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 .
DETAILED ACTION
1. The response to the office action filed on January 22, 2026 is acknowledged.
Status of the Application
2. Claims 1, 4-10 are pending under examination. Claims 3-4 were canceled. The Applicant’s arguments and the amendment have been considered and found persuasive for the following reasons. The amendment recites new limitations and to address the new limitations in the claims, a new combination of references is used as follows to address the amendment.
Response to Arguments:
3. The rejection of claims under 35 USC 103 has been withdrawn in view of the amendment.
New Rejections Necessitated by the Amendment
Claim Rejections - 35 USC § 112
4. 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 and 4-10 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 step (c) recites a solution containing a first set of primers and also recites a first non-liquid reagent does not contain any amplification oligomers. The metes and bounds of the claim are unclear and indefinite because it is not clear if the amplification oligomers are referring to primers or any other oligomers other than primers.
Claim Rejections - 35 USC § 103
5. 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.
Claims 1 and 4-10 are rejected under 35 U.S.C. 103 as being unpatentable over Williams et al. (US 2009/0155123) in view of Glezer et al. (US 2012/0178091) and Cracauer et al. (US 2008/0261220).
Williams al. teach a method of claim 1, a method of performing a lab developed test (LDT) for detecting a nucleic acid analyte on an automated analyzer, the method comprising the steps of:
(a) using a computer, selecting one or more user-defined parameters for a protocol for performing the lab developed test on the analyzer, each user-defined parameters of a protocol defining a step to be performed by the analyzer during the lab developed test (para 0037-0052, 0094-0096, 0139);
(b) performing the lab developed test with the protocol of step (a), wherein the analyzer stores one or more system-defined parameters (stored set of parameters) which are combined with the one or more user defined parameters for performing the LDT, the one or more system-developed parameters are installed on the analyzer prior to performing step (a) (para 0038-0052, 0151, 0158-0160);
(c &d) during step (b) dissolving (reconstituting) one or more or first and second non-liquid reagents (lyophilized) comprising a polymerase and nucleotide triphosphates primer and probes for performing diagnostic test (para 0050-0064, 0095-0096, 0166-0174, 0213-0214, 0232-0238).
With reference to claims 4-5, Williams et al. teach that the computer is a personal computer and analyzer is not connected to the computer (para 0038-0040, 0048).
With reference to claim 6, Williams et al. teach that the method further comprises after step (a) and prior to step (b) the steps of exporting the protocol and installing the protocol on the analyzer (para 0139).
With reference to claim 7, Williams et al. teach that the user-defined parameter selected, defined or modified at one or a series of screens displayed on the computer (para 0038-0039).
With reference to claims 8-10, Williams et al. teach that the step (a) comprises selecting a default thermal profile, defining comprises one or more parameters of a thermal profile for performing a thermal cycling reaction, which includes, temperature step, duration of each temperature step and number of thermal cycles for the thermal cycling reaction, wherein the reaction consists or comprises at least two discrete temperature steps (para 0151-0160, 0201).
However, Williams et al. did not specifically teach dissolving the first non-liquid reagent and the second non-liquid reagent with a solvent that does not contain any amplification oligomers (primers) or a primer or polymerase and performing an invitro diagnostic assay defined by a protocol containing only one or more system-defined parameters.
Glezer et al. teach an automated method for nucleic acid amplification using microfluidic device comprising a cartridge, wherein cartridge comprises amplification reagent chambers comprising packs comprising lyophilized first set of PCR reagents and a second set of PCR reagents, each comprising a polymerase, dNTPs and primers and reconstituting said first and second reagents with a solvent that does not comprise any amplification oligomers/primers or a polymerase (para 0090-0097, 0117-0118).
Cracauer et al. teach automated nucleic acid detection assays comprising user selected protocols for specific in-vitro diagnostic assays, wherein the assay uses a protocol containing one or more system defined parameters comprising analyte-specific reagent assays (para 0023-0028, 0031-0035, 1103-1106, 1236-1263).
It would have been prima facie obvious to one of the ordinary people skilled in the art before the effective filling date of the invention to combine the method of Williams et al.
with dissolving or reconstituting amplification reagents in a solvent that does not contain any amplification oligomers/primers or a polymerase as taught by Glezer et al. and in-vitro diagnostic assay using system defined parameters as taught by Cracauer et al. to improve the sensitivity of the automated method for analyzing biological sample. The ordinary person skilled in the art would have motivated to combine the references and have a reasonable expectation of success that the combination would improve the sensitivity of the assays because Glezer et al. explicitly taught reconstituting or dissolving lyophilized or stored amplification reagents with a solvent that does not contain amplification oligomers/primers or a polymerase (para 0090-0097) and Cracauer et al. explicitly taught use automated assays, wherein analyte specific reagent parameters or system-defined parameters were set to validate invitro diagnostic assays (para 1237-1263) and such a modification of the method of Williams et al. with the method as taught by Glezer et al. and Cracauer et al. is considered obvious over the cited prior art.
Conclusion
No claims are allowable.
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 SURYAPRABHA CHUNDURU whose telephone number is (571)272-0783. The examiner can normally be reached 8.00am-4.30pm.
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Suryaprabha Chunduru
Primary Examiner
Art Unit 1681
/SURYAPRABHA CHUNDURU/Primary Examiner, Art Unit 1681
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