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 June 30, 2026.
Currently, claims 46 and 56-92 are pending in the instant application. Claims 65 and 78-79 are withdrawn from further consideration as being drawn to nonelected inventions. Accordingly, claims 46, 56-64, 66-77, and 80-92 are 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.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 § 103
Claims 46, 56-64, 66-77, and 80-92 remain rejected under 35 U.S.C. 103 as being unpatentable over Barner et al. in view of Fontin-Mleczek et al. and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious because Barner provides no experimental data pertaining to MAGE-A3 and Barner’s broad antigen lists fail to provide a reasonable expectation in arriving at the claimed method. In response, it is noted that there is no legal requirement that a cited prior art reference must provide working examples or experimental data in order to render obvious a method claim. Further, applicant’s attention is directed to the fact that for obviousness under §103, “all that is required is a reasonable expectation of success”, and it does not require “absolute predictability of success”. See In re O ’Farrell, 853 F.2d 894, 7 USPQ2d 1673 (Fed. Cir. 1988) at 1681. Furthermore, applicant’s attention is directed to the fact that applicant 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). That is, the administration of a combination of tumor antigen-encoding mRNA vaccine constructs including MAGE-A3, NY-ESO-1, and tyrosinase in conjunction with an anti-PD1 antibody was also taught by Fontin-Mleczek, which thus provides a reasonable expectation of success to practice the instantly claimed method when the combination of the cited references and the state of the technical skills/knowledge disclosed therein are fully taken into consideration.
Applicant argues that Fontin-Mleczek’s Example 2 does not relate to MAGE-A3. Again, applicant’s attention is directed to the fact that there is no legal requirement that a cited prior art reference must provide working examples or experimental data in order to render obvious a method claim. Note that there is no enablement rejection in the instant application despite the fact that the instant specification provides no working example/experimental data pertaining to the instantly claimed in vivo method comprising administering (a) and (b) in a cancer subject further comprising “second RNA molecule” and “a third RNA molecule” because of a well-established reasonable expectation of success and/or a lack of a high level of unpredictability as gleaned from the teachings of the relevant prior art such as those cited in the instant obviousness rejection. That is, applicant’s argument pertaining to the cited prior art’s lack of working examples exactly corresponding to the claimed method is not in line with applicant’s own lack of working examples commensurate in scope with the claims.
Applicant argues that de Fougerolles does not teach the claimed results provided by the combination. In response, it is noted that applicant 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 cited references do not provide “evidence that MAGE-A3 would behave predictably like OVA, NY-ESO-1, or 5T4”. Again, applicant’s attention is directed to the fact obviousness under §103 does not require absolute predictability of success. Now, it was known in the art that the combination of “MAGE-A3 and NY-ESO-1” mRNAs can induce “CD8+ T lymphocyte" responses in cancer subjects as taught by Barner, and furthermore, each of MAGE-A3, MY-ESO-1, and tyrosinase was an art-recognized tumor antigen as taught by Fontin-Mleczek. As such, one of ordinary skill in the art would have had a reasonable, if not absolute, expectation of success/predictability in arriving at and practicing the instantly claimed combination method.
Applicant argues that Fontin-Mleczek teaches “the unpredictability of the asserted combination” because “the combination of an RNA vaccine and a PD1 pathway inhibitor was based on a surprising finding” of “enhanced survival that could not be expected from the prior art.” In response, since applicant did not specifically point out the specific passage pertaining to Fontin-Mleczek’s teachings regarding the alleged “unpredictability”, the examiner will assume applicant’s arguments pertain to page 59 of Fontin-Mleczek. For the completeness of the record and for discussion purpose, the entire paragraph at page 59 pertinent to applicant’s argument is reproduced below, wherein underline has been added for emphasis.
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As clearly shown above, Fontin-Mleczek expressly taught and recommended as of February 22, 2013 (the priority date) that a combination treatment comprising “an RNA coding for a tumor antigen in combination with a PD-1 pathway inhibitor” for stronger anti-tumor effects that may occur “in a synergistic manner”. The above paragraph does not whatsoever teach that the state of the art pertaining to the claimed combination method prior to April 22, 2016, the priority date sought in the instant application, was unpredictable as misinterpreted and alleged by applicant. Rather, the above paragraph expressly and highly recommends use of an RNA coding for any tumor antigen (e.g., MAGE-A3, MY-ESO-1, and tyrosinase) disclosed in Fotin-Mleczek in combination with a PD-1 pathway inhibitor for a greater anti-tumor effect, thereby providing an ample motivation as well as more than a reasonable expectation of success in arriving at the claimed combination method.
Applicant argues that a post-filing reference by Sahin (2020) provides evidence pertaining to the unpredictable nature of the claimed subject matter because the clinical result reported in the post-filing reference “required a specialized RNA-LPX vaccine platform and an exploratory human melanoma trial”, wherein the clinical result in the 2020 reference “was not a predictable result already demonstrated or reasonable expected” from the instantly cited prior art references. In response, applicant’s attention is directed to the fact that a clinical or a pre-clinical level of working example is not required to rendered obvious a claimed method. Applicant is invited to point to a legal basis or a case law that requires a clinical stage result in a prior art in an obviousness rejection under §103 for rendering obvious applicant’s claimed method. Now, it is noted that the post-filing reference in fact corroborates the teachings of Fontin-Mleczek, especially those disclosed in the paragraph reproduced from page 59 as shown at the previous page hereinabove as the post-filing reference teaches that the RNA coding for a tumor antigen “synergizes with anti-PD1 therapy” (see page 111), wherein such teaching is consistent with and corroborates Fontin-Mleczek’s expressly disclosure that the combination of an RNA coding for a tumor antigen and an anti-PD1 inhibitor provided “an improved survival of tumor challenged mice in a synergistic manner”. Hence, the post-filing reference does not support the alleged unpredictability, which is not present as evidenced at least by the teachings of Fontin-Mleczek; rather, the post-filing reference is consistent with and echoes the teachings of Fontin-Mleczek.
In view of the foregoing, this rejection is maintained.
Double Patenting
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-16 of U.S. Patent No. 9,737,595 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 9,974,845 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,117,920 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-13 of U.S. Patent No. 10,307,472 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 and 17-19 of U.S. Patent No. 10,434,158 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5 and 7-25 of U.S. Patent No. 11,458,195 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2 and 7-20 of U.S. Patent No. 11,559,570 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-14 of U.S. Patent No. 12,178,863 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-35 of U.S. Patent No. 12,447,209 B2 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 48-50 of Application No. 18/929,823 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
Claims 46, 56-64, 66-77, and 80-92 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 64, 67-69, and 74-86 of Application No. 19/086,551 in view of Barner et al., Fontin-Mleczek et al., and de Fougerolles et al. for the reasons as set forth in the Office action mailed on December 31, 2025 and for the reasons stated below.
Applicant's arguments filed on June 30, 2026 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious for the same reasons provided in the §103 rejection above. In response, it is noted that applicant’s arguments provided in the §103 rejection are not found persuasive. Accordingly, this rejection is maintained.
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
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