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 .
Priority
Applicant’s claim to priority from PCT/US2019/048361 filed 08/27/2019 and Provisional application No. 62/723,233 filed 08/27/2018 is hereby acknowledged. This application is a National Stage entry under 35 U.S.C. § 371 of PCT/US2019/048361.
Application status
Amendments to claims filed 04/07/2026 are hereby acknowledged. Claims 2-7 and 9 are cancelled. Claims 10-14,16-20 are withdrawn Therefore, claims 1, 8 and 15 are under consideration in this office action.
Any objection or rejection not reiterated herein has been overcome by amendments and is therefore withdrawn.
Applicant’s amendments and arguments have been thoroughly reviewed, but are not persuasive to place the claims in condition for allowance for the reasons that follows.
The following rejections are maintained from Office Action dated 01/07/2026, but are modified as necessitated by Applicant’s amendments:
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.
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 non-obviousness.
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.
Claims 1, 8 and 15 are rejected under 35 U.S.C. § 103 as being
unpatentable over Pantelic (Pantelic, L. et al. Journal of Virology, Vol. 79, No.3 (Feb., 2005), pp:1753-1764; previously cited) in view of Mascarenhas (Mascarenhas, J.X. et al. Biotechnology and Bioengineering, Vol.114, No.3 (Mar., 2017), pp:576-588; previously cited), Adamson (Adamson, S.R. Dev. Biol. Stand. Basel, Karger, Vol. 93 (1998), pp: 89-96; previously cited), Huang (Huang, C.C. et al. "A pathway analysis of poly(I:C)-induced global gene expression change in human peripheral blood mononuclear cells". Physiol. Genomics, Vol. 26 (2006), pp: 125–133; previously cited) and Choi (Choi, S.S. et al. Hepatology, Vol. 54 (2011), pp: 1580-1590; previously cited).
Regarding claims 1 and 15, Pantelic teaches "[D]ifferential induction of
antiviral effects against West Nile Virus in primary mouse macrophages ( ... ) by alpha/beta Interferon (IFN) and Poly (I-C)" (see title). Pantelic teaches effective pretreatment with Interferon alpha/beta inhibiting West Nile virus replication in primary macrophages from mice (see page 1755, right column, "Results" section, line 41). Pantelic also teaches the effect of Poly (I-C) on West Nile virus replication in primary macrophages (see page 1758, first column (left), line 6). Therefore, Pantelic teaches a method of inhibiting viral infection, administering IFN and poly (I-C) to the sample in an amount effective at decreasing the virus titer.
Pantelic does not teach CHO cells. Pantelic does not teach a biopharmaceutical process. Pantelic does not teach that Poly I:C is effective to suppress expression of Gfi1 in the CHO cells and activate expression of STAT1 in the CHO cells.
However, Adamson teaches that CHO cells are being used for biopharmaceutical process and that CHO cells can be infected by virus in spite of resistance to some retroviruses (see page 89-90, "[l]ntroduction" section).
Mascarenhas teaches a method of improving viral resistance to Minute Virus of
Mice in CHO cells. On page 578, second column (right), lines 22-24, Mascarenhas
discloses "[T]he Cosmc and Mgat1 knockouts also show significant inhibition of infection likely due to their effect on decreasing cell surface sialic acid." Therefore, Mascarenhas
teaches a different method of inhibiting viral infection in CHO cells. Mascarenhas uses
gene editing ( see page 579, first column (left) "ZFN-Mediated or CRISPR-Cas9 Gene
editing" section) to inhibit mouse minute virus adventitious contamination in CHO cells,
targeting specifically genes involved in sialic acid metabolism, since sialic acid is an
important part of cell surface receptor modification for virus entry. Mascarenhas uses
multiple compounds included in a CRISPR-Cas gene editing system, i.e. using a gRNA to specifically target genes of interest in glycosylation pathways in CHO cells. The
compounds elicit viral resistance by compromising virus entry into CHO cells.
Huang teaches that Poly I:C is capable of inducing STAT1 expression by a factor of 5.38 after 3hours stimulation of Peripheral blood mononuclear cells (PBMCs) and by a factor of 3.74 after 24hours (see Table 3). Therefore, Huang teaches that STAT1 is an early-to-late response genes to poly I:C stimulation.
Choi teaches a cell line that is not permissive to HCV viral infection, Huh7 cell line, in which Gli1 expression is suppressed, and compares to a cell line, Huh7.5 cell line, that is permissive to HCV viral infection, in which Gli1 expression is 30 times higher (see figure 1D). Choi teaches that using an antagonist of Hedgehog (Hh) pathway, cyclopamine, reduced HCV RNA and protein levels, as well as Gli1 expression level (see figure 2). Therefore, Choi teaches a compound that prevents, and inhibits viral infection that also suppresses Gli1 expression.
Therefore, it would be obvious to one with ordinary skills in the art, before the effective filing date of the claimed invention to have substituted the cell line in the method of inhibiting viral infection taught by Pantelic with CHO cells taught by Mascarenhas, as both disclosures are drawn to methods of inhibiting or preventing viral infections in cells. It would have been obvious to one with ordinary skill in the art before the effective filing date of the claimed invention to have combined the teachings of Pantelic, Adamson, Mascarenhas, Huang and Choi, and have treated the CHO cells with Poly I:C as taught by Pantelic and Huang to activate innate immune response. Treating the CHO cells with Poly I:C would increase the level of antiviral genes expressed in the cells, such as STAT1, as taught by Huang, and inhibit Gli1 expression correlated with viral infections as taught by Choi.
One with ordinary skills in the art could have performed this modification to inhibit or prevent adventitious viral infections in an industrial setting, with a reasonable expectation of success and arrived at the claimed invention.
Regarding claim 8, drawn to “the method of claim 1 wherein the virus is VSV,
EMCV REO, an RNA virus, or a DNA virus”, Pantelic teaches not only West Nile virus
inhibition, but also EMCV inhibition; See page 1754, second column (right), line 10, "[V]iruses" section. West Nile virus belonging to the Flaviridae family and Flavivirus
genus, is an RNA virus; see page 1753, first column (left), lines 1-6. EMCV (Encephalomyocarditis virus) is a picornavirus, also an RNA virus; see page 1762, first
column (left), "[D]iscussion" section, lines 9-14.
Response to Arguments
Applicant's arguments filed 04/07/2026 have been fully considered but they are not persuasive.
Applicant argues on page 7 of Remarks, in section III “Claim rejections under 35 U.S.C.§ 103”, page 5 of Remarks filed 04/07/2026, that “The teachings of Pantelic, Mascarenhas, Adamson, Huang and Choi therefore cannot be said to support a prima facie case of obviousness, at least because the references—even when taken together—do not actually disclose or suggest a method according to Applicant’s claims.”
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).
Applicant also argues on page 8 of Remarks, that “However, this is an incredibly broad overreaching of the teachings of the cited art and is a conclusion that is necessarily based on hindsight gleaned from Applicant’s disclosure rather than the teachings of the art itself”.
In response to applicant's argument that the examiner's conclusion of obviousness is based upon improper hindsight reasoning, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).
Applicant is claiming a method that is a cell culture system known in the art, a cell line isolated by others and routinely used in the art, with the use of molecules that are known in the art, having as an end-result an effect on genes’ expression, said genes being known, having been isolated by others in the art. The method as claimed is a combination of known molecules and known techniques, to trigger a known immune response, to combat adventitious viral infections known in the art. After Examiner’s searches, it is clear that the claims are not patentable since Applicant is simply highlighting newly found properties/end-results to a system that is largely known, with materials that are routinely used in the art.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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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/A.D./Examiner, Art Unit 1636
/NANCY J LEITH/Primary Examiner, Art Unit 1636
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