DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 05/27/2026, have been fully considered. Rejections and/or objections not reiterated from previous office actions are hereby withdrawn. The following rejections and/or objections are either reiterated or newly applied. They constitute the complete set presently being applied to the instant application.
Continued Examination Under 37 CFR 1.114
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and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114.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 05/27/2026 has been entered.
Claim Rejections - 35 USC § 103 - Obviousness
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.
Claim(s) 136, 139, 144-149, 161,163 and 165-166 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Menachem (US 2010/0062023 A1), in view of Jäger et al (Steroids, 141, 2019, 41-45).
Ben-Menachem taught that, in forming a composition for generating an immune response in a subject, or for vaccinating a subject, BBGL-II or a compound of formula A, is utilized [0065]. The compounds were used for inducing an immune response to Borrelia burgdorferi in a subject. Administration was particularly useful for preventing or treating Lyme disease in a subject [abstract]. Ben-Menachem taught vaccines [0067].
Ben-Menachem did not teach BBGL-I, as recited in claims 136 and 165.
Jäger taught that BbGL1 is an immunogenic compound isolated from Borrelia burgdorferi [Highlights], for treating Lyme disease [last paragraph of section 1]. As per Jäger, both BbGl1 and BbGL2 have an immunogenic response to B. burgdorferi [section 1].
Since Ben-Menachem taught BBGL-II for inducing an immune response to Borrelia burgdorferi, as particularly useful for treating Lyme disease, it would have been prima facie obvious to one of ordinary skill in the art to include within the teachings of Ben-Menachem, BbGL1, as taught by Jäger. The ordinarily skilled artisan would have been so motivated because, as taught by Jäger, both BbGl1 and BbGL2 have an immunogenic response to B. burgdorferi [Jäger at section 1].
Further regarding the instant claim 165, the claim recites that the composition (BBGL1 + BBGL2) elicits a stronger immune response than a composition comprising either BBGL1 or BBGL2 alone.
The combined Ben-Menachem and Jäger teach a vaccine composition comprising BBGL1 + BBGL2. It appears that the compositions of the instant claims (vaccine comprising BBGL1 + BBGL2) and those of the prior art (vaccine comprising BBGL1 + BBGL2) would reasonably be expected to have substantially the same physical and chemical properties (stronger immune response than a composition comprising either BBGL1 or BBGL2 alone).
Inherent features need not be recognized at the time of the invention. There is no requirement that a person of ordinary skill in the art would have recognized the inherent disclosure at the time of invention, but only that the subject matter is in fact inherent in the prior art reference. MPEP 2112 II. It should be noted that a chemical composition (BBGL1 + BBGL2) and its properties (stronger immune response when the antigens are together in the vaccine) are inseparable. If the prior art teaches the identical chemical compounds, then the properties that the Applicant discloses and/or claims are necessarily present.
Claim 139 is rendered prima facie obvious because Ben-Menachem taught synthetic [0058]; and, chemical synthesis [0063].
Claims 144-147 are rendered prima facie obvious because Ben-Menachem taught covalent conjugation to a carrier protein [0038, 0061-0062], said protein carrier one of bovine serum albumin or keyhole limpet hemocyanin [0068].
Claims 148-149 are rendered prima facie obvious because Ben-Menachem taught excipients and adjuvants [0082].
Claim 161 is rendered prima facie obvious because Ben-Menachem taught that administration of a therapeutically effective amount is particularly useful for preventing or treating Lyme disease in a subject, whereby the subject was any mammal, including a human [abstract, 0080].
Claims 163 and 166 are rendered prima facie obvious because Ben-Menachem taught intravenous and oral administration [0082].
Claim 164 is rendered prima facie obvious because Ben-Menachem taught detecting antibody titers of sera from subjects (rabbits and mice) immunized with BBGL-II [0012 and 0025-0026].
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
Applicant argued that the instant Example 11 [pages 68-71 of the instant Specification] demonstrates that a vaccine composition comprising both BBGL-1 and BBGL-2 results in a significantly stronger immune response than using either BBGL-1 or BBGL-2 alone. Applicant argued that the vaccine composition of the instant claim 136 yields an improved ability to raise an immune reaction, as compared to that of Ben-Menachem. Applicant argued that the instant invention is unexpected over Ben-Menachem.
The Examiner acknowledges the evidence relating to this unexpected result (stronger immune response when both antigens are included in the vaccine). The data [Example 11 and Figure 7a] show that for two antigens (BBGL1 and BBGL2), there was a difference in the % inhibition (in vitro neutralization of Borrelia burgdorferi) when an adjuvant (QS-21) was included in the composition. This effect, by the adjuvant, on the combination of the antigens (for the neutralization of Borrelia burgdorferi), is not recognized by the prior art, and thus, this effect (stronger immune response) is unexpected.
However, once unexpectedness has been established, the probative value of the evidence as compared to the invention as claimed must be determined, i.e., claims must be “commensurate in scope” with the showing. See MPEP 716.02(d). In other words, the showing of unexpected results must be reviewed to see if the results occur over the entire claimed range. And this is not considered to be the case with the instant claims. The instant claim 136 does not limit the infection or the adjuvant. And for both limitations, the data is not considered to be commensurate in scope.
The conditions tested were the antigens (both BBGL1 and BBGL2), the adjuvant (QS-21) and the infection (Borrelia burgdorferi). However, other adjuvants and infections would be expected to interact differently with the claimed antigens, and it is unclear whether the effect (stronger immune response) would be present when there are other adjuvants and infections. Thus, the data show that the particular combination (BBGL1, BBGL2, QS-21, Borrelia burgdorferi) influences the improved vaccine composition, but the instant claim 136 does not state any additional limitation beyond “BBGL1 and BBGL2 antigens”. It is noted that amendment of the instant claim 136 with QS-21 and Borrelia burgdorferi limits the adjuvant and the infection, and is considered commensurate in scope in this respect.
Claim(s) 140-143 and 152 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Menachem (US 2010/0062023 A1), in view of Jäger et al (Steroids, 141, 2019, 41-45) and further in view of Fountain et al (USP 5,000,958 A).
The 35 U.S.C. 103 rejection over Ben-Menachem, in view of Jäger, was previously described. Additionally, Ben-Menachem taught administration of the compounds a via liposome delivery system [0079].
Although Ben-Menachem taught administration via a liposome delivery system, Ben-Menachem was not specific embedded in an outer membrane of the liposome, or encapsulated, as instantly recited in claims 140-143 and 152.
Ben-Menachem referenced, by incorporation, Fountain et al. [0079].
Fountain taught liposome preparations, whereby active agents are added to either the aqueous phase or the organic phase during the formation of the liposomes so that each, according to its solubility, is incorporated into the liposome bilayer or the aqueous phase of the resultant liposome [col 9, lines 25-32].
Since Ben-Menachem incorporated by reference Fountain, it would have been prima facie obvious to one of ordinary skill in the art to include, within Ben-Menachem, the teachings of Fountain et al.
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
Applicant argued that Fountain does not cure the deficiencies of Ben-Menachem.
The Examiner disagrees. Ben-Menachem is not deficient, except where Fountain taught liposomes having actives embedded in an outer membrane of the liposome, or encapsulated therein [see the body of the rejection].
Claim(s) 150 is rejected under 35 U.S.C. 103 as being unpatentable over Ben-Menachem (US 2010/0062023 A1), in view of Jäger et al (Steroids, 141, 2019, 41-45) and further in view of Hipp et al (US 2018/0296663 A1).
The 35 U.S.C. 103 rejection over Ben-Menachem, in view of Jäger, was previously described.
As discussed, Ben-Menachem generally taught vaccines, and generally taught adjuvants.
Ben-Menachem did not teach β-glucan, as recited in claim 150.
Hipp taught vaccine compositions [title] comprising β-glucan e.g. PLEURAN™ as an adjuvant [0243].
Since Ben-Menachem generally taught adjuvants, it would have been prima facie obvious to one of ordinary skill in the art to include, within the teachings of Ben-Menachem, β-glucan, as taught by Hipp [0243]. Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use. See MPEP 2144.07. In the instant case, it is prima facie obvious to select β-glucan for incorporation into a vaccine composition, based on its recognized suitability for its intended use as an adjuvant, as taught by Hipp.
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
Applicant argued that claim 150 is patentable in view of dependency.
The Examiner disagrees. No claims are allowed.
Claim(s) 154-155 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Menachem (US 2010/0062023 A1), in view of Jäger et al (Steroids, 141, 2019, 41-45), in view of Fountain et al (USP 5,000,958 A) and further in view of Tardi et al (US 2004/0022817 A1).
The 35 U.S.C. 103 rejection over Ben-Menachem, in view of Jäger et al, further in view of Fountain was previously discussed.
The combination of Ben-Menachem, in view of Jäger and Fountain, did not teach the lipids recited in claims 154-155.
Tardi taught liposomes [claim 12] comprising, as vesicle-forming lipids, DSPE, DSPG and cholesterol [0071].
Since the combined teachings of Ben-Menachem, in view of Jäger and Fountain, taught liposomes, it would have been prima facie obvious to one of ordinary skill in the art to include, within Ben-Menachem, Jäger and Fountain, DSPE, DSPG and cholesterol, as taught by Tardi et al. The ordinarily skilled artisan would have been motivated to formulate the liposome, as taught by Tardi [0071].
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
Applicant argued that claims 154-155 are patentable in view of dependency.
The Examiner disagrees. No claims are allowed.
Claim(s) 157-158 are rejected under 35 U.S.C. 103 as being unpatentable over Ben-Menachem (US 2010/0062023 A1), in view of Jäger et al (Steroids, 141, 2019, 41-45), in view of Fountain et al (USP 5,000,958 A), further in view of Tardi et al (US 2004/0022817 A1) and further in view of Metselaar et al (US 2015/0050329 A1).
The 35 U.S.C. 103 rejection over Ben-Menachem, in view of Jäger, in view of Fountain and Tardi was previously described.
Additionally, Ben-Menachem taught 23.2 weight % BBGL-II [0107].
Additionally, Tardi taught DSPC [0071]. The motivation to combine Tardi with Ben-Menachem and Fountain was previously described.
Although the combined teachings of Ben-Menachem, Fountain and Tardi taught liposomes comprised of vesicle forming lipids, the combined teaching of the art did not teach the amounts as recited in claims 157-158.
Meteselaar taught liposomes formed of vesicle-forming lipids [abstract], including DSPC, DSPG and cholesterol [0037-0038]. The liposomes comprised 0-50 mole % of cholesterol, 50-90 mol % non-charged lipids (e.g., DSPC) [0040]; and, 0-10 mole % negatively charged lipid (e.g., DSPG) [0039].
Since Ben-Menachem, Fountain and Tardi taught vesicle-forming lipids, it would have been prima facie obvious to one of ordinary skill in the art to have included Meteselaar’s amounts within the combined teachings of Ben-Menachem, Fountain and Tardi. The ordinarily skilled artisan would have been motivated to form the liposome, as taught by Meteselaar [0037-0040].
The instant claim 157 recites DSPC/DSPG/Cholesterol/BBGL2 in a weight ratio of 7:2:1:1.
The instant claim 158 recites DSPC/DSPG/Cholesterol/BBGL2 in a molar ratio of 7:2:1:1.
Ben-Menachem taught 23.2 weight % BBGL-II. Meteselaar taught 0-50 mole % of cholesterol, 50-90 mol % non-charged lipids (e.g., DSPC); and, 0-10 mole % negatively charged lipid (e.g., DSPG). In the case where the claimed ranges "overlap or lie inside ranges disclosed by the prior art", a prima facie case of obviousness exists. MPEP 2144.05 A.
Regarding the amounts of BBGL2 and DSPC as recited in claims 157-158, the claims require 7 % and 1 % (weight or molar percent). Ben-Menachem taught 23.2 weight % BBGL-II; and, Meteselaar taught 50-90 % molar DSPC. The ordinarily skilled artisan would have been motivated to have modified these amounts to have been 7 % and 1 %, as claimed. Where the general conditions of a claim are disclosed in the prior art, it is not inventive to discover the optimum or workable ranges by routine experimentation. See MPEP 2144.05(II)(A). In this case, the general conditions of forming a composition for generating an immune response in a subject, or for vaccinating a subject with BBGL-II; and, for forming liposomes, have been taught by the prior art; as such, it would not have been inventive for the skilled artisan to have discovered the optimum dosage of liposomal compositions comprising BBGL-II, via routine experimentation.
Furthermore, and as to claims 157-158, the claims require amounts in weight or molar ratios. Ben-Menachem taught amounts in weight ratios; and, Meteselaar taught amounts in molar ratios. However, it is prima facie obvious to one of ordinary skill in the art to empirically determine the weight amounts and/or molar amounts of the ingredients, from Ben-Menachem’s and Meteselaar’s disclosures and the guidance contained therein.
Response to Arguments
Applicant's arguments filed 05/27/2026 have been fully considered but they are not persuasive.
Applicant argued that claims 157-158 are patentable in view of dependency.
The Examiner disagrees. No claims are allowed.
Conclusion
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/CELESTE A RONEY/Primary Examiner, Art Unit 1612
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