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 .
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.
Claim 1 is rejected under 35 U.S.C. 103 as being unpatentable over Zhu, J. et al. (Virol J 10, 91 (2013)), Chen et al. (Journal of Virological Methods Volume 173, Issue 1, April 2011, Pages 7-12), Olmo et al. (20100196878), and TRANSLATION OF SEQ ID# 1.
Zhu, J. et al. teach that rotavirus is the causative agent of diarrhea and that VP6 is the major diagnostic antigen (Background).
Zhu, J. et al. teach that VP6 can be expressed from nucleic acid and then coated on plates to detect antibody (Figure 5).
The figure also shows that the antibody is tittered to optimized as well as determine background.
The VP6 used is from Group 1 (Cloning and phylogeny of VP6 gene of PRV).
The time of coating is overnight a sample dilution buffer, and a chromogenic substrate (Immunoreactivity of the anti-VP6 antibody to other control viruses).
Zhu, J. et al. does not teach 350ng/well of coating plate with VP6, stop solution, or sow milk or specific values for controls or sequence of SEQ ID# 1.
Chen et al. teach wash and stop solution (2.9. Blocking ELISA).
Zhu, J. et al. and Chen et al. do not teach the translation of SEQ ID# 1.
TRANSLATION OF SEQ ID# 1 results in the sequence shown in TRANSLATION OF SEQ ID# 1.
One of ordinary skill in the art would be able to choose from other known sequences to use in the assay with the expectation of success knowing that it is an exchange of porcine rotavirus VP6 proteins.
The value of 350ng/well of coating plate with VP6 can be determined by routine experimentation.
One of ordinary skill in the art before the effective date of filing would have been able to optimize the protein in the assay as optimization and testing of ranges and cut off values is routine in the art, see, Zhu, J. et al. Figures 5 and 8 and Chen et al. Figures 2 and 4.
One of ordinary skill in the art before the effective date of filing would have been motivated to detect antibodies to porcine rotavirus VP6 because it is the causative agent of disease and use the VP6 because it is the diagnostic marker for infection as taught by Zhu, J. et al.
Thus, it would have been prima facie obvious before the effective date of filing to modify the assay of Zhu, J. et al. with the elements taught by Chen et al. detect antibodies to porcine rotavirus VP6 using an art known sequence to make the VP6 knowing the ELISA assay is routinely used and optimized for each set of antigen/antibody and have the expectation of success knowing the elements have been used in the art.
Applicant argues Zhu teach coating with virus at a different concentration per well, Chen is drawn to a different virus, neither teach sow milk, neither teach the rigorous dements for sow milk testing, that there is no motivation to combine or expectation of success, the amino acid is different than SEQ ID# 1, and argues the limitations are not met.
Applicant’s arguments have been fully considered and not found persuasive.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986).
In response to applicant’s argument that there is no teaching, suggestion, or motivation to combine the references, the examiner recognizes that obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art. See In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the level of skill in the art is high and optimization is routine as pointed out in the rejection.
Zhu et al. do teach coating plate with VP6 (Figure 5). A reference is added for sow milk (all milk is sow milk) because the limitation was changed from milk or serum to sow milk. Applicant does not point out any difference in the sequence and the SEQ# 1 is a nucleic acid and cannot be used in the assay as protein. The claims require the protein encoded by SEQ # 1, not SEQ ID# 1.
Applicant’s do not point to difficulties or unexpected results in using sow milk, or 350 ng/well. The arguments of counsel cannot take the place of evidence in the record. In re Schulz, 145 USPQ 716, 718 (CCPA 1965); In re Geisler, 43 USPQ2d 1362 (Fed. Cir. 1997) (“An assertion of what seems to follow from common experience is just attorney argument and not the kind of factual evidence that is required to rebut a prima facie case of obviousness.”).
Conclusion
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.
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MYRON G. HILL
Examiner
Art Unit 1671
/M.G.H/Examiner, Art Unit 1671
/Shanon A. Foley/Primary Examiner, Art Unit 1671
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