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
Claims 1, 6, 9, 11, 15-18 and 24-27 are pending.
Claims 15-18, and 24-27 are withdrawn.
Claims 1, 6, 9 and 11 are under examination.
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).
However the newly claimed limitation in claim 1 that “the nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 13 “comprises nucleotide substitutions at positions corresponding to positions 432 and 435 of SEO ID NO: 16, such that G is substituted with T at each of said positions,” does not appear to be supported by the priority document. While Applicant discloses SEQ ID NO: 14, which meets this criteria (pg. 72-73 and claim 6), one specific sequence does not support the full breadth of numerous sequences, which do not appear to be contemplated by the priority document, encompassed by Applicant’s claims.
Therefore, because claim 1 is not supported by the priority document, the effective filing date of claims 1, 6, 9 and 11 which are under examination is the filing date of PCT/KR2020/008472 filed on 29th, June, 2020.
Response to Arguments
Applicant’s arguments, filed 26th, March, 2026, have been fully considered but are not found persuasive.
Applicant argues “the claims of the instant application are supported by the claims and the disclosure of the priority documents” (pg. 7). Applicant specifically argues Exemplary support for claim 1 is in “claims 1, 5 and 8” of the priority document.
In response, claims 1, 5 and 8 of the priority document do not provide specific support for the claimed limitation. While claim 6 includes SEQ ID NO: 14, this one specific sequence does not support the full breadth of numerous sequences encompassed by Applicant’s claims.
New Claim Objections
Claim 1 is objected to because of the following informalities:
Claim 1 is objected to because the claim refers to the sequence identifiers rather than the sequence set forth in the sequence identifiers.
To overcome this objection, it is recommended that Applicant amend to “wherein the HSV-TK effector domain polypeptide consists of an amino acid sequence selected from the group consisting of the sequence set forth in SEQ ID NO: 3, 5, 7, 9, 11, and 13.”
Appropriate correction is required.
New Claim Rejections - 35 USC § 112(a)
Written Description
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 1, 6, 9 and 11 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.
In the amendment filed on 26th, March, 2026 claim 1 was amended to recite a new limitation that the nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 13 “comprises nucleotide substitutions at positions corresponding to positions 432 and 435 of SEO ID NO: 16, such that G is substituted with T at each of said positions.” This new limitation appears to be new matter.
By nature of their ultimate dependency on claim 1, claims 6, 9 and 11 are also included in this rejection.
A review of the originally filed specification by the Examiner did NOT find any specific basis for the recited limitation. The disclosure (including the specification, claims and sequence listing) as originally filed, does not contain a specific recitation of the limitation.
In fact, the closest support for such a limitation is the specific disclosure of one sequences, SEQ ID NO: 14, which meets this criteria. One specific sequence of SEQ ID NO: 14 does not provide support for the full breadth of sequences that encode the amino acid sequence of SEQ ID NO: 13 and comprise “nucleotide substitutions at positions corresponding to positions 432 and 435 of SEO ID NO: 16, such that G is substituted with T at each of said positions.”
Applicant has not provided the specific location of support for this amendment. When filing an amendment an applicant should show support in the original disclosure for new or amended claims. See MPEP §§ 714.02 and 2163.06 ("Applicant should ... specifically point out the support for any amendments made to the disclosure.") The claim is a new or amended claim, the support for the limitation is not apparent, and applicant has not pointed out where the limitation is supported (see MPEP 2163 (I), and therefore the limitation appears to be new matter.
As noted by MPEP 608.04(a), 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. In the instant case one skilled in the art would NOT consider the full genus of sequences encoding SEQ ID NO: 13 that comprise “nucleotide substitutions at positions corresponding to positions 432 and 435 of SEO ID NO: 16, such that G is substituted with T at each of said positions” to be explicitly, implicitly, or inherently supported by Applicant’s disclosure.
Hence, there is insufficient written descriptions support for the instantly claimed limitation of and Applicant has not shown possession of the invention.
Response to Arguments
Applicant’s arguments, filed 26th, March, 2026, have been fully considered but are not found persuasive.
Applicant argues “Applicant amends claim 1 for clarity” and “no new matter has been introduced” (pg. 7).
In response, this is not found persuasive because the amendment to claim 1 introduces a new structural limitation to the claim which is not supported by Applicant’s specification for the reasons stated above.
Withdrawn Claim Rejections - 35 USC § 112 (b)
The rejection of claims 1, 6, 9 and 11 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action are withdrawn in view of Applicant’s amendments.
Moot Claim Rejections - 35 USC § 112 (b)
The rejection of claims 12-13 under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite as set forth in the previous office action are moot in view of the cancellation of these claims.
Examiner’s Remark Concerning the Common Ownership Statement
It is noted that Applicant submitted a statement of common Ownership pursuant to 35 U.S.C. § 102(b)(2)(C) and 37 C.F.R. § 1.104(c)(4) that was filed on 26th, March, 2026.
Applicant is directed to MPEP 717.02(b) (IV) which sets forth the requirements to establish a Joint Research Agreement.
It is noted that because Applicant has not amended “the specification of the application under examination to disclose the names of the parties to the joint research agreement, if not already disclosed, in accordance with 37 CFR 1.71(g)” and the statement of common ownership is not “signed in accordance with 37 CFR 1.33(b)” (see MPEP 717.02(b) (IV)), the statement of common ownership is not sufficient to overcome the rejection under 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.
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)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
Claims 1, 6 and 9 remain rejected 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).
The applied reference has common Inventors and Assignee with the instant application. Based upon the earlier effectively filed date of the reference, it constitutes prior art under 35 U.S.C. 102(a)(2). This rejection under 35 U.S.C. 102(a)(2) might be overcome by: (1) a showing under 37 CFR 1.130(a) that the subject matter disclosed in the reference was obtained directly or indirectly from the inventor or a joint inventor of this application and is thus not prior art in accordance with 35 U.S.C. 102(b)(2)(A); (2) a showing under 37 CFR 1.130(b) of a prior public disclosure under 35 U.S.C. 102(b)(2)(B) if the same invention is not being claimed; or (3) a statement pursuant to 35 U.S.C. 102(b)(2)(C) establishing that, not later than the effective filing date of the claimed invention, the subject matter disclosed in the reference and the claimed invention were either owned by the same person or subject to an obligation of assignment to the same person or subject to a joint research agreement.
Regarding claim 1, Hwang discloses a recombinant oncolytic virus (“recombinant vaccinia virus” claim 1 and pg. 1) 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 (“The foreign genes are HSV-T” claims pg. 1) wherein the HSV-TK effector domain polypeptide consists of the amino acid sequence of SEQ ID NO: 13, with the proviso that the nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 13 comprises nucleotide substitutions at positions corresponding to positions 432 and 435 of SEO ID NO: 16, such that G is substituted with T at each of said positions, and further comprises a nucleotide substitution from CCC to CTC at positions corresponding to positions 551 to 553 of SEQ ID NO: 16 (SEQ ID NO: 2 of Hwang is a 100% match to instant SEQ ID NO: 14 which encodes SEQ ID NO: 13 and meets this proviso), and wherein the oncolytic virus is a vaccinia virus (“vaccinia virus” claim 1 pg. 1) (see also Preparation Examples 2-4 pg. 13).
Regarding claim 6, further to the discussion of claim 1 above, as stated above (see claim 1 rejection above), Hwang discloses the nucleotide sequence encoding the polypeptide is SEQ ID NO: 14 (SEQ ID NO: 2 of Hwang is a 100% match to instant SEQ ID NO: 14).
Regarding claim 9, further to the discussion of claim 1 above, Hwang discloses a pharmaceutical composition comprising as an active ingredient: the recombinant oncolytic virus (abstract; claims; pg. 2 1st-2nd, 5th, 8th, and 13th para.; pg. 4 10th-11th para.; pg. 6 1st para.; pg. 7 2nd para.; pg. 9 2nd, 7th and 16th para.; pg. 10 2nd-5th, 7th , 13th, and 15th para.; pg. 11 6th para.; pg. 12 7th and 11th para.).
Accordingly, Hwang anticipates instant claims.
Response to Arguments
Applicant’s arguments, filed 26th, March, 2026, have been fully considered but are not found persuasive.
Applicant argues the filing of the certified English Translation of the Priority document and the filing of the common ownership statement overcome this rejection (pg. 9).
In response, the filing of the certified English Translation of the Priority document is not sufficient to overcome this rejection because the new limitation of claim 1 that the nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 13 “comprises nucleotide substitutions at positions corresponding to positions 432 and 435 of SEQ ID NO: 16, such that G is substituted with Tat each of said positions” is not fully supported by the priority document, as discussed above (see “Remark on Priority” above).
The common ownership statement is not sufficient to overcome this rejection because that because Applicant has not amended “the specification of the application under examination to disclose the names of the parties to the joint research agreement, if not already disclosed, in accordance with 37 CFR 1.71(g)” and the statement of common ownership is not “signed in accordance with 37 CFR 1.33(b)” (see MPEP 717.02(b) (IV)) (see “Examiner’s Remark Concerning the Common Ownership Statement” above).
Moot Claim Rejections - 35 USC § 103
The rejection of claims 11-12 under 35 U.S.C. 103 as being unpatentable over Apperley et al. (WO2001079502 A2; henceforth “Apperley”) in view of Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) as set forth in the previous office action are moot in view of the cancellation of these claims.
Withdrawn Claim Rejections - 35 USC § 103
The rejection of claims 1, 6, 9 and 11 under 35 U.S.C. 103 as being unpatentable over Apperley et al. (WO2001079502 A2; henceforth “Apperley”) in view of Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments and the Declaration under 37 C.F.R. 1.132 filed on 26th, March, 2026.
Response to Declaration under 37 C.F.R. 1.132
The Declaration under 37 CFR 1.132 filed 26th, March, 2026. is sufficient to overcome the rejection of claims 1, 6, 9 and 11 under 35 U.S.C. 103 as being unpatentable over Apperley et al. (WO2001079502 A2; henceforth “Apperley”) in view of Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) as set forth in the previous office action.
Examiner’s Remark Regarding the Declaration under 37 C.F.R. 1.132
It is noted that the information in the declaration applies to the elected embodiment of the nucleotide sequences that encodes SEQ ID NO: 13 which as currently claimed requires “the proviso that the nucleotide sequence encoding the amino acid sequence of SEQ ID NO: 13 comprises nucleotide substitutions at positions corresponding to positions 432 and 435 of SEO ID NO: 16, such that G is substituted with Tat each of said positions, and further comprises a nucleotide substitution from CCC to CTC at positions corresponding to positions 551 to 553 of SEQ ID NO: 16” as well as SEQ ID NO: 14 recited in claim 6, which encodes SEQ ID NO: 13 and meets the proviso of claim 1. The Declaration does not appear to apply to unelected species of nucleotide sequences that encode SEQ ID NO: 3, 5, 7, 9 and 11 recited in claim 1 and it does not appear to apply to the more specific unelected nucleotide sequences of SEQ ID NO: 4, 5, 8, 10 and 12 of claim 6. This is because the unexpected results presented in the Declaration appear to require the “targeted synonymous nucleotide substitutions at G-rich and C-rich hotspots (G432T, G435T, and C552T)” that encompass the proviso of claim 1 that only applies to the elected sequence of the nucleotide sequence encoding SEQ ID NO: 13.
It is noted that nucleotide sequences encoding SEQ ID NO: 3, 5, 7, 9 and 11 recited in claim 1 and the specific nucleotide sequences of SEQ ID NO: 4, 5, 8, 10 and 12 as recited in claim 6, are unelected species and are not currently under consideration.
New 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.
Claim 11 is rejected 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”).
Regarding claim 11, further to the discussion of claim 1 above, although Hwang teaches a pharmaceutical composition comprising as an active ingredient: the recombinant oncolytic virus (abstract; claims; pg. 2 1st-2nd, 5th, 8th, and 13th para.; pg. 4 10th-11th para.; pg. 6 1st para.; pg. 7 2nd para.; pg. 9 2nd, 7th and 16th para.; pg. 10 2nd-5th, 7th , 13th, and 15th para.; pg. 11 6th para.; pg. 12 7th and 11th para.), Hwang is silent to including GCV in the pharmaceutical composition.
Nevertheless, regarding claim 11, Apperley teaches including GCV in a pharmaceutical composition in combination with a 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). Apperley teaches the HSV-tk/GCV system is one of the most widely used approaches in suicide gene therapy (pg. 1 2nd para.). Apperley teaches cells expressing the HSV-tk gene can phosphorylate GCV and eventually leading to cell death as a result of interfering with the ability to replicate DNA and that this approach is currently used in more than 30 clinical trials for gene therapy of a variety of human 20 cancers (pg. 1 2nd para.).
Therefore, regarding claim 11, it would have been obvious to a person of ordinary skill in the art before the effective filing date of the claimed invention to prepare the pharmaceutical composition comprising the recombinant oncolytic virus of Hwang, and combine the known prior art element of the GCV of Apperley to obtain the predictable result of a pharmaceutical composition. One of ordinary skill would have been motivated to do so as taught by Apperley so that the composition can be used to phosphorylate GCV and eventually leading to cell death and be used in gene therapy for cancers. Regarding the reasonable expectation of success, Apperley evidences preparation of GCV in a pharmaceutical composition in combination with a 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).
Hence, the claimed invention as a whole was prima facie obvious.
Moot Non-Statutory Double Patenting
U.S. Patent No. 11857585
The rejection of claims 12-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8 and 10 of US patent No. 11857585 (Hwang et al.; henceforth Hwang) in view of Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) as set forth in the previous office action is moot in view of the cancellation of these claims.
Withdrawn Non-Statutory Double Patenting
U.S. Patent No. 11857585
The rejection of claims 1, 9 and 11-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8 and 10 of US patent No. 11857585 (Hwang et al.; henceforth Hwang) in view of Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
The rejection of claim 6 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6, 8 and 10 of US patent No. 11857585 (Hwang et al.; henceforth Hwang) in view of Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) as applied to claim 1 above, and in further view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) as set forth in the previous office action is withdrawn in view of Applicant’s amendments.
Moot Provisional Non-Statutory Double Patenting
Copending Application No. 17638143
The provisional rejection of claims 12-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6 of copending application No. 17638143 (claims filed 12th, September, 2025) in view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) and Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) is moot in view of the cancellation of these claims.
Copending Application No. 17638144
The provisional rejection of claims 12-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 9 of copending application No. 17638144 (claims filed 17th, November, 2025) in view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) and Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) is moot in view of the cancellation of these claims.
Copending Application No. 17638750
The provisional rejection of claims 12-13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6 of copending application No. 17638750 (claims filed 30th, May, 2025) in view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) and Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) is moot in view of the cancellation of these claims.
Withdrawn Provisional Non-Statutory Double Patenting
Copending Application No. 17638143
The provisional rejection of claims 1, 6, 9 and 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6 of copending application No. 17638143 (claims filed 12th, September, 2025) in view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) and Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) is withdrawn in view of Applicant’s amendments.
Copending Application No. 17638144
The provisional rejection of claims 1, 6, 9 and 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 6 and 9 of copending application No. 17638144 (claims filed 17th, November, 2025) in view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) and Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) is withdrawn in view of Applicant’s amendments.
Copending Application No. 17638750
The provisional rejection of claims 1, 6, 9 and 13 on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, and 6 of copending application No. 17638750 (claims filed 30th, May, 2025) in view of Apperley et al. (WO2001079502 A2; henceforth “Apperley”) and Degreve et al. (Mol Pharmacol. 2000 Dec;58(6):1326-32.; see IDS filed 27th, August, 2024; henceforth “Degreve”) is withdrawn in view of Applicant’s amendments.
Conclusion
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.
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 /VALARIE E BERTOGLIO/Primary Examiner, Art Unit 1632
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