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 claims 1-10 in the reply filed on December 1, 2025 is acknowledged. Claims 11-20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.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 Objections
Claim 1 is objected to because of the following informalities:
At the end of line 5 of claim 1, the comma should be deleted. In addition, the limitation “two or more sockets” should be preceded by “the”.
Appropriate corrections are required.
Claim Rejections - 35 USC § 112
In the event the determination of the status of the application as subject to AIA (or as subject to pre-AIA ) is incorrect, any correction of the statutory basis for the rejection will not be considered a new ground of rejection if the rationale supporting the rejection would be the same under either status.
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 1-10 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 1 is indefinite because of the clause, “two or more stoppers…of the plug body having a first end and a second end”, is ambiguous. Grammatically, the clause conveys that the plug body comprises the two ends, but based on the specification, it appears that the clause intends to convey that the stoppers comprise the two ends. Clarification is required.
Claim 1 recites a lumen traversing a socket in the plug body (see line 5) and separately a socket lumen (see line 12). The relationship between the two lumens is unclear. Both lumens are associated with a socket and extend through plug body. It is unclear whether the limitation “socket” in “socket lumen” is intended to provide context (i.e. refer back to the lumen associated with a socket in line 5) or whether it intends to establish new nomenclature referring to a separate lumen. Clarification is required.
In claim 1, the limitation “at least one second stopper” is indefinite. The limitation suggests the existence of more than one second stopper, meaning the limitation “second” is not numerical, but rather it intends to convey type (i.e. second type of stopper). That said, the distinction between the first stopper and the second stopper(s) is unclear.
Claim 2 is indefinite because it is unclear what it intends to convey. Based on the definition established in the claim, the diameter of the middle section IS “a diameter of the two or more stoppers”. Consequently, it is unclear what the claim intends to convey (the middle section has a diameter smaller than another diameter of the two or more stoppers?).
In claim 8, there is no antecedent basis for the limitation “the plug”. The claim establishes antecedence for “plug device” and “plug body”, but not “plug” on its own.
Claims not explicitly rejected are rejected due to dependency.
Claim Rejections - 35 USC § 102
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, 2 and 6-10 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kao et al. (“Kao”) (US 2007/0015289 A1).
With respect to claim 1, Kao discloses a fluid exchange plug device configured for insertion into two or more wells 26 of a multi-well plate 20, the plug device comprising (see Figs. 22a-b):
a plug body 404/408 having an upper surface and a lower surface;
two or more sockets 402 positioned within the plug body, each comprising a first (top) opening, a second (bottom) opening and a lumen (lumen defining socket 402) therebetween, wherein the two or more sockets 402 are accessible by the first opening on the upper surface of the plug body;
two or more stoppers 450 extending from the lower surface of the plug body, each stopper having a first (top) end and a second (bottom) end, wherein the second end comprises at least one opening 434 (see Fig. 22b);
wherein each stopper 450 is positioned below each socket (see Fig. 22a) and is sized to fit within a well 26 of a multi-well plate 20 (see Fig. 22b), wherein the second opening is fluidly connected to the at least one opening 434 of the second end by at least one lumen 410 extending through the plug body (see Fig. 22a), and
wherein the second (bottom) end of a first stopper is fluidly connected to the second (bottom) end of a second stopper by a stopper lumen 406 extending laterally through the plug body (see Fig. 22b and 23a).
With respect to claim 2, the two or more stoppers 450 further comprise a middle section (midpoint of the projection 434) positioned anywhere along the length of each stopper, wherein the middle section has a diameter smaller than a diameter at the first end (top) of the two or more stoppers.
With respect to claim 6, the two or more sockets 402 each are sized to receive fluidic or microfluidic tubing.
Absent the claim specifying the dimensions of the tubing and/or the nature of the reception, any opening large enough and/or configured to receive a tubing is sufficient to anticipate the claim. In this case, the sockets 402 function as input ports (see [0393]). Consequently, it is deemed to be sufficiently sized and/or it is configured to receive a tubing.
With respect to claim 7, the two or more sockets 402 are each adjacent to each other and the two or more stoppers 450 are each adjacent to each other (see Fig. 22a).
With respect to claim 8, the plug device is configured for insertion into a multi-well plate comprising the claimed arrangement of wells (see [0211]).
With respect to claims 9 and 10, absent more context (e.g. specifying the material from which the device is made such that it is considered “single-use” or multiple-use”), the subject matter of the claims is deemed to be directed to intended use. That said, the plug device taught by Kao can be a single-use device or a multiple-use device depending on the number of times it is used.
Claim Rejections - 35 USC § 103
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 3 and 4 are rejected under 35 U.S.C. 103 as being unpatentable over Kao in view of Cauley, III et al. (“Cauley”) (US 2014/0080226 A1).
With respect to claim 3, while Kao discloses that the stoppers 450 are intended to be shaped to be received by the rims of wells 26, and further discloses a need to prevent cross-contamination between individual wells 26 (see [0399]), Kao does not disclose that each stopper comprises a gasket or an O-ring positioned on the middle section. However, based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided a gasket on the middle section of the stoppers 450 to ensure a liquid-tight fitting between the stoppers 450 and the rims of wells 26, as taught by Cauley (see Fig. 1 illustrating a gasket 52 fitted between nozzles of a dispenser 76 and wells 66 of a microplate 54).
With respect to claim 4, while Kao discloses that the stoppers 450 each extend from the lower surface of the plug body to an extent that inhibits cross-contamination between wells 26 (see [0399]), Kao does not explicitly disclose the length of the extension. Nevertheless, based on the disclosure, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have provided the stoppers 450 with a length that is sufficient to inhibit cross-contamination, for example a length that falls within the claimed range.
Claim 5 is rejected under 35 U.S.C. 103 as being unpatentable over Kao in view of Parkinson (AU 2013284286 A1).
With respect to claim 5, Kao does not disclose that the sockets 402 (which function as inlet ports) each comprise a threaded interior. However, it is well-known in the art to provide inlet ports of microfluidic devices with internal threads for connecting fluid delivery tubing (see Fig. 4 and [0011] of Parkinson). In light of the disclosure of Parkinson, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention have provided the interior of sockets 402 taught by Kao with threads for connecting a fluid delivery device that can be used to introduce fluid into the sockets 402.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to PAUL S HYUN whose telephone number is (571)272-8559. The examiner can normally be reached M-F 8:30-5:00.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796