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 1-13, 16-17, 20-21, 23-28, and 32-36 are pending. Claims 31 and 38 were canceled; no claims were added; and claims 21, 23-25, 28, and 32-34 were amended in the Reply filed 8/04/2026. Claims 1-13, 16-17, and 20 remain withdrawn as directed to a non-elected invention. Claims 26-27 and 35-36 remain withdrawn as directed to non-elected species. Claims 21, 23-25, 28, and 32-34 are presently considered.
Election/Restriction
Applicant’s election without traverse of Group II (products, claims 21-28, 31-36, and 38 as filed 3/13/2026) and the subgenus of patentably indistinct species of pharmaceutical composition comprising “SVV” and “anti-PD-1 antibody” in the reply filed on 3/13/2026 was previously acknowledged.
The originally elected species was discussed in the previous action (see, e.g., Action mailed 5/05/2026 at 2-3), examined, and deemed anticipated and/or obvious in view of the prior art of record (see, e.g., Action mailed 5/05/2026, passim). In the subsequent reply filed 8/04/2026, the claim scope was amended to exclude the originally elected species by amending the claims to recite and require a third component, namely “a CTLA-4 inhibitor” (see, e.g., instant claim 21). Per MPEP § 803.02(III)(A),
Should applicant, in response to a rejection of a Markush claim, overcome the rejection by amending the Markush claim to exclude the species anticipated or rendered obvious by the prior art, the amended Markush claim will be examined again. The examination will be extended to the extent necessary to determine patentability of the Markush claim. In the event prior art is found during this examination that anticipates or renders obvious the amended Markush claim, the claim will be rejected and the action can be made final
Accordingly, examination has been extended to a non-elected species, namely an art-recognized “SVV”, an art-recognized “anti-PD-1 antibody”1, and an art-recognized “CTLA-4 inhibitor”.
Accordingly, examination has been extended to the subgenus of species comprising SVV, the PD-1 inhibitor of Nivolumab, and the CTLA-4 inhibitor of Ipilimumab. This non-elected species reads upon instant claims 21, 23-25, 28, and 32-34. Following extensive search and examination, the non-elected species has been deemed obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A), claims to other, unexamined non-elected species are withdrawn.
Claims 1-13, 16-17, 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. Election was made without traverse in the reply filed on 3/13/2026.
Claims 26-27 and 35-36 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 3/13/2026.
Claims 21, 23-25, 28, and 32-34 are presently considered.
Priority
The priority claim to US Provisional Application 63/135914 (filed 1/11/2021) is acknowledged.
Information Disclosure Statement
The IDS filed 8/04/2026 is acknowledged.
Claim Interpretation and Examiner Notes
For purposes of examination, the claim scope has been interpreted as set forth below per the guidance set forth at MPEP § 2111. If Applicant disputes any interpretation, Applicant is invited to unambiguously identify any alleged misinterpretations or specialized definitions in the subsequent response to the instant action. Applicant is advised that a specialized definition should be properly supported and specifically identified (see, e.g., MPEP § 2111.01(IV), describing how Applicant may act as their own lexicographer).
Amended claims 21 and 32 are representative of the pending claim scope, and both are directed to products defined by the physical structures that the products contain. Applicable claim interpretations are discussed below.
“Comprising” is an open-ended transitional term (see, e.g., MPEP § 2111.03(I)), wherein additional steps or components are not excluded. However, “‘[c]omprising’ is a term of art used in claim language which means that the named elements are essential” (see, e.g., id.; see also Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997)).
The phrase “pharmaceutical composition” is described as including a pharmaceutically acceptable carrier and/or excipient (see, e.g., Spec. filed 7/10/2023 at ¶¶[0042]-[0043]).
A “kit” is interpreted consistent with the specification (see, e.g., Spec. filed 7/10/2023 at ¶¶[0111]-[0112]), and a “kit” is understood to encompass a pharmaceutical composition as recited at claim 21. Accordingly, amended claim 32 is rejected for the reasons applicable to amended claim 21.
The phrasse “anti-PD-1” or “anti-PD-1 antibody” are understood to include at least the murine antibody of RMP1-14 and Nivolumab (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]). Nivolumab is an anti-programmed death-1 (PD-1) monoclonal antibody that is well-known in the prior art and has been taught for use in immunotherapies of cancers (see, e.g., Rajan et al.2 at title, abs).
“SVV” is understood to be “Seneca Valley Virus” (see instant claim 1), and is described in the Specification as including various strains including SVV-001, NTX-010, and ATCC Patent Deposit Number PTA-5343 (see, e.g., Spec. filed 7/10/2023 at ¶[0033]). Guo3 identifies that SVV is a prior art element, known oncolytic virus, and is also known as “Senecavirus A”, and is a non-enveloped RNA virus of the genus Senecavirus, family Picornaviridae (see, e.g., Guo at 1-2 at bridging ¶). Likewise, Burke4 identifies that SVV is a well-known oncolytic virus known in the prior art. The combination of SVV with additional agents in combination therapies was known in the prior art (see, e.g., Guo at 3 at col II at §§ Combination regimens as rational strategies” to page 4 at col I at 1st full ¶)
“SVV derivative” is described in the Specification (see, e.g., Spec. filed 7/10/2023 at ¶[0033]) and prior art (see, e.g., US 2019/0030099 Al at [0003]-[0005]).
“CTLA-4 inhibitor” is understood to include at least Ipilimumab (BMS) (see, e.g., Spec. filed 7/10/2023 at ¶[0121]).
Additional claim interpretations are discussed below.
Withdrawn Claim Rejections
All prior rejections are withdrawn in view of the cancellation of claims 31 and 38, the amendments filed 8/04/2026 removing language pertaining to “curative” treatment5 or treatment “preventing or removing all signs of the disease or disorder” 6, and in view of the amendments filed 8/04/2026 excluding the originally elected subgenus of patentably indistinct species by requiring the additional component of a CTLA-4 inhibitor.
However, the amendments filed 8/04/2026 have necessitated revised rejections in view of the prior art of record, and these revised rejections have been placed on record below.
Revised Claim Rejections Necessitated by Applicant Amendment
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.
[Revised Rejection 01]
Claims 21, 23-25, 28, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over US 2019/0030099 Al (Jan. 31, 2019; cited in previous action).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab (BMS) is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Regarding instant claims 21, 23-25, 28, 32-34, and pharmaceutical compositions comprising (i) SVV, (ii) a PD-1 inhibitor such as Nivolumab, and (iii) a CTLA-4 inhibitor such as Ipilimumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising SVV as well as checkpoint inhibitors (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051], claims 10-12). US’099 explicitly identifies and discloses pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), and further explains that
Suitable immunotherapies that may be used in combination with SVV include, but are not limited to, the use of checkpoint inhibitors, such as Nivolumab, Pembrolzumab, and Ipilimumab. SVV may be administered in combination with an immunotherapy or in sequence with it ( e.g., before or after). The combinations can also include additional compositions, which include additional agents in one or both of the compositions, such as another active agent, such as an anticancer compound or therapeutic agent or another different oncolytic virus, and/or a diagnostic agent.
(see, e.g., US’099 at ¶[0051]).
Accordingly, US’099 provides literal and explicit guidance motivating artisans to artisans to administer “in combination” the components of SVV and immunotherapies including Nivolumab (i.e., an anti-PD-1 antibody) and Ipilimumab (i.e., an anti-CTLA-4 antibody) (see, e.g., US’099 at ¶¶[0051]-[0052]). Such a combination would be readily understood to include pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), further comprising checkpoint inhibitors such as Nivolumab and Ipilimumab (see, e.g., US’099 at ¶[0051]; see also id. at ¶¶[0045]-[0046], [0052], claims 10-13).
The disclosure of US’099 differs from the instant claims as follows: Although US’099 directs artisans to combinations of SVV and checkpoint inhibitors such as Nivolumab and Ipilimumab, US’099 does not reduce to practice a pharmaceutical composition comprising SVV, Nivolumab, Ipilimumab, and a pharmaceutically acceptable carrier.
However, US’099 provides direct guidance to make and use such combinations (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052]), and claims methods of administering such compositions (see, e.g., US’099 at claims 10-13), wherein the predicted and expected activity of each individual component was known and the expected utility of the combination of components was known (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052], claims 10-13), namely the combination would be usable in the treatment of cancer. Regarding the specific selection of the anti-PD-1 antibody of Nivolumab and the anti-CTLA-4 antibody Ipilimumab, Nivolumab and Ipilimumab are two of only three specifically disclosed checkpoint inhibitors (see, e.g., US’099 at ¶[0051]), and furthermore the courts have previously noted that "[r]eading a list and selecting a known compound to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle." (see, e.g., Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945), at 335).
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): The invention is the combination of prior art elements (i.e., the known oncolytic virus of SVV, and the known checkpoint inhibitors of Nivolumab and Ipilimumab) according to known methods of forming a combination therapy suitable for administration in combination as disclosed by US’099, to yield predictable results, namely a pharmaceutical composition comprising SVV, Nivolumab, Ipilimumab, and a pharmaceutically acceptable carrier, wherein such composition is suitable for use in the treatment of cancer; and wherein each component merely performs its art-recognized role in combination as it does separately (see, e.g., MPEP §§ 2143(I)(A), 2143(I)(G), 2144.07).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to combine prior art compounds in a formulation suitable for combination therapies wherein the compounds are administered in combination.
Accordingly, claims 21, 23-25, 28, and 32-34 are rejected.
[Revised Rejection 02]
Claims 21, 23-25, 28, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 7638318 in further view of US 2019/0030099 Al (Jan. 31, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection and preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Regarding instant claims 21, 23-25, 28, 32-34, and a pharmaceutical composition comprising SVV or an SVV derivative, the primary reference pertains to pharmaceutical compositions comprising SVV or an SVV derivative (see, e.g., US’318 at claims 4-7 and 9; see esp. claims 4 and 7), understood to be useful for killing abnormally proliferative cells (see, e.g., US’318 at claim 9) (e.g., cancer or tumor cells).
The issued claims differ from the pending claim scope as follows: The primary reference does not specifically disclose pharmaceutical compositions comprising SVV (or SVV derivatives) comprising a PD-1 inhibitor, such as the anti-PD-1 antibody Nivolumab and further comprising a CTLA-4 inhibitor, such as the antibody Ipilimumab.
However, the utility of pharmaceutical formulations comprising SVV (or SVV derivatives) and variations thereof were already known in the prior art. Specifically, regarding instant claims 21, 23-25, 28, 32-34, and pharmaceutical compositions comprising SVV and checkpoint inhibitors such as Nivolumab and Ipilimumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising SVV and checkpoint inhibitors (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051], claims 10-13). US’099 explicitly identifies and discloses pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), and explains that SVV may be utilized in combination with checkpoint inhibitors such as Nivolumab and Ipilimumab, which may be utilized and “administered in combination” with SVV (see, e.g., US’099 at ¶[0051]). Accordingly, US’099 provides literal and explicit guidance motivating artisans to artisans to administer “in combination” the components of SVV, Nivolumab (i.e., an anti-PD-1 antibody), and Ipilimumab (i.e., an anti-CTLA-4 antibody) (see, e.g., US’099 at ¶¶[0051]-[0052]). Such a combination would be readily understood to include pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), further comprising checkpoint inhibitors, including Nivolumab and Ipilimumab (see, e.g., US’099 at ¶[0051]; see also id. at ¶¶[0045]-[0046], [0052], claims 10-13). US’099 provides direct guidance to make and use such combinations (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052]), and claims methods of administering such compositions (see, e.g., US’099 at claims 10-13), wherein the predicted and expected activity of each individual component was known and the expected utility of the combination of components was known (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052], claims 10-13), namely the combination would be usable in the treatment of cancer.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): First, the invention is the combination of prior art elements (i.e., the known oncolytic virus of SVV as taught by the primary and secondary references, and the known checkpoint inhibitors of Nivolumab and Ipilimumab as taught by the secondary reference) according to known methods of forming a combination therapy suitable for administration in combination as disclosed by US’099, to yield predictable results, namely a pharmaceutical composition comprising SVV, Nivolumab, Ipilimumab, and a pharmaceutically acceptable carrier, wherein such composition is suitable for use in the treatment of cancer; and wherein each component merely performs its art-recognized role in combination as it does separately (see, e.g., MPEP §§ 2143(I)(A), 2143(I)(G), 2144.07). Second, or alternatively, the claimed invention is obvious improvement of the prior art invention of the primary reference, wherein the methodology of the primary reference for killing abnormally proliferative cells is improved by co-administering checkpoint inhibitors (i.e., Nivolumab and Ipilimumab) in addition to SVV (or an SVV derivative) as taught and suggested by the secondary reference, which would necessarily require the creation of pharmaceutical compositions comprising the oncolytic virus and the checkpoint inhibitors of Nivolumab and Ipilimumab, wherein such improvement (or application of a known technique) would predictably result in improved killing of cancer and tumor cells (see, e.g., MPEP §§ 2143(I)(C), (D), (F)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to combine prior art compounds in a formulation suitable for combination therapies wherein the compounds are administered in combination in known methods to achieve known and expected results.
Accordingly, claims 21, 23-25, 28, and 32-34 are rejected.
[Revised Rejection 03]
Claims 21, 23-25, 28, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8753622 in further view of US 2019/0030099 Al (Jan. 31, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection and preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Regarding instant claims 21, 23-25, 28, 32-34, and a pharmaceutical composition comprising SVV or an SVV derivative, the primary reference pertains to methods of killing tumor cells by administering an unspecified composition comprising SVV or an SVV derivative (see, e.g., US’622 at claims 1-4), understood to be useful for killing abnormally proliferative cells (see, e.g., US’622 at claim 1 and 3-4). Although the issued claims do not directly recite or claim a pharmaceutical formulation, an artisan would readily appreciate that performing the methods as claimed would necessarily and inherently require the existence of a pharmaceutical formulation comprising the SVV (or SVV derivative) in a pharmaceutically acceptable carrier (see, e.g., US’622 at claims 1-4).
The issued claims differ from the pending claim scope as follows: The primary reference does not specifically disclose pharmaceutical compositions comprising SVV (or SVV derivatives) comprising a PD-1 inhibitor, such as the anti-PD-1 antibody Nivolumab and further comprising a CTLA-4 inhibitor, such as the antibody Ipilimumab.
However, the utility of pharmaceutical formulations comprising SVV (or SVV derivatives) and variations thereof were already known in the prior art. Specifically, regarding instant claims 21, 23-25, 28, 32-34, and pharmaceutical compositions comprising SVV and a checkpoint inhibitor such as Nivolumab and Ipilimumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising SVV and checkpoint inhibitors (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051], claims 10-13). US’099 explicitly identifies and discloses pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), and explains that SVV may be utilized in combination with checkpoint inhibitors such as Nivolumab and Ipilimumab, which may be utilized and “administered in combination” with SVV (see, e.g., US’099 at ¶[0051]). Accordingly, US’099 provides literal and explicit guidance motivating artisans to artisans to administer “in combination” the components of SVV, Nivolumab (i.e., an anti-PD-1 antibody), and Ipilimumab (i.e., an anti-CTLA-4 antibody) (see, e.g., US’099 at ¶¶[0051]-[0052]). Such a combination would be readily understood to include pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), further comprising checkpoint inhibitors, including Nivolumab and Ipilimumab (see, e.g., US’099 at ¶[0051]; see also id. at ¶¶[0045]-[0046], [0052], claims 10-13). US’099 provides direct guidance to make and use such combinations (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052]), and claims methods of administering such compositions (see, e.g., US’099 at claims 10-13), wherein the predicted and expected activity of each individual component was known and the expected utility of the combination of components was known (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052], claims 10-13), namely the combination would be usable in the treatment of cancer.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): First, the invention is the combination of prior art elements (i.e., the known oncolytic virus of SVV as taught by the primary and secondary references, and the known checkpoint inhibitors of Nivolumab and Ipilimumab as taught by the secondary reference) according to known methods of forming a combination therapy suitable for administration in combination as disclosed by US’099, to yield predictable results, namely a pharmaceutical composition comprising SVV, Nivolumab, Ipilimumab, and a pharmaceutically acceptable carrier, wherein such composition is suitable for use in the treatment of cancer; and wherein each component merely performs its art-recognized role in combination as it does separately (see, e.g., MPEP §§ 2143(I)(A), 2143(I)(G), 2144.07). Second, or alternatively, the claimed invention is obvious improvement of the prior art invention of the primary reference, wherein the methodology of the primary reference for killing abnormally proliferative cells is improved by co-administering checkpoint inhibitors (i.e., Nivolumab and Ipilimumab) in addition to SVV (or an SVV derivative) as taught and suggested by the secondary reference, which would necessarily require the creation of pharmaceutical compositions comprising the oncolytic virus and the checkpoint inhibitors of Nivolumab and Ipilimumab, wherein such improvement (or application of a known technique) would predictably result in improved killing of cancer and tumor cells (see, e.g., MPEP §§ 2143(I)(C), (D), (F)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to combine prior art compounds in a formulation suitable for combination therapies wherein the compounds are administered in combination in known methods to achieve known and expected results.
Accordingly, claims 21, 23-25, 28, and 32-34 are rejected.
[Revised Rejection 04]
Claims 21, 23-25, 28, and 32-34 are rejected under 35 U.S.C. 103 as being unpatentable over U.S. Patent No. 8039606 in further view of US 2019/0030099 Al (Jan. 31, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding rejection and preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Regarding instant claims 21, 23-25, 28, and 32-34, and a pharmaceutical composition comprising SVV or an SVV derivative, the primary reference pertains to methods of killing tumor cells by administering an unspecified composition comprising SVV or an SVV derivative (see, e.g., US’606 at claims 1-3; see esp. id. at claim 3), which are claimed (and therefore understood to be useful for) for use in a method of killing abnormally proliferative cells (e.g., tumor and cancer cells) (see, e.g., US’606 at claim 3). Although the issued claims do not directly recite or claim a pharmaceutical formulation, an artisan would readily appreciate that performing the methods as claimed would necessarily and inherently require the existence of a pharmaceutical formulation comprising the SVV (or SVV derivative) in a pharmaceutically acceptable carrier (see, e.g., US’606 at claims 3).
The issued claims differ from the pending claim scope as follows: The primary reference does not specifically disclose pharmaceutical compositions comprising SVV (or SVV derivatives) comprising a PD-1 inhibitor, such as the anti-PD-1 antibody Nivolumab and further comprising a CTLA-4 inhibitor, such as the antibody Ipilimumab.
However, the utility of pharmaceutical formulations comprising SVV (or SVV derivatives) and variations thereof were already known in the prior art. Specifically, regarding instant claims 21, 23-25, 28, 32-34, and pharmaceutical compositions comprising SVV and checkpoint inhibitors such as Nivolumab and Ipilimumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising SVV and checkpoint inhibitors (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051], claims 10-13). US’099 explicitly identifies and discloses pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), and explains that SVV may be utilized in combination with checkpoint inhibitors such as Nivolumab and Ipilimumab, which may be utilized and “administered in combination” with SVV (see, e.g., US’099 at ¶[0051]). Accordingly, US’099 provides literal and explicit guidance motivating artisans to artisans to administer “in combination” the components of SVV, Nivolumab (i.e., an anti-PD-1 antibody), and Ipilimumab (i.e., an anti-CTLA-4 antibody) (see, e.g., US’099 at ¶¶[0051]-[0052]). Such a combination would be readily understood to include pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), further comprising checkpoint inhibitors, including Nivolumab and Ipilimumab (see, e.g., US’099 at ¶[0051]; see also id. at ¶¶[0045]-[0046], [0052], claims 10-13). US’099 provides direct guidance to make and use such combinations (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052]), and claims methods of administering such compositions (see, e.g., US’099 at claims 10-13), wherein the predicted and expected activity of each individual component was known and the expected utility of the combination of components was known (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052], claims 10-13), namely the combination would be usable in the treatment of cancer.
Therefore, it would have been obvious to one of ordinary skill in the art, either before the effective filing date of the claimed invention (AIA ) or otherwise at the time the invention was made (pre-AIA ), to arrive at the instantly claimed invention in view of the prior art for at least the following reason(s): First, the invention is the combination of prior art elements (i.e., the known oncolytic virus of SVV as taught by the primary and secondary references, and the known checkpoint inhibitors of Nivolumab and Ipilimumab as taught by the secondary reference) according to known methods of forming a combination therapy suitable for administration in combination as disclosed by US’099, to yield predictable results, namely a pharmaceutical composition comprising SVV, Nivolumab, Ipilimumab, and a pharmaceutically acceptable carrier, wherein such composition is suitable for use in the treatment of cancer; and wherein each component merely performs its art-recognized role in combination as it does separately (see, e.g., MPEP §§ 2143(I)(A), 2143(I)(G), 2144.07). Second, or alternatively, the claimed invention is obvious improvement of the prior art invention of the primary reference, wherein the methodology of the primary reference for killing abnormally proliferative cells is improved by co-administering checkpoint inhibitors (i.e., Nivolumab and Ipilimumab) in addition to SVV (or an SVV derivative) as taught and suggested by the secondary reference, which would necessarily require the creation of pharmaceutical compositions comprising the oncolytic virus and the checkpoint inhibitors of Nivolumab and Ipilimumab, wherein such improvement (or application of a known technique) would predictably result in improved killing of cancer and tumor cells (see, e.g., MPEP §§ 2143(I)(C), (D), (F)).
No evidence of unexpected results commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02 have been placed on record to date.
Furthermore, there would be a reasonable expectation of success because the prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). Furthermore, it is well within the ordinary skill in the art to combine prior art compounds in a formulation suitable for combination therapies wherein the compounds are administered in combination in known methods to achieve known and expected results.
Accordingly, claims 21, 23-25, 28, and 32-34 are rejected.
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.
[Revised NSDP 01]
Claims 21, 23-25, 28, and 32-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 4, 7-8, and 11 of U.S. Patent No. 12502414 B2. Although the claims at issue are not identical, they are not patentably distinct from each other as explained below.
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Like the instant claims, issued claim 4 of US’414 is also directed to pharmaceutical compositions (i.e., products) comprising an SVV or an SVV derivative in combination with a pharmaceutically acceptable carrier (see, e.g., US’414 at claim 4).
The difference between the issued claims pertaining to products, and the products as recited at instant claims 21, 23-25, 31-34, and 38 is understood to be that claim 4 of US’414 does not explicitly recite the presence of a PD-1 inhibitor (e.g., such as Nivolumab) or a CTLA-4 inhibitor (e.g., such as Ipilimumab) as required by the instant claims.
However, US’414 claims methods of utilizing pharmaceutical compositions to treat cancer (see, e.g., US’414 at claims 1, 7-8, and 11), which necessitates the existence of such products. Notably, the issued claim scope of US’414 explicitly identifies that such administered compounds may include both a PD-1 inhibitor and a CTLA-4 inhibitor (see, e.g., US’414 at claims 1 and 7), wherein such additional anti-cancer therapeutics may be administered simultaneously or subsequently with the SVV or SVV derivative (see, e.g., US’414 at claim 8), to patients having cancer (see, e.g., US’414 at claims 1 and 11). Accordingly, an artisan would readily appreciate that the claims necessarily encompassed or otherwise rendered obvious pharmaceutical compositions comprising SVV (or an SVV derivative) in combination with at least one or more additional anti-cancer therapeutic agents, including checkpoint inhibitors such as a PD-1 inhibitor and CTLA-4 inhibitor (compare US’414 at claims 1, 4, 7-8, and 11 with instant claims 21-23, 31-33, and 38). Regarding instant claims 21-25, 28, 32-34, and the specific usage of a PD-1 inhibitor that is an anti-PD-1 antibody, and the specific usage of a CTLA-4 inhibitor that is an antibody, per MPEP § 804(II)(B)(1), it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim (see, e.g., MPEP § 804(II)(B)(1)), and here the term “PD-1 inhibitor” used by US’414 at claim 7 would be understood to include “ an inhibitor of programmed cell death protein 1 (PD-1) signaling such as a monoclonal antibody that binds to PD-1” (see, e.g., US’414 at col. 13 at lines 62-67); likewise the term “CTLA-4 inhibitor” used by US’414 at claim 7 would be understood to include a monoclonal antibody that binds to CTLA-4, such as Ipilimumab or any other possible CTLA-4 inhibitor, including other antibodies or compounds capable of inhibiting CTLA-4 without limitation (see, e.g., US’414 at col. 13 at line 62 to col. 14 at line 8, col. 17 at lines 15-20).
Accordingly, the differences between the reference claims and instant claims appear to be minor at best because both claim sets read upon pharmaceutical compositions comprising SVV and both a PD-1 inhibitor as well as a CTLA-4 inhibitor7; and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent”8 is clearly “yes”. MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim methods requiring and rending obvious the products currently claimed (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to make and use pharmaceutical compositions comprising only known components for use in known methods (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (B), (E), and (G)). Therefore, the instant claims are directed to obvious variants of the issued claims.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to obvious variants of the claimed pharmaceutical compositions suitable for use in the methods of treating cancer as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 21, 23-25, 28, and 32-34 are rejected.
[Revised NSDP 02]
Claims 21, 23-25, 28, and 32-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 4-7 and 9 of U.S. Patent No. 7638318 in view of US 2019/0030099 Al (Jan. 31, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 28, and 32-34, and a pharmaceutical composition comprising SVV or an SVV derivative, the issued claims pertain to a pharmaceutical composition comprising SVV or an SVV derivative (see, e.g., US’318 at claims 4-7 and 9; see esp. claims 4 and 7), understood to be useful for killing abnormally proliferative cells (see, e.g., US’318 at claim 9).
The issued claims differ from the pending claim scope as follows: The issued claims do not specifically recite or require that the claimed pharmaceutical composition further comprise checkpoint inhibitors, such as a PD-1 inhibitor (e.g., Nivolumab) and a CTLA-4 inhibitor (e.g., Ipilimumab).
However, the utility of pharmaceutical formulations and variations thereof was already known in the prior art. Specifically, regarding instant claims 21-25, 28, 32-34, and pharmaceutical compositions comprising SVV and checkpoint inhibitors such as Nivolumab and Ipilimumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising SVV and checkpoint inhibitors (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051], claims 10-13). US’099 explicitly identifies and discloses pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), and explains that SVV may be utilized in combination with checkpoint inhibitors such as Nivolumab and Ipilimumab, which may be utilized and “administered in combination” with SVV (see, e.g., US’099 at ¶[0051]). Accordingly, US’099 provides literal and explicit guidance motivating artisans to artisans to administer “in combination” the components of SVV and also the checkpoint inhibitors of Nivolumab (i.e., an anti-PD-1 antibody) and Ipilimumab (i.e., a CTLA4-inhibitor) (see, e.g., US’099 at ¶¶[0051]-[0052], claims 10-11). Such a combination would be readily understood to include pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), further comprising checkpoint inhibitors such as Nivolumab and Ipilimumab (see, e.g., US’099 at ¶[0051]; see also id. at ¶¶[0045]-[0046], [0052], claims 10-13). US’099 provides direct guidance to make and use such combinations (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052]), and claims methods of administering such compositions (see, e.g., US’099 at claims 10-13), wherein the predicted and expected activity of each individual component was known and the expected utility of the combination of components was known (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052], claims 10-13), namely the combination would be usable in the treatment of cancer.
Accordingly, the differences between the reference claims and instant claims would have been obvious at the time of filing, and amounted to a known variation of SVV (or SVV derivatives) pharmaceutical formulations, wherein such compositions could desirably and advantageously comprise SVV and check-point inhibitors including PD-1 inhibitors such as Nivolumab and CTLA4-inhibitors such as Ipilimumab 9; and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent”10 is clearly “yes”. MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)). Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim methods requiring and rending obvious the products currently claimed (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine (or simply substitute) known components into known pharmaceutical compositions having known utility, exactly as specifically taught and suggested by the prior art (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (B), and (G)). Therefore, the instant claims are directed to obvious variants of the issued claims.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to obvious variants of the claimed pharmaceutical compositions suitable for use in the methods of treating cancer as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 21, 23-25, 28, and 32-34 are rejected.
[Revised NSDP 03]
Claims 21, 23-25, 28, and 32-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 8753622 in view of US 2019/0030099 Al (Jan. 31, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Regarding instant claims 21, 23-25, 28, 32-34, and a pharmaceutical composition comprising SVV or an SVV derivative, the issued claims pertain to methods of killing tumor cells by administering an unspecified composition comprising SVV or an SVV derivative (see, e.g., US’622 at claims 1-4), understood to be useful for killing abnormally proliferative cells (see, e.g., US’622 at claim 1 and 3-4). Although the issued claims do not directly recite or claim a pharmaceutical formulation, an artisan would readily appreciate that performing the methods as claimed would necessarily and inherently require the existence of a pharmaceutical formulation comprising the SVV (or SVV derivative) in a pharmaceutically acceptable carrier (see, e.g., US’622 at claims 1-4)11.
The issued claims differ from the pending claim scope as follows: The issued claims do not specifically recite or require that a composition comprising SVV (or SVV derivative) may additionally comprise checkpoint inhibitors, such as a PD-1 inhibitor (e.g., Nivolumab) and a CTLA-4 inhibitor (e.g., Ipilimumab).
However, the utility of pharmaceutical formulations and variations thereof was already known in the prior art. Specifically, regarding instant claims 21, 23-25, 28, 32-34, and pharmaceutical compositions comprising SVV and checkpoint inhibitors such as Nivolumab and Ipilimumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising SVV and checkpoint inhibitors such as Nivolumab and Ipilimumab (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051], claims 10-13). US’099 explicitly identifies and discloses pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), and explains that SVV may be utilized in combination with checkpoint inhibitors such as Nivolumab and Ipilimumab, which may be utilized and “administered in combination” with SVV (see, e.g., US’099 at ¶[0051]). Accordingly, US’099 provides literal and explicit guidance motivating artisans to artisans to administer “in combination” the components of SVV and also the checkpoint inhibitors of Nivolumab (i.e., an anti-PD-1 antibody) and Ipilimumab (i.e., a CTLA4-inhibitor) (see, e.g., US’099 at ¶¶[0051]-[0052], claims 10-11). Such a combination would be readily understood to include pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), further comprising checkpoint inhibitors such as Nivolumab and Ipilimumab (see, e.g., US’099 at ¶[0051]; see also id. at ¶¶[0045]-[0046], [0052], claims 10-13). US’099 provides direct guidance to make and use such combinations (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052]), and claims methods of administering such compositions (see, e.g., US’099 at claims 10-13), wherein the predicted and expected activity of each individual component was known and the expected utility of the combination of components was known (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052], claims 10-13), namely the combination would be usable in the treatment of cancer.
Accordingly, the differences between the reference claims and instant claims would have been obvious at the time of filing, and amounted to a known variations of SVV (or SVV derivatives) pharmaceutical formulations, wherein such compositions could desirably and advantageously comprise SVV and checkpoint inhibitors (e.g., PD-1 inhibitors such as Nivolumab and CTLA-4 inhibitors such as Ipilimumab) 12; and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent”13 is clearly “yes”. MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)).
Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim methods requiring and rending obvious the products currently claimed (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine (or simply substitute) known components into known pharmaceutical compositions having known utility, exactly as specifically taught and suggested by the prior art; and therefore improving the methods of the issued claims by including additional anticancer drugs, such as checkpoint inhibitors such Nivolumab and Ipilimumab , would be obvious and merely yield the expected and predicted results, namely an improved method of killing tumor cells by administering a composition comprising SVV (or an SVV derivative) and the checkpoint inhibitors Nivolumab (i.e. a PD-1 inhibitor) and Ipilimumab (i.e., a CTLA4-inhibitor) (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (B), and (G)). Therefore, the instant claims are directed to obvious variants of the issued claim scope.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to obvious variants of the claimed pharmaceutical compositions suitable for use in the methods of treating cancer as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 21, 23-25, 28, and 32-34 are rejected.
[Revised NSDP 04]
Claims 21, 23-25, 28, and 32-34 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-3 of U.S. Patent No. 8039606 in view of US 2019/0030099 Al (Jan. 31, 2019).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Regarding instant claims 21, 23-25, 28, 32-34, and a pharmaceutical composition comprising SVV or an SVV derivative, the issued claims pertain to methods of killing tumor cells by administering an unspecified composition comprising SVV or an SVV derivative (see, e.g., US’606 at claims 1-3; see esp. id. at claim 3), which are claimed (and therefore understood to be useful for) for use in a method of killing abnormally proliferative cells (see, e.g., US’606 at claim 3). Although the issued claims do not directly recite or claim a pharmaceutical formulation, an artisan would readily appreciate that performing the methods as claimed would necessarily and inherently require the existence of a pharmaceutical formulation comprising the SVV (or SVV derivative) in a pharmaceutically acceptable carrier (see, e.g., US’606 at claims 3) 14.
The issued claims differ from the pending claim scope as follows: The issued claims do not specifically recite or require that a composition comprising SVV (or SVV derivative) may additionally comprise checkpoint inhibitors, such as a PD-1 inhibitor (e.g., Nivolumab) and a CTLA-4 inhibitor (e.g., Ipilimumab).
However, the utility of pharmaceutical formulations and variations thereof was already known in the prior art. Specifically, regarding instant claims 21, 23-25, 28, 32-34, and pharmaceutical compositions comprising SVV and checkpoint inhibitors such as Nivolumab and Ipilimumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising SVV and checkpoint inhibitors such Nivolumab and Ipilimumab (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051], claims 10-13). US’099 explicitly identifies and discloses pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), and explains that SVV may be utilized in combination with checkpoint inhibitors such as Nivolumab and Ipilimumab, which may be utilized and “administered in combination” with SVV (see, e.g., US’099 at ¶[0051]). Accordingly, US’099 provides literal and explicit guidance motivating artisans to artisans to administer “in combination” the components of SVV and also the checkpoint inhibitors of Nivolumab (i.e., an anti-PD-1 antibody) and Ipilimumab (i.e., a CTLA4-inhibitor) (see, e.g., US’099 at ¶¶[0051]-[0052], claims 10-11). Such a combination would be readily understood to include pharmaceutical formulations comprising SVV in a pharmaceutically acceptable carrier (see, e.g., US’099 at ¶¶[0047]-[0050]), further comprising checkpoint inhibitors such as Nivolumab and Ipilimumab (see, e.g., US’099 at ¶[0051]; see also id. at ¶¶[0045]-[0046], [0052], claims 10-13). US’099 provides direct guidance to make and use such combinations (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052]), and claims methods of administering such compositions (see, e.g., US’099 at claims 10-13), wherein the predicted and expected activity of each individual component was known and the expected utility of the combination of components was known (see, e.g., US’099 at ¶¶[0007], [0026], [0045]-[0052], claims 10-13), namely the combination would be usable in the treatment of cancer.
Accordingly, the differences between the reference claims and instant claims would have been obvious at the time of filing, and amounted to a known variations of SVV (or SVV derivatives) pharmaceutical formulations, wherein such compositions could desirably and advantageously comprise SVV and checkpoint inhibitors (e.g., PD-1 inhibitors such as Nivolumab and CTLA-4 inhibitors such as Ipilimumab) 15; and therefore the answer to the question “Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent”16 is clearly “yes”. MPEP § 804(II)(B)(2)-(3) further identify that a Nonstatutory Double Patenting Rejection may be appropriate based upon either an anticipation analysis or an obviousness analysis (see, e.g., MPEP § 804(II)(B)(2)-(3)).
Under an obviousness analysis (see, e.g., MPEP § 804(II)(B)(3)), it is noted that the scope and content of the patent claim relative to the application claims at issue have been discussed above (see, e.g., MPEP § 804(II)(B)(3)(A)), and that the differences are that the instant claims attempt to claim methods requiring and rending obvious the products currently claimed (see, e.g., MPEP § 804(II)(B)(3)(B)). Accordingly, the present claims are directed to obvious variants of the reference claims because it is well-within the ordinary skill in the art to combine (or simply substitute) known components into known pharmaceutical compositions having known utility in known methods of treating tumor cells, exactly as specifically taught and suggested by the prior art; and therefore improving the methods of the issued claims by including known checkpoint inhibitors such as the PD-1 inhibitor of Nivolumab and the CTLA-4 inhibitor Ipilimumab, would be obvious and would merely yield the expected and predicted results, namely an improved method of killing tumor cells by administering a composition comprising SVV (or an SVV derivative), a PD-1 inhibitor such as Nivolumab, and a CTLA-4 inhibitor such as Ipilimumab (see, e.g., MPEP § 804(II)(B)(3)(C)-(D); see also MPEP §§ 2143(I)(A), (B), and (G)). Therefore, the instant claims are directed to obvious variants of the issued claim scope.
As issued claims in a U.S. patent, the reference claims are presumed to satisfy all statutory requirements in the absence of evidence to the contrary. Accordingly, the instant claims are directed to an obvious, claimed variant of the patent claims, namely the claims are directed to obvious variants of the claimed pharmaceutical compositions suitable for use in the methods of treating cancer as set forth in the issued claims. Therefore, the instant claims substantially overlap in scope with the issued claims and unambiguously encompass obvious variants of the issued claims.
As required at (C) of MPEP § 804(II), the rejection is not prohibited by 35 U.S.C. 121.
As noted at MPEP § 804(II)(B)(4), the reference patent and the instant Application are understood to require only a one-way test for distinctiveness.
Accordingly, instant claims 21, 23-25, 28, and 32-34 are rejected.
[Revised Provisional NSDP 01]
Claim 21, 23-25, 28, and 32-34 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 13, and 43 of copending Application No. 18/272,986 (reference application; corresponding to US 20240307470-A1).
Claim interpretation: The applicable claim interpretation has been set forth in a preceding section above, and those interpretations are incorporated into the instant rejection. Nivolumab is understood to be a species of “anti-PD-1 antibody” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]), and Ipilimumab is understood to be a species of “CTLA-4 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶[0121]). Additional claim interpretations are set forth below.
Although the claims at issue are not identical, they are not patentably distinct from each other because App’986 recites and claims pharmaceutical compositions comprising SVV (or an SVV derivative) (see, e.g., App’986 at claims 1, 13, and 43). Although the claims do not explicitly recite checkpoint inhibitors, such embodiments are obvious variants of the copending claim set, and obvious variants may be considered in non-statutory double-patenting rejections (see, e.g., MPEP § 804(II)(B)(1), “those portions of the specification which provide support for the reference claims may also be examined and considered when addressing the issue of whether a claim in the application defines an obvious variation of an invention claimed in the reference patent or application”) 17. Here, App’986 explicitly identifies that such compositions may comprise PD-1 inhibitors and CTLA-4 inhibitors (see, e.g., App’986 at Spec. filed 7/18/2023 at [0165]; see also MPEP § 804(II)(B)(1)). Accordingly, such compositions comprising such agents are obvious variants of the claimed pharmaceutical compositions (see also App’986 at claim set filed 7/18/2023 at claims 43-45, expressly reciting and claiming pharmaceutical compositions further comprising a PD-1 inhibitor and a CTLA-4 inhibitor). Accordingly, the scope of the copending claims substantially and materially overlaps with the pending claims, and is not patentably distinct relative to the instant claims.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
Response to Arguments
Applicant’s arguments with respect to the amended claim scope of pending claims 21-25, 28, and 32-34 have been fully considered, but such arguments are substantially rendered moot in view of the revised grounds of rejection necessitated by Applicant’s amendments filed 8/04/2026, which excluded the originally elected species, and required the presence of the additional component of a CTLA-4 inhibitor. Remaining applicable arguments are addressed below.
Arguments Pertinent to Revised 35 USC § 103 Rejections
Arguments directed to canceled or withdrawn claims are moot. It is the Examiner’s understanding that Applicant addresses the revised rejections at pages 7-10 of the Reply filed 8/04/2026. Applicable arguments are addressed below.
SVV, PD-1 inhibitors, and CTLA-4 inhibitors were all prior art elements and were all known and art-recognized anti-cancer agents: It is the Examiner’s understanding that Applicant is alleging that “[t]here would have been no reason or motivation for those of ordinary skill in the art to arrive at the claimed pharmaceutical compositions or kits” (see, e.g., Reply filed 8/04/2026 at 7 at final ¶) because “Miles does not specifically teach or suggest combination of SVV, a PD-1 inhibitor, and a CTLA-4 inhibitor” (see Reply filed 8/04/2026 at 8 at 1st ¶; see also 9 at 1st ¶, 9 at final two ¶¶, 10 at 1st partial ¶ to 2nd full ¶). This is not persuasive because US’099 (“Miles”) explicitly taught and claimed pharmaceutical compositions explicitly “wherein the SVV is administered in combination with another therapeutic agent”, which was explicitly identified as including “checkpoint inhibitors” (plural) (see, e.g., US’099 at claims 10-12), wherein only three checkpoint inhibitors were expressly exemplified (e.g., US’099 at ¶[0051]), namely “Nivolumab, Pembrolzumab, and Ipilimumab” (see id), wherein both Nivolumab and Pembrolzumab are PD-1 inhibitors, and Ipilimumab is a CTLA-4 inhibitor, which means that only two checkpoint inhibitor targets (i.e., PD-1 and CTLA-4) are explicitly exemplified (e.g., US’099 at ¶[0051]). Furthermore, the usage of the plural “checkpoint inhibitors” (plural) (see, e.g., US’099 at claims 10-12, esp. claim 12) would direct artisans to utilize two or three of the only three exemplified checkpoint inhibitors (e.g., this would lead to combinations of all three, N+P, N+I, or P+I, wherein all combinations except N+P comprise both a PD-1 inhibitor and a CTLA-4 inhibitor). Accordingly, the allegation that US’099 does not teach such combinations is directly contradicted by the disclosure and claims of US’099 as cited by the Examiner, and Applicant provides no objective rationale for dismissing or ignoring such explicit guidance. Accordingly, such arguments are not persuasive because they fail to address the merits of the rejection, including cited portions of the prior art that contradict the Applicant’s statements.
Combining prior art elements according to known methods to yield predictable results is obvious: It is the Examiner’s understanding that Applicant is alleging that “[t]here would have been no reason or motivation for those of ordinary skill in the art to arrive at the claimed pharmaceutical compositions or kits” (see, e.g., Reply filed 8/04/2026 at 7 at final ¶) because “the person of ordinary skill in the art would not have sought to combine SVV with two checkpoint inhibitors” (see id. at Reply filed 8/04/2026 at 1st ¶; see also id. at 9 at 1st ¶ and 9 at final two ¶¶). This statement is made in the absence of explanation or objective supporting evidence. Obviousness may be established by combining or modifying the teachings of the prior art to produce the claimed invention where there is some teaching, suggestion, or motivation to do so found either in the references themselves or in the knowledge generally available to one of ordinary skill in the art (see In re Fine, 837 F.2d 1071, 5 USPQ2d 1596 (Fed. Cir. 1988), In re Jones, 958 F.2d 347, 21 USPQ2d 1941 (Fed. Cir. 1992), and KSR International Co. v. Teleflex, Inc., 550 U.S. 398, 82 USPQ2d 1385 (2007). In this case, the prior art expressly claims and directs artisans to combine SVV with “checkpoint inhibitors” (plural) (see, e.g., US’099 at claims 10-12, esp. claim 12; see also id. at ¶[0051], noting that only three checkpoint inhibitors are exemplified, two PD-1 inhibitor antibodies, and one CTLA-4 inhibitor antibody). Furthermore, applicants fail to dispute that the rejections at issue satisfy all elements of the explicitly cited rationales for supporting a determination of obviousness under MPEP §§ 2143(I)(A), 2143(I)(G), 2144.07 (see also MPEP § 2144.06(I), quoting In re Kerkhoven and explaining that "It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose.... [T]he idea of combining them flows logically from their having been individually taught in the prior art"; note that here all components were taught for use in the treatment of cancer, and the combination would be predicted and expected to be useful in the treatment of cancer). Accordingly, such arguments are not persuasive because combining known anti-cancer therapeutics according to explicit prior art guidance to predictably yield a “combined” composition for the same, exact purpose of treating cancer, is obvious.
Reliance upon unclaimed features fails to distinguish the claimed invention in view of the prior art: It is the Examiner’s understanding that Applicant is alleging that “[t]here would have been no reason or motivation for those of ordinary skill in the art to arrive at the claimed pharmaceutical compositions or kits” (see, e.g., Reply filed 8/04/2026 at 7 at final ¶) because “Miles provided no indication that the specific combination of SVV with the two checkpoint inhibitors as claimed would be useful in treating cancers that are refractory to a monotherapy with either or both checkpoint inhibitors” (see, e.g., Reply filed 8/04/2026 at 8 at 1st ¶ to 2nd ¶, 9 at 1st ¶, 9 at final two ¶¶, 10 at 1st full ¶). 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., “useful in treating cancers that are refractory to a monotherapy with either or both checkpoint inhibitors”, “sufficient to overcome the cancer’s resistance”, “reducing tumor volume in mice with Pan02 pancreatic cancer cell xenografts”, etc.) are 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).
Allegations suggesting “lack of predictability” or “lack of reasonable expectation of success”: It is the Examiner’s understanding that Applicant is alleging a lack of predictability or otherwise a lack of reasonable expectation of success (see, e.g., Reply filed 8/04/2026 at 7-10). This is not persuasive because the Applicant’s assertions do not reflect the proper legal standards for evaluating predictability. MPEP § 2143.02(II) explains that “[o]bviousness does not require absolute predictability”, but instead clarifies that only “at least some degree of predictability is required” (see, e.g., MPEP § 2143.02(II)). Here, the rejection explicitly addresses predictability and reasonable expectation of success, but Applicant fails to address the explicitly identified predicted and expected results set forth in the rejection. Here, the Examiner’s basis for “predictability” is merely based upon the presumption that the prior art is fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)). As explained at MPEP § 2143.02, predictability and reasonable expectation of success are satisfied when “all the claimed elements were known in the prior art and one skilled in the art could have combined the elements as claimed by known methods with no change in their respective functions, and the combination would have yielded nothing more than predictable results to one of ordinary skill in the art”. Here zero evidence of unexpected results commensurate in scope with the requirements of MPEP 716.02 have been set forth on record, all elements of the claimed invention were known in the prior art, one of ordinary skill was fully enabled to combined each component using routine methods in the biochemical arts per the guidance of the primary reference, and the elements would have merely performed their art-recognized, respective functions (see Rejection, above). Accordingly, such arguments are not persuasive.
Examiner is permitted to establish obviousness using any rationale set forth at MPEP §2143 and §2144: It is the Examiner’s understanding that Applicant identifies that their rationale for arriving at the claimed invention differs from the rationale relied upon by the Examiner to establish obviousness (see, e.g., Reply filed 8/04/2026 at 8 at 1st ¶ to 2nd ¶, 9 at final two ¶¶, 10 at 1st full ¶, 9 at 1st full ¶, referring to Applicant’s rationale for arriving at a product, namely a composition comprising three anti-cancer therapeutics, namely that such combinations allegedly are “useful in treating cancers that are refractory to a monotherapy with either or both checkpoint inhibitors”, “sufficient to overcome the cancer’s resistance”, “reducing tumor volume in mice with Pan02 pancreatic cancer cell xenografts”, etc.). Examiner notes that this is not persuasive because an examiner may support a determination of obviousness by relying upon a rationale that differs from the Applicant’s rationale (see, e.g., MPEP § 2144(IV)). Here, the Examiner’s rationales are explicitly identified in the rejection, and include the rationales of MPEP § 2143(I)(A), (G), and MPEP § 2144.07, but Applicant fails to address or specifically dispute these rationales supporting a determination of obviousness. Accordingly, it is neither disputed nor dispositive of obviousness that the Examiner did not support a rationale that was not actually relied upon to establish prima facie obviousness.
Allegations suggesting “skepticism of experts”: It is the Examiner’s understanding that Applicant’s statements amount to a suggestion that the Examiner’s position would be met with skepticism of experts (see, e.g., Reply filed 8/04/2026 at 8 at 1st ¶ to 2nd ¶, 9 at final two ¶¶, 10 at 1st full ¶, passim, alleging that one of ordinary skill in the art would not combine SVV with two checkpoint inhibitors as presently claimed). If Applicant means to suggest the existence of skepticism of experts, such evidence should be filed per MPEP § 716.05 as evidence is required to establish skepticism of experts. In the absence of such evidence, such statements are understood to be unsupported conjecture of counsel. The prior art is presumed fully enabled (see, e.g., MPEP § 2121(I)) for all that it discloses (see, e.g., MPEP §§ 2123(I)-(II)), including “all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments” (see, e.g., MPEP § 2123(I)), and no objective evidence rebutting this presumption has been placed on record to date.
Allegations of unexpected results are not commensurate in scope with the requirements of MPEP §§ 716, 716.01, and 716.02: It is the Examiner’s understanding that Applicant is alleging the existence of unexpected results sufficient to rebut prima facie obviousness, and specifically alleges that an unclaimed method using unclaimed parameters allegedly “produced greater than expected results” (see, e.g., Reply filed 8/04/2026 at 8 at final ¶, 9 at final two ¶¶, 10 at 1st to 2nd full ¶¶). However, to establish such unexpected results, the allegations must be timely and supported by objective evidence (see, e.g., 37 C.F.R. 1.132; see MPEP §§ 716.01, 716.01(a), 716.01(c)); to be of probative value the proffered evidence must be related to the claimed invention (see MPEP §§ 716.01(b), discussing nexus requirement and noting that "[w]here the offered secondary consideration actually results from something other than what is both claimed and novel in the claim, there is no nexus to the merits of the claimed invention"); the evidence must establish that the expected results occur to an unexpected extent (see, e.g., MPEP § 716.02(a)(I)), on the basis of statistically and practically significant evidence (see, e.g., MPEP § 716.02(b)(I)), which is fully explained (see, e.g., MPEP § 716.02(b)(II)), commensurate in scope with the claimed invention (see, e.g., MPEP § 716.02(d)), and wherein a comparison of the claimed invention with the closest prior art of record is provided (see, e.g., MPEP § 716.02(e)). Furthermore, even if evidence satisfying MPEP §§ 716.02, 716.02(a), 716.02(b), 716.02(d), and 716.02(e) is set forth on record, such evidence may not be sufficient to rebut prima facie obviousness because the evidence of expected and unexpected results must be weighed (see, e.g., MPEP § 716.02(c)(I)) and the totality of the record considered (see, e.g., MPEP §§ 716.01(d), 716.02(f)), including teachings in the prior art and evidence of expected results which weigh in favor of a determination of obviousness (see, e.g., MPEP § 716.02(c)(II)). Here, the allegations of unexpected results are understood to be premised upon the data shown at Example 2 and Figures 2A and 4 (see, e.g., Reply filed 8/04/2026 at 8 at final ¶), which have been fully reviewed, but deemed insufficient to establish unexpected results for the following reasons: First, the proffered evidence is not commensurate in scope with the claimed invention as required by MPEP § 716.02(d), at least because the claims are not limited to the model, dosages, or specific chemical compounds utilized in the examples. Second, the proffered data is of unknown statistical significance, and therefore does not satisfy Applicant’s burden under MPEP § 716.02(b)(I), and the data is not clearly greater than the predicted and expected additive effect of the prior art elements. Third, evidence showing that anti-cancer agents have anti-cancer effects is evidence of the expected and predicted results, which weighs in favor of obviousness rather than non-obviousness (see, e.g., MPEP §716.02(c)(II)). Accordingly, for at least these reasons, the proffered data is insufficient to establish unexpected results commensurate in scope with the requirements of MPEP §716, §716.01, and §716.02, wherein such results are sufficient to rebut prima facie obviousness. Accordingly, zero evidence of any unexpected results commensurate in scope with the requirements of MPEP § 716.02 have been placed on record at this time.
Allegations suggesting improper or impermissible hindsight: It is the Examiner’s understanding that Applicant is suggesting that the Examiner’s position fails to establish a prima facie case of obviousness because the prior art does not lead an artisan to the instant invention “[i]n the absence of Applicant’s disclosure” (see, e.g., Reply filed 8/04/2026 at 9 at 2nd ¶, 10 at penultimate ¶). If Applicant means to suggest that the Examiner arrived at the instantly claimed invention via the use of improper hindsight, this is not persuasive because any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight reasoning. But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971). Here, Applicant fails to identify a single aspect of the claimed invention that was not explicitly taught, disclosed, or suggested by the prior art relied upon by the Examiner, and merely performs anything other than its art-recognized function.
In sum, all applicable arguments and objective evidence has been fully considered as it applied to the revised claim rejections necessitated by Applicant’s amendments. However, none of the arguments have been found persuasive for the reasons disclosed above. In particular, the combination of known prior art elements having known functionality and known use in cancer treatments to form a combined composition having the same application and utility (i.e., to treat cancer) is obvious.
Arguments Pertinent to Revised NSDP Rejections
Arguments directed to canceled or withdrawn claims are moot. It is the Examiner’s understanding that Applicant addresses the revised rejections at pages 11-12 of the Reply filed 8/04/2026. Applicable arguments are addressed below.
It is the Examiner’s understanding that Applicant provides a single, sentence argument for each rejection, which is the assertion that “There is nothing in [the issued claims] that teaches or suggests a combination of SVV (or an SVV derivative) specifically with a PD-1 inhibitor and a CTLA-inhibitor” or “There is nothing in the cited claims of the reference patents, even in combination with US '099, that teaches or suggests a combination of SVV (or an SVV derivative) specifically with a PD-I inhibitor and a CTLA-4 inhibitor” (see, e.g., Reply filed 8/04/2026 at 11 at §§ I-II). Applicants fail to explain or elaborate their position, or to support such assertion with any objective evidence that materially or substantially addresses the merits of the rejections, case law, MPEP citations, and reference citations provided in the rejections of record. Accordingly, such assertion amounts to an argument of counsel, made in the absence of objective evidence, that dismisses the merits of the rejection in the absence of evidence or explanation. Such arguments are not persuasive for the reasons, facts, citations, and applicable laws and rules set forth in the revised rejections above, which were necessitated by Applicant’s amendments.
Arguments Pertinent to Revised Provisional NSDP Rejection
Arguments directed to canceled or withdrawn claims are moot. It is the Examiner’s understanding that Applicant addresses the provisional revised NSDP rejection at page 12 of the Reply filed 8/04/2026. Applicable arguments are addressed below.
It is the Examiner’s understanding that Applicant provides a single, sentence argument for the provisional rejection, namely “There is no suggestion in [the co-pending claims] of the ‘986 application to combine SVV (or SVV derivative) with a PD-1 inhibitor and a CTLA-inhibitor” (see, e.g., Reply filed 8/04/2026 at 12 at § III). Applicants fail to explain or elaborate their position, or to support such assertion with any objective evidence that materially or substantially addresses the merits of the rejections, case law, MPEP citations, and reference citations provided in the rejections of record. Accordingly, such assertion amounts to an argument of counsel, made in the absence of objective evidence, that dismisses the merits of the rejection in the absence of any evidence or explanation. Therefore, such arguments are not persuasive for the reasons, facts, citations, and applicable laws and rules set forth in the revised rejection above, which was necessitated by Applicant’s amendments.
Summary
Accordingly, all arguments set forth in the Reply filed 8/04/2026 were fully considered but not found persuasive for reasons discussed above. Therefore, the claims are rejected in view of the revised rejections, wherein all revisions were necessitated by Applicant’s amendments.
Pertinent Prior Art
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure.
WO2020210711 (Hallenbeck; Oct. 15, 2020; cited in IDS filed 7/10/2023 as cite No. 5) was discussed in the Restriction/Election requirement of record.
US20220202884A1 (corresponding to US Application No. 17/601,768; cited in previous action) pertains to similar combination therapies utilizing SVV in combination with additional therapeutic agents.
US2017/0157188 A1 (cited in previous action) pertains to pharmaceutical formulations comprising SVV derivatives encoding Nivolumab that may be formulated in combination with additional anticancer therapeutics (see, e.g., US’188 at claims 1-2, 13-15, 18, 20-24, and 25).
US 20200140563 A1 (cited in previous action) pertains to pharmaceutical formulations comprising SVV, and methods of administering such compositions in combination with PD-1 inhibitors (see, e.g., US’563 at claims 1-2, 6, and 10-13).
US 20180318365 A1 (cited in previous action) pertains to methods of treating tumors by administering pharmaceutical formulations comprising an oncolytic virus in combination with PD-1 inhibitors (see, e.g., US’365 at claims 1-3, 15, 42).
Conclusion
No claims are allowed.
Applicant's amendment necessitated the new or revised 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 RANDALL L BEANE whose telephone number is (571)270-3457. The examiner can normally be reached Mon.-Fri., 7 AM to 2 PM ET.
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, Lianko G. Garyu can be reached at (571) 270-7367. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/RANDALL L BEANE/Primary Examiner, Art Unit 1654
1 The phrase “anti-PD-1” is understood to include any anti-PD-1 antibody, including RMP1-14 and Nivolumab (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]).
2 Rajan et al., Nivolumab, anti-programmed death-1 (PD-1) monoclonal antibody immunotherapy: Role in advanced cancers. Hum Vaccin Immunother. 2016 Sep;12(9):2219-31. doi: 10.1080/21645515.2016.1175694. Epub 2016 May 2. PMID: 27135835; PMCID: PMC5027703; hereafter “Rajan”; cited in previous action.
3 Guo ZS. Oncolytic immunotherapy for metastatic cancer: lessons and future strategies. Ann Transl Med. 2020 Sep;8(17):1113. doi: 10.21037/atm.2020.04.42. PMID: 33145332; PMCID: PMC7575964; cited in IDS filed 3/13/2026 as cite no. 10; cited in previous action.
4 Burke MJ. Oncolytic Seneca Valley Virus: past perspectives and future directions. Oncolytic Virother. 2016 Sep 6;5:81-9. doi: 10.2147/OV.S96915. PMID: 27660749; PMCID: PMC5019429; cited in IDS filed 9/12/2023 as cite no. 8; cited in previous action.
5 See, e.g., Spec. filed 7/10/2023 at ¶[0040]).
6 See, e.g., Spec. filed 7/10/2023 at ¶[0040]).
7 See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences.
8 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
9 See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences.
10 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
11 See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010), noting that “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see U.S. Patent No 5,563,165 (“’165 patent”), at [57], col.1 ll.11-14, col.3 ll.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 l.49-col.108 l.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.”
12 See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences.
13 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
14 See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010), noting that “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see U.S. Patent No 5,563,165 (“’165 patent”), at [57], col.1 ll.11-14, col.3 ll.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 l.49-col.108 l.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.”
15 See, e.g., MPEP § 804(II)(B), “To decide the question above, the examiner should first construe the claim(s) in the application under examination and the claim(s) in the reference application or patent to determine what are the differences.
16 See, e.g., MPEP § 804(II)(B), noting that “In determining whether a nonstatutory basis exists for a double patenting rejection, the first question to be asked is: Is any invention claimed in the application anticipated by, or an obvious variation of, an invention claimed in the patent? If the answer is yes, then a nonstatutory double patenting rejection may be appropriate.”
17 See also Sun Pharmaceutical Industries, Ltd. v. Eli Lilly & Co., 611 F.3d 1381 (Fed. Cir. 2010), noting that “Similarly, in Pfizer, the earlier patent claimed several compounds and the specification disclosed their use in treating inflammation and inflammation-associated disorders. 518 F.3d at 1363 & n.9; see U.S. Patent No 5,563,165 (“’165 patent”), at [57], col.1 ll.11-14, col.3 ll.3-27. The later patent then claimed a method of using these compounds for treating inflammation, inflammation-associated disorders, and specific inflammation-associated disorders, including arthritis, pain, and fever. Pfizer, 518 F.3d at 1363 & n.9; see U.S. Patent No. 5,760,068 (“’068 patent”) col.97 l.49-col.108 l.29. After rejecting the patentee’s objection to our consideration of the specification of the earlier patent, we determined that the later patent “merely claims a particular use described in the [earlier] patent of the claimed compositions of the [earlier] patent.” Pfizer, 518 F.3d at 1363 & n.8. As such, we concluded that the asserted claims of the later patent were not “patentably distinct” from the claims of the earlier patent, and thus the later patent was invalid for obviousness-type double patenting. Id. at 1368.”
Prosecution Insights