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 .
Priority
The instant application is a National Stage entry of International application PCT/GB2023/050443 filed 28 February 2023.
Receipt is acknowledged of certified copies of papers required by 37 CFR 1.55 pertaining to Great Britain national application 2202754.4 filed 28 February 2022.
Status of the Claims
Claims 1-20 are pending, presented for examination, and rejected as set forth in greater detail below.
Claim Interpretation
Applicants Claims are directed to oil-in-water emulsions containing agar, a defined water activity, and a surfactant which is a glycerol having at least one hydroxyl group esterified by diacetyl tartaric acid, and at least one hydroxyl group esterified by a fatty acid. Claims 2 and 9 specify the pH of the composition. Claims 3-7 narrow the identity of the of the surfactant to various diacetyl tartaric acid esters of mono- and diglycerides (DATEM), more specifically those including fatty acids “obtained from” an edible oil. Applicants by this language invokes so-called “product-by-process” language, and are reminded that “even though product-by-process claims are limited by and defined by the process, determination of patentability is based on the product itself. The patentability of a product does not depend on its method of production. If the product in the product-by-process claim is the same as or obvious from a product of the prior art, the claim is unpatentable even though the prior product was made by a different process.” In re Thorpe, 777 F.2d 695, 698, 227 USPQ 964, 966 (Fed. Cir. 1985). This is of particular relevance when the language describes a chemical compound, such as a fatty acid. For purposes of claim interpretation, art that describes either DATEM with fatty acids obtained from edible oils such as the sunflower or palm oil of Claim 5, or which is described as containing any fatty acids known to be present in edible oils such as the sunflower or palm oil of Claim 5, will be considered as sufficient to address the limitations of these claims. Claim 8 indicates the composition is to possess a defined water activity, understood as a measure of the free water in the composition. Claim 10 limits the concentration of agar in the composition, Claim 11 the weight percentage of the aqueous phase of the emulsion, and Claims 12 and 13 the inclusion of sugars or sugar alcohols in defined concentrations. Claims 14 and 15 limit the identity and amount of oil present in the emulsion. Claim 14 again invokes product-by-process language in defining the oil present as a “physiologically tolerable lipids derived from..” a variety of sources. As above, any lipids described as either originating or being derived from, or containing any lipid known to be present in the lipid sources recited will be considered sufficient to address these limitations. Claims 16-18 incorporate various active agents into the composition. Claim 19 defines the composition as being provided in a “unit dose form,” which claim 20 indicates is uncoated. As no particular structure, form, or quantity of the “unit dose form” is recited by the claims, nor is any particular controlling definition of what constitutes a “unit dose form” provided by applicants specification, any non-coated unit recited by the prior art will be considered sufficient to address the language of these claims.
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 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 1-5 and 7-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hanasaki (U.S. PGPub. 2019/0281852) as evidenced by Akkaya (Murat Reis Akkaya, Prediction of Fatty Acid Composition of Sunflower Seeds by Near-Infrared Reflectance Spectroscopy, 55 J Food Sci. Tech. 2318 (June 2018)).
Hanasaki describes oil-in-water emulsions which maintain stability even when the oil component of the emulsion undergoes a phase change owing to temperature changes. (Abs.; [0025-27]). Hanasaki indicates that agar may be incorporated into the compositions to stabilize the emulsion particles, and should be incorporated in concentrations most preferably falling within the range of 0.5-15% by weight of the emulsion, defining a range overlapping and therefore rendering obvious the limitations of Claim 10. [0092-93; 0104]; 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.”). Hanasaki indicates that the surfactant component to be used include food-grade emulsifiers, [0114; 0224], including C12-22 fatty acid esters of diacetyltartaric acid. [0114; 0229]. Akkaya indicates that sunflower oils contain each of palmitic, stearic, oleic, linoleic, and behenic acids, which are C16, C18, and C22 fatty acids, meaning that Hanasaki describes diacetyltartaric acid esters of fatty acids which are “obtained from” sunflower oil and therefore addresses the surfactant limitations of Claims 1, 3-5, and 7. Akkaya Pg.2320 “Table 1.” Hanasaki indicates that the aqueous phase typically constitutes between 20-95% of the weight of the oil in water emulsion, defining a range overlapping and therefore rendering obvious the limitations of Claim 11. [0155], See Peterson, supra. Hanasaki also indicates the oil phase of the oil in water emulsions may represent between 5-60% of the weight of the composition, addressing the limitations of Claim 15. [0153]. Hanasaki indicates the oil phase should be an edible oil or fat, [0139], with each of the rapeseed, corn, olive, and sunflower oils of Claim 14 enumerated among the useful alternatives. [0142]. Hanasaki indicates that sweeteners may be included in these emulsions, with the sugars and sugar alcohols applicants describe as “bulking agents” specifically identified as such compounds. [0168-70]. While Hanasaki does not specify the particular concentrations of sugars or sugar alcohols to be included, Hanasaki describes each of sugars and sugar alcohols as providing sweetening properties to the compositions into which they are incorporated. On this basis, a person of ordinary skill in the art would reasonably conclude that the amounts of each are result-effective variables that achieve the results each of the components referred to provide. As such, it would have been routine to optimize the amounts of these components within the total composition suggested by Hanasaki, addressing the limitations of Claim 13. 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.). Hanasaki indicates that vitamins, minerals, and medically active components may be included in these oil in water emulsions, which may be provided in the form of foods and beverages including nutritional supplement drinks, nutritional tonics, recreational beverages, chilled sweets, and noodle cups, each of which constitute “unit dose forms” which fail to recite the inclusion of a coating, addressing the limitations of Claims 16-20. [0187; 0287]. While not absolutely identified as a requirement by the teachings of Hanasaki, multiple embodiments of these emulsions are described as being buffered to a pH of 7, thereby addressing the pH limitations of Claims 2 and 9. [0347; 0350-51]; See Peterson, supra; see also 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). While Hanasaki does not specify that these emulsions are to possess a water activity of 0.4-0.9 or 0.5-0.8, applicants are reminded that where an otherwise valid case of prima facie obviousness has been established, the burden shifts to applicant to demonstrate that a claimed functional property is applicable to the claim in its broad scope. See In re Greenfield, 197 USPQ 227, 229 (CCPA 1978). Because 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 the prior art appears to contain the exact same ingredients and applicant’s own disclosure supports the suitability of the prior art composition as the inventive composition component, the burden is properly shifted to applicant to show otherwise. 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.”). Because water activity relates to the availability of free water in a composition and represents the ratio of water vapor pressure of a composition when compared to the water vapor pressure of pure water under identical conditions, by Hanasaki’s description of oil in water emulsions containing each of the agar, water, oil, surfactants, sugars or sugar alcohols, vitamins, minerals, or pharmaceuticals as are required by the claims, the burden of establishing the distinctness of the water activity of the Hanasaki compositions falls to the applicants.
The specific combination of features claimed is disclosed within the broad teachings of the reference, but such “picking and choosing” within several variables does not necessarily give rise to anticipation. Corning Glass Works v. Sumitomo Elec., 868 F.2d 1251, 1262 (Fed. Circ. 1989). Where, as here, the reference does not provide any motivation to select this specific combination of agar, water, oil, surfactants, sugars or sugar alcohols, and vitamins, minerals, or pharmaceuticals, anticipation cannot be found.
That being said, however, 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 agar, water, oil, surfactants, sugars or sugar alcohols, and vitamins, minerals, or pharmaceuticals from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Claims 1-20 are rejected under 35 U.S.C. 103 as being unpatentable over Hanasaki and Akkaya as applied to claims 1-5 and 7-20 above, and further in view of Van Schie (U.S. PGPub. 2003/0162893).
Hanasaki suggests the claimed oil-in-water emulsions combining agar, water, oil, surfactants, sugars or sugar alcohols, and vitamins, minerals, or pharmaceuticals, but does not specify that the surfactant is a DATEM having the E-number E472e.
This is cured by the teachings of Van Schie, which establishes that the diacetyl tartaric acid esters of mono- and diglycerides based on C12-22 fatty acids is known as E472e (DATEM).
It would have been prima facie obvious to have used the diacetyl tartaric acid esters of mono- and diglycerides based on C12-22 fatty acids known as E472e (DATEM) as the C12-22 fatty acid esters of diacetyltartaric acid suggested by Hanasaki, owing to the fact that E472e (DATEM) was known to be useful as a diacetyl tartaric acid esters of mono- and diglycerides based on C12-22 fatty acid food grade surfactant at the time the instant application was filed. 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 Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945).
Conclusion
No Claims are allowable.
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.
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/SEAN M BASQUILL/Primary Examiner, Art Unit 1614
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