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 Status
The amended claim set filed on 18 September 2023 is acknowledged. Claims 48-68 are currently pending. Of those, no claims are amended. Claims 48-68 are new, and claims 58-68 are withdrawn. Claims 1-47 are cancelled. Claims 48-57 will be examined on the merits herein.
Election/Restrictions
Applicant’s election without traverse of Group I (claims 48-57) in the reply filed on 5 December 2025 is acknowledged. Claims 58-68 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 5 December 2025.
Priority
The instant application is a 371 of application PCT/SE2021/050460 (filed 05/14/2021) and claims priority to U.S. Provisional Application 63/025,550 (filed 15 May 2020). Therefore, the effective filing date of instant claims 48-57 is 15 May 2020.
Information Disclosure Statement
The information disclosure statements (IDS) submitted on 14 November 2022 and 12 December 2022 are submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, each information disclosure statement is being considered by the examiner.
Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 48, 51-52, and 56-57 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chen et al. (2017, Immunol. Lett.; herein “Chen”).
Regarding claim 48 and 51-52, Chen teaches a DNA vaccine encoding the Hc domain of botulinum neurotoxin serotype A (AHc) (i.e., a bacterial exotoxin) fused with scDEC, a single-chain Fv antibody (scFv) that is specific to DEC205, a surface marker on dendritic cells (Abstract), including conventional type I dendritic cells. Chen also teaches that the DC-targeted DNA vaccine induced strong humoral immune responses and induced more DC maturation than a non-DC-targeted vaccine, which may be helpful for boosting the immune response (Abstract).
Regarding claim 56, Chen teaches a plasmid (i.e., an expression vector) comprising the nucleotide sequence encoding AHc and scDEC (section 2.1).
Regarding claim 57, Chen teaches that 293Ft cells were transfected with the plasmids comprising the nucleotide sequence encoding AHc and scDEC (i.e., cells containing the nucleotide sequence encoding AHc and scDEC) (section 2.2).
Claim Rejections - 35 USC § 103
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.
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.
Claims 48-52 and 54-57 are rejected under 35 U.S.C. 103 as being unpatentable over Eliasson et al. (2008, Vaccine; herein “Eliasson”) in view of Chen (2018, Immunol. Lett.).
Regarding claims 48-50 and 54-57, Eliasson teaches a fusion protein comprising the A1 subunit of cholera toxin (CTA1-DD) and the ectodomain of the matrix protein 2 (M2e) of influenza A (pg. 274, left col., para. 2). Eliasson teaches that the fusion protein was produced by transforming an expression vector encoding CTA1-M2e-DD (i.e., a nucleotide sequence comprising a nucleotide sequence encoding CTA1 and a nucleotide sequence encoding M2e) into E. coli DH5 cells (i.e., cells comprising the nucleotide sequences encoding CTA1 and M2e) (pg. 1244-1245, paragraph bridging pages). Eliasson also teaches that the fusion protein is able to generate M2e-specific memory cells and protect against influenza A infection (Abstract).
However, Eliasson does not teach a scFv that specifically binds to a surface marker on antigen presenting cells, as in claim 48, including dendritic cells, as in claim 51, or conventional type 1 dendritic cells, as in claim 52.
The teachings of Chen with respect to claims 48, 51-52, and 56-57 are set forth in para. 8-10.
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to combine the nucleotide sequence encoding the fusion protein comprising CTA1-DD and M2e taught by Eliasson with the nucleotide sequence encoding the scDEC antibody targeting DEC205 on dendritic cells taught by Chen, thereby arriving at the invention of claims 48-52 and 54-57. The person of ordinary skill in the art would have been motivated to make the modification because Chen teaches that the DC-targeted vaccine induced stronger immunity compared to the non-targeted vaccine. Therefore, the combination is also desirable (see MPEP 2144(II)). The person of ordinary skill in the art would have had a reasonable expectation of success because the DNA vaccine of Chen demonstrates that scDEC can be fused with bacterial exotoxin subunits in a fusion protein, and one of ordinary skill in the art would believe that combining modifying the CTA1-M2e-DD fusion protein of Eliasson to target dendritic cells would produce an immune response at least as well as that taught in Eliasson. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., nucleotide sequences encoding CTA1, scFv targeting dendritic cells, and M2e) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Claims 48, 51-53, and 56-57 are rejected under 35 U.S.C. 103 as being unpatentable over Hadley (US 2011/0142860 A1).
Regarding claims 48, Hadley teaches an anti-CD103 antibody (i.e., an antibody that specifically binds to a surface marker on an antigen presenting cell) conjugated to a lethal compound (Abstract and para. 4). Hadley teaches that the anti-CD103 antibody may be a single chain variable fragment (scFv) (para. 34) and that the lethal compound may be shigella neurotoxin, botulism toxin, diphtheria toxin, tetanus toxin, or cholera toxin (i.e., bacterial exotoxins) (para. 66). Hadley also teaches isolated nucleic acids encoding the antibody or binding agents (e.g., bacterial exotoxins) (para. 55).
Regarding claims 51-53, Hadley teaches that the antibody binds CD103 (Abstract and para. 4), which is present on conventional type 1 dendritic cells (cDC1s).
Regarding claim 56, Hadley teaches that the isolated nucleic acid encoding the conjugate may be in a vector (para. 55).
Regarding claim 57, Hadley teaches that the isolated nucleic acid encoding the conjugate may be maintained in recombinant host cells (para. 55).
Therefore, it would have been prima facie obvious, before the effective filing date of the claimed invention, to a person of ordinary skill in the art, to modify the nucleic acid encoding the anti-CD103 antibody and lethal compound conjugate by using a scFv as the anti-CD103 antibody and a bacterial exotoxin as the lethal compound, as taught by Hadley, to arrive at the invention of claims 48, 51-53, and 56-57. The person of ordinary skill in the art would have been motivated to make the modification because Hadley teaches scFvs and bacterial exotoxins as specific components that may be used in their generic antibody-lethal-compound conjugate structure. The person of ordinary skill in the art would have had a reasonable expectation of success because methods of making scFvs, toxins, and antibody conjugates are well known in the art. Therefore, the combination leads to expected results because each element performs the same function as is does individually.
Additionally, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that combining prior art elements according to known methods to yield predictable results, is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007) also discloses that the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results. In the instant case, all elements (i.e., anti-CD103 scFv and bacterial exotoxin) were known in the art. In addition, combining these elements yields a method/composition wherein each element merely performs the same function as it does separately; thus, the results of the combination would be recognized as predictable to one of ordinary skill in the art. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BAILEY M MORGAN whose telephone number is (703)756-5388. The examiner can normally be reached M-F 9-5 ET.
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, DANIEL KOLKER can be reached at (571) 272-3181. 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.
/BAILEY M MORGAN/Examiner, Art Unit 1645
/DANIEL E KOLKER/Supervisory Patent Examiner, Art Unit 1645