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 .
Response to Amendment
The Amendment filed on 1/22/2026 has been entered. Claims 103-119 remain pending in the application.
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) 103-105 and 117 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Patent No. 5,936,527, hereinafter Isaacman.
Regarding claim 103, Isaacman teaches a biological analysis system (intended use MPEP § 2114 (II)) comprising: a housing (column 4, lines 48-53); a sample block (column 4, lines 48-53) disposed within the housing (column 4, lines 48-53) and configured to receive a sample holder comprising a sample holder RFID tag (intended use MPEP § 2114 (II), the drawers or shelves would be capable of receiving a sample holder with RFID tag); a first RFID antenna (one of item 21) configured during use to receive RFID data from the sample holder RFID tag (intended use MPEP § 2114 (II) and is taught in columns 8-9, lines 61-14); and an RFID reader (item 14) configured to receive the RFID data from the first RFID antenna (column 7, lines 25-41); wherein the biological analysis system is configured to determine at least one of (i) a presence of the sample holder within the sample block (intended use MPEP § 2114 (II), the biological analysis system is not interpreted to be a controller or processor and therefore the recitation of being configured to is regarded as the intended use of the biological analysis system, furthermore if an RFID isn’t present in the drawers or shelves then the device would recognize that that the sample holder is not present) or (ii) an orientation of the sample holder within the sample block based on the RFID data received by the first RFID antenna (intended use MPEP § 2114 (II)).
Regarding claim 104, Isaacman teaches further comprising: a second RFID antenna (another of item 21), the second RFID antenna configured during use to receive the RFID data from the sample holder RFID tag (intended use MPEP § 2114 (II) and is taught in columns 8-9, lines 61-14); wherein the RFID reader is configured to receive the RFID data from the second RFID antenna (columns 8-9, lines 61-14 and figure 4).
Regarding claim 105, Isaacman teaches further comprising at least one RFID writer (item 26) configured to write data on the sample holder RFID tag (columns 10-11, lines 61-15).
Regarding claim 117, Isaacman teaches wherein an orientation of the sample holder is based on the strength of the data or signal from the RFID tag (intended use MPEP § 2114 (II)).
Claim(s) 103 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by United States Application Publication No. 2011/0095864, hereinafter Trueeb.
Regarding claim 103, Trueeb teaches a biological analysis system (abstract) comprising: a housing (paragraph [0010]); a sample block (where items 22 are) disposed within the housing (figure 1) and configured to receive a sample holder (item 22) comprising a sample holder RFID tag (item 26); a first RFID antenna (one of item 14.1) configured during use to receive RFID data from the sample holder RFID tag (paragraphs [0039]); and an RFID reader (the reader portion as described in paragraphs [0009] and [0029]) configured to receive the RFID data from the first RFID antenna (paragraphs [0009] and [0029]); wherein the biological analysis system is configured to determine at least one of (i) a presence of the sample holder within the sample block (intended use MPEP § 2114 (II), the biological analysis system is not interpreted to be a controller or processor and therefore the recitation of being configured to is regarded as the intended use of the biological analysis system, furthermore if item 22 isn’t present in the device then the device would recognize that that the sample holder is not present) or (ii) an orientation of the sample holder within the sample block based on the RFID data received by the first RFID antenna (intended use MPEP § 2114 (II) and this limitation is taught as the device would recognize which of two orientations item 22 is inserted into the device).
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.
Claim(s) 104-113 and 117 is/are rejected under 35 U.S.C. 103 as being unpatentable over Trueeb in view of United States Application Publication No. 2003/0174099, hereinafter Bauer.
Regarding claim 104, Trueeb teaches further comprising: a second RFID antenna (on of item 14.2), the second RFID antenna configured during use to receive the RFID data from the sample holder RFID tag (paragraph [0039]).
Trueeb fails to specifically disclose the RFID reader is configured to receive the RFID data from the second RFID antenna.
Bauer teaches a system with multiple antennae which are all connected to a single reader unit so that each group of antennae is connected to a single reader (Bauer, paragraph [0077]) and minimizes the amount of transmission wires (Bauer, paragraph [0009]).
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 each of the RFID antennae connected to one reader because it would allow each group of antennae to connected to a single reader (Bauer, paragraph [0077]) and minimizes the amount of transmission wires (Bauer, paragraph [0009]).
Regarding claim 105, Trueeb teaches further comprising at least one RFID writer (the writer portion as described in paragraphs [0009] and [0029]) configured to write data on the sample holder RFID tag (paragraphs [0009] and [0029]).
Regarding claim 106, Trueeb teaches wherein the system comprises the sample holder (item 22) and the sample holder RFID tag (item 26).
Regarding claim 107, Trueeb teaches wherein: sample holder comprises a plurality of spatially separated reaction locations (paragraph [0038]), each of the plurality of spatially separated reaction locations comprising a plurality of characteristics (intended use MPEP § 2114 (II)); the sample holder RFID tag includes RFID data comprising data for the plurality of characteristics each of the reaction location (paragraph [0030]); wherein the RFID data comprises at least 8 kilobytes, at least 64 kilobytes, or at least 128 kilobytes (paragraph [0008]).
Regarding claim 108, Trueeb teaches wherein the RFID writer is configured to write assay information generated during an assay onto the sample holder RFID tag (paragraphs [0009] and [0029]).
Regarding claim 109, 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 Trueeb and Bauer and the apparatus of modified Trueeb is capable of having the system use the assay information. As such, it is deemed that the claimed apparatus is not differentiated from the apparatus of modified Trueeb (see MPEP §2114).
Regarding claim 110, Trueeb teaches wherein the plurality of characteristics comprises one or more of a: sample holder ID (paragraph [0030]); sample holder expiration date (paragraph [0030]); sample holder part number (paragraph [0030]); sample holder barcode; sample holder lot number (paragraph [0030]); sample holder type (paragraph [0030]); sales order number; EDT file format; EDF file format; or internet links or addresses.
Regarding claim 111, Trueeb teaches wherein the plurality of characteristics comprises one or more of a: storage temperature and/or storage temperature range; sample concentration; sample concentration recommended range; assay name(s) and/or locations on sample holder (paragraph [0030]); assay IDs (paragraph [0030]); suggested protocol or required protocol; sample name (paragraph [0030]); master mix name; master mix change; dye name; suggested or required filter or set of filters to be used during an assay on the sample holder; passive reference dye; reaction volume; target name (paragraph [0030]); dye name; sample name (paragraph [0030]); analysis settings (paragraph [0030]); flag setting; sample type (paragraph [0030]); or target type (paragraph [0030]).
Regarding claim 112, Trueeb teaches wherein the plurality of characteristics comprises one or more of a: run protocol comprising one or more of a heated cover temperature, reaction volume, temperature step value, temperature stage value; or well information for one or more wells, the information including one or more of target name (paragraph [0030]), dye name, or sample name (paragraph [0030]); reagent name (paragraph [0030]).
Regarding claim 113, Trueeb teaches wherein the RFID data on the sample holder RFID include re-writeable data (paragraphs [0008], [0029] and [0030]) comprising one or more of a: passive reference dye; reaction volume; target name (paragraph [0030]); dye name; sample name (paragraph [0030]); analysis settings; flag setting; sample type (paragraph [0030]); target type (paragraph [0030]); run protocol comprising one or more of a heated cover temperature, reaction volume, temperature step value, temperature stage value; or well information for one or more wells, the information including one or more of target name (paragraph [0030]), dye name, or sample name (paragraph [0030]); reagent name (paragraph [0030]).
Regarding claim 117, Trueeb teaches wherein an orientation of the sample holder is based on the strength of the data or signal from the RFID tag (paragraph [0038]).
Response to Arguments
Applicant's arguments filed 1/22/2026 have been fully considered but they are not persuasive.
In response to applicant's argument that Issacman fails to disclose a sample block or a sample holder received within a sample block, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. The claim has not specified the structure of the sample block nor of the sample holder. Therefore any structure which is capable of being a “sample block” or a “sample holder” would read on the instant limitations. The metal filing cabinets are capable of being a “sample block” as samples would be able to be put inside of the metal filing cabinets. Furthermore, the drawers or shelves within the metal filing cabinets would be capable of reading on a sample holder as the drawers or shelves would be capable of holding a sample.
In response to applicant's argument that Isaacman does not determine the presence or orientation of an object relative to a receive structure, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As described above, the biological analysis system is not interpreted to be a controller or processor and therefore the recitation of being configured to is regarded as the intended use of the biological analysis system. Additionally, the device of Isaacman would register if the RFID is present in the device or not and therefore would determine the presence of the sample holder.
Regarding applicant’s argument that Trueeb does not disclose a sample block configured to receive a sample holder is not persuasive. The sample block is considered to be the location within the device where items 22 are placed. Trueeb may not specifically disclose what structure this is, however, there would be some structure there which would support the sample holders as the sample holders are not just floating in space within the device. As there would be some structure present, as shown in figure 1, this structure is considered to be the sample block. The examiner notes that the claims have not specified the structure of the sample block itself and therefore any structure which would hold the sample holder would read on the sample block.
In response to applicant's argument that Trueeb does not determine the presence or orientation within a sample block, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. As described above, the biological analysis system is not interpreted to be a controller or processor and therefore the recitation of being configured to is regarded as the intended use of the biological analysis system. Additionally, the device of Trueeb would register if the RFID is present in the device or not and therefore would determine the presence of the sample holder and would also recognize the orientation of items 22 within the device depending upon which RFID antenna detects the RFID.
In response to applicant's argument that Trueeb does not use RFID data received by an antenna relative to a sample block to make such determinations, a recitation of the intended use of the claimed invention must result in a structural difference between the claimed invention and the prior art in order to patentably distinguish the claimed invention from the prior art. If the prior art structure is capable of performing the intended use, then it meets the claim. Firstly, the examiner notes that the claim is written such that the presence of the sample holder does not need to be determined by the RFID data as the claim can be read that everything following (ii) is part of (ii) and is not part of part (i) and therefore only needs to determine the presence. As described above, the biological analysis system is not interpreted to be a controller or processor and therefore the recitation of being configured to is regarded as the intended use of the biological analysis system. Additionally, the device of Trueeb would register if the RFID is present in the device or not and therefore would determine the presence of the sample holder and would also recognize the orientation of items 22 within the device depending upon which RFID antenna detects the RFID.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
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, 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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/MATTHEW D KRCHA/ Primary Examiner, Art Unit 1796