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.Applicants amendment filed on 10/14/25 is acknowledged.
2. Claims 1,3-13,19-25 are pending.
3. Claims 19-23 stand withdrawn from further consideration by the Examiner, 37 C.F.R. § 1.142(b) as being drawn to nonelected inventions.
Claims 1,3-13, 24 and 25 read on a immunostimulatory composition consisting of saponin and CpG oligonucleotide are under consideration in the instant application.
The following new ground of rejection is necessitated by the amendment filed on 10/14/25
4. 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.
5. Claims 1,3-13, 24 and 25 are rejected under 35 U.S.C. 103 as being unpatentable over US Patent Application 20240130973 and US Patent Application 20220347286 in view of US Patent US Patents 9878035, 5981,185
Applicant asserts that combination of specific CpG oligodeoxynucleotide with saponin or adjuvant comprising saponin show a synergistic effect with high efficiency and thus was surprising and unexpected.
Contrary to Applicants’ assertion as is evidence from the teaching of WO 0009159, IDS) the synergistic effect of a combination of specific CpG CpG oligodeoxynucleotide with saponin was know in the prior art ( see entire document, pages 2,11 and 14 in particular). Thus it is the Examiner’s position that it would not be surprising and unexpected to one skill in the art that combination of specific CpG oligodeoxynucleotide with saponin would have high efficiency to provide more potent immune response.
As has been stated previously, US Patent Application’973 teaches an immunostimulatory composition (adjuvant) comprising a saponin ( QS-21) CpG oligodeoxynucleotide and antigen ( viral antigens). ( see entire document, paragraphs 0008, 0013, 0059, 0093 in particular).
US Patent Application’973 teaches an immunostimulatory composition (adjuvant) comprising a saponin ( QS-21) CpG oligodeoxynucleotide and antigen ( viral antigens) ( see entire document, paragraphs 0045 in particular).
It is noted US Patent Application’973 and US Patent Application’973 do not explicitly teach the CpG oligonucleotide of SEQ IDs as recited in amended claim 1
US Patent ‘035 teaches an immunostimulatory composition, comprising CpG oligodeoxynucleotide of SEQ ID N:3 that is 100% identical to the instantly claimed CpG oligodeoxynucleotide of SEQ ID :6 ( see sequence alignment)
US Patent ‘035 teaches an immunostimulatory composition, comprising CpG oligodeoxynucleotide of SEQ ID N:4 that is 100% identical to the instantly claimed CpG oligodeoxynucleotide of SEQ ID :7 ( see sequence alignment)
US Patent ‘185 teaches an immunostimulatory composition, comprising CpG oligodeoxynucleotide of SEQ ID N:84 that is 100% identical to the instantly claimed CpG oligodeoxynucleotide of SEQ ID :8 ( see sequence alignment)
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 substitute CpG oligodeoxynucleotide taught by US Patent Application’973 and US Patent Application’973 with CpG oligodeoxynucleotide taught by US Patent ‘ ‘035 and US Patent’ 185 with a reasonable expectation of success because the prior art teach a successful use of each of the recited CpG oligodeoxynucleotide in an immunostimulatory composition and general knowledge that CpG oligodeoxynucleotide various size and sequences was well know and routinely used in immunostimulatory compositions.
Claims 3, 6, 8, 24 and 25 are included because it would be conventional and within the skill of the art to : (i) determine an optimal type of saponin to be used (ii) determine the optimum weigh ratio of CpG oligodeoxynucleotide to saponin to be used in adjuvant . 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).
From the combined teaching of the references, it is 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.
6. 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 https://www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer
7. The claims 1,3 -13, 24 and 25 stand provisionally rejected on the grounds of nonstatutory double patenting of the claims of copending Application Nos. US 20240066112 A1, US 20230076371 A1 ( now allowed), US 20230073321 A1; US 20230233665 A1; US 20190125863 A1 (now allowed); US 20190083604 A1 for the same reasons sedt forth in the previous Office Action mailed on , mailed on 07/22/25.
Applicant’s arguments filed on 10/14/25 have been fully considered but have not been found convincing.
Applicant asserts that as amended the claims 1,3 -13, 24 and 25 are significantly different and patentably distinct from the claims of copending applications.
Contrary to Applicant’s assertion it is the Examiner’s position that even if amended claims now recited “consisting of” rather than comprising they are not significantly different and patentably different from the claims of copending Application because each of copending claims and instantly claims recited an immunostimulatory composition with acting compounds of saponin and CpG oligodeoxynucleotide and thus are not patentable distinct or non-obvious.
This is a provisional nonstatutory double patenting rejection because the conflicting claims have not in fact been patented.
8. No claim is allowed.
9. 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.
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, 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
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