Detailed Office 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 the Claims
Acknowledgement is hereby made of receipt and entry of the communication filed 04 December, 2025. Claims 1-20 are pending in the instant application. Applicant’s election of Group I (claims 1-11) is noted. Because Applicant did not distinctly and specifically point out the purported errors in the restriction requirement, the election has been treated as an election without traverse (M.P.E.P. § 818.03(a)). Accordingly, claims 12-20 have been withdrawn from further consideration by the Examiner, pursuant to 37 C.F.R. § 1.142(b), as being drawn to a non-elected invention. Claims 1-11 are currently under examination.
37 C.F.R. § 1.98
The information disclosure statement filed 04 April, 2023, has been placed in the application file and the information referred to therein has been considered. Applicant is reminded that the listing of references in the specification (e.g., see pp. 61-64) is not a proper information disclosure statement. 37 C.F.R. § 1.98(b) requires a list of all patents, publications, applications, or other information submitted for consideration by the Office, and M.P.E.P. § 609.04(a), subsection I. states, “the list may not be incorporated into the specification but must be submitted in a separate paper.” Therefore, unless the references have been cited by the examiner on form PTO-892, they have not been considered.
37 C.F.R. § 1.821-1.825
37 C.F.R. § 1.831(a) requires that patent applications which contain disclosures of nucleotide and/or amino acid sequences that fall within the definitions of 37 C.F.R. § 1.831(b) must contain a "Sequence Listing XML", as a separate part of the disclosure, which presents the nucleotide and/or amino acid sequences and associated information using the symbols and format in accordance with the requirements of 37 C.F.R. § 1.831-1.835. This "Sequence Listing XML" part of the disclosure may be submitted:
1. In accordance with 37 C.F.R. § 1.831(a) using the symbols and format requirements of 37 C.F.R. § 1.832 through 1.834 via the USPTO’s patent electronic filing system (Patent Center) (see Section I.1 of the Legal Framework for Patent Electronic System (https://www.uspto.gov/patents-application-process/filing-online/legal-framework-efs-web), hereinafter "Legal Framework") in XML format, together with an incorporation by reference statement of the material in the XML file in a separate paragraph of the specification (an incorporation by reference paragraph) as required by 37 C.F.R. § 1.835(a)(2) or 1.835(b)(2) identifying:
a. the name of the XML file
b. the date of creation; and
c. the size of the XML file in bytes; or
2. In accordance with 37 C.F.R. § 1.831(a) using the symbols and format requirements of 37 C.F.R. § 1.832 through 1.834 on read-only optical disc(s) as permitted by 37 C.F.R. § 1.52(e)(1)(ii), labeled according to 37 C.F.R. § 1.52(e)(5), with an incorporation by reference statement of the material in the XML format according to 37 C.F.R. § 1.52(e)(8) and 37 C.F.R. § 1.835(a)(2) or 1.835(b)(2) in a separate paragraph of the specification identifying:
a. the name of the XML file;
b. the date of creation; and
c. the size of the XML file in bytes.
This application contains sequence disclosures (e.g., see pp. 48, 53, and 58-60) that are encompassed by the definitions for nucleotide and/or amino acid sequences set forth in 37 C.F.R. § 1.821(a)(1) and (a)(2). However, this application fails to comply with the requirements of 37 C.F.R. § 1.821 through 1.825 for the reason(s) set forth below. Applicants are reminded that the sequence rules embrace all unbranched nucleotide sequences with ten or more bases and all unbranched, non-D amino acid sequences with four or more amino acids, provided that there are at least 4 “specifically defined” nucleotides or amino acids. The rules apply to all sequences in a given application, whether claimed or not. All such sequences are relevant for the purposes of building a comprehensive database and properly assessing prior art. It is therefore essential that all sequences, whether only disclosed or also claimed, be included in the database. See 37 C.F.R. § 1.821(a) and M.P.E.P. § 2421.02.
With respect to sequences appearing in the specification which are not identified by sequence identifiers in accordance with 37 C.F.R. § 1.821(d), Applicant must provide the following:
- A substitute specification in compliance with 37 C.F.R. § 1.121(b)(3) and 1.125 inserting the required sequence identifiers, consisting of:
- A copy of the previously-submitted specification, with deletions shown with strikethrough or brackets and insertions shown with underlining (marked-up version);
- A copy of the amended specification without markings (clean version); and
- A statement that the substitute specification contains no new matter.
The specification is objected to for failing to comply with the sequence requirements.
37 C.F.R. § 1.84
The drawings filed 04 April, 2023, have been reviewed and are acceptable.
35 U.S.C. § 112(b)
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.
Claims 5, 8, and 10 are rejected under 35 U.S.C. § 112(b) as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor, regards as the invention. Two separate requirements are set forth under this statute: (1) the claims must set forth the subject matter that applicants regard as their invention; and (2) the claims must particularly point out and distinctly define the metes and bounds of the subject matter that will be protected by the patent grant.
Regarding claim 5, the phrases “such as CXCL9, CXCL10, CCL3, CCL4 and/or CCL5” and “such as CXCL20” renders the claim indefinite because it is unclear whether the limitations following the phrase are part of the claimed invention. See M.P.E.P. § 2173.05(d). Amendment of the claim language to reference the specific chemokines (e.g., comprising the chemokine CCL20 or a Th1-related chemokine selected from the group consisting of CXCL9, CXCL10, etc.) would be acceptable.
Regarding claim 8, the claim references a broad limitation (e.g., viral antigen) while also reciting a narrower range directed toward to viral antigens (e.g., influenza virus or coronavirus). A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) is considered indefinite, since the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See M.P.E.P. § 2173.05(c). Note the explanation given by the Board of Patent Appeals and Interferences in Ex parte Wu, 10 U.S.P.Q.2d 2031, 2033 (Bd. Pat. App. & Inter. 1989), as to where broad language is followed by “such as” and then narrow language. The Board stated that this can render a claim indefinite by raising a question or doubt as to whether the feature introduced by such language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. Note also, for example, the decisions of Ex parte Steigewald, 131 U.S.P.Q. 74 (Bd. App. 1961); Ex parte Hall, 83 U.S.P.Q. 38 (Bd. App. 1948); and Ex parte Hasche, 86 U.S.P.Q. 481 (Bd. App. 1949). Appropriate correction is required.
Concerning claim 10, this claim is vague and indefinite because it fails to reference an earlier claim. Accordingly, the metes and bounds of the patent protection desired cannot be ascertained.
Joint Inventors, Common Ownership Presumed
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 at the time any inventions covered therein were effectively filed absent any evidence to the contrary. Applicant is advised of the obligation under 37 C.F.R. § 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned at the time a later invention was effectively filed 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.
35 U.S.C. § 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 of this title, 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.
Graham v. Deere
The factual inquiries set forth in Graham v. John Deere Co., 383 U.S. 1, 148 U.S.P.Q. 459 (1966), that are applied for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
Claims 1-4, 6-8, 10, and 11 are rejected under 35 U.S.C. § 103 as being unpatentable over Gupta et al. (2014) in view of Iglesias et al. (2007). Claim 1 is directed toward a recombinant lentiviral vector genome comprising a polynucleotide encoding a fusion polypeptide, wherein said fusion polypeptide comprises arranged from N-terminal to C-terminal ends a first recombinant polypeptide and a second polypeptide, wherein: (i) said first recombinant polypeptide comprises a multimerization scaffold which comprises at least one collectin or a fragment thereof suitable to enable self-assembly of multimers of the first polypeptide, fused with at least one antigenic polypeptide; (ii) said second polypeptide comprises a CD40L ectodomain or a receptor binding fragment thereof. Claims 2-4 reference the structure of the fusion protein (e.g., collectin comprises a crosslinking region, collagen-like region, and neck region (claim 2); the antigen is inserted into the collagen-like region (claim 3); and the collectin is truncated in the CRD region (claim 4)). Claims 6 and 7 reference the collectin SP-D (claim 6) and a monomeric or polymeric form of the fusion protein. Claim 8 further defines the antigen of interest (e.g., viral, bacterial, parasitic, or tumour). Claim 10 references a pTRIPΔU3 insert wherein the fusion polypeptide is under the control of a mammalian promoter. Claim 11 recites a DNA plasmid encoding the recombinant vector.
Gupta et al. (2014) discloses the preparation of a tripartite fusion protein including the collectin surfactant protein D (SPD), HIV-1 Gag as an antigen, and CD40L (see Figs. 1A and B, next page). SPD serves as a scaffold for the multitrimer protein complex. The authors reported (see Abstract, p. 1492) that “This SPD-Gag-CD40L protein activated CD40-bearing cells and bone marrow-derived DCs in vitro. Compared to a plasmid for Gag antigen alone (pGag), DNA vaccination of mice with pSPD-Gag-CD40L induced an increased number of Gag-specific CD8+ T cells with increased avidity for major histocompatibility complex class I-restricted Gag peptide and improved vaccine-induced protection from challenge by vaccinia-Gag virus.” The authors also demonstrated that SPD-Gag-CD40L expression from Ad5 provided robust immune responses as compared to Ad5-Gag. It was concluded that this format provides a strongly protective CD8+ T cell response. This teaching does not disclose a fusion protein expressed from a lentiviral genome.
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Iglesias et al. (2007) discloses pTRIPΔU3 lentiviral expression vectors encoding two different HLA-restricted human immunodeficiency virus type 1 (HIV-1) polyepitopes (see Fig. 1A, p. 1204, next page). These constructs contain a mammalian promoter e.g., CMVie) that drives gene expression. Immunization with these vectors stimulates strong, broad, and long-lasting viral-specific CTL responses in vivo.
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Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to express the collectin SPD-Gag-CD40L fusion protein of Gupta et al. (2014), in the pTRIP lentiviral expression vector of Iglesias et al. (2007). Expression of collectin fusion proteins in this system would reasonably be expected to produce strong, broad, and long-lasting immune responses against the immunogen of choice. Moreover, the collectin SPD fusion proteins of Gupta et al. (2014) contain the arrangement cross-linking region, collagen-like region, and neck region (claims 2 and 6). The antigen was inserted into the collagen-like region of SPD (claim 3). Moreover, CD40L was inserted into the CRD region of SPD40 thereby producing a truncated form of the collectin (claim 4). Mono- and multimeric forms of the fusion protein were produced (claim 7). With respect to claim 10, the pTRIPΔU3 lentiviral expression vector is the same expression vector originally utilized by Applicants. Depending upon the antigen employed, one of ordinary skill in the art could modify the backbone utilizing those sites that are convenient to arrive at the claimed sequence identifier, absent evidence to the contrary. These constructs are produced from DAN plasmids (claim 11).
Claim 5 is rejected under 35 U.S.C. § 103 as being unpatentable over Gupta et al. (2014) in view of Iglesias et al. (2007), as applied supra to claim 1, and further in view of Sun et al. (2017). Claim 5 further requires the inclusion of a chemokine (e.g., CCL20/ MIP-3α) in the fusion polypeptide. Sun et al. (2017) demonstrate that fusion proteins comprising CCL20 display augmented mucosal immune responses to the antigen of interest (see Abstract, p. 1). The authors noted that CCL20 acts as an effective mucosal adjuvant when incorporated into an Env fusion protein. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to incorporate CCL20 into the collectin fusion protein of Gupta et al. (2014). One of ordinary skill in the art would reasonably expect CCL20 to augment the immune response against the antigen of interest.
Claim 9 is rejected under 35 U.S.C. § 103 as being unpatentable over Gupta et al. (2014) in view of Iglesias et al. (2007), as applied supra to claim 1, and further in view of and Wu et al. (2016). Claim 9 further recites the utilization of one or more Mycobacterium tuberculosis antigens (e.g., EsxA, EspC, EsxH, PE19, Hrp1, and RpfD). Wu et al. (2016) disclose a scaffold structure (e.g., HSP65) comprising multiple M. tuberculosis antigens including EsxA (ESAT-6) and PE19 (see Materials and Methods, pp. 4 and 5). The inclusion of these antigens in the scaffold produced robust immune responses. Therefore, it would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to utilize the Mtb antigens disclosed by Wu et al. (2016), in the collectin scaffold provided by Gupta et al. (2014). One of ordinary skill in the art would have reasonably expected their incorporation into the SpD scaffold to produce strong and long-lasting immune responses against the Mtb antigens.
Correspondence
Any inquiry concerning this communication should be directed to Jeffrey S. Parkin, Ph.D., whose telephone number is (571) 272-0908. The Examiner can normally be reached Monday through Friday from 10:00 AM to 6:00 PM. A message may be left on the Examiner's voice mail service. 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 are unsuccessful, the Examiner's supervisor, Michael Allen, Ph.D., can be reached at (571) 270-3497. Direct general status inquiries to the Technology Center 1600 receptionist at (571) 272-1600.
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Respectfully,
/JEFFREY S PARKIN/Primary Examiner, Art Unit 1671 23 December, 2025