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 .
Election/Restrictions
Applicant’s election without traverse of probiotics as the species of active agent to be included in the compositions claimed in the reply filed on 11 May 2026 is acknowledged.
Status of the Claims
Claims 1-6 and 10-27 are pending.
Claims 15-20 and 23-27 are withdrawn from consideration as directed to a non-elected invention.
Claims 1-6, 10-14, 21, and 22 are presented for examination and rejected as set forth below.
Claim Interpretation
Applicants claims are directed to oleogel emulsion compositions comprising an active ingredient suspended within a composition containing an oil, wax, and aqueous phase containing an oleogelator, with the volume of hydrophobic components being present in relation to the aqueous component in defined volume ratio of “1:4 to 4:1,” and where the oleogelator is present as a percentage of the aqueous phase. To be sure, applicants indicate that the oleogelator is to be present “in the aqueous phase” of the composition. However, given the identity and nature of the oleogelators to be present in the composition, the Examiner is unclear how an amphiphilic component, as the oleogelators of the present applicant all are, could remain partitioned in the aqueous phase of the emulsion claimed. See, e.g., David Julian McClements & Seid Mahdi Jafari, Improving Emulsion Formation, Stability and Performance Using Mixed Emulsifiers; A Review, 251 Adv. Coll. Interf. Sci. 55, 57 (2018)(describing partitioning behavior of amphiphilic emulsifiers)(of record). Given the known behavior of the amphiphilic oleogelators to be used in the composition, the examiner has determined that the amendments to the claims define the quantity of oleogelator to be present in the oleogel composition as a percentage of the volume of aqueous component now required by the claims. Dependent claims 2 and 10 narrow the active ingredient to a probiotic. Claims 3-5 narrow the identity of the oil, wax, and oleogelator, respectively. Claim 6 places limitations on the amount of wax relative to the oil in the gel. Claims 11 and 1 specify stability parameters of the oleogel, and Claim 14 the gel melting temperature of the composition. Claim 14 specifies that he composition is a “food product”; as no particular limitation is placed on the structure of Claim 14 by this language, anything described as edible or orally deliverable will be considered “food or a food product” within the meaning of Claim 14. Claim 21 specifies that the oleogelator to be used is pectin.
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.
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.
Claims 1-6, 10-14, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Chen (CN101721931), in view of Han (CN 105997926).
Chen describes stable suspensions which combine 45-70% edible oil with 1-10% water, 10-40% edible solid powder, 1-5% of a surfactant, and 1-5% of a stabilizer, among other components, to provide stable multiphase suspension systems. Given the combination of aqueous and oily phases with surfactants, the overlap of concentrations claimed with that of the Chen reference, and the fact that Chen describes nearly identical steps of separately combining aqueous phase components on one hand and oily phase components on the other with heating which are then combined to provide the “multiphase suspension systems” containing each of the actives, oils, waxes, and aqueous phase components with “oleogelators” the art describes as surfactants, the examiner considers this equivalent to the emulsions and concentration of emulsion components recited by present claim 1, which Chen combines into an edible composition addressing the “food” limitations of Claim 14. (Pg.1; pg.3, [0038-43]), See In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003) (“A prima facie case of obviousness typically exists when the ranges of a claimed composition overlap the ranges disclosed in the prior art.”). The disclosed concentrations of oil and suspending agent provide for a total oily phase component concentration of between about 46-75% of the composition, against which up to 10% of the composition is to be water, providing a range of oil:water phase ratios including about 4.6:1. While appearing to be just outside of the range of oil/wax to aqueous phase of the newly amended claim 1, the approximate 4.6:1 ratio suggested by the teachings of Chen are sufficiently close to those of the amended claims to render such a range obvious, thereby addressing the newly added limitations of Claim 1. See Titanium Metals Corp. of America v. Banner, 778 F.2d 775, 783, 227 USPQ 773, 779 (Fed. Cir. 1985) (indicating that a prima facie case of obviousness exists where the claimed ranges or amounts do not overlap with the prior art but are merely close). Specifically, the concentration of component compositions claimed by the appellees in Titanium Metals differed from the values disclosed by the prior art by as much as 17% of the claimed values, and in the absence of evidence tending to establish different results were achieved by such a miniscule differences in concentrations, were upheld to be obvious permutations of the art disclosed. Id. Here, the range taught by Chen differs from the present claims by 15%, squarely within the difference considered obvious by the court in Titanium Metals. Applicants are also reminded that in the absence of evidence tending to establish that any differences in concentration or relative amounts of composition components gives rise to unexpected results, these differences ordinarily fail to confer patentability on such claimed compositions. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.). In a similar manner, the ranges of water, representing 1-10% of the composition, and surfactant, representing 1-5% of the composition, give rise to compositions where the surfactant is present in amounts of 10% relative to the aqueous phase, rendering obvious limitations of Claim 1. See Peterson, supra. Each of the presently claimed soybean, olive, corn, and fish oils are recited as suitable edible oils, with probiotics recited as the edible solid powder, lecithin as the surface active agent, and beeswax as the suspending agent. (Pg.2, [0017]).
It must be remembered that “[w]hen a patent simply arranges old elements with each performing the same function it had been known to perform and yields no more than one would expect from such an arrangement, the combination is obvious.” KSR v. Teleflex, 127 S.Ct. 1727, 1740 (2007) (quoting Sakraida v. A.G. Pro, 425 U.S. 273, 282 (1976)). “[W]hen the question is whether a patent claiming the combination of elements of prior art is obvious,” the relevant question is “whether the improvement is more than the predictable use of prior art elements according to their established functions.” (Id.). Addressing the issue of obviousness, the Supreme Court noted that the analysis under 35 USC 103 “need not seek out precise teachings directed to the specific subject matter of the challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ.” KSR at 1741. The Court emphasized that “[a] person of ordinary skill is… a person of ordinary creativity, not an automaton.” Id. at 1742.
Consistent with this reasoning, it would have been prima facie obvious to have selected various combinations of 45-70% corn oil with 1-10% water, 10-40% probiotic powder, 1-5% of lecithin, and 1-5% of beeswax, among other components, to provide stable edible probiotic emulsions having a ratio of hydrophobic phase to water of 4:1, and a concentration of surfactant relative to the aqueous phase of about 10% from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Despite this, Chen does not describe including a probiotic having the properties required by Claims 10-13.
Han describes probiotic suspensions combining a probiotic of Claim 2, specifically Bifidobacterium powder, with each of the soybean oil recited by Claim 3, the beeswax of Claim 4, and lecithin of Claim 5, where the beeswax is present in an amount of 4% relative to the soybean oil standard. (Pg.3, 5, 6). In addition, Han additionally indicates that the content of viable bacteria can fall within the range of 1-10x109 cfu/g, and the maintenance of a high degree of viable cell forming cultures is the purpose of the formulations described. (Pg.3, 6, 8). Han demonstrates a retention in excess of log8 activity for at least 90 days. (Pg.8). While these are not recited in quite the same terms as the present claims, considering the recited values are in excess of Log9 and Han advocates the long-term preservation of colony-forming activity, the active ingredient amounts and storage stability of Claims 10-12 are considered result-effective variables suitable for optimization through nothing more than routine optimization within the parameters recited by Han. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.). Concerning the properties recited by Claim 13, the examiner notes that applicants own specification indicates that a 5% beeswax solution in a liquid oil needed to be heated to 48C for the solid wax to be melted, and represents the only representation of an oleogel according to the present claims. The U.S. Patent office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the composition claimed, the burden is properly shifted to applicant to show otherwise.
It would have been prima facie obvious for a skilled artisan to have used as the probiotic powder recited by Chen the probiotic food supplement described by Han, owing to the fact that Chen recites powdered probiotics as among the suitable powdered supplements for inclusion in the foods described therein, and Han indicates that probiotics addressing the activity requirements of Claims 10-12 are suitable for inclusion into foodstuffs such as those taught by Chen. See Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683 F.3d 1356, 1364 (Fed. Cir. 2012) (finding a “strong case of obviousness based on the prior art references of record. [The claim] recites a combination of elements that were all known in the prior art, and all that was required to obtain that combination was to substitute one well-known…agent for another”).
Claims 1-6, 10-14, 21, and 22 are rejected under 35 U.S.C. 103 as being unpatentable over Chen and Han as applied to claims 1-6, 10-14, and 22 above, and further in view of Yang (Xi Yang, et al, Pomegranate Peel Pectin Can Be Used as an Effective Emulsifier, 85 Food Hydrocoll. 30 (2015)).
Chen and Han, discussed in greater detail above, suggest stable suspensions combining each of the presently claimed soybean, olive, corn, and fish oils as suitable edible oils, with probiotics as the edible solid powder, lecithin as the surface active agent, and beeswax as the suspending agent in concentrations and ratios overlapping and therefore rendering obvious the requirements of the present claims.
Neither Chen not Han describe the use of pectin as an emulsifier for these food compositions.
This is cured by the teachings of Yang, which indicates that at the time the instant application was filed, pectins were understood to be useful as effective emulsifiers in foodstuff applications, as well as acknowledging that pectins have long been recognized as possessing a variety of properties, including the ability to act as a gelator.
It therefore would have been prima facie obvious to have substituted pectin for the lecithin described by Chen as a foodstuff surfactant, owing to the art-recognized utility of pectin to act as a foodstuff surfactant. See Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (indicating that "Reading a list and selecting a known component to meet known requirements is no more ingenious than selecting the last piece to put in the last opening in a jig-saw puzzle. It is not invention.”).
Response to Arguments
Applicant's arguments filed 23 January 2026 have been fully considered but they are not persuasive.
Applicants argue that the Chen reference disclosure of a “multi-phase suspension system” which combines each of an edible oil such as the soybean, olive, corn, and fish oils of the present claims with water, an edible solid powder such as a probiotic of the present claims, a surfactant such as lecithin of the present claims, and the beeswax of the instant claims as a stabilizer, among other components, to provide stable multiphase suspension systems. Because the combination of aqueous and oily phases with surfactants, the overlap of concentrations claimed with that of the Chen reference, and the fact that Chen describes nearly identical steps of separately combining aqueous phase components on one hand and oily phase components on the other with heating which are then combined to provide the “multiphase suspension systems” containing each of the actives, oils, waxes, and aqueous phase components with “oleogelators” the art describes as surfactants as applicants recite in their withdrawn claims as suitable for forming what applicants describe as an “oleogel,” the examiner considers this equivalent to the emulsions and concentration of emulsion components recited by present claims. Applicants insistence that the fact Chen employs different descriptive words for each of these components fails to distinguish the prior art compositions from those claimed. This is because it has long been held that the reason or motivation to modify a prior art reference may often suggest what the inventor has done, but for a different purpose or to solve a different problem. It is not necessary that the prior art suggest the combination to achieve the same advantage or result discovered by applicant. See, e.g., In re Kahn, 441 F.3d 977, 987, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006) (motivation question arises in the context of the general problem confronting the inventor rather than the specific problem solved by the invention). Chen proposes combining soybean, olive, corn, or fish oils with water, lecithin, beeswax, and probiotics in the amounts claimed and in the manner claimed. Applicants are reminded that where the claimed invention and prior art are identical or substantially identical in structure or composition, or are produced by identical or substantially identical processes, a prima facie case of either anticipation or obviousness has been established. In re Best, 562 F.2d 1252, 1255, 195 USPQ 430, 433 (CCPA 1977). “When the PTO shows a sound basis for believing that the products of the applicant and the prior art are the same, the applicant has the burden of showing that they are not.” In re Spada, 911 F.2d 705, 709, 15 USPQ2d 1655, 1658 (Fed. Cir. 1990) (indicating that “products of identical chemical composition cannot have mutually exclusive properties.”). Here, applicants advance no convincing evidence or argument to contradict the fact that the art expressly suggests combining soybean, olive, corn, or fish oils with water, lecithin, beeswax, and probiotics in the amounts claimed and in the manner claimed.
Applicants next recite various limitations of dependent claims and assert these are not addressed by the art relied upon by the examiner. Applicants’ arguments are legally insufficient to properly raise an issue concerning the patentability of the invention claimed. In re Lovin, 652 F.3d 1349, 1357 (Fed. Cir. 2011) (“[T]he Board reasonably interpreted Rule 41.37 to require more substantive arguments in an appeal brief than a mere recitation of the claim elements and a naked assertion that the corresponding elements were not found in the prior art.”).
Applicants assertion that the art of record fails to address limitations recited in the claims concerning the properties to be possessed by the probiotic is likewise unpersuasive. As set forth previously and again above, Han indicates that the content of viable bacteria can fall within the range of 1-10x109 cfu/g, and the maintenance of a high degree of viable cell forming cultures is the purpose of the formulations described, while demonstrating retention in excess of log8 activity for at least 90 days. While these are not recited in quite the same terms as the present claims, considering the recited values are in excess of Log9 and Han advocates the long-term preservation of colony-forming activity, the active ingredient amounts and storage stability of Claims 10-12 are considered result-effective variables suitable for optimization through nothing more than routine optimization within the parameters recited by Han. See In re Aller, 220 F.2d 454, 456, 105 USPQ 233, 235 (CCPA 1955) (indicating that 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.). Applicants provide no evidence to establish that such optimization would be undertaken in an area of the art rife with uncertainty and myriad pitfalls; obviousness does not require absolute predictability. See In re Rinehart, 531 F.2d 1048, 189 USPQ 143 (CCPA 1976) (indicating that evidence showing there was no reasonable expectation of success may support a conclusion of nonobviousness).
Concerning Applicants arguments related to the properties recited by Claim 13, the examiner notes that applicants own specification indicates that a 5% beeswax solution in a liquid oil needed to be heated to 48C for the solid wax to be melted, and represents the only representation of an oleogel according to the present claims. The U.S. Patent office is not equipped with analytical instruments to test prior art compositions for the infinite number of ways that a subsequent applicant may present previously unmeasured characteristics. When as here, the prior art appears to contain the same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the composition claimed, the burden is properly shifted to applicant to show otherwise.
For at least these reasons, applicants arguments are unpersuasive.
Conclusion
No Claims are allowable.
All claims are identical to or patentably indistinct from, or have unity of invention with claims in the application prior to the entry of the submission under 37 CFR 1.114 (that is, restriction (including a lack of unity of invention) would not be proper) and all claims could have been finally rejected on the grounds and art of record in the next Office action if they had been entered in the application prior to entry under 37 CFR 1.114. Accordingly, THIS ACTION IS MADE FINAL even though it is a first action after the filing of a request for continued examination and the submission under 37 CFR 1.114. See MPEP § 706.07(b). 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 SEAN M BASQUILL whose telephone number is (571)270-5862. The examiner can normally be reached Monday through Thursday, 5:30 AM to 4 PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Ali Soroush can be reached at (571) 272-9925. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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