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, 20-28, 31-36 and 38 are pending. Claims 1-13, 16-17, 20, 26-28 and 35-36 are withdrawn as directed to non-elected species. Claims 21-25, 31-34, and 38 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 is acknowledged.
Applicant did not identify a single Example (see, e.g., Requirement mailed 1/15/2026 at 6 at 1st bullet), but rather identified multiple examples (see, e.g., Reply filed 3/13/2026 at 6-7). Accordingly, it is understood that Applicant has opted to elect a narrow subgenus of patentably indistinct species comprising any art-recognized “SVV” and any art-recognized “anti-PD-1 antibody” (i.e., a subgenus of obvious variants). Accordingly, 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]).
The originally elected subgenus of patentably indistinct species is understood to read upon instant claims 21-25, 31-34, and 38 wherein the Anti-PD-1 antibody is understood to be a PD-1 inhibitor and antibody. However, claims 26-27 and 35-36 do not read upon the originally elected species, wherein an “SVV” and an “SVV derivative” are presumed to be distinct structures, and the originally elected subgenus of patentably indistinct species comprises an “SVV” but not an “SVV derivative”1. Claim 28 does not read upon the originally elected species, because it requires “an anti-CTLA-4 antibody” to be present, which was not identified as present in the originally elected subgenus of patentably indistinct species.
Following extensive search and examination, the originally elected species has been deemed anticipated and/or obvious in view of the prior art as applied below. Per MPEP § 803.02(III)(A),
Following election, the Markush claim will be examined fully with respect to the elected species and further to the extent necessary to determine patentability. Note that where a claim reads on multiple species, only one species needs to be taught or suggested by the prior art in order for the claim to be anticipated or rendered obvious...
If the Markush claim is not allowable, the provisional election will be given effect and examination will be limited to the Markush claim and claims to the elected species, with claims drawn to species patentably distinct from the elected species held withdrawn from further consideration.
Accordingly, claims 21-25, 31-34, and 38 are rejected in view of the originally elected species and claims that do not read upon the originally 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 21-25, 31-34, and 38 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 7/10/2023; 9/12/2023 (11 pages); 9/12/2023 (8 pages); 9/12/2023 (6 pages); 10/10/2023; and 3/13/2026 are acknowledged and presently considered.
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).
Claim 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]).
The preamble at claim 32 reciting a “kit for treating cancer in a subject” is not explicitly defined, but “for treating cancer in a subject” is a recitation of an intended use presumably requiring the explicitly recited components at claim 32 and a pharmaceutically acceptable carrier. Claim 32 is therefore understood to encompass pharmaceutical compositions as recited at claim 21.
The phrase “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]).
The “wherein” clauses at claims 21 and 32 (“wherein the cancer is refractory to monotherapy with the checkpoint inhibitor”); claim 22 (“wherein the cancer is also refractory to monotherapy with SVV”); and claims 31 and 38 (“wherein the cancer comprises a triple negative breast cancer, …. or a soft tissue cancer”) do not limit the physical product being claimed, because such recitations are directed to recitations of intended use that does not structurally limit the product being claimed. This determination is reasonable because the claims are directed to products, not methods, and per MPEP § 2111.04(I), “Claim scope is not limited by …. claim language that does not limit a claim to a particular structure”, and further states that a “whereby clause” in a claim “is not given weight when it simply expresses the intended result of a process step positively recited”. Here, each “wherein” clause does not unambiguously correspond to a clear structure/function relationship in the original disclosure that pertains to the physical structure being claimed, and therefore are not functional limitations. Accordingly, the “wherein” clauses at each of claims 21-22, 31-32, and 38 are understood to merely recite an intended or expected result fully satisfied by the positively recited structures set forth in the body of the claim. Therefore, the “wherein” clauses are understood to be fully satisfied by any pharmaceutical composition comprising at least SVV and an anti-PD-1 antibody. If this is incorrect, Applicant should explicitly identify what exact embodiments within the scope of the independent claims is excluded from the dependent claims by the wherein clauses.
Additional claim interpretations are discussed below.
Claim Rejections
Claim Rejections - 35 USC § 112(a), Scope of Enablement
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 21-25, 31-34, and 38 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for alleviative treatment reducing the progression, severity and/or duration of a disease condition or at least one symptom thereof, does not reasonably provide enablement for “curative” treatment5 or treatment “preventing or removing all signs of the disease or disorder” 6. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to use the invention commensurate in scope with these claims.
The applicable legal standards for enablement are discussed at MPEP § 2164 and the specific legal standards relevant to determinations regarding the scope of enablement are set forth at MPEP § 2164.08. MPEP § 2164 identifies the following relevant factors for determining “undue” experimentation: (A) The breadth of the claims; (B) The nature of the invention; (C) The state of the prior art; (D) The level of one of ordinary skill; (E) The level of predictability in the art; (F) The amount of direction provided by the inventor; (G) The existence of working examples; and (H) The quantity of experimentation needed to make or use the invention based on the content of the disclosure.” The factors which have led the Examiner to conclude that the specification fails to teach how to make and/or use the claimed invention without undue experimentation, are addressed in detail below.
The enablement of compositions reciting activity or intended use must be considered.
Here, the claims are directed to a compound, but the compound is defined by the recitation “for treating a cancer in a subject” and specifically for treating a cancer “wherein the cancer is refractory to monotherapy with the checkpoint inhibitor”7. This is pertinent because “for treating” is defined to include “curative” treatment8 or treatment “preventing or removing all signs of the disease or disorder” 9. Accordingly, the recitation of use limiting the scope of the product for “treating” is defined to include preventing and curing cancer10.
Zero examples of curing or preventing any type of cancer has been disclosed on record. No dosage capable of achieving an absolute cure or preventing any type of cancer using the claimed product in humans or animal models has been identified on record. The closest support is shown at Figure 2, wherein “SVV+Anti-PD-1+Anti-CTLA4” substantially reduces tumor volume in a Pan02 pancreatic syngeneic tumor implanted into mice to near zero (see, e.g., Spec. filed 7/10/2023 at ¶¶[0122]-[0123], [0127]. [0129], Fig. 2). Although reported as “cures” in the disclosure (see id), “near zero” and increased survival is not equivalent in the art to a “cure” or “prevention”. No guidance regarding dosages required to specifically “cure” or “prevent” all types of “cancer in a subject” as presently claimed is actually provided (see, e.g., Spec. filed 7/10/2023 at ¶¶[0040], [0044]).
The state of prior art: The lack of guidance and working examples is pertinent because the general state of cancer treatment arts teaches that while treatment of many cancer are routine, that complete cures and preventions of cancers are unexpected, and such claims must be supported by objective evidence commensurate in scope with such claims.
Relative skill of those in the art, and the predictability or unpredictability of the art: Although the relative skill in the art is high, the general predictability of the art regarding the complete cure and/or prevention of multiple types of cancer because whole organism medical treatments are subject to high variability based upon subject parameters (e.g., age, weight, gender, and state of health), route of administration, dosage, therapeutic windows, etc. Furthermore, absent objective supporting evidence, an artisan would not find a claim for a panacea capable of “curing” or “preventing” large numbers of cancers to be credible. Here, at best, limited evidence is provided regarding a single type of cancer, namely a pancreatic syngeneic tumor, which is shown to substantially decrease in volume upon treatment, but no cure or prevention of such cancers is unambiguously shown.
The quantity of experimentation required to practice the claimed invention based on the teachings of the specification. While data regarding alleviating symptoms and progression of cancers using compounds as claimed were known in the art at the time of the invention, it was not routine in the art to cure or prevent cancers commensurate in scope with the preamble statement of claim 21. Accordingly, in the absence of clear guidance regarding dosages capable of preventing or curing a representative range of cancers encompassed by the instant “for treating” statement at claim 21, one of skill in the art would not reasonable conclude that such compounds as claimed could credibly achieve or yield prevention and cure as claimed. Rather, artisans would be burdened to extensively test such compositions upon dozens of various types of cancers to see if prevention and/or cure was even possible.
Therefore, at the time of filing, an artisan would reasonably doubt that such activity was possible to achieve in the absence of credible and substantial guidance in the form of credible dosages preventing and/or curing a representative number of cancer types within the claimed genus. No such credible and substantial guidance has been set forth on record. Accordingly, to practice the full scope of the instant invention including 100% prevention and cure of all types of cancers within the scope of claim 21, an artisan would be unduly burdened to actually identify an “effective” dose, administration routes, and patient populations (age, gender, weight, etc.), and types of cancers capable of being cured or prevented; however, current evidence does not support a conclusion that such outcomes are necessarily possible.
Conclusion: Therefore, in view of the lack of guidance and working examples, high degree of unpredictability, and failure to address the concerns present in the art, an artisan would be unduly burdened with experimentation in order to practice the full scope of the instantly claimed invention.
Applicant may overcome this rejection by amending claim 21 to either completely remove the phrase “for treating a cancer in a subject” and “wherein the cancer is refractory to monotherapy with the checkpoint inhibitor”. Alternatively, Applicant may amend the claim scope by adding “wherein treatment is alleviative treatment for reducing the progression, severity and/or duration of the cancer or at least one symptom thereof”.
Accordingly, claims 21-25, 31-34, and 38 are rejected.
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.
[Rejection 01]
Claims 21-25, 31-34, and 38 are rejected under 35 U.S.C. 103 as being unpatentable over 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]). Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 31-34, 38, and pharmaceutical compositions comprising both SVV and a checkpoint inhibitor such as Nivolumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising both SVV and a checkpoint inhibitor (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051]). 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
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 Nivolumab (i.e., an anti-PD-1 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 a checkpoint inhibitor such as Nivolumab (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, US’099 does not reduce to practice a pharmaceutical composition comprising SVV, Nivolumab, 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, Nivolumab is one 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 inhibitor of Nivolumab) 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, 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 21-25, 31-34, and 38 are rejected.
[Rejection 02]
Claims 21-25, 31-34, and 38 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. Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 31-34, 38, 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.
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 21-25, 31-34, 38, and pharmaceutical compositions comprising both SVV and a checkpoint inhibitor such as Nivolumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising both SVV and a checkpoint inhibitor (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051]). 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, 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 Nivolumab (i.e., an anti-PD-1 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 a checkpoint inhibitor such as Nivolumab (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 inhibitor of Nivolumab 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, 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 Nivolumab 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 both the oncolytic virus and the checkpoint inhibitor of Nivolumab, 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 21-25, 31-34, and 38 are rejected.
[Rejection 03]
Claims 21-25, 31-34, and 38 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. Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 31-34, 38, 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.
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 21-25, 31-34, 38, and pharmaceutical compositions comprising both SVV and a checkpoint inhibitor such as Nivolumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising both SVV and a checkpoint inhibitor (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051]). 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, 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 Nivolumab (i.e., an anti-PD-1 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 a checkpoint inhibitor such as Nivolumab (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 inhibitor of Nivolumab 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, 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 Nivolumab 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 both the oncolytic virus and the checkpoint inhibitor of Nivolumab, 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 21-25, 31-34, and 38 are rejected.
[Rejection 04]
Claims 21-25, 31-34, and 38 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. Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 31-34, 38, 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.
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 21-25, 31-34, 38, and pharmaceutical compositions comprising both SVV and a checkpoint inhibitor such as Nivolumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising both SVV and a checkpoint inhibitor (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051]). 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, 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 Nivolumab (i.e., an anti-PD-1 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 a checkpoint inhibitor such as Nivolumab (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 inhibitor of Nivolumab 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, 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 Nivolumab 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 both the oncolytic virus and the checkpoint inhibitor of Nivolumab, 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 21-25, 31-34, and 38 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.
[NSDP 01]
Claims 21-25, 31-34, and 38 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” or “PD-1 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]). 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 21-25, 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 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, US’414 identifies that such administered compounds may include a PD-1 inhibitor (see, e.g., US’414 at claims 1 and 7), which may be administered simultaneously as SVV or an 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 that the claims necessarily encompassed or otherwise rendered obvious pharmaceutical compositions comprising both SVV (or an SVV derivative) in combination with an additional anti-cancer therapeutic agent, namely a PD-1 inhibitor (compare US’414 at claims 1, 4, 7-8, and 11 with instant claims 21-23, 31-33, and 38). Regarding instant claims 24-25, 34, and the specific usage of a PD-1 inhibitor that is an anti-PD-1 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).
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 PD-1 inhibitors11; 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”12 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 21-25, 31-34, and 38 are rejected.
[NSDP 02]
Claims 21-25, 31-34, and 38 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” or “PD-1 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]). Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 31-34, 38, 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 a checkpoint inhibitor, such as a PD-1 inhibitor, such as an anti-PD-1 antibody, such as Nivolumab.
However, the utility of pharmaceutical formulations and variations thereof was already known in the prior art. Specifically, regarding instant claims 21-25, 31-34, 38, and pharmaceutical compositions comprising both SVV and a checkpoint inhibitor such as Nivolumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising both SVV and a checkpoint inhibitor (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051]). 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, 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 Nivolumab (i.e., an anti-PD-1 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 a checkpoint inhibitor such as Nivolumab (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 both SVV and PD-1 inhibitors such as Nivolumab 13; 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”14 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 21-25, 31-34, and 38 are rejected.
[NSDP 03]
Claims 21-25, 31-34, and 38 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” or “PD-1 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]). Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 31-34, 38, 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).
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 a checkpoint inhibitor, such as a PD-1 inhibitor, such as an anti-PD-1 antibody, such as Nivolumab.
However, the utility of pharmaceutical formulations and variations thereof was already known in the prior art. Specifically, regarding instant claims 21-25, 31-34, 38, and pharmaceutical compositions comprising both SVV and a checkpoint inhibitor such as Nivolumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising both SVV and a checkpoint inhibitor (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051]). 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, 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 Nivolumab (i.e., an anti-PD-1 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 a checkpoint inhibitor such as Nivolumab (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 both SVV and PD-1 inhibitors such as Nivolumab 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, exactly as specifically taught and suggested by the prior art; and therefore improving the methods of the issued claims by including a PD-1 inhibitor such as Nivolumab, would be obvious and merely yield the expected and predicted results, namely an improved method of killing tumor cells by administering a composition comprising both SVV (or an SVV derivative) and a PD-1 inhibitor such as Nivolumab (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 21-25, 31-34, and 38 are rejected.
[NSDP 04]
Claims 21-25, 31-34, and 38 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” or “PD-1 inhibitor” (see, e.g., Spec. filed 7/10/2023 at ¶¶[0120]-[0127]). Additional claim interpretations are set forth below.
Regarding instant claims 21-25, 31-34, 38, 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).
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 a checkpoint inhibitor, such as a PD-1 inhibitor, such as an anti-PD-1 antibody, such as Nivolumab.
However, the utility of pharmaceutical formulations and variations thereof was already known in the prior art. Specifically, regarding instant claims 21-25, 31-34, 38, and pharmaceutical compositions comprising both SVV and a checkpoint inhibitor such as Nivolumab, US’099 teaches and discloses pharmaceutical formulations suitable for “combination therapy”, comprising both SVV and a checkpoint inhibitor (see, e.g., US’099 at ¶¶[0007], [0026], [0047]-[0051]). 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, 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 Nivolumab (i.e., an anti-PD-1 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 a checkpoint inhibitor such as Nivolumab (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 both SVV (or SVV derivatives) and PD-1 inhibitors such as Nivolumab 17; 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”18 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 a PD-1 inhibitor such as Nivolumab, 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 both SVV (or an SVV derivative) and a PD-1 inhibitor such as Nivolumab (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 21-25, 31-34, and 38 are rejected.
[Provisional NSDP 01]
Claim 21-25, 31-34, and 38 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-2, 13, 15, 35-37, and 43-45 of copending Application No. 18/272,986 (reference application; corresponding to US 20240307470-A1).
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) and a checkpoint inhibitor such as a PD-1 inhibitor (see, e.g., App’986 at claims 43-45, noting that claims 1-2 and 13 reasonably inform artisans that the claim scope reads upon SVV-001 and SVV derivatives), and wherein a “PD-1 inhibitor” is a generic term that includes monoclonal antibodies that bind to PD-1, such as Ipilimumab (see, e.g., App’986 at Spec. filed 7/18/2023 at [0165]; see also MPEP § 804(II)(B)(1), explaining that it is permissible to use the specification as a dictionary to learn the meaning of a term in a claim). 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.
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) pertains to similar combination therapies utilizing SVV in combination with additional therapeutic agents.
US2017/0157188 A1 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 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 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.
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.
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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 See, e.g., Nystrom v. TREX Co., Inc., 424 F. 3d 1136, 1143 (Fed. Cir. 2005), explaining that "When different words or phrases are used” a “difference in meaning is presumed".
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”.
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.
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.
5 See, e.g., Spec. filed 7/10/2023 at ¶[0040]).
6 See, e.g., Spec. filed 7/10/2023 at ¶[0040]).
7 In re Gardner, 427 F.2d 786, 166 USPQ 138 (C.C.P.A. 1970), “In effect, by [claiming therapeutic activity, applicants] are claiming in terms of use. It behooves them, therefore, to disclose how to use, as section 112 ordains . . . .”.
8 See, e.g., Spec. filed 7/10/2023 at ¶[0040]).
9 See, e.g., Spec. filed 7/10/2023 at ¶[0040]).
10 See, e.g., Spec. filed 7/10/2023 at ¶[0040]).
11 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.
12 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.”
13 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.
14 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.”
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, 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.
18 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.”
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