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 without traverse of Group I, claims 1-14 and 21-22 in the reply filed on 5/22/2026 is acknowledged.
Claims 15-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
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.
Claims 12-14 are 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 regards as the invention.
Claim 12 recites the limitation "first external container" and “second external container” in line 3. There is insufficient antecedent basis for this limitation in the claim. The claim previously refers to a cleaning buffer container and a washing buffer container which are presumed to be the same “external containers,” but the language should be made consistent for clarity.
Claims 13 and 14 depend from claim 12 and incorporate the same indefiniteness.
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.
Claims 1, 3-6, 9, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Iriki (US PGPub 2023/0251232 A1) and Petro et al (US PGPub 2006/0054543 A1) in view of Goto et al (WO 2015/029251 A1), in view of or with evidence from Lendl (US 6,737,651 B1).
With respect to claim 1, Iriki teaches a fraction collector as part of a preparative chromatographic system [Abs] which includes a detector (10) within a flow path which is positioned downstream of a chromatographic column (8) and suitable sample injector (6) and which is upstream of a fraction collection subsystem (14) which is designed to direct sample fractions to various containers based on the detected properties, under the guidance of a controller (such that the system is automated) [Abs, 0011-0014, Fig. 1]. Iriki essentially differs from the instant claims in that Iriki does not specify employing infrared for the detector and, further, does not specify employing a carousel for moving the various containers into the flow path. Regarding the presence of a nozzle, Iriki teaches various ports of a switching valve (20) which direct fluid out of the flow path and into a collection container, which is sufficient to at minimum render the term nozzle obvious absent clarification of the structural requirements.
Petro teaches systems for liquid chromatography [Abs] which allow for sample analysis and collection of fractions in various vessels in an automated manner [0031] via the use of a controller [0065]. The fraction collector may be a carousel of vials or similar vessels under control of the controller to change which vessel is fed from the outlet [0075, 0077] e.g. as directed by a signal from a detector (126). This can include the use of a valve to direct or control flow based on the signal detection and the status of the carousel [0078]. Petro further teaches that various types of detectors may be employed including infrared detectors [0114] although the shape or configuration is not critical. Injection devices are provided for injecting sample into a column upstream of the fractionator e.g. injector valve (112) [0060, Fig. 1]. Petro essentially differs from the instant claims in that Petro is silent to a flow path through the device which includes both the detector and the carousel (instead teaching them as separate branches of a split flow). Regarding the presence of a nozzle, Petro teaches the outlet of a feed line which deposits sample into e.g. various vials on a carousel, which is sufficient to at minimum render the term nozzle obvious absent clarification of the structural requirements.
It would have been obvious to one of ordinary skill in the art to modify the system of Petro to feature a flow path which contains both the detector and the fraction collector i.e. in an inline configuration such as that of Iriki in order to gain the benefit of allowing for convenient real-time monitoring and collection of the sample without requiring any portion of the fraction to be directed to waste; Petro already suggests that simultaneous monitoring and collection may be desirable [0076] and one of ordinary skill in the art would recognize that the configuration of Iriki facilitates this while also avoiding the need to direct any sample to waste after detection. See also MPEP 2143 I.B; simple substitution of one known flow configuration for another, recognized in the art as suitable for the purposes of automated fraction collection in the field of chromatography, would have been obvious to one of ordinary skill in the art.
Additionally or alternatively, it would have been obvious to one of ordinary skill in the art to modify the system of Iriki to feature IR detectors and sample carousels as in Petro because Petro teaches that these features are useful for accomplishing the same tasks as those of Iriki i.e. providing sample fraction detection and facilitating direction of fractions to suitable vessels for collection. As above, a simple substitution of one known, useful configuration for another represents an obvious engineering choice for one of ordinary skill in the art.
Regarding the use of a pinch valve, at least Petro teaches valves to shut off flow e.g. when the carousel is changing as above, and Iriki teaches a “BPR” which is a back pressure controller (12) [0012], but neither specify the use of pinch valves specifically. However, Goto teaches pinch valve structures for chromatography which provide useful control of e.g. pressure through the system [Abs] and which is noted by Goto as having a low dead volume [pg. 2, 5th paragraph]. It would have been obvious to modify the combined system of Iriki and Petro to include a pinch valve for this reason i.e. to provide a valve structure with low dead volume which can facilitate pressure control and/or flow shutoff in an efficient manner.
Regrading the structural components of the sensor assembly i.e. the emitter, detector, and channel, such structures would be considered inherent requirements or at minimum implicit features of standard flow-through detectors of the types employed by Iriki and Petro. See e.g. Lendl which discusses structures for infrared sample analysis using e.g. a flow-through cuvette positioned between a source and a detector [Abs]. Alternatively, if this is not considered an inherent or implicit feature, at minimum it would have been obvious to look to the art for standard detector structures such as those of Lindl to employ in the combined system of Iriki and Petro.
With respect to claims 3 and 4, Goto teaches employing a recess for receiving the valve member of the pinch valve [Abs] which is a converging shape; this is properly an arm, tip, and block configuration (see e.g. [Fig. 4] of Goto). Goto does not specify that the recess is curved, however changes in shape are obvious engineering choices to one of ordinary skill in the art (see MPEP 2144.04 IV.B) and Goto already teaches a converging recessed shape of which a curve would be an obvious example.
With respect to claims 5 and 6, as above at least Iriki teaches providing the detector inline between the column and the fraction collector. There is no teaching or suggestion that this would be part of the carousel structure in Iriki’s configuration (which doesn’t employ a carousel) or in Petro’s configuration (in which the detector is spaced apart in a separate branch); as such, maintaining the detector separate from the carousel would have been obvious even given the aforementioned combination.
With respect to claim 9, Petro teaches pumps (108), (110) under system control for feeding the injection valve [0060, Fig. 3]; Iriki similarly teaches a liquid delivery device (4) for feeding the injection valve under control of the controller [0012, 0014].
With respect to claim 11, as above Petro teaches that the valve may be actuated based on information from the detector i.e. to shut off flow when the carousel is switching to facilitate collection of different fractions or the like. Further, at least in view of Iriki, manipulating the valve for backpressure control would further have been obvious.
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Iriki and Petro et al in view of Goto et al, in view of or with evidence from Lendl, further in view of Stewart (US PGPub 2004/0144159 A1).
Iriki, Petro and the rest teach as above but are silent to a support to which all components may be mounted.
However, Stewart teaches a chromatography system [Abs] designed for portable use in a manner that insulates the components against shock, and teaches mounting all components including column, injector, detector, sampler, etc. are all mounted rigidly to a frame and case for the sake of mitigating shock and preventing vibrations from causing damage between various parts of the system [0066].
It would have been obvious to include a similar frame element for the combined system of Iriki and Petro in order to gain the benefit of facilitating portability while protecting against shock, vibrations, and related issues as in Stewart.
Claim 7 is rejected under 35 U.S.C. 103 as being unpatentable over the combination of Iriki and Petro et al in view of Goto et al, in view of or with evidence from Lendl, further in view of Wittwer et al (US 7,670,832 B2).
Petro teaches a carousel as above but is silent to specific driving mechanisms such as a gear.
However, Wittwer teaches a sample monitoring system [Abs] in which samples are arranged on a carousel which is actuated by way of a stepper motor and drive gear [Col. 49 lines 60-67] which allows for very precise control of the positioning of the sample containers.
It would have been obvious to one of ordinary skill in the art to provide such mechanisms in the combined system of Iriki and Petro for the same reason i.e. to allow for very fine, automated control of the position of the carousel to facilitate proper use of the various containers thereon.
Claim 8, 10, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Iriki and Petro et al in view of Goto et al, in view of or with evidence from Lendl, further in view of Roenneburg et al (US PGPub 2006/0054544 A1).
With respect to claims 8 and 10, Petro and Iriki teach as above; Petro further teaches that the sample fractioning may be carried out on a “blind” basis using time or amount determinations [0080], although Petro does not specifically discuss the use of drop counting for determination of amount.
However, Roenneburg teaches a fraction collector [Abs] and teaches that a drop counter represents a conventional means of determining a size of a fraction in the art [0003]. As such, providing for counting of drops in the combined system of Petro and Iriki would have been obvious, to allow for determination of fraction amounts. Similarly, actuating the carousel based upon such measurement would have been obvious, to facilitate collection of such fractions in appropriate containers.
With respect to claims 21 and 22, as above the combined system of Petro and Iriki include controllers for automatic control of samples for loading into a column, detection of sample properties, actuation of fractionating systems such as carousels, control of valves for stopping or switching flow and backpressure control, and the like. Further, in view of Roenneburg, configuring the system to specifically count drops i.e. for fraction volume determination would have been obvious. Examiner notes that the term “any of the following actions” is interpreted as reciting them in the alternative i.e. the controller need not be configured to perform each of the actions as long as it can perform at least some of them. An alternative ground of rejection is presented below to address the potential interpretation in which the controller is required to be capable of carrying out each of the recited actions.
Claims 12-14 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Iriki and Petro et al in view of Goto et al, in view of or with evidence from Lendl, further in view of Stephens et al (US 4,926,702 A).
Iriki and Petro teach as above; at least Petro teaches multiple separate paths from multiple separate sources with separate pumps which may feed the column under control of the controller, though there is no teaching of providing such sources which bypass the injection device e.g. for cleaning or washing buffers.
However, Stephens teaches a sample injector and detector [Abs] which contains a channel (17) which bypasses the injector valve and which is employed for washing/cleaning cycles [Col. 3 lines 26-61]. This may include multiple different sources [Col. 3 lines 64-Col. 4 line 8] e.g. one source for washing and another for drying. It would have been obvious to one of ordinary skill in the art to provide such bypass connection from multiple sources to the column of the combined system of Iriki and Petro to facilitate cleaning, purging, and the like as in Stephens, all under control of the controller for automated operation as in Iriki and Petro.
Claims 21 and 22 are rejected under 35 U.S.C. 103 as being unpatentable over the combination of Iriki and Petro et al in view of Goto et al, in view of or with evidence from Lendl, in view of Stephens et al and Roenneburg et al, further in view of Yamazaki (US PGPub 2021/0310997 A1).
See the alternative rejections of claims 21 and 22 above; if the system is intended to have the capability to perform each of the actions independently, and not just “any” of them, then in addition to the above analysis, providing programming for cleaning/washing cycles would have been obvious in view of Stephens. Iriki, Petro, and the rest are silent to provision of means for displaying statuses or indicators or the like.
However, Yamazaki teaches a liquid chromatography system [Abs] and teaches inclusion of a display device [0016] connected to a controller [0028] which may display statuses and information e.g. chromatograms [0041]. It would have been obvious to include such display device and suitable associated programming in the combined system of Iriki and Petro in order to allow for display of status information, chromatograms, and similar useful information which a user may need.
Conclusion
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/BRADLEY R SPIES/Primary Examiner, Art Unit 1776
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