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 .
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 1/27/2026 has been entered.
Applicant’s election of the species of GBP2, GIMAP4 and TLR5 in the reply filed on 11/12/2024 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)).
Claims 56, 58-64, 69-75 are pending. Claims 1-55, 57, 65-68 have been cancelled.
The following rejections are modified with response to arguments following.
This action is NONFINAL.
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) 56-63, 66,69-75 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garrett et al. (WO2006/113529 October 26, 2006) in view of Hossain et al. (US Patent Application Publication 2009/0203534 August 13, 2009)
With regard to claim 56, Garrett et al teaches a composition of cDNA from whole peripheral blood (which has eukocytes) (para 18, 150). Garrett et al. teaches that the cDNA was obtained from a subject with a clinical sign of SIRS (para 239). Garrett et al. teaches that the cDNA includes GBP2 (p. 260). Garrett et al. teaches use of a TaqMan probe to use in RT-PCR (para 202). However, Garrett et al. does not teach a structures with GIMAP4 and TLR5 cDNA. Garrett et al. teaches a DNA polymerase and primers that are capable of hybridizing to opposite complementary strands of cDNA (para 198-199).
With regard to claims 58-61, 69-70, Garrett et al. teaches use of a TaqMan probe to use in RT-PCR (para 202). A TaqMan probe comprises a reporter (fluorescent) and a quencher on the probe.
With regard to claim 62, Garrett et al. teaches different fluorescent makers can be attached to detect different targets (para 202).
With regard to claim 63, Garrett et al. teaches the composition includes a thermostable DNA polymerase (para 199).
However, Garrett does not teach a structures with GIMAP4 and TLR5 cDNA.
With regard to claim 56, 69-70, Hossain et al. teaches in SIR patients (para 5-6) that one should design a composition to detect expression of GBP2, GIMAP4, TLR5 (table 1 and para 122). As such Hossain et al. suggests reasons to detect GBP2, GIMAP4, TLR5.
With regard to claims 71-72, the claims do not limit the claims more that a complex of a target and the probes that are suggested above.
With regard to claims 73-75, the claims are drawn to placing mixtures of these cDNA, primers, probes into different tubes or a single plate. As the Garrett teaches reaction mixtures of PCR, it would be obvious that one can place the reagents in one tube or plate or in separated reaction mixtures. This appears to be routine experimentation to place reaction mixtures together or separately.
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the compositions of Garrett et al. to further include known cDNA structures associated with SIRs in order to design a composition which includes primers and probes for detection of these known genes as taught by Hossain et al. The ordinary artisan would have a reasonable expectation of success as Hossain et al. teaches that these genes are associated with SIRS and therefore it would be reasonable for the ordinary artisan to design compositions that include cDNA from each of these regions from a patient with clinical symptoms of SIRs.
Response to Arguments
The reply traverses the rejection. A summary of the arguments is provided below with response to arguments following.
The reply asserts that Garrett excluded the GIMAP4 and TLR5 from the invention (p. 11). The reply asserts that Hossain is directed to RNA and not to the claimed cDNA (p. 12). The reply asserts that Garrett discloses specific criteria for biomarkers and that GIMAP4 and TLR5 does not encompass this criteria (p 13). The reply asserts that the references does not teach these specific biomarkers from thousands of potential markers (p. 13).
These arguments have been reviewed but have not been found persuasive.
The reply appears to be asserting that one would not select the particular genes as Garrett et al. does not teach that these genes are selected for Garretts expression study. The inclusion of different primers and probes for different known genes is routine in the prior art. The composition does not limit the genes and therefore could even include all the genes in Garrett and Hossain et al. The composition is not limited to only genes that have differential expression. The teaching of Hossain et al. teaches that these genes can be detected in populations that can have some clinical sign of SIRS. This clinical sign could encompass any sign that could be associated with SIRS including a fever. The claims do not require the subject has SIRS. The ordinary artisan would have a reasonable expectation of designing compositions with any of these genes to make an analysis of conditions of the population. The structure of the genes in the composition would be the same structures that are encompassed by the combination of teachings. Although none of the references teach the specific combination of biomarkers, it is obvious absent secondary consideration that one can place any known biomarkers into a solution. Furhtermore the fact that Hossain et al. teaches RNA, does not overcome the obviousness as it is well within the skill of the ordinary artisan to take known targets and detect them with primers and probes as taught by Garrett.
Claim(s) 63 is/are rejected under 35 U.S.C. 103 as being unpatentable over Garrett et al. (WO2006/113529 October 26, 2006) and Hossain (US Patent Application Publication 2009/0203534 August 13, 2009) in view of Claims 56-63, 66,69-75 and in view of Neely et al. (US Patent Application Publication 2013/0244238 September 19, 2013).
Garrett et al teaches a composition of cDNA from whole peripheral blood (which has leukocytes) (para 18, 150). Garrett et al. teaches that the cDNA was obtained from a subject with a clinical sign of SIRS (para 239). Garrett et al. teaches that the cDNA includes GBP2 (p. 260). However, Garrett et al. does not teach a structures with GIMAP4 and TLR5 cDNA. Garrett et al. teaches a DNA polymerase and primers that are capable of hybridizing to opposite complementary strands of cDNA (para 198-199). Garrett et al. teaches use of a TaqMan probe to use in RT-PCR (para 202). A TaqMan probe comprises a reporter (fluorescent) and a quencher on the probe. Garrett et al. teaches the composition includes a thermostable DNA polymerase (para 199). Hossain et al. teaches in SIR patients (para 5-6) that one should design a composition to detect expression of GBP2, GIMAP4, TLR5 (table 1 and para 122). As such Hossain et al. suggests reasons to detect GBP2, GIMAP4, TLR5.
However, Garrett et al. and Hossain et al. does not teach that the thermostable DNA polymerase is Taq polymerase.
With regard to claim 64, Neely teaches that a composition that comprises cDNA that used in a TaqMan based RT-PCR includes Taq polymerase (para 353).
Therefore it would be prima facie obvious to one of ordinary skill in the art at the time of the effective filing date to modify the thermostable DNA polymerase in the composition of Garrett et al and Hossain et al. to use on of the finite number of thermostable DNA polymerase such as the taq polymerase taught by Neely to design a composition that would be capable of using in a RT PCR.
Response to Arguments
The reply does not present any other argument for the combination with Neely other than the arguments presented above in the reply.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to KATHERINE D SALMON whose telephone number is (571)272-3316. The examiner can normally be reached 9-530.
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/KATHERINE D SALMON/Primary Examiner, Art Unit 1682
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