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
Applicant’s amendment filed on 10/20/25 is acknowledged.
1. Claims 1-32 are pending.
Claims 1-29 and 32 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 30 and 31 read on a method of preserving level of infectivity of an infective virus are under consideration in the instant application.
The following new ground of rejection is necessitated by the amendment filed on 10/20/25
3. 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 30 and 31 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20050085427 (IDS) and US Patent Application 20090098632 (IDS) in view of newly cited US Patent Application 20250064890 and US Patent Application 20200352862
Applicant’s argument filed on 10/20/25 have been fully considered but have not been found convincing
Applicant asserts that (i) US Patent Application’632 does not recited the use of cyclodextrin or NODA; (ii) US Patent Application’427 does not teach or suggest the use of sodium dihydrogen phosphate dihydrate; (iii) None of the prior art references teach or suggest the same concentration of each component as claimed; (iv)the specification describe a novel formulation which preserve virus infectivity when stored at -20o C for at least one year.
Applicants have traversed the primary and the secondary references pointing to the differences between the claims and the disclosure in each reference. Applicant is respectfully reminded that the rejection is under 35 USC103 and that unobviousness cannot be established by attacking the references individually when the rejection is based on the combination of the references. see In re Keller, 642 F.2d 4B, 208 USPQ 871, 882 (CCPA 1981) See MPEP 2145. This applicant has not done, but rather argues the references individually and not their combination. One cannot show non-obviousness by attacking references individually where the rejections are based on a combination of references. In re Young 403 F.2d 759, 150 USPQ 725 (CCPA 1968).
Newly cited US Patent Application ‘890 teaches the use of sodium dihydrogen phosphate dihydrate in the cryopreservation buffer that preserve the stability of frozen biological material ( see entire document, paragraph 0088 in particular).
Moreover, as is evidence from US Patent Application 20240074995 and US Patent Application 20230054318 storage buffers comprising preservatives such as sodium dihydrogen phosphate dihydrate or sodium phosphate were well known to one of ordinary skill in the art before the effective filing date of the claimed invention.
Newly cited US Patent Application’862 teaches a viral stabilization buffer comprising SYN3 ( NOVA) for storage and preservation ( see entire document, paragraphs 0043, 0081, 0096 in particular)
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 substitute sodium phosphate with sodium dihydrogen phosphate dihydrate in the buffer taught by US Patent Application ‘427 and add SYN3 (NOVA) to said cryopreservation buffer with a reasonable expectation of success because the prior art teaches that storage buffers comprising preservatives such as sodium dihydrogen phosphate dihydrate or sodium phosphate and SYN3 (NOVA) can be used for preservation of viral particles.
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.
With regards to Applicant’s comments that “none of the prior art references teach or suggest the same concentration of each component as claimed”
It has been recently stated that KSR forecloses the argument that a specific teaching, suggestion, or motivation are required to support a finding of obviousness See Board decision ( see KSR International Co v Teleflex Inc., 550U.S.-, 82 USPQ2d 1385, 2007).
Moreover, as has been stated in the previous Office Action, mailed on 04/09/24, it is the Examiner’s position that though US Patent Application ‘427 and US Patent Application’ 632 do not explicitly teach the same concentration of each component as instantly claims it would be conventional and within the skill of the art to : determine an effective amount each component in the cryoprotective buffer. 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.
It is well settled that "discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art." In re Boesch, 617 F.2d 272, 276, 205 USPQ 215, 219 (CCPA 1980). See also Merck & Co. v. Biocraft Labs. Inc., 874 F.2d 804, 809, 10 USPQ2d 1843, 1847-48 (Fed. Cir. 1989) (determination of suitable dosage amounts in diuretic compositions considered a matter of routine experimentation and therefore obvious).
Applicant provide no evidences or declaration of why it would not be obvious and within the skill of the art to determine an effective concentration of each component as instantly claimed.
With regards to Applicant’s statement that “the specification describe a novel formulation which preserve virus infectivity when stored at -20o C for at least one year”.
With regards to Applicant’s statement that “the specification describe a novel formulation which preserve virus infectivity when stored at -20o C for at least one year”.
It is the Examiner’s position that since each prior art reference teaches cryoprotective buffer comprising glycerol and sucrose, sodium dihydrogen phosphate dehydrate and SYN3 (NOVA) it would be immediately obvious to one skill in the art that said feature i.e. preserving stability of adenovirus at -20oC for at least one year would be an obvious feature of the cryoprotective buffer taught by prior art references.
As has been stated previously, US Patent Application’427 teaches a composition comprising adenovirus and a cryoprotective buffer, wherein said buffer comprises glycerol, sucrose, 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 teach that buffer comprises tromethamine, and that adenovirus suspended at concentration of about 3x1011 particles per ml.
US Patent Application’ 632 teaches a method comprising storing adenovirus in 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 buffer composition taught by US Patent Application ‘427 with a reasonable expectation of success because the prior art teach a cryoprotective buffer comprising tromethamine can be used for storing.
“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).
It is notes that US Patent Application ‘427 and US Patent Application’ 632 do not explicitly teach preserving the level of infectivity of an infective virus for at least one year. However, it is the Examiner’s position that it would be immediately obvious to one skill in the art that said feature would be an obvious feature of the cryoprotective buffer taught by the prior art references.
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.
5. 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 ].
6. The claims 30 and 31 are is provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Applications US 20250024830 ; No.20230175012; US 20240043873; US 20240117379.
Although the conflicting claims are not identical, they are not patentably distinct from each other because the claims of copending US Patent Applications US 20250024830 ; No.20230175012; US 20240043873; US 20240117379 are drawn to a composition comprising cyclodextrin, tromethamide and sodium phosphate that are used in the presently claimed methods, and wherein the presently claims methods are disclosed in the specification of the US Patent Applications 20250024830 ; No.20230175012; US 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.
It is noted that Applicant requested to hold that provisional double patenting rejection in abeyance until allowable subject matter is identified.
7. No claim is allowed.
8. Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 609(B)(2)(i). Applicant is reminded of the extension of time policy as set forth in 37 CFR 1.136(a).
A shortened statutory period for reply to this final action is set to expire THREE MONTHS from the mailing date of this action. In the event a first reply is filed within TWO MONTHS of the mailing date of this final action and the advisory action is not mailed until after the end of the THREE-MONTH shortened statutory period, then the shortened statutory period will expire on the date the advisory action is mailed, and any extension fee pursuant to 37 CFR 1.136(a) will be calculated from the mailing date of the advisory action. In no event, however, will the statutory period for reply expire later than SIX MONTHS from the mailing date of this final action.
9. 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, Daniel Kolker can be reached on 571/ 272-3181
The fax number for the organization where this application or proceeding is assigned is 571/273-8300
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/MICHAIL A BELYAVSKYI/Primary Examiner, Art Unit 1644