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) in the reply filed on 10/28/2025 is acknowledged. Claims 15-16 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected groups II and III, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 10/28/2025.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 10/12/2022 and 1/30/2023 are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Status
Claims 1-16 is pending with claims 1-14 being examined and claims 15-16 are withdrawn.
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 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.
Claim(s) 1-5, and 9-13 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Stafford (US 20170297015 A1; hereinafter “Stafford”; already of record on IDS filed 10/12/2022).
Regarding claim 1, Stafford teaches a device for wetting biological material with at least one liquid (Stafford; Abstract; a microplate which comprises one or more internal modifications which aid the introduction and removal of fluids from the wells of the plate and minimize the damage caused to biological matter), the device comprising:
at least one retaining device (Stafford; Fig. 16, 23B; para [283]; The microplate holder) and at least suction device (Stafford; Fig. 16, 23B; para [283]; a pipette tip 1), wherein the retaining device serves to receive a specimen slide in a support plane (Stafford; para [283]; The microplate holder comprises a means for securing the microplate to the platform; the examiner interprets the specimen slide as the microplate; the limitation is directed to the function and/or the manner of operating the retaining device, all the structural limitations of the claim has been disclosed by Stafford and the retaining device of Stafford is capable of “receiv[ing] a specimen slide in a support plane”. As such, it is deemed that the claimed retaining device is not differentiated from the retaining device of Stafford (see MPEP §2114)), wherein the specimen slide carries the biological material (Stafford; para [303]; In FIG. 23A, a pipette tip 1 is introduced to a microplate well 2 which contains a monolayer of adherent cells 7), and wherein the suction device serves to suction off liquid from the retaining device (Stafford; para [106, 137]; the first aspect of the present invention decreases the amount of time required to introduce or aspirate fluid in comparison to an unmodified microplate/known systems which incur the same level of cellular damage to biological material located within the wells upon introduction/aspiration of fluid), and wherein a front side of the suction device does not extend parallel to the support plane (Stafford; para [303]; In FIG. 23A, The well has a raised area 6 located on the well base. The indentation 5 and the raised area 6 are spaced).
Regarding claim 2, Stafford teaches the device according to claim 1, wherein the front side of the suction device extends in a slanted manner with respect to the support plane (Stafford; Fig. 19, 20). The examiner notes that the pipette is angled as seen in Fig. 19, 20.
Regarding claim 3, Stafford teaches the device according to claim 1, wherein the front side of the suction device extends overall in a single plane (Stafford; Fig. 19, 20). The pipettes front side, interpreted as the tips, extends downward over the plane parallel to the microplate washer head.
Regarding claim 4, Stafford teaches the device according to claim 1, wherein the front side of the suction device is concave or convex or irregularly shaped (Stafford; para [127]; The indentation may be any shape, for example, cuboidal, pyramidal, hemispherical, conical, cylindrical, or any form of prism, and located in any orientation. Pipette tips are typically circular in cross-section, and tailoring the shape of the indentation to the shape of the pipette tip end). The front side of the suction device would be irregularly shaped based on the shape of the indentation.
Regarding claim 5, Stafford teaches the device according to claim 1, wherein the front side of the suction device is formed in a slanted manner (Stafford; Fig. 20A; para [297]; The microplate washer head 25 is rotated to an angle which is substantially the same as the angle of inclination of the microplate by a pin 26, in order to compensate for the angle that the microplate is held at by the microplate holder).
Regarding claim 9, Stafford teaches the device according to claim 1, wherein the suction device is formed at least in regions as a hose or tube (Stafford; Fig. 20A; para [300]; a dispensing tip 30 and an aspirating tip 29).
Regarding claim 10, Stafford teaches the device according to claim 1, wherein a bottom of the retaining device has at least two planes, such that an upper bottom surface and a lower bottom surface are realized (Stafford; Fig. 15C, 17, para [294]; A raised area 21 located on the base portion 8 of the microplate holder protrudes into the base of the microplate 7, and the holder comprises a further raised area 22). The examiner interprets the upper bottom surface as the raised area of the microplate holder and interprets the lower bottom surface as the base portion.
Regarding claim 11, Stafford teaches the device according to claim 10, wherein a support is formed on the lower bottom surface, and wherein the support projects at least substantially up to the height of the upper bottom surface (Stafford; Fig. 15C, 16). The examiner notes that the support, interpreted as the nut, raises the upper bottom surface from the lower bottom surface.
Regarding claim 12, Stafford teaches the device according to claim 11, wherein the support is formed spaced apart from further elements of the retaining device wherein it projects freely from the lower bottom surface (Stafford; Fig. 15B). The examiner notes that the further elements, interpreted as the screw, engages or disengages the end of screw from the platform.
Regarding claim 13, Stafford teaches the device according to claim 1, wherein at least one support surface is formed on a bottom of the retaining device (Stafford; Fig. 15C; para [292]; base portion 8), and wherein the support surface extends from a side wall to a back wall of the retaining device (Stafford; Fig. 16; examiner notes that the base platform contacts the microplate, thus extending from part of the bottom of the side wall and back wall interpreted as the other wall perpendicular to the side wall of the microplate).
Claim(s) 1, 7-8, and 14 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Einsle (WO 2018115145 A1; hereinafter “Einsle”; English translation attached).
Regarding claim 1, Einsle teaches a device for wetting biological material with at least one liquid (Einsle; Abstract), the device comprising:
at least one retaining device (Einsle; Fig. 1; page 17; a one-piece base body 4) and at least suction device (Einsle; Fig. 1; page 18; the suction nozzle 12), wherein the retaining device serves to receive a specimen slide in a support plane (Einsle; Fig. 1; page 17; a one-piece base body 4 with a platform for receiving the slide 2), wherein the specimen slide carries the biological material (Einsle; Fig. 1; page 17;
wet biological material deposited on the active surface of the slide 2), and wherein the suction device serves to suction off liquid from the retaining device (Einsle; Fig. 1; page 18; The suction nozzle 12 'is in fluid communication with the corner region 6 through the connection with the slide 2, so that the liquid for wetting the biological material can be completely sucked by the negative pressure which can be generated in the suction nozzle 12), and wherein a front side of the suction device does not extend parallel to the support plane (Einsle; Fig. 1, 2; the suction device, interpreted as the suction nozzle is not parallel to the support plane when the cap is not attached as seen in Fig. 1 and 2).
Regarding claim 7, Einsle teaches the device according to claim 1, wherein the front side of the suction device is in contact with the specimen slide and a side wall of the retaining device and a back wall of the retaining device at least during a suction process (Einsle; Fig. 14; page 23; the suction nozzle 12 according to FIG. 13 in a suction position as it may be in the closed state of an incubation chamber 1'. In particular, it is shown how the slide 2 can be present in the incubation chamber 1 'and how the recess 56 can receive the corner region 6 of the slide 2 so that both the suction opening 57 and the suction channel 54 of the suction nozzle 12).
Regarding claim 8, Einsle teaches the device according to claim 1, wherein a free end of the suction device, is in contact with the specimen slide and with a rounded corner of the retaining device at least during a suction process (Einsle; Fig. 14; page 13, the suction nozzle can be arranged in the incubation chamber so that the suction opening encloses the corner of the not in the collecting position or only slightly raised corner region of the slide… the corner of the slide can protrude into the suction opening of the suction nozzle, so that by closing the lid of the incubation on the one hand, a fluid connection between the located in the capillary liquid and the suction opening), wherein the rounded corner connects a back wall and a side wall of the retaining device to one another (Einsle; Fig. 6; examiner notes that the back wall is interpreted as 40 and side wall interpreted as 37).
Regarding claim 14, Einsle teaches the device according to claim 10, wherein a heating device with at least one heating element is arranged for heating the at least one retaining device, wherein the heating element is dimensioned in such a way that the entire bottom of the retaining device and/or, if appropriate, the entire upper bottom surface of the retaining device is sufficiently heated, irrespective of its size (Einsle; page 18, the platform or bottom plate of the base 4 can be exactly and advantageously positioned on an underlying temperature element, for example on a hot plate or on a heating block).
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 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 6 is rejected under 35 U.S.C. 103 as being unpatentable over Stafford.
Regarding claim 6, Stafford teaches the device according to claim 1, wherein the front side of the suction device extends at an angle in the range from 5° to 45°, with respect to the support plane (Stafford; Fig. 20A; para [177, 299]; the pins may extend at 45 degrees from the washer head…In FIG. 20A illustrates the ways in which a washer head in an automated system may be manipulated in order to communicate with a microplate inclined to the desired angle, x by a device). As set forth in MPEP 2144.05, in the case where the claimed range “overlap or lie inside ranges disclosed by the prior art”, a prima facie case of obviousness exists, In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In re Woodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990).
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Austin Q Le whose telephone number is (571)272-7556. The examiner can normally be reached Monday - Friday 9am - 5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Elizabeth Robinson can be reached at (571)272-7129. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/A.Q.L./Examiner, Art Unit 1796
/ELIZABETH A ROBINSON/Supervisory Patent Examiner, Art Unit 1796