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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 12/18/2025 has been entered.
Response to Amendment
The Amendment filed on 12/18/2025 has been entered. Claims 1-10 and 27-46 remain pending in the application.
Information Disclosure Statement
The information disclosure statement filed 1/8/2026, specifically the reference TW 201830891 fails to comply with 37 CFR 1.98(a)(2), which requires a legible copy of each cited foreign patent document; each non-patent literature publication or that portion which caused it to be listed; and all other information or that portion which caused it to be listed. It has been placed in the application file, but the information referred to therein has not been considered. The examiner notes that only the abstract has been provided and not the document itself.
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 1-10 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 “each linear fiducial comprises five or fewer rows of sample sites,” however, this limitation does not have support in the specification as filed. The specification discusses having three or more rows of sample sites and five rows of sample sites in paragraph [00114]. However, the specification does not disclose having less than three rows of sample sites (which also includes zero rows of sample sites). Therefore, the limitation that each linear fiducial comprises five or fewer rows (which includes zero, one or two rows) does not have support.
Claims 31-38 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 31 recites “each linear fiducial comprises five or fewer rows of sample sites,” however, this limitation does not have support in the specification as filed. The specification discusses having three or more rows of sample sites and five rows of sample sites in paragraph [00114]. However, the specification does not disclose having less than three rows of sample sites (which also includes zero rows of sample sites). Therefore, the limitation that each linear fiducial comprises five or fewer rows (which includes zero, one or two rows) does not have support.
Claims 39-46 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 39 recites “each linear fiducial comprises five or fewer rows of sample sites,” however, this limitation does not have support in the specification as filed. The specification discusses having three or more rows of sample sites and five rows of sample sites in paragraph [00114]. However, the specification does not disclose having less than three rows of sample sites (which also includes zero rows of sample sites). Therefore, the limitation that each linear fiducial comprises five or fewer rows (which includes zero, one or two rows) does not have support.
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 1-10 and 31-46 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.
Claim 1 recites that “each linear fiducial comprises five or fewer rows of sample sites,” however this limitation is unclear as this limitation would also include zero rows of sample sites. If there are zero rows of sample sites, it is unclear what would be defining each linear fiducial thereby rendering the claim as unclear. Claims 9-10 are rejected by virtue of their dependence on a rejected base claim.
Claim 31 recites that “each linear fiducial comprises five or fewer rows of sample sites,” however this limitation is unclear as this limitation would also include zero rows of sample sites. If there are zero rows of sample sites, it is unclear what would be defining each linear fiducial thereby rendering the claim as unclear. Claims 32-38 are rejected by virtue of their dependence on a rejected base claim.
Claim 39 recites that “each linear fiducial comprises five or fewer rows of sample sites,” however this limitation is unclear as this limitation would also include zero rows of sample sites. If there are zero rows of sample sites, it is unclear what would be defining each linear fiducial thereby rendering the claim as unclear. Claims 40-46 are rejected by virtue of their dependence on a rejected base claim.
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.
Claim(s) 1-10, 31-37 and 39-46 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2018/0260940, hereinafter Langlois.
Regarding claim 1, Langlois teaches a patterned flow cell (item 500), comprising: a substrate (item 500); a plurality of sample sites in a non-fiducial region of the substrate (paragraph [0050] and figure 7), wherein the plurality of sample sites are arranged in a periodic pattern (figure 7); a plurality of coarse-alignment fiducials (item 510) formed on the substrate separate from the plurality of sample sites (figure 7); and a plurality of linear fiducials formed on the substrate (figure 7, the first five full horizontal rows of sample sites to the bottom of each of item 510), wherein each linear fiducial comprises five or fewer rows (figure 7, the first five full horizontal rows of sample sites to the bottom of each of item 510) of sample sites and blanks arranged in accordance with the periodic pattern (intended use MPEP § 2114 (II), as disclosed in the following phrase of the claim a blank can be where an empty site is located, the filling or not filling of the sample sites is regarded as the intended use of the sample sites as the user could fill or not fill any sample site and therefore some of the sample sites could be filled and some left empty to form a blank (empty site) thereby forming the linear fiducials), wherein each blank corresponds to a location in the periodic pattern where a sample site should be located but is not (optional) or where an empty sample site is located (see supra) and wherein the five or fewer rows together form a respective linear fiducial that is optically discernable from the periodic pattern associated with the non-fiducial region (intended use MPEP § 2114 (II) and the empty and filled sample sites would be optically discernable from the periodic pattern).
Regarding claim 2, Langlois teaches wherein the periodic pattern comprises a hexagonal or a rectilinear pattern (figure 7, the pattern is hexagonal and paragraph [0050]).
Regarding claim 3, Langlois teaches wherein the coarse-alignment fiducials comprise bullseye patterns (figure 7 and paragraph [0078]).
Regarding claim 4, Langlois teaches wherein a subset of the plurality of linear fiducials are formed on the substrate between pairs of coarse-alignment fiducials (the first five full horizontal rows of sample sites below the middle two of item 510, figure 7).
Regarding claim 5, Langlois teaches wherein the plurality of coarse-alignment fiducials are in a vertically offset pattern with respect to the plurality of linear fiducials (the first five full horizontal rows of sample sites are in a vertical offset pattern with respect to the plurality of linear fiducials, figure 7).
Regarding claim 6, Langlois teaches wherein the linear fiducials of the plurality of linear fiducials are formed in an x-dimension (figure 7, the first five full horizontal rows of sample sites to the bottom of each of item 510) corresponding to a direction in which rows of pixels are scanned when imaging the patterned flow cell (intended use MPEP § 2114 (II), the imagining is the intended use of the apparatus and the imagining is capable of occurring in the direction specified).
Regarding claim 7, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Langlois and the apparatus of Langlois is capable of having each row of each linear fiducial comprise one or more blanks (empty sample sites). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Langlois (see MPEP §2114).
Regarding claim 8, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Langlois and the apparatus of Langlois is capable of having each linear fiducial comprise one or more rows with no blanks flanked by rows with one or more blanks (empty sample sites). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Langlois (see MPEP §2114).
Regarding claim 9, Langlois teaches wherein each linear fiducial comprises three, four, or five rows of the periodic pattern (figure 7, the first five full horizontal rows of sample sites to the bottom of each of item 510).
Regarding claim 10, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Langlois and the apparatus of Langlois is capable of each linear fiducial comprise one or more rows comprising an alternating pattern of sample sites and blanks (empty sample sites). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Langlois (see MPEP §2114).
Regarding claim 31, Langlois teaches a patterned flow cell (item 500), comprising: a substrate (item 500); a plurality of sample sites in a non-fiducial region of the substrate (paragraph [0050] and figure 7), wherein the plurality of sample sites are arranged in a periodic pattern (figure 7); a plurality of coarse-alignment fiducials (item 510) formed on the substrate separate from the plurality of sample sites (figure 7); and a plurality of linear fiducials formed on the substrate (paragraph [0050] and figure 7, five of the rows from the top of item 510 as shown in figure 7), wherein each linear fiducial comprises five or fewer rows of sample sites and blanks (paragraph [0050] and figure 7, five of the rows from the top of item 510 as shown in figure 7 which has missing wells) arranged in accordance with the periodic pattern (figure 7), wherein each blank corresponds to a location in the periodic pattern where a sample site should be located but is not (paragraph [0050] and figure 7, there are missing wells where item 510 is) and wherein the five or fewer rows together form a respective linear fiducial that is optically discernable from the period pattern associated with the non-fiducial region (intended use MPEP § 2114 (II) and the missing wells and sample wells would be optically discernable from the periodic pattern).
The examiner notes that each group of five rows of sample sites within/around item 510 is considered to be a separate linear fiducial.
Regarding claim 32, Langlois teaches wherein the periodic pattern comprises a hexagonal or a rectilinear pattern (figure 7, the pattern is hexagonal and paragraph [0050]).
Regarding claim 33, Langlois teaches wherein the coarse-alignment fiducials comprise bullseye patterns (figure 7 and paragraph [0078]).
Regarding claim 34, Langlois teaches wherein each linear fiducial comprises three, four, or five rows of the periodic pattern (five of the rows from the top of item 510 as shown in figure 7).
Regarding claim 35, Langlois teaches wherein each row of each linear fiducial comprises one or more blanks (paragraph [0050] and figure 7, there are missing wells in the five of the rows from the top of item 510).
Regarding claim 36, Langlois teaches wherein each linear fiducial comprises one or more rows with no blanks each flanked by rows with one or more blanks (figure 7, the portion of the wells within item 510 is considered to be the whole row and between the largest and second largest ring, there are three row and the middle row is considered to have to missing sites and the one above has missing sites and the end and the bottom row has missing sites in the middle of the row).
Regarding claim 37, Langlois teaches wherein each linear fiducial comprises one or more rows comprising an alternating pattern of sample sites and blanks (figure 7, there is an alternating pattern of missing wells in the five of the rows from the top of item 510).
Regarding claim 39, Langlois teaches a patterned flow cell (item 500), comprising: a substrate (item 500); a plurality of sample sites in a non-fiducial region of the substrate (paragraph [0050] and figure 7), wherein the plurality of sample sites are arranged in a periodic pattern (figure 7); a plurality of coarse-alignment fiducials (item 510) formed on the substrate separate from the plurality of sample sites (figure 7); and a plurality of linear fiducials formed on the substrate (figure 7, the first five full horizontal rows of sample sites to the bottom of each of item 510), wherein each linear fiducial comprises five or fewer rows (figure 7, the first five full horizontal rows of sample sites to the bottom of each of item 510) of sample sites and blanks arranged in accordance with the periodic pattern (intended use MPEP § 2114 (II), as disclosed in the following phrase of the claim a blank can be where an empty site is located, the filling or not filling of the sample sites is regarded as the intended use of the sample sites as the user could fill or not fill any sample site and therefore some of the sample sites could be filled and some left empty to form a blank (empty site) thereby forming the linear fiducials), wherein each blank corresponds to a location in the periodic pattern where an empty sample site is located (see supra) and wherein the five or fewer rows together form a respective linear fiducial that is optically discernable from the periodic pattern associated with the non-fiducial region (intended use MPEP § 2114 (II) and the empty and filled sample sites would be optically discernable from the periodic pattern).
Regarding claim 40, Langlois teaches wherein the periodic pattern comprises a hexagonal or a rectilinear pattern (figure 7, the pattern is hexagonal and paragraph [0050]).
Regarding claim 41, Langlois teaches wherein the coarse-alignment fiducials comprise bullseye patterns (figure 7 and paragraph [0078]).
Regarding claim 42, Langlois teaches wherein each linear fiducial comprises three, four, or five rows of the periodic pattern (figure 7, the first five full horizontal rows of sample sites to the bottom of each of item 510).
Regarding claim 43, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Langlois and the apparatus of Langlois is capable of having each row of each linear fiducial comprise one or more blanks (empty sample sites). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Langlois (see MPEP §2114).
Regarding claim 44, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Langlois and the apparatus of Langlois is capable of having each linear fiducial comprise one or more rows with no blanks flanked by rows with one or more blanks (empty sample sites). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Langlois (see MPEP §2114).
Regarding claim 45, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Langlois and the apparatus of Langlois is capable of each linear fiducial comprise one or more rows comprising an alternating pattern of sample sites and blanks (empty sample sites). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Langlois (see MPEP §2114).
Regarding claim 46, these limitations are directed to the function of the apparatus and/or the manner of operating the apparatus, all the structural limitations of the claim has been disclosed by Langlois and the apparatus of Langlois is capable of each linear fiducial comprise a center row comprising an alternating pattern of sample wells and blanks and a pair of flanking rows comprising all blanks (empty sample sites). As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of Langlois (see MPEP §2114).
Response to Arguments
Applicant's arguments filed 12/18/2025 have been fully considered but they are not persuasive.
The examiner notes that the rejections above have been modified such that each linear fiducial has five or fewer rows of sample sites and blanks.
Regarding applicant’s argument that the Examiner stated that the missing wells where item 510 is the intended use of the claimed device. The examiner is not stating that the missing wells are the intended use of the claimed device, but rather when the blanks are empty sample sites are the intended use of the sample sites. While using the device, a person would be able to not fill certain sample sites in rows and arrive at the claimed invention. The filling or not filling of the wells is considered to be the intended use of the device and sample wells and therefore, as long as the sample wells are capable of being filled or not filled in accordance with the claim, the prior art would read on the instant claims.
Regarding applicant’s argument that Langlois does not contemplate having five or fewer rows of sample sites and blanks forming the linear fiducial is not found persuasive. The rejection has been modified above, such that the linear fiducials are now being considered as five rows of sample sites and thereby reading on the instant claims. The claim has not limited the number of linear fiducials and therefore there can be multiple linear fiducials where each linear fiducial comprises five or less rows of sample sites.
Regarding applicant’s argument that the linear fiducials are not vertically offset with respect to the course alignment fiducials is not found persuasive. The linear fiducials are considered to be the first five full horizontal rows of sample sites to the bottom of each of item 510 and as these are closer to the course alignment fiducials on one side compared to the other, the linear fiducials are considered to be vertically offset with the course alignment fiducials.
Regarding applicant’s argument of claim 46, as discussed above, the filling or not filling of the sample wells is considered to be the intended use of the sample wells. The sample wells could be filled in accordance to the claim and therefore renders the claim as anticipated.
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.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
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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