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 with traverse of Group I in the reply filed on 6/22/2026 is acknowledged. The traversal is on the ground(s) that Mayerich fails to disclosed a liquid shaping tool arranged to distribute the liquid comprising a reagent to a substantially uniform liquid layer of a desired thickness while the sample holder rotates, to provide the liquid layer to cover an outer circumference of the matrix layer and therefore is not a special technical feature. This is not found persuasive because the claim does not specify that the liquid layer covers an entirety of the outer circumference of the matrix layer and therefore as long as the liquid layer cover a portion of the outer circumference, then the prior art would teach this limitation. As can be seen in figure 2A of Mayerich, item 65 covers at least a portion of the outer circumference, thereby reading on this limitation. Additionally, as the sample is rotated item 55 would distribute the liquid to a substantially uniform liquid layer.
The requirement is still deemed proper and is therefore made FINAL.
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) 9 and 13-19 is/are rejected under 35 U.S.C. 103 as being unpatentable over WO 2018/160629, hereinafter Mayerich in view of United States Application Publication No. 2020/0131502, hereinafter Norberg.
Regarding claim 9, Mayerich teaches a method for performing an assay of a plurality of concatemers (figure 2A), comprising: providing a matrix layer (item 15) at least partly covering an outer surface of a rotatable body (support core), wherein the plurality of samples (item 10) are distributed in the matrix layer in both a lateral direction and a thickness direction of the matrix layer (figure 2A); rotating the rotatable body around an axis (item 20); providing, using a liquid dispenser, a liquid (item 65) to the matrix layer on the rotatable body (claim 10); distributing the liquid, using a liquid layer shaping tool (item 55), to a liquid layer that is substantially uniform and of a desired thickness covering an outer circumference of the matrix layer, while the rotatable body rotates (item 55 distributes a substantially uniform and of a desired thickness partially covering an outer circumference of the matrix layer, figure 2A), and performing at least a part of the assay of the plurality of concatemers while rotating the rotatable body (paragraphs [0038]-[0041]).
Mayerich fails to teach providing the plurality of concatemers in a matrix layer at least partly covering an outer surface of a rotatable body.
Norberg teaches a method for DNA processing in which long concatemers contain multiple copies of starting molecules increased sensitivity of the assay, and were retained inside the polymer beads (Norberg, paragraph [0114]).
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 concatemers in the matrix layer because long concatemers contain multiple copies of starting molecules thereby increasing sensitivity of the assay (Norberg, paragraph [0114]).
Mayerich and Norberg fail to specifically teach the matrix layer is less than 100 µm thick.
Mayerick teaches using a microtome blade to ablate the surface during rotation to allow imaging of subsequent layers of the sample (abstract).
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 thickness of the matrix layer to a range of less than 100 µm thick which would allow for the all of the layers of the sample to be analyzed (the last layer would be less than 100 um thick) (MPEP § 2144.05 (II)).
Regarding claim 13, Mayerich teaches performing the assay comprises adding a reagent to the liquid layer (paragraph [0033])
Regarding claim 14, Mayerich teaches a reagent is selected based on the at least one assay parameter and added to the liquid layer (paragraphs [0033] and [0061]).
Regarding claim 15, Mayerich teaches the reagent comprises a fluorophore (paragraph [0033]).
Regarding claims 16 and 17, modified Mayerich teaches all limitations of claim 9; however, modified Mayerich fails to teach providing the plurality of concatemers comprises distributing a plurality of circularized DNA fragments in the matrix layer and amplifying the plurality of circularized DNA fragments to form the concatemers and amplifying the plurality of circularized DNA fragments is performed by means of rolling circle amplification, RCA.
Norberg further teaches providing the plurality of concatemers comprises distributing a plurality of circularized DNA fragments in the matrix layer and amplifying the plurality of circularized DNA fragments to form the concatemers (Norberg, paragraph [0114]) and amplifying the plurality of circularized DNA fragments is performed by means of rolling circle amplification, RCA (Norberg, paragraph [0114]) as it would increase the size of transposon ends (Norberg, paragraph [0093]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have distributing a plurality of circularized DNA fragments in the matrix layer and amplifying the plurality of circularized DNA fragments to form the concatemers (Norberg, paragraph [0114]) and amplifying the plurality of circularized DNA fragments is performed by means of rolling circle amplification, RCA because it would increase the size of transposon ends (Norberg, paragraph [0093]).
Regarding claim 18, modified Mayerich teaches each concatemer comprises at least one DNA strand (see supra).
Modified Mayerich fails to teach the method further comprises attaching a nucleoside triphosphate containing deoxyribose, dNTP, to the at least one DNA strand, and wherein the dNTP comprises a fluorescent label.
Norberg further teaches the use of deoxynucleotide triphosphates (Norberg, paragraph [0090]) and a fluorescent label (Norberg, paragraph [0053]).
Examiner further finds that the prior art included each element claimed (as set forth above), although not necessarily in a single prior art reference, with the only difference between the claimed invention and the prior art being the lack of actual combination of the elements within a single reference. Moreover, an ordinarily skilled artisan could have combined the elements as claimed by known methods (e.g., using deoxynucleotide triphosphates and a fluorescent label), and that in combination, each element merely would have performed the same function as it did separately (i.e., DNA amplification), and an ordinarily skilled artisan would have recognized that the results of the combination were 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 combine the method of reference Mayerich with deoxynucleotide triphosphates and a fluorescent label of reference Norberg, since the result would have been predictable.
Regarding claim 19, Mayerich teaches the assay further comprises confocal microscopy imaging (paragraph [0025]).
Claim(s) 10-12 is/are rejected under 35 U.S.C. 103 as being unpatentable over Mayerich and Norberg as applied to claim 9 above, and further in view of United States Application Publication No. 2014/0273194, hereinafter Handique.
Regarding claim 10, Mayerich and Norberg teach all limitations of claim 9; however, they fail to teach the rotatable body comprises an identifier carrying information associated with an identity of the rotatable body, the method further comprising: reading the identifier to retrieve the identity of the rotatable body; retrieving at least one assay parameter associated with the identity; and adjusting the assay in accordance with the retrieved at least one assay parameter.
Handique teaches a substrate which comprises an identifier carrying information associated with an identity of the support (Handique, paragraph [0047]), the method further comprising: reading the identifier to retrieve the identity of the rotatable body (Handique, paragraph [0047]); retrieving at least one assay parameter associated with the identity (Handique, paragraph [0047]); and adjusting the assay in accordance with the retrieved at least one assay parameter (Handique, paragraph [0048]) so that the system is able to identify the substrate and use the appropriate protocol for the device (Handique, paragraph [0048]).
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 an identifier carrying information and to read the identifier carrying information, retrieve an assay parameter and adjust the assay because it would allow the system is able to identify the substrate and use the appropriate protocol for the device (Handique, paragraph [0048]).
Regarding claim 11, modified Mayerich teaches performing said at least a part of the assay comprises scanning the rotatable body along the axis, and wherein a range of the scanning is determined by the at least one assay parameter (see supra).
Regarding claim 12, modified Mayerich, as described above, teaches all limitations of claim 10; however, modified Mayerich, as described above, fails to teach performing said at least a part of the assay comprises controlling a temperature, and wherein a setpoint of the temperature is determined by the at least one assay parameter.
Handique further teaches a thermal control module which controls the heat and/or cooling aspects of the system to facilitate imaging and analysis of target objects (Handique, paragraph [0049]).
It would have been obvious to one having ordinary skill in the art before the effective filing date of the claimed invention to have said at least a part of the assay comprises controlling a temperature, and wherein a setpoint of the temperature is determined by the at least one assay parameter because it would facilitate imaging and analysis of target objects (Handique, paragraph [0049]).
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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