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 . Applicant’s preliminary amendment filed 5/5/2026 is acknowledged. Claims 1-194, 201, 204-205, and 207 have been canceled. Claims 195, 202, 203, and 207 have been amended. Claims 195-200, 202-203, 206-207, 209-212 are pending.
Election/Restrictions
Applicant’s election of Group II, claims 203, 206-207, and 209-212 in the reply filed on 5/5/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)). Accordingly, the claims 195-200 and 202 are withdrawn from consideration as being drawn to a non-elected invention.
Priority
This application is a 371 of PCT/IB2021/000443 filed 06/25/2021 which claims benefit of 63/119,833 filed 12/01/2020 and claims benefit of 63/044,719 filed 06/26/2020.
Information Disclosure Statement
The information disclosure statement (IDS) submitted on 12/18/2025, 7/3/2023, 12/22/2022 are acknowledged. The submissions are in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Drawings
The drawings were received on 12/22/2022. These drawings are found acceptable by the examiner.
Claim Objections
Claims 206, 207, 209, 210, 211 and 212 are objected to because of the following informalities: (a) The claims 206, 207, 209, 210, 211 and 212 should be amended to insert a comma (,) after “203” in line 1. Appropriate correction is required.
Claim Interpretation
The independent claim 203 is directed to a thermocycler system for ultra-fast PCR, the system comprising:(a) a microplate supported by a carriage;(b) a heat block for heating the microplate to an extension temperature;(c) a heat block for heating the microplate to a denaturing temperature; and(d) an optical scanner for tracking the progress of the thermocycling reaction by taking fluorescence measurements, wherein the microplate comprises a metallic material, which on one side is coated with a first polymeric material and affixed with sample containment wells, wherein the metallic material comprises aluminum or an aluminum alloy and the first polymeric material comprises polypropylene, wherein the sample containment wells are formed of a second polymeric material sealed to the first polymeric material, and wherein the carriage is for transferring the microplate rapidly between the heated blocks.
Such limitations as “for ultra-fast PCR”, “for tracking the progress of the thermocycling reaction by taking fluorescence measurements”, and “for transferring the microplate rapidly between the heated blocks” are intended use limitations, for the “thermocycler system”, “the optical scanner” and “the carriage” respectively. MPEP 2114 states "[A]pparatus claims cover what a device is, not what a device does." Hewlett-Packard Co.v.Bausch & Lomb Inc., 909 F.2d 1464, 1469, 15 USPQ2d 1525, 1528 (Fed. Cir. 1990) (emphasis in original). A claim containing a "recitation with respect to the manner in which a claimed apparatus is intended to be employed does not differentiate the claimed apparatus from a prior art apparatus" if the prior art apparatus teaches all the structural limitations of the claim. Ex parte Masham, 2 USPQ2d 1647 (Bd. Pat. App. & Inter. 1987). MPEP states “[F]unctional claim language that is not limited to a specific structure covers all devices that are capable of performing the recited function. Therefore, if the prior art discloses a device that can inherently perform the claimed function, a rejection under 35 U.S.C. 102 and/or 35 U.S.C. 103 may be appropriate. See In re Translogic Technology, Inc., 504 F.3d 1249, 1258, 84 USPQ2d 1929, 1935-1936 (Fed. Cir. 2007). In view of the foregoing, for the purpose of application of prior art, the claims are being given the broadest reasonable interpretation by the examiner.
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.
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) 203, 206-207, 209-212 is/are rejected under 35 U.S.C. 103 as being unpatentable over Camillo et al {Camillo, used interchangeably herein} (US 20160325284, November 2016).
Regarding claim 203, 206-207, 209-212, Camillo teaches a thermocycler system for ultra-fast PCR, the system comprising:(a) a microplate supported by a carriage;(b) a heat block for heating the microplate to an extension temperature;(c) a heat block for heating the microplate to a denaturing temperature; and(d) an optical scanner for tracking the progress of the thermocycling reaction by taking fluorescence measurements, wherein the microplate comprises a metallic material, which on one side is coated with a first polymeric material and affixed with sample containment wells, wherein the metallic material comprises aluminum or an aluminum alloy and the first polymeric material comprises polypropylene, wherein the sample containment wells are formed of a second polymeric material sealed to the first polymeric material, and wherein the carriage is for transferring the microplate rapidly between the heated blocks (see paragraphs [0199] – [0200], [0202] – [0206], [208] – [0209], {0224], [0237], [0240] which teaches the microplate comprising metallic material including polypropylene, [0228] which teaches that the microplate can be adjusted using a drive system, ([0266], and [0273] which teaches a tracking scanner indicia on the bottom of the microplate and performing vision scan (optical scanning) [0312], [0273], [0275], [0282], [0290]-[0291], [0306] which teaches a carriage support for the microplate for movement wherein the carriage assembly moves along conveyer. See para. [0517] – [0521] which teaches that the thermocycler system may comprise at least one or multiple thermocycler blocks to provide temperature cycles.
Camillo teaches LED excitation sources at [0053-[0054]. The reference further teaches imaging and scanning which utilizes photodiodes ([0589]. Camillo teaches wherein the microplate includes a bar code on the side opposite the coated side, the bar code to be scanned by a bar code scanner disposed underneath the microplate ([0266], and [0273] which teaches a tracking scanner on the bottom of the microplate and performing vision scan (optical scanning) [0312]. Camillo teaches wherein the microplate further comprises a layer of an infrared radiation (IR)-normalizing material (para. [0230]). Carmillo teaches further comprising a liquid handling or autopipette platform ([0359], [0370], [0412]). Carmillo discloses in the figure 3 a perspective view of a microplate of the disclosure which depicts the microplate being substantially fat with a top and bottom side (see Figure 2).
Further with regards to the limitation, “wherein the microplate comprises a metallic material, which on one side is coated with a first polymeric material and affixed with sample containment wells, wherein the metallic material comprises aluminum or an aluminum alloy and the first polymeric material comprises polypropylene, wherein the sample containment wells are formed of a second polymeric material sealed to the first polymeric material”, Camillo teaches that the microplate comprises a mixture of thermally conductive material and other materials, such as non-thermally conductive materials or insulators, wherein the non-thermally conductive material, such as a polymer material [0241]. The reference teaches that the microplate can comprise of a mixture of polymers and thermally conductive active materially ([0249] – [0251]). Finally, Camillo also teaches wherein the microplate may comprise of a glass surface having an absorbed layer of a poycationic polymer [0429] thereon.
It would have been prima facie to one of ordinary skill in the art at the time of the effective filing date of the claimed invention to have utilized multiple polymeric material on the microplate in the thermocycler system as discussed by Camillo et al for the obvious benefit of the thermocycler system and components therein being using in reactions requiring elevated temperature, such as in PCR-based assay as discussed by Camillo.
Conclusion
No claims are allowed. Any inquiry concerning this communication or earlier communications from the examiner should be directed to CYNTHIA B WILDER whose telephone number is (571)272-0791. The examiner can normally be reached Flexible.
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/CYNTHIA B WILDER/ Primary Examiner, Art Unit 1681
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