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 .
Claim Status
Claims 1 and 3-10 are pending
Continued Examination
A request for continued examination under 37 CFR 1.114 was filed in this application after a decision by the Patent Trial and Appeal Board, but before the filing of a Notice of Appeal to the Court of Appeals for the Federal Circuit or the commencement of a civil action. Since this application is eligible for continued examination under 37 CFR 1.114 and the fee set forth in 37 CFR 1.17(e) has been timely paid, the appeal has been withdrawn pursuant to 37 CFR 1.114 and prosecution in this application has been reopened pursuant to 37 CFR 1.114. Applicant’s submission filed on 2/5/2026 has been entered.
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 1 and 3-10 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 3 recites the limitation "purging partly purified feed material". There is insufficient antecedent basis for this limitation in the claim. The term “partly purified feed material” was previously defined in claim 1; it is not clear if this is the same or different partly purified feed material.
Claims 7-8 recites the limitation "purging partly purified feed material". There is insufficient antecedent basis for this limitation in the claim. The term “partly purified feed material” was previously defined in claims 1 and 3; it is not clear if this is the same or different partly purified feed material.
Claim 9 recites the limitation "". There is insufficient antecedent basis for this limitation in the claim. The term “partly purified feed material” was previously defined in claim 1; it is not clear if this is the same or different partly purified feed material.
Claim Rejections - 35 USC § 103
The text of those sections of Title 35, U.S. Code not included in this action can be found in a prior Office action.
Claims 1 and 3-10 are rejected under 35 U.S.C. 103 as being unpatentable over WO2008/153472 by Bryntesson et al. (Bryntesson).
In regard to claim 1, Bryntesson teaches a method for purifying a target product in a flow-through chromatography system comprising at least a first column loaded with feed material from a feed source (P9/L28 to P10/24). Bryntesson teaches after binding of impurities a partly purified feed material is present in the at least first column (P11/L9-25). Bryntesson teaches the at least first column is purged after binding of impurities to produce purged material comprising the partly purified feed material (P11/L9-25). Bryntesson teaches the purged material from the column is passed upstream of the at least one column to be re-purified (P11/L9-25).
Bryntesson teaches said upstream passing of the purged material is passing to the feed source (P9/L28 to P10/24; P11/L9-25); the term “feed” is interpreted in light of the instant specification as “a liquid which contains two or more compounds to be separated.” (see instant specification at page 6, lines 2-4).
Bryntesson does not explicitly teach the purged material is passed through the same feed source. However, Bryntesson teaches a person of skill in the field will understand it is not essential to discard any outflow; a person of skill can decide whether to direct the flow before, at, or after the breakthrough; a person of skill can determine when to redirect the feed in relation to breakthrough curves; the system is a repetitive loop; wash liquid and feed may be applied simultaneously; flow rate regulation is achieved using appropriate valves.
One of ordinary skill in the art at the time the invention was effectively filed would be motivated to choose the location of the feed in order to create an efficient system, minimize discarded flow, in a continuous system.
In regard to claim 3, Bryntesson teaches providing an outlet sensor arranged downstream of the at least first column (P10/L7-24; P13/L16-20). Bryntesson teaches loading the first column with feed material from the feed source (P10/L7-24). Bryntesson teaches detecting impurity breakthrough based on a signal detected by the outlet sensor of the first column (P10/L7-24; P13/L16-20). Bryntesson teaches when a predetermined impurity breakthrough is detected, disconnecting the first column from the feed source (P10/L7 to P11/L4). Bryntesson teahces purging partly purified feed material from the first column using a purging buffer (P11/L9-25).
Bryntesson does not explicitly teach the purged material is passed through the same feed source. However, Bryntesson teaches a person of skill in the field will understand it is not essential to discard any outflow; a person of skill can decide whether to direct the flow before, at, or after the breakthrough; a person of skill can determine when to redirect the feed in relation to breakthrough curves; the system is a repetitive loop; wash liquid and feed may be applied simultaneously; flow rate regulation is achieved using appropriate valves.
One of ordinary skill in the art at the time the invention was effectively filed would be motivated to choose the location of the feed in order to create an efficient system, minimize discarded flow, in a continuous system.
In regard to claim 4, Bryntesson teaches each outlet sensor is a UV sensor and the predetermined impurity breakthrough corresponds to a predetermined percentage of impurities in a target product downstream of each column (P10/L7-24; P13/L16-20).
In regard to claim 5, Bryntesson teaches impurities in the target product at the breakthrough point (P10/L7-24; P13/L16-20). Bryntesson does not teach a specific percentage of impurities in the target product; as the method cost of construction and efficiency of operation are variables that can be modified, among others, by adjusting said percentage of impurity, the precise percentage of impurity would have been considered a result effective variable by one having ordinary skill in the art at the time the invention was made. As such, without showing unexpected results, the claimed percentage of impurities cannot be considered critical. Accordingly, one of ordinary skill in the art at the time the invention was made would have optimized, by routine experimentation, the desired percentage of impurities in the method of Bryntesson to obtain the desired balance between the construction cost and the operation efficiency (In re Boesch, 617 F.2d. 272, 205 USPQ 215 (CCPA 1980)), since it has been held that where the general conditions of the claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. (In re Aller, 105 USPQ 223).
In regard to claim 6, Bryntesson teaches the method further comprises dynamically controlling the impurity breakthrough (P10/L7-24; P13/L16-20).
Bryntesson does not explicitly teach the UV sensor is upstream each column; however, it would have been obvious to one having ordinary skill in the art at the time the invention was made to place a UV sensor on an upstream location in order to detect desired components at a desired location in the system, since it has been held that rearranging parts of an invention involves only routine skill in the art while the device having the claimed dimensions would not perform differently than the prior art device, In re Japikse, 86 USPQ 70 and since it has been held that a mere reversal of the essential working parts of a device involves only routine skill in the art, In re Einstein, 8 USPQ 167.
In regard to claim 7, Bryntesson teaches the flow-through chromatography system further comprises a second column (P9/L28 to P10/24). Bryntesson teaches a second outlet sensor (P9/L28 to P10/28; Figure 5).
Bryntesson teaches directing the feed material to the second column when disconnecting the first column from the feed source (P9/L28 to P10/24). Bryntesson teaches detecting impurity breakthrough based on a signal detected by the second outlet sensor of the second column (P9/L28 to P10/24). Bryntesson teaches when a predetermined impurity breakthrough is detected by the sensor of the second column, disconnecting the second column from the feed source (P10/L7 to P11/L4)). Bryntesson teaches purging partly purified feed material from the second column using purging buffer (P10/L7 to P11/L4)).
Bryntesson does not explicitly teach the purged material is passed through the same feed source. However, Bryntesson teaches a person of skill in the field will understand it is not essential to discard any outflow; a person of skill can decide whether to direct the flow before, at, or after the breakthrough; a person of skill can determine when to redirect the feed in relation to breakthrough curves; the system is a repetitive loop; wash liquid and feed may be applied simultaneously; flow rate regulation is achieved using appropriate valves.
One of ordinary skill in the art at the time the invention was effectively filed would be motivated to choose the location of the feed in order to create an efficient system, minimize discarded flow, in a continuous system.
In regard to claim 8, Bryntesson teaches regenerating the first column after purging partly purified feed material from the first column using a regenerating buffer (P7/L5-17). Bryntesson teaches directing the feed material to the first column when disconnecting the second column from the feed source (P7/L5-17).
In regard to claim 9, Bryntesson teaches the flow-through chromatography system is a continuous chromatography system at least three columns wherein at least partly purified feed material flow through the at least first column after binding of impurities and wherein the partly purified feed material from the first column is subsequently passed onto a second column for binding of impurities in the partly purified feed material (P9/L28 to P11/4).
In regard to claim 10, Bryntesson teaches the method comprises loading each column in the flow-through chromatography system consecutively (P9/L28 to P11/4).
Response to Arguments
Applicant's arguments filed 2/5/2026 have been fully considered but they are not persuasive.
In regard to the Applicant’s argument that the “partly purified feed material” remaining in the columns is not wasted by the Applicant’s claimed methods; the background section of application at paragraph [0018] notes there is no waste and the cited art does not teach or suggest methods in which the volume left in a column after disconnection from a feed source is not discarded in the wash; the Examiner does not find this persuasive.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., not wasted) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
Furthermore, Bryntesson explicitly teaches the purged material from the column is passed upstream of the at least one column to be re-purified (P11/L9-25).
Bryntesson teaches in conventional operation a certain amount of target compound is lost and not recovered; however, the present method the material is directed to a column in order to capture target compound (P11/L9-25). Bryntesson teaches in at least Figure 5 that output material is reintroduced into the inlet of a column (Figure 5). Further, Bryntesson is teaching recycling the material to the inlet of a column (entering as a feed) in order to be subsequently purified.
While Bryntesson does not explicitly teach the purged material is passed through the same feed source; Bryntesson does teach the purged material is passed through the inlet of the column. One of ordinary skill in the art of chromatography will readily understand that in order to not discard any outflow (as explicitly taught by Bryntesson) that the purged material can be directed to the “feed source” in order to minimize system waste. One of ordinary skill in the art at the time the invention was effectively filed would be motivated to choose the location of the feed in order to create an efficient system, minimize discarded flow, in a continuous system.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KARA M PEO whose telephone number is (571)272-9958. The examiner can normally be reached 9 to 5:30.
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/KARA M PEO/Primary Examiner, Art Unit 1777
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