DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
This office action is in response to an amendment filed 1/23/2026.
Claims 1, 3, 9, 10, 12, 14-17, 19 and 21-23 are pending.
This application claims priority to U.S. serial number 16/703,915, now abandoned, which claims priority to provisional application 62/775,604 filed 12/5/2018.
Response to Amendments
Applicants amendment are sufficient to overcome the rejections under 35 USC 112, b. Applicants arguments were sufficient to overcome the rejection. A search of the art demonstrated that relevant art was present. As this is a new rejection not necessitated by applicants’ amendment, this action is not final. Applicants arguments are primarily directed against Johnson et al. hence, they are moot in view of the new art. While Johnson provided teachings of a linear expression vector containing the phosphorothioate-modified nucleotides at the 5’ ends, the teachings did not support large scale production or combination with references that did teach large scale production. However, new art was found.
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 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 pre-AIA 35 U.S.C. 103(a) which forms the basis for all obviousness rejections set forth in this Office action:
(a) A patent may not be obtained though the invention is not identically disclosed or described as set forth in section 102, if the differences between the subject matter sought to be patented and the prior art are such that the subject matter as a whole would have been obvious at the time the invention was made to a person having ordinary skill in the art to which said subject matter pertains. Patentability shall not be negatived by the manner in which the invention was made.
Claims 1, 10, 15, 16 and 21-23 are rejected under pre-AIA 35 U.S.C. 103(a) as being unpatentable over Allen et al (Cancer Immunology, Immunotherapy (2018) 67:627–638) in view of Wang et al (Vet Microbiology, 2017, pages 124-130) and in view of Potapov and Ong (PLoS ONE, 2017, pages 1-19) and Weiner et al (U.S. 20200030426) and Scarselli et al (U.S. 20080090778). This is a new rejection.
Allen et al teach methods of producing a linear DNA vaccine devoid of all plasmid DNA and that comprises a promoter and terminator sequence. The sequence is used for cancer therapy in conjunction with immune checkpoint inhibitors and provides improvements over plasmid DNA. Allen teaches large scale amounts but does not provide explicit details on that step. However, Wang et al teach methods of producing amplicons to large scale (see page 125, col 2) with phosphorothioate modified primers. The product is similar to Allen et al substitute for plasmid DNA (see page 125, col 1).
As to the polymerase, Wang et al uses a polymerase with an error rate of 3.8 x10-3. But, polymerases with lower error rates are well known in the art and provided. For example, Q5 has an error rate of 5.3 x 10-7 (see Table 3 of Potapov and Ong). One would be motivated to use these for lower mutational effects. The PCR products were purified and concentrated (see section 2.4) thus defining an efficacious dose.
Considering well known targets for immunotherapy, TERT is used to target colorectal cancer. Weiner et al teach use of consensus TERT sequences (abstract) to treat colorectal cancer (see ¶0638) in combination with CTLA-4 or PD-1 (see ¶0104). Similarly, Scarselli et al teach treatment of colorectal cancer with a vector encoding TERT operably linked to a TPA signal sequence to ensure the secretion of the TERT protein (¶0012, 0128 And 0129). Delivery is directly to the tumor (see ¶0005).
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the step of plasmid less construction as taught by Allen et al in view of Wang et al and Potapov and Ong in the methods of Weiner and Scarselli et al. Such a modification would have resulted in a method encompassed by the claimed invention. As noted above: 1) Cancer therapy has been attempted using linear amplicon DNA for a time as demonstrated by Allen et al and 2) ancillary art teaching improved polymerases as shown by Potapov and Ong and 3) large scale production methods were known as shown by Wang et al wherein application of these techniques with their improved conditions for immunotherapy as attested by Allen and Wang to 4) Weiner et al with TERT as a DNA vaccines in combination with immunomodulators to treat colorectal cancer and 5) Scarselli teaches that the method can also improve location with TPA signal sequences. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the plasmid less vaccines would be faster to construct. Furthermore, the lack of plasmid DNA is known to decrease non-specific antigenic reactions.
As to claim 10, TERT has been shown to show protective effects when used against colorectal cancer and is so asserted in at least Weiner (see e.g. ¶0016).
Claims 3, 9, 12, 14, 17 and 19 are rejected under 35 U.S.C. 103 as being unpatentable over Wang et al (Vet Microbiology, 2017, pages 124-130) in view of Potapov and Ong (PLoS ONE, 2017, pages 1-19) and Weiner et al (U.S. 20200030426) and Scarselli et al (U.S. 20080090778) as applied to claims 1, 10, 15, 16 and 21-23 above, and further in view of Mayfield et al (US 20140219971) and Paterson and Peters et al (US 20060233835).
Several components required of the claims are missing from the art above. However, such steps are well known in the art.
Regarding claims 3, 12 and 17, Mayfield et al teach addition of SUMO to enhance vaccine activity (see e.g. ¶0122).
Regarding claims 9, 14 and 19, Paterson and Peters teach DNA vaccines expressing immunomodulators (see e.g. ¶0004). This provides less non-specific immune activation.
Based on such teachings, it would have prima facie been obvious to one of ordinary skill in the art at the time the invention was made to incorporate the specifics of improving vaccines with SUMO, nucleic acid checkpoint inhibitors and low error rate PCR enzymes. Such a modification would have resulted in a method encompassed by claim 3, 9, 12, 14, 17 and 19. 1)Mayfield teaches that SUMO sequences improve vaccine activity which is desired for tumor efficacy, 2) Paterson and Peters teach expressing immunomodulators with the DNA. These additions and substitutions were available to a person of skill in the art for use in the methods of making and administering cancer vaccines. Thus, a person of ordinary skill in the art, absent evidence to the contrary, would have reasonably expected that the expanded protocol would allow improved treatment.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MARIA MARVICH whose telephone number is (571)272-0774. The examiner can normally be reached on 8 am - 5 pm.
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/MARIA MARVICH/Primary Examiner, Art Unit 1633
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