+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 .
RESPONSE TO APPLICANT’S AMENDMENT
1. A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been saing1.114. Applicant's submission filed on 11/03/25 has been hereby entered.
2. Claims 1-9 are pending.
Claims 1-9 read on a method treating a subject suffering from bladder cancer, comprising administering to the subject a composition comprising replication-deficient adenovirus encoding interferon alpha-2b wherein said virus was preserve in a buffer as recited in claim 1 are under consideration in the instant application.
3. Claims 1-9 stand rejected under 35 U.S.C. 103 as being unpatentable over US Patent Patent Application 20100008889 in view of US Patent Application 20050085427 (IDS) and US Patent Application 20090098632 (IDS) , US Patent Application 20240074995 and US Patent Application 20230054318 for the same reasons set forth in the previous Office Action, mailed on 05/02/25
Applicant arguments filed on 11/03/25 have been fully considered but have not been found convincing.
Applicant’s arguments and the Examiner’s rebuttal are essentially the same as of record.
Moreover, it is noted that during telephonic interview for the parent case 18/381,782 on 03/10/26 Applicant informed the Examiner that newly found prior art references submitted as new IDS on 02/26/26 indicated and teaches that skilled in the art would expect that claimed buffer formulation comprising all recited components would preserved viral infectivity when kept under – 60C for extended period of time.
As has been stated previously, US Patent Application’889 teaches a method of treating bladder cancer in a patient, comprising administering to said patient a composition comprising replication-deficient adenovirus encoding interferon alpha-2b ( see entire document, paragraphs 0037, 0046, 0087, 0099 in particular)
US Patent’889 does not explicitly teaches a method of preserving ( storing in frozen state) replication-deficient adenovirus encoding interferon alpha-2b wherein said virus was preserve in a buffer as recited in claim 1.
US Patent Application’427 teaches a method of storing an adenovirus in a cryoprotective buffer composition comprising adenovirus and a cryoprotective buffer, wherein said buffer comprises glycerol, sucrose, SYN3 (NODA); polysorbate 80, citric acid monohydrate, sodium phosphate buffer, hydroxypropyl cyclodextrin and tromethamine (Tris)( see entire document, paragraphs 0080, 0081,0123-0163,0188-0191 in particular).
US Patent Application’427 does not explicitly teaches the presence of sodium dihydrogen phosphate dihydrate in the storage buffer.
US Patent Application ‘995 teaches a storage buffers comprising preservatives such as sodium dihydrogen phosphate dihydrate or sodium phosphate ( see entire documents, paragraphs 0162, 0167 in particular).
US Patent Application ‘318 teaches a storage buffers comprising preservatives such as sodium dihydrogen phosphate dihydrate or sodium phosphate ( see entire documents, paragraph 0119 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been obvious and within the skills of one of ordinary in the art before the effective filing date of the claimed invention to preserve replication-deficient adenovirus encoding interferon alpha-2b recited in US Patent Application’889 in in a cryoprotective buffer recited in claim 1 with a reasonable expectation of success because the prior art teaches that storage buffers comprising preservatives as recited in claim 1 were successfully used for stored adenovirus in a frozen state.
It is noted that though prior art references do not explicitly teaches a method steps of thawing frozen adenovirus as recited in claims it would be conventional and within the skill of the art to identify an optimal means and protocols for thawing frozen adenovirus. Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
Further, it has been held that where the general conditions of a claim are disclosed in the prior art, discovering the optimum or workable ranges involves only routine skill in the art. In re Aller, 220 F2d 454,456,105 USPQ 233; 235 (CCPA 1955). see MPEP § 2144.05 part II A.
US Patent Application’889 and US Patent Application ‘427 do not explicitly teach that storage buffer comprises magnesium chloride hexahydrate and that adenovirus suspended at concentration of about 3x1011 particles per ml.
US Patent Application’ 632 teaches a composition comprising adenovirus and a cryoprotective buffer, wherein said buffer comprises glycerol, sucrose tromethamine, magnesium chloride hexahydrate . US Patent Application’ 632 teaches that adenovirus suspended at concentration of about 3 x1011 particles per ml ( see entire document, paragraphs 0028, 0033, 0034, 0040, 0048 and table 2 in particular).
All the claimed elements were known in the prior art and one skill in the art could have combine the elements as claimed by known methods with no change in their respective function and the combination would have yield predictable results to one of ordinary skill in the art at the time of the invention ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Thus it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to add tromethamine and magnesium chloride hexahydrate to the buffer composition taught by US Patent Application ‘427 with a reasonable expectation of success because the prior art teach a composition comprising 3 x1011 adenovirus particles per ml and a buffer, wherein said buffer comprises glycerol, sucrose tromethamine, magnesium chloride hexahydrate
“It is prima facie obvious to combine two compositions each of which is taught by the prior art to be useful for the same purpose, in order to form a third composition to be used for the very same purpose. . . [T]he idea of combining them flows logically from their having been individually taught in the prior art.” In re Kerkhoven, 626 F.2d 846, 850, 205USPQ 1069, 1072 (CCPA 1980) (see MPEP 2144.06).
From the teachings of the references, it was apparent that one of ordinary skill in the art would have had a reasonable expectation of success in producing the claimed invention.
Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art at the time the invention was made, as evidenced by the references, especially in the absence of evidence to the contrary.
4. 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. See 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); and 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) may be used to overcome an actual or provisional rejection based on a nonstatutory double patenting ground provided the conflicting application or patent is shown to be commonly owned with this application. See 37 CFR 1.131(c). 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. 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 filing date of the application will determine what form 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 [ 1 ].
5. The claims 1-8 are provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application US 20230226154. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of copending Applications recited a method of treating a bladder cancer in a subject comprising administering replication-deficient adenovirus encoding interferon alpha-2b.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
6. The claims 1-9 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications No.20230175012 ,20240043873, US 20240117379 A1. Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of copending Applications No.20230175012 ,20240043873, US 20240117379 are drawn to a cryopreserving buffer comprising adenovirus that are used in the presently claimed methods, and wherein the presently claims methods are disclosed in the specification of the copending Applications No.20230175012 ,20240043873, US 20240117379.
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.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
7. It is noted that Applicant requested to hold that double patenting rejection in abeyance until allowable subject matter is identified.
8. No claim is allowed.
9. All claims are either identical to or patentably indistinct from claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114.
Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
10. Any inquiry concerning this communication or earlier communications from the examiner should be directed to Michail Belyavskyi whose telephone number is 571/ 272-0840 The examiner can normally be reached Monday through Friday from 9:00 AM to 5:30 PM. A message may be left on the examiner's voice mail service. If attempts to reach the examiner by telephone are unsuccessful, the examiner's supervisor, Gregory Emch can be reached on 571/ 272-8149 .
The fax number for the organization where this application or proceeding is assigned is 703-872-9306.
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644