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 .
Election/Restrictions
Applicant’s election of Group II, claims 23-29, and the required species: A) a heterologous nucleotide sequence: viral antigen, in the reply filed on 8/10/2026 is acknowledged. Because applicant did not distinctly and specifically point out the supposed errors in the restriction requirement, the election has been treated as an election without traverse (MPEP § 818.01(a)).
It is noted that Applicant was not completely responsive to the species requirement, but to expedite prosecution, we are proceeding with examination. Please choose a particular sequence, with SEQ ID NO: and no variable residues, of the heterologous nucleotide sequence.
Claims 1-3, 5, 7, 9, 10, 13, and 15-19 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, and claims 26 and 29 are withdrawn from further consideration as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 8/10/2026.
Claims 23-25, 27, and 28 are under examination on the merits.
Information Disclosure Statement
The Information Disclosure Statements (IDSs) submitted on 8/11/2026 and 3/15/2024 are in compliance with 37 CFR 1.97. Accordingly, the references listed in the IDSs are being considered by the examiner.
The listing of references in the specification is not a proper information disclosure statement. 37 CFR 1.98(b) requires a list of all patents, publications, or other information submitted for consideration by the Office, and MPEP § 609.04(a) 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.
Claim Objections
Claims 23 and 25 are objected to for depending on a withdrawn claim (claim 1). The examiner recommends amending claims 23 and 25 to incorporate the limitations of claim 1’s composition. Appropriate correction is required.
Claim Interpretation
The examiner is interpreting the elected species “viral antigen” not to read on a “cancer antigen”, because the specification indicates that “in one embodiment, the viral vector comprises an expression construct encoding a first antigenic protein or peptide associated with a viral infection and a second antigenic protein or peptide associated with cancer” (p. 30).
The specification indicates “a construct comprising a nucleic acid sequence operably linked to an expression control sequence is referred to herein as an “expression unit” (p. 9).
The specification indicates “a vector may be encapsulated by viral capsid proteins or may comprise naked nucleic acids associated with one or more molecules for facilitating entry into a cell” (pp. 9-10).
The specification indicates the term "treating or preventing viral infections" means to inhibit the replication of the particular virus, to inhibit viral transmission, or to prevent the virus from establishing itself in its host, and to ameliorate or alleviate the symptoms of the disease caused by the viral infection (p. 13).
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Scope of Enablement
Claims 23-25, 27, and 28 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating cancer in a subject that is permissive to ECTV infection with a composition comprising a cancer antigen expressed by the cancer, does not reasonably provide enablement for treating cancer with a generic heterologous nucleic acid sequence, or viral antigen not expressed by that cancer, in a subject that is not permissive to ECTV infection.
Additionally, the specification is enabling for inducing an immune response in a subject that is permissive to ECTV infection (e.g., mouse), but does not reasonably provide enablement for inducing an immune response in a subject that is not permissive to ECTV infection.
The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The breadth of the claims is found in claims 23 and 25.
The nature of the invention is a method for inducing an immune response in a subject comprising administering the composition of claim 1 to the subject in an amount effective to induce an immune response (claim 23); or a method for treating cancer, a viral infection, or a disease or disorder associated therewith, in a subject in need thereof, the method comprising administering the a recombinant ectromelia virus (ECTV) vector comprising at least one expression unit comprising at least one heterologous nucleic acid sequence to the subject (claim 25).
The level of skill of one skilled in this art is high.
The specification teaches engineered ECTV that expresses a heterologous protein (luciferase) after in vivo infection, and induces an antibody response in infected mice (Example 1). The specification also teaches that ECTV infected and lysed human and rat cells in vitro (Example 2; Fig. 2), and that VACV injected into TS/A tumors of BALB/c mice that had previously been vaccinated against VACV significantly inhibited tumor growth. The specification makes additional prophetic hypotheses about ECTV immunization leading to elimination of tumors after intra-tumoral ECTV administration, possibly by anti-ECTV CD8 T cells and epitope spread to bona-fide tumor antigens (Example 3).
Additionally, the specification states that ECTV can infect rat tumors (Examples 2 and 3; Fig. 3). However, it is unclear from the specification if these rat tumors were in rats or mice, because the description of Figure 3 in the specification (p. 6), indicates that a female Fischer 344 rat was injected with AY-27 tumor cells, ECTV-Luc, and that mice were imaged. The specification indicates that AY-27 cells are rat bladder urothelial carcinoma cells (p. 6), and thus the examiner is interpreting the specification to indicate that ECTV can infect at the very least, some rat cells in certain circumstances. Further, it appears that the ECTV localized to the tumor cells and expressed luciferase, but it is not clear that any anti-tumor effect or immune response was stimulated. Notably, the specification discloses that ECTV has a very narrow host range for the mouse, and is apathogenic in all non-mouse species tested, including rats, rabbits, guinea pigs, hamsters, and humans (spec., p. 1). These teachings do not enable the full breadth of the claims because the specification does not disclose successful treatment of cancer in a subject with ECTV encoding a heterologous nucleic acid sequence that is a generic viral antigen, or any ECTV in general, nor does it demonstrate inducing an immune response or treating cancer the wide range of hosts that are non-permissive to ECTV infection.
The state of the prior art is such that it is well established in the art that poxviruses are well-suited as viral vectors, including for cancer vaccines (Essajee, et al. Expert Opin. Biol. Ther. 2004. 4(4):575-588; Table 1; Essajee, generally). There have been a number of studies, including cancer clinical trials using poxviruses with specific target antigens (Essajee, Table 3). In one example, Prostate-specific antigen (PSA) is a 34 kDa glycoprotein that is expressed by prostatic epithelial cells and is highly overexpressed in areas of prostate inflammation and neoplasia. A vaccinia virus expressing human PSA was shown to elicit a short-lived anti-PSA IgM response and PSA-reactive T cells for up to 270 days after vaccination in rhesus monkeys that express PSA with 95% homology to human PSA, and vaccinia virus encoding PSA was evaluated in a Phase I clinical trial with 14 out of 33 prostate cancer patients showing a stable serum PSA level for at least 6 months after vaccination (p. 582, col. 2, last para.). However, these poxvirus-based cancer vaccines encoded a tumor-associated antigen. Cheng, et al. (Biomed Res Int. 2017;2017:6456180. doi: 10.1155/2017/6456180. Epub 2017 Dec 21. PMID: 29430463) indicates that ECTV has a verry narrow host range (p. 1, col. 2).
Thus, the state of the art recognized that it would be highly unpredictable that an ECTV vector comprising at least one heterologous nucleic acid sequence encoding a viral antigen, could be used to treat cancer, or a disease or disorder associated therewith. The minimal structure which the skilled artisan would consider predictive of the function of treating cancer with any viral vector includes a cancer antigen on or encoded by the vector and expressed by the cancer. Similarly, the state of the art recognized that it would be highly unpredictable that an ECTV vector could stimulate an immune response or treat cancer in a non-permissive host, because ECTV has a very narrow host range. One of skill in the art would neither expect nor predict the appropriate functioning of the methods as broadly as currently claimed.
In view of the lack of the predictability of the art to which the invention pertains as evidenced by Essajee, the lack of guidance and direction provided by applicants, and the absence of working examples, undue experimentation would be required to use the claimed ECTV vectors in the full scope of the claimed methods with a reasonable expectation of success, absent a specific and detailed description in applicant’s specification of how to effectively practice this and absent working examples providing evidence which is reasonably predictive that the claimed ECTV are functional in methods of treating cancer or inducing an immune response in a non-permissive subject, commensurate in scope with the claimed invention.
Moreover, claims not containing elements critical or essential to the practice of the invention, such as a heterologous nucleic acid sequence encoding a cancer antigen expressed by the cancer to be treated, are not enabled by the disclosure. See In re Mayhew, 527 F.2d 1229, 188 USPQ 356 (CCPA 1976).
Note that an enabling disclosure for the preparation and use of only a few analogs of a product does not enable all possible analogs where the characteristics of the analogs are unpredictable. See Amgen Inc. v. Chugai Pharmaceutical Co. Ltd. (18 USPQ 2d 1027 (CAFC 1991)).
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.
Claims 24, 25, 27, and 28 are 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.
Regarding claim 24, which recites the limitation "the at least one antigen" in 2-4. There is insufficient antecedent basis for this limitation in the claim.
Claims 25, 27, and 28 require “[a] method for treating cancer, a viral infection, or a disease or disorder associated therewith” (claim 25, lines 1-2).
The metes and bounds of the claim are unclear because it is unclear in which diseases or disorders are “associated” therewith cancer or a viral infection. It is unclear if these diseases or disorders directly flow from the cancer or viral infection, those caused by inflammation in response to the cancer and/or virus, or could they be secondary effects caused by treatment of the cancer or viral infection. Importantly, the specification does not define “associated with.” Thus, The term “associated with” is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. The claims are very broad, such that their scope is unclear.
See Ex parte Miyazaki, 89 USPQ2d 1207 (BPAI 2008) (“[R]ather than requiring that the claims are insolubly ambiguous, we hold that if a claim is amenable to two or more plausible claim constructions, the USPTO is justified in requiring the applicant to more precisely define the metes and bounds of the claimed invention by holding the claim unpatentable under 35 U.S.C. §112, second paragraph, as indefinite.”).
Claims 27 and 28 do not clarify the scope of the claims by defining what “associated with” means, and are thus also indefinite.
Claim Rejections – Improper Markush Grouping
Claims 25, 27, and 28 are rejected on the judicially-created basis that they contain an improper Markush grouping of alternatives.
See In re Harnisch, 631 F.2d 716, 721-22 (CCPA 1980) and Ex parte Hozumi, 3 USPQ2d 1059, 1060 (Bd. Pat. App. & Int. 1984).
The improper Markush grouping includes species of the claimed invention that do not share both a substantial structural feature and a common use that flows from the substantial structural feature. The members of the improper Markush grouping do not share a substantial structural feature and a common use that flows from the substantial structural feature for the following reasons:
MPEP 803.02 provides guidance on the analysis of a proper Markush group. Members of a proper Markush group are disclosed in the specification to possess at least one property in common which is mainly responsible for their function in the claimed relationship, and it is clear from their very nature or from the prior art that all of them possess this property. The MPEP further provides that in the members of a proper Markush group there should be (1) a common utility, and (2) a substantial structural feature essential to that utility.
In the instant case, claims 25, 27, and 28 include the group of treating a cancer, a viral infection, or a disease or disorder associated therewith, which do not appear to share a substantial structural feature. Thus, a common use/function cannot flow from a shared substantial structural feature in these claims. Specifically, these diseases are very different, including how they affect different cell types, and have different causes and treatments. For example, viral infection is not caused by a cell at all but a virus. Cancers involve abnormal/mutated cells as their source. One disorder involving either could be an inflammatory disorder which involves normal cells. Viruses, cancer cells, and normal cells are structurally different and do not all share a common structure necessary for their role in the claims. Since the instant claims contain Markush groups with members of disease targets (cancer, viral infection, or disease or disorder associated therewith) lacking shared, discernable, discrete domains associated with the claimed function of treating a cancer, a viral infection, or a disease or disorder associated therewith activity, the claims contain an improper Markush group and are rejected here.
In response to this rejection, Applicant should either amend the claim(s) to recite only individual species or grouping of species that share a substantial structural feature as well as a common use that flows from the substantial structural feature, or present a sufficient showing that the species recited in the alternative of the claims(s) in fact share a substantial structural feature as well as a common use that flows from the substantial structural feature. This is a rejection on the merits and may be appealed to the Board of Patent Appeals and Interferences in accordance with 35 U.S.C. §134 and 37 CFR 41.31(a)(1).
Claim Rejections - 35 USC § 102
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 (i.e., changing from AIA to pre-AIA ) 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 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 23 and 25 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Smith, et al. (PGPub US20050169940A1, published 8/4/2005).
The Prior Art
Smith teaches a recombinant poxvirus having a genome comprising a non-poxvirus gene or a fragment of a nonpoxvirus gene which encodes an antigen (para, [0014]), where the recombinant poxvirus is preferably an ectromelia virus (para. [0027]). Additionally, Smith discloses that the gene encoding the antigen is preferably engineered to be associated with transcriptional regulatory sequences for expression of the gene by poxvirus in an infected host cell, and include a promoter and terminator from a poxvirus (para. [0064]). Smith also teaches that the gene that encodes an antigen may be any nonpoxvirus gene, which a cellular immune response against in a subject is desirable, and suitable genes include those encoding immunogenic peptides or polypeptides of an infectious pathogen, such as an influenza virus (para. [0053]). Smith further teaches that the recombinant poxviruses may be used as a vaccine for the prophylaxis of an infection caused in a subject by a pathogenic agent (para. [0052).
Accordingly, Smith teaches methods for inducing an immune response or treating a viral infection, or a disease or disorder associated therewith, in a subject comprising administering a recombinant ECTV vector comprising at least one expression unit comprising at least one heterologous nucleic acid sequence to a subject in an amount effective to induce an immune response, as required by claims 23 and 25
Therefore, claims 23 and 25 are anticipated by Smith.
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.
The factual inquiries 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.
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.
Claims 23-25, 27, and 28 are rejected under 35 U.S.C. 103 as being unpatentable over Smith, et al. (PGPub US20050169940A1, published 8/4/2005) and Prabakaran, et al. (PLoS One. 2014 Sep 17;9(9):e107316. PMID: 25229722).
The Prior Art
Smith teaches a recombinant poxvirus having a genome comprising a non-poxvirus gene or a fragment of a nonpoxvirus gene which encodes an antigen (para, [0014]), where the recombinant poxvirus is preferably an ectromelia virus (para. [0027]). Additionally, Smith discloses that the gene encoding the antigen is preferably engineered to be associated with transcriptional regulatory sequences for expression of the gene by poxvirus in an infected host cell, and include a promoter and terminator from a poxvirus (para. [0064]). Smith also teaches that the gene that encodes an antigen may be any nonpoxvirus gene, which a cellular immune response against in a subject is desirable, and suitable genes include those encoding immunogenic peptides or polypeptides of an infectious pathogen, such as an influenza virus (para. [0053]). Smith further teaches that the recombinant poxviruses may be used for vaccines for the prophylaxis or treatment of a disease associated with aberrant cells (para. [0054]), or for use as a vaccine for the prophylaxis of an infection caused in a subject by a pathogenic agent (para. [0052]).
Accordingly, Smith teaches methods for inducing an immune response or treating a viral infection, or a disease or disorder associated therewith, in a subject comprising administering a recombinant ECTV vector comprising at least one expression unit comprising at least one heterologous nucleic acid sequence to a subject in an amount effective to induce an immune response, as required by claims 23 and 25.
However, Smith does not teach the immune response comprises the production of antibodies specific for the at least one antigen, nor a recombinant ECTV vector that further comprises a target nucleotide sequence encoding a viral antigen, as required by claim 27. The examiner is interpreting the language “wherein the recombinant ECTV vector further comprises a target nucleotide sequence encoding a viral antigen” to mean that the ECTV vector comprises a second nucleotide sequence, in addition to the at least one expression unit comprising at least one heterologous nucleic acid sequence of claim 1.
Prabakaran discloses an MVAtor vector expressing three H5 HA antigens from strains A/Vietnam 1203/04, A/Indonesia/669/06, and A/Anhui/01/05 (MVAtor-tri-HA), developed to elicit broad cross protection against diverse clades by covering amino acid variations in the major neutralizing epitopes of HA among H5N1 subtypes (Abstract). Prabakaran further discloses that mice immunized with MVAtor-tri-HA induced robust cross-neutralizing immunity to diverse H5N1 clades, completely protected against a divergent clade of H5N1 infection (clade 7), and serological surveillance of post-vaccinated guinea pig sera demonstrated that MVAtor-tri-HA vector was able to elicit strong cross-clade neutralizing immunity against twenty different H5N1 strains from six clades that emerged between 1997 and 2012 (Results, p. 1). Prabakaran further discloses that to construct MVAtor-tri-HA vector, the three HAs were fused to the PsynI, PsynII, and H5 promoters, respectively, within one DNA fragment, and the complete transgenic cassette incorporating the three HAs was cloned into the MVA genome (p. 2, col. 2). Prabakaran also discloses that vaccination led to a significant increase in specific, neutralizing antibody titers against homologous H5N1 strains, such that mice immunized with MVAtor-tri-HA vector showed cross-neutralizing antibodies against different clades of H5N1 strains (p. 7, col. 1; Fig. 3).
It would have been obvious to one of ordinary skill in the art to modify the ECTV vectors taught by Smith to encode the fragment encoding three HAs fused to respective promoters, as taught by Prabakaran. Prabakaran discloses that an MVA vaccine encoding those three HAs induced specific, cross-neutralizing antibodies to H5N1 strains. A person of ordinary skill in the art would expect an ECTV comprising the HA expression units disclosed by Prabakaran would similarly induce antibodies specific for the viral antigen, because the immune system will recognize the epitopes as foreign and mount an immune response against them. Additionally, MVA is a poxvirus, like ECTV (the spec. indicates vaccinia virus is an orthopoxvirus (p. 1, and Prabakaran teaches MVA is a modified vaccinia virus, p. 2, col. 1, para. 2). Additionally, the three HA encoding genes each have a respective promoter, so they are interpreted as being separate expression units as required by claim 1, and thus either of the other two HA encoding gene and its fused promoter would constitute the obvious ECTV vector further comprising a target nucleotide sequence encoding a viral antigen, and specifically an influenza viral antigen, as required by claims 27 and 28.
It also would have been obvious to one of ordinary skill in the art to optimize the effective dose so as to get sufficient expression of targets to elicit an immune response. It has long been settled to be no more than routine experimentation for one of ordinary skill in the art to discover an optimum value of a result effective variable. "[W]here the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum of workable ranges by routine experimentation." Application of Aller, 220 F.2d 454, 456, 105 USPQ 233, 235-236 (C.C.P.A. 1955). "No invention is involved in discovering optimum ranges of a process by routine experimentation." Id. at 458, 105 USPQ at 236-237. The "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." Application of Boesch, 617 F.2d 272, 276, 205 USPQ 215, 218-219 (C.C.P.A. 1980). Since Applicant has not disclosed that the specific limitations recited in instant claims are for any particular purpose or solve any stated problem, and the prior art teaches that parameter magnitudes that are encompassed by instant claims, often vary according to the sample being analyzed and various matrices, solutions and parameters appear to work equally as well, absent unexpected results, it would have been obvious for one of ordinary skill to discover the optimum workable ranges of the methods disclosed by the prior art by normal optimization procedures known in the art.
One of ordinary skill in the art would have been motivated to elicit broad cross protection against diverse clades by covering amino acid variations in the major neutralizing epitopes of HA among H5N1 subtypes. There would have been a reasonable expectation of success because Prabakaran discloses that mice immunized with MVAtor-tri-HA encoding those HA antigens induced robust cross-neutralizing immunity, including specific antibodies, to diverse H5N1 clades, and were completely protected against a divergent clade of H5N1 infection. Therefore, claims 23-25, 27, and 28 were prima facie obvious before the priority date of the instant invention.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to JEFFREY MARK SIFFORD whose telephone number is 571-272-7289. The examiner can normally be reached 8:30 a.m. - 5:30 p.m. ET with alternating Fridays off.
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/JEFFREY MARK SIFFORD/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
