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
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 of Group III and SEQ ID# 18-19 and 21 in the reply filed on 5/21/26 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)).
Claim Rejections - 35 USC § 112
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 10-13 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.
The claims include analogs. The term is not specifically defined but at para 712, analogs can include substitutions. It is not clear what is included in analogs or substitutions.
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.
Boivin WO2004057021 p 15, l 19 primers and probes lyophilized
Claim(s) 10-13 are rejected under 35 U.S.C. 103 as being unpatentable over Ganzenmueller et al. (Rev. Med. Virol. 2012; 22: 194–208), Boivin (WO2004057021), Nanjing Anpu Precision Medical Test Co Ltd (CN110468234), and Gardner et al. (US20130267429).
For claim 11, Ganzenmueller et al. teach that adenovirus is a problem in post-transplant patients (abstract), that samples are assayed by pcr to detect adenovirus (Figure 1), and that many PCR assays and protocols have been worked out for detecting all hAdV (human adenovirus).
Ganzenmueller et al. does not teach specific sequences or dried components.
For claim 10, Boivin teach PCR primers and probes may be lyophilized (page 15, line 19).
For claims 12-13, Nanjing Anpu Precision Medical Test Co Ltd. teach oligonucleotides that overlap with SEQ ID# 18 (prior art SEQ ID# 22 primer) and prior art SEQ ID#24, a labeled probe, comprises SEQ ID# 19.
Gardner et al. teach adenovirus primer SEQ ID# 20599 that comprises SEQ ID# 21.
One of ordinary skill in the art before the effective time of filing would know that the skill in the art is high as shown by the ability to detect all hAdV by PCR as shown in Ganzenmueller et al. Table 1.
One of ordinary skill in the art before the effective time of filing would motivated to screen for hAdV because it is a problem post-transplant as taught by Ganzenmueller et al. (abstract).
One of ordinary skill in the art before the effective time of filing would have been able to design primers and probes to detect hAdV because it is well known in the art as shown in Ganzenmueller et al. and had the expectation of success knowing that PCR has been used to detect hAdV.
Thus, it would have been prima facie obvious before the effective time of filing to modify the hAdV PCR detection assay of Ganzenmueller et al. with the dried product of Boivin and with modify the sequences of Nanjing Anpu Precision Medical Test Co Ltd. and Gardner et al. with the expectation of success.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MYRON G HILL whose telephone number is (571)272-0901. The examiner can normally be reached on Mon, Tues, Thurs, Fri..
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Michael Allen can be reached on 571-270-3497. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1648
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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