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 .
Applicant’s Response to Election/Restriction Filed, Amendment, and Arguments/Remarks, filed 29 December 2025, have been entered. Claims 1-20 and 28-31 are currently pending. Claims 2-19 and 28 have been amended by Applicants’ amendment filed on 29 November 2025. Claims 1, 20, and 28 are independent claims.
Applicant’s election without traverse of the invention of Group II, drawn to a method for treating or alleviating a tumor in a subject, is acknowledged.
Additionally, Applicant’s election of the following species without traverse is acknowledged:
Immunostimulatory agents: b. IL-12;
Immunotherapeutic agents: a. anti-PD-1;
Brain tumors: a. glioma.
Claims 1 and 20 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 2-19 and 28-31 are currently pending in the application and under examination to which the following grounds of rejection are applicable. An action on the merits follows.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/CN2021/135336, filed 03 December 2021, which claims priority to PCT/CN2020/133943, filed 04 December 2020. Filing of a certified copy of PCT/CN2020/133943, filed 04 December 2020, is acknowledged.
Thus, the earliest possible priority for the instant application is 04 December 2020.
Information Disclosure Statement
The information disclosure statements filed 03 June 2023, 24 April 2024, 17 July 2024, and 22 April 2025 have been considered by the Examiner. Examiner notes the filing of IDS Size Fee assertions for the IDS filed 22 April 2025, as required under 37 CFR 1.98, indicating that no IDS size fee is required under 37 CFR 1.17(v) at this time.
Claim Objections
Claims 3, 5-6, 8-19, and 28 are objected to because of the following informalities:
The claims each recite abbreviations without first writing out the terms for which they stand: “ICP0” and “LAT” in claim 3; “UL”, “US”, “UL1”, “UL56”, “US1”, and “US12” in claim 4; “HSV-1“ and “KOS” in claim 5; “HSV-1” in claim 6, “UL” and “US” in claim 8; “UL” and “UL56” in claim 9; “US” and “US1” in claim 10; “oHSV-1” and “HSV-1” in claim 11; “oHSV” in claim 12; “GM-CSF”, “IL-2”, “IL-12”, “IL-15”, “IL-24”, and “IL-27” in claim 13; “IL-12” in claim 14; “PD-1” and “CTLA-4” in claim 15; “PD-1” in claim 16; “UL3”, “UL4” and “UL” in claim 17; “oHSV-1”, “IL-12”, and “PD-1” in claim 18; “IL-12”, “PD-1”, “UL3”, “UL4”, and “UL” in claim 19; and “oHSV-1”, “ICP34.5”, “ICP0”, “ICP4”, “ORF P”, “ORF O”; “UL”, and “US” in claim 28.
Appropriate correction is required.
Claim 31 is objected to because of the following informalities: claim 31 recites the term “glioblastoma multiform”, which appears to be a typographical misspelling of “glioblastoma multiforme”. Appropriate correction is required.
Claim Rejections - 35 USC § 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.
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 2-19 and 28-31 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. Claims 2-4, 7, 9-19, and 29-31 are included in this rejection due to their dependence on claim 28, claim 6, and/or claims 8-10.
Independent claim 28 has multiple issues of indefiniteness.
Claim 28 recites the limitation "oHSV-1" in lines 2 and 3. There is insufficient antecedent basis for this limitation in the claim. Claim 28 has not prior recitation of an oHSV-1.
Claim 28 recites “wherein the oHSV-1 comprises a modified genome” in lines 3-4, but does not indicate what the genome is modified in comparison to. The term “modified” in claim 28 is a relative term which renders the claim indefinite. The term “modified” 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.
Claim 28 recites the limitation "the modification" in line 4. There is insufficient antecedent basis for this limitation in the claim. Claim 28 has a prior recitation of a modified genome, but no prior recitation of a modification.
Claim 28 recites, “an alternation of a copy of ɣ34.5”, which is indefinite because it is unclear what Applicant intends to encompass as an “alternation”. For example, it is unclear whether Applicant intends to encompass a tandem duplication of ɣ34.5, alternative copies of ɣ34.5, deleterious mutant copies of ɣ34.5, deletions of ɣ34.5, or some other change to the ɣ34.5 gene.
Claim 28 also recites, “incapable of expressing functional ICP34.5 protein” in line 6 and “capable of expressing respective functional proteins” in line 13, which are indefinite because it is unclear to what extent the incapable or capable functions of the oHSV-1 genes are meant to be manifest within the method steps of the instant invention, and under what conditions the capability or incapability is meant to manifest. For example, it is unclear whether the method requires the expression of functional proteins from the UL and US component single-copy genes. Additionally, it is unclear how the genes are capable or incapable of expressing function proteins in that genes encode a protein but are not themselves responsible for expressing the proteins.
Recitation in claim 28 of the term “duplicated” in line 8 is indefinite because it is unclear whether the duplication is meant to be an active step of the claimed or method or whether the claim merely intends to encompass wherein two copies of the non-coding sequences exist within the internal inverted repeat region prior to deletion.
Claim 28 recites the limitation "the double-copy genes" in line 10. There is insufficient antecedent basis for this limitation in the claim.
As such, the metes and bounds of the claim cannot be determined.
Claims 5 and 6 each recite the limitation "the HSV-1" in line 1 of each. There is insufficient antecedent basis for this limitation in the claim. Claims 5 and 6 are each dependent on claim independent claim 28, which has no prior recitation of an HSV-1. As such, the metes and bounds of the claim cannot be determined.
Claim 8 recites, “wherein the deletion of an internal inverted repeat region starts from the stop codon of the last gene in the UL component to the promoter of the first gene in the US component”, which is indefinite because it is unclear whether the stop codon and/or promoter are included in the deleted sequences. As such, the metes and bounds of the claim cannot be determined.
Additionally, claims 8-10 are further indefinite by claim 8 reciting that “the deletion of an internal inverted repeat region starts from the stop codon of the last gene in the UL component to the promoter of the first gene in the US component”, claim 9 reciting that the last gene is UL56, and claim 10 reciting that the first gene is US1; such that claims 8-10 conflicts with the limitation of independent claim 28, upon which it depends (claim 8 depends on claim 6, which depends on claim 28), in that the final UL gene (e.g., UL56 gene) is in the reverse orientation relative to the direction of a protocol (P) standard gene arrangement for UL1-UL56, as diagram depicted in instant Figure 1 [as evidenced by ViralZone, 2017, retrieved on 06 March 2026 from: <web.archive.org/web/20170523041329/https://viralzone.expasy.org/5756>, archived on 23 May 2017], and is oriented such that the promoter is the closest part of the gene to the internal repeat region. Therefore, by claiming to delete from the stop codon of the UL56 gene to the promoter of the US1 gene, Applicant is claiming to delete at least the full coding sequence of the UL56 gene, thereby reciting a limitation which conflicts with the limitation of claim 28 which recites, “wherein all single-copy genes in both UL and US components of the genome are intact such that they are capable of expressing respective functional proteins”.
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As such, the metes and bounds of the claims cannot be determined.
In the interest of compact prosecution, claims 8-10 have been interpreted such that the deletion comprises sequences between the UL56 promoter and the US1 promoter.
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 (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 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) 2-19 and 28-31 are rejected under 35 U.S.C. 103 as being unpatentable over Zhou [US20190083555A1, published 21 March 2019]; in view of Nakashima [US20180133269A1, published 17 May 2018]; and ViralZone [2017, retrieved on 06 March 2026 from: <web.archive.org/web/20170523041329/https://viralzone.expasy.org/5756>, archived on 23 May 2017].
Regarding independent claim 28, Zhou teaches a method for treating or alleviating a glioblastoma by administering to a subject in need thereof an effective amount of an oncolytic HSV-1 (oHSV-1), or a pharmaceutical composition comprising the oHSV-1, wherein the oHSV-1 comprises a modified genome, and the modified genome comprises a deletion of an internal inverted repeat region of the genome which deletes one copy of each of the double-copy genes (i.e., ICP0, ICP4, ICP34.5, ORF P, and ORF O) and one copy of the duplicated non-coding sequences within the internal inverted repeat region, and wherein all single-copy genes in both UL and US components of the genome are intact such that they are capable of expressing the encoded functional proteins [0002, 0013, 0017-0018, 0041-0045, 0047].
Zhou also teaches prior oHSV-1 constructs which comprise the deletion of both copies of the ɣ34.5 gene, leading to an absence of ICP34.5 protein [0006-0007].
Zhou does not teach wherein the modified oHSV-1 comprises a modification of a copy of the ɣ34.5 gene that is in a terminal repeat of the genome, wherein the modification renders that copy of the ɣ34.5 gene incapable of expressing functional ICP34.5 protein in combination with the deletion of the internal inverted repeat region described above.
However, Nakashima teaches a method for treating or alleviating a glioblastoma by administering to a subject in need thereof an effective amount of an oncolytic HSV-1 (oHSV-1), wherein the oHSV-1 comprises a modified genome, and the modified genome comprises both a deletion of a copy of a ɣ34.5 gene within a terminal repeat of the genome, thereby rendering that copy of ɣ34.5 gene incapable of expressing functional ICP34.5 protein, and a deletion of a copy of the ɣ34.5 gene within an internal repeat of the genome [0009, Figure 1, 4, claims 1, 7, 10, 14, 20]. Nakashima further teaches that deletion of the two copies of ɣ34.5 allows the oHSV1 to be relatively selective in destroying gliomas and not normal brain cells [0009].
Therefore, an ordinarily skilled artisan at the time of filing the instant application would have been motivated to delete both copies of the ɣ34.5 genes (i.e., the copy in the terminal repeat and the copy in the internal repeat) to render the oHSV1 relatively selective in destroying gliomas and not normal brain cells.
Regarding claims 29-31, Zhou and Nakashima teach the limitations of independent claim 28. Additionally, Zhou teaches the use of tissue specific promoters specific for expression in glioma brain tumors, as elected, including glioblastoma multiforme (GBM) tumor cells [0033, 0069]. Further, Nakashima teaches that malignant gliomas are the most abundant primary brain tumors, are the most common subtype of primary brain tumors, and are one of the deadliest human cancers [0004]. Nakashima also teaches that GBM is the most aggressive cancer manifestation, and that treatment for GBM fail to provide long-lasting control with 50% of afflicted patients dying within 15 months from diagnosis in spite of a variety of treatments [0004]. Nakashima additionally teaches that because few treatment options are available for many of the refractory tumors, the exploration of novel and innovative therapeutic approaches is important [0004]. Therefore, an ordinarily skilled artisan at the time of filing the instant application would have been motivated to select a GBM glioma as the cancer to target with the oHSV1 as taught by Zhou and Nakashima to improve treatment outcomes of GBM.
Regarding claim 2, Nakashima teaches wherein the modification to a copy of the ɣ34.5 gene in a terminal repeat of the genome comprises a deletion of all or part of the coding or regulatory region of the copy of ɣ34.5 gene in the terminal repeat (i.e., lacking both copies of the HSV1 gene ɣ34.5) [0010, 0015, 0017, Figure 1, 4].
Regarding claim 3, Zhou teaches wherein the duplicated non-coding sequences include introns of ICP0, LAT domain, and “a” sequence [0047].
Regarding claim 4, Zhou teaches wherein the all single-copy genes in both UL and US components include UL1 to UL56 genes in the UL component and US1 to US12 genes in the US component [0047].
Regarding claim 5, Zhou teaches wherein the oHSV-1 is selected from strains F, KOS, and 17 [0046, claim 4].
Regarding claim 6, Zhou teaches wherein the oHSV-1 has a genome isomer of prototype (P) [0103, claim 3].
Regarding claim 7, Zhou teaches wherein the deletion of an internal inverted repeat region causes excision of nucleotide positions 117005 to 132096 in the genome of F strain, in that the homology arms for cloning comprise sequences upstream of nucleotide 11705 and downstream of nucleotide 132096 [0103, Figure 1, 2, SEQ ID NO: 4, 7, 8, 9, claim 5].
Regarding claims 8-10, as discussed above for the 35 U.S.C. 112(b) rejection, the limitations of claims 8-10 conflict with the limitation of claim 28 which recites, “wherein all single-copy genes in both UL and US components of the genome are intact such that they are capable of expressing respective functional proteins” in that ViralZone teaches that the UL56 gene in the standard orientation (wherein the UL genes are arranged such that UL56 is the last UL gene before the internal repeat), is oriented away from the internal repeat such that the promoter is proximal to the internal repeat and the stop codon is further from the internal repeat. Therefore, in the interest of compact prosecution, claim 8 has been interpreted such that the deletion comprises sequences between the UL56 promoter and the US1 promoter. Zhou teaches a deletion between the promoter of UL56 gene and the promoter of US1 gene [0041].
Regarding claims 11-19, Zhou teaches wherein the oSHV-1 comprises a heterologous nucleic acid sequence encoding an immunostimulatory (e.g., the elected IL-12) and an immunotherapeutic agent (e.g., the elected anti-PD-1 agent) which do not interfere with ethe expression of native genes of the HSV-1 genome [0001, 0011, 0022, 0059-0063, 0071-0072, 00109, Figure 1, 2, claim 9, 12, 15]. Zhou also teaches wherein the heterologous nucleic acid sequence encoding IL-12 is incorporated into the internal inverted repeat region and the heterologous nucleic acid sequence encoding the anti-PD-1 agent is incorporated between UL3 and UL4 genes in the UL component [0060-0061].
Given the motivations of Nakashima to delete both ɣ34.5 genes to render the oHSV1 relatively selective in destroying gliomas and not normal brain cells and to select a GBM glioma as the cancer to target with the oHSV1 as taught by Zhou and Nakashima to improve treatment outcomes of GBM, it would have been prima facie obvious to an ordinarily skilled artisan at the time of filing the instant application to modify the method of Zhou to incorporate a deletion of the second ɣ34.5 gene (e.g., the ɣ34.5 gene present in the terminal repeat of the HSV-1 genome) with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 2-19 and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-29 of U.S. Patent No. 10,821,140, hereafter referred to as the ‘140 patent, in view of Nakashima [US20180133269A1, published 17 May 2018].
The ‘140 patent claims are drawn to an HSV-1 vector comprising a deletion modification in a wild-type HSV-1 genome, wherein the vector comprises (i) sequences required for expression of all single-copy open reading frames in the genome, comprising the ORFs themselves and regulating sequences necessary for expression of each ORF, wherein the regulating sequences include promoters which are kept intact; (ii) only one copy of each of all double-copy genes in the genome; and (iii) only one copy of duplicated non-coding sequences in the genome (claim 1). Dependent claims further limit the claims such that the double copy genes comprise genes encoding ICP0, ICP4, ICP34.5, ORF P, and ORF O.
The ‘140 patent claims differ from the instant claims in that the ‘140 patent claims do not recite wherein the copy of the y34.5 gene in the terminal repeat of the genome is modified to render it incapable of expressing functional ICP34.5 protein.
However, Nakashima teaches a method for treating or alleviating a glioblastoma by administering to a subject in need thereof an effective amount of an oncolytic HSV-1 (oHSV-1), wherein the oHSV-1 comprises a modified genome, and the modified genome comprises both a deletion of a copy of a ɣ34.5 gene within a terminal repeat of the genome, thereby rendering that copy of ɣ34.5 gene incapable of expressing functional ICP34.5 protein, and a deletion of a copy of the ɣ34.5 gene within an internal repeat of the genome [0009, Figure 1, 4, claims 1, 7, 10, 14, 20]. Nakashima further teaches that deletion of the two copies of ɣ34.5allows the oHSV1 to be relatively selective in destroying gliomas and not normal brain cells [0009].
Therefore, it would have been obvious to an ordinarily skilled artisan at the time of filing the instant application would have been to delete both ɣ34.5 genes to render the oHSV1 relatively selective in destroying gliomas and not normal brain cells.
The ‘140 patent claims further differ from the instant claims in that the ‘140 patent claims are drawn to a product and the instant claims are drawn to a method of using the product, but double-patenting rejections of claims to a method of using based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Accordingly, the ‘140 patent claims encompass and render obvious the claims of the instant application.
Claims 2-19 and 28-31 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11,439,679, hereafter referred to as the ‘679 patent, in view of Nakashima [US20180133269A1, published 17 May 2018].
The ‘679 patent claims are drawn to a pharmaceutical composition for treating or alleviating cancer in a subject, comprising a pharmaceutically acceptable carrier and a recombinant oHSV-1, wherein the oHSV-1 has a deletion modification in a wildtype HSV-1 genome and comprises: (i) sequences required for expression of all single-copy ORFs in the genome, comprising the ORFs themselves and regulating sequences necessary for expression of each ORF, wherein the regulating sequences include promoters which are kept intact, (ii) only one copy of each of all double-copy genes in the genome; (iii) only one copy of duplicated non-coding sequences in the genome; and (iv) a heterologous nucleic acid sequence encoding IL-12 and an anti-PD-1 agent, wherein the heterologous nucleic acid sequence encoding IL-12 is inserted into the deleted region of the modified HSV-1 genome, and the heterologous nucleic acid sequence encoding the anti-PD-1 agent is inserted between UL3 and UL4 genes in the UL component of the modified HSV-1 genome, and wherein the incorporation of the heterologous nucleic acid sequence does not interfere with the expression of the wildtype HSV-1 genes (claim 1).
The ‘697 patent claims differ from the instant claims in that the ‘697 patent claims do not recite wherein the copy of the y34.5 gene in the terminal repeat of the genome is modified to render it incapable of expressing functional ICP34.5 protein.
However, Nakashima teaches a method for treating or alleviating a glioblastoma by administering to a subject in need thereof an effective amount of an oncolytic HSV-1 (oHSV-1), wherein the oHSV-1 comprises a modified genome, and the modified genome comprises both a deletion of a copy of a ɣ34.5 gene within a terminal repeat of the genome, thereby rendering that copy of ɣ34.5 gene incapable of expressing functional ICP34.5 protein, and a deletion of a copy of the ɣ34.5 gene within an internal repeat of the genome [0009, Figure 1, 4, claims 1, 7, 10, 14, 20]. Nakashima further teaches that deletion of the two copies of ɣ34.5allows the oHSV1 to be relatively selective in destroying gliomas and not normal brain cells [0009].
Therefore, it would have been obvious to an ordinarily skilled artisan at the time of filing the instant application would have been to delete both ɣ34.5 genes to render the oHSV1 relatively selective in destroying gliomas and not normal brain cells.
The ‘697 patent claims further differ from the instant claims in that the ‘697 patent claims are drawn to a product and the instant claims are drawn to a method of using the product, but double-patenting rejections of claims to a method of using based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Accordingly, the ‘697 patent claims encompass and render obvious the claims of the instant application.
Claims 2-19 and 28-31 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-5, 11-16, and 18-24 of copending Application No. 17/635,537, hereafter referred to as the ‘537 application, in view of Nakashima [US20180133269A1, published 17 May 2018].
The ‘537 application claims are drawn to a method for treating cancer in a subject comprising systemically administering to the subject a pharmaceutical composition comprising a therapeutically effective amount of an oHSV-1, wherein the oHSV-1 is modified compared to a wildtype HSV to have (i) a deletion of nucleotide positions 117005 to 132096 in the genome of F strain of HSV-1, and (ii) an addition of a heterologous nucleic acid sequence encoding an immunostimulatory agent and/or an immunotherapeutic acid (claim 1). The ‘537 application claims further recite wherein the immunostimulatory agent is IL-12 (claim 2, 5) and the immunotherapeutic agent is an anti0PD-1 agent (claim 3, 5). The ‘537 application claims also recite wherein the cancer is glioma (claim 13).
The ‘537 application claims differ from the instant claims in that the 537 application claims do not recite wherein the copy of the ɣ34.5 gene in the terminal repeat of the genome is modified to render it incapable of expressing functional ICP34.5 protein.
However, Nakashima teaches a method for treating or alleviating a glioblastoma by administering to a subject in need thereof an effective amount of an oncolytic HSV-1 (oHSV-1), wherein the oHSV-1 comprises a modified genome, and the modified genome comprises both a deletion of a copy of a ɣ34.5 gene within a terminal repeat of the genome, thereby rendering that copy of ɣ34.5 gene incapable of expressing functional ICP34.5 protein, and a deletion of a copy of the ɣ34.5 gene within an internal repeat of the genome [0009, Figure 1, 4, claims 1, 7, 10, 14, 20]. Nakashima further teaches that deletion of the two copies of ɣ34.5allows the oHSV1 to be relatively selective in destroying gliomas and not normal brain cells [0009].
Therefore, it would have been obvious to an ordinarily skilled artisan at the time of filing the instant application would have been to delete both ɣ34.5 genes to render the oHSV1 relatively selective in destroying gliomas and not normal brain cells.
Therefore, the 537 application claims encompass and render obvious the claims of the instant application.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634