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, 2, 4, 5, 7-10, 13-16, 23-26, 28, 31 and 32 in the reply filed on January 7, 2026 is acknowledged. Claim 33 is withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on November 1, 2022 and October 25, 2023 are being considered by the examiner.
Claim Objections
Claim 10 is objected to because of the following informalities:
In the last line of claim 10, the limitation “comprise” should be “comprises”.
Appropriate correction is 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 10 and 24 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.
In claim 10, the relationship between “a channel” introduced in claim 10 and the channel introduced in claim 1 is unclear. Based on context (the footprints are identical), it appears that the two channels refer to a common channel. If so, the limitation “a channel” should be changed to “the channel”. If the claim intends to introduce a second channel, then it is unclear to which channel the limitation “the channel” in claim 10 refers.
In claim 24, the relationship between the additional channels and the rest of the elements of the flow cell is unclear. Claim 1 recites that the first channel port connects “the channel” to the exterior of the flow cell. It is unclear whether this recitation directed to “the channel” applies to the additional channels introduced in claim 24 (i.e. all of the channels are connected to the first channel port).
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, 4, 10, 13, 25 and 31 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Sibbald et al. (“Sibbald”) (US 4,865,716).
With respect to claim 1, Sibbald discloses a flow cell comprising (see Figs. 1-2):
(a) a gasket 6 interposed between a first substrate 4 and a second substrate 1, wherein the gasket, the first substrate and the second substrate are impermeable to aqueous liquid and liquid adhesive (see lines 5-7, col. 1), wherein the gasket 6 has a footprint on the first substrate that delineates a channel (space inside the gasket) for containing the aqueous liquid;
(b) a via (one of the pores) in the gasket, the via containing a solidified (see line 5, col. 2 disclosing that the adhesive cures) liquid adhesive that bonds the first substrate to the second substrate (see abstract), wherein the solidified liquid adhesive in the via is separated from the channel by the gasket (while the adhesive flows out of the via to other parts of the gasket, it is evident that the part of the adhesive inside the via is separated from the channel by the gasket); and
(c) a first channel port 2 connecting the channel to the exterior of the flow cell, wherein the first channel port is permeable to the aqueous liquid (see line 52, col. 1 disclosing that the port 2 is a duct).
With respect to claim 2, the flow cell further comprises a via port 7 connecting the via to the exterior of the flow cell (see Fig. 2 and line 2, col. 2).
With respect to claim 4, the gasket comprises a plurality of vias (pores), the vias each containing a solidified liquid adhesive that bonds the first substrate to the second substrate (see abstract), wherein the solidified liquid adhesive in the vias is separated from the channel by the gasket (this is evident, as discussed above).
With respect to claim 10, the gasket 6 has a footprint on the second substrate 1 that delineates the channel for containing the aqueous liquid, wherein the footprint on the first substrate is the same shape as the footprint on the second substrate (see Fig. 2), and wherein the first substrate 4 comprises a planar surface that forms a first side (bottom) of the channel and the second substrate 1 comprises a planar surface that forms a second side (top) of the channel (see Figs. 1-2).
With respect to claim 13, the flow cell further comprises a second channel port 3 connecting the channel to the exterior of the flow cell, wherein the second channel port 3 is permeable to the aqueous liquid (see Fig. 1).
With respect to claim 25, the gasket 6 delineates the distance between the first and second substrate in the channel (see Figs. 1 and 2).
With respect to claim 31, the channel comprises a turn of at least ninety degrees (see annotation below), wherein the turn* has an inner wall and an outer wall, the inner wall having substantially the same length as the outer wall (see annotation below).
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*While the gasket has an outer perimeter that exceeds the inner perimeter, the subject matter of the claim is limited to the part of the channel/gasket that defines a “turn”. In other words, the scope of the claim is broad enough to encompass the wall sections having identical lengths identified above.
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 5, 7 and 8 are rejected under 35 U.S.C. 103 as being unpatentable over Sibbald in view of Glezer et al. (“Glezer”) (US 2005/0142033 A1).
With respect to claim 5, while Sibbald discloses that the channel comprises a surface 5 that is sensitive to a constituent of a fluid sample (see abstract and line 33, col. 1), the disclosure of Sibbald is mainly directed to a gasket for forming a flow cell, and hence Sibbald does not explicitly disclose that the channel comprises an array of analytes attached to the first substrate. Nevertheless, in light of the broad disclosure directed to the flow cell, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have formed the flow cell as any conventional flow cell, including a flow cell comprising patterned arrays of analytes attached to multiple surfaces (e.g. the first substrate) of the flow cell, as taught by Glezer (see [0091]).
With respect to claim 7, as discussed above, the flow cell would comprise patterned arrays attached to multiple surfaces (e.g. the first and second substrates) of the flow cell.
With respect to claim 8, 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 first surface with any conventional type of probes/ligands used in a flow cell, for example oligonucleotides for binding complementary strands of nucleic acid (see also [0167] and [0907] of Glezer disclosing use of oligonucleotides/nucleic acids as probes). The modification would enable one to conduct nucleic acid assays.
Claim 9 is rejected under 35 U.S.C. 103 as being unpatentable over Sibbald in view of Glezer as applied to claims 5, 7 and 8 above, and further in view of Ugolin et al. (“Ugolin”) (US 2006/0239864 A1).
With respect to claim 9, neither Sibbald nor Glezer disclose the density of reaction sites. However, 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 first substrate with a density of reaction sites that provides a suitable balance of maximizing binding and the ability to discriminate individual binding reactions, for example at least 100 binding sites per square mm as taught by Ugolin (see [0130] and [0132] disclosing up to 1 million binding sites per 20 sq. cm in a FET-based sensor).
Claim 14 is rejected under 35 U.S.C. 103 as being unpatentable over Sibbald.
With respect to claim 14, because the disclosure of Sibbald is directed to a seal (a gasket) used to form a flow cell, it does not disclose the details of the flow cell itself, including whether an aqueous liquid is present in the channel. Nevertheless, based on the intended use of the flow cell (see abstract), it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have introduced an aqueous fluid (bodily fluid in a buffer/solvent) into the flow cell to perform analysis of the aqueous fluid.
Claim 15 is rejected under 35 U.S.C. 103 as being unpatentable over Sibbald as applied to claim 14 above, and further in view of Harrison et al. (“Harrison”) (US 2019/0212258 A1).
With respect to claim 15, while Sibbald discloses that the flow cell is intended to receive a fluid (see abstract), Sibbald does not disclose the pressure resistance of the flow cell. Nevertheless, 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 flow cell with structural integrity such that it can withstand fluid pressure typical for a flow cell, for example at least 10 psi as taught by Harrison (see [0045]-[0046]). The ability to select a curable adhesive that can meet the requirements set forth above is deemed to be within the endeavor of one of ordinary skill in the art. Naturally, the modified flow cell would comprise an aqueous liquid in the channel, wherein the liquid exerts a pressure of at least 10 psi.
Claim 26 is rejected under 35 U.S.C. 103 as being unpatentable over Sibbald in view of Esfandyarpour et al. (“Esfandyarpour”) (US 2014/0057339 A1).
Sibbald does not disclose the thickness of the gasket that defines the height of the flow cell. Nevertheless, 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 flow cell with a height (i.e. thickness of the gasket) that is conventional and suitable for a FET-based sensor, for example a height that falls within the claimed range, as taught by Esfandyarpour (see [0399] disclosing a flow cell having a height of 0.3 mm).
Claims 28 and 32 are rejected under 35 U.S.C. 103 as being unpatentable over Sibbald in view of Fry et al. (“Frye”) (US 6,272,939 B1).
With respect to claims 28 and 32, as discussed above, the disclosure of Sibbald is directed to a seal (a gasket) used to form a sensor. Consequently, it does not disclose the details of the sensor itself, including whether one or both of the first and second substrates is transparent to UV, VIS or IR radiation. That said, it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to have used the gasket taught by Sibbald to seal a substrate and a cover of an optical detection chamber of a biochip, as taught by Frye (see Fig. 5 and lines 14-16, col. 7 disclosing a biochip comprising layers 32 and 34 that form a detection chamber therebetween, wherein the layers are joined using a gasket; see also lines 20-25, col. 7 disclosing that one of the layers can be optically transparent to facilitate optical detection). The modification would facilitate optical detection of analytes using a flow cell and it would arrive at a system comprising the elements recited in claims 28 and 32.
Allowable Subject Matter
Claims 16 and 23 are objected to as being dependent upon a rejected base claim, but they would be allowable if they are rewritten in independent form including all of the limitations of the base claim and any intervening claims. In addition, claim 24 would be allowable if it is rewritten to overcome the 35 U.S.C. 112(b) set forth in this Office action and to include all of the limitations of the base claim and any intervening claims. The following is a statement of reasons for the indication of allowable subject matter:
As discussed above, Sibbald discloses the flow cell of claim 1. However, the gasket taught by Sibbald is made from a porous material (e.g. a filter paper) intended to take up a curable fluid adhesive via capillary action, wherein the pores constitute vias. Consequently, Sibbald does not disclose:
a gasket made from a pressure sensitive adhesive as recited in claim 16, or
a via that contiguously encircles a channel as recited in claims 23 and 24.
Moreover, based on the disclosure of Sibbald, there is no motivation to modify the gasket so as to arrive at the claimed inventions.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Luan Van can be reached at 571-272-8521. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/PAUL S HYUN/Primary Examiner, Art Unit 1796