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 1-18 and 21 (claim 21 depends on independent claim 1) in the reply filed on 04/22/2026 is acknowledged.
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 12-13 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.
The term “about” in claim 12 is a relative term which renders the claim indefinite. The term “about” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. Claim 13 is rejected 112(b) since it depends on clam 12 of the instant application.
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.
Claims 1-18 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by WO2013/166203A2-Jackson et al (hereinafter “Jackson”).
Regarding claim 1, Jackson discloses a pipette (pipette device 100, para. [0045], line 2, Fig. 1) comprising: a proximal section having a handle (handle 15, para. [0047], line 1, Fig. 1, where Fig. 1 shows the proximal end of device 100 having a handle 15); a distal section configured to reversibly attach to a pipette tip (reversible attachable pipette tip 70, para. [0045], line 2, Fig. 1); a first actuator (pipette plunger end 20a, para. [0050], lines 5-6) disposed in the proximal section that when actuated is operable to control (pipette plunger end 20a is shown in Fig. 1 disposed proximally to pipette body 300): i) a pipetting function of the pipette (the pipette is set to the load position (and/or eject position) as shown in FIG 2A, which is achieved by pressing pipette plunger 20 down (by a user or mechanical means) past a dispense stop position such that pipette plunger end 20a is closest to the pipette body 300, para. [0050], lines 5-6); and ii) grasping and ungrasping of a plunger disposed within a lumen of the pipette tip (the pressing of pipette plunger 20 down by a user or mechanical means past a dispense stop position such that pipette plunger end 20a is closest to the pipette body 300, para. [0050], lines 5-6, Fig. 1); and a second actuator (detent push off surface 21, para. [0050], line 7, Fig. 1) disposed in the proximal section that when actuated is operable to cause the pipette tip to detach from the distal section of the pipette (as pipette plunger 20 is pushed down (moves down), the detent push off surface 21 pushes the detent cantilevers 31 apart. As soon as pipette plunger 20 reaches the eject/load position (e.g., when a user or a mechanical means has compressed both the pipette plunger spring and the gripper spring), the detent cantilevers 31 fall off the detent push off surface 21 locking the pipette plunger 20 in the eject/load position, para. [0051], lines 1-3).
Regarding claim 2, Jackson discloses a pipette electrode disposed in the distal section (electrode 60 is shown disposed on a distal end of pipette device 100, Fig. 1) and electrically coupled to the plunger when grasped (electrode 60 is screwed onto pipette end 55 by means of threads/grooves on both electrode 60, para. [0045], line 12, where plunger 20 extends through pipette body 300 to the distal end of the pipette, where electrode 60 is disposed, shown in Fig. 1).
Regarding claim 3, Jackson discloses wherein the pipetting function comprises aspirating a fluid into, or dispensing a fluid from, a pipette tip attached to the distal section (moving one or more components therein into various positions for loading and/or ejecting a pipette tip; aspirating a sample; and dispensing a sample, para. [0050], lines 1-2).
Regarding claim 4, Jackson discloses herein the first actuator has a first undepressed position and a second partially depressed position, and wherein transitioning the first actuator from the first undepressed position to the second partially depressed position causes dispensing from the pipette tip and transitioning of the first actuator from the second partially depressed position to the first undepressed position causes aspirating into the pipette tip (the act of loading a pipette tip 70 generates enough force to separate the detents 31 and move the pipette plunger up unlocking the pipette plunger 20 out of the detent, the pipette plunger spring 50 then moves the plunger 20 to its most extended out position (with end 20a being farthest away from pipette body 300) also referred to as the aspirate position shown in FIG. 3A and FIG. 1, para. [0053], lines 1-3; the first undepressed, second partially depressed, and a third depressed position occur via pipette plunger 20 may be depressed by a user mechanically such as by pressing the plunger by hand or finger or by an automated means such as by a robotic device, para. [0050], lines 6-8).
Regarding claim 5, Jackson discloses wherein the first actuator has a third fully depressed position (the act of loading a pipette tip 70 generates enough force to separate the detents 31 and move the pipette plunger up unlocking the pipette plunger 20 out of the detent, the pipette plunger spring 50 then moves the plunger 20 to its most extended out position (with end 20a being farthest away from pipette body 300) also referred to as the aspirate position shown in FIG. 3A and FIG. 1, para. [0053], lines 1-3; the first undepressed, second partially depressed, and a third depressed position occur via pipette plunger 20 may be depressed by a user mechanically such as by pressing the plunger by hand or finger or by an automated means such as by a robotic device, para. [0050], lines 6-8).
Regarding claim 6, Jackson discloses wherein transitioning the first actuator from the second partially depressed position to the third fully depressed position causes ungrasping of the plunger, and transitioning the first actuator from the third fully depressed position to the second partially depressed position causes grasping of the plunger (the first undepressed, second partially depressed, and a third depressed position occur via pipette plunger 20 may be depressed by a user mechanically such as by pressing the plunger by hand or finger or by an automated means such as by a robotic device, para. [0050], lines 6-8).
Regarding claim 7, Jackson discloses a gripper mechanism disposed in the distal section (gripper 40 is a small collet that extends when plunger 20 is fully depressed, para. [0052], line 2, Fig. 1, shown disposed on the distal end of pipette device 100, Fig. 1), the gripper mechanism operable to transition between a closed configuration and an open configuration upon transitioning of the first actuator between the second partially depressed position and the third fully depressed position (when plunger 20 is released, gripper 40 clamps down on a pipette tip 70 that is to be used for pipetting, para. [0052], lines 2-3).
Regarding claim 8, Jackson discloses wherein the gripper mechanism (discussed previously above) comprises: a gripper jaw (first end 40a, para. [0045], line 12 Fig. 1), the gripper jaw comprising a jaw opening (slot 41, para. [0045], line 13, Fig. 1) for receiving an engagement section of the plunger; and a gripping sleeve (pipette end 55 encloses gripper 40, and which also encloses first end 40a, shown in Fig. 1) positioned around the gripper jaw configured to exert an inward force on the gripper jaw to cause the gripper jaw to exert a compressive force on the engagement section of the plunger to retain the engagement section of the plunger within the jaw opening when the first actuator is in the first depressed position or the second partially depressed position (pipette end 55 connects pipette body 300 to electrode tip 60 and provides a guide for gripper 40, para. [0045], lines 16-17; pipette end 55 encloses gripper 40 and extends over first end 40a and second end 40b of gripper 40 and the over second end 20b of the plunger 20. Pipette end 55 has a first end 55a proximate magnet Ml and second end 55b in releasable contact with electrode 60. Pipette end 55 connects pipette body 300 to electrode tip 60 and provides a guide for gripper 40, para. [0057], lines 1-4).
Regarding claim 9, Jackson discloses wherein the gripper jaw (first end 40a, Fig. 1) and gripping sleeve (pipette end 55, Fig. 1) are configured to translate within the pipette while retaining the engagement section of the plunger within the jaw opening to cause translation of a lumen section of the plunger within the lumen of the pipette tip to facilitate the pipetting function (pipette end 55 encloses gripper 40 and extends over first end 40a and second end 40b of gripper 40 and the over second end 20b of the plunger 20. Pipette end 55 has a first end 55a proximate magnet Ml and second end 55b in releasable contact with electrode 60. Pipette end 55 connects pipette body 300 to electrode tip 60 and provides a guide for gripper 40, para. [0057], lines 1-4; further, Fig. 1 show both gripper jaw—first end 40a and gripping sleeve—pipette end 55 are disposed in pipette device 100).
Regarding claim 10, Jackson discloses wherein the gripper jaw is moved distally relative to the gripping sleeve when the first actuator is transitioned from the second partially undepressed position to the third fully depressed position thereby releasing the plunger from the gripper jaw (pipette end 55 encloses gripper 40 and extends over first end 40a and second end 40b of gripper 40 and the over second end 20b of the plunger 20, para. [0045], lines 16-17; further, when the first undepressed, second partially depressed, and a third depressed position occur via pipette plunger 20 may be depressed by a user mechanically such as by pressing the plunger by hand or finger or by an automated means such as by a robotic device, para. [0050], lines 6-8).
Regarding claim 11, Jackson discloses wherein the second actuator has a first undepressed position and a second depressed position (further, when the first undepressed, second partially depressed, and a third depressed position occur via pipette plunger 20 may be depressed by a user mechanically such as by pressing the plunger by hand or finger or by an automated means such as by a robotic device, para. [0050], lines 6-8).
Regarding claim 12, comprising a tip interface (shown below in annotated Fig. 3C below) disposed circumferentially about the gripper jaw, the tip interface including a retention platform (shown below in annotated Fig. 3C below) configured to engage tabs of an attachment interface (gripper fingers 42, para. [0052], lines 2-3, Fig. 3C) of the pipette tip to secure a tip sleeve defining the lumen of the pipette tip (interior of tip 70, Fig. 3C) to the distal section of the pipette.
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Regarding claim 13, Jackson discloses a tip ejection sleeve operably connected to the second actuator and disposed adjacent to the tip interface (a pipette device of this disclosure having a trigger the force by a user for loading and/or ejecting a pipette tip is reduced to ~41b and for a pipette having a detent according to the present disclosure the force for loading and/or ejecting a tip, para. [0078], lines 2-4), the tip ejection sleeve operable to move distally with respect to the tip interface when the second actuator is actuated by transitioning the second actuator from the first undepressed position to the second depressed position and displace the attachment interface of the pipette tip from the retention platform to detach the tip sleeve from the pipette (depressing the pipette plunger to a dispense position to dispense aspirated sample comprising electroporated cells; and ejecting a used pipette tip by pressing on the pipette plunger or trigger, para. [0095], lines 10-12).
Regarding claim 14, Jackson discloses wherein the second actuator is configured to traverse a blank travel distance when pressed prior to causing detachment of the one or more tabs from the retention platform (the pressing of pipette plunger 20 down by a user or mechanical means past a dispense stop position such that pipette plunger end 20a is closest to the pipette body 300, para. [0050], lines 5-6, Fig. 1); depressing the pipette plunger to a dispense position to dispense aspirated sample comprising electroporated cells; and ejecting a used pipette tip by pressing on the pipette plunger or trigger, para. [0095], lines 10-12).
Regarding claim 15, Jackson discloses wherein the gripper mechanism (when plunger 20 is released, gripper 40 clamps down on a pipette tip 70 that is to be used for pipetting, para. [0052], lines 2-3) is configured to retain the engagement section of the plunger within the gripper opening throughout detachment of the attachment interface from the retention platform (gripper 40 is retained within pipette end 55 when plunger 20 is not depressed, thus the latter result in a retained engagement section of pipette device 100).
Regarding claim 16, Jackson discloses wherein, when the attachment interface and tip sleeve of the pipette tip are detached from the distal section of the pipette, transitioning the first actuator from the second partially depressed position to the third fully depressed position causes release of an engagement section of a plunger retained with the gripper jaw thereby releasing the pipette tip from the distal section of the pipette (cantilevers 31 and detent protrusions 31 'do not lock the detent push off surface 21, and a user will feel a "stop" since this position corresponds to pipette plunger spring 50 being fully compressed. The gripper spring 40' is much stronger than the pipette plunger spring 50, which enhances the "stop" feel at the dispense position. After a user has completed sample aspiration and sample dispensing, the user can proceed to the eject load position to eject a used tip 70 which is shown in FIG 3C (also FIG 2A). Pipette tips 70 that are used may be ejected by gripper fingers 42 shown in FIGS 2B and 2C pushing outward to push pipette tip 70 out, para. [0054], lines 3-9).
Regarding claim 17, Jackson discloses wherein the pipette electrode is electrically coupled to the gripper jaw of the gripper mechanism (pipette electrode 60 is shown coupled to the gripper jaw—first end 40a, shown in Fig. 2A).
Regarding claim 18, Jackson discloses wherein the gripper jaw is composed of an electrically conductive material (pipette body 300 may be made of plastic materials, although metals may also be used in the construction, para. [0067], lines 5-6) and operable to allow an electrical pulse applied to the pipette electrode to pass through the pipette electrode, through the gripper jaw (loading a tip which generates force to move a pipette plunger to aspirate position in a pipette with a detent); providing an electrical pulse to the cells in the pipette tip to allow electroporation, para. [0014], lines 8-11), through the plunger retained within the jaw opening of the gripper jaw, through a sample containing cells contained within the lumen of the pipette tip, and through a second electrode disposed adjacent a distal end of the pipette tip, thereby electroporating the cells contained in the sample (applying an electric current to the sample located in a pipette tip of the electroporation system comprises applying electrical current to a plunger located within the body of the pipette tip and to an electrode contacting a sample in a sample reservoir, para. [0016], lines 3-5).
Therefore, the reference of Jackson meet the limitation s of claims 1-18.
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 21 is rejected under 35 U.S.C. 103 as being unpatentable over WO2013/166203A2-Jackson et al (hereinafter “Jackson”).
Regarding claim 21, Jackson teaches An electroporation system comprising: a pipette of claim 1 (pipette device 100, para. [0045], line 2, Fig. 1, also discussed above in claim 1); a pipette tip (pipette tip 70, para. [0045], line 3, Fig. 1). However, Jackson does not teach a pipette docking assembly and a pulse generator.
For claim 21, a different embodiment of Jackson teaches a pipette docking assembly (pipette stand/rack 12 can be in electrical contact via cable 1 with an electroporation device 600 comprising at least a pulse generator 10 (para. [0084], lines 3-5, Fig 10), which reads on the instant claim limitation of a pipette docking assembly and a pulse generator.
It would have been obvious to one of ordinary skill, in the art at the time, to further include a pipette docking assembly and a pulse generator as taught by a different embodiment of Jackson, because a different embodiment of Jackson teaches a pulse generator provides an electrical pulse to the cells in the pipette tip to allow for electroporation (para. [0014], lines 9-10, Fig. 10) and a different embodiment of Jackson teaches an electroporation system may also comprise a pipette stand or pipette rack 12 to rest a pipette device 100/200 (para. [0081], lines 9-10, Fig. 10).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to LENORA A. ABEL whose telephone number is (571)272-8270. The examiner can normally be reached Monday-Friday 7:00am-4:00pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Marcheschi can be reached at (571) 272-1374. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/L.A.A./ Examiner, Art Unit 1799
/MICHAEL L HOBBS/ Primary Examiner, Art Unit 1799
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