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 .
Continued Examination Under 37 CFR 1.114
A request for continued examination under 37 CFR 1.114, including the fee set forth in 37 CFR 1.17(e), was filed in this application after final rejection. Since this application is eligible for continued examination under 37 CFR 1.114, and the fee set forth in 37 CFR 1.17(e) has been timely paid, the finality of the previous Office action has been withdrawn pursuant to 37 CFR 1.114. Applicant's submission filed on 07 August 2026 has been entered.
Formal Matters
Applicant’s claim amendments and arguments in the reply filed on 07 August 2026 are acknowledged and have been fully considered due to the entered request for continued examination. Claims 1-13 and 15 are pending. Claims 8-13 and 15 are under consideration in the instant office action. Claim 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention an/or species, there being no allowable generic or linking claims.
Withdrawn Objections/Rejections
Rejections and/or objections not reiterated from the previous office actions are hereby withdrawn as are those rejections and/or objections expressly stated to be withdrawn.
New Objections/Rejections-Necessitated by Amendments
Claim Objections
Claim 8 in the preamble recites “a … formulation comprising particles, wherein said solid formulation consists of….” The double transition is awkward. Amend to a single consistent form, e.g., “A cold-liquid wettable solid particulate formulation consisting of particles of: (i) … and (ii) ….” Additionally, “Cold-liquid wettable” should be hyphenated consistently or rewritten as “wettable in a cold liquid.” Furthermore, the recitation “said polysorbate 80 is not diluted in water or another solvent and is not mixed with another wetting agent” is process language in a product claim and should be placed so it is clear it is intended as a product limitation, or deleted if it is only a method of making.
Claim 9 is not a complete sentence and lacks a proper transitional phrase. It reads: “The formulation according to claim 8 and at least one … additive and/or excipient.” Amend to a recognized form, e.g., “The formulation of claim 8, further comprising at least one pharmaceutically, food-, or cosmetically acceptable additive or excipient.” (See also the § 112(d) rejection below; if the parent remains closed “consists of,” claim 9 cannot properly add a further ingredient.).
In claim 11 “powder or granules or tablets to be dissolved in water or in a water-based liquid or mouth dissolvable powder or granules” is run-on. Amend for parallel structure, e.g., “in the form of a powder, granules, or tablets for dissolution in water or a water-based liquid, or in the form of a mouth-dissolvable powder or granules.”
In claim 12 “adsorbed on and spread inhomogeneously or partially homogeneously over” is ungrammatical. Applicant should amend e.g., “adsorbed on, and spread homogeneously or partially homogeneously over, at least a portion of the outer surface of the particles.”
The claims jump from 13 to 15. Renumber or account for canceled claim 14 in the listing of claims.
Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of the first paragraph of 35 U.S.C. 112(a):
(a) IN GENERAL.—The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor or joint inventor of carrying out the invention.
The following is a quotation of the first paragraph of pre-AIA 35 U.S.C. 112:
The specification shall contain a written description of the invention, and of the manner and process of making and using it, in such full, clear, concise, and exact terms as to enable any person skilled in the art to which it pertains, or with which it is most nearly connected, to make and use the same, and shall set forth the best mode contemplated by the inventor of carrying out his invention.
Claim 8 (and claims 9–13 and 15 by dependence) are rejected under 35 U.S.C. § 112(a) as failing to comply with the written description requirement if the specification does not describe, as originally filed: a solid formulation that consists of only PEA and PS80 in the 90–95/5–10 window; and PS80 applied neat (not diluted in water or another solvent) and not combined with any other wetting agent. The specification’s working examples use diluted PS80, a second surfactant, or additional excipients in the “solid formulation,” the present closed claim and the negative limitations are new matter relative to the original disclosure.
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 8-13 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.
Claim 8 recites that the solid formulation consists of (i) PEA from 90% to 95% by weight and (ii) polysorbate 80 from 5% to 10% by weight, based on the total weight of the solid formulation. Because “consists of” excludes any third component, the two percentages must total 100%. Several pairings that literally fall inside both ranges do not total 100% (e.g., 90% PEA + 5% PS80 = 95%; 95% PEA + 10% PS80 = 105%). A person of ordinary skill cannot determine which combinations are inside the claim: every value in each range, or only complementary pairs (90/10 through 95/5). That ambiguity renders claim 8 indefinite. See MPEP 2173.05(c). Dependent claims 9–13 and 15 inherit the defect. Claims 13 and 15 recite complementary pairs (about 90/10; 90/10, 93/7, 95/5) and would cure the range problem if rewritten in independent form or if claim 8 were amended to require that the two amounts sum to 100%.
Regarding the negative limitation recitation “not diluted … and not mixed with another wetting agent” (claim 8; claims 9–13 and 15 by dependence). Claim 8 requires that “said polysorbate 80 is not diluted in water or another solvent and is not mixed with another wetting agent.” (a) “Another solvent.” There is no prior recitation of a first solvent. It is unclear whether “another” means any solvent other than water, or a solvent other than some unrecited first solvent. (b) Product vs. process. The claim is a composition claim. Dilution and mixing are process steps. It is unclear whether the claim is limited to a product in which PS80, as it exists in the finished particles, is undiluted and is the sole wetting agent, or whether it is limited only by how PS80 was handled before or during manufacture. Process limitations in product claims are definite only to the extent they identify a structural or compositional feature of the product. Here one of ordinary skill in the art cannot tell what structure is required beyond “PEA + PS80.” See MPEP 2173.05(p); In re Thorpe. (c) “Another wetting agent.” “Another” lacks a clear antecedent as to what counts as a wetting agent besides PS80 (e.g., whether residual moisture, PEA itself, or an impurity is excluded).
The preamble functional term “cold-liquid wettable” does not specify the liquid, the temperature that is “cold,” the test method, or the degree of wetting required. On this record it is unclear whether the phrase is merely intended use or a required property and, if the latter, how infringement would be determined. See MPEP 2173.05(g).
Claim 9 recites “The formulation according to claim 8 and at least one acceptable pharmaceutical, food or cosmetic grade additive and/or excipient.”(a) There is no transitional phrase. It is unclear whether the additive is part of the claimed formulation, packaged with it, or merely contemplated.(b) Claim 8 consists of only PEA and PS80. Claim 9 adds at least one further ingredient. One of ordinary skill in the art cannot determine the metes and bounds of claim 9 (closed two-component product vs. open product with excipients). (c) “Acceptable pharmaceutical, food or cosmetic grade” is a trailing modifier; it is unclear whether “acceptable” applies to all three grades or only to “pharmaceutical.”
In claim 11— alternative forms: “[I]n the form of a powder or granules or tablets to be dissolved in water or in a water-based liquid or mouth dissolvable powder or granules” does not make clear: whether “to be dissolved in water or in a water-based liquid” modifies tablets only, or also powder/granules; whether “mouth dissolvable powder or granules” is a further alternative to the water-dissolved forms or a restatement of the same powder/granules; and what “mouth dissolvable” requires (disintegration time, medium, etc.).
Claim 12 recites “[S]pread inhomogeneously or partially homogeneously over at least a portion of the outer surface” mixes three vague degree terms. “Partially homogeneously” has no ordinary meaning in this art (homogeneous over part of the surface vs. a non-uniform coating). Combined with “at least a portion,” the claim covers everything from a continuous uniform coat to a trace of PS80 on one region of one particle. Furthermore, the phrase “inhomogeneously” is unclear. The specification as applied in this action does not supply a standard.
Claim 13 recites “about 10%” PS80 and “about 90%” PEA in a formulation that consists of those two components. “About” introduces an unstated tolerance. If “about 90%” can be 89% or 91%, the companion “about 10%” cannot keep the composition at 100% without a third component or a corresponding adjustment that is not claimed. The scope of “about” in this closed system is indefinite.
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claims 9–11 are rejected under 35 U.S.C. § 112(d) as being of improper dependent form for failing to further limit the subject matter of the claim upon which they depend, or for failing to include all the limitations of that claim.
Claim 8 states that the solid formulation consists of PEA and polysorbate 80 only.Claim 9 recites the formulation of claim 8 and at least one additive and/or excipient. That added component is excluded by the “consists of” language of claim 8. Claim 9 therefore does not incorporate all limitations of claim 8 and does not further limit claim 8; it attempts to enlarge the closed composition. Claims 10 and 11 depend from claim 9 and are rejected for the same reason.Applicant may cancel claims 9–11, amend claim 8 to “comprising” (or “consisting essentially of,” if supported), or rewrite claim 9 as an independent claim that does not depend from a closed two-component claim.
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.
Claims 8-11 remain rejected under 35 U.S.C. 103 as being unpatentable over KOKKINIS et al. (WO 2018/187849, previously cited).
Applicants’ claims
Applicant claims a cold-liquid wettable solid particulate formulation consisting of (i) palmitoylethanolamide (PEA) from 90% to 95% by weight and (ii) polysorbate 80 from 5% to 10% by weight, wherein the polysorbate 80 is not diluted in water or another solvent and is not mixed with another wetting agent. Dependent claims add an additive/excipient and product type/form (claims 9–11), adsorption of polysorbate 80 on the particle surface (claim 12), and the specific ratios about 90/10, 90/10, 93/7, and 95/5 (claims 13 and 15).
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
Kokkinis teaches a cold-water-dispersible chemical delivery system (title). Hydrophobic compounds are poorly dispersible in liquids; Kokkinis prepares liquid-dispersible compositions by combining a solid substance comprising the hydrophobic compound with a dispersing agent while applying a shear force (abstract; claim 1), including high-shear mixing (claim 2). The solid substance may be a powder (claim 3).The hydrophobic compound includes a fatty acid ethanolamide (claim 5), specifically palmitoylethanolamide (PEA) (claim 6; see also paragraphs 0048, 0059 and Example 7). The dispersing agent may comprise a surfactant, a carrier oil, and/or a solvent (claim 18). Surfactants include polysorbate 80 (paragraphs 0029–0031). The dispersing agent may comprise one or more surfactants, with total surfactant 5% (w/w)–99% (w/w), preferably 10–90%, and in other embodiments 5–15%, 10–25%, 20–75%, or 50–75% (paragraphs 0029–0030). Kokkinis expressly teaches that the dispersing agent “may only comprise one surfactant” (paragraph 0030). In a further embodiment the dispersing agent comprises two or more surfactants selected from a list that includes polysorbate 80, each at 0.5–70% (w/w) (paragraph 0031). Uses include dietary supplements, nutraceuticals, and pharmaceuticals (¶ 0063). The compositions may further comprise suitable excipients or additives and may be in the form of tablets, filled capsules, liquids, or free-flowing powders (paragraph 0072). Example 7 prepares a PEA composition from 9.39 kg PEA and 0.61 kg dispersing agent (plus 0.1 kg colloidal silica) by high-shear mixing while the dispersing agent is spray-added (Example 7). That PEA charge is already on the order of ~93% of the PEA-plus-dispersing-agent mass before silica.
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
Kokkinis does not, in a single working example, show a solid formulation that consists of only PEA and polysorbate 80 at 90–95% / 5–10% by weight, with an express statement that the polysorbate 80 was not diluted in water or another solvent and was not mixed with another wetting agent. That difference is addressed by the prima facie showing below.
Finding of Prima Facie Obviousness Rational and Motivation
(MPEP 2142-2143)
It would have been prima facie obvious to a person of ordinary skill in the art before the effective filing date to produce the claimed invention from the teachings of Kokkinis by incorporating PEA powder + polysorbate 80 as the sole dispersing surfactant becauseKokkinis identifies PEA as the hydrophobic solid to be made cold-liquid-dispersible and identifies polysorbate 80 as a suitable dispersing surfactant. The same passage teaches that the dispersing agent may comprise only one surfactant (paragraph 0030). Selecting PEA as the solid and polysorbate 80 as that single surfactant is the selection of known materials for their known functions: PEA as the active hydrophobic powder; polysorbate 80 as a nonionic wetting/dispersing agent. That selection is obvious. Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327 (1945); MPEP 2144.07. One of ordinary skill in the art is not required to use two surfactants. The prior Office mapping to a PS20/PS80 mixture addressed an earlier claim construction. Amended claim 8 is a binary PEA/PS80 product. That binary product is the single-surfactant embodiment Kokkinis already teaches. Example 7’s use of Etocas 35 plus oils and lecithin is a preferred multi-component dispersing agent. Preferred embodiments do not teach away from a broader or non-preferred embodiment. In re Susi, 440 F.2d 442 (CCPA 1971). Disclosure of alternatives is not a teaching away unless the reference criticizes, discredits, or discourages the claimed solution. In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Kokkinis does not criticize polysorbate 80 used alone. With regard to amounts of ingredients 90–95% PEA and 5–10% polysorbate 80, Kokkinis places total surfactant in the dispersing agent in ranges of 5–99%, including 5–15% and 10–25% (paragraphs 0029–0030). Those ranges overlap the claimed 5–10% polysorbate 80. Overlapping ranges support a prima facie case of obviousness. In re Wertheim, 541 F.2d 257 (CCPA 1976); In re Woodruff, 919 F.2d 1575 (Fed. Cir. 1990); MPEP 2144.05(I). High PEA loading follows from using a small amount of surfactant as a surface wetting aid rather than as a bulk carrier. Example 7 already uses a PEA-majority charge (~9.39 kg PEA / 0.61 kg dispersing agent). Optimizing the PEA:surfactant ratio to keep a free-flowing powder that still wets in cold liquid is routine. Claims 13 and 15 (about 90/10; 90/10, 93/7, 95/5) are points inside the overlapping range and are obvious absent evidence that those points are critical. Regarding the recitation “Not diluted in water or another solvent and not mixed with another wetting agent” these negatives do not patentably distinguish the product.Kokkinis claim 1 combines the solid hydrophobic substance with the dispersing agent under shear. Liquid polysorbate 80 may be used as the surfactant itself. The single-surfactant embodiment of paragraph 0030 is, by definition, not mixed with another wetting agent. Nothing in Kokkinis requires that the sole surfactant first be diluted in water or a co-solvent.To the extent Applicant treats these clauses as product-by-process limitations, patentability is determined by the product, not the method of making it. “[E]ven 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 (Fed. Cir. 1985); Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n.14 (Fed. Cir. 2009); MPEP 2113. A PEA particulate solid surface-wetted with polysorbate 80 is the product one of ordinary skill in the art would expect from shear-combining PEA powder with polysorbate 80. With regard to the recitations “adsorbed / spread on the outer particle surface” high-shear combination of liquid surfactant with PEA powder (Kokkinis claims 1–3; Example 7 spray-addition under shear) would reasonably result in polysorbate 80 being adsorbed on and spread over at least a portion of the particle surface. The surface-location language does not distinguish the product. With regard to the recitations in claims 9-11 additive, product type, and form Kokkinis teaches that the compositions may further comprise suitable excipients or additives and may be used as dietary supplements, nutraceuticals, and/or pharmaceuticals, in the form of tablets, capsules, or free-flowing powders (paragraphs 0063, 0072). Those teachings meet claims 9–11 to the extent those claims are given effect despite the § 112(d) conflict with the closed “consists of” parent. Kokkinis’s stated objective is cold-liquid dispersibility of hydrophobic solids, expressly including PEA powder, using a listed nonionic surfactant, which may be a single surfactant, including polysorbate 80. One of ordinary skill in the art would have expected PEA particles treated with 5–10% polysorbate 80 to wet in cold aqueous liquid. That is the established function of the selected materials used as Kokkinis directs. KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 417, 421 (2007) (“predictable use of prior art elements according to their established functions”; a person of ordinary skill is a person of ordinary creativity, not an automaton). The analysis need not seek a precise teaching of the exact claim. Id. at 418. No unexpected results comparing the closed 90–95 / 5–10 PEA/polysorbate 80 solid to the closest Kokkinis PEA/single-surfactant or PEA-majority embodiment are of record. In the absence of such evidence, the invention as a whole would have been obvious. In re Baxter Travenol Labs., 952 F.2d 388 (Fed. Cir. 1991); MPEP 716.02(e).
In light of the foregoing, the subject matter of claims 8–13 and 15 would have been obvious within the meaning of 35 U.S.C. § 103. The invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date, as evidenced by Kokkinis, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 07 August 2026 have been fully considered but they are not persuasive.
Applicant argues the Office must show every element, a reason to combine, and predicted success.
The above assertions are not found persuasive because that is the correct legal framework. It is met. Kokkinis is a single reference. The question is not combination of two documents; it is whether one of ordinary skill in the art, reading Kokkinis as a whole, would have found the claimed product obvious. Kokkinis already places in one disclosure: (i) solid/powder PEA, (ii) polysorbate 80 as a dispersing surfactant, (iii) a dispersing agent that may comprise only one surfactant, (iv) total surfactant including 5–15 wt% and 10–25 wt%, and (v) combining the solid PEA with the dispersing agent under shear to make a cold-water-dispersible powder. That is every structural element of claim 8. Predicted success follows from Kokkinis’s stated purpose—wetting/dispersing hydrophobic PEA in cold liquid with a listed nonionic surfactant. KSR, 550 U.S. at 417, 421 (“predictable use of prior art elements according to their established functions”; one of ordinary skill in the art is a person of ordinary creativity).
Applicant argues there is no reason one of ordinary skill in the art would have selected a closed PEA/PS80 formulation, undiluted, without other wetting agents, in the 90–95 / 5–10 window, from Kokkinis’s broader disclosure.
The above assertions are not found persuasive because Applicant treats the breadth of Kokkinis as if it were a teaching away. It is not. (a) Closed PEA + single surfactant. Kokkinis paragraph 0030 states the dispersing agent “may only comprise one surfactant.” PS80 is on the list (paragraphs 0029–0031). PEA is the named hydrophobic solid (claims 5–6; Example 7). Selecting one listed surfactant for one named hydrophobic powder is Sinclair & Carroll/MPEP 2144.07, not an undisclosed combination. “Consists of” PEA + PS80 is the single-surfactant embodiment Kokkinis already contemplates. A genus does not have to work an example of every species. Merck v. Biocraft, 874 F.2d 804, 807 (Fed. Cir. 1989); MPEP 2144.08. Example 7’s use of Etocas 35 + oils + lecithin is a preferred multi-component dispersing agent; preferred embodiments do not teach away from a broader or non-preferred embodiment (mere disclosure of alternatives is not a teaching away unless the reference criticizes, discredits, or discourages the claimed solution). Kokkinis does not criticize PS80 alone. (b) Not diluted / not mixed with another wetting agent. These are negative limitations. Kokkinis claim 1 combines a solid hydrophobic substance with the dispersing agent under shear. Liquid polysorbate 80 is conventionally used neat or as the surfactant phase; nothing in Kokkinis requires predilution in water or a co-solvent, or a second wetting agent, when the single-surfactant embodiment of ¶ 0030 is used. Exclusion of a second wetting agent is that embodiment. Even if the negatives are read as product-by-process, patentability is of the product. In re Thorpe, 777 F.2d 695, 697 (Fed. Cir. 1985); MPEP 2113. A PEA particle surface-wetted with PS80 is the product a POSA would expect from shear-mixing PEA powder with PS80. (c) 90–95% PEA / 5–10% PS80. Kokkinis places total surfactant in the dispersing agent at 5–99%, including 5–15% and 10–25% (¶¶ 0029–0030). Those ranges overlap claimed 5–10% PS80. Overlapping ranges are prima facie obvious. In re Wertheim; In re Woodruff; MPEP 2144.05(I). High PEA loading (about 90%+) is the ordinary result of using surfactant as a surface wetting aid rather than as a bulk carrier. Example 7 itself is already PEA-majority: 9.39 kg PEA + 0.61 kg dispersing agent + 0.1 kg silica (~93% PEA before silica). A POSA optimizing a free-flowing, cold-liquid-wettable PEA powder would have arrived at ~5–10% PS80 by routine experimentation. Applicant has not shown criticality of 90–95 / 5–10 versus the overlapping Kokkinis bands. (d) “Broader and more open-ended” is not a defense. Obviousness does not require a blueprint of the exact claim. KSR, 550 U.S. at 418. Picking PEA, picking PS80 from the Markush list, using it alone, and landing in an overlapping weight band is the predictable exercise of ordinary skill, not hindsight.
Applicant argues the Office has not shown the combination would be a predicted success.
The above assertions are not found persuasive because Kokkinis’s entire invention is a method of making hydrophobic solids, expressly including PEA powder, cold-water-dispersible by combining them with a dispersing agent that may be a single listed surfactant, including PS80. Success in wetting PEA with PS80 is the result Kokkinis already attributes to that class of agents. Applicant points to no property of a binary PEA/PS80 90–95/5–10 solid that a POSA would have expected to fail. There is no contrary teaching, no inoperability argument, and no comparative data.
Applicant argues new claims 12–15 are patentable for the same reasons.
The above assertions are not found persuasive because claim 12 (PS80 adsorbed/spread on at least part of the particle surface) is the expected result of shear-combining liquid PS80 with PEA powder (Kokkinis claims 1–3). Claims 13 and 15 reciting about 90/10 and the species 90/10, 93/7, and 95/5 are points inside the overlapping range and are obvious absent evidence of unexpected results. MPEP 2144.05. Applicant offered none.
Claims 8–13 and 15 are rejected under 35 U.S.C. § 103 as being unpatentable over Kokkinis et al. (WO 2018/187849, previously cited). This is a new ground only insofar as the rationale is recast to the amended closed PEA/polysorbate 80 claim. The same reference is applied.
Conclusion
No claims are allowed.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
