DETAILED ACTION
1. The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
2. 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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 10/27/25 has been entered.
3. Claims 9-10, 13, 14 and 17 are pending upon entry of amendment filed on 10/27/25.
4. The following rejections remain.
5. 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.
6. Claims 9-10, 13, 14 and 17 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Fox et. al. (U.S. Application 2015/0017191 A1, reference on IDS filed on 11/15/2021, of record) for the reasons set forth in the office action mailed on 4/28/25.
Fox teaches PfCel-TOS vaccine composition comprising recombinant malaria antigen PfCelTOS, squalene, and TLR4 agonist, when injected into mice generates strong lgG2a response to the antigen (e.g., see [0191]-[0198] of Example 1). Fox teaches an oil-in-water emulsion comprising a TLR4 agonist and metabolizable oil that generate an antigen-specific immune response to one or more antigens wherein the metabolizable oil comprises a surfactant (see entire document, particularly claims 1, 11, 16, and 24). Fox also discloses an embodiment of the invention wherein their oil nanoemulsion, squalene, additionally comprises water, an organic solvent (squalene), and one or more surfactants such as a non-ionic surfactant (Pluronic F-68) and a cationic surfactant (DMPC) (see entire document, particularly paragraphs [0032], [0059], [0176], and [0248]). Fox further discloses an embodiment of the invention wherein it contains an immunostimulatory compound, such as a toll-like receptor agonist, which may be an oligonucleotide containing a CpG motif, particularly QS-21 that is identified as the saponin triterpene glycoside (see entire document, particularly paragraphs [0051], [0139], [0140], [0147], and [0148]). Fox finally discloses that the identity of the one or more antigens may include a “polypeptide... recombinant construct...derived from...an infectious pathogen...or cell or tissue associated with infection, cancer, autoimmune disease, allergy, asthma, or any other condition where stimulation of an antigen-specific immune response would be desirable or beneficial” (paragraph [0093]). Therefore, the reference teachings anticipate the instant invention.
Applicant’s response filed on 10/27/25 has been fully considered but they were not persuasive.
Applicant has asserted that the ‘191 publication is not available as an anticipatory reference as it fails to teach all the limitations of the claimed invention. Applicant has asserted that the nanoemulsion is comprising oil, water, organic solvent, cationic surfactant and nonionic surfactant is not taught as the nanoemulsion of the ‘191 publication is phospholipid comprising DPPC or DPMC. Applicant has further asserted that the ‘191 publication fails to teach immunostimulatory compound of toll-like receptor antagonist or triterpene glycoside saponin.
However, unlike Applicant’s assertion, QS-21 of the ‘191 publication reads on the triperpene glycoside saponin and the ‘191 publication remains as an anticipatory reference.
Further, in lack of specific component of nanoemulsion, the adjuvant nanoemulsion taught by the ‘191 publication reads on the adjuvant comprising oil, water, organic solvent and cationic and nonionic surfactant as in claimed invention. Note the Example discloses oil phase (e.g. oil and water), organic solvent, nonionic surfactant and cationic surfactant (see [195]). Applicant is advised to recite specific species and/or concentration of component to obviate the rejection.
7. 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.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
8. Claims 9, 10, 13, 14 and 17 are rejected under 35 U.S.C. 103 as being unpatentable over Baker et. al. (U.S. Patent 7,314,624, of record) in view of Fox et. al. (U.S. Application 2015/0017191 A1, reference on IDS filed on 11/15/2021, of record) for the reasons set forth in the office action mailed on 4/28/25.
Baker recites a method of inducing an immune response to an immunogen comprising a nanoemulsion, itself comprising oil, ethanol, surfactant, an ammonium compound, water, and an immunogen. Dependent claim 3 further limits the immunogen to an inactivated pathogen. Dependent claim 7 further limits the oil to a list comprising squalene. Dependent claim 8 further limits the surfactant to a group consisting of ionic and nonionic surfactants.
The reference teachings differ from the instant invention by not reciting an immunostimulatory compound such as ODN and QS-21.
However, Fox discloses an oil-in-water emulsion, that comprises a TLR4 agonist and metabolizable oil, can generate an antigen-specific immune response to one or more antigens (see entire document, particularly claims 1, 11, 16, and 24). Fox further discloses an embodiment of their invention wherein an immunostimulatory compound, such as a toll-like receptor agonist, may be an oligonucleotide containing a CpG motif, particularly QS-21, that is identified as the saponin triterpene glycoside (see entire document, particularly paragraphs [0051], [0139], [0140], [0147], and [0148]).
It would thus be obvious to one of ordinary skill in the art to utilize the method of inducing an immune response to an immunogen recited in Baker with the embodiment of the immunostimulatory compound such as the ODN and QS-21, as disclosed in Fox. A person with ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, because ODN and QS-21 were known in the art as an effective immunostimulatory compound and can be combined with antigen and adjuvant to induce antigen specific immune response. Therefore, the combined teachings of Baker and Fox would render the instant invention obvious.
Applicant’s response filed on 10/27/25 has been fully considered but they were not persuasive.
Applicant has asserted that the combination of the references is not obvious as the cited references fails to teach the claimed invention.
Applicant has further asserted that the ‘624 patent fails to teach the ODN or saponin and the ‘191 publication relates to GLA and DMPC and teaches away from the claimed invention. In addition, the combination of the references is based on the hindsight reasoning and there is no motivation to combine the references; combination of the references is not obvious.
As discussed above in section 6 of this office action, the claimed emulsion does not exclude GLA or DMPC. IT reads on combination of oil, water and organic solvent, cationic surfactant and non-ionic surfactant and the adjuvant of the ‘624 patent is readable upon the nanoemulsion (note claim 1 comprises oil, water, ethanol (e.g. solvent), cationic surfactant and non-ionic surfactant (e.g. note claims 9-10). Applicant is specify the elements to obviate the components of the nanoemulsion.
Further, the ‘624 patent teaches the vaccine composition comprising nanoemulsion, oil, ethanol, surfactants (note claims, col. 16) and this elicits immune response. In Fig 5 of the ‘624 patent, the vaccine composition is allowed to add various other excipients or modifiers to elicit specific response evidenced by Figs 6-22 to modify TH1-TH2 responses. As such, to elicit immune response of interest, additional adjuvant ODN and/or suggested in the ‘191 publication and the rejection is not based on the hindsight reasoning or it does not teach away from the claimed invention. Applicant is reminded that the rejection is based on the combination of the references and cannot attack the references individually.
The deficiency is corrected by the teachings of the ‘191 publication and the combination of the references remains obvious.
Therefore, the combination of the references remains obvious and the rejection is maintained.
9. 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 AlA. 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 |.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.
10. Claims 9-10, 13, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-4 of U.S. Patent No. 11,173,207 (the ‘207 patent).
The instant claims are drawn to an immunogenic composition formulated for generating an antigen-specific immune response in a subject comprising one or more antigens, a nanoemulsion adjuvant, itself comprising oil, water, an organic solvent, a cationic and nonionic surfactant, and at least one immunostimulatory compound. Dependent claim 12 further limits the immunostimulatory compound to a toll-like receptor agonist, which further limits to a synthetic oligodeoxynucleotide in claim 13, which further limits to containing a CpG motif in claim 14, to a saponin in claim 15, to triterpene glycoside saponin in claim 16, and to QS-21 in claim 17.
The claims in the ‘207 patent recites a method of generating an immune response in a subject comprising administering to the subject an immunogenic composition comprising one or more antigens, a nanoemulsion adjuvant, itself comprising oil, water, an organic solvent, a cationic surfactant, and a nonionic surfactant, and at least one immunostimulatory a triterpene glycoside saponin. Dependent claim 3 further limits the toll-like receptor antagonist to a synthetic oligodeoxynucleotide. Dependent claim 4 further limits the one or more antigens as selected from a list of antigens also described in the instant application.
Although the claims at issue are not identical, they are not patentably distinct from each other because the claims in the ‘207 patent are drawn to a method of generating an immune response in a subject by administering an immunogenic composition that is the same or nearly the same as the instantly claimed immunogenic composition. As such, the claims in the ‘207 Patent anticipate the instant invention.
As Applicant has requested that the double patenting rejection be held in abeyance until the patentable subject matter has identified in this application, the double patenting rejection is maintained.
11. Claims 9-10, 13, 14 and 17 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1-23 of U.S. Patent No. 7,314,624 (the ‘624 patent) in view of Fox et. al. (U.S. Application 2015/0017191 A1, reference on IDS filed on 11/15/2021).
The instant claims are drawn to an immunogenic composition formulated for generating an antigen-specific immune response in a subject comprising one or more antigens, a nanoemulsion adjuvant, itself comprising oil, water, an organic solvent, a cationic and nonionic surfactant, and at least one immunostimulatory compound including ODN or QS-21.
The claims in the ‘624 patent recite a method of inducing an immune response to an immunogen comprising a nanoemulsion, itself comprising oil, ethanol, surfactant, an ammonium compound, water, and an immunogen. Dependent claim 3 further limits the immunogen to an inactivated pathogen. Dependent claim 7 further limits the oil to a list comprising squalene. Dependent claim 8 further limits the surfactant to a group consisting of ionic and nonionic surfactants.
The claims in the ‘624 Patent differ from the instant invention by not reciting an immunostimulatory compound such as ODN and QS-21.
However, Fox discloses an oil-in-water emulsion, that comprises a TLR4 agonist and metabolizable oil, can generate an antigen-specific immune response to one or more antigens (see entire document, particularly claims 1, 11, 16, and 24). Fox further discloses an embodiment of their invention wherein an immunostimulatory compound, such as a toll-like receptor agonist, may be an oligonucleotide containing a CpG motif, particularly QS-21, that is identified as the saponin triterpene glycoside (see entire document, particularly paragraphs [0051], [0139], [0140], [0147], and [0148}).
It would thus be obvious to one of ordinary skill in the art to utilize the method of inducing an immune response to an immunogen recited in the ‘624 patent with the embodiment of a possible immunogen as the ODN QS-21, as recited in Fox. A person with ordinary skill in the art would have been motivated to do so, and have a reasonable expectation of success, because QS-21 is known in the art as an effective immunostimulatory compound. Therefore, the claims in ‘624 patent would render the instant claims obvious.
In view of the discussion above in sections 6-8 of this office action, the rejection is maintained.
12. No claims are allowable
13. Any inquiry concerning this communication or earlier communications from the examiner should be directed to YUNSOO KIM whose telephone number is (571)272-3176. The examiner can normally be reached Mon-Fri 8:30-5.
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Yunsoo Kim
Patent Examiner
Technology Center 1600
December 15, 2025
/YUNSOO KIM/Primary Examiner, Art Unit 1641