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 Claim Status The amendment on January 29, 2026 is acknowledged. Claims 1,3-9,11-24,26,28,30-32,34-37,39-40,43,46-52 , 54 are currently pending. Claim 54 is new. Claims 2, 10, 25, 27, 29, 33, 38, 41-42, 44-45, 53 are canceled. Claims 11-15, 22-24, 26, 28, 30-32, 46-52 have been withdrawn. Claims 1, 3-8, 16-21, 35-37, 39, 40, 43, 54 will be examined on the merits herein. Election/Restrictions Applicant’s election without traverse of Group I (claims 1, 3-9, 11-24, 26, 28, 30-32, 34-37, 39, 40, 43 in reply filed on January 29, 2026 is acknowledged. Claims 9,11-15,22-24,26,28,30-32,34 and 46-52 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention, there being no allowable generic or linking claim. In response, Applicant elects a CpG adjuvant. C laims 1, 3-8, 16-21, 35-37, 39 - 40, 43, 54 encompass the elected species. Election was made without traverse in the reply filed on January 29, 2026. Information Disclosure Statement (IDS) The information disclosure statement (IDS) submitted on September 26, 2025 is in compliance with the provisions of 37 CFR 1.97. Accordingly, the information disclosure statement is being considered by the examiner. Claim Rejections - 35 USC § 112 The following is a quotation of 35 U.S.C. 112(b): (b ) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention. The following is a quotation of 35 U.S.C. 112 (pre-AIA), second paragraph: The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the appl icant regards as his invention. Claim s 19-20, 37, 43 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention. Claims 19-20 are reciting “preferably”. This language is indefinite, because it is unclear whether the claim is limited to what comes after “preferably”. For example, in claim 20, it is unclear whether the claim is limited to ~pH 6.5 or if it includes all pHs from ~6 to ~7. C laim 37 recites “200 ug of toxoid”. The claim is indefinite because it unclear if it means 200 ug of each toxoid (A and B) or both combined . Claim 43 is indefinite because it is unclear whether it is a product or a method. The claim is literally a product claim, in that it begins “The immunogenic composition”. But it recites that it is administered at a dose volume of 0.5mL. Thus , it is unclear whether the claim requires the step of administering, or if it only requires the product itself. Claim Rejections - 35 USC § 102 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. Claim s 1, 3- 6, 8, 16-2 0 , 35-37, 39, 43, 54 are rejected under 35 U.S.C. 102 (a)(1) as being anticipated by Sidhu et al. (US 8481692 B2; hereafter Sidhu; PTO-892). As to claim 1 , Sidhu teaches “ an immunogenic composition that includes a mutant Clostridium difficile toxin A and/or a mutant Clostridium difficile toxin B ” . T he methods of treating or the methods of inducing an immune response includes an immunogenic composition that further includes an adjuvant ( column 3 ; lines 30- 46 ) . Sidhu also teaches that “ t he adjuvant is a CpG oligonucleotide , most preferably a CpG oligodeoxynucleotides (CpG ODN). As to claim s 3 -4 , Sidhu teaches CpG ODN are of the B Class that preferentially activate B cells. In aspects of the invention, the CpG ODN has the nucleic acid sequence 5' T*C*G*T*C*G*T*T*T*T*T*C*G*G*T*G*C*T*T*T*T 3' ( SEQ ID NO: 48 ) wherein * indicates a phosphorothioate linkage. The CpG ODN of this sequence is known as CpG 24555 , which is described in WO2010/067262 ( column 54 ; lines 5-13 ) . Sidhu teaches “ NHPs (10 per group) were immunized IM at weeks 0, 2, and 4 with different ratios of mutant toxin A drug substance and mutant toxin B drug substance ( 10 . mu.g of mutant toxin A drug substance plus either 10, 50, or 100 u g of mutant toxin B drug substance ; d esignated 10A:10B, 10A:50B and 10A:100B, respectively, in Table 49 and Table 50 ), formulated with ISCOMATRIX (45Upper dose) or with Alh /CpG / (250 u g/500 u g per dose) (column 112; lines 16-24) . Sidhu also teaches The 5-week IM repeat-dose toxicity study with PF-06425095 ( an immunogenic composition including triple mutant toxin A drug substance and triple mutant toxin B drug substance in a combination with adjuvants aluminum hydroxide and CpG 24555) in Cynomolgus monkeys was conducted to assess the potential toxicity and immunogenicity of C. difficile triple mutant toxin A drug substance and triple mutant toxin B drug substance in a combination with the adjuvants aluminum hydroxide and CpG 24555 (PF-06425095) . See column 113, lines 30-36 . “ There were no adverse findings in this study . PF-06425095 was well-tolerated and produced only local inflammatory reaction without evidence of systemic toxicity (column113; lines 58-60) . As to claims 5 - 6 , Sidhu teaches Toxoid A and Toxoid B in combination with the adjuvant Alhydrogel / CpG 24555 at 0.2 or 0.4 and CpG 24555 at 1 mg/dose. See example 43; column 113; lines 29-44. Sidhu teaches that “ t ypically, about 10, 20, 50 or 100 ug per immunogen is used for each human injections (column 58; lines 27 -37). Sidhu also teaches Different ratios of mutant toxin A and mutant toxin B (10 ug of mutant A plus either 10, 50, or 100 ug of mutant B) formulated with Alh / CpG (250 ug/500 ug per dose). See column 112, lines 17-34. As to claim 8 , 54 , Sidhu teaches CpG 24555 is used together with an aluminium hydroxide salt such as Alhydrogel ” ( Column 107 ; lines 51 - 56 , Table 44 ). “T he adjuvant includes aluminum hydroxide gel and a CpG oligonucleotide (Column 3; lines 59-60) . “ Optionally, the pharmaceutical composition includes two or more different adjuvants. Preferred combinations of adjuvants include any combination of adjuvants including, for example, at least two of the following adjuvants: alum, MPL, QS-21, ISCOMATRIX, CpG, and Alhydrogel . An exemplary combination of adjuvants includes a combination of CpG and Alhydrogel . ” (Column 54; lines 35-41 ) . As to claim 16 , 17 , Sidhu teaches “ The buffers include phosphate (such as potassium phosphate, sodium phosphate); acetate (such as sodium acetate); succinate (such as sodium succinate); glycine; histidine ; carbonate, Tris (tris(hydroxymethyl)aminomethane), and/or bicarbonate (such as ammonium bicarbonate) buffers. Preferably, the composition includes tris buffer ” (column 52, lines 9-13 ) . Sidhu also teaches preferred amounts of histidine buffer include from minimum of about 1mM, 5-10 mM, mostly preferably, 10 mM histidine buffer , for example per 0.5 mL dose. See column 52; lines 2 4 -33. Preferred amounts of phosphate buffer include from a minimum amount of about 1 mM, 5-10 mM, preferably, 10 mM phosphate buffer , for example 0.5 mL dose. See column 52; lines 34-43). As to claim s 18 - 20 , Sidhu teaches t he immunogenic composition of claim 1, wherein the CpG adjuvant comprises 60 mM sodium chloride and pH 6.5 ± 0.5 (formulation rationale for CpG/ Alhydrogel diluent) , see column s 10 7 , 1 08 , Table 44 , lines 51-55 ) . As to claims 35-36 , Sidhu teaches that SEQ ID: 4, 6, 84 and 86 . These sequences are identical and equivalent to the same SEQ ID numbers in Sidhu’s t eachings . See Figure below. Sidhu also teaches “ The primary structure of triple mutant toxin A is shown in SEQ ID NO: 4. The NH.sub.2-terminal Met residue at position 1 of SEQ ID NO: 4 is originated from the initiation codon of SEQ ID NO: 12 and is absent in isolated protein (e.g., see SEQ ID NO: 84). Accordingly, in Example 12 to Example 45, "SEQ ID NO: 4" refers to SEQ ID NO: 4 wherein the initial methionine (at position 1) is absent ” (847) . Sidhu teaches “ The primary structure of triple mutant toxin B is shown in SEQ ID NO: 6. The NH.sub.2-terminal Met residue at position 1 of SEQ ID NO: 6 is originating from the initiation codon and is absent in isolated protein (e.g., see SEQ ID NO: 86) . Accordingly, in Example 12 to Example 45, " SEQ ID NO: 6" refers to SEQ ID NO: 6 wherein the initial methionine (at position 1) is absent ” (848) . As to claim 37, 39 , 43 , Sidhu teaches immunizations with different ratios of mutant toxin A and toxin B, including ratio 1:1 (10ug of Toxoid A:10 ug Toxoid B) formulated with CpG 500 ug/dose ( column 1 12 ; lines 17-34, table 49, line 60). Sidhu also teaches the formulation rationale for CpG:Al h ydrogel (adjuvant) diluent. Sidhu teaches adjuvant dose per 0.5 mL is 0.5 mg Aluminum and 1m g CpG. See for example columns 107 , 108 ; Table 44. “ The binding of the proteins to Alhydrogel was also tested with the lyophilized drug product formulation containing 200 ug/mL of each drug substance and Alhydrogel ranging from 0.25 to 1.5 mg/ml . The drug product was reconstituted with diluents containing the varying concentrations of Alhydrogel and the percent of each mutant toxin bound was measured . All tested concentrations of Alhydrogel demonstrated 100% binding of the antigens. The binding kinetics of the proteins to Alhydrogel at the target dose of mutant toxin A drug substance and mutant toxin B drug substance (200 u g/mL each) were also assessed . The results show that 100% of the mutant toxin drug substances were bound to Alhydrogel throughout the 24-hour RT time course. CpG 24555 and Alhydrogel : CpG 24555 is a synthetic 21-mer oligodeoxynucleotide (ODN) having a sequence 5-TCG TCG TTTTTC GGT GCT TTT-3 (SEQ ID NO: 48). An exemplary formulation for a combination of CpG 24555 and Alhydrogel diluents is shown in Table 44. The exemplary formulation may be used in combination with the drug product described above. See column 107; lines 37-57. Claim Rejections - 35 USC § 103 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. The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows: 1. Determining the scope and contents of the prior art. 2. Ascertaining the differences between the prior art and the claims at issue. 3. Resolving the level of ordinary skill in the pertinent art. 4. Considering objective evidence present in the application indicating obviousness or nonobviousness . Claims 7, 21 , 40 are rejected under 35 U.S.C. 103 as being unpatentable over Sidhu et al. (US 8481692 B2; hereafter Sidhu; PTO-892) in view of Davis et al . (US 8552165 B2; hereafter Davis; PTO-892). Sidhu teaches all features of claims 1, 3-6, 8, 16-20, 35-37, 39, 43, 54 , as laid out above. Sidhu teaches immunogenic composition, comprising toxoid A and toxoid B, and a CpG adjuvant, including CpG 24 555 , and lyophilized and reconstituted toxoid A and B . However, Sidhu does not teach 3.6 mg/mL of CpG or CpG 24555 as in claim s 7, 21 , 40 . Davis teaches immunostimulatory oligonucleotides , such as CpG 24555 and methods of using immunostimulatory oligonucleotides to induce an antigen-specific immune response that can be useful as a prophylactic vaccine prevention (i.e., an infectious disease) . Davis also teaches that “ one of ordinary skill in the art can empirically determine the effective amount of a particular CpG immunostimulatory oligonucleotide and/or antigen and/or other therapeutic agent without necessitating undue experimentation in light of this disclosure ” , which is pertinent to claims 7, 21 , 40 . “ Typically range from about 0.1 ug to 50 mg per administration which, depending on the application, could be given daily, weekly, or monthly and any other amount of time therebetween. More typically local doses range from about 10 ug to 10 mg per administration , and optionally from about 100 ug to 1 mg, with 2-4 administrations being spaced days or weeks apart. More typically, immune stimulant doses range from 1 ug to 10 mg per administration , and most typically 10 ug to 1 mg, with daily or weekly administrations ” , which is pertinent to claims 7, 21 , 40 . For example, column 27, lines 27-67 . It would have been obvious to one of ordinary skill in the art to combine the teachings of Sidhu and Davis because Sidhu already taught toxoid A and Toxoid B with the adjuvant , CpG 24555 of Davis to be efficient for eliciting immune response , thereby arriving at the invention 7, 21 , 40 . It would have been obvious to substitute these known equivalents; MPEP 2144.06. KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc ., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, Sidhu teaches a product (and a method) that only differs from the claimed invention by the substitution of a single element (i.e. concentration of CpG 24555 ); the substituted element ( 3.6 mg/mL CpG 24555 ) was already known to be used to augment immune response , therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of substituting an antigen for another with a reasonable expectation of success ( i.e . the substitution of the element would lead to predictable results) . Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary. 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 . Claim s 1, 3 - 8 , 16-21, 35-3 6 , 39, 40, 43, 54 are rejected on the ground of nonstatutory double patenting as being unpatentable over c laim s 1 - 2, 8-9, 10, 20 of Sidhu et al. ( U.S. Patent No. US 8481692 B2 ; hereafter Sidhu; PTO-892) in view of Davis et al . ( U.S. Patent No. 8552165 B2; hereafter Davis; PTO-892 ) . US Patent No. US 8481692 B2 claims SEQ ID NO: 84, 4 which is Clostridium difficile toxin A, and also a composition comprising same and an adjuvant. See '692, claims 1 -2, 8, 20 for example. Patent '692 also claims that toxoid B (SEQ ID NO: 86, 6) , should be included in the same composition; see claims 9-10. Patent '692 US Patent '692 also claims SEQ ID NO : 4 , 6, which are the sequences of toxoid A and toxoid B , wherein the methionine residue at position 1 is optionally not present; see ‘692, claims 2, 10 . Patent '692 However, '692 does not claim a CpG adjuvant as in claim 1 or the particular adjuvants recited in claims 3-4. US Patent '165 discloses SEQ ID NO:1, which is a CpG sequence identical to present SEQ ID NO:48, and discloses that it is immunostimulatory oligonucleotide (CpG 24555) , suggesting that it can be used as an adjuvant. US Patent '165 discloses “ CPG ODN 24555 advantageously allows generating poly - functional antigen-specific T cells populations when used as an adjuvant which can be of importance in a vaccine setting ” . See column 2; lines 1-65; column 31; column 4; lines 1-30; column 9; lines 4 -18. Patent '165 US Patent '165 discloses CPG 24555 is better than CPG 10103 for generating poly-functional antigen-specific T cells populations when used as an adjuvant to Hepatitis B Surface Antigen (HBsAg) . See Figure 13A. “CpG 2455 was superior to CpG 10103 and CpG 7909 in augmenting Influenza A antigen (HA)- specific IgG”. See for example column 39; Table 3; Figure 15-16. Patent '165 US Patent '165 discloses “ t he importance of the poly-functionality of T cells in immunogenicity has been highlighted recently. In particular poly-functionality of antigen specific T cells in terms of chemokine production (such as IFN-gamma., TNF-alpha and IL-2) has been correlated in some instances to their protective potential (see e.g. Harari A, et al., Immunol Rev. 2006; 211:236-54, Makedonas G and Betts MR. Springer Semin Immunopathol . 2006; 28(3):209-19, Precopio M L et al., J Exp Med. 2007 204 (6):1405-16, Xu R et al. Vaccine. 2008; 26(37):4819-29) thought to be due to their better effector function compared to T cells that secrete but a single cytokine. ” . See column 9, lines 4-15. Patent '165 US Patent '165 also discloses “ method of inducing an antigen-specific immune response in a subject in need thereof comprises administering to a subject an antigen and an immunostimulatory oligonucleotide comprising nucleotide sequence SEQ ID NO: 1 in an effective amount to induce an antigen-specific immune response in said subject. In some embodiments, the antigen is a microbial antigen, a self - antigen or an addictive Substance ” . For example, “ the antigen is a nicotine hapten conjugated to the carrier, which the nicotine hapten is conjugated is diphtheria toxin (DT) ” . See for example claim 1; column 3; lines 30-67; column 4; lines 1- 30 . Patent '165 Claims 5-6 are included in this rejection as '165 teaches 0.833 mg/ ml CpG 24555; see column 40 lines 20-27. Patent '165 Claim s 7 , 21, 39- 40 are included in this rejection as '165 provides guidance on how to optimize the dose of the CpG; see column 27; lines 27-67; column 28; lines 1-46. Patent '165 Claim 8 is included in this rejection as '165 teaches CpG and the adjuvant, aluminum hydroxide ; see for example column 6, lines 55, figures 14-16. Patent '165 Claim s 16, 18, 20 are included in this rejection as '165 teaches Phosphate buffered saline (PBS) at pH 7.2; see col umns 32 , lines 15-30 and sodium chloride; see column 29, lines 20-25. Patent '165 Claim 43 is included in this rejection as it does not limit the composition but rather recites an intended use. Claim 54 is included in this rejection as claim 20 of US ‘692 do not recite any adjuvant that should not be used . Therefore , it would have been obvious to a PHOSITA to modify the invention claimed in Patent US ‘692 to include CpG 2455 as taught by US ‘165 , arriving at the invention of claims 1 , 3- 8, 16, 18, 20-21, 35-36 , 39-40, 43, 54 . See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination. Reasonable expectation of success would be expected because US ‘692 specifically suggests using an immunogenic composition comprising toxoid A and toxoid B and does not specify any adjuvant that should not be used. Also, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc ., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (the claims of US 8481692 B2 ) teaches a product that only differs from the claimed invention by the combination of a single component (i.e. a vaccinal adjuvant, CpG; CpG 24555) was already known and known to function as a vaccinal adjuvant, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of choosing an adjuvant disclosed as being useful with a reasonable expectation of success ( i.e . the substitution of the element would lead to predictable results), particularly because U.S. Patent No. 8552165 B2 teaches that CpG 24555 was known to be a potent vaccinal adjuvant. Therefore, the claimed invention is prima facie obvious in view of the teachings of the prior art, absent any convincing evidence to the contrary. Claim s 17 , 19, 37 are rejected on the ground of nonstatutory double patenting as being unpatentable over claims 1 -2, 8-9, 10, 20 of Sidhu et al. ( U.S. Patent No. US 8481692 B2 ; hereafter Sidhu; PTO-892) in view of Davis ( U.S. Patent No. 8552165 B2; hereafter Davis; PTO-892) and further in view of Middaugh et al. ( WO 2009035707 A1 , hereafter Middaugh; PTO-892) . The reason why claims 1, 3-8, 16 , 18, 20 -21, 35-36, 39, 40, 43, 54 would have been obvious over US ‘692 in view of US ‘165 are set forth above. However, neither reference teaches histidine or phosphate buffer is at concentration of about 5 mM to 15 mM, or preferably 10 mM , as claim 17 or the sodium chloride at a concentration of about 20 nM to 100 nM , or preferably about 50 nM or about 60 nM as claim 19. US ‘692 and US ‘165 also do not teach about 3.6 mg/mL of CpG or CpG 24555, as claim 39 and 40, respectively or toxoid A and toxoid B in a ratio of about 3:1 to about 1:1 and/or the composition comprise 200 ug of toxoid. WO ‘ 707 A1 teaches “ t he compositions of the invention include one or more compounds such as, for example, buffers (e.g., citrate, phosphate, glycine, histidine, carbonate, or bicarbonate; 5-100 mM . T he buffer is selected from the group consisting of citrate, phosphate, glycine, histidine, carbonate, and bicarbonate, and is at a concentration of 5-100 mM. See US ‘707 claim 14. WO ‘ 707 A1 teaches “ the salts are selected from the group consisting of sodium chloride , potassium chloride, magnesium chloride, and magnesium acetate, up to 150 mM . S ee WO ‘707 claim 21. WO ‘ 707 A1 teaches “ the compositions include both toxoid A and toxoid B , but compositions including only one of these are also included in the invention ” . “ T he total amount of toxoid in the compositions can be e.g., 100 ng-1 mg, 100 ng-500 μg , 1-250 μg , 10-100 μg , 25-75 μg , or 50 μg , and the ratios may be 2:1, 3:1 , or 3:2 (A:B). The compositions may optionally be stored in vial in single unit dosage ” . See ‘707 page 7, lines 11-19; page 35; claims 4-6. “T he toxoids A and B are present in the composition in a ratio of 3: 1 to 3:2, or 1 :1 (A:B) ” . see ‘707 claim 6 . Therefore , it would have been obvious to a PHOSITA to modify the invention claimed in Patent US ‘692 to include the buffer concentrations and amounts/ratios of toxoids A and B as taught by US ‘707 , arriving at the invention of claims 17, 19, 37. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination. Reasonable expectation of success would be because US 8481692 B2 specifically suggests immunogenic compositions comprising toxoid A and or/toxoid B but does not specify any buffer or toxoid concentration that should be used. Also, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc ., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (the claims of US 8481692 B2 ) teaches a product that only differs from the claimed invention by the combination of a single component (i.e. excipients, buffers, amounts/ratios/doses of antigen and adjuvants ) was already known and known to function as components used for formulation of vaccines, therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of choosing an adjuvant disclosed as being useful with a reasonable expectation of success ( i.e . the substitution of the element would lead to predictable results), particularly because WO 2009035707 A1 teaches that the vaccinal formulation of a vaccine comprising toxoids A and B was already known to be optimized regarding solubility and stability of the vaccinal composition, especially the antigens, toxoids A and B. Clai m s 1, 3 -8, 16, 18, 20-21, 3 6 - 37, 39, 40, 43, 54 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 45 -4 7, 49 of copending Application No. 18/446,883 (‘883) in view of Davis ( U.S. Patent No. 8552165 B2; hereafter Davis; PTO-892) . Application ‘883 claims administering 200 ug of SEQ ID NO: 84 and SEQ ID NO: 86 ; See for example claim 30 , 45-46 . Application '883 claims administering an adjuvant in general; see claim 47-48. However, Application ‘883 does not claim a dministering a CpG sequence in particular . US ‘165 teaches CpG adjuvant as set forth in SEQ ID NO:48 and teaches that it can be used as an adjuvan t; see for example claim 1 ; column 3; lines 30-67; column 4; lines 1- 30. Patent '165 . Claims 5-6 are included in this rejection as '165 teaches 0.833 mg/ ml CpG 24555; see column 40 lines 20-27. Patent '165 Claim s 7 , 21, 39-40 are included in this rejection as '165 provides guidance on how to optimize the dose of the CpG; see column 27; lines 27-67; column 28; lines 1-46. Patent '165 . Claim s 16, 18, 20 are included in this rejection as '165 teaches Phosphate buffered saline (PBS) at pH 7.2; see col umns 32 , lines 15-30 and sodium chloride; see column 29, lines 20-25. Patent '165 Claim 43 is included in this rejection as it does not limit the composition but rather recites an intended use. Claim 54 is included in this rejection as conflict claim 4 7 of US’ 883 does not recite any adjuvant that should not be used. Therefore , it would have been obvious to a person of ordinary skill in the art to modify the method claimed by '883's claim 30 and 45- 4 7 by substituting in the CpG adjuvant of ‘165 arriving at the invention of claims 1, 3-8, 16, 18, 20- 21, 3 6 -37, 39-40, 43, 54 . See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination. Reasonable expectation of success would be because application ‘883 specifically suggests immunogenic compositions comprising toxoid A and or/toxoid B but does not specify any adjuvant that should not be used. Also, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc ., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the prior art (the claims of application 18/446,883 ) teaches a method comprising a product that only differs from the claimed invention by the combination of a single component (i.e. adjuvant, CpG; CpG 24555 ) was already known and known to function as components used for boost ing the immune response against vaccinal antigens therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of choosing an adjuvant disclosed as being useful with a reasonable expectation of success ( i.e . the substitution of the element would lead to predictable results), particularly because CpG 24555’s adjuvant taught by US ‘165 was already known to be very effective for boosting immune response in a vaccinal composition comprising antigens. Clai ms 17, 19 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 30, 45-47, 49 of copending Application No. 18/446,883 (‘883) in view of Davis ( U.S. Patent No. 8552165 B2; hereafter Davis; PTO-892) and further in view of Middaugh et al. ( WO 2009035707 A1 , hereafter Middaugh; PTO-892) . The reason why 1, 3-8, 16, 18, 20-21, 36-37, 39, 40, 43, 54 would have been obvious over Application ‘ 833 in view of US ‘165 are set forth above. However, neither reference teaches histidine or phosphate buffer is at concentration of about 5 mM to 15 mM, or preferably 10 mM, as claim 17 or the sodium chloride at a concentration of about 20 nM to 100 nM , or preferably about 50 nM or about 60 nM as claim 19. Claim 17 is included in this rejection as WO ‘ 707 A1 teaches phosphate and histidine buffer at concentrations at 5-100 mM . See ‘707 claim 14. Claim 19 is included in this rejection as WO ‘ 707 A1 teaches sodium chloride, potassium chloride, magnesium chloride up to 150 mM . Therefore , it would have been obvious to a PHOSITA to modify the invention claimed in application ‘ 833 to include histidine/Phosphate buffer concentrations , and sodium chloride amounts as taught by US ‘707 , arriving at the invention of claims 17, 19. See MPEP 2144(II): “The strongest rationale for combining references is a recognition, expressly or impliedly in the prior art … that some advantage or expected beneficial result would have been produced by their combination. Reasonable expectation of success would be because application ‘833 specifically suggests immunogenic compositions comprising toxoid A and or/toxoid B but does not specify any buffer or sodium chloride concentration that should not be used. Also, KSR International Co. v. Teleflex Inc., 127 S. Ct. 1727, 1741 (2007), discloses that the simple substitution of one known element for another to obtain predictable results is obvious unless its application is beyond that person's skill. KSR International Co. v. Teleflex Inc ., 127 S. Ct. 1727, 1741 (2007) also discloses that "the combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results". In the instant case, the claims of application ‘883 teach a method/product that only differs from the claimed invention by the combination of a single component (i.e. Histidine/Phosphate buffer and sodium chloride concentration ) was already known and known to function as components used for vaccine formulation , therefore no change in the function of the substituted element occurred; and one of ordinary skill in the art would be capable of choosing a histidine/phosphate buffers and sodium chloride concentration disclosed in WO ‘707 as being useful with a reasonable expectation of success ( i.e . the substitution of the element would lead to predictable results), particularly because WO 2009035707 A1 teaches solubility and stability of a vaccine comprising toxoids A and B . Conclusion No claims are allowable. 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