DETAILED ACTION
Previous Rejections
Applicant’s arguments, filed 11/12/2025, 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
Claim Rejections - 35 USC § 112 –
Scope of Enablement and Prevention
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claims 161 and 163 are rejected under 35 U.S.C. 112(a) or 35 U.S.C. 112 (pre-AIA ), first paragraph, because the specification, while being enabling for treating Lyme disease, does not reasonably provide enablement for the “prevention of a condition caused by Borrelia infection”, generally. The specification does not enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make the invention commensurate in scope with these claims.
To be enabling, the specification of the patent must teach those skilled in the art how to make and use the full scope of the claimed invention without undue experimentation. In re Wright, 999 F.2d 1557, 1561 (Fed. Cir. 1993). Explaining what is meant by “undue experimentation,” the Federal Circuit has stated:
The test is not merely quantitative, since a considerable amount of experimentation is permissible, if it is merely routine, or if the specification in question provides a reasonable amount of guidance with respect to the direction in which the experimentation should proceed to enable the determination of how to practice a desired embodiment of the claimed invention. PPG v. Guardian, 75 F.3d 1558, 1564 (Fed. Cir. 1996).[1]
The factors that may be considered in determining whether a disclosure would require undue experimentation are set forth by In re Wands, 8 USPQ2d 1400 (CAFC 1988) at 1404 where the court set forth the eight factors to consider when assessing if a disclosure would have required undue experimentation. Citing Ex parte Forman, 230 USPQ 546 (BdApls 1986) at 547 the court recited eight factors:
1) the quantity of experimentation necessary,
2) the amount of direction or guidance provided,
3) the presence or absence of working examples,
4) the nature of the invention,
5) the state of the prior art,
6) the relative skill of those in the art,
7) the predictability of the art, and
8) the breadth of the claims.
These factors are always applied against the background understanding that scope of enablement varies inversely with the degree of unpredictability involved. In re Fisher, 57 CCPA 1099, 1108, 427 F.2d 833, 839, 166 USPQ 18, 24 (1970). Keeping that in mind, the Wands factors are relevant to the instant fact situation for the following reasons:
1. The nature of the invention, state and predictability of the art, and relative
skill level
The invention relates to treating Lyme disease comprising administering a composition comprising BBGL-I and/or BBGL-II. The relative skill of those in the art is high, that of an MD or PHD. That factor is outweighed, however, by the unpredictable nature of the art. As illustrative of the state of the art, the Examiner cites The Guardian (https://www.theguardian.com/science/2019/jul/20/lyme-disease-is-solution-on-way).
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The Guardian taught that while Lyme disease can sometimes be treated with antibiotics if detected early, not everyone responds; and, for patients who have developed chronic symptoms, there is currently no cure [page 2, 5th paragraph].
The breadth of the claims
Since the instant Specification provides no limiting definition of the term “prevention”, the term will be interpreted expansively. The term “prevention” may vary widely in meaning, from “preventing” a disease from occurring to “preventing” it from progressing. Nor is the term limited by any time frame.
The claims are thus very broad insofar as they suggest that one will not experience the disease when taking the claimed agent; that should one get the disease, it will not worsen; or that following its treatment, it will not recur. While such “prevention” might theoretically be possible under strictly controlled laboratory conditions, as a practical matter it is nearly impossible to achieve in the “real world” in which patients live.
3. The amount of direction or guidance provided and the presence or absence of working examples
The Specification provides no direction or guidance for practicing the claimed invention in its “full scope”. No reasonably specific guidance is provided concerning useful protocols for carrying out the invention as claimed, other than treating Lyme disease comprising administering a composition comprising BBGL-I and/ or BBGL-II. The latter is corroborated by the working examples.
4. The quantity of experimentation necessary
Because of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112, since to practice the claimed invention in its “full scope” a person of ordinary skill in the art would have to engage in undue experimentation, with no reasonable expectation of success.
The Applicant is encouraged to remove the word “prevention” from claim 161.
Response to Arguments
Applicant’s arguments filed 11/12/2025 have been fully considered but they are not persuasive.
Applicant amended claim 161 to remove the Borelia infection, and requested withdrawal of the rejection.
The Examiner responds that the “Borelia infection” was not the cause of the rejection, but rather the term “prevention”. The Examiner encourages the Applicant to remove the word “prevention from claim 161.
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, 151, 159, 161 and 163-164 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 did not teach BBGL-I, as recited in claim 136.
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].
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].
Claims 151 and 163 are rendered prima facie obvious because Ben-Menachem taught intravenous administration [0082].
Claim 159 is rendered prima facie obvious because Ben-Menachem taught vaccines [0067].
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].
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 with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Claim(s) 140-143, 152 and 160 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, 152 and 160.
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 with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
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 with respect to the instant claim(s) have been considered but are moot because the new ground of rejection does not rely on any reference applied in the prior rejection of record for any teaching or matter specifically challenged in the argument.
Conclusion
Applicant's amendment necessitated the new ground(s) of rejection presented in this Office action. Accordingly, THIS ACTION IS MADE FINAL. See MPEP § 706.07(a). 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 nonprovisional extension fee (37 CFR 1.17(a)) 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.
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/CELESTE A RONEY/ Primary Examiner, Art Unit 1612
[1] As pointed out by the court in In re Angstadt, 537 F.2d 498 at 504 (CCPA 1976), the key word is “undue”, not “experimentation”.