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
Newly submitted claims 15-22 are directed to an invention that is independent or distinct from the invention originally claimed for the following reasons:
The newly added claims and the previous pending claims are related as process and apparatus for its practice. The inventions are distinct if it can be shown that either: (1) the process as claimed can be practiced by another and materially different apparatus or by hand, or (2) the apparatus as claimed can be used to practice another and materially different process. (MPEP § 806.05(e)). In this case the apparatus can be used by a materially different process, such as one that employs a different sequence of connection, disconnection, and solvent use, or one that does not require connection to multiple different containers during sequences of use, or one that does not require the same particular intermediate steps regarding drip-collection and the like.
Since applicant has received an action on the merits for the originally presented invention, this invention has been constructively elected by original presentation for prosecution on the merits. Accordingly, claims 15-22 are withdrawn from consideration as being directed to a non-elected invention. See 37 CFR 1.142(b) and MPEP § 821.03.
To preserve a right to petition, the reply to this action must distinctly and specifically point out supposed errors in the restriction requirement. Otherwise, the election shall be treated as a final election without traverse. Traversal must be timely. Failure to timely traverse the requirement will result in the loss of right to petition under 37 CFR 1.144. If claims are subsequently added, applicant must indicate which of the subsequently added claims are readable upon the elected invention.
Should applicant traverse on the ground that the inventions are not patentably distinct, applicant should submit evidence or identify such evidence now of record showing the inventions to be obvious variants or clearly admit on the record that this is the case. In either instance, if the examiner finds one of the inventions unpatentable over the prior art, the evidence or admission may be used in a rejection under 35 U.S.C. 103 or pre-AIA 35 U.S.C. 103(a) of the other invention.
Response to Amendment
The amendment filed 2/03/2026 has been entered. Claim 2 has been cancelled. New claims 15-22 have been added. Claims 1, 3, and 5-22 are pending in the application. Claims 15-22 stand withdrawn from further consideration due to election by original presentation of the previously presented and currently pending apparatus (solvent supply) claims i.e. claim 1 and dependent claims.
Response to Arguments
Applicant's arguments filed 2/03/2026 have been fully considered but they are not persuasive, or are addressed with a modified ground of rejection as discussed below.
Regarding applicant’s argument that song does not disclose that “at the first resting position, the tubing end is distantly situated beyond a reference to prevent physical contact” where such reference is “selected from the group consisting of: the solvent container…” or that “the tubing arm is further configured to allow the tubing end to move from the coupling position to the first resting position when the tubing end is decoupled…”, this argument is not persuasive. Song clearly teaches that the system used to move the tubing, such as a motorized rigid assembly, may be rotated or withdrawn from the receiving position (i.e. the position that corresponds to the appropriate container) to permit removal or placement of a solvent container, and may then be rotated or replaced to achieve connection with the container [0054]. Such a container could not be removed and replaced if the second position (that which differs from the receiving position, i.e. that which the assembly would rotate or withdrawn the tubing to) was not spaced apart from the container in a manner sufficient to prevent contact; or, at minimum, the teachings of these functions would render the claim requirements obvious because the function which is explicitly required by Song is to move the tubing out of the way to facilitate removal/replacement of the solvent container. Interpretations regarding potential difference between a motorized rigid assembly embodiment and a robotic arm embodiment are as previously addressed, not sufficient to overcome at minimum obviousness if not anticipation, particularly in view of the supporting prior art such as Hooser and Hollingsworth in which arm structures are clearly capable of being employed to facilitate multi-position toggling between e.g. working and non-working positions, or to hold tubing out of the way or in working positions.
Arguments regarding Song being silent to the terms “first resting position” and “reference” are similarly not persuasive. The claimed reference explicitly includes within its scope the solvent container, which is the reference point for positioning discussed by Song (where Song uses the term “receiving position” to substantially the same meaning), and the first resting position would correspond to Song’s teaching of rotation or withdrawal away from the receiving position, to a different position which permits removal of the solvent container. These are clearly consistent with the functional requirements of the claimed positions and the claimed capabilities are therefore anticipated by the teachings of Song or, in the alternative, at minimum obvious over the teachings of Song (or Song as supported by Hooser and Hollingsworth).
Claim Rejections - 35 USC § 102/103
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 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.
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, 3, 5, 12, and 14 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Song et al (WO 2018/134750 A1), or over Song et al in view of Hooser (US PGPub 2003/0116167 A1) and/or Hollingsworth (US 4,564,179).
With respect to claims 1 and 12, Song teaches solvent containers, trays, and related supply systems for chromatography systems [Abs]. The system may include provision for automatic connection and disconnection from relevant solvent containers, e.g. using motorized assembly to move a solvent line into or out of connection with a container; embodiments may employ a robotic arm [0054]. Associated solvent lines may be flexible with single or multiple tubing sections and appropriate connectors, i.e. of a length suitable for use with a relevant support arm and having a range of motion restricted thereby [0052]. Solvent lines are provided as a means of conveyance of the solvent from the containers to the relevant chromatography system e.g. a suitable column (separation unit) using a suitable solvent, mobile phase, elution, wash, or the like during a suitable stage of separation [0003].
Song is therefore interpreted as anticipating or at minimum rendering obvious the claimed invention of claims 1 and 12. Specifically, the requirement that the tubing arm is capable of being positioned in a first rest position to prevent physical contact from a reference is a necessary requirement of the positively taught feature of facilitating disconnect from a solvent container, as discussed above, or at minimum represents an obvious capability to facilitate such disconnection in a predictable manner. Similarly, provision of a mobile phase drive i.e. a pump or equivalent is a necessary or at minimum obvious feature for connection to the tubing or the like because the tubing is explicitly provided as part of a conveyance from a stationary supply container to a chromatography system i.e. a column.
Additionally or alternatively, if the recitation of a “motorized rigid assembly” or related robotic arm embodiments as in Song, or to a movable support arm as in Song [0052, 0054] is not considered sufficient to meet the claim requirements, the use of movable, rotatable, or articulable arms for holding laboratory equipment, medical equipment, and even specifically tubing lines is known in the art such that combination of the movable support arm and the motorized rigid assembly by way of a movable, articulable, or rotatable arm would have been obvious to facilitate the required connection and disconnection states already discussed by Song (i.e. the state in which the tubing is connected, and a second state in which the tubing is disconnected such that the container can be replaced, as discussed in [0054] of Song).
For example, Hollingsworth teaches an articulated support arm apparatus for holding a work device which may be movable by an operator into a variety of desired positions, and then locked in place during work [Abs] in a fail-safe manner. Hollingsworth specifically discusses the potential utility of the arm for use in a laboratory environment because of the fail-safe manner [Col. 7 lines 46-65]. See also Hooser which teaches a support arm for use in a respiratory circuit [Abs] with structures which allow the arm to be selectively fixed in place or repositionable by a user. The arm contains a specific end support structure (50) for engaging tubing [0037]. The design allows for easy repositioning of the arm in various positions as needed by a user [0038] while also locking into place when needed. Both Hollingsworth and Hooser represent analogous prior art because, at minimum, they are reasonably pertinent to the problem faced by the inventor i.e. they teach mechanisms and structures for providing support to laboratory equipment, tubing, or similar structures in a manner that allows for adjustable positioning.
As such, providing an arm structure which can function to both hold the tubing, and can be repositioned to move the tubing between states already contemplated by Song, would have been at minimum obvious to one of ordinary skill in the art e.g. by employing arm structures already conventionally known in the art.
Regarding the configuration in which the tubing is allowed to move from the coupling position to the first resting position when the tubing is decoupled from the solvent container, as above, the claimed configuration is taught or at minimum obvious as discussed above, because the intention is to position the connection in a disconnected state e.g. by rotation away from the container at least in some configurations to prevent connection to the containers and to allow the containers to be physically removed from the base, which requires that they be unobstructed.
Applicant amended to require the presence of a container base configured to support a solvent container; Song teaches that containers may be inserted and removed from a tray (110) which may be coded to specifically receive particular types of containers in specific positions [0048].
Applicant further amended to require that the reference is selected from a solvent container, tubing, base, sink, or component of the separation system; as above the reference may be a position relative to a solvent container (or, similarly, an associated container base [Fig. 3]) i.e. to ensure disconnect from the container to allow container replacement.
With respect to claim 3, as above the tubing arm may be part of e.g. a robotic embodiment in which it is designed to substantially maintain a tubing connection in various positions such as a connected position to one of many supplies or a disconnected position to facilitate replacement of containers.
With respect to claim 5, as above the tubing may be flexible, and further the tubing may contain a connection designed to ensure that the relevant tubing connects only with a specific associated container [0053] with a suitable coupling head.
With respect to claim 14, as above the system may connect flows from various containers including mobile phase for delivery to a column capable of carrying out separations or the like of a liquid sample. Examiner notes that the specific material worked upon and specific intended use do not distinguish the structure of the claimed system (see MPEP 2114 II and 2115).
Claims 6-8, 10, and 11 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al (or over Song et al in view of Hooser and/or Hollingsworth) in view of Quame (US 3,843,323 A).
With respect to claims 6-8, Song teaches as above, but is silent to specific constructional details of the arm e.g. the use of a portion of tubing being feely flexible, or to the use of an elastic member such as a spring.
However, Quame teaches a similar automated system for connecting and disconnecting sources of solvent using a tubing arm, with embodiments [Fig. 17; Col. 12 line 69-Col. 13 line 27] in which an upright central shaft (216) supports connected portions of the arm (266), (252), (256) to hold onto the tubing at a section (204) for facilitating connection, where the tubing has a freely flexible section e.g. (250) which facilitates upstream connection, and where the arm contains an elastic section in the form of a spring (264) which is used maintain position in the absence of a force moving the arm downward for e.g. connection to a container.
Because Song is silent to specific constructional details of the arm, it would have been obvious to one of ordinary skill in the art to look to the art e.g. Quame to find features useful for automated/robotic arms within the context of fluid connections, and to implement such features e.g. fixed support, flexible tubing, and spring tension and the like in the manner described by Quame in order to implement the broad design of Song.
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With respect to claims 10 and 11, as discussed above the spring (264) of Quame maintains the tubing in an upright position when there is no force applied i.e. “when freely movable.” Further, given the use of a spring, the velocity of movement would be controlled or fixed based on the physical properties of the spring i.e. the spring constant. Similarly, the path of movement would be predefined based on the designed points of rotation of the arm. Further, Quame provides for positioning of the arm adjacent a washing pan (270) or, alternatively, discard station for removal of used capillary tubing [Col. 17 lines 6-35] such that provision of a waste sink is at minimum obvious in a similar configuration.
Claim 13 are rejected under 35 U.S.C. 103 as being unpatentable over Song et al (or over Song et al in view of Hooser and/or Hollingsworth) in view of Zhang (CN 205679575 U).
Song teaches as above including the use of a standard chromatography column, i.e. those including various detectors such as mass spec or the like [0030, 0035]. The systems also necessarily include processing and data handling capabilities e.g. for identifying solvents [0057], and designing such systems to manage sample data is a standard, obvious feature of chromatography systems. Similarly, providing suitable volumes for e.g. sample collection is an obvious, necessary feature implicit in the recitation of such a system.
Song does not teach particular features of the system that may not be considered inherently necessary, such as a sample dispatcher/autosampler, or a degassing apparatus. However, Zhang teaches chromatography systems including those employing automated solvent container connections and replacements [Abs] and teaches inclusion of features such as a degassing module, and autosampler, as well as suitable detectors and related flow paths.
It would have been obvious to include such features in the system suggested by Song as standard features useful in chromatography systems, particularly as a means to increase the autonomy of the system and reduce operator labor as in Zhang.
Conclusion
THIS ACTION IS MADE FINAL. Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRADLEY R SPIES whose telephone number is (571)272-3469. The examiner can normally be reached Mon-Thurs 8AM-4PM.
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/BRADLEY R SPIES/Primary Examiner, Art Unit 1777
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