DETAILED ACTION
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 .
Summary
Claims 1-2, 4-15, 17-18, and 21-23 are pending in this office action. Claims 21-23 are new. Claims 3, 16, and 19-20 are cancelled. All pending claims are under examination in this application.
Priority
The current application was filed on September 29, 2023 is a 371 of PCT/NL2022/050181 filed March 31, 2022. The current application claims foreign priority to NL2027878 filed on March 31, 2021.
Claim Rejections - 35 USC § 103
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 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 non-obviousness.
Claims 1, 4-15, and 21-22 are rejected under 35 U.S.C. 103 as being unpatentable over Burnison et al. (US2018/0289809A1) in view of Bianca et al. (BR102019013856A2) and Jannin et al. (EP3482774A1).
[The Examiner is going to introduce each reference and then combine them where appropriate to reject the instant claims.]
1. Burnison et al.
Burnison et al. is considered the closest prior art as it teaches formulations of hydrophilic compounds (see title). Furthermore, Burnison et al. disclose a formulation that includes a continuous hydrophobic phase, a hydrophilic phase, at least one hydrophobic compound substantially dissolved in the hydrophilic phase, and a stabilizing component. The stabilizing component can contain D-a-tocopheryl polyethylene glycol 1000 succinate (TPGS) and/or at least one emulsifier having a hydrophilic-lipophilic balance (HLB) value of at least 10. In one alternative, the stabilizing component contains a first, polysorbate emulsifier having an HLB value of at least 10, and a second emulsifier having an HLB value of less than 10 (see abstract).
2. Bianca et al.
Bianca et al. teach a solid lipid composition for production of a nanostructured lipid carrier (see title). In addition, Bianca et al. disclose a solid lipid composition for the production of a nanostructured lipid carrier. The present invention relates to a solid lipid composition composed by melting followed by recrystallization of a mixture of at least one wax, a butter, an oil, and a surfactant, the present composition being heated with water is able to form nanostructured lipid carriers less than 500 nanometers in size. This invention contemplates the process of preparing the solid lipid composition, its use as a
nanostructured lipid carrier to transmit lipophilic and hydrophilic assets, and its use as a nanotechnological active ingredient for application in dermatological and cosmetic preparations. The present invention belongs to the technical sector of nanotechnology applied to health and cosmetics (see abstract).
3. Jannin et al.
Jannin et al. teach a solid self-emulsionable system and method for making same by printing in three dimensions (see title). Additionally, Jannin et al. disclose a self-emulsifiable solid system in contact with a hydrophilic phase provided, after ingestion, by physiological liquid, said self-emulsifiable system comprising: at least one active ingredient; and the following excipients: a lipophilic phase; a surfactant having a hydrophilic/lipophilic balance (HLB) greater than 8; optionally a co-surfactant; said system being capable of being obtained by 3-dimensional (3D) printing. Self-emulsifiable solid system in contact with a hydrophilic phase provided, after ingestion, by physiological liquid, said self-emulsifiable system comprising: at least one active ingredient; and the following excipients: a lipophilic phase; a surfactant having a hydrophilic/lipophilic balance (HLB) greater than 8; optionally a co-surfactant; said system being capable of being obtained by 3-dimensional (3D) printing (see abstract).
Combination of Burnison et al., Bianca et al., and Jannin et al.
Regarding instant claim 1, Burnison et al., Bianca et al., and Jannin et al. teach a composition comprising a continuous hydrophobic phase formulation. The necessary citations of Burnison et al., Bianca et al., and Jannin et al. that pertain to instant claim 1 are presented in Table I.
Table I
Instant Claim 1
Burnison et al., Bianca et al., and Jannin et al. Citations
A composition comprising:
a continuous hydrophobic phase,
a hydrophilic phase dispersed in said hydrophobic phase,
a hydrophilic active ingredient dissolved in the hydrophilic phase, and
a stabilizing component comprising:
o 4-20 wt% of an emulsifier having a hydrophilic-lipophilic balance (HLB) value of at least 10, and
o 80-96 wt% of an emulsifier having an HLB value of less than 10,
Burnison et al. disclose the following within claim 1:
1. A formulation comprising: a continuous hydrophobic phase;
a hydrophilic phase dispersed throughout said continuous hydrophobic phase;
a stabilizing component comprising:
from 8% to 30% (overlapping region) by weight D-a-tocopheryl polyethylene glycol 1000 succinate (TPGS) based upon total weight of the stabilizing component, and
from 70% to 92% (overlapping region) by weight at least one emulsifier having an HLB value of less than 10; and
a hydrophilic component (active ingredient) comprising a compound that is normally insoluble in said continuous hydrophobic phase at room temperature absent an emulsifying agent, wherein the hydrophilic component is substantially dissolved in the hydrophilic phase utilizing reverse micelles comprising the TPGS and the emulsifier, and wherein the weight ratio of the stabilizing component to the hydrophilic component is at least 10:1 (see claim 1 within Burnison et al.).
wherein the continuous hydrophobic phase comprises a solid lipid component comprising 50-100 wt% of one or more high melting point triglycerides and between 0-50 wt% of one or more waxes.
Burnison et al. disclose the use of triglycerides. The low HLB emulsifier may include a compound selected from the group consisting of … triglyceride (see paragraph [0060] within Burnison et al.). Additionally, Burnison et al. disclose that the triglycerides may be medium chain (C6-C12) triglycerides, long chain (C14-C20) triglycerides … (see paragraph [0065] within Burnison et al.). Such solid triglycerides include trilaurin (C12), tripalmitin (C16), tristearin (C17), and triarachidin (C19).
Jannin et al. disclose the use of the semi-solid lipids Gelucire ® 44/14 and Gelucire ® 50/13, and within the Table 1 formulation these two semi-solid lipids comprise 69.77% of the formulation (see Table 1 within Jannin et al.; also see PTO-892 NPL U and 2U-2W).
Burnison et al. disclose the use of the solid lipid bee’s wax as an additional ingredient (see paragraph [0104] within Burnison et al.).
Bianca et al. disclose the solid lipid composition that deals with this invention should consist of at least one oil, a wax, a butter and a surfactant (see paragraph [041] within Bianca et al.). Furthermore, Bianca et al. disclose that this lipid mass
has the appearance of wax, and is called a solid lipid composition, having the main function of forming a nanostructured lipid carrier when subjected to an emulsification process followed by sonication, using from 2 to 20% of the solid lipid composition and 80 to 98% of water, and you can also add other ingredients to the preparation (see paragraph [040] within Bianca et al.).
Therefore, a skilled artisan (POSITA; person of ordinary skill in the art) would combine the Burnsion et al. reference with the Bianca et al. and Jannin et al. to establish the biologically active hydrophilic compounds into a stable formulation with a hydrophobic carrier. Additionally, it is within the scope of a skilled artisan (POSITA) to add more than one triglyceride (as exemplified within Bianca et al.) or more than one wax.
Instant claims 5-15 within this 35 U.S.C. § 103 section are directly dependent on instant claim 1 and are taught in full by the combination of Burnison et al., Bianca et al., and Jannin et al.
Combination of Burnison et al., Bianca et al., and Jannin et al.
Regarding instant claims 4 and 5, Burnison et al., Bianca et al., and Jannin et al. teach wherein the continuous hydrophobic phase comprises a solid lipid component comprising 50-100 wt% of one or more high melting point triglycerides and 0-50% of one or more waxes. Please see the discussion and citations within instant claim 1 regarding the solid lipid and wax addition to the formulation.
Regarding instant claims 6 and 7, Burnison et al., Bianca et al., and Jannin et al. teach wherein the triglyceride is selected from the group consisting of trilaurin, tripalmitin, tristearin, triarachidin and tribehenin. Bianca et al. disclose the use of the triglyceride tribehenin (see paragraph [043] within Bianca et al.).
Regarding instant claim 8, Burnison et al., Bianca et al., and Jannin et al. teach wherein the stabilizing component comprises 5-7.9% of the emulsifier having an HLB value of at least 10 and 92.1-95% of the emulsifier having an HLB of less than 10. Please see the discussion and citations within instant claim 2 regarding the stabilizing component within the formulation.
Regarding instant claim 9, Burnison et al., Bianca et al., and Jannin et al. teach wherein the emulsifier having an HLB value of less than 10 comprises a fatty acid mono-ester of sorbitan. Burnison et al. disclose the use of the fatty acid mono-ester of sorbitan (see claim 6 within Burnison et al.).
Regarding instant claims 10, 12, and 20, Burnison et al., Bianca et al., and Jannin et al. teach wherein the emulsifier having an HLB value of less than 10 is sorbitan sesquioleate, polyglyceryl-2-sesquioleate and/or glyceryl monooleate. Burnison et al. disclose the use of sorbitan sesquioleate such as SPANTM 83 surfactant from Croda Inc. (see paragraph [0064] within Burnison et al.).
Regarding instant claims 11 and 19, Burnison et al., Bianca et al., and Jannin et al. teach wherein the emulsifier having an HLB value of at least 10 comprises D-a-tocopheryl polyethylene glycol 1000 succinate (TPGS). Burnison et al. disclose the use of TPGS (see claim 1 within Burnison et al.; also see PTO-892 NPL V).
Regarding instant claim 13, Burnison et al., Bianca et al., and Jannin et al. teach wherein the weight ratio of the stabilizing component to the hydrophilic active ingredient is less than 10:1. Please see the discussion and citations within instant claim 3 regarding the weight ratio of the stabilizing component to the hydrophilic active ingredient is less than 10:1 within the formulation for the relevant rejection text.
Regarding instant claim 14, Burnison et al., Bianca et al., and Jannin et al. teach wherein the stabilizing component comprises 5-6.9 wt% of TPGS and 92.1-95 wt% sorbitan sesquioleate, polyglyceryl-2-sesquioleate and/or glyceryl monooleate. Please see the discussion and citations within instant claims 2, 10, and 11 for the necessary rejection text.
Regarding instant claim 15, Burnison et al., Bianca et al., and Jannin et al. teach a method for preparing the composition of instant claim 1, comprising:
- dissolving the hydrophilic active substances in the hydrophilic phase,
- dissolving the surfactant of high HLB value in the hydrophilic phase at elevated temperature,
- gradually adding and mixing the surfactant of low HLB value in the same mixture while gradually cooling,
- preparing the hydrophobic phase without the high melting point triglycerides and the waxes by mixing the required ingredients,
- mixing the hydrophobic phase into the mixture or mixing a large part of the hydrophobic phase into the mixture and dissolving the high melting point triglycerides and optionally the waxes in the remaining small part of the hydrophobic phase under heating to 60 °C,
- heating the mixed formulation to 50-55 °C,
- optionally mixing the solution of the high melting point triglycerides and optionally the waxes into the mixed formulation,
- stirring and cooling the mixture to 50 °C, and
- pouring the mixture in final containers.
Burnison et al. disclose a similar preparation (see Example 1 within Burnison et al.). A skilled artisan (POSITA) would heat the mixture where appropriate in order to ensure proper mixing of the formulation.
Regarding instant claim 21, Burnison et al., Bianca et al., and Jannin et al. teach wherein the one or more high melting point triglycerides are selected from the group consisting of trimyristin, trilaurin, tripalmitin, tristearin, triarachidin, tribehenin and combinations thereof, wherein the one or more waxes are selected from the group consisting of beeswax, carnauba wax, candelilla wax, sunflower wax, rice bran wax, berry wax, myrica fruit wax, cetyl palmitate, cetyl alcohol or an ester thereof, cetostearyl alcohol or an ester thereof, and combinations thereof, and wherein between 5 and 35 wt% of the mixture of high melting point triglycerides and one or more waxes is constituted by the one or more waxes. Please see the citations and discussion within instant claim 1 for the necessary rejection text. Additionally, Bianca et al. disclose the solid lipid composition, using from 2 to 20% of the solid lipid composition (see paragraph [040] within Bianca et al.; comprising waxes such as beeswax, carnauba wax, or cetyl alcohol; see paragraph [043] within Bianca et al.).
Regarding instant claim 22, Burnison et al., Bianca et al., and Jannin et al. teach wherein the solid lipid component is present in an amount of 10-20% based on the total weight of the composition. Bianca et al. disclose the solid lipid composition, using from 2 to 20% of the solid lipid composition (see paragraph [040] within Bianca et al.).
Analogous Art
The Burnison et al., Bianca et al., and Jannin et al. references are directed to the same field of endeavor as the instant claims, that is, a composition comprising:
a continuous hydrophobic phase,
a hydrophilic phase dispersed in said hydrophobic phase,
a hydrophilic active ingredient dissolved in the hydrophilic phase, and
a stabilizing component comprising:
o 4-20 wt% of an emulsifier having a hydrophilic-lipophilic balance (HLB) value of at least 10, and
o 80-96 wt% of an emulsifier having an HLB value of less than 10,
wherein the continuous hydrophobic phase comprises a solid lipid component comprising 50-100 wt% of one or more high melting point triglycerides and between 0-50 wt% of one or more waxes.
Obviousness
It would have been prima facie obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the formulation composition for a hydrophilic active ingredient disclosed by Burnison et al., using the teachings of Bianca et al. and Jannin et al.
One would have been motivated to do so to obtain a formulation composition that contains a mixture of solid lipids, waxes, and emulsifiers as taught by Bianca et al. and Jannin et al.
Starting with Burnison et al., the skilled person only had to try the necessary claim limitations disclosed by Bianca et al. and Jannin et al. The combination of Burnison et al., Bianca et al., and Jannin et al. would allow one to arrive at the present application without employing inventive skill. This combination of the formulation composition for a hydrophilic active ingredient taught by Burnison et al. along with the use of the necessary claim limitations taught by Bianca et al. and Jannin et al. would allow a research and development scientist (POSITA) to develop the invention taught in the instant application.
It would have only required routine experimentation to modify the formulation composition for a hydrophilic active ingredient disclosed by Burnison et al. with the use of the necessary claim limitations taught by Bianca et al. and Jannin et al. This combined modification would have led to an enhanced formulation composition for a hydrophilic active ingredient that would be beneficial for patients.
In the context of instant method claim 15 the desired purpose defines an effect that arises from and is implicit in the method step(s). Thus, where the purpose is limited to stating a technical effect that inevitably occurs during the performance of the claimed method step(s), and is therefore inherent in that/those step(s), that technical effect is not limiting to the subject-matter of the claim. Thus, the present method claim, defining the application/use of the composition according to the prior art, and defining its purpose as "use", is anticipated by any document of the state of the art describing a method of application/use although not mentioning this specific use.
Allowable Subject Matter
Claim 2 is allowed. The instant claim 2 amendment describing the tocopheryl polyethylene glycol 1000 succinate (TPGS) emulsifier at a level of 4-7.9 wt% was absent within the cosmetic and pharmaceutical arts. Motivation is lacking to add this new limitation to the closest prior art of Burnison et al. As a result, dependent claims 17-18 and 23 are also allowed.
Response to Arguments
Applicant's arguments filed February 9, 2026 have been fully considered but they are not persuasive.
The instant claim amendments were sufficient to address the duplicate claim warning and the 35 U.S.C. §112(b) rejections. Therefore, they are all withdrawn from the non-final office action dated October 9, 2025.
The amendments did not necessitate a new ground of rejection.
Applicant Argument: The Applicant argues that the Burnison et al. reference does not support the use of high-melting-point triglycerides of the hydrophobic phase.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Yes, all of the citations noted by the Applicant on page 7 of the Remarks Section do support the absence of a high-melting-point triglyceride within the hydrophobic phase within Burnison et al. However, Burnison et al. does not have to disclose an example within the specification for every variation that is cited. Burnison et al. disclose the use of triglycerides. The low HLB emulsifier may include a compound selected from the group consisting of … triglyceride (see paragraph [0060] within Burnison et al.). Additionally, Burnison et al. disclose that the triglycerides may be medium chain (C6-C12) triglycerides, long chain (C14-C20) triglycerides … (see paragraph [0065] within Burnison et al.). Such solid triglycerides include trilaurin (C12), tripalmitin (C16), tristearin (C17), and triarachidin (C19).
The Applicant states, “Where triglycerides are mentioned in Burnison, they are disclosed as optional components or as part of low-HLB emulsifiers, not as high-melting-point triglycerides forming the solid lipid component of the continuous hydrophobic phase as required by claim 1.” At no point within the specification within Burnison et al. is the use of high-melting-point triglycerides forming the solid lipid component of the continuous hydrophobic phase listed with the modifier as optional.
Applicant Argument: The Applicant argues that the secondary references of Bianca et al. and Jannin et al. are directed to fundamentally different systems and are not combinable with Burnison et al.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Yes, the secondary references of Bianca et al. and Jannin et al. do not claim map with instant claim 1. However, they both support the use of several components discussed within Burnison et al.
In order for a reference to be proper for use in an obviousness rejection under 35 U.S.C. 103, the reference must be analogous art to the claimed invention. In re Bigio, 381 F.3d 1320, 1325, 72 USPQ2d 1209, 1212 (Fed. Cir. 2004). A reference is analogous art to the claimed invention if: (1) the reference is from the same field of endeavor as the claimed invention (even if it addresses a different problem); or (2) the reference is reasonably pertinent to the problem faced by the inventor (even if it is not in the same field of endeavor as the claimed invention). Note that "same field of endeavor" and "reasonably pertinent" are two separate tests for establishing analogous art; it is not necessary for a reference to fulfill both tests in order to qualify as analogous art. See Bigio, 381 F.3d at 1325, 72 USPQ2d at 1212. The examiner must determine whether a reference is analogous art to the claimed invention when analyzing the obviousness of the subject matter under examination. When more than one prior art reference is used as the basis of an obviousness rejection, it is not required that the references be analogous art to each other. See Sanofi-Aventis Deutschland GMbH v. Mylan Pharms. Inc., 66 F.4th 1373, 1380, 2023 USPQ2d 552 (Fed. Cir. 2023) and Corephotonics, Ltd. v. Apple Inc., 84 F.4th 990, 1007, 2023 USPQ2d 1202 (Fed. Cir. 2023) [see M.P.E.P. 2141.01(a)].
[Furthermore, Applicant may also argue impermissible hindsight reasoning. However, it must be recognized that any judgment on obviousness is in a sense necessarily a reconstruction based upon hindsight [or piece-meal reasoning.] But so long as it takes into account only knowledge which was within the level of ordinary skill at the time the claimed invention was made, and does not include knowledge gleaned only from the applicant's disclosure, such a reconstruction is proper. See In re McLaughlin, 443 F.2d 1392, 170 USPQ 209 (CCPA 1971).]
Applicant Argument: The Applicant argues that the dependent claims meet the allowable subject matter criteria.
Examiner’s Rebuttal: The Examiner respectfully disagrees. All of the dependent claim limitations are successfully mapped by the Examiner.
Applicant Argument: The Applicant argues that compositions of instant claim 1, comprising a solid lipid component in which the majority consists of high-melting-point triglycerides provides unexpected results.
Examiner’s Rebuttal: The Examiner respectfully disagrees. Evidence of unexpected results must be weighed against evidence supporting prima facie obviousness in making a final determination of the obviousness of the claimed invention. In re May, 574 F.2d 1082, 197 USPQ 601 (CCPA 1978) (Claims directed to a method of effecting analgesia without producing physical dependence by administering the levo isomer of a compound having a certain chemical structure were rejected as obvious over the prior art. Evidence that the compound was unexpectedly nonaddictive was sufficient to overcome the obviousness rejection. Although the compound also had the expected result of potent analgesia, there was evidence of record showing that the goal of research in this area was to produce an analgesic compound which was nonaddictive, enhancing the evidentiary value of the showing of nonaddictiveness as an indicium of nonobviousness.). [see M.P.E.P. 716.02(c)]. In this instance, the prior art of record is stronger than the unexpected results. The prima facie case for obviousness presented within the 35 U.S.C. §103 section of this office action affords a “direct pathway” of research for a skilled artisan (POSITA) to develop and obtain similar results as observed by the inventors.
On a scale of patentability, the prima facie case of obviousness outweighs the unexpected results which have been noted by the Examiner.
Thus, the 35 U.S.C. §103 rejection for instant claims 1, 4-15, and 21-22 is maintained.
Conclusion
Claims 2, 17-18, and 23 are allowed.
Claims 1, 4-15, and 21-22 are not 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.
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/JOHN W LIPPERT III/Examiner, Art Unit 1615 /DANAH AL-AWADI/Primary Examiner, Art Unit 1615
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