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 I (claims 1-10) in the reply filed on 9/17/2025 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)).
Applicant’s election of a combination of UL49.5 with gI or gE, or both for the target gene, and GM-CSF for the immunomodulatory molecule is also acknowledged. While applicant’s election of a combination of UL49.5 with gI or gE, or both is not responsive as the requirement is for election of a single species, however, based on the instant amendment, the restriction requirement is withdrawn for the target genes.
Claims 31-36 are newly added, claims 11-30 have been withdrawn from consideration as being drawn to non-elected subject matter, and claims 1-10 and 31-36 have been considered on the merits.
Claim Objections
Claim 1 is objected to because of the following informalities: the term “BHV-1” would be disclosed in a full name, i.e. bovine herpesvirus-1, followed by the abbreviation in the parenthesis. Appropriate correction is required.
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.
Claims 33-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention. This is a new matter rejection.
The instant amendment filed on 9/17/2025 introduces new claims 33-36, and these claims are directed to the formulation comprises a chemotherapeutic agent, a checkpoint inhibitor, immunogenic antibodies, or an immune cell therapy. Claim 32 discloses that the formulation comprises a recombinant BHV-1 mutant virus of claim 1 and a pharmaceutically acceptable carrier, and the formulation according to claims 33-36 comprise a chemotherapeutic agent, a checkpoint inhibitor, immunogenic antibodies, or an immune cell therapy.
The instant specification does not disclose any formulation comprising the BHV-1 mutant virus; a pharmaceutically acceptable carrier; and a chemotherapeutic agent, a checkpoint inhibitor, immunogenic antibodies, or an immune cell therapy. Rather, the specification discloses that the formulation would be used in addition to other agents or therapy as claimed. Thus, the newly added claims directed to the formulation comprising a chemotherapeutic agent, a checkpoint inhibitor, immunogenic antibodies, or an immune cell therapy introduces new matter to the instant application.
In amended cases, subject matter not disclosed in the original application is sometimes added and a claim directed thereto. Such a claim is rejected on the ground that it recites elements without support in the original disclosure under 35 U.S.C. 112, first paragraph, Waldemar Link, GmbH & Co. v. Osteonics Corp. 32 F.3d 556, 559, 31 USPQ2d 1855, 1857 (Fed. Cir. 1994); In re Rasmussen, 650 F.2d 1212, 211 USPQ 323 (CCPA 1981). See MPEP § 2163.06 - § 2163.07(b) for a discussion of the relationship of new matter to 35 U.S.C. 112, first paragraph. New matter includes not only the addition of wholly unsupported subject matter, but may also include adding specific percentages or compounds after a broader original disclosure, or even the omission of a step from a method. See MPEP § 608.04 to § 608.04(c). See In re Wertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976) and MPEP § 2163.05 for guidance in determining whether the addition of specific percentages or compounds after a broader original disclosure constitutes new matter.
Written Description Rejection
Claims 1-10 and 31-36 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
The instant claims are directed to a mutant BHV-1 virus comprising a mutation in UL49.5 to yield a mutant exhibiting enhanced cancer selectivity and/or enhanced immunostimulatory activity. The scope of “mutation in UL49.5” would be extensive as the mutation would encompass point mutation, truncation/deletion mutation, and such mutation would be in any position of amino acids of UL45.9 protein. The “mutation” is further limited with the functionality of the mutation and the mutation has to produce the claimed enhanced properties. However, there is no disclosure in the claims if such property is limited to a specific mutation or not. Thus, under the broadest reasonable interpretation, the claims are interpreted to any mutant BHV-1 in UL49.5 and any mutation in UL49.5 would necessarily and sufficiently produce the claimed properties.
The specification, however, discloses a single embodiment of BHV-1 mutant which contains two specific mutations in amino acids 30-32 deletion and cytoplasmic tail deletion, i.e. BHV-1-UL49.5Δ30-32ΔCT mutant.
There is no other example of mutation in UL49.5 that would meet the claimed property of enhanced cancer selectivity and/or enhanced immunostimulatory activity.
The instant claims are only a definition of a useful result rather than a definitionof what achieves that result. Many such species of the genus may achieve that result. The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. See In re Wilder, 736 F.2d 1516, 1521, 222 USPQ 369, 372 73 (Fed. Cir. 1984). Accordingly, naming a type of material generally thought to exist, in the absence of knowledge as to what that material consists of, is not a description of that entire material.
M.P.E.P. §2163 recites, “The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice, reduction to drawings, or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus…when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus.”
Considering extensive number of potential mutations in UL49.5 that could provide the claimed property in a mutant BHV-1, and only a single example of such mutation to meet the required property, it is considered that the instant specification failed to provide sufficient written description to support the entire scope of the claimed invention.
Scope of Enablement Rejection
Claims 1-10 and 31-36 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 the mutant BHV-1 that has deletion mutations in amino acids 30-32 and the cytoplasmic tail, i.e. BHV-1-UL49.5Δ30-32ΔCT mutant, does not reasonably provide enablement for any other mutation in UL49.5. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make/use the invention commensurate in scope with these claims.
Enablement is considered in view of the Wands factors (MPEP 2164.01 (a)). The court in Wands states: "Enablement is not precluded by the necessity for some experimentation such as routine screening. However, experimentation needed to practice the invention must not be undue experimentation. The key word is 'undue,' not 'experimentation.' " (Wands, 8 USPQ2d 1404). Clearly, enablement of a claimed invention cannot be predicated on the basis of quantity of experimentation required to make or use the invention. "Whether undue experimentation is needed is not a single, simple factual determination, but rather is a conclusion reached by weighing many factual considerations." (Wands, 8 USPQ2d 1404). The factors to be considered in determining whether undue experimentation is required include: (1) the quantity of experimentation necessary, (2) the amount or direction or guidance presented, (3) the presence or absence of working examples, (4) the nature of the invention, (5) the state of the prior art, (6) the relative skill of those in the art, (7) the predictability or unpredictability of the art, and (8) the breadth of the claims. While all of these factors are considered, a sufficient amount for a prima facie case are discussed below.
The instant claims are directed to a mutant BHV-1 virus comprising a mutation in UL49.5 to yield a mutant exhibiting enhanced cancer selectivity and/or enhanced immunostimulatory activity. The scope of “mutation in UL49.5” would be extensive as the mutation would encompass point mutation, truncation/deletion mutation, and such mutation would be in any position of amino acids of UL45.9 protein. The “mutation” is further limited with the functionality of the mutation and the mutation has to produce the claimed enhanced properties. However, there is no disclosure in the claims if such property is limited to a specific mutation or not.
The claimed mutant BHV-1 requires to possess the functional property of “enhanced cancer selectivity and/or enhanced immunostimulatory activity enhanced cancer selectivity and/or enhanced immunostimulatory activity”, and yet the claims do not disclose what structural feature would necessarily provide the claimed property to the BHV-1 mutant. Rather, any mutant in UL49.5 is disclosed in the claims.
Furthermore, the claimed property is directed to the intended results when the claimed product is utilized for the purpose of cancer treatment.
Thus, under the broadest reasonable interpretation, the claims are interpreted to any mutant BHV-1 in UL49.5 and any mutation in UL49.5 would necessarily and sufficiently produce the claimed properties.
The specification, however, discloses a single embodiment of BHV-1 mutant which contains two specific mutations in amino acids 30-32 deletion and cytoplasmic tail deletion, i.e. BHV-1-UL49.5Δ30-32ΔCT mutant.
There is no other example of mutation in UL49.5 that would meet the claimed property of enhanced cancer selectivity and/or enhanced immunostimulatory activity.
The instant specification defines the term “enhanced immunostimulatory activity” is used herein to refer to a BHV-1 mutant that has lost the function of a viral protein involved in evading the host immune defense, e.g. viral UL49.5 protein that activates degradation of the transporter associated with antigen processing (TAP).
While the complete deletion of UL49.5 gene and thus, the expression thereof would be encompassed for the claimed property, however, the scope as claimed would not be limited to the total deletion of UL49.5 gene, and it would encompass any mutation or deletion of any portion of the UL49.5 gene. However, the specification fails to provide any guidance where in UL49.5 gene or which amino acid of UL49.5 protein would be mutated in order to obtain the loss of UL49.5 function.
M.P.E.P. § 2164.03 reads, “The amount of guidance or direction needed to enable the invention is inversely related to the amount of knowledge in the state of the art as well as the predictability in the art. In re Fisher, 427 F.2d 833, 839, 166 USPQ 18, 24 (CCPA 1970). The ‘amount of guidance or direction’ refers to that information in the application, as originally filed, that teaches exactly how to make or use the invention. The more that is known in the prior art about the nature of the invention, how to make, and how to use the invention, and the more predictable the art is, the less information needs to be explicitly stated in the specification. In contrast, if little is known in the prior art about the nature of the invention and the art is unpredictable, the specification would need more detail as to how to make and use the invention in order to be enabling. See, e.g., Chiron Corp. v. Genentech Inc., 363 F.3d 1247, 1254, 70 USPQ2d 1321, 1326 (Fed. Cir. 2004) (“In applications directed to inventions in arts where the results are unpredictable, the disclosure of a single species usually does not provide an adequate basis to support generic claims. In cases involving unpredictable factors, such as most chemical reactions and physiological activity, more may be required.”).”
The level of one of ordinary skill in the art at the time of invention was advanced, being that of a person holding a Ph.D. or an M.D.; however, because of the immaturity of the art, and its unpredictability, as shown by the other factors, one of skill in the art at the time of invention by Applicant would not have been able to make and/or use the invention claimed, to its fully-claimed scope, without undue experimentation.
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 8 and 33-36 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.
Claim 8 discloses that the gene encoding the immunomodulatory molecule is inserted within a target gene. It is not clear if the “target gene” is different from the “one or more target genes” in claim 1 or it is referring to the “target gene” in claim 1. Clarification is required.
Claims 33-36 disclose that the formulation comprises a chemotherapeutic agent, a checkpoint inhibitor, immunogenic antibodies, or an immune cell therapy. It is not clear what the scope of these limitations is. Are these components additional element of the formulation comprising the BHV-1 mutant virus and the carrier? Or the mutant virus expresses any of these components? Clarification is required.
Claim 36 discloses that the formulation comprises an immune cell therapy. It is not clear what subject matter this limitation intends to point out. The “therapy” is not a product or component to be in a formulation. It is not clear how the “cell therapy” would be a part of the formulation as claimed. Clarification is required.
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.
Claim(s) 1, 5, 7 and 32 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Osterrieder et al. (US 8,637,046 B2) as evidenced by Mossman et al. (WO2009/033278; IDS ref.).
Osterrieder et al. teach a recombinant BHV-1 that contains modified genes (col. 17, lines 29-47), the modification includes in UL49.5 (col.15, lines 60-65) and BHV-1 GL756 deletion mutants for UL49.5, i.e. BHV-1ΔUL49.5 mutant (Example 5). Osterrieder et al. also teach another BHV-1 mutant that contains two in-frame translational stop codons into the wild-type UL49.5 sequence, and produce truncated UL49.5 protein (Example 6).
Regarding the target gene being mutated to yield a mutant that exhibits enhanced cancer selectivity and/or enhanced immunostimulatory activity, Osterrieder et al. do not particularly teach the characteristics of the mutant. However, the mutant BHV-1 taught by Osterrieder et al. contains the claimed mutation in the target gene of UL49.5, the mutant BHV-1 of Osterrieder et al. would inherently have the same characteristics as the claimed BHV-1 mutant.
Regarding the BHV-1 is oncolytic virus, the limitation is considered inherent for the BHV-1 as Mossman et al. teach that BHV-1 is an oncolytic virus that infect human tumor cells but not normal human cells (para. 4 and 7). The term “oncolytic” is interpreted as an intended purpose of the claimed product. At the same time, it is an inherent property of BHV-1 according to Mossman et al. Therefore, in the absence of any other structural feature(s) necessary for the virus being oncolytic, it is considered that the BHV-1 mutant taught by Osterrieder et al. would be oncolytic.
Regarding claim 5, the wherein clause is directed to the property of the claimed mutant BHV-1 virus (BHV-1ΔUL49.5 mutant), as the BHV-1 mutant taught by Osterrieder et al. is considered identical to the claimed mutant virus, it is expected that the BHV-1 mutant of Osterrieder et al. has identical property as the claimed virus in the absence of any evidence to the contrary.
Regarding claim 7, as the mutant BHV-1 of Osterrieder et al. do not express UL49.5, the function of UL49.5 is deficient and thus, the BHV-1 mutant of Osterrieder et al. would meet the limitation.
Regarding claim 32, Osterrieder et al. teach the use of pharmaceutically acceptable carriers (col. 18, line 5).
Thus, the reference anticipates the claimed invention.
Claim(s) 1, 5 and 7 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Wei et al. (2011, PLOS One; IDS ref.) as evidenced by Mossman et al. (WO2009/033278; IDS ref.)
Wei et al. teach BHV-1 comprising cytoplasmic tail (CT) null and UL40.5 luminal domain mutants including the BHV-1 UL49.5 Δ30-32 CT null virus (Abstract).
Regarding the target gene being mutated to yield a mutant that exhibits enhanced cancer selectivity and/or enhanced immunostimulatory activity, Wei et al. do not particularly teach the characteristics of the mutant. However, the BHV-1 mutant having UL49.5Δ30-32 CT null taught by Wei et al. is identical to the mutant BHV-1 disclosed in the instant application (see Example 3, para. 60), and thus, the BHV-1 mutant having UL49.5Δ30-32 CT null taught by Wei et al. is expected to have the identical property as the claimed mutant BHV-1.
Regarding the BHV-1 is oncolytic virus, the limitation is considered inherent for the BHV-1 as Mossman et al. teach that BHV-1 is an oncolytic virus that infect human tumor cells but not normal human cells (para. 4 and 7).
Regarding claim 5, the wherein clause is directed to the property of the claimed mutant BHV-1 virus (BHV-1ΔUL49.5 mutant), as the BHV-1 mutant taught by Wei et al. is considered identical to the claimed mutant virus, it is expected that the BHV-1 mutant of Wei et al. has identical property as the claimed virus. The term “oncolytic” is interpreted as an intended purpose of the claimed product. At the same time, it is an inherent property of BHV-1 according to Mossman et al. Therefore, in the absence of any other structural feature(s) necessary for the virus being oncolytic, it is considered that the BHV-1 mutant taught by Wei et al. would be oncolytic.
Regarding Claim 7, as the BHV-1 mutant of Wei et al. is identical to the claimed mutant, it is expected that the BHV-1 mutant of Wei et al. would have the same property to prevent degradation of TAP. Furthermore, Wei et al. teach that the mutant BHV-1 promote efficient TAP inhibition and MHC-I down-regulation functions (Abstract).
Thus, the reference anticipates the claimed invention.
Claim(s) 1-3, 5, 7-10 and 31-32 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Chowdhury (US2018/0353596 A1) as evidenced by Mossman et al. (WO2009/033278; IDS ref.) and Kim et al. (2019, Cancer Immunol. Res.)
Chowdhury teach a recombinant BoHV-1 designated as UL49.5Δ30-32CT-null/gE-CTΔ/Us9Δ virus (see Fig.3A), and this virus contains deletion at amino acid 30-32 and 80-96 of UL49.5 (Δ30-32 and CT-null) and deletion of cytoplasmic tail of gE (para. 4). Thus, the BoHV-1 of Chowdhury would meet the limitation of claims 1 and 3.
Regarding the BHV-1 is oncolytic virus, the limitation is considered inherent for the BHV-1 as Mossman et al. teach that BHV-1 is an oncolytic virus that infect human tumor cells but not normal human cells (para. 4 and 7). The term “oncolytic” is interpreted as an intended purpose of the claimed product. At the same time, it is an inherent property of BHV-1 according to Mossman et al. Therefore, in the absence of any other structural feature(s) necessary for the virus being oncolytic, it is considered that the BHV-1 mutant taught by Chowdhury would be oncolytic.
Regarding claims 2 and 8-10 directed to the virus expressing a gene encoding an immunomodulatory molecule (claim 2); the gene encoding the immunomodulatory molecule being inserted within a target gene (claim 8); the immunomodulatory molecule being a chemokine (claim 9); and the immunomodulatory molecule being GM-CSF (claim 10), Chowdhury teach the BHV-1 mutant having UL49.5Δ30-32CT-null further comprising the cassette expressing GM-CSF inserted into a gene (gG deletion site) of the BHV-1(Fig. 22; para. 30). This teaching would meet the limitations of claims 2 and 8-10.
Regarding claim 5, the wherein clause is directed to the property of the claimed mutant BoHV-1 virus (UL49.5Δ30-32CT-null/gE-CTΔ/Us9Δ), as the BoHV-1 mutant taught by Chowdhury is considered identical to the claimed mutant virus, it is expected that the BHV-1 mutant of Wei et al. has identical property as the claimed virus in the absence of any evidence to the contrary. In the absence of any evidence that the term “oncolytic” requires any specific structure of the BoHV-1, it is considered that the BoHV-1 mutant taught by Chowdhury would be oncolytic.
Regarding claim 7, as the BoHV-1 mutant of Chowdhury is identical to the claimed mutant, it is expected that the BoHV-1 mutant of Chowdhury would have the same property to prevent degradation of TAP.
Regarding claim 31, the wherein clause is directed to the property of the immunomodulatory molecule, and the intended result of the molecule when the claimed product is utilized. GM-CSF expressed by the BHV-1 mutant of Chowdhury as discussed above is known to promote antitumor immunity according to Kim et al. (see abstract).
Regarding claim 32, Chowdhury teach carriers such as sterile aqueous or non-aqueous solutions including polyethylene glycol (para. 152 and 162).
Thus, the reference anticipates the claimed invention.
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.
Claim(s) 3-4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Osterrieder et al. (supra) as applied to claims 1, 5 and 7 above, in view of Kaashoek et al. (1998, Vaccine; IDS ref.).
Osterrieder et al. anticipate the subject matter of claims 1, 5 and 7, and thus, render them obvious (see above).
Regarding claims 3-4 and 6 directed to the target genes being UL49.5 and gE (claim 3); UL49.5 and gI (claim 4), or UL49.5, gE and gI (claim 6), while Osterrieder et al. teach the mutation in UL49.5, however, they do not teach the target genes expressing gE, gI or gE and gI along with UL49.5.
Kaashoek et al. teach that the deletion of gI and gE genes in BHV-1 would reduce the immunogenicity to the virus (Abstract). Kaashoek et al. teach that based on residual virulence and immunogenicity, both the gI and the gE deletion mutants are candidates for incorporation in live BHV-1 vaccines (Abstract).
It would have been obvious to a person skilled in the art to delete gE and gI genes in the BHV-1 mutant of Osterrieder et al. with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the gE and gI genes encode non-essential glycoprotein of BHV1, and yet they would induce immune response when utilized in a therapy, and the deletion of these non-essential protein encoding genes would provide a benefit for the purpose of BHV-1 mutant taught by Osterrieder et al. as a vaccine.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 4 and 6 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chowdhury (supra) as applied to claims 1-3, 5, 7-10 and 31-32 above, in view of Kaashoek et al. (supra).
Chowdhury anticipated the subject matter of claims 1-3, 5, 7-10 and 31-32, and thus render them obvious (see above).
Regarding claims 4 and 6, Chowdhury do not teach the target gene includes glycoprotein I (gI).
Kaashoek et al. teach that the deletion of gI and gE genes in BHV-1 would reduce the immunogenicity to the virus (Abstract). Kaashoek et al. teach that based on residual virulence and immunogenicity, both the gI and the gE deletion mutants are candidates for incorporation in live BHV-1 vaccines (Abstract).
It would have been obvious to a person skilled in the art to delete both gE and gI genes in the BHV-1 mutant of Chowdhury with a reasonable expectation of success. A person of ordinary skilled in the art would have been motivated to do so because the gE and gI genes encode non-essential glycoprotein of BHV1, and yet they would induce immune response when utilized in a therapy, and the deletion of these non-essential protein encoding genes would provide a benefit for the purpose of BHV-1 mutant taught by Chowdhury as a vaccine.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Claim(s) 33-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Chowdhury (supra) as applied to claims 1-3, 5, 7-10 and 31-32 above, in view of Mossman et al. (supra) and Tsimberidou et al. (2020, Cancer Treatment Review)
Chowdhury teach the subject matter of claims 1-3, 5, 7-10 and 31-32 (see above).
Regarding claims 33-36, Chowdhury do not teach the limitations.
Mossman et al. teach that mutant BHV-1 can be used for the ability to selectively kill tumor cells (para. 37).
It would have been obvious to a person skilled in the art to use the mutant BHV-1 taught by Chowdhury for the purpose of killing tumor cells, i.e. cancer treatment, with a reasonable expectation of success. While Chowdhury intend to utilize the mutant BHV-1 as a vaccine and to express immunomodulatory molecule, such as GM-CSF, however, one skilled in the art would recognize that the mutant BHV-1 would have another purpose based on Mossman et al. as Mossman et al. teach that BHV-1 does not productively infect normal human cells but it is oncolytic without any genetic engineering to require for the oncolytic effect (para. 35). Thus, it would be reasonable to utilize the mutant BHV-1 of Chowdhury for treating a cancer.
By doing so, it would have been obvious to a person skilled in the art to use the mutant BHV-1 of Chowdhury along with any other known tumor treating agents. It is well known in the art that the listed species of chemotherapeutic agent, a checkpoint inhibitor, immunogenic antibodies and immune cell therapy are utilized in cancer treatment. For example, Tsimberidou et al. teach various cancer treatment paradigm including chemotherapy, checkpoint inhibitors, immunotherapy and cellular therapy, e.g. chimeric antigen receptor T-cells (see entire document; Abstract).
Thus, it would have been prima facie obvious to a person skilled in the art to combine the BHV-1 mutant of Chowdhury as an oncolytic agent taught by Mossman et al. along with various known cancer therapies taught by Tsimberidou et al. with a reasonable expectation of success.
Therefore, the invention as a whole would have been prima facie obvious to a person of ordinary skill before the effective filing date of the claimed invention.
Conclusion
No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TAEYOON KIM whose telephone number is (571)272-9041. The examiner can normally be reached 9-5 EST Monday-Friday.
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, JAMES SCHULTZ can be reached at 571-272-0763. 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.
/TAEYOON KIM/Primary Examiner, Art Unit 1631