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 .
Status of Application/Amendment/Claims
This Office action is in response to the communications filed on December 15, 2025.
Currently, claims 1, 3-17, 19-20, and 24-25 are pending and under examination on the merits in the instant application.
The following rejections are either newly applied or are reiterated and are the only rejections and/or objections presently applied to the instant application.
Response to Arguments and Amendments
Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.
Maintained Rejections
Claim Rejections - 35 USC § 112
Claims 11-13 remain rejected under 35 U.S.C. 112(a) as failing to comply with the written description requirement for the reasons as set forth in the Office action mailed on September 16, 2025 and for the reasons set forth below.
Applicant's arguments filed on December 15, 2025 have been fully considered but they are not persuasive. Applicant argues that page 16 and Figure 4 of the instant application provide support for sugar and fatty acid moieties being functional molecules for the claimed immune competent cells. Contrary to applicant’s argument, Figure 4 of the instant application at best illustrates mannose and GalNAc conjugates as being sugar moieties. However, there is no adequate written description support that the genus of sugar/fatty acid moieties or the species of mannose and GalNAc are “cell-specific targeting group or ligand, which targets immune competent cells” as required and claimed. That is, there is no detailed description/support that the mannose or GalNAc in Figure 4 is “specific” for targeting “immune competent cells”.
Applicant further points out “Appendix 1”, “Appendix 2”, and “Appendix 3” and argues that they demonstrate that the claimed moieties “are capable of specifically targeting immune competent cells.” In response, it is noted that each of the Appendix pointed out by applicant cannot be identified as the documents submitted by applicant on December 15, 2025 are not labeled. Hence, the examiner is unable to identify which documents correspond to “Appendix 1”, “Appendix 2”, and “Appendix 3” thus cannot verify applicant’s assertions. The examiner, however, does duly note that applicant’s assertion is not found factually correct at least by a document that expressly presents that a fatty acid, anadamide, does not specifically target an immune competent as the fatty acid is shown to successfully target mouse hippocampus neural cells. Similarly, the same document expressly shows that the GalNAc moiety is not “specific” in targeting immune competent cells as it is successful in targeting hepatocytes. See page 2 of the document whose first page is “Targeted RNA drug delivery – possible new treatment options”. Hence, the document with no publication date clearly supports the examiner’s position, not applicant’s assertion. Applicant’s attention is directed to the fact that the mere submission of the documents without evidentiary labels (e.g., Exhibit) or without in a proper IDS is not a proper request for examiner’s consideration of the documents.
In view of the foregoing, it is concluded that the instant specification as originally filed fails to adequately describe that the sugar and fatty acid moieties are “specific” ligands/groups that specifically target immune competent cells as required by the claims. Further, the documents without any publication date or with a post-filing date (e.g., year 2024) also fail to show that the sugar/fatty acid moieties were known in the prior art before the effective filing date to be “specific” for targeting immune competent cells, nor does a post-filing document can possibly show that the instant specification itself demonstrates inventor’s possession of the claimed subject matter as of the filing date sought in the instant case.
“Nor is it sufficient [to comply with the written description requirement], as
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Ariad argues, that “skilled workers actually practiced this teaching soon after the 1989 application was filed.” See Vas-Cath, 935 F.2d at 1563-64 (holding that a written description analysis occurs “as of the filing date sought”)…. Conversely, we have repeatedly stated that actual “possession” or reduction to practice outside of the specification is not enough. Rather, as stated above, it is the specification itself that must demonstrate possession.” (emphasis added). Ariad Pharmaceuticals Inc. v. Eli Lilly & Co. 593 F3d 1336, 94 USPQ2d 1161 (Fed. Cir. 2010).
Accordingly, this rejection is maintained.
Claim Rejections - 35 USC § 103
Claims 1, 3-11, 14-17, 19-20, and 24-25 remain rejected under 35 U.S.C. 103 as being unpatentable over Frischmuth et al. in view of Peng et al. and Ting et al. for the reasons as set forth in the Office action mailed on September 16, 2025 and for the reasons set forth below.
Applicant's arguments filed on December 15, 2025 have been fully considered but they are not persuasive. Applicant argues that “Frischmuth must still be able to account for all the limitations of the claims” in order to render the rejected claims obvious. Contrary to applicant’s argument, there is no legal basis that a single reference, the primary reference, must teach all of the claimed limitations for obviousness under §103. Such legal basis applies to an anticipation rejection under §102.
Applicant argues that it would not have been obvious to apply Frischmuth’s mRNA modification to the mRNA encoding the nucleoprotein N of SARS-CoV-2 because one skilled in the art would have rather modified the spike protein (S) of SARS-CoV-2. In response, it is noted that applicant did not provide any explanation as to why one of ordinary skill would not make an mRNA vaccine against the N protein but only pursue making an mRNA vaccine against the S protein of SARS-CoV-2. As set forth in the last Office action, Frischmuth expressly taught that the disclosed “alkyne- and/or azide-modified mRNA” is useful in making “an mRNA vaccine”, wherein making an mRNA vaccine encoding the “N protein of the SARS-CoV-2 virus” was an art-recognized goal as evidenced by Peng, wherein the nucleotide sequence of the N protein was already known and available in the relevant art as disclosed by Peng. Applicant did not provide any persuasive argument as to why one skilled in the art would not apply Frischmuth’s teachings in making an mRNA vaccine encoding Peng’s N protein of the SARS-CoV-2 virus. It appears applicant’s rationale is predicated on the assertion that the instant application showed “for the first time” that the claimed SARS-CoV-2 N protein-encoding mRNA is “an efficient vaccine.” In response, it is noted that an “efficient vaccine” may at best be only applicable to claim 25 drawn to a method for vaccination of an individual against viral infection, wherein such vaccination method against SARS-CoV-2 would have been reasonably predicted to be efficient in view of the teachings of Peng. Furthermore, it is noted that the instant specification demonstrates no efficacy of efficiency of the claimed mRNA as there is no in vivo working example disclosed in the specification. Hence, the examiner is unable to understand the basis of applicant’s argument that the instant application is the “first” demonstration showing that the claimed mRNA is an efficient vaccine against SARS-CoV-2.
Applicant argues that the claims are not obvious because the claimed subject matter provides “surprising advantages” such that “a long-term immunization is achieved” through the memory T-cell response that is “particularly advantageous.” In response, it is noted that there is no disclosure in the instant specification that shows the allegedly advantageous “long-term immunization” as there is no actual in vivo immunization disclosure in the instant specification. Hence, applicant’s arguments pertaining to unexpected, surprising results are not supported by objective, factual evidence. In addition, the rejected claims do not recite/require a “long-term immunization”. Hence, the factually unsupported unexpected results are not commensurate in scope with the rejected claims. Moreover, it was art-recognized scientific knowledge that “central memory CD4 and CD8 T cells” are involved in antiviral immune responses as evidenced by Ting. As such, applicant’s argument pertaining to the involvement of memory T-cell response being “particularly advantageous” in providing long-term immunization was suggested in the prior art.
In view of the foregoing, this rejection is maintained.
Claims 1, 3-11, 14-17, 19-20, and 24-25 remain rejected under 35 U.S.C. 103 as being unpatentable over Frischmuth et al. in view of Lu et al., Jin et al., Zhao et al., Peng et al. and Ting et al. for the reasons as set forth in the Office action mailed on September 16, 2025 and for the reasons set forth below.
Applicant's arguments filed on December 15, 2025 have been fully considered but they are not persuasive. Applicant argues that Frischmuth does not teach a modified mRNA encoding the N protein of the SARS-CoV-2 virus and a STING receptor agonist adjuvant. In response, applicant’s attention is directed to the fact that 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 argues that the instant obviousness is possibly “only with the benefit of improper hindsight reasoning after reading Applicant’s own disclosure”. 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 argues that the “provided appendices demonstrate” that the claimed targeting molecules “are particularly well suited for targeting the desired immune-competent cells”, wherein the cell-targeting is not suggested by any of the cited references alone or in combination. In response, claims 12-13 pertaining to sugar moieties that are claimed to be “specific” for immune competent cells are not included in the instant rejection. Further, the obviousness in attaching a T cell lymphocyte-specific ligands to the mRNA encoding the N protein of the SARS-CoV-2 virus in relation to claim 11 is fully explained at page 15 of the last Office action. Regarding the “provided appendices”, it is noted that the documents improperly submitted on December 15, 2025 do not appear to teach the sugar moieties of claims 12-13, which are not rejected, in the instant rejection are “specific” in targeting immune competent cells as explained in the §112(a) rejection above.
Accordingly, this rejection is maintained.
Double Patenting
Claims 1, 3-11, 14-17, 19-20, and 24-25 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,257,267 B2 in view of Peng et al. and Ting et al. for the reasons as set forth in the Office action mailed on September 16, 2025 because applicant did not provide any substantial rebuttal arguments addressing the supposed errors of this rejection.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DANA H SHIN whose telephone number is (571)272-8008. The examiner can normally be reached Monday-Thursday: 8am - 6:30pm.
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/DANA H SHIN/Primary Examiner, Art Unit 1635