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 was filed 15 December 2023 and is the national stage entry of PCT/EP2022/066086 filed 14 June 2022. The Applicant claims priority to foreign application EP21179768.3 filed 16 June 2021. An English translated copy of the foreign document has been provided. Therefore, the effective filing date of the instant application is 16 June 2021.
Election/Restrictions
Claim 16 is withdrawn from further consideration pursuant to 37 CFR 1.142(b), as being drawn to a nonelected invention, there being no allowable generic or linking claim. Applicant timely traversed the restriction (election) requirement in the reply filed on 30 July 2026.
Applicant's election with traverse of Group I (claims 1-15) and soybean oil, oleic acid, glycerol, phosphatidyl choline, and tocopherol for the species election in the reply filed on 30 July 2026 is acknowledged. The traversal is on the ground(s) that Deng (US 2017/0128362 A1) does not teach mixing an emulsion with an amino acid/glucose solution suitable for parenteral administration and does not teach an oil-in-water emulsion.
This is not found persuasive because Deng teaches a fat emulsion, which is a liquid composed of two immiscible substances, typically some form of fat and water (evidenced by cancer.gov, pg. 1). Therefore, a fat emulsion is interpreted as broadly including an oil-in-water emulsion. Additionally, Otero-Millan teaches including glucose/amino acid solutions in emulsion mixtures for increased viscosity, which helps to provide stability to parenteral emulsion mixtures (abs, pg. 24).
Since Deng does not specifically teach using an amino acid solution or glucose solution to their emulsion in claim 1, one of ordinary skill in the art would have been motivated to use Otero-Millan’s teaching to include glucose for enhancer stability reasons and amino acids for protective/buffering abilities (pg. 24). “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
The requirement is still deemed proper and is therefore made FINAL.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-6, 8-10, 14, and 15 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 1-6, 8-10, 14, and 15, the word "preferably" renders the claim indefinite because it is unclear whether the limitation(s) following the phrase are part of the claimed invention. See MPEP § 2173.05(d).
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.
Claim(s) 1-15 is/are rejected under 35 U.S.C. 103 as being unpatentable over Deng (US 2017/012836 A1; cited in IDS) in view of Otero-Millan (Stability of lipid emulsion in total parenteral nutrition: An overview of literature, Clinical Nutrition, ESPEN, 2021).
Regarding claim 1, Deng teaches an emulsion composition (abs, entire teaching) comprising water and 2-30% of an oil (abs). Soybean oil and water (aqueous phase 1) are used to form an emulsion (Example 7). Soybean oil and water are mixed together (para. 63) (steps a and b). A pre-emulsion is formed and homogenized five times at 65 degrees Celsius with a microfluidizer under 14,000 psi (steps c and d) (para. 75). The pre-emulsion is diluted with water (aqueous phase 2) and forms an emulsion (steps e and f), which is then heated at 121 degrees Celsius (sterilization, step g) (para. 65). Phosphatidyl choline is used as an emulsifier and the amount of soybean oil is 10% (Table 15). When the emulsifier is phosphatidyl choline, the amount of phosphatidyl choline in terms of the total weight of the emulsifier, is interpreted as 100%. Glycerol is added (para. 67), which reduces the PFAT5 to below 0.05% (Table 31, para. 96), post several freeze-thaw cycles, which is interpreted as at least 24 hours.
Regarding claims 2, 4, and 5, the amount of oil may be 10-30% (para. 15) and the amount of soybean oil may be 10% (Table 15). The pre-emulsion is diluted to 100 mL by sterile injection water (para. 65).
Regarding claim 3, soybean oil may be used (Example 7).
Regarding claims 6 and 11, the composition may comprise oleic acid (para. 65).
Regarding claims 7 and 10, the composition may comprise tocopherol as an antioxidant (para. 25).
Regarding claim 8, glycerol is added (para. 67), which reduces the PFAT5 to below 0.05% (Table 31, para. 96), post several freeze-thaw cycles, which is interpreted as at least 24 hours.
Regarding claim 9, phosphatidyl choline is used as an emulsifier and the amount of soybean oil is 10% (Table 15). When the emulsifier is phosphatidyl choline, the amount of phosphatidyl choline in terms of the total weight of the emulsifier, is interpreted as 100%.
Regarding claim 12, glycerol is used at different concentrations (Table 31, para. 96).
Regarding claims 13 and 14, a pre-emulsion is formed and homogenized five times at 65 degrees Celsius with a microfluidizer under 14,000 psi (steps c and d) (para. 75).
Regarding claim 15, soybean oil may be used (Example 7). A pre-emulsion is formed and homogenized five times at 65 degrees Celsius with a microfluidizer under 14,000 psi (steps c and d) (para. 75).
Deng does not specifically teach an amino acid solution or glucose solution in claims 1 and 8.
Otero-Millan teaches using amino acid and glucose solutions in order to enhance the stability of emulsion compositions (abs). Glucose provides greater viscosity and improves emulsion stability and amino acids have a protecting and buffering capacity for emulsions (pg. 24).
In regards to selecting the combination of ingredients and steps recited in claim 1, “[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)). “When 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 obvious to have selected various combinations of various disclosed ingredients from within a prior art disclosure, to arrive at compositions “yielding no more than one would expect from such an arrangement.”
Deng teaches compositions and methods for making an emulsion composition comprising the ingredients and general steps of instant claim 1, whereas the claimed invention is directed towards a method for manufacturing an oil-in-water emulsion comprising a water phase and 5-25% of an oil phase. Since Deng teaches the individual components and steps of the claimed invention, it is obvious for one of ordinary skill in the art to select the different combinations of ingredients and steps to arrive at the claimed invention with a reasonable expectation of success.
Since Deng does not specifically teach an amino acid solution or glucose solution in claims 1 and 8, one of ordinary skill in the art would have been motivated to use Otero-Millan’s teaching of using glucose and amino acid solutions for increased emulsion stability. “Generally, it is prima facie obvious to select a known material for incorporation into a composition, based on its recognized suitability for its intended use (see MPEP § 2144.07).”
Regarding the concentrations in claims 2, 4, and 5, and the processing parameters (i.e. 24 hours) in claims 1 and 13, the amount of oil may be 10-30% (para. 15) and the amount of soybean oil may be 10% (Table 15). The pre-emulsion is diluted to 100 mL by sterile injection water (para. 65). Furthermore, glycerol is added (para. 67), which reduces the PFAT5 to below 0.05% (Table 31, para. 96), post several freeze-thaw cycles, which is interpreted as at least 24 hours. That being said and in lieu of objective evidence of unexpected results, the amounts and parameters can be viewed as variables that achieve the recognized result of successfully performing the process of forming an emulsion composition, which a skilled artisan would have been easily motivated to modify and adjust based on the broad teachings of Deng. The optimum or workable range of concentrations and parameters can be accordingly characterized as routine optimization and experimentation (see MPEP 2144.05 (II)B). “[Discovery of an optimum value of a result effective variable in a known process is ordinarily within the skill of the art.” In re Boesch, 617 F.2d 272, 276 (CCPA 1980). Applicants provide no evidence of any secondary consideration, such as unexpected results, that would render the optimized amounts of ingredients or specific parameters as nonobvious.
Conclusion
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/D.A.K./Examiner, Art Unit 1613
/ANDREW S ROSENTHAL/ Primary Examiner, Art Unit 1613
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