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 .
Claims 1-22 are pending as amended 6/22/23, and are considered herein.
Formalities
Applicant’s priority is as a 371 to PCT/KR2021/019663, filed 12/22/21, which claims priority to 10-2020-018024 (KR), filed 12/22/20 and 10-2021-0184947, filed 12/22/21.
The IDS filing of 6/22/23 and references therein, have been considered, and signed copy is provided herewith.
The drawings of 6/22/23 are accepted.
The specification as amended 6/22/23 is not found to have any issues therein, and thus, is accepted.
Claim Objections
Applicant is advised that should claim 1 be found allowable, claims 5-9, 11-14, and 20-21 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim 5 requires the modified reovirus to be derived from a wild-type human reovirus. The structure of the virus could be made from any reovirus’s components, and thus, the scope is substantially the same as Claim 1.
Claim 6 recites the modified reovirus of Claim 1, but calls it a composition for treating/preventing cancer. As such the structure is substantially identical to Claim 1.
Claim 7 recites several cancer types but this does not change the structure of the reovirus claimed, and thus, it has substantially the same scope as Claim 1.
Claim 8 recites the cancer is resistant to taxanes. However, this does not change the structure of the reovirus claimed, and thus, the structure claimed remains substantially the same.
Claim 9 recites several specific taxanes. However, this does not change the structure of the reovirus claimed, and thus, the structure claimed remains substantially the same.
Claim 11 recites that the reovirus is intended for IT or IV administration, but this does not change the structure of the reovirus claimed. Thus, the structure remains substantially the same.
Claim 12 two administrations to an individual, however, such does not change the structure of the reovirus that is claimed.
Claim 13 recites the composition of claim 1 co-administered with a wild type reovirus. However, this does not change the structure of the composition claimed.
Claim 14 modifies claim 13, and requires administration before or after the wild type reovirus. However, this does not change the structure of the reovirus claimed.
Claim 20 claims the reovirus of claim 1, but calls it a composition for an intended use. Such does not change the structure being claimed.
Claim 21 modifies the administration timing with regard to the intended use. However, that does not change the structure claimed.
Thus Claims 5-9, 11-14, and 20-21 are substantially the same scope as Claim 1, despite the slight difference in wording.
Applicant is advised that should claim 15 be found allowable, claim 17 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m). Claim 17 requires the checkpoint inhibitor to be in a mixture with the reovirus. However, Claim 15, from which it depends, is to a composition comprising both. Thus, despite a slight difference in wording, these claims have substantially the same scope.
Claim Rejections - 35 USC § 112
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.
Claim 18 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. Claim 18 requires that the reovirus and checkpoint inhibitor formulated separately. Such is outside the scope of Claim 15, which is to a single composition comprising both components. 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.
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 1-9, 11-14, 19-22 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 47-46 of copending Application No. 18/694,516 (reference application). Although the claims at issue are not identical, they are not patentably distinct from each other because:
Claims 1, 5-9, 11-14, and 19-21: Claim 27 teaches a recombinant vector, comprising a stop codon in the S1 gene of reovirus. Example 1 demonstrates as essential written description that RP116 is the embodiment embodying these claims as essential written description, and applicant’s own disclosure that the various mutations are found in RP116.
Claims 2-4: Applicant, in characterizing RP116, demonstrates that the RP116 reovirus of Kim contains the same mutations (e.g., Applicant’s Table 1). Applicant cannot claim that which is already known, because they further characterized it.
Claim 19: the composition anticipates the kit, unless there is structure that modifies the actual structure of the composition. Thus, the claim is met.
Claim 22: Claim 42 teaches administration to tumor.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-14, and 19-22 is/are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Kim, et al. (2011) “Attenuated reovirus displays oncolysis with reduced host toxicity”, British Journal of Cancer, 104: 290-99 and as further evidenced by Song, et al. (2024) “The reovirus variant RP116 is oncolytic in immunocompetent models and generates reduced neutralizing antibodies to Type 3 Dearing”, Molecular Therapy: Onocology, 32(3): 200846, 18 pages (see page 3, left column, paragraphs 1-2, which ties the structure of Kim as being that of RP116).
Claims 1-14, and 20-21: Kim teaches a delta 251-455 AV reovirus (e.g., p. 2, left column, penultimate paragraph; and Table 1, along with the mutations found in RP116 as characterzed by applicant. (See also, double patenting warnings: SUPRA, as these claims, despite having different wording, only claim the same structure.)
Claims 2-4: Applicant, in characterizing RP116, demonstrates that the AV reovirus of Kim contains the same mutations (e.g., Applicant’s Table 1). Applicant cannot claim that which is already known, because they further characterized it.
Claim 10: Kim teaches 1E7 PFU/tumor (e.g., p. 292, col. 2, paragraph 2), and thus, absent reason to believe otherwise, this meets TCID50 as presently claimed. The Examiner cannot perform the experiments to determine the TCID50.
Claim 19: the composition anticipates the kit, unless there is structure that modifies the actual structure of the composition. Thus, the claim is met.
Claim 22: the composition is injected IT with the RP116 (e.g., p. 292, col. 2, paragraph 2).
Art Made of Record
Kim, et al. (2011) “Attenuated reovirus displays oncolysis with reduced host toxicity”, British Journal of Cancer, 104: 290-99, is noted to be the first disclosure of RP116, which is then further described in Song, et al. (2024) “The reovirus variant RP116 is oncolytic in immunocompetent models and generates reduced neutralizing antibodies to Type 3 Dearing”, Molecular Therapy: Onocology, 32(3): 200846, 18 pages (see page 3, left column, paragraphs 1-2, which ties the structure of Kim as being that of RP116). (It is recognized this art is utilized in the anticipatory rejections, however, this explanation is here to make clear the history of this variant of reovirus.)
Claims 15-16 are 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. To wit, the use of the combination of RP116 and an immune checkpoint inhibitor is not taught or suggested in the art. While they are both known separately, it was not known if the use of such inhibitors would work to further inhibit cancer growth with the RP116, or if they utilized overlapping metabolic pathways and would not produce any increased effect. Thus, while allowable over the art, the objections remain as they depend from rejected base claim(s).
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ROBERT M KELLY whose telephone number is (571)272-0729. The examiner can normally be reached M-F: 8a-5p.
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ROBERT M. KELLY
Examiner
Art Unit 1638
/ROBERT M KELLY/Primary Examiner, Art Unit 1638