DETAILED ACTION
Applicants’ arguments, filed 12 January 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 Rejections and/or objections not reiterated from previous office actions are hereby withdrawn.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.
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.
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.
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.
Claim(s) 1-4, 6-8, 15-21 and 29-36 is/are rejected under 35 U.S.C. 103 as being unpatentable over Fox et al. (WO 2019/051149 A1) in view of Chaux et al. (WO 2019/052975 A1).
Fox et al. (hereafter referred to as Fox) is drawn to a liposomal formulation comprising a saponin, used for enhancing an immune response, as of Fox, title and abstract. Fox teaches the following in one embodiment, as of page 56, relevant text reproduced below with annotation by the examiner.
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As to claim 1, the claim requires a liposome. Fox teaches this, as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a saponin. Fox teaches this as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a sterol. Fox teaches this as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a phospholipid. Fox teaches this as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a TLR-4 agonist with a particular chemical structure. The examiner understands that the GLA, SLA, and/or LPS of Fox are TLR4 agonists. The examiner understands this in view of at least Fox, page 12, relevant text reproduced below; the figure reproduced below also shows the structure of GLA.
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Fox differs from the claimed invention because the TLR4 agonist of Fox has a different chemical structure as compared with the chemical structure recited by the instant claims.
Chaux et al. (hereafter referred to as Chaux) is drawn to an immunogenic composition. The composition of Chaux comprises TLR4 agonists, as of Chaux, page 20, multiple locations on the page. Chaux teaches the required TLR4 agonist as of at least page 22, relevant structure reproduced below.
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That the indicated structure is a TLR4 ligand is discussed on page 21, last two lines of Chaux. Chaux suggests combination of a TLR4 agonist with a liposome, as of Chaux, page 29, lines 20-22.
It would have been prima facie obvious for one of ordinary skill in the art to have substituted the TLR4 agonist of Chaux in place of the GLA taught by Fox to be used in the liposome of Fox. Fox is drawn to a liposome for vaccination comprising a phospholipid, cholesterol, saponin, and TLR-4 agonist which may be GLA/SLA. Chaux teaches the above compound as the TLR-4 agonist. As such, the skilled artisan would have been motivated to have substituted the compound of Chaux in place of the GLA/SLA of Fox to have predictably acted as a TLR-4 agonist with a reasonable expectation of success. The simple substitution of one known ingredient (e.g. the compound of Chaux) in place of another (e.g. GLA or SLA, as of Fox) in order to have achieved predictable results (acting as a TLR-4 agonist) is prima facie obvious. See MPEP 2143, Exemplary Rationale B.
As to claim 1, the claim requires a liposome. Fox teaches this, as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a saponin. Fox teaches this as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a sterol. Fox teaches this as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a phospholipid. Fox teaches this as of the above-reproduced text from page 56, paragraphs 0200 and 0201.
As to claim 1, the claim requires a TLR-4 agonist with a particular chemical structure. The compound of Chaux is understood to read on this requirement.
As to claim 1, the claim requires a particular weight ratio of the saponin to TLR4 agonist. Fox teaches saponin at between about 1-10 micrograms and lipopolysaccharide (i.e. TLR-4 agonist) between about 3-25 micrograms per dose, as of Fox, page 61, claim 1. This would appear to be a ratio range of
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This would appear to be a range of TLR4 agonist to saponin of 25:1 to 1:3.33. This would appear to overlap with the claimed range of about 1:1 to about 1:50. While the prior art does not disclose the exact claimed values, but does overlap: in such instances even a slight overlap in range establishes a prima facie case of obviousness. See MPEP 2144.05(I).
In the alternative as to claim 1, even if, purely en arguendo, the ratio of TLR4 agonist to saponin in Fox did not overlap with the claimed ratio, this would not have been sufficient to have overcome the prima facie case of obviousness. 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 condition of a vaccine composition comprising a liposome with a TLR4 agonist and a saponin has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum TLR4 agonist to saponin ratio via routine experimentation.
As to claim 2, the above-indicated compound of Chaux appears to be the same compound recited by the instant claims; as such, the skilled artisan would have expected to have had the same solubility in ethanol as recited by the instant claims. When the structure recited in the reference is substantially identical to that of the claims (in this case, the identical structure relied upon by the examiner is that of E6020, not of the entire composition), claimed properties or functions are presumed to be inherent. See MPEP 2112.01(I & II).
As to claim 3, the compound of Chaux is understood to read on the additional requirements of this claim.
As to claim 4, Fox teaches QS-21, as of page 56.
As to claim 6, Fox teaches cholesterol, as of page 56, paragraph 0200.
As to claim 7, Fox teaches a saponin to sterol weight ratio of about 1:110 to about 1:200, as of Fox, pages 19-20, paragraph 0081. The skilled artisan would have understood the about 1:110 ratio taught by Fox to have read on the required 1:100 ratio of the instant claims. Even if, purely en arguendo, the skilled artisan would have understood the ratio of Fox to have been different from the claimed ratio, this would not have been sufficient to have overcome the prima facie case of obviousness. 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 condition of a vaccine composition comprising a liposome with a saponin and sterol has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum saponin to sterol ratio via routine experimentation.
As to claim 8, Fox teaches a phosphatidylcholine, as of page 56 of Fox, reproduced above.
As to claim 15, the skilled artisan would have understood the compositions of Fox and Chaux to have been adjuvants because the TLR-4 agonists of both references would have stimulated the immune system.
As to claim 16, the skilled artisan would have understood the compositions of Fox and Chaux to have been immunogenic compositions because the TLR-4 agonists of both references would have stimulated the immune system and generates an immune response.
As to claim 17, Chaux appears to teach the required antigen as of the abstract of the reference. Fox teaches a liposome comprising QS-21 (a saponin), cholesterol (a sterol), phosphatidylcholine (a phospholipid), and a TLR4 agonist.
As to claim 18, Chaux teaches the following antigens, as of page 9 of Chaux, relevant text reproduced below.
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This is understood to read on the required antigen.
As to claim 19, Chaux teaches the following from page 11, relevant text reproduced below.
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This is understood to read on the additional requirements of claim 19.
As to claim 20, the skilled artisan would have been motivated to have used gB and gH/gL/UL128/UL130/UL131 as the only antigens, as of Chaux, page 4, relevant text reproduced below.
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As to claim 21, Chaux teaches QS-21, which is a Quillaja Saponaria saponin on page 38; this is also taught by Fox, page 10, paragraph 0045. Fox also teaches sterols including cholesterol as of page 19, paragraph 0080 of Fox, and phospholipids including phosphatidylcholine, as of page 21 of Fox. Regarding the ratio of saponin to sterol, Fox teaches ratios of about 1:110 to about 1:150 on page 66, claim 45 of Fox. The ratio of about 1:110 of Fox may be understood to overlap with the required ratio of 1:100. Nevertheless, even if, purely en arguendo, the skilled artisan would have understood the ratio of Fox to have been different from the claimed ratio, this would not have been sufficient to have overcome the prima facie case of obviousness. 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 condition of a vaccine composition comprising a liposome with a saponin and sterol has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum saponin to sterol ratio via routine experimentation.
As to claim 29, the claim requires a particular weight ratio of the saponin to TLR4 agonist. Fox teaches saponin at between about 1-10 micrograms and lipopolysaccharide (i.e. TLR-4 agonist) between about 3-25 micrograms per dose, as of Fox, page 61, claim 1. This would appear to be a ratio range of
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This would appear to be a range of TLR4 agonist to saponin of 25:1 to 1:3.33. This is not the same as what is required by the instant claims. Nevertheless, 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 condition of a vaccine composition comprising a liposome with a TLR4 agonist and a saponin has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum TLR4 agonist to saponin ratio via routine experimentation.
As to claim 30, Chaux teaches the following formula, as of page 30, relevant text reproduced below.
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The above-reproduced figure would appear to read on the required chemical structure.
As to claim 31, Chaux teaches QS-21 on page 38; this is also taught by Fox, page 10, paragraph 0045.
As to claim 32, Fox teaches cholesterol on page 19, paragraph 0080.
As to claim 33, Fox teaches a saponin to sterol weight ratio of about 1:110 to about 1:200, as of Fox, pages 19-20, paragraph 0081. The skilled artisan would have understood the about 1:110 ratio taught by Fox to have read on the required 1:100 ratio of the instant claims. Even if, purely en arguendo, the skilled artisan would have understood the ratio of Fox to have been different from the claimed ratio, this would not have been sufficient to have overcome the prima facie case of obviousness. 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 condition of a vaccine composition comprising a liposome with a saponin and sterol has been taught by the prior art. As such, it would not have been inventive for the skilled artisan to have discovered the optimum saponin to sterol ratio via routine experimentation.
As to claim 34, Fox teaches DSPC, DPPC, POPC, and other phosphatidylcholines on page 21.
As to claim 35, Chaux teaches gBdTm on page 4 lines 15-20.
As to claim 36(i), this limitation has been met for essentially the same reason that claim 31 is rejected.
As to claim 36(ii), this limitation has been met for essentially the same reason that claim 32 is rejected.
As to claim 36(iii), this limitation has been met for essentially the same reason that claim 33 is rejected.
As to claim 36(iv), this limitation has been met for essentially the same reason that claim 34 is rejected.
Note Regarding Reference Date: The instant application appears to have an earliest effective filing date of 28 October 2020. Chaux was published on 21 March 2019 and Fox was published on 14 March 2019. As such, both references were published over a year earlier than the effective filing date of the instant application. As such, both references are prior art under AIA 35 U.S.C. 102(a)(1). The exceptions under AIA 35 U.S.C. 102(b)(1) would not appear to be applicable to either reference.
Response to Arguments
Applicant has provided arguments regarding the currently pending rejections, as of applicant’s response on 12 January 2026 (hereafter referred to as applicant’s response). These arguments are addressed below.
Applicant disputes that it would have been prima facie obvious for the skilled artisan to have substituted the compound of Chaux in place of the GLA, SLA, and/or LPS of Fox, as of applicant’s response, starting on page 14.
As an initial matter, prior to addressing applicant’s arguments, the examiner notes that applicant does not appear to dispute that the compound of Chaux reads on the claimed TLR4 agonist. This compound has been known in the art as E6020.
In applicant’s arguments, part 1, starting on the middle of page 15 and going through the top of page 17, applicant argues that the skilled artisan would not have been motivated to have substituted the compound of Chaux in place of GLA and/or SLA, as of Fox. On page 16 of applicant’s response, applicant provides a diagram of the chemical structures of GLA, SLA, and Formula (I) of the instant claims in order to highlight the alleged structural differences between these compounds.
This is not persuasive. It is the examiner’s position that there are more chemical structural similarities between GLA, SLA (both of Fox) and the E6020 compound of Chaux than is recognized by applicant’s arguments. The E6020 compound of Chaux is similar to the GLA/SLA of Fox in that both the compound of Chaux and the GLA-SLA of Fox are amphiphilic, which means that they have a hydrophobic portion and a hydrophilic portion covalently bound together. In order to best make this point, the examiner has annotated the figure from page 30 of Chaux, which was reproduced on page 13 of the prior office action, and has reproduced this below next to the structure of GLA, with annotations by the examiner.
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As such, both the GLA of Fox and the compound of Chaux are amphiphilic compounds, having hydrophobic moieties covalently bound to hydrophilic moieties. In at least that respect, the compounds of Fox and Chaux are structurally similar.
Nevertheless, the skilled artisan would have been motivated to have substituted the compound of Chaux in place of that of Fox in view of the functional properties of these compounds. Both the compound of Chaux and that of Fox have been identified in the prior art as being TLR4 agonists. As such, the skilled artisan would have been motivated to have substituted the TLR4 agonists of Chaux in place of the GLA/SLA of Fox in order to have predictably acted as a TLR4 agonist with a reasonable expectation of success. See the bottom paragraph of page 6 of the prior office action mailed on 10 October 2025.
Applicant makes the following argument on the bottom of page 16 of applicant’s response, and is reproduced below.
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As best understood by the examiner, arguments such as that set forth above might reasonably be persuasive in the case wherein the relevant issue for determining patentability is whether a novel chemical structure is prima facie obvious, e.g. in the case of close structural similarity, as per MPEP 2144.09. However, this fact pattern does not apply to the instant application. In the instant application, the E6020 TLR4 agonist of Chaux has the same chemical structure as the claimed TLR4 agonist, and the relevant issue for determining patentability is whether a novel formulation comprising this structure is prima facie obvious. The above-reproduced argument would appear to be potentially relevant for a case in which the issue is the obviousness of a novel chemical structure, not the obviousness of a novel chemical formulation comprising known chemical structures.
Applicant also discusses the issue of how the compound of Chaux behaves in a dynamic environment such as a liposome, as of the top line of page 17 of applicant’s response. The examiner interprets this argument as applicant arguing that the fact that the compound of Chaux acts as a TLR4 agonist in a non-liposomal environment does not necessarily indicate that there would have been a reasonable expectation that the compound of Chaux could have successfully acted as a TLR4 agonist in a “dynamic” liposomal environment. This is not persuasive because Chaux teaches placement of the compound of Chaux (referred to as E6020, which is the same compound as recited by the instant claims) as well as GLA in a liposome, as of Chaux, page 29, relevant text reproduced below with annotation by the examiner.
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As such, Chaux provides motivation for the skilled artisan to have formulated the TLR4 agonist of Chaux in a liposome. Therefore, there would have been a reasonable expectation that the compound of Chaux could have successfully acted as a TLR4 agonist in the dynamic environment of a liposome. Obviousness requires a reasonable expectation of success, not absolute predictability. See MPEP 2143.02(II).
Alleged Unexpected Results: Applicant has subsequently provided data regarding alleged unexpectedly improved results, which is discussed in applicant’s response starting on page 17, section 2. See applicant’s response on page 18, top paragraph, reproduced below.
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Example 1 describes the following preparation, as of page 111 of the specification, relevant text reproduced below.
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This liposomal preparation is subsequently purified, and then QS21 (saponin) is subsequently added, as of page 111, relevant text reproduced below.
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As such, applicant has described the preparation of liposomes comprising DOPC, cholesterol, E6020 (the recited TLR4 agonist), and QS21 (the recited saponin), which is referred to as “SPA14.”
In example 1, applicant also discusses the formulation of a comparative example referred to as AS01B.
The examiner notes the following issues related to these examples. First, to be of probative value, there must be a nexus between secondary evidence provided by applicant and the claimed invention. See MPEP 716.01(b). In this case, it is unclear if there is such a nexus. This is because the claimed invention appears to be drawn to a composition comprising a combination of at least two types of liposomes. See the following text reproduced below from instant claim 1.
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In contrast, the liposome referred to by the instant specification as SPA14 appears to be drawn to a single type of liposome comprising E6020, QS21, as well as phospholipid and cholesterol; see the text reproduced above from Example 1 of the instant application. As such, it is unclear if there is a nexus between the SPA14 of the instant specification, which appears to comprise a single type of liposomes, and the instantly claimed invention, which comprises a combination of at least two types of liposomes.
Additionally, the claimed invention must be compared with the closest subject matter to actually exist in the prior art. See MPEP 716.02(e). In this case, the closest subject matter to actually exist in the prior art would appear to be Example 1 of Fox, which is reproduced below.
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In contrast, according to applicant’s response on page 18, first paragraph, the AS01B comparative example of the instant specification comprises MPL (i.e. monophosphoryl lipid) instead of GLA, though applicant’s arguments indicate that MPL is a mixture including GLA as the most active compound therein.
As such, both the composition of Fox and the comparative example AS01B appear to be drawn to a liposome comprising all of the required ingredients with the exception of including a different TLR4 agonist as compared with what is required by the instant claims. With that being said, the skilled artisan may have expected greater immunostimulatory activity of the composition of Fox as compared with the AS01B of the instant specification. This is because Fox appears to use only the most active compound as the TLR4 agonist, whereas the AS01B, which is the comparative example in the instant application, appears to use a mixture of more active and less active compounds as the TLR4 agonist.
As such, the examiner takes the position that even if, purely en arguendo, the inventive example was to show superior results against AS01B, it would not necessarily translate in superior results as compared with the example of Fox because the skilled artisan would have expected the TLR4 agonist of Fox (which is GLA) to have been more active than the TLR agonist of AS01B (which includes GLA but is not solely GLA). As such, the examiner takes the position that applicant has failed to compare the claimed invention against the closest subject matter to actually exist in the prior art.
Applicant argues that data in the instant application shows that liposomes can be prepared by using significantly less TLR4 agonist, as of applicant’s response, pages 18-19. However, a comparison of the amount of TLR4 agonist used in the SPA14 formulation and/or the claimed invention vs. the amount of TLR4 agonist used in AS01B would appear to be an “apples-to-oranges” comparison because the TLR4 agonist in the claimed invention appears to be a pure material whereas the TLR4 agonist in AS01B appears to be an impure material.
Also regarding the TLR4 agonist amount, applicant makes the following argument on page 19, which is reproduced below.
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Regarding the issue of unexpected results, this is not probative of non-obviousness because applicant did not compare the claimed invention to the composition of Fox, and the composition of Fox is closer to the claimed invention than the AS01B in the instant application. Regarding the issue of the prima facie case of obviousness, the examiner notes that the TLR4 agonist to saponin ratio taught by the broad disclosure of Fox appears to overlap with the claimed ratio. This issue is explained on the bottom half of page 7 of the office action mailed on 10 October 2025.
Looking to the data in the instant application, the examiner notes multiple experiments and figures comparing SPA14 against AS01B. However, the majority of these experiments do not appear to show a statistically significant advantage of either SPA14 or AS01B. As an example of an experiment that fails to show a statistically significant advantage, the examiner notes figure 10A, which is reproduced below.
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Data failing to show a statistically significant difference between the claimed invention and the comparative example cannot be probative of non-obviousness.
Applicant then argues that the claimed composition results in a more balanced Th1/Th2 cytokine polarization, as of applicant’s response, page 10, third paragraph. In response, the examiner notes that the burden is on applicant to establish that the differences in results are in fact unexpected and unobvious and of both statistical and practical significance. See MPEP 716.02(b)(I). In this case, the practical significance of a more balanced Th1/Th2 cytokine polarization has not been made clear by applicant’s response. In fact, applicant makes the following argument on page 19, relevant text reproduced below.
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The examiner’s interpretation of the above-reproduced statement appears to indicate superior results of the comparative example AS01B as compared with inventive example SPA14 because it would appear to indicate that the comparative example has higher frequencies of antibody-secreting B cells and interferon gamma secreting T-cells. As such, this statement would appear to indicate that the comparative example provides superior results as compared with the inventive example.
Applicant then makes the following argument, as of page 19.
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As best understood by the examiner, the examiner notes that the term “reactogenicity” is generally used with vaccines to refer to the magnitude of the temporary adverse reaction to the vaccine that occurs within the first few hours to days of the vaccine having been administered. For example, a vaccine that causes large amounts of swelling, redness, or pain at the injection site is more reactogenic than a vaccine that causes little swelling, little redness, and little pain at the injection site. As such, decreasing reactogenicity while maintaining the effectiveness of the vaccine would appear to be a practical improvement. With that being said, the practical effect of neutrophils, fibrinogen, globulin, and CRP is unclear because it is unclear as to what extent these features correlate with reactogenic side effects such as swelling, redness, or pain at the injection site.
Additionally, the data presented in Example 11 of the instant specification is not clear to the examiner. Such data includes tables such as Tale 10 on page 156, which is reproduced below.
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It is unclear as to what ingredients are comprised with Groups 1-7; as such, it is unclear how the data presented in this table as well as other tables is probative of non-obviousness.
Applicant then makes the following argument on the paragraph bridging pages 19-20, which is reproduced in part below.
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This argument appears to relate to the process by which the claimed invention is prepared rather than the composition of the claimed invention itself. As such, the above-reproduced argument does not appear to relate to the pending composition claims, though may potentially relate to claims drawn to methods of making the claimed invention that are not currently pending and were not elected in the response to the restriction requirement set forth on 8 September 2025. Arguments about limitations which are not claimed are not persuasive; see MPEP 2145(VI).
As such, applicant’s arguments are not persuasive and the data presented by applicant is insufficient to overcome the prima facie case of obviousness.
Conclusion
No claim is allowed.
THIS ACTION IS MADE FINAL. 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to ISAAC SHOMER whose telephone number is (571)270-7671. The examiner can normally be reached 7:30 AM to 5:00 PM Monday Through Friday.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Sahana Kaup can be reached at (571)272-6897. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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ISAAC . SHOMER
Primary Examiner
Art Unit 1612
/ISAAC SHOMER/ Primary Examiner, Art Unit 1612