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 .
Response to Amendment/Disposition of Claims
Applicant’s Amendment filed on 08 June 2026 has been received and entered. Claims 1-7 and 11-12 were pending and examined on their merits. Claims 1-2, 4, 6, and 11 have been amended. Claim 7 has been cancelled. No new claims have been added. Claims 8-10 and 13-32 are also pending but remain withdrawn from consideration as being drawn to non-elected inventions and/or species per Applicant’s response to the restriction and election of species requirement filed on 12 December 2023.
Accordingly, Claims 1-6 and 11-12 will be examined on their merits.
Examiner’s Note
All paragraph numbers (¶) throughout this office action, unless otherwise noted, are from the US PGPub of this application US 022/0088183 A1, Published 24 March 2022. Applicant’s amended Specifications are presented on 13 February 2026, 16 April 2024, 14 September 2021, and 25 February 2021 are acknowledged and entered.
Applicant is encouraged to utilize the new web-based Automated Interview Request (AIR) tool for submitting interview requests; more information can be found at https://www.uspto.gov/patent/laws-and-regulations/interview-practice.
Response to Arguments
Applicant's arguments filed 08 June 2026 regarding the previous Office action dated 28 April 2026 have been fully considered. If they have been found to be persuasive, the objection/rejection has been withdrawn below. Likewise, if a rejection/objection has not been recited, said rejection/objection has been withdrawn. If the arguments have not been found to be persuasive, or if there are arguments presented over art that has been utilized in withdrawn rejections but utilized in new rejections, the arguments will be addressed fully with the objection/rejection below.
Claim Objections
Withdrawn Objections
(Objection Withdrawn) – The objection to Claim for containing minor informalities is withdrawn in light of the amendments to the claim.
New Objections
(New Objection) – Claim 1 is objected to because of the following informalities: it is suggested that the claim be amended by deleting part of Line 3, “or a nucleic acid with at least 100% homology to the γ134.5 gene”, so that the claim instead recites “A chimeric oncolytic virus, comprising: a modification of the one or both herpesvirus gamma (1)34.5 genes that reduces its expression…”.
Appropriate correction is required.
Claim Rejections - 35 USC § 112(b); Second Paragraph
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.
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 1 and 6, and dependent claims 2-5, 7, and 11-12 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims and the cancellation of one of the claims.
(Rejection Withdrawn) – The rejection of Claims 1, and dependent claims 2-7 and 11-12 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims and the cancellation of one of the claims.
(Rejection Withdrawn) – The rejection of Claims 1-2, 4, and 11, and dependent claims 3, 5-7, and 12 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims and the cancellation of one of the claims.
(Rejection Withdrawn) – The rejection of Claims 1, and dependent claims 2-7 and 11-12 thereof, under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, is withdrawn in light of the amendments to the claims and the cancellation of one of the claims.
New Rejections
(New Rejection – necessitated by amendment) – Claims 1, and dependent claims 2-6 and 11-12 thereof, 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 1, it recites “HSV-a” as a type of herpesvirus. It is unclear what the metes and bounds of the claims are as “HSV-a” is not defined in the instant Specification and does not appear to be a term of the art, and thus represents an unknown entity. It is suggested that the claim be amended to recite the intended HSV, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claim 1 is rejected on the grounds of being indefinite. Claims 2-6 and 11-12 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of Claim 1.
(New Rejection – necessitated by amendment) – Claims 1 and 6, and dependent claims 2-5 and 11-12 thereof, 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.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance, claim 1 recites the broad recitation “one or both herpesvirus gamma (1)34.5 genes”, and the claim also recites “comprising SEQ ID NO: 1”, which is the narrower statement of the range/limitation. Claim 6 recites the broad recitation “wherein the CMV nucleic acid comprises an IRS-1 gene”, and the claim also recites “comprising SEQ ID NO: 2”, which is the narrower statement of the range/limitation. The claims are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims. It is suggested that the claims be amended by removing reference to either the genes or the SEQ ID NOs, but Applicant is free to amend the claims as they deem necessary.
Since a skilled artisan would not be reasonably apprised as to the metes and bounds of the claimed invention, instant Claims 1 and 6 are rejected on the grounds of being indefinite. Claims 2-5 and 11-12 are also rejected, since they depend upon Claim 1 but do not remedy the deficiencies of Claim 1.
Claim Interpretation
The claims in this application are given their broadest reasonable interpretation using the plain meaning of the claim language in light of the specification as it would be understood by one of ordinary skill in the art.
Claim Rejections - 35 USC § 112(a); First Paragraph
Withdrawn Rejections
(Rejection Withdrawn) – The rejection of Claims 1-7 and 11-12 under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, for being enabling for a chimeric oncolytic virus comprising a herpesvirus having a modified nucleic acid sequence comprising a modification of the one or more gamma (1)34.5 genes (γ134.5) comprising SEQ ID NO: 1 or a nucleic acid with 100% homology to the γ134.5 gene that reduces its expression, wherein the modification is a complete or partial deletion of the γ134.5 gene (SEQ ID NO: 1) HSV-1, an inserted exogenous stop codon or other nucleotide or nucleotides, the mutation or deletion of the promoter or the insertion of an exogenous promoter that alters expression of the γ134.5 gene, or one or more inserted nucleotides that results in a codon frame-shift; a second viral nucleic acid sequence encoding a protein kinase R (PKR) evasion protein that does not cause virulence; and a third nucleic acid sequence encoding a tumor-associated antigen wherein the tumor-associated antigen is associated with an overexpressed or aberrantly expressed self-antigen, but not reasonably providing enablement for a chimeric oncolytic virus comprising a herpesvirus having a modified nucleic acid sequence comprising just any modification of the one or more gamma (1)34.5 genes (γ134.5) comprising SEQ ID NO: 1 or a nucleic acid with less than 100% homology to the γ134.5 gene that reduces its expression, wherein the modification is a complete or partial deletion of the γ134.5 gene (SEQ ID NO: 1) HSV-1, an inserted exogenous stop codon or other nucleotide or nucleotides, the mutation or deletion of the promoter or the insertion of an exogenous promoter that alters expression of the γ134.5 gene, or one or more inserted nucleotides that results in a codon frame-shift; a second viral nucleic acid sequence encoding a protein kinase R (PKR) evasion protein that does not cause virulence; and a third nucleic acid sequence encoding a tumor-associated antigen wherein the tumor-associated antigen is associated with an overexpressed or aberrantly expressed self-antigen is withdrawn in light of the amendments to the claims and the cancellation of one of the claims.
(Rejection Withdrawn) – The rejection of Claims 1-7 and 11-12 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 is withdrawn in light of the amendments to the claims and the cancellation of one of the claims.
Maintained Rejections
(Rejection Maintained) – The rejection of Claims 1-7 and 11-12 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 for containing new matter is withdrawn as it relates to Claim 7, in light of the cancellation of this claim, but is maintained as it relates to Claims 1-6 and 11-12.
Response to Arguments
Applicant's arguments filed with respect to the rejection of Claims 1-7 and 11-12 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 for containing new matter have been fully considered but they are not persuasive.
In their Response, Applicant apologizes “for the inadvertent inclusion of these boxes rather than the appropriate Greek letters, and have amended the claims to remove these typographic errors” (see Page 2 of Remarks, Paragraph 4). While these amendments and arguments address the first part of the new matter rejection, they fail to address the second part of the new matter rejection, which was that the instant Specification does not provide any indication that more than one copy of the γ134.5 gene was modified and that it does not explicitly teach that both copies were modified, which is now contemplated by amended Claim 1. As such, the rejection of Claims 1-7 and 11-12 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 for containing new matter is withdrawn as it relates to the boxes present in Claims 1-2, 4, and 11 and as it relates to Claim 7, in light of the cancellation of this claim, but is maintained as it relates to Claims 1-6 and 11-12.
New Rejections
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.
(New Rejection – necessitated by amendment) – Claims 1-6 and 11-12 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 limitation of “HSV-a” recited in Claim 1 represents new matter which is not supported by the original disclosure filed on 25 February 2021. This term is not recited anywhere in the instant Specification. As such, this amended independent claim recites a new embodiment of the claimed invention which was not explicitly disclosed in the original Specification.
The original disclosure should teach, contemplate, and thus anticipate the instant claims. Therefore, Claims 1-6 and 11-12 do not mee the written description requirement as they contain new matter.
Claim Rejections - 35 USC § 112(d); Fourth Paragraph
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
(New Rejection – necessitated by amendment) – Claim 2 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends.
Regarding Claim 2, it recites the limitation “wherein the herpesvirus is an α-herpesvirus”. In light of the recitation of “HSV-a” in Claim 1 and to the extent that Claim 1 was meant to say “HSV-α”, Claim 2 fails to further limit Claim 1, upon which it depends, as “HSV-α” appears to be another way to recite “α-herpesvirus”. As such, Claim 2 simply reiterates a limitation already present in independent Claim 1.
Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
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.
(Rejection Maintained) – The rejection of Claims 1-7 and 11-12 under 35 U.S.C. 103 as being unpatentable over Cassady et al. (US 2008/0206199 A1, Published 28 August 2008), Laus et al. (WO 97/24438, Published 10 July 1997), and Workenhe et al. (Workenhe, S. T., Verschoor, M. L., & Mossman, K. L. (2015). The role of oncolytic virus immunotherapies to subvert cancer immune evasion. Future Oncology (London, England), 11(4), 675–689.) is withdrawn as it relates to Claim 7, in light of the cancellation of the claim, but is maintained as it relates to Claims 1-6 and 11-12.
Response to Arguments
Applicant's arguments filed with respect to the ion of Claims 1-7 and 11-12 under 35 U.S.C. 103 have been fully considered but they are not persuasive.
In their Response, Applicant reiterates previous arguments presented as well as previous rebuttals presented by the Examiner. Applicant argues that they “previously argued that Workenhe et al. state that “genetic modification of Ovs to express cytokines, chemokines and TAAs are potential mechanisms pursued to increase immune stimulation in the tumor microenvironment and enhance the detection of TAAs by antigen presentation” (see Page 3 of Remarks, Paragraph 3). Applicant then argues that “much of the discussion following this statement relates to expression of cytokines such as GM-CSF from the oncolytic virus, which is not relevant to the claimed invention, and that while there is some discussion of the use of self-antigens on page 681, it is noted on page 682 (left column, lines 3-7) that ‘These studies shown that altered self-antigens that are administered in an immunogenic oncolytic virus vector can overcome immunological tolerance to cancer antigens’” (see Page 3, Paragraph 3). Applicant also argues that “the antigens were modified by including a variety of different mutations”, “these studies were done using a different virus (VSV)”, and that “Workenhe does not demonstrate that unaltered self-antigens can be used to overcome immune tolerance, and because the previous work was done using a different virus system, it does not provide a reasonable expectation of success that results can be obtained using unaltered self-antigens in a different virus delivery system (e.g., HSV)” (see Page 3, Paragraph 3). Additionally, Applicant argues that “the Examiner has argued that Applicant’s definition of a tumor-associated antigen in the specification includes a wide range of possible antigens, including altered antigens” (see Page 3, Last Paragraph) and that Paragraph [0080] describes tumor-associated antigens as a genus of antigens including a wide variety of different ‘species’”. Furthermore, Applicant argues that one “of these species is ‘overexpressed or aberrantly expressed cellular proteins’, which Applicants have used as the basis for ‘overexpressed or aberrantly expressed self-antigens’”, that because “the claims has been limited to this species, it is inappropriate to include other, non-claimed species of tumor-associated antigens such as altered cell surface glycolipids and glycoproteins as falling within the scope of claim 1”, and that Workenhe only envisions altered tumor antigens as being capable of providing an immune response (see Page 4, First Paragraph). Finally, Applicant argues that they “previously argued that Laus et al. and Hatano et al. used an entirely different methods to stimulate an immune response, and that this would in no way render obvious the use of EphA2 and PAP to stimulate an immune response in a different context, such as the use of a chimeric oncolytic herpesvirus” and “that these references identify certain antigens such as EphA2, but they in no way render the present claims obvious, while also arguing that “the prior art understanding of these antigens is that they would be ineffective for stimulating the immune system, and would be effective only for targeting cells that expressed these antigens, either for diagnosis or therapy” (see Page 4, Last Paragraph).
Examiner does not find these arguments persuasive. Additionally, some of the arguments presented were presented previously and were already rebutted by the examiner, but will be rebutted again in this Office Action.
In response to applicant's arguments against the references individually, one cannot show nonobviousness by attacking references individually where the rejections are based on combinations of references. See In re Keller, 642 F.2d 413, 208 USPQ 871 (CCPA 1981); In re Merck & Co., 800 F.2d 1091, 231 USPQ 375 (Fed. Cir. 1986). In fact, Applicant only attacks the supporting references but largely ignores the primary reference, Cassady et al. Again, while Examiner acknowledges that Workenhe et al. does not explicitly disclose HSV-1 expressing a TAA and only recites it as a potential therapy, they do still contemplate it, and thus this would provide the suggestion to a person having ordinary skill in the art to carry out such as experiment. As such, this renders this aspect of the instant invention obvious as the prior art had already contemplated it. Additionally, Cassady et al. teach a chimeric oncolytic HSV-1 expressing a tumor-specific antigen and Laus et al. teach expression vectors encoding a polypeptide complex comprising a tumor-associated protein. The combination of these references would suggest and provide sufficient motivation to a person having ordinary skill in the art to combine these teachings and arrive at the claimed invention.
Applicant’s argument that Workenhe et al. uses a different virus delivery system, namely VSV, again conveniently ignores the fact that Workenhe et al. disclose multiple oncolytic viruses, including VSV, HSV-1, Adenovirus, and vaccinia virus, including an Adenovirus expressing melanoma TAAS. The prior art serves as a reference for all that it teaches. Applicant is reminded that preferred embodiments are not the only teaching of a reference.
“The use of patents as references is not limited to what the patentees describe as their own inventions or to the problems with which they are concerned. They are part of the literature of the art, relevant for all they contain.” In re Heck, 699 F.2d 1331, 1332-33, 216 USPQ 1038, 1039 (Fed. Cir. 1983) (quoting In re Lemelson, 397 F.2d 1006, 1009, 158 USPQ 275, 277 (CCPA 1968)).
A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Laboratories, 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir.), cert. denied, 493 U.S. 975 (1989). See also > Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005)(reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); < Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. “The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed.”).
Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). “A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use.” In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994). Furthermore, “[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed….” In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). MPEP 2123. As such, it cannot simply be disregarded that Workenhe et al. contemplate HSV-1, or other viruses, expressing tumor-associated antigens.
Applicant’s argument that oncolytic viruses expressing GM-CSF is not relevant to the instant invention is also not persuasive. Again, as noted in the previous Office Action and the Final Rejection mailed on 13 November 2025, GM-CSF is an example of a dendritic cell-binding protein, as taught by Laus et al. Laus et al. teach GM-CSF fused to a tumor-associated protein and expressed from a vector as a polypeptide antigen. This renders the corresponding limitations of instant Claim 1 obvious, so it is actually quite relevant to the instantly claimed invention, despite Applicant’s assertion otherwise. Additionally, GM-CSF expression is not excluded from the claims rejected, for example, and so the art reads on the instant claims.
In response to applicant's argument that the references fail to show certain features of the invention, it is noted that the features upon which applicant relies (i.e., unaltered self-antigens) are again still not recited in the rejected claim(s). Although the claims are interpreted in light of the specification, limitations from the specification are not read into the claims. See In re Van Geuns, 988 F.2d 1181, 26 USPQ2d 1057 (Fed. Cir. 1993). Claim 1 does not distinguish between altered and unaltered self-antigens. It recites the genus of “self-antigens”. As such, it reads on both altered and unaltered self-antigens. Applicant argues that Workenhe et al. teach oncolytic viruses expressing altered self-antigens, which means that Applicant is admitting, on the record, that the prior art reference does teach self-antigens. The prior art reference teaches a species of the claimed genus. If Applicant only wishes Claim 1 to read on unaltered self-antigens, then the claim should be amended as such and explicitly recite that limitation, as was suggested in the previous Office Action. Again, Applicant appears to be arguing their own Specification as the definition of tumor-associated antigen provided by Applicant in the instant Specification would disagree with Applicant’s arguments. Paragraph 0080 of the PGPub states, in part that tumor-associated antigens “can include, for example, products of mutated oncogenes and tumor suppressor genes, overexpressed or aberrantly expressed cellular proteins, tumor antigens produced by oncogenic viruses, oncofetal antigens, altered cell surface glycolipids and glycoproteins or cell-type specific differentiation antigens” (emphasis added). Applicant also fails to define “altered”, as the term could read on self-antigens mutated experimentally or those which are simply naturally-occurring variants of the wild-type self-antigen. Applicant’s arguments are not commensurate with the scope of the instant claims, particularly instant Claim 1.
Regarding the arguments presented against Laus et al. and Hatano et al., any deficiencies present in Laus et al. and Hatano et al. in any previously-withdrawn rejections have been remedied by the addition of Workenhe et al., as noted in the Final Rejection mailed on 13 November 2025. While these references alone may not render present claims obvious, their teachings, in combination with those of Cassady et al. and Workenhe et al., do render the instant claims obvious and would provide sufficient motivation for a person having ordinary skill in the art to carry out such modifications and have a reasonable expectation of success. While the teachings of Laus et al. and Hatano et al. might not have been sufficient for effectively stimulating the immune system at the time they were published, their teachings in light of the teachings of Cassady et al. and Workenhe et al. would have shed new light on these prior art references.
Thus, for at least all of the reasons stated above, the rejection of Claims 1-7 and 11-12 under 35 U.S.C. 103 as being unpatentable over the prior art is withdrawn as it relates to Claim 7, in light of the cancellation of the claim, but is maintained as it relates to Claims 1-6 and 11-12.
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.
(Rejection Maintained) – The provisional rejection of Claims 1-7 and 11-12 on the ground of nonstatutory double patenting as being unpatentable over claims 1-9, 11, and 18-20 of copending Application No. 18/869,720 (US 2025/0295719 A1) in view of Cassady et al. (US 2008/0206199 A1, Published 28 August 2008), Laus et al. (WO 97/24438, Published 10 July 1997), and Workenhe et al. (Workenhe, S. T., Verschoor, M. L., & Mossman, K. L. (2015). The role of oncolytic virus immunotherapies to subvert cancer immune evasion. Future Oncology (London, England), 11(4), 675–689.) is withdrawn as it relates to Claim 7, in light of the cancellation of the claim, but is maintained as it relates to Claims 1-6 and 11-12.
Response to Arguments
Applicant's arguments filed with respect to the provisional rejection of Claims 1-7 and 11-12 on the ground of nonstatutory double patenting have been fully considered but they are not persuasive.
In their Response, Applicant requested “that this rejection be held in abeyance, pending the actual issuance of App. No. 18/869,720 and the identification of otherwise allowable subject matter has been identified, and which point Applicants may filed a terminal disclaimer or amend the claims to exclude the expression of IL-27”. As such, this rejection is withdrawn as it relates to Claim 7, in light of the cancellation of the claim, but is maintained as it relates to Claims 1-6 and 11-12 for reasons of record.
Conclusion
No claims are allowed.
The prior art made of record, but not relied upon, and considered pertinent to applicant's disclosure is listed below:
Nolin et al. (US 2015/0250837 A1, Published 10 September 2015)
Nolin et al. teach an oncolytic herpesvirus, such as HSV-1, comprising a heterologous nucleic acid encoding a PD-1 binding agent, wherein the genome has a mutation in each ICP34.5 locus such that the HSV cannot express a functional ICP34.5 gene product. This reference has not been utilized, as rejection would have been redundant to those set forth above.
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any nonprovisional extension fee (37 CFR 1.17(a)) pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to CAREY A STUART whose telephone number is (703)756-4668. The examiner can normally be reached Monday - Friday, 7:30 AM - 4:30 PM EST.
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, Michael Allen can be reached at 571-270-3497. 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.
/CAREY ALEXANDER STUART/Examiner, Art Unit 1671 /Michael Allen/Supervisory Patent Examiner, Art Unit 1671
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