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.
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.
Claim(s) 1, 4, 8-9, 13, 15-18, 25-28 is/are rejected under 35 U.S.C. 103 as being unpatentable over Lopez (WO 2016/179034 A2, November 2016, of record) and in further view of GenBank X03614.1 (GenBank, 2005, pages 1-8) and Rychlik (Nucleic Acids Research, 01 Nov 1989, 17(21):8543-8551, of record).
Lopez is drawn to methods and compositions relating to immunostimulatory RNA motifs that act as adjuvants and/or immunostimulatory agents to enhance host immune responses (see Abstract). Lopez teaches that double-stranded RNA (dsRNA) structures with 5'-di or triphosphates trigger immunostimulant genes wherein dsRNA structures or motifs are parts of viruses including Sendai virus (SeV) immunostimulatory defective viral genome (iDVG) (see paragraphs [007-008]). Lopez discloses the SEQ ID NOs: 1-5 (see Figures 16-20), which first 25 nucleotides are 93.6% identical to instant SEQ ID NO: 1. Lopez teaches that the RNA motif or pharmaceutical compositions comprising the nucleotide sequence of SEQ ID NO: 1 or its modified variants have immunostimulatory activity and can be combined with pharmaceutically acceptable carrier (see paragraphs [0014 - 0021]). Lopez teaches that the modified variants of the RNA motif are generated by substitution, deletion, or addition of a nucleotide(s) (see paragraph [0066]). Lopez teaches that additional nucleotides can be added either to the 5' or 3' end of the DVG70-114 sequence or SEQ ID NO: 1 (see paragraph [0066]). Lopez teaches that the RNA motif comprising DVG70-114 is capable of eliciting a strong immune response (i.e. the RNA motif sequence of the 45 nucleotide bases, wherein the portion of first 25 nucleotides refers to Sequence A/SEQ ID NO: 1 from 5' end and Sequence B/SEQ ID NO: 2 from 3'as being reverse complementary to the Lopez's 25 nucleotides) (see paragraph [0054]). Lopez teaches that the RNA motif comprising DVG70-114 sequence can be stabilized by adding additional nucleotides to either 5 or 3 end of the sequence wherein either 5' or 3' overhang or the additional bases of the DVG70-114 portions are complementary (see paragraph [0085]). Lopez teaches that the additional nucleotides of one overhang is obtained from the parent DVG-268 sequence while the additional nucleotides of the other overhang are not (i.e. interpreted as these portions of the RNA sequence can be or cannot be complementary bases) (see paragraph [0085]). Lopez teaches that 10 to 20 nucleotides can be added to the 5' end and 10 to 20 nucleotides can be added to the 3' end and the 5' and 3' overhangs have 1 to 15 complementary pairs (i.e. referring to additional length of (N)13-25 (N)5-10 to the opposite ends following first 25 bases) (see paragraphs [0085-0086]).
Lopez do not teach extended sequences comprising combined SEQ ID NO: 1 and 3 and combined SEQ ID NO: 2 and 4 as in instant claim 1 and such sequences further elongated by adding 7 nucleotide sequences from claims 25-28, or Tm value of extended portion, (N)5-10, of 20 degrees C.
GenBank teaches genome of Sendai virus (see pages 5-8). Nucleotides 70-94 of the genome are identical to instant SEQ ID NO: 1 (see page 5). Nucleotides 95-119 of the genome are identical to instant SEQ ID NO: 3 (see page 5). Nucleotides 120-126 are UUCUGCA (see page 5), identical to the N(5-10) sequence from instant claims 25 and 27. Thus, nucleotides 70-126 of the genome have the sequence identical to combination of SEQ ID NOs: 1 and 3 and UUCUGCA, as claimed in instant claims 1, 13, 25 and 27. It is further noted that combined instant sequences of SEQ ID NOs: 2 and 4 and UGCAGAA are fully complementary to combination of SEQ ID NOs: 1 and 3 and UUCUGCA.
Rychlik is drawn to a method for choosing optimal nucleotides as probes for hybridization, primers for sequencing or DNA amplification and determining temperature of duplex dissociation using simple dynamic algorithm (see Abstract). Rychlik teaches an algorithm for determination of duplex dissociation temperature, Td (i.e. Tm or melting temperature) based on the length and type of bases, referring this a more practical method of Td/Tm determination, such as the melting temperature is the sum of number of every AT (or AU) base pair X 2°C and number of every GC base pair X 4°C (pg. 8544, paragraph 1, lines 1-4). Based on this method a (N)5-10 RNA molecule would have a Tm range of 20-40 when N=10 and 20 being the lower value calculated as 2x 10 A-U bp and 40 being the higher value from 4 X 10 G-C bp. Rychlik also describes a method for computing helix stability or nearest neighbor thermodynarmic parameters that determines comparable Tm values when compared with the first method (pg. 8545, paragraph 1 and pg. 8547).
It would have been obvious to one of the ordinary skill in the art before the effective filing date of the claimed invention to modify double-stranded RNA taught by Lopez based on genome structure of Sendai virus, arriving at instant invention. One of the ordinary skill in the art would be motivated to do so, because Lopez teach double-stranded RNA based on SEQ ID NO: 1 as immunostimulant, wherein SEQ ID NO: 1 is based on Sendai virus genome, and can be further extended, motivating one of the art to extend such RNA based on GenBank Sendai virus genome, arriving at RNA as claimed in instant claims. The length of such extension can be further determined based on melting temperature teachings by Rychlik.
Allowable Subject Matter
It is noted that double-stranded RNA as claimed in claims 1 and 13, which comprises SEQ ID NO: 5, is free of prior art.
Applicant was notified of such allowable subject matter by a phone call on 07/13/2026, but no response was received.
Response to Arguments
Applicant's arguments filed 06/13/2026 have been fully considered but they are not persuasive.
Previous rejections are withdrawn in view of new amendments, arguments are moot.
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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to EKATERINA POLIAKOVA whose telephone number is (571)270-5257. The examiner can normally be reached Mon-Fri 8-5.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Jennifer Dunston can be reached at (571)272-2916. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
Information regarding the status of published or unpublished applications may be obtained from Patent Center. Unpublished application information in Patent Center is available to registered users. To file and manage patent submissions in Patent Center, visit: https://patentcenter.uspto.gov. Visit https://www.uspto.gov/patents/apply/patent-center for more information about Patent Center and https://www.uspto.gov/patents/docx for information about filing in DOCX format. For additional questions, contact the Electronic Business Center (EBC) at 866-217-9197 (toll-free). If you would like assistance from a USPTO Customer Service Representative, call 800-786-9199 (IN USA OR CANADA) or 571-272-1000.
/EKATERINA POLIAKOVA-GEORGANTAS/Primary Examiner, Art Unit 1637
Prosecution Insights