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 March 26, 2026.
Currently, claims 115-117, 122-124, and 127-130 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Withdrawn Rejections
Any rejections/objections not repeated in this Office action are hereby withdrawn.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 § 103
Claims 115-117, 123, and 128-130 remain rejected under 35 U.S.C. 103 as being unpatentable over Shen et al. in view of Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious because Shen actually taught combining mRNA vaccines with “agents that enhance TLR7/8 signaling” by pointing out claim 4 and FIG. 14 of Shen thus one of ordinary skill in the art would not have been motivated to combine an mRNA vaccine with an inhibitor of TLR7/8. In response, it is noted that Shen’s teachings do contain experimental data as provided in FIG. 14 as well as FIG. 4B that the addition of “ODN2095” (a “TLR7/8 inhibitor”) to the mRNA vaccine significantly decreased the level of cytokines that were induced by the mRNA vaccine to the normal level (see “PBS”). As such, the induction of cytokines by the mRNA vaccine was taught to be normalized by the addition of “ODN2095”. That is, one of ordinary skill in the art not wishing to induce cytokine levels by an mRNA vaccine in a subject being treated with the vaccine would have been sufficiently and reasonably motivated to combine the mRNA vaccine with an inhibitor of a “TLR7/8 inhibitor” so as not to induce cytokine levels in the subject while providing the vaccine to the subject. Regarding claim 4 of Shen pointed out by applicant, it is noted that claim 4 is not the only disclosure/teaching of Shen. Note that Shen also expressly taught that the additional “therapeutic agent” that can be included with the LPP (lipoplex) encapsulating the mRNA vaccine can be “an immunosuppressive agent” (see paragraph 0156), wherein Schmitt’s 9-mer 2’-O-methyl-modified oligonucleotide was an art-recognized immunosuppressive agent as it “potently attenuates TLR7/8-induced immune responses”. As such, one of ordinary skill in the art would have reasonably deemed Schmitt’s 9-mer oligonucleotide (5’-gagcGmGCca) “an immunosuppressive agent” that can be combined with an mRNA vaccine in a lipoplex and would have reasonably expected normalized cytokine levels induced by the mRNA vaccine when combined with Schmitt’s 9-mer oligonucleotide in place of a functionally equivalent agent “ODN2095”.
Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected under 35 U.S.C. 103 as being unpatentable over Kariko et al. in view of Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the claims are not obvious because Kariko taught that nucleoside modification diminished cytokine (TNF-a and IL-12) secretion to almost zero by pointing out paragraph 0203 thus there would not have been a reason to further reduce TLR7/8. In response, it is noted that FIGS. 3A-3B described in Kariko’s paragraph 0203 pertain to in vitro MDDC cells transfected with modified RNA-1571 (SEQ ID NO:2). Now, FIG. 3C and paragraph 0203 of Kariko expressly teach that the level of TNF-a induced by modified RNAs differ depending on “RNAs of different length and sequence”. For instance, RNA-1571 (SEQ ID NO:2) encoding Renilla luciferase tested in FIGS. 3A-3B induced about 120 pg/ml of TNF-a in MDDC, whereas RNA-730 (SEQ ID NO:3) encoding “the human melanoma antigen MART-1” induced about 200 pg/ml of TNF-a. See FIG. 3C and paragraph 0191. As such, the results relied on by applicant pertaining to the non-antigen, Renilla luciferase-encoding RNA are not indicative of the TNF-a levels provided by the modified RNAs including Kariko’s SEQ ID NO:3 encoding “the human melanoma antigen MART-1” or any RNA encoding “a therapeutic polypeptide” as claimed in the instant case. That is, there is no evidence in Kariko that the TNF-a levels would be zero in a subject treated with a modified RNA encoding a therapeutic polypeptide, thereby teaching away from further administering an inhibitor of TLR7/8.
Applicant argues that the claims are not obvious because of the unexpected results such that the limitation of “(ii)” “also increases/prolongs expression of the RNA encoded protein” “besides reduced immunostimulation” by pointing out paragraph 0607 of the specification. In response, it is noted that the instant specification does not contain paragraph numbers. As such, the examiner is unable to verify applicant’s statement. Further, it is noted that FIG. 3 of the instant application at best appears to demonstrate that the addition of Gm18 to the unmodified mRNA (SEQ ID NO:83) encoding PpLuc increases the expression level of PpLuc in the liver of mice compared to mRNA alone at 24 hours post-injection. See Example 3.5 and Table 4. In the instant case, the rejected claims do not require any limitation pertaining to the increased PpLuc protein expression in the liver at 24 hours post-injection of (i) and (ii) in the subject, nor do the claims pertain to use of an unmodified RNA as in the working example of the instant application. As such, even if the results described in Example 3.5 should be deemed unexpected, such limitation is not recited thus the results disclosed in the specification are not commensurate in scope with the rejected claims. Note that the “objective evidence of nonobviousness must be commensurate in scope with the claims which the evidence is offered to support.” See MPEP §716.02.
Accordingly, this rejection is maintained.
Double Patenting
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 22 of U.S. Patent No. 9,683,233 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘233 patent claim by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 19-20 of U.S. Patent No. 10,738,306 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘306 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 10,080,809 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘809 patent claim by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 10,988,754 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘754 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-18 of U.S. Patent No. 11,078,247 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘247 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claim 15 of U.S. Patent No. 11,141,474 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘474 patent claim by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 11,141,476 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘476 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 17-18 of U.S. Patent No. 11,254,951 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘951 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-17 of U.S. Patent No. 11,464,836 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘836 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 16-18 of U.S. Patent No. 11,464,847 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘847 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-19 of U.S. Patent No. 11,478,552 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘552 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-6 of U.S. Patent No. 11,865,084 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘084 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-21 of U.S. Patent No. 12,227,549 B2 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘549 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 12,533,422 B2 (issued in Application No. 17/136,724) in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘422 patent claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 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 Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘823 claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 44-45 and 48 of Application No. 19/239,908 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘908 claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Claims 115-117, 122-124, and 127-130 remain provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-30 of Application No. 19/258,882 in view of Kariko et al. and Schmitt et al. for the reasons as set forth in the Office action mailed on September 26, 2025 and for the reasons set forth below.
Applicant's arguments filed on March 26, 2025 have been fully considered but they are not persuasive. Applicant argues that the instant claims are not obvious over the ‘882 claims by pointing out paragraph 0203 of Kariko and by providing the essentially the same argument provided in the §103 rejection above. In response, it is noted that applicant’s arguments relying on Kariko’s disclosure pertaining to FIGS. 3A-3B are not found to support the alleged lack of motivation/reason for the claimed combination method because Kariko’s modified SEQ ID NO:2 encoding luciferase is not representative/indicative of other RNAs encoding therapeutic polypeptides (e.g., Kariko’s SEQ ID NO:3) inducing a higher level of TNF-a than the luciferase-encoding SEQ ID NO:2 as explained in the §103 rejection above, which is fully incorporated by reference herein. Accordingly, this rejection is maintained.
Potential Double Patenting
Applicant’s attention is directed to the fact that each of Application Nos. 19/356,749, 19/362,320, and 19/412,751 filed after the mailing date of the last Office action contains claims that would be subject to a provisional NSDP rejection.
New Rejections Necessitated by Amendment
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.
Claim 127 is 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.
Claim 127 recites the limitation "the mRNA molecule" in line 1. There is insufficient antecedent basis for this limitation in the claim.
Conclusion
No claim is allowed.
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.
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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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, RAM SHUKLA can be reached at 571-272-0735. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DANA H SHIN/Primary Examiner, Art Unit 1635
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