DETAILED ACTION
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Applicant’s Response to Election/Restriction Filed, Amendment, and Arguments/Remarks, filed 02 January 2026, have been entered. Claims 1-13 and 15-21 are currently pending. Claims 1 and 15 are independent claims. Applicant’s election without traverse of the invention of Group I, drawn to a surface engineered recombinant virus, is acknowledged.
Additionally, Applicant’s election without traverse of the following species is acknowledged:
Artificial coating: a. silica;
Virus: w. adenovirus;
Targeting ligand: f. small molecule: i. folate.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim.
Claims 7, 9, and 13 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected species, there being no allowable generic or linking claim. Note that claim 13 is withdrawn as being drawn to a nonelected species because the elected virus, adenovirus, is a non-enveloped virus.
Claims 1-6, 8, and 10-12 are currently pending in the application and under examination to which the following grounds of rejection are applicable. An action on the merits follows.
Priority
The present application is a 35 U.S.C. 371 national stage filing of International Application No. PCT/US2021/036021, filed 04 June 2021, which claims priority to U.S. Provisional Application Nos: 63/193,014, filed 25 May 2021; 63/041,744, filed 19 June 2020; 63/036,874, filed 09 June 2020; 63/036,329, filed 08 June 2020; 63/036,337, filed 08 June 2020; and 63/034,862, filed 04 June 2020.
Thus, the earliest possible priority for the instant application is 04 June 2020.
Information Disclosure Statement
The information disclosure statements filed 02 December 2022 have been considered by the Examiner.
Specification
The disclosure is objected to because of the following informalities: The specification recites, “IL-1□” in [0030], which appears to be a typographical error.
Appropriate correction is required.
The use of the term “Imlygic” in [0005, 0049], “AZD1222” in [0005, 0050, 0122], “Ad5-nCov” in [0005, 0050, 0122], “Pexa-Vec” in [0049], “Reolysin” in [0049], “Cavatak” in [0049], “Marabex” in [0049], “ORCA-010” in [0049], “ParvOryx” in [0049], “LOAd703” in [0049], “PV701” in [0049], “ONCOS-102” in [0049], “Seprehvir” in [0049], “Telomelysin” in [0049], “JX-929” in [0049], “Ad-VirRx007” in [0049], “NG-348” in [0049], “RP1/RP2/RP3” in [0049], “WO-12” in [0049], “MB-107” in [0053], “Starbeam ALD-102” in [0053, 0057], as well as many others recited in [0053], which are trade names or a marks used in commerce, has been noted in this application. The terms should be accompanied by the generic terminology; furthermore the term should be capitalized wherever it appears or, where appropriate, include a proper symbol indicating use in commerce such as ™, SM , or ® following the term.
Although the use of trade names and marks used in commerce (i.e., trademarks, service marks, certification marks, and collective marks) are permissible in patent applications, the proprietary nature of the marks should be respected and every effort made to prevent their use in any manner which might adversely affect their validity as commercial marks.
Note that the specification has not been inspected sufficiently to identify all uses of trade names and/or marks used in commerce. It is Applicant’s responsibility to ensure complete compliance.
Claim Objections
Independent claim 1 is objected to because of the following informalities: claim 1 ends with a “,” instead of a “.”. Appropriate correction is required.
Claims 4, 5, 6, and 11 are objected to because of the following informalities: the claims recite the abbreviations “NG-641” (claim 4); “AZD1222”, “ChAdOx1-nCov19”, “Ad5-nCoV”, “VSV”, and “Ad26” (claim 5); “Ad5” (claim 6); and “IL4RPep-1”, “AS-1411”, and “GBI-10” (claim 11) without first writing out the term for which they are abbreviations. Appropriate correction is required.
Claim Rejections - 35 USC § 112(b)
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8, and 10-12 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Independent claim 1 is indefinite for the recitation of “said virus comprising : a recombinant virus” as it is unclear how a recombinant virus comprises itself. As such the metes and bounds of the claims are indefinite.
Claims 2, 8, and 10-11 are indefinite in their recitation of “the artificial coating”. There is not proper antecedent basis for the recitation of “the artificial coating” as independent claim 1, upon which claims 2, 8, and 10-11 depend, recites “an artificial coating layer”. As such, the metes and bounds of the claim cannot be determined.
Claims 4 and 5 contain the trademark/trade names “Imlygic” (claim 4) and “AZD1222” and “Ad5-nCov” (claim 5). Where a trademark or trade name is used in a claim as a limitation to identify or describe a particular material or product, the claim does not comply with the requirements of 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph. See Ex parte Simpson, 218 USPQ 1020 (Bd. App. 1982). The claim scope is uncertain since the trademark or trade name cannot be used properly to identify any particular material or product. A trademark or trade name is used to identify a source of goods, and not the goods themselves. Thus, a trademark or trade name does not identify or describe the goods associated with the trademark or trade name. In the present case, the trademark/trade names are used to identify/describe oncolytic therapeutic viruses derived from HSV-1 (claim 4) or adenovirus (claim 5), accordingly, the identification/description is indefinite. As such, the metes and bounds of the claim cannot be determined.
Claims 4-6 each recite terms in parentheses, which are indefinite because it is unclear whether the parenthetical terms are meant to further limit the preceding terms or whether they are merely exemplary, attributions, or alternative terms of the preceding limitations. As such, the metes and bounds of the claims cannot be determined.
Claim 5 recites “and is selected from” in line 5, which is indefinite because it is unclear whether the list is an open or closed list. . As such, the metes and bounds of the claim cannot be determined.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claim(s) 1-3, 8, and 10-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Ortac [US20160067191A1, published 10 March 2016].
Regarding claims 1-3, Ortac discloses a surface-engineered recombinant virus, wherein the virus comprises a recombinant virus (e.g., adenovirus, as elected) having a recombinant genome (e.g., expressing the fluorescent protein RFP) and an artificial coating layer surrounding the recombinant virus (e.g., a silica gel matrix encapsulating the virus, as elected) [abstract, 0009, 0027, 0049, Figure 2, 4].
Regarding claim 8, Ortac discloses wherein the artificial silica coating is applied by conducting a charge-mediated sol-gel condensation reaction directly onto the surface of the recombinant virus [0008].
Regarding claims 10-11, Ortac discloses wherein the artificial coating comprises a targeting ligand, such as a small molecule folate targeting ligand as elected [0030-0031, 0049].
Regarding claim 12, Ortac discloses wherein the recombinant virus is replication-defective/non-replicative [0046].
Accordingly, by teaching all of the limitation of claims 1-3, 8, and 10-12, Ortac anticipates the instant invention as claimed.
Claim Rejections - 35 USC § 103
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
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.
Claim(s) 1 and 4-6 are rejected under 35 U.S.C. 103 as being unpatentable over Ortac [US20160067191A1, published 10 March 2016]; in view of Ritchie et al. [2019, Drugs of the Future, 44(7), 599-604]; and Le et al. [2020, Nature Reviews: Drug Discovery, 19, 305-306, published 09 April 2020].
Regarding claim 1, Ortac discloses a surface-engineered recombinant virus, wherein the virus comprises a recombinant virus (e.g., adenovirus, as elected) having a recombinant genome (e.g., expressing the fluorescent protein RFP) and an artificial coating layer surrounding the recombinant virus (e.g., a silica gel matrix encapsulating the virus, as elected) [abstract, 0009, 0027, 0049, Figure 2, 4].
Regarding claim 4, Ortac teaches the limitations of claim 1. Ortac also teaches wherein the recombinant virus is oncolytic [0009, 0018, 0034]. Ortac also discloses that the disclosed technology can be used as a therapeutic approach for clinical translation with the goal of opening up the use of oncolytic viruses to more cancer therapeutic application and improving the clinical response rates of oncolytic viruses [0009].
However, Ortac does not teach wherein the oncolytic virus is NG-641 (PsiOxus).
Ritchie teaches that extensive preclinical data were presented demonstrating that NG-641 has the desired antitumor properties including the ability to induce rapid activation of T cells and killing of stromal fibroblasts, and to promote the selective T-cell-mediated killing of FAP+ fibroblasts by infected tumor cells in primary malignant cell cultures leading to decreased TFG-β levels [column 10 ¶ 2-3]. Therefore, and ordinarily skilled artisan at the time of filing the instant application would have been motivated to use an NG-641 oncolytic virus.
Regarding claim 5, Ortac teaches the limitations of claim 1. However, Ortac does not teach wherein the virus is a vaccine and is selected from the list recited in claim 5.
Le teaches that the COVID-19 vaccine Ad5-nCoV from CanSino Biologicals is an adenovirus type 5 vector that expresses the COVID 19 Spike (S) protein and was one of the most advanced candidate COVID-19 vaccines in clinical development as of April 8, 2020 [column 1 ¶ 3, column 3 ¶ 1, Table 1]. Le also teaches that the scale of the humanitarian and economic impact of the COVID-19 pandemic was driving evaluation of next-generation vaccine technology platforms through novel paradigms to accelerate development of vaccines against COVID-19 to respond to the global COVID-19 outbreak [column 1 ¶ 1-2]. Therefore, an ordinarily skilled artisan at the time of filing the instant application would have been motivated to use the Ad5-nCoV adenovirus as a vaccine for the prevention of COVID-19.
Regarding claim 6, Ortac teaches the limitations of independent claim 1. Ortac also teaches wherein the adenovirus is replication deficient/non-replicative with deletions in the E1/E3 regions [0046].
However, Ortac does not teach wherein the virus is Ad5 Adenovirus vector, and wherein the recombinant genome encodes SARS-CoV-2 spike protein.
As discussed above, Le teaches that the COVID-19 vaccine Ad5-nCoV from CanSino Biologicals is an adenovirus type 5 vector that expresses the COVID 19 Spike (S) protein and was one of the most advanced candidate COVID-19 vaccines in clinical development as of April 8, 2020 [column 1 ¶ 3, column 3 ¶ 1, Table 1].
Given the motivation taught by Ritchie to use an NG-641 oncolytic virus to treat cancer and the motivation taught by Le use the Ad5-nCoV adenovirus as a vaccine for the prevention of COVID-19, it would have been prima facie obvious to an ordinarily skilled artisan at the time of filing the instant application to modify the surface-engineered recombinant virus of Ortac to include either the oncolytic virus NG-641 or the vaccine virus Ad5-nCoV with a reasonable expectation of success.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-6, 8, and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-10 of U.S. Patent No. 10,869,841, hereafter referred to as the ‘841 patent; in view of Ritchie et al. [2019, Drugs of the Future, 44(7), 599-604].
The ‘841 patent claims are drawn to a bioactive virus delivery device comprising a virus, wherein the polymer material is bound to the surface of the virus via an electrostatic interaction, and an exterior silica gel matrix formed directly on the surface of the interior polymer material and virus to envelope, encapsulate, and preserve biological activity of the virus, wherein an outer surface of the silica gel matrix comprises a secondary functionalization [claim 1].
Claim 1 of the invention is directed to a surface-engineered recombinant virus, said virus comprising: a recombinant virus having a recombinant genome; and an artificial coating layer surrounding the recombinant virus.
Both claims require a virus and an artificial coating layer surrounding the virus. In relation to the instantly claimed “artificial coating layer”, the “exterior silica gel matrix formed directly on the surface of the interior polymer material” recited in claim 1 of the ‘841 patent is species of the claimed genus of artificial coating layer.
The ’841 patent claims differ from the instant claims by not reciting that the virus is a recombinant virus having a recombinant genome. However, Ritchie teaches that therapeutic vaccination is a highly attractive, feasible and noninvasive approach to eliminating persistent hrHPV infection and cervical intraepithelial neoplasia [Ritchie et al. 2019, Drugs of the Future, 44(7), 599-604, column 8 ¶ 4] and that adenovirus is a versatile platform for the selective systemic delivery of tumor-specific immune-gene therapy [column 9 ¶ 3].
Therefore, it would have been obvious to an ordinarily skilled artisan at the time of filing the instant application to include a transgene encoding for a therapeutic agent in the genome of a virus.
As such, the ‘841 patent claims recite a device which comprises the surface-engineered virus of the instant claims. Accordingly, the ‘841 patent claims encompass and render obvious the claims of the instant application as written.
Claims 1-6, 8, and 10-12 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-15 of U.S. Patent No. 11,684,585, hereafter referred to as the ‘585 patent; in view of Ritchie et al. [2019, Drugs of the Future, 44(7), 599-604].
The ‘585 patent claims are drawn to a method of making a bioactive virus delivery device comprising a virus, wherein the polymer material is bound to the surface of the virus via an electrostatic interaction, and an exterior silica gel matrix is formed directly on the surface of the interior polymer material and virus to envelope, encapsulate, and preserve biological activity of the virus, wherein an outer surface of the silica gel matrix comprises a secondary functionalization [claim 1].
Claim 1 of the invention is directed to a surface-engineered recombinant virus, said virus comprising: a recombinant virus having a recombinant genome; and an artificial coating layer surrounding the recombinant virus.
Both claims require a virus and an artificial coating layer surrounding the virus. In relation to the instantly claimed “artificial coating layer”, the “exterior silica gel matrix formed directly on the surface of the interior polymer material” recited in claim 1 of the ‘841 patent is species of the claimed genus of artificial coating layer.
The ’585 patent claims differ from the instant claims by reciting a method of making a device comprising a virus and by not reciting that the virus is a recombinant virus having a recombinant genome. However, by teaching a method of making the product, the ‘585 patent claims anticipate the product itself.
Additionally, Ritchie teaches that therapeutic vaccination is a highly attractive, feasible and noninvasive approach to eliminating persistent hrHPV infection and cervical intraepithelial neoplasia [Ritchie et al. 2019, Drugs of the Future, 44(7), 599-604, column 8 ¶ 4] and that adenovirus is a versatile platform for the selective systemic delivery of tumor-specific immune-gene therapy [column 9 ¶ 3].
Therefore, it would have been obvious to an ordinarily skilled artisan at the time of filing the instant application to include a transgene encoding for a therapeutic agent in the genome of a virus.
As such, the ‘585 patent claims recite a device which comprises the surface-engineered virus of the instant claims. Accordingly, the ‘585 patent claims encompass and render obvious the claims of the instant application as written.
The ’585 patent claims methods and the instant claims are directed to compositions, but double-patenting rejections of claims to a method of making based on a claimed composition are proper. This rejection is necessitated by the decision of the Court of Appeals for the Federal Circuit in Pfizer Inc. v Teva pharmaceuticals USA Inc., 86 USPQ2d 1001, at page 1008 (March 2008), which indicates that there is no patentable distinction between claims to a product and a method of using that product disclosed in the specification of the application and that the preclusion of such a double patenting rejection under 35 USC 121 does not apply where the present application is other than a divisional application of the patent application containing such patentably indistinct claims.
Claims 1-6, 8, and 10-12 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 11-25 of copending Application No. 18/320,928, hereafter referred to as the ‘928 application; in view of Ritchie et al. [2019, Drugs of the Future, 44(7), 599-604].
The ‘928 application claims are drawn to a bioactive virus delivery device comprising a virus, wherein the polymer material is bound to the surface of the virus via an electrostatic interaction, and an exterior silica gel matrix formed directly on the surface of the interior polymer material and virus to envelope, encapsulate, and preserve biological activity of the virus, wherein an outer surface of the silica gel matrix comprises a secondary functionalization [claim 1].
Claim 1 of the invention is directed to a surface-engineered recombinant virus, said virus comprising: a recombinant virus having a recombinant genome; and an artificial coating layer surrounding the recombinant virus. The ’ 928 application claims essentially differ from the instant claims by not reciting that the virus is a recombinant virus having a recombinant genome.
However, Ritchie teaches that therapeutic vaccination is a highly attractive, feasible and noninvasive approach to eliminating persistent hrHPV infection and cervical intraepithelial neoplasia [Ritchie et al. 2019, Drugs of the Future, 44(7), 599-604, column 8 ¶ 4] and that adenovirus is a versatile platform for the selective systemic delivery of tumor-specific immune-gene therapy [column 9 ¶ 3].
Therefore, it would have been obvious to an ordinarily skilled artisan at the time of filing the instant application to include a transgene encoding for a therapeutic agent in the genome of a virus.
As such, the ‘928 application claims recite a device which comprises the surface-engineered virus of the instant claims. Accordingly, the ‘928 application claims encompass and render obvious the claims of the instant application as written.
This is a provisional nonstatutory double patenting rejection.
Conclusion
No claim is allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to Dr. KATIE L PENNINGTON whose telephone number is (703)756-4622. The examiner can normally be reached M-Th 8:30 am - 5:30 pm, Friday 8:30 am - 12:30 pm CT.
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DR. KATIE L. PENNINGTON
Examiner
Art Unit 1634
/KATIE L PENNINGTON/Examiner, Art Unit 1634
/MARIA G LEAVITT/Supervisory Patent Examiner, Art Unit 1634