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 07/10/2023 was filed before the mailing date of the FAOM. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
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:
“control unit” in claim 1 “can be understood as any control device for a gas flow, as e.g. a valve or a processor” (paragraph 17) or an equivalent structure
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
Claim 31 is objected to because of the following informalities:
Claim 31 recites “least one of a a flow sensor” and should be amended to “least one of a [[a]] flow sensor”
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 2-5, 7-10, 17 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as failing to set forth 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 2 recites “operable according to GMP requirements” and is indefinite because GMP requirements change over time. One of ordinary skill would not be able to determine the scope of bounds of this limitation.
Claim 3 recites “the GMP requirements are the requirements of the EU guidelines for good manufacturing practice for medicinal products, annex 1” and is indefinite because GMP requirements change over time. One of ordinary skill would not be able to determine the scope of bounds of this limitation.
Claim 4 recites “the GMP requirements are the requirements of the FDA and/or cGMP” and is indefinite because GMP requirements change over time. One of ordinary skill would not be able to determine the scope of bounds of this limitation.
Claim 5 recites “least a grade D room according to the EU guidelines for good manufacturing practice” and is indefinite because EU GMP requirements change over time. One of ordinary skill would not be able to determine the scope of bounds of this limitation.
Claim 7 recites a broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 7 recites the broad recitation “about 0.2 to about 0.6 m/s”, and the claim also recites “about 0.36 to about 0.54 m/s” which is the narrower statement of the range/limitation. The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Claim 8 recites “at least a H13 filter” and is indefinite because HEPA H13 standards defined by EN1822 changes over time. One of ordinary skill would not be able to determine the scope of bounds of this limitation. Claims 10 and 17 dependent on claim 8 are also rejected.
Claim 9 recites “at least a H13 filter” and is indefinite because HEPA H13 standards defined by EN1822 changes over time. One of ordinary skill would not be able to determine the scope of bounds of this limitation.
Claim 10 recites “20 to about 120 exchange volumes of gas per hour and per m3 process chamber” and is unclear how “20 to about 120 exchange volumes” is measured “per m3” when the size of the process chamber is not defined. For prosecution, the limitation “20 to about 120 exchange volumes” will be interpreted to mean 1m3 of volume.
Claim 73 recites “optionally, sanitizing the process chamber (2)” and is unclear whether the limitation is a positively recited step of the invention. For prosecution, the limitation will be interpreted as optional.
Claim 74 recites “optionally, sanitizing the process chamber (2)” and is unclear whether the limitation is a positively recited step of the invention. For prosecution, the limitation will be interpreted as optional.
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.
Claims 1-7, 17, 31, 70, and 73 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenquist et al (WO2019096925A1 published 05/23/2019; hereinafter Rosenquist).
Regarding claim 1, Rosenquist teaches a manufacturing device (10) for a pharmaceutical product (a volume tailorable manufacturing system 200 – Figs. 2a-b), comprising:
- a housing (walls of the volume tailorable manufacturing system 200 – Figs. 2a-b),
- a process chamber (a first multi-product suite 210 – Figs. 2a-b),
- a technical chamber (a second multi-product suite 215 – Figs. 2a-b),
- a separation element (a supply system 220 – Figs. 2a-b), and
- a control unit (a seal 240 in each outlet 230a and inlet 220a – Figs. 2a-b and page 8 line 13) (the seal 240 is deemed to be an equivalent structure to a valve; see 112f interpretation),
wherein the housing is closed relative to the environment outside the housing (the walls of the volume tailorable manufacturing system 200 are closed – Figs. 2a-b),
wherein the housing encompasses the process chamber and the technical chamber (the walls of the volume tailorable manufacturing system 200 encompasses the first and second multi-product suites – Figs. 2a-b),
wherein the process chamber is separated from the technical chamber by the separation element (first and second multi-product suites are separated by the supply system 220 – Figs. 2a-b),
wherein the control unit is configured to control a gas flow through the process chamber (the seal 240 is capable of controlling a flow via a control facility to direct a unidirectional flow in a circulation system of the multi-product suite 210 – page 9 line 18),
wherein the control unit is configured to control the gas flow to provide in the process chamber a positive pressure relative to the environment (the seal 240 is capable of holding a positive pressure in the first multi-product suite 210 – Figs. 2a-b), and
wherein the control unit is further configured to control the gas flow to provide the gas flow through the process chamber as a gas shower falling in the direction of gravity (the seal 240 is capable of controlling a flow to direct a gas shower in the direction of gravity – Figs. 2a-b);
wherein the process chamber is suitable and used for manufacturing the pharmaceutical product (the first multi-product suite 210 is capable of being used for manufacturing a pharmaceutical product – Figs. 2a-b);
wherein the technical chamber 3 is suitable and used for providing technical media supply (the second multi-product suite 210 is capable of being used for providing technical media supply – Figs. 2a-b);
wherein the separation element is plate-shaped (the supply system 220 is flat and therefore plate shaped – Figs. 2a-b).
However, Rosenquist (Figs. 2a-b) does not teach wherein the technical chamber is dimensioned to provide a larger available space to the gas compared to the process chamber to expand the gas in the technical chamber to provide a lower pressure compared to the process chamber.
Rosenquist (Figs. 2c) teaches a multi-product suites embodiment wherein the technical chamber (a connected multi-product suites 211 and 212 – Fig. 2c) is dimensioned to provide a larger available space to the gas compared to the process chamber to expand the gas in the technical chamber (a multi-product suite 210 – Fig. 2c) to provide a lower pressure compared to the process chamber (the multi-product suites 211 and 212 provide a larger space than the multi-product suite 210, thereby allowing a gas to expand and having a lower pressure – Fig. 2c). Rosenquist teaches to use the multi-product suites to expand a production volume capability of a manufacturing system for quality assured manufacturing of biopharmaceutical products (page 1 lines 1-2).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the first and second multi-product suite 210, as taught by Rosenquist (Figs. 2a-b), with the expanded manufacturing system 200, taught by Rosenquist (Figs. 2c), to expand a production volume capability of a manufacturing system for quality assured manufacturing of biopharmaceutical products. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Rosenquist teaches embodiments of the same invention.
Regarding claim 2, Rosenquist teaches the manufacturing device (10) according to claim 1, wherein at least the process chamber (2) is operable according to GMP requirements (the manufacturing system 200 is capable of being used in a GMP setting – Figs. 2a-b).
Regarding claim 3, Rosenquist teaches the manufacturing device (10) according to claim 2, wherein the GMP requirements are the requirements of the EU guidelines for good manufacturing practice for medicinal products, annex 1 (the manufacturing system 200 is capable of being used in a GMP setting – Figs. 2a-b).
Regarding claim 4, Rosenquist teaches the manufacturing device (10) according to claim 2, wherein the GMP requirements are the requirements of the FDA and/or cGMP (the manufacturing system 200 is capable of being used in a GMP setting – Figs. 2a-b).
Regarding claim 5, Rosenquist teaches the manufacturing device (10) according to claim 3, wherein the process chamber (2) is configured to be at least a grade D room according to the EU guidelines for good manufacturing practice for medicinal products, annex 1 (the manufacturing system 200 is capable of being used in a GMP setting – Figs. 2a-b).
Regarding claim 6, Rosenquist teaches the manufacturing device (10) according to claim 1, wherein the gas shower is laminar (the seal 240 is capable of being used to create a laminar gas shower – Figs. 2a-b).
Regarding claim 7, Rosenquist teaches the manufacturing device (10) according to claim 1, wherein a speed of the gas shower is in a range of about 0.2 to about 0.6 m/s, or about 0.36 to about 0.54 m/s (the seal 240 is capable of being used to create a laminar gas shower a range of about 0.2 to about 0.6 m/s – Figs. 2a-b).
Regarding claim 31, Rosenquist teaches the manufacturing device (10) according to claim 1, further comprising a sensor unit comprising at least one of a a flow sensor, a pressure sensor, a temperature sensor, a humidity sensor, a microbial sensor, a particulate sensor, an organics sensor, and/or a leakage sensor (processing circuitry may refer to, for example, one or more computers, computing entities, distributed systems, processing devices, processing entities – Rosenquist page 14 lines 5-6).
Regarding claim 59, Rosenquist teaches a manufacturing module (100) for a pharmaceutical product,
comprising at least two manufacturing devices (10) according to claim 1, wherein the at least two manufacturing devices (10) are coupled with each other (an expanded manufacturing system 200 has been achieved using multi-product suites 211, 212 configured to be connected to further multi products suites – Rosenquist Fig. 2C).
Regarding claim 70, Rosenquist teaches a manufacturing system for a pharmaceutical product, comprising a manufacturing device (10) according to claim 1 as well as a clean room, wherein the manufacturing device (10) is arranged in the clean room (manufacturing system 200 further comprises clean room areas 260 – Rosenquist page 8 line 18).
Regarding claim 73, Rosenquist teaches a method for producing a pharmaceutical product, wherein the method comprises the following steps:
- providing a manufacturing device (10) according to claim 1 (a volume tailorable manufacturing system 200 – Figs. 2a-b);
- providing a gas flow through the process chamber (2), wherein the gas flow through the process chamber (2) is a gas shower (a circulation system formed by the supply and return system that interconnect the first and 20 second multi-product suites – page 9 lines 19-20) falling in the direction of gravity (a portion of the air flows in the direction of gravity – Figs. 2a-b);
- providing a positive pressure in the process chamber relative to the environment (positive pressure personnel suits – page 1 line 22);
- providing a process media (media preparation areas 580 – page 12 line 25) and a technical media (buffer preparation areas 590 – page 12 line 25) for the unit; and
- operating the unit to obtain the pharmaceutical product (a scale increase of the production of compound A – page 7 line 3),
- optionally, sanitizing the process chamber (see 112b above).
Claims 8-10, 17 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenquist in view of Eshima et al (US20160263545A1 published 09/15/2016; hereinafter Eshima).
Regarding claim 8, Rosenquist teaches the manufacturing device (10) according to claim 1,
However, Rosenquist does not teach further comprising a first filter unit (6) arranged upstream of the process chamber (2), wherein the first filter unit (6) comprises at least a H13 filter.
Eshima teaches a system for producing radiopharmaceuticals comprising a first filter unit (6) arranged upstream of the process chamber (2) (HEPA filters are provided with a laminar flow hood to prepare the pharmaceutics – paragraph 231), wherein the first filter unit (6) comprises at least a H13 filter (the HEPA filter is capable of having a H13 standard – paragraph 231; see 112b). Eshima teaches to use HEPA filters to create a clean interior to determine the airborne particulate density of possible contaminates (paragraph 231).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the manufacturing system 200, taught by with a HEPA filter, taught by Eshima, to create a clean interior to determine the airborne particulate density of possible contaminates. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success Rosenquist and Eshima teach systems for manufacturing pharmaceuticals.
Regarding claim 9, Rosenquist teaches the manufacturing device (10) according to claim 8, further comprising a second filter unit arranged between the process chamber and the technical chamber (HEPA filters are provided with a laminar flow hood to prepare the pharmaceutics – Eshima paragraph 231), wherein the second filter unit comprises at least a H13 filter (the HEPA filter is capable of having a H13 standard – Eshima paragraph 231; see 112b).
Regarding claim 10, Rosenquist teaches the manufacturing device according to claim 8, wherein the control unit is configured to control the gas flow to provide in the process chamber about 20 to about 120 exchange volumes of gas per hour and per m3 process chamber (the seal 240 is capable of controlling the gas flow to provide in the process chamber about 20 to about 120 exchange volumes of gas per hour and 1m3 of volume – Rosenquist Figs. 2a-b and page 8 line 13).
Regarding claim 17, Rosenquist teaches the manufacturing device (10) according claim 8, wherein the control unit is configured to control the gas flow to provide the gas flow from the process chamber into the technical chamber parallel to the gas flow in the process chamber, but in an opposite direction (the seal 240 is capable of controlling parallel and opposite direction gas flows in the first and second multi-product suites 210, 215 – Rosenquist Figs. 2a-b).
Claims 42, 46, 74 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenquist in view of Zenhausern et al (US20150238958A1 published 08/27/2015; hereinafter Zenhausern).
Regarding claim 42, Rosenquist teaches the manufacturing device (10) according to claim 1, further comprising a process media supply unit (media preparation areas 580 – page 12 line 25).
However, Rosenquist does not teach a mixing unit, a de-novo DNA synthesis unit, a purification unit and a filtration unit, wherein the device is configured to produce DNA.
Zenhausern teaches a sample preparation method a mixing unit (extraction of DNA from the released lysate solution – paragraph 46), a de-novo DNA synthesis unit (multiplex PCR amplification of STR loci – paragraph 46), a purification unit (the result analysis for allelic peak – paragraph 46) and a filtration unit (separation of PCR products by capillary electrophoresis – paragraph 46), wherein the device is configured to produce DNA (multiplex PCR amplification produces DNA – paragraph 46). buccal, saliva and blood swabs. Zenhausern also teaches that all the swab sample preparation was performed in a biological hood (paragraph 107).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the manufacturing system, as taught by Rosenquist, with the sample preparation method performed in a biological hood, taught by Zenhausern, to gain the additional functions of the sample preparation method. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Rosenquist and Zenhausern teach clean room techniques for processing biological agents.
Regarding claim 46, Rosenquist, modified by Zenhausern, teaches the manufacturing device (10) according to claim 42, further comprising a process media supply unit (media preparation areas 580 – page 12 line 25), a mixing unit (extraction of DNA from the released lysate solution – paragraph 46), a de-novo DNA synthesis unit (multiplex PCR amplification of STR loci – paragraph 46), a DNA template generation unit (a DNA extraction module – paragraph 39), a purification unit (the result analysis for allelic peak – paragraph 46), a filtration unit (separation of PCR products by capillary electrophoresis – paragraph 46), a formulation unit (analysis steps combining DNA extraction – paragraph 41) and an RNA generation unit (multiplex PCR module – paragraph 67).
Regarding claim 74, Rosenquist, modified by Zenhausern, teaches a method for producing DNA, wherein the method comprises the following steps:
providing a manufacturing device according to claim 42 (a volume tailorable manufacturing system 200 – Figs. 2a-b),
providing a gas flow through a process chamber (a circulation system formed by the supply and return system that interconnect the first and 20 second multi-product suites – page 9 lines 19-20), wherein the gas flow through the process chamber is a gas shower falling in the direction of gravity (a portion of the air flows in the direction of gravity – Figs. 2a-b);
providing a positive pressure in the process chamber relative to the environment (positive pressure personnel suits – page 1 line 22);
providing a process media (media preparation areas 580 – page 12 line 25) and a technical media (buffer preparation areas 590 – page 12 line 25) for the units; and
mixing the process media required for the de-novo DNA synthesis in a mixing unit (extraction of DNA from the released lysate solution – Zenhausern paragraph 46), followed by generating DNA in a de-novo DNA synthesis unit (multiplex PCR amplification of STR loci – Zenhausern paragraph 46), followed by purifying the DNA in a purification unit (the result analysis for allelic peak – Zenhausern paragraph 46) and by filtering the DNA in a filtering unit to obtain the DNA (separation of PCR products by capillary electrophoresis – Zenhausern paragraph 46),
optionally, sanitizing the process chamber (see 112b above).
Claims 53-54 are rejected under 35 U.S.C. 103 as being unpatentable over Rosenquist, modified by Zenhausern, in view of Dabrowski et al (US20180311637A1 published 11/01/2018; hereinafter Dabrowski).
Regarding claim 53, Rosenquist, modified by Zenhausern, teaches the manufacturing device (10) according to claim 46.
However, Rosenquist, modified by Zenhausern, does not teach wherein the purification unit comprises at least one chromatography purification unit as the device configured to be in contact with the process media.
Dabrowski teaches wherein the purification unit comprises at least one chromatography purification unit as the device configured to be in contact with the process media (Purification can also eliminate most of the truncated molecules. Various purification methods may by be implemented by the purification system including Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) – paragraph 27). Dabrowski teaches to use a HPLC system to separate full intended sequence and truncated (shorter) molecules of the synthesis reaction products (paragraph 27).
It would have been obvious to one of ordinary skill in the art before the effective filing date to modify the device, as taught by Rosenquist as modified by Zenhausern, with the HPLC purification system, taught by Dabrowski, to separate full intended sequence and truncated (shorter) molecules of the synthesis reaction products. One of ordinary skill would have expected that this modification could have been performed with a reasonable expectation of success because Rosenquist, Zenhausern, Dabrowski teach clean room manufacturing techniques.
Regarding claim 54, Rosenquist, as modified by Zenhausern modified by Dabrowski, teaches the manufacturing device (10) according to claim 53, wherein the chromatography purification unit comprises a high-pressure liquid chromatography unit (Reverse-Phase High Performance Liquid Chromatography (RP-HPLC) – Dabrowski paragraph 27) and/or an affinity chromatography unit.
Conclusion
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/T.C.S./Examiner, Art Unit 1796
/CHARLES CAPOZZI/Supervisory Patent Examiner, Art Unit 1798