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 .
DETAILED ACTION
Election Restrictions
1. Applicant’s election without traverse of Group I and species (methioninase; cytosine deaminase/5-fluorocytosine; adenovirus; E1B-55 kDa gene deletion) in the reply filed on 4/13/2026 is acknowledged.
Claims 15-21 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected Invention, there being no allowable generic or linking claim. Election was made without traverse in the reply filed on 4/13/2026.
Claims 1-10 are under consideration.
Information Disclosure Statement
2. The information disclosure statements (IDS) were submitted on 4/7/2023; 3/11/2026. The submission is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner.
Claim Objections
3. Applicant is advised that should claim 4 be found allowable, claim 8 will be objected to under 37 CFR 1.75 as being a substantial duplicate thereof. When two claims in an application are duplicates or else are so close in content that they both cover the same thing, despite a slight difference in wording, it is proper after allowing one claim to object to the other as being a substantial duplicate of the allowed claim. See MPEP § 608.01(m).
Claim Rejections - 35 USC § 112
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.
4. Claims 1-10 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.
See claims 1-10 as submitted 12/21/2023.
Claim 1 recites “essential-agent-depletion-enzyme”. The term “essential-agent-depletion-enzyme” and “essential” more specifically is a relative term which renders the claim indefinite. The term is not defined by the claim, the specification does not provide a standard for ascertaining the requisite degree, and one of ordinary skill in the art would not be reasonably apprised of the scope of the invention. It is noted that the specification only teaches wherein “essential-agent-depletion-enzyme” refers to an enzyme that is capable of depleting, removing or otherwise negating the effect of an essential agent for physiological functioning (p. 20). It is not clear what the metes and bounds of the term “essential” are. Claims 2-10 depend on this claim.
Further as to claim 7, the claim depends on claim 6 and recites “essential-agent-depletion-enzyme”. It is not clear if the virus “further” comprises essential-agent-depletion-enzyme or not, as claim 6 already recites methioninase.
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.
5. Claims 1, 2, 4, 5, 8, 9, 10 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, as failing to comply with the written description requirement. The claim(s) contains subject matter which was not described in the specification in such a way as to reasonably convey to one skilled in the relevant art that the inventor or a joint inventor, or for applications subject to pre-AIA 35 U.S.C. 112, the inventor(s), at the time the application was filed, had possession of the claimed invention.
See claims 1, 2, 4, 5, 8, 9, 10 as submitted 12/21/2023.
See also the 35 U.S.C. 112(b) rejection above.
Claim 1 recites “an essential-agent-depletion enzyme”. Thus, the claims are drawn to compositions comprising a genus of “essential-agent-depletion enzyme”.
The following quotation from section 2163 of the Manual of Patent Examination
Procedure is a brief discussion of what is required in a specification to satisfy the 35 U.S.C. 112 written description requirement for a generic claim covering several distinct inventions:
The written description requirement for a claimed genus may be satisfied through sufficient description of a representative number of species by actual reduction to practice..., reduction to drawings..., or by disclosure of relevant, identifying characteristics, i.e., structure or other physical and/or chemical properties, by functional characteristics coupled with a known or disclosed correlation between function and structure, or by a combination of such identifying characteristics, sufficient to show the applicant was in possession of the claimed genus... See Eli Lilly, 119 F.3d at 1568, 43 USPQ2d at 1406. 'A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus.
Thus, when a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. Support for a genus is generally found where the applicant has provided a number of examples sufficient so that one in the art would recognize from the specification the scope of what is being claimed.
In the present case, the application teaches: "essential-agent-depletion-enzyme" refers to an enzyme that is capable of depleting, removing or otherwise negating the effect of an essential agent for physiologic functioning [0045]; methionine, asparagine, adenosine, uric acid; adenosine-deaminase, and uricase [0045].
However, given the relative nature of the term “essential” and the breadth of the term "enzyme," the specification does not identify a representative sample of "essential-agent-depletion-enzymes" in view of the breadth of the claims. Thus, the application does not identify a representative sample within the breadth of the claimed genus.
There is no apparent common conserved structure to the "essential-agent-depletion-enzyme" that distinguishes those that have function as compared to those that do not. There is therefore a high level of uncertainty as to which "essential-agent-depletion-enzymes" fall within the scope of the indicated genus.
Further, the specification has identified "essential-agent-depletion-enzyme" only by function: capability of depleting, removing or otherwise negating the effect of an essential agent for physiologic functioning. However, the specification does not provide a specific structure of enzymes within the genus that correlates with the required function. Because there is no identification of structures common to each enzyme, nor sufficient representative examples of the enzyme by which such a structure may be determined, the application fails to provide sufficient written description support for the identified genus of "essential-agent-depletion-enzymes" through identification of a structure and function. While the enzymes are required to be capable of depleting, removing or otherwise negating the effect of an essential agent for physiologic functioning, this is not alone sufficient structure to correlate with the function. This is because the mere presence of an enzyme does not demonstrate that an enzyme would be capable of depleting, removing or otherwise negating the effect of an essential agent for physiologic functioning.
For the reasons above, the application has not provided sufficient written description support for the genus of enzymes identified in claim 1.
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.
6. Claims 1, 3, 5-7, 10 are rejected under 35 U.S.C. 103 as being unpatentable over Finer et al. (WO2019133847)(See PTO-892: Notice of References Cited) in view of Seggern et al. (US20080124360A1)(See PTO-892: Notice of References Cited).
See claims 1, 3, 5-7, 10 as submitted 12/21/2023.
See also the 35 U.S.C. 112(b) rejection above.
Finer et al. teaches: oncolytic viruses, including comprising one or more therapeutic molecules (abstract)(as recited in claim 1); including methioninase [0255](as recited in claims 1, 3, 6); adenovirus (claim 47 of Finer et al.)(as recited in claim 5); asparaginase [0247](as recited in claim 7); wherein oncolytic viruses are able to replicate in tumor cells [0080](as recited in claim 1).
Finer et al. does not teach: viral genome deletion.
Seggern et al. teaches: oncolytic viruses, including adenoviruses for therapy [0294]; including oncolytic viruses with deletion in E1b-55 KD gene; wherein deletion of E1b-55KD restricts replication to p53-deficient cells [0250](as recited in claims 1, 10).
One of ordinary skill in the art would have been motivated to use deletion as taught by Seggern et al. with the virus as taught by Finer et al. Finer et al. teaches oncolytic adenovirus, and Seggern et al, which also teaches oncolytic adenovirus, teaches the advantage wherein use of genome deletion restricts replication to specific cells, thereby increasing control and effectiveness.
One of ordinary skill in the art would have had a reasonable expectation of success for using deletion as taught by Seggern et al. with the virus as taught by Finer et al. There would have been a reasonable expectation of success given the underlying materials (oncolytic adenovirus as taught by Finer et al. and Seggern et al.) and methods are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
7. Claims 2, 4, 8, 9 are rejected under 35 U.S.C. 103 as being unpatentable over Finer et al. in view of Seggern et al. as applied to claims 1, 3, 5-7, 10 above, and further in view of Fernandez-Santidrian et al. (CA3116192A1)(See PTO-892: Notice of References Cited).
See claims 2, 4, 8, 9 as submitted 12/21/2023.
See the teachings of Finer et al. in view of Seggern et al. above. It is noted that Finer et al. teaches: oncolytic viruses, including comprising one or more therapeutic molecules (abstract).
Finer et al. in view of Seggern et al. does not teach: coding region for a prodrug converting enzyme; prodrug; cytosine deaminase/5-fluorocytosine
Fernandez-Santidrian et al. teaches: viral therapy and modified viruses (abstract); including gene therapy wherein cytosine deaminase resulted in tumor site conversion of 5-fluorocytosine to the chemotherapeutic 5-fluorouracil (p. 56); prodrug activators (cytosine deaminase) (p. 95); flucytosine (p. 136).
One of ordinary skill in the art would have been motivated to use combination as taught by Fernandez-Santidrian et al. with the virus as taught by Finer et al. in view of Seggern et al. Finer et al. in view of Seggern et al. teaches modified virus comprising one or more therapeutic molecules, and Fernandez-Santidrian et al, which also teaches modified viruses, teaches the added advantage for efficiency for treating cancer wherein cytosine deaminase with 5’fluorocytosine resulted in tumor site conversion of 5-fluorocytosine to the chemotherapeutic 5-fluorouracil (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using combination as taught by Fernandez-Santidrian et al. with the virus as taught by Finer et al. in view of Seggern et al. There would have been a reasonable expectation of success given the underlying materials and methods (therapy with modified viruses as taught by Fernandez-Santidrian et al. and Finer et al. and Seggern et al.) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
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.
8. Claims 1, 3, 5, 6, 7 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138.
See claims 1, 3, 5, 6, 7 as submitted 12/21/2023.
Claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138 recite a replication-competent oncolytic virus comprising: a first, a second, and a third transgene, whereas each transgene expresses GM-CSF, IL-12, IL-15, TNF-α, 4-1BBL, CCL4, CCL5/RANTES, CXCL11, or an essential-agent-depletion-enzyme; wherein the third transgene expresses an essential-agent-depletion-enzyme selected from methioninase, adenosine deaminase, or cytosine deaminase, asparaginase or uricase; wherein the virus is an adenovirus; wherein the adenovirus further comprises a 24-bp deletion in E1A Conserved Region 2 (CR2), and a 2428 bp BsiWI-BglII deletion in the E3 region. Further it is noted a method of using a product renders the product obvious.
Although the claims at issue are not identical, they are not patentably distinct from each other because both instant claims 1, 3, 5, 6, 7 and claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138 recite a replication-competent oncolytic virus comprising: a coding-region for an essential-agent-depletion-enzyme; and a viral-genome deletion.
This is a provisional nonstatutory double patenting rejection because the patentably indistinct claims have not in fact been patented.
9. Claims 2, 4, 8, 9 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138 as applied to claims 1, 3, 5, 6, 7 above and further in view of Fernandez-Santidrian et al. (cited above).
See claims 2, 4, 8, 9 as submitted 12/21/2023.
See the recitations of claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138 above, including as to deaminase and anti-cancer drugs.
Claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138 do not recite: coding region for a prodrug converting enzyme; prodrug; cytosine deaminase/5-fluorocytosine.
See the teachings of Fernandez-Santidrian et al. above.
One of ordinary skill in the art would have been motivated to use combination as taught by Fernandez-Santidrian et al. with the virus as recited in claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138. Claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138 recite modified virus comprising transgenes and use of anti-cancer drugs, and Fernandez-Santidrian et al, which also teaches modified viruses, teaches the added advantage for treating cancer wherein cytosine deaminase with 5’fluorocytosine resulted in site conversion to chemotherapeutic (See MPEP 2144.06: Substituting equivalents known for the same purpose).
One of ordinary skill in the art would have had a reasonable expectation of success for using combination as taught by Fernandez-Santidrian et al. with the virus as recited in claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138. There would have been a reasonable expectation of success given the underlying materials and methods (therapy with modified viruses as taught by Fernandez-Santidrian et al. and claims 1, 5, 10, 11, 15-18 of copending Application No. 18/254138) are known, successfully demonstrated, and commonly used as evidenced by the applied prior art.
Therefore the invention as a whole would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention.
This is a provisional nonstatutory double patenting rejection.
Conclusion
10. No claims are allowed.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to M FRANCO G SALVOZA whose telephone number is (571)272-4468. The examiner can normally be reached M-F 8:00 to 5:00.
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/M FRANCO G SALVOZA/Primary Examiner, Art Unit 1672
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