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
1. It is noted that claim 48 is recited twice. Thus, the second claim 48 is interpreted as claim 49, claim 49 is interpreted as claim 50, and claim 50 is interpreted as claim 51.
Claims 41-51 are under consideration.
Information Disclosure Statement
2. The information disclosure statement (IDS) submitted on 12/12/2024. 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. Claim 42 is objected to because of the following informalities: The claim should recite “as determined by viral particle…” for improved grammar.
Appropriate correction is required.
Claim Rejections - 35 USC § 102/103
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 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.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
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.
4. Claims 41-51 are rejected under 35 U.S.C. 102(a)(1)/(a)(2) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Ihnat et al. (US20030170216)(cited in applicant’s IDS submitted 12/12/2024).
See claims 41-51 as submitted 11/26/2024.
Ihnat et al. teaches: treating cancer by gene therapy [0002]; using therapeutic gene delivered by viral vector delivery system to cancerous epithelial tissues and organs, such as the bladder using recombinant adenoviral vector delivery system formulated in combination with SYN3 (interpreted to read upon structure as recited in claim 41 (See Result 9 of 11 of STIC Search Request in Supplemental Content Tab))[0002; 0082; 0026](as recited in claims 41, 47); including intravesical administration [0069](as recited in claim 41); wherein stability testing was accomplished by HPLC [0096](as recited in claim 42); including cytokine gene interferons [0041](as recited in claim 47); SYN3 can be present in a concentration of from about 0.001 mg/ml to about 150 mg/ml [0035](as recited in claim 50); storage at 4 degrees C [0083](as recited in claim 51).
As to claims 43-46, 48, as such limitations do not appear to recite any actual further steps, such results or recitations are considered to flow from the composition and steps as recited in claim 41 (See also MPEP 2111.04: The determination of whether each of these clauses is a limitation in a claim depends on the specific facts of the case. See, e.g., Griffin v. Bertina, 283 F.3d 1029, 1034, 62 USPQ2d 1431 (Fed. Cir. 2002) (finding that a wherein clause limited a process claim where the clause gave meaning and purpose to the manipulative steps ); In Hoffer v. Microsoft Corp., 405 F.3d 1326, 1329, 74 USPQ2d 1481, 1483 (Fed. Cir. 2005), the court held that when a whereby clause states a condition that is material to patentability, it cannot be ignored in order to change the substance of the invention. Id. However, the court noted that a whereby clause in a method claim is not given weight when it simply expresses the intended result of a process step positively recited. Id. (quoting Minton v. Nat l Ass n of Securities Dealers, Inc., 336 F.3d 1373, 1381, 67 USPQ2d 1614, 1620 (Fed. Cir. 2003)).
As to claim 49, Ihnat et al. teaches: concentrations of compositions in the range of about 1.times.10 particles/ml to 2.times.10.sup.12 particles/ml, more typically about 1.times.10.sup.8 particles/ml to 9.times.10.sup.11 particles/ml, most typically 1.times.10.sup.10 particles/ml to 9.times.10.sup.11 particles/ml [0055](See MPEP 2144.05: I. OVERLAPPING, APPROACHING, AND SIMILAR RANGES, AMOUNTS, AND PROPORTIONS: In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art" a prima facie case of obviousness exists. In reWertheim, 541 F.2d 257, 191 USPQ 90 (CCPA 1976); In reWoodruff, 919 F.2d 1575, 16 USPQ2d 1934 (Fed. Cir. 1990)).
In view of the foregoing, all the claimed limitations are found in one reference and are taught to be optional variations to a ‘base’ method they exemplify. As such, the claimed method is within the scope of Ihnat et al., and thus Ihnat et al. renders the method prima facie obvious. The rationale to support this conclusion of obviousness is that Ihnat et al. provides a teaching, suggestion, and motivation to substitute different variables disclosed within the reference. Furthermore, there is no evidence on the record that indicates that the claimed supplement exhibits any unexpected results compared to the prior art.
Thus, Ihnat et al. anticipates or renders obvious the instant claims.
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.
5. Claims 41-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-20 of U.S. Patent No. 11547668 in view of Ihnat et al. (cited above).
See claims 41-51 as submitted 11/26/2024.
Claims 1-20 of U.S. Patent No. 11547668 recite a lyophilized composition comprising an infective recombinant adenovirus mixed with a surfactant in an amount effective to preserve the infectivity of the recombinant adenovirus, wherein the composition contains substantially no water, wherein the recombinant adenovirus comprises a transgene, and wherein the surfactant has Structure I (as recited in U.S. Patent No. 11547668).
Claims 1-20 of U.S. Patent No. 11547668 do not recite method of treating bladder cancer.
See the teachings of Ihnat et al. above.
One of ordinary skill in the art would have been motivated to use adenovirus as recited in claims 1-20 of U.S. Patent No. 11547668 with the method as taught by Ihnat et al. Ihnat et al. teaches a method of treating bladder cancer using recombinant adenovirus and SYN3, and claims 1-20 of U.S. Patent No. 11547668 recite such an adenovirus and SYN3 (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 adenovirus as recited in claims 1-20 of U.S. Patent No. 11547668 with the method as taught by Ihnat et al. There would have been a reasonable expectation of success given the underlying materials 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.
6. Claims 41-51 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-12 of U.S. Patent No. 11311487 in view of Ihnat et al. (cited above).
See claims 41-50 as submitted 11/26/2024.
Claims 1-12 of U.S. Patent No. 11311487 recite a method of treating a human subject, the method comprising: a. obtaining a surfactant having Structure I (as disclosed in U.S. Patent No. 11311487) b. obtaining a recombinant adenovirus comprising a transgene and having infectivity; c. mixing the adenovirus with the surfactant to form an admixture; d. storing the admixture at about 4° C. or room temperature for at least about one week, wherein after said storage the adenovirus retains a higher level of infectivity relative to control; and e. contacting human cells with the admixture, thereby treating the human subject in need thereof.
Claims 1-20 of U.S. Patent No. 11547668 do not recite method of treating bladder cancer.
See the teachings of Ihnat et al. above.
One of ordinary skill in the art would have been motivated to use method as recited in claims 1-12 of U.S. Patent No. 11311487 with the method as taught by Ihnat et al. Ihnat et al. teaches a method of treating bladder cancer using recombinant adenovirus and SYN3, and claims 1-12 of U.S. Patent No. 11311487 also recite such an adenovirus and SYN3 (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 adenovirus as recited in claims 1-12 of U.S. Patent No. 11311487 with the method as taught by Ihnat et al. There would have been a reasonable expectation of success given the underlying materials 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.
Conclusion
7. 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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