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 .
Claim Status
In the amendment filed 7th, August, 2026, Applicant added new claim 28
Claims 1, 6, 9, 11, 15-18 and 24-28 are pending.
Claims 15-18, and 24-27 are withdrawn.
Claims 1, 6, 9, 11 and 28 are under examination.
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 2nd, September, 2026 has been entered.
Species Rejoinder
The species election requirement between polypeptide amino acid sequences and sequences encoding them as set forth in the Lack of Unity mailed on 11th, September, 2024 has been reconsidered in view of the prior art and examination below.
SEQ ID NO: 3-12, drawn to previously non-elected species are no longer withdrawn from consideration.
In view of the above noted withdrawal of the species election requirement, applicant is advised that if any claim presented in a continuation or divisional application is anticipated by, or includes all the limitations of, a claim that is allowable in the present application, such claim may be subject to provisional statutory and/or nonstatutory double patenting rejections over the claims of the instant application.
Once a restriction or species election requirement is withdrawn, the provisions of 35 U.S.C. 121 are no longer applicable. See In re Ziegler, 443 F.2d 1211, 1215, 170 USPQ 129, 131-32 (CCPA 1971). See also MPEP § 804.01.
Remark on Priority
It is noted that Applicant has submitted a certified English translation of the priority document of KOREA, REPUBLIC OF 10-2019-0077377 filed on 27th, June, 2019. The certified English translation appears to be in accordance with 37 CFR 41.154(b) and 41.202(e).
In view of Applicant’s amendments, the instant claims 1, 6, 9, 11 and 28 under examination are given the effective filing date of the priority document of 27th, June, 2019 because the presently amended claims are supported by the priority document.
Withdrawn Claim Objections
The objection to claim 1 due to informalities set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 112(a)
Written Description
The rejection of claims 1, 6, 9 and 11 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 as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Withdrawn Claim Rejections - 35 USC § 102
The rejection of claims 1, 6 and 9 under 35 U.S.C. 102(a)(2) as being anticipated by Hwang et al. (WO-2021040496-A1; priority to KR20190106736A filed 29th, August, 2019; henceforth Hwang; citations refer to attached translation) as set forth in the previous office action is withdrawn in view of Applicant’s amendment. Specifically, as set forth above, the instant Application is now given the effective filing date of the priority document and therefore the Hwang reference is no longer prior art.
Withdrawn Claim Rejections - 35 USC § 103
The rejection of claim 11 under 35 U.S.C. 103 as being unpatentable over Hwang et al. (WO-2021040496-A1; priority to KR20190106736A filed 29th, August, 2019; henceforth Hwang; citations refer to attached translation) in view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) as set forth in the previous office action is withdrawn in view of Applicant’s amendment. Specifically, as set forth above, the instant Application is now given the effective filing date of the priority document and therefore the Hwang reference is no longer prior art.
Examiner’s Remark
Upon further consideration, the prior art of Apperley et al. (WO-2001079502-A2; henceforth “Apperley”) is applied under 35 U.S.C. 102 below because it anticipates the species of SEQ ID NO:7 and SEQ ID NO: 8 which are now rejoined and considered in this office action.
New Claim Rejections - 35 USC § 102
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1, 6, 9 and 11 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Apperley et al. (WO2001079502 A2; henceforth “Apperley”).
Regarding claim 1, Apperley discloses a recombinant oncolytic virus comprising a recombinant
nucleic acid, said recombinant nucleic acid being a nucleotide sequence that encodes a herpes
simplex virus thymidine kinase (HSV-TK) effector domain polypeptide (“polynucleotide encoding a thymidine kinase” abstract; see also claims 1, 12-13, 17-18 and Figure 1)
wherein the oncolytic virus is a vaccinia virus (pg. 24 line 13).
Regarding claims 1 and 6, Apperley discloses the nucleotide sequence that encodes a herpes
simplex virus thymidine kinase (HSV-TK) effector domain polypeptide as SEQ ID NO: 20 (see also Example 2; Figure 11, which comprises a Sequence that is 100% identical to instant SEQ ID NO: 8, and therefore the HSV-TK effector domain polypeptide consists of a sequence 100% identical to instant SEQ ID NO: 7.
Regarding claim 9, further to the discussion of claim 1 above, Apperley discloses a pharmaceutical composition comprising as an active ingredient: the recombinant oncolytic virus (pg. 16 3rd -4th para.; claim 17).
Regarding claim 11, further to the discussion of claim 1 above, as stated above (see claim 9 rejection above), Apperley discloses a pharmaceutical composition comprising as an active ingredient: the recombinant oncolytic virus (pg. 16 3rd -4th para.; claim 17) and, Apperley also discloses including GCV in a pharmaceutical composition in combination with the virus encoding HSV-TK HSV-tk/GCV system (pg. 1 2nd para.; pg. 2-3; pg. 31-34; Figures 4, 9-10, 12, 14-15, 17A, 18; Examples 1-4).
Accordingly, Apperley anticipates instant claims.
Response to Arguments
Applicant’s arguments, filed 7th, August, 2026 with respect to 35 U.S.C. 102 have been fully considered but are moot since the amendments required the rejoinder of unelected species and therefore required a new grounds of rejection.
New 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.
Examiner’s Remark
Upon further consideration, the nonstatutory double patenting over US Patent No. 11857585 is reapplied in this office action because it anticipates or makes obvious the species of SEQ ID NO: 3-4 and 11-12 which are rejoined and considered in this office action.
HSV-TK Amino Acid Sequence of SEQ ID NO: 3 or 11
Nucleotide sequence encoding the polypeptide of SEQ ID NO: 4 or 12
New Non-Statutory Double Patenting
US Patent No. 11857585
Claims 1, 6, 9 and 11 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8, 10 and 16 of US patent No. 11857585.
Although the claims at issue are not identical, they are not patentably distinct for the reasons stated below.
The subject matter claimed in the instant application is disclosed in the referenced patent as follows: the recombinant oncolytic virus anticipates or makes obvious the recombinant oncolytic virus of instant Application.
Regarding claim 1, US patent No. 11857585 claims a recombinant oncolytic virus comprising a recombinant nucleic acid, said recombinant nucleic acid being a nucleotide sequence that encodes a herpes simplex virus thymidine kinase (HSV-TK) effector domain polypeptide (“A recombinant oncolytic virus comprising a nucleotide sequence encoding a truncated fragment of HSV-TK (herpes simplex virus thymidine kinase) or a variant thereof”; claim 1), wherein the HSV-TK effector domain polypeptide consists of an amino acid sequence of SEQ ID NO: 7 (claim 1; SEQ ID NO:7 of Hwang1 is 100% identical to instant SEQ ID NO:3 and is the same length (see SCV rag file result 1)) and wherein the oncolytic virus is a vaccinia virus (claim 6).
Regarding claim 1, US patent No. 11857585 claims and alternative embodiment of wherein the HSV-TK effector domain polypeptide consists of an amino acid sequence of SEQ ID NO: 11 (claim 1 SEQ ID NO: 8 is 100% identical and is the same length as instant SEQ ID NO: 11; see SCV rag file result 1).
Regarding claim 6, further to the discussion of claim 1 above, US patent No. 11857585 separately claims the nucleotide sequence encoding the polypeptide is the sequence set forth in SEQ ID NO: 4 (SEQ ID NO: 10 is 100% identical to instant SEQ ID NO: 4 and is the same length; see SCV rng file result 2) (claim 16), or an alternative embodiment of the nucleotide sequence encoding the polypeptide is the sequence set forth in SEQ ID NO: 12 (SEQ ID NO: 11 is 100% identical to instant SEQ ID NO: 12 and is the same length; see SCV rng file result 2) and it would therefore be obvious to prepare the recombinant oncolytic virus with this specific nucleotide sequence.
Regarding claim 9, further to the discussion of claim 1 above, US patent No. 11857585 claims a pharmaceutical composition comprising as an active ingredient: the recombinant oncolytic virus (claim 8 and claim 10).
Regarding claim 11, further to the discussion of claim 1 above, US patent No. 11857585 claims a pharmaceutical composition comprising as active ingredients: the recombinant oncolytic virus of claim 1; and ganciclovir (GCV) or aciclovir (ACV) (claim 10).
Since the instant application claims are anticipated by or obvious over cited patent claims, said claims are not patentably distinct.
Pertinent Art
HSV-TK Amino Acid Sequence of SEQ ID NO: 3
The post-filing art of Hwang et al. (US Patent No. 12220437; Published 11th, February, 2025 with priority to 7th, September, 2018) made of record but not relied upon is considered pertinent to Applicant’s disclosure. US Patent No. 12220437 lists inventors of Taeho Hwang and Mong Cho and an Applicant of Bionoxx Inc which appear to be the same inventors and Applicant of the instant Application.
US Patent No. 12220437 claims a method for treating a cancer in a subject in need
thereof, which comprises administering (a) a recombinant oncolytic virus comprising a nucleotide sequence encoding a truncated fragment of HSV-TK wherein the variant of the truncated fragment of HSV-TK comprises the amino acid sequence of SEQ ID NO: 3 (claim 1; SEQ ID NO:7 of Hwang et al. is 100% identical to instant SEQ ID NO:3 and is the same length (see SCV rag file result 1)).
HSV-TK Amino Acid Sequence of SEQ ID NO: 7
The prior art of Fotin-Mleczek et al. (WO-2016170176-A1), made of record but not relied upon is considered pertinent to Applicant’s disclosure. Fotin-Mleczek discloses a sequence that is 100% identical to instant SEQ ID NO: 7 (SEQ ID NO 6849; see SCV rag file result 2).
Allowable Subject Matter
SEQ ID NO: 14 is free of the prior art and therefore claim 28 is free of the prior art.
SEQ ID NO: 5-6 and 9-10 are free of the prior art and are also free of double patenting issues as of the mailing of this office action.
New Claim Objections
Claim 28 is objected to as being dependent upon a rejected base claim, but would be allowable if rewritten in independent form including all of the limitations of the base claim and any intervening claims.
Conclusion
No claim is allowable.
Correspondence
Any inquiry concerning this communication or earlier communications from the examiner should be directed to BRIANA N EBBINGHAUS whose telephone number is (703)756-4548. The examiner can normally be reached M-F 9:30 AM to 5:30 PM ET.
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/BRIANA N EBBINGHAUS/Examiner, Art Unit 1632
/EMILY A CORDAS/Primary Examiner, Art Unit 1632
