (see [0040]).
With respect to Claim 3, Maikov teaches the sensing chamber of claim 1, wherein:
the plurality of segments include a first segment permitting interrogation of the fluid with at least one fluorescence sensor (which corresponds to one of the optical sensing units OSU1, OUS2 …OSUm configured to detect fluorescence) (see [0087], which recites “each optical sensing unit is configured to illuminate a region of the fluid and detect light returned from the illuminated region (transmission and/or reflection and/or scattering). The detected light is thus indicative of the optical response of the fluid to the illumination (e.g. absorbance, fluorescence and scattering of light) indicative of material-related parameters of the fluid contents”) ( see also [0171]).
With respect to Claim 4, Maikov teaches the sensing chamber of claim 3, wherein:
the plurality of segments include a second segment defining a light transmissive region of the at least one fluidic channel permitting interrogation of the fluid with a transmitted or backscattered light instrument (optical detector in [0033], which recites “The optical detector device may comprise at least one detector accommodated to detect light components transmitted through the optical windows and light components scattered from at least one of the optical windows”).
With respect to Claim 5, Maikov teaches the sensing chamber of claim 4, wherein:
the plurality of segments include a third segment defining a light reflective region of the at least one fluidic channel permitting interrogation of the fluid with a reflected light instrument (which corresponds to one of the optical sensing units OSU1, OUS2 …OSUm configured to detect reflected light (see [0087], which recites “the optical sensing unit(s) may be of any known suitable type. Each optical sensing unit is configured to illuminate a region of the fluid and detect light returned from the illuminated region (transmission and/or reflection and/or scattering).”).
With respect to Claim 7, Maikov teaches sensing chamber of claim 3, wherein:
the at least one fluorescence sensor is configured to measure at least one of dissolved oxygen, pH, carbon dioxide and/or analytes (oil in water, chlorophyll and cyanobacteria in [0110]) in the fluid (see [0110]).
With respect to Claim 8, Maikov teaches sensing chamber of claim 5, wherein:
the reflected light instrument is configured to determine a parameter of the fluid via at least one of optical density sensing, turbidimetry, digital holographic microscopy, light dynamic scattering and/or optical interferometry (see [0037], which recites “sensing units may be configured to determine… turbidity”).
With respect to Claim 9, Maikov teaches sensing chamber of claim 1, further comprising:
a plurality of electrodes (at least one electrode sensing unit in [0046]) configured to contact the fluid within the fluidic channel (see [0145], which recites “the chamber 64 b is configured to receive/assemble therein the electro-chemical sensing system including at least one electrode sensing unit 60 (constituting electro-chemical sensing unit)…. at the electrode sensing unit(s) is/are assembles in the housing (in the respective module(s)/compartment(s) of the housing) such that an active part of the sensing unit (electrode(s)) is exposed to the fluid being measured, i.e. interacts with the fluid”), the plurality of electrodes permitting electrochemical monitoring of the fluid within the fluidic channel”) (see [0046]-[0047]).
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 (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 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Maikov (US20230358675) in view of McDevitt (US20100291588).
With respect to Claim 6, Maikov teaches the sensing chamber of claim 5.
Maikov doesn’t teach a mirror positioned behind the third segment of the fluidic channel for reflection of light generated by the reflected light instrument.
In the analogous art of providing analytical devices, McDevitt (US20100291588) teaches a mirror (dichroic mirror 312 in [0300]).
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 sensing chamber disclosed by Maikov by incorporating the mirror disclosed by McDevitt such that the mirror positioned behind the third segment of the fluidic channel for reflection of light generated by the reflected light instrument with a reasonable expectation of success for the benefit of collimating light onto a detector thereby making the light path compact (see [0300], which recites “Light 306 reflected and/or emitted from a detection system of detection region 108 may pass through lens 294, dichroic mirrors 312, 314, filter 302, and lens 296 where light 306 is collimated onto detector 284”).
Claim 10 is rejected under 35 U.S.C. 103 as being unpatentable over Maikov (US20230358675) in view of Lee (US20100003666).
With respect to Claim 10, Maikov teaches sensing chamber of claim 8.
Maikov doesn’t teach that the electrochemical monitoring includes at least one of electrical impedance spectroscopy, galvanometry, amperometry and/or polarography.
In the analogous art of providing analytical devices, Lee teaches electrochemical monitoring includes at least one of electrical impedance spectroscopy, galvanometry, amperometry and/or polarography (see [0076], which recites “the detection module can incorporate both electrical sensing and optical illumination to enable a scheme where the label probes or cells include multiple detection moieties”) (see [0077], which recites “the detection modules of the invention comprise electrodes”) (see [0079], which recites “electronic detection is used, including amperommetry, … time-dependent electrochemical analyses (chronoamperometry, chronopotentiometry, cyclic chronopotentiometry and amperometry, … chronogalvametry, …) …. AC impedance measurement”). 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 sensing chamber disclosed by Maikov by incorporating the electrochemical monitoring disclosed by Lee for the benefit of providing time-dependent electrochemical analysis of the analyte. In addition, the combination of familiar elements is likely to be obvious when it does no more than yield predictable results. See KSR International Co. v. Teleflex Inc., (see MPEP § 2143, A.).
Claim 11 is rejected under 35 U.S.C. 103 as being unpatentable over Maikov (US20230358675) in view of Welter (US20070042490).
With respect to Claim 11, Maikov teaches the sensing chamber of claim 1.
Maikov doesn’t teach that the front plate and the back plate are formed from a transparent and biocompatible material.
In the analogous art of providing analytical devices, Welter (US US20070042490) teaches the front plate and the back plate are formed from a transparent and biocompatible material (polycarbonate in [0026], which recites “Irradiation chamber 700 (FIG. 2) is formed by joining two plates, a front and a back plate … of a material ideally transparent”) (polycarbonate is transparent and biocompatible) (see also [0036], which recites “irradiation chamber of the present invention can be made from a biocompatible material”).
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 sensing chamber disclosed by Maikov such that the front plate and the back plate are formed from a transparent and biocompatible material as disclosed by Welter for the benefit of holding biological fluid or components thereof such as blood or blood products to facilitate their exposure to electromagnetic radiation such as UV light (see [0001]).
Claim 20 is rejected under 35 U.S.C. 103 as being unpatentable over Simon (US20090298129) in view of Maikov (US20230358675).
With respect to claim 20, Simon (US20090298129) teaches a disposable kit (kit 2500 in [0203]) for a bioprocessing system (system 10 in [0109], which recites “the system 10 is used to process biological samples”), comprising:
a tray (tray 14 in [0203]);
a bioprocessing vessel received (“vessel that may be heated” in [0132]) within the tray (tray 14) (see [0132], which recites “The tray 14 can be substantially rigid and includes a number of features and/or stations 242 which may be molded, formed, attached or otherwise integrated with tray to accommodate. Some or all of the following components are examples of features that may be integrated into the tray 14: … a thermal cycler PCR plate 610 and/or other substrate or vessel that may be heated”); and
a sensing chamber (spectrophotometer cuvettes 660 in [0132]) mounted to the tray (tray 14).
Simon doesn’t teach that the sensing chamber is a flow-through sensing chamber having a front plate and a back plate, a fluidic channel intermediate the front plate and the back plate, a first port in fluid communication with the fluidic channel and permitting a flow of fluid into the fluidic channel, and a second port in fluid communication with the fluidic channel and permitting a flow of fluid out of the fluidic channel.
In the analogous art of providing analytical devices, Maikov (US20230358675) teaches a flow-through sensing chamber (housing 11 in [0120]) having a front plate (cover top 12 in [0121]) and a back plate (element 16 in Fig. 7), a fluidic channel (fluid path in [0128]) intermediate the front plate (cover 12) and the back plate (element 16), a first port (fluid inlet 16 in [0159]) in fluid communication with the fluidic channel (fluidic path) and permitting a flow of fluid into the fluidic channel (fluidic path), and a second port (outlet 28 in [0131]) in fluid communication with the fluidic channel (fluid path) and permitting a flow of fluid out of the fluidic channel (fluid path).
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 sensing chamber disclosed by Simon such that the sensing chamber is a flow-through sensing chamber having a front plate and a back plate, a fluidic channel intermediate the front plate and the back plate, a first port in fluid communication with the fluidic channel and permitting a flow of fluid into the fluidic channel, and a second port in fluid communication with the fluidic channel and permitting a flow of fluid out of the fluidic channel as disclosed by Maikov for the benefit of enabling continuous measurement in high throughput, automation manner.
Conclusion
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/JONATHAN BORTOLI/Examiner, Art Unit 1797 /JENNIFER WECKER/Primary Examiner, Art Unit 1797
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