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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 4/6/2026 has been entered.
Response to Amendment
The Amendment filed on 4/6/2026 has been entered. Claims 1-4, 6, 11, 16, 17, 22, 24 and 27-29 remain pending in the application.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 1-4, 6, 11 and 16 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. Claim 1 recites that the base substrate is a rigid substrate, however, the specification as filed does not provide support for this recitation. The applicant’s points to claim 12 and figure 4 as provided support for the amendments to claim 1, however, neither the claim nor figure describes that rigidity of the base substrate. Additionally, no where else in the specification describes the rigidity of the base substrate either and that it is rigid as is currently claim. Therefore, the limitation that the base substrate is a rigid substrate does not have written support in the specification as filed.
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(s) 1-4 is/are rejected under 35 U.S.C. 103 as being unpatentable over United States Application Publication No. 2020/0129974, hereinafter Ren in view of United States Application Publication No. 2016/0284508, hereinafter Carson and United States Application Publication No. 2004/0241881, hereinafter Kuriger.
Regarding claim 1, Ren teaches a detection chip (figure 4), comprising: a detection layer (items 12 and 28), and including a plurality of detection holes (items 30A-30F), wherein, each of at least a portion of the plurality of detection holes has a hole wall (figure 4) provided with a hydrophilic layer (paragraph [0115]), and a contact angle of the hydrophilic layer is within 20 degrees (paragraph [0115]), wherein, an adapter primer (item 22) is disposed inside of the detection hole (figure 4); and the adapter primer is connected to a surface of the hydrophilic layer through a covalent bond (paragraph [0172]), wherein the detection chip further comprises a cover layer (item 24), wherein, the cover layer is provided on a side of the adapter primer that is away from the base substrate (figure 4), wherein, a material of the cover layer comprises a water-soluble polymer (paragraph [0178]), wherein the water-soluble polymer comprises a copolymer of N-(5-azidoacetamidopentyl) acrylamide and acrylamide (paragraph [0178]), wherein the detection chip further comprises: a cover plate (item 26), bonded by a binder to a side of the detection layer that is away from the base substrate (figure 4 and paragraph [0155]), and comprising a sample inlet and a sample outlet (paragraph [0177]), the cover plate comprises a plate surface opposite to the base substrate (figure 4), wherein a detection channel is located between the cover plate and the cover layer (figure 4), and the cover layer is only located in the detection hole (each detection hole is interpreted to be the whole of each of 30A-30F and it can be seen the item 24 is only within each of items 30A-30F), wherein, the detection layer comprises a binding material layer (item 28) and a hydrophobic material layer (item 12); the binding material layer comprises a plurality of holes (figure 4); and the hydrophobic material layer is provided on the binding material layer (figure 4), to form a plurality of detection holes at positions of the plurality of holes (figure 4 and paragraph [0161]); and a material of the hydrophobic material layer comprises silicon nitride (paragraph [0069]).
Ren fails to specifically teach the distance between the plate surface and the detection layer is 50 micrometers to 100 micrometers.
Ren further teaches that the volume of each well can be selected to accommodate the throughput, resolution, analyte composition or analyte reactivity expected for downstream use of the flow cell (paragraph [0124]).
It would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention, to determine, through routine experimentation, the optimum distance between the plate surface and the detection layer to a range of 50-100 micrometers which would allow the throughput, resolution, analyte composition or analyte reactivity expected for downstream use of the flow cell (paragraph [0124]) (MPEP § 2144.05 (II)).
Ren fails to specifically teach wherein the sample inlet and the sample outlet are arranged in an edge region of the cover plate.
Ren further teaches that the lid may include inlet and outlet ports that are to fluidically engage other ports (not shown) for directing fluid(s) into the respective flow channels 30A, 30B, 30C, 30D, 30E, 30F (e.g., from a reagent cartridge or other fluid storage system) and out of the flow channel (e.g., to a waste removal system) (paragraph [0193]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have made the sample inlet and outlet ports at an edge of the cover plate because it would allow for the fluid to pass from the start to the end of the flow channel (paragraph [0193]).
Ren fails to teach a base substrate and the detection layer provided on the base substrate.
Carson teaches a device with a turntable (base substrate) that is a rigid substrate (Carson, paragraph [0025]) with the substrate (detection layer) provided on the turntable so that the substrate can be rotated about a central axis (Carson, paragraph [0025]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have added a turntable (base substrate) with the detection layer on the turntable because it would allow for the detection layer to be rotated about a central axis (Carson, paragraph [0025]).
Ren and Carson fail to teach a material of the binding material layer comprises optical clear adhesive.
Kuriger teaches a device which utilizes an optically clear adhesive so that the device can be read through the structure (Kuriger, paragraph [0025]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have utilized an optically clear adhesive because it would allow for the device the to be read through the structure (Kuriger, paragraph [0025]).
Regarding claim 2, Ren teaches wherein, a contact angle of a surface of the detection layer that is away from the base substrate is 80 degrees to 150 degrees (paragraph [0115]).
Regarding claim 3, Ren teaches wherein, slope angles formed by side walls of at least a portion of the plurality of detection holes and a plate surface of the base substrate are 85 degrees to 90 degrees (paragraph [0054]).
Regarding claim 4, Ren teaches a diameter of the detection hole is 0.75 micrometers to 1.75 micrometers (paragraph [0127]); and a separation distance between adjacent detection holes is 0.25 micrometers to 1.25 micrometers (paragraph [0121]), wherein, a depth of the detection hole is 0.75 micrometers to 1.75 micrometers (paragraph [0126).
Claim(s) 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ren, Carson and Kuriger in view of United States Application Publication No. 2005/0130173, hereinafter Leamon.
Regarding claim 6, Ren, Carson and Kuriger teaches all limitations of claim 1; however, they fail to teach a bottom surface of the detection hole that is close to the base substrate comprises an arc surface that is concave toward a direction of the base substrate.
Leamon teaches a reaction chambers in an array with the cavities have a planar bottom or a concave bottom (Leamon, paragraph [0201]).
Examiner further finds that the prior art contained a device/method/product (i.e., a concave bottom) which differed from the claimed device by the substitution of component(s) (i.e., a flat bottom) with other component(s) (i.e., a concave bottom), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a flat with a concave bottom), and the results of the substitution (i.e., acting as the bottom surface of the well) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute a flat bottom of reference Ren with a concave bottom of reference Leamon, since the result would have been predictable.
Claim(s) 11 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ren, Carson and Kuriger in view of United States Application Publication No. 2003/0098248, hereinafter Vogel.
Regarding claim 11, Ren, Carson and Kuriger teach the substrate is silicon dioxide, silicon nitride or silicon coated with a ceramic oxide (paragraph [0069])
Ren, Carson and Kuriger fail to teach the detection layer comprises silicon nitride; and a material of the hydrophilic layer comprises silicon oxide.
Vogel teaches a device which utilizes silicon nitride as the base and silicon oxide as the coating (Vogel, paragraph [0247]).
Examiner further finds that the prior art contained a device/method/product (i.e., silicon nitride as the base and silicon oxide as the coating) which differed from the claimed device by the substitution of component(s) (i.e., the substrate is silicon dioxide, silicon nitride or silicon coated with a ceramic oxide) with other component(s) (i.e., silicon nitride as the base and silicon oxide as the coating), and the substituted components and their functions were known in the art as above set forth. An ordinarily skilled artisan at the time of invention could have substituted one known element with another (i.e., a substrate made from silicon dioxide, silicon nitride or silicon coated with a ceramic oxide with silicon nitride as the base and silicon oxide as the coating), and the results of the substitution (i.e., creating a detection surface) would have been predictable.
Therefore, pursuant to MPEP §2143 (I), Examiner concludes that it would have been obvious to an ordinarily skilled artisan at the time of invention to substitute the substrate is silicon dioxide, silicon nitride or silicon coated with a ceramic oxide of reference Ren with a silicon nitride as the base and silicon oxide as the coating of reference Vogel, since the result would have been predictable.
Claim(s) 16 is/are rejected under 35 U.S.C. 103 as being unpatentable over Ren, Carson and Kuriger in view of United States Patent No. 7,666,360, hereinafter Schellenberger.
Regarding claim 16, Ren, Carson and Kuriger teach all limitations of claim 1; however, they fail to teach the plurality of detection holes are divided into a plurality of groups of detection holes; the plurality of groups of detection holes are arranged in an array; and each of the plurality of groups of detection holes comprises a plurality of detection holes arranged in an array, a separation distance between adjacent two groups of the plurality of groups of detection holes is greater than a separation distance between two adjacent detection holes of the plurality of detection holes in each of the plurality of groups of detection holes.
Schellenberger teaches a detection device which has a plurality of detection holes are divided into a plurality of groups of detection holes (Schellenberger, column 3, lines 1-11); the plurality of groups of detection holes are arranged in an array (Schellenberger, column 3, lines 1-11); and each of the plurality of groups of detection holes comprises a plurality of detection holes arranged in an array (Schellenberger, column 3, lines 1-11), a separation distance between adjacent two groups of the plurality of groups of detection holes is greater than a separation distance between two adjacent detection holes of the plurality of detection holes in each of the plurality of groups of detection holes (Schellenberger, column 3, lines 1-11) so that an operator can more easily identify a particular hole based upon which set, group, row, and column the hole is located in on the testing plate (Schellenberger, column 3, lines 1-11).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have arranged the detection holes as described in the claim because it would allow for an operator to more easily identify a particular hole based upon which set, group, row, and column the hole is located in on the testing plate (Schellenberger, column 3, lines 1-11).
Response to Arguments
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., a rigid substrate + … + covering layer of water-soluble polymer, in the third paragraph of page 8) are not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993).
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
Regarding applicant’s argument of Ren not teaching the detection channel which includes a rigid substrate + adhesive material layer of optically transparent adhesive + hydrophobic material layer of silicon nitride, the examiner agrees with this statement. However, the reference of Carson is being utilized for the teaching of a rigid substrate and Kuriger is being utilized for the teaching of using an optically transparent adhesive.
Regarding applicant’s argument of Carson, Leamon, Vogel, Kuriger and Schellenberger failing to teach rigid substrate + adhesive material layer of optically transparent adhesive + hydrophobic material layer of silicon nitride, the examiner agrees with this statement in that each reference individually fails to teach rigid substrate + adhesive material layer of optically transparent adhesive + hydrophobic material layer of silicon nitride. However, as described above, the combination of references of Ren, Carson and Kuriger teach these limitations.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D KRCHA whose telephone number is (571)270-0386. The examiner can normally be reached M-Th 7am-5pm.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Maris Kessel can be reached at (571)270-7698. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796
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