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 .
Formal Matters
Applicant’s arguments in the reply filed on 07 November 2025 are acknowledged and have been fully considered. Claims 1-11 are pending. Claims 8-11 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 Claim 1-7 are withdrawn from further consideration pursuant to 37 CFR 1.142(b) as being drawn to a nonelected invention an/or species, there being no allowable generic or linking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. Applicant’s arguments did not overcome the rejections set forth in the previous office action under 35 USC 103 for reasons described in the previous office action and herein below.
Rejections Maintained
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
Applicants claim a cold-liquid wettable solid formulation.
Determination of the Scope and Content of the Prior Art
(MPEP 2141.01)
KOKKINIS et al. teach cold-water-dispersible chemical delivery system (see title). KOKKINIS et al. teach the use of hydrophobic compounds for oral administration is limited due to the inability of the compounds to disperse in liquids. The present invention relates generally to a method of preparing compositions comprising hydrophobic compounds that can be dispersed in liquid. In particular, the method relates to combining a solid substance comprising a hydrophobic compound with a dispersing agent under high shear (see abstract). A method of preparing a liquid dispersible composition comprising a hydrophobic compound and a dispersing agent, the method comprising the step of combining a solid substance comprising the hydrophobic compound with the dispersing agent whilst applying a shear force (see claim 1). The method of claim 1 wherein said shear force is created by high shear mixing (see claim 2). The method of claim 1 or claim 2, wherein the solid substance is a powder (see claim 3). The method of any one of claims 1 to 3, wherein the hydrophobic compound is a fatty acid ethanolamide (see claim 5). The method of claim 5, wherein the fatty acid ethanolamide is palmitoyiethanolamide (PEA) (see claim 6). The method of any one of claims 1 to 17, wherein the dispersing agent comprises two or more components selected from the group consisting of a surfactant, a carrier oil, and a solvent (see claim 18). The method of any one of claims 1 to 18, wherein the dispersing agent comprises 30% (w/w) - 90% (w/w) surfactant (see claim 19). The surfactant may be selected from the group consisting of hydrogenated castor oil, lecithin, macrogolglycerol hydroxystearate, oat oil polar lipids, phosphatidylcholine, poloxamers, polyoxyl 35 castor oil, polyoxyl 40 castor oil, polysorbate 20, polysorbate 60, polysorbate 80, polyglycerol polyricinoleate, D-alpha-tocopherol polyethylene glycol 1000 succinate (TPGS), glyceryl monooleate and polyglycerol esters of fatty acids. In preferred embodiments of the invention, the dispersing agent comprises a non-ionic surfactant and/or a phospholipid surfactant. The dispersing agent may comprise one or more surfactants, wherein the total amount of surfactant in the dispersing agent is 5% (w/w) - 99% (w/w). Preferably, the total amount of surfactant in the dispersing agent is 10% (w/w) - 90% (w/w). In other embodiments, the total amount of surfactant in the dispersing agent is 50% (w/w) - 75% (w/w), or 10% (w/w) - 25% (w/w), 50% (w/w) - 99% (w/w), 20% (w/w) - 75% (w/w), 5% (w/w) - 15% (w/w). For example, the dispersing agent may comprise about 0.5% (w/w) - 10 % (w/w) of one or more phospholipid surfactants and 60% (w/w) - 99% (w/w) of one or more non- ionic surfactants, or the dispersing agent may comprise a total of at least about 2.5% (w/w) - 10 % (w/w) phospholipid surfactants and a total of at least 70% (w/w) - 99% (w/w) of non- ionic surfactants. In other examples, the dispersing agent may only comprise one surfactant at about 50% (w/w) - 70% (w/w), or dispersing agent may comprise about 0.2% (w/w) - 10 % (w/w) of one surfactant such as lecithin and 60% (w/w) - 99% (w/w) of a different surfactant, such as hydrogenated castor oil or a derivative or precursor thereof (see paragraphs 0029-0030). In other examples, the dispersing agent may comprise 60% (w/w) - 99% (w/w) hydrogenated castor oil, 0.2% (w/w/) - 2.5% (w/w) lecithin or oat oil, and/or 0.5% (w/w) - 5% (w/w) glyceryl monooleate, or the dispersing agent may comprise 5% (w/w) - 50% (w/w) phospholipid surfactant, and 0.5% (w/w) - 5% (w/w) of a different surfactant. In a further example, the dispersing agent comprises two or more surfactants selected from the group consisting of hydrogenated castor oil, lecithin, macrogolglycerol hydroxystearate, oat oil, polar lipids, phosphatidylcholine, poloxamers, polyoxyl 35 castor oil, polyoxyl 40 castor oil, polysorbate 20, polysorbate 60, polysorbate 80, polyglycerol polyricinoleate, D-alpha- tocopherol polyethylene glycol 1000 succinate (TPGS), glyceryl monooleate and polyglycerol esters of fatty acids, wherein each of the surfactants are present at a concentration of 0.5% (w/w) - 70% (w/w) (see paragraph 0031). Non-limiting uses for the liquid dispersible compositions produced by the method of the invention include dietary supplements, nutraceuticals and/or pharmaceuticals. A dietary supplement may be any product intended to supplement the diet and improve health and wellness. A nutraceutical may be any product derived from animal or plant sources with extra health benefits in addition to the basic nutritional value found in foods, and may be used to promote general well-being, control minor symptoms of disease and disorders and prevent malignant processes. In general, pharmaceuticals are synthetic or imitations of natural substances that the body needs to manufacture or utilize to maintain health and fight disease and disorders. The skilled addressee would also appreciate that dietary supplements, nutraceuticals and pharmaceutical are distinguishable by the regulatory thresholds they must meet (see paragraph 0063). The liquid dispersible compositions and medicaments of the present are generally for oral administration and may be in any form and further comprise suitable excipients or additives. The forms that may be employed, include, but are not limited to, tablets or filled capsules, or liquids such as suspensions, emulsions, elixirs, or capsules filled with the same, or free flowing powders (paragraph 0072).
Ascertainment of the Difference Between Scope of the Prior Art and the Claims
(MPEP 2141.02)
KOKKINIS et al. do not teach in a single embodiment or example a composition of PEA with a mixture of polysorbate 20 and polysorbate 80. This is addressed by the prima facie argument set forth 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 before the effective filing date of the instant invention to produce the instant invention by following the teachings of KOKKINIS et al. KOKKINIS et al. Cold-water-dispersible chemical delivery system (see title). KOKKINIS et al. teach the use of hydrophobic compounds for oral administration is limited due to the inability of the compounds to disperse in liquids. The present invention relates generally to a method of preparing compositions comprising hydrophobic compounds that can be dispersed in liquid. In particular, the method relates to combining a solid substance comprising a hydrophobic compound with a dispersing agent under high shear (see abstract). A method of preparing a liquid dispersible composition comprising a hydrophobic compound and a dispersing agent, the method comprising the step of combining a solid substance comprising the hydrophobic compound with the dispersing agent whilst applying a shear force (see claim 1). The method of claim 1 wherein said shear force is created by high shear mixing (see claim 2). The method of claim 1 or claim 2, wherein the solid substance is a powder (see claim 3). The method of any one of claims 1 to 3, wherein the hydrophobic compound is a fatty acid ethanolamide (see claim 5). The method of claim 5, wherein the fatty acid ethanolamide is palmitoyiethanolamide (PEA) (see claim 6). The method of any one of claims 1 to 17, wherein the dispersing agent comprises two or more components selected from the group consisting of a surfactant, a carrier oil, and a solvent (see claim 18). The method of any one of claims 1 to 18, wherein the dispersing agent comprises 30% (w/w) - 90% (w/w) surfactant (see claim 19). The surfactant may be selected from the group consisting of hydrogenated castor oil, lecithin, macrogolglycerol hydroxystearate, oat oil polar lipids, phosphatidylcholine, poloxamers, polyoxyl 35 castor oil, polyoxyl 40 castor oil, polysorbate 20, polysorbate 60, polysorbate 80, polyglycerol polyricinoleate, D-alpha-tocopherol polyethylene glycol 1000 succinate (TPGS), glyceryl monooleate and polyglycerol esters of fatty acids. In preferred embodiments of the invention, the dispersing agent comprises a non-ionic surfactant and/or a phospholipid surfactant. The dispersing agent may comprise one or more surfactants, wherein the total amount of surfactant in the dispersing agent is 5% (w/w) - 99% (w/w). Preferably, the total amount of surfactant in the dispersing agent is 10% (w/w) - 90% (w/w). In other embodiments, the total amount of surfactant in the dispersing agent is 50% (w/w) - 75% (w/w), or 10% (w/w) - 25% (w/w), 50% (w/w) - 99% (w/w), 20% (w/w) - 75% (w/w), 5% (w/w) - 15% (w/w). For example, the dispersing agent may comprise about 0.5% (w/w) - 10 % (w/w) of one or more phospholipid surfactants and 60% (w/w) - 99% (w/w) of one or more non- ionic surfactants, or the dispersing agent may comprise a total of at least about 2.5% (w/w) - 10 % (w/w) phospholipid surfactants and a total of at least 70% (w/w) - 99% (w/w) of non- ionic surfactants. In other examples, the dispersing agent may only comprise one surfactant at about 50% (w/w) - 70% (w/w), or dispersing agent may comprise about 0.2% (w/w) - 10 % (w/w) of one surfactant such as lecithin and 60% (w/w) - 99% (w/w) of a different surfactant, such as hydrogenated castor oil or a derivative or precursor thereof (see paragraphs 0029-0030). In other examples, the dispersing agent may comprise 60% (w/w) - 99% (w/w) hydrogenated castor oil, 0.2% (w/w/) - 2.5% (w/w) lecithin or oat oil, and/or 0.5% (w/w) - 5% (w/w) glyceryl monooleate, or the dispersing agent may comprise 5% (w/w) - 50% (w/w) phospholipid surfactant, and 0.5% (w/w) - 5% (w/w) of a different surfactant. In a further example, the dispersing agent comprises two or more surfactants selected from the group consisting of hydrogenated castor oil, lecithin, macrogolglycerol hydroxystearate, oat oil, polar lipids, phosphatidylcholine, poloxamers, polyoxyl 35 castor oil, polyoxyl 40 castor oil, polysorbate 20, polysorbate 60, polysorbate 80, polyglycerol polyricinoleate, D-alpha- tocopherol polyethylene glycol 1000 succinate (TPGS), glyceryl monooleate and polyglycerol esters of fatty acids, wherein each of the surfactants are present at a concentration of 0.5% (w/w) - 70% (w/w) (see paragraph 0031). Non-limiting uses for the liquid dispersible compositions produced by the method of the invention include dietary supplements, nutraceuticals and/or pharmaceuticals. A dietary supplement may be any product intended to supplement the diet and improve health and wellness. A nutraceutical may be any product derived from animal or plant sources with extra health benefits in addition to the basic nutritional value found in foods, and may be used to promote general well-being, control minor symptoms of disease and disorders and prevent malignant processes. In general, pharmaceuticals are synthetic or imitations of natural substances that the body needs to manufacture or utilize to maintain health and fight disease and disorders. The skilled addressee would also appreciate that dietary supplements, nutraceuticals and pharmaceutical are distinguishable by the regulatory thresholds they must meet (see paragraph 0063). The liquid dispersible compositions and medicaments of the present are generally for oral administration and may be in any form and further comprise suitable excipients or additives. The forms that may be employed, include, but are not limited to, tablets or filled capsules, or liquids such as suspensions, emulsions, elixirs, or capsules filled with the same, or free flowing powders (paragraph 0072). The selection of a known material such as the mixture of polysorbate 20 and polysorbate 80 from the teachings of KOKKINIS et al. based on its suitability (being dispersing agent) for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) The examiner also brings applicant’s attention that the concept of picking any of the dispersing agent from the Markush list of KOKKINIS et al. is prima facie obvious and is within the purview of one of ordinary skill in the art as the specific combination of features claimed are taught by KOKKINIS et al. If applicants resort to argue the reference does not provide any motivation to select this specific dispersing agents, 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. One of ordinary skill in the art would have had a reasonable expectation of success in producing the instant invention by following the teachings of the teachings of KOKKINIS et al. because KOKKINIS et al. a substantially identical or similar composition. It should be noticed that claim 8 is written in a product-by-process format. "[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, 227 USPQ 964, 966 (Fed. Cir. 1985) (citations omitted) (Claim was directed to a novolac color developer. The process of making the developer was allowed. The difference between the inventive process and the prior art was the addition of metal oxide and carboxylic acid as separate ingredients instead of adding the more expensive pre-reacted metal carboxylate. The product-by-process claim was rejected because the end product, in both the prior art and the allowed process, ends up containing metal carboxylate. The fact that the metal carboxylate is not directly added, but is instead produced in-situ does not change the end product.). Furthermore, "[b]ecause validity is determined based on the requirements of patentability, a patent is invalid if a product made by the process recited in a product-by-process claim is anticipated by or obvious from prior art products, even if those prior art products are made by different processes." Amgen Inc. v. F. Hoffmann-La Roche Ltd., 580 F.3d 1340, 1370 n. 14, 92 USPQ2d 1289, 1312, n. 14 (Fed. Cir. 2009). See also Biogen MA Inc. v. EMD Serono, Inc., 976 F.3d 1326, 1334, 2020 USPQ2d 11129 (Fed. Cir. 2020) ("Biogen is certainly correct that the scope of composition and method of treatment claims is generally subject to distinctly different analyses. But where, as here, the novelty of the method of administration rests wholly on the novelty of the composition administered, which in turn rests on the novelty of the source limitation, the Amgen analysis will necessarily result in the same conclusion on anticipation for both forms of claims."); United Therapeutics Corp. v Liquidia Techs., Inc., 74 F.4th 1360, 1373, 2023 USPQ2d 862 (Fed. Cir. 2023) (the court held that product-by-process claims were properly rejected as "anticipated by a disclosure of the same product irrespective of the processes by which they are made."); and Purdue Pharma v. Epic Pharma, 811 F.3d 1345, 117 USPQ2d 1733 (Fed. Cir. 2016). However, in the context of an infringement analysis, a product-by-process claim is only infringed by a product made by the process recited in the claim. Id. at 1370 ("a product in the prior art made by a different process can anticipate a product-by-process claim, but an accused product made by a different process cannot infringe a product-by-process claim").
In light of the forgoing discussion, the Examiner concludes that the subject matter defined by the instant claims would have been obvious within the meaning of 35 USC 103. Therefore, the invention as a whole was prima facie obvious to one of ordinary skill in the art before the effective filing date of the instant invention, as evidenced by the references, especially in the absence of evidence to the contrary.
Response to Arguments
Applicant's arguments filed 07 November 2025 have been fully considered but they are not persuasive.
Applicant argues in particular, the use of PEA as a hydrophobic compound is explicitly described in [0048], [0059], and Example 7, and both polysorbate 20 and polysorbate 80 are listed among the preferred surfactants in [0029] but as alternative to each other. With regard to the specific combination of PEA + mixture of polysorbate 20 and 80, Example 7 (batch no. MT20170615_01) describes a PEA formulation using Etocas 35 as the main surfactant (97% w/w). Etocas 35 is an ethoxylated hydrogenated castor oil, not a polysorbate. The formulation also includes lecithin, lime oil, olive oil, vitamin E acetate, and oat oil. There is no explicit example in WO'849 that combines PEA with polysorbate 20 and polysorbate 80 in the same formulation. It follows that claim 8 is novel at least for this reason. The use of the singular "a dispersing agent," combined with the subsequent claim 19 ("the dispersing agent comprises 30-90% (w/w) surfactant"), unequivocally confirms that the patent describes formulations based on a single surfactant. No part of the text suggests or supports the simultaneous use of multiple surfactants; on the contrary, WO'849 teaches to avoid it - constituting a clear teaching away from the PS20 + PS80 combination. The expression "selected from" indicates an alternative selection, not a simultaneous combination. WO'849 does not provide any guidance on how to combine polysorbates, or how to optimize HLB for ingredients.
The above assertions are not found persuasive because first KOKKINIS et al. teach a method of preparing a liquid dispersible composition comprising a hydrophobic compound and a dispersing agent, the method comprising the step of combining a solid substance comprising the hydrophobic compound with the dispersing agent whilst applying a shear force (see claim 1). The transitional term "comprising", which is synonymous with "including," "containing," or "characterized by," is inclusive or open-ended and does not exclude additional, unrecited elements or method steps. See, e.g., Mars Inc. v. H.J. Heinz Co., 377 F.3d 1369, 1376, 71 USPQ2d 1837, 1843 (Fed. Cir. 2004) ("[L]ike the term ‘comprising,’ the terms ‘containing’ and ‘mixture’ are open-ended."). Invitrogen Corp. v. Biocrest Manufacturing, L.P., 327 F.3d 1364, 1368, 66 USPQ2d 1631, 1634 (Fed. Cir. 2003) ("The transition ‘comprising’ in a method claim indicates that the claim is open-ended and allows for additional steps."); Genentech, Inc. v. Chiron Corp., 112 F.3d 495, 501, 42 USPQ2d 1608, 1613 (Fed. Cir. 1997) ("Comprising" is a term of art used in claim language which means that the named elements are essential, but other elements may be added and still form a construct within the scope of the claim.); Moleculon Research Corp. v. CBS, Inc., 793 F.2d 1261, 229 USPQ 805 (Fed. Cir. 1986); In re Baxter, 656 F.2d 679, 686, 210 USPQ 795, 803 (CCPA 1981); Ex parte Davis, 80 USPQ 448, 450 (Bd. App. 1948) ("comprising" leaves "the claim open for the inclusion of unspecified ingredients even in major amounts"). In Gillette Co. v. Energizer Holdings Inc., 405 F.3d 1367, 1371-73, 74 USPQ2d 1586, 1589-91 (Fed. Cir. 2005), the court held that a claim to "a safety razor blade unit comprising a guard, a cap, and a group of first, second, and third blades" encompasses razors with more than three blades because the transitional phrase "comprising" in the preamble and the phrase "group of" are presumptively open-ended. "The word ‘comprising’ transitioning from the preamble to the body signals that the entire claim is presumptively open-ended." Id. In contrast, the court noted the phrase "group consisting of" is a closed term, which is often used in claim drafting to signal a "Markush group" that is by its nature closed. Id. The court also emphasized that reference to "first," "second," and "third" blades in the claim was not used to show a serial or numerical limitation but instead was used to distinguish or identify the various members of the group. The examiner contends due to the use of the transitional phrase “comprising” that the inclusion of one or more hydrophobic compounds and one or more dispersing agents in the recited method is not excluded. Furthermore, contrary to Applicant’s assertions KOKKINIS et al. clearly teach a combination of polysorbate 20 and polysorbate 80. KOKKINIS et al. teach the method of claim 1 wherein said shear force is created by high shear mixing (see claim 2). The method of claim 1 or claim 2, wherein the solid substance is a powder (see claim 3). The method of any one of claims 1 to 3, wherein the hydrophobic compound is a fatty acid ethanolamide (see claim 5). The method of claim 5, wherein the fatty acid ethanolamide is palmitoyiethanolamide (PEA) (see claim 6). The method of any one of claims 1 to 17, wherein the dispersing agent comprises two or more components selected from the group consisting of a surfactant, a carrier oil, and a solvent (see claim 18). The method of any one of claims 1 to 18, wherein the dispersing agent comprises 30% (w/w) - 90% (w/w) surfactant (see claim 19). The dispersing agent may comprise one or more surfactants, wherein the total amount of surfactant in the dispersing agent is 5% (w/w) - 99% (w/w). Preferably, the total amount of surfactant in the dispersing agent is 10% (w/w) - 90% (w/w). In other embodiments, the total amount of surfactant in the dispersing agent is 50% (w/w) - 75% (w/w), or 10% (w/w) - 25% (w/w), 50% (w/w) - 99% (w/w), 20% (w/w) - 75% (w/w), 5% (w/w) - 15% (w/w). For example, the dispersing agent may comprise about 0.5% (w/w) - 10 % (w/w) of one or more phospholipid surfactants and 60% (w/w) - 99% (w/w) of one or more non- ionic surfactants, or the dispersing agent may comprise a total of at least about 2.5% (w/w) - 10 % (w/w) phospholipid surfactants and a total of at least 70% (w/w) - 99% (w/w) of non- ionic surfactants. In other examples, the dispersing agent may only comprise one surfactant at about 50% (w/w) - 70% (w/w), or dispersing agent may comprise about 0.2% (w/w) - 10 % (w/w) of one surfactant such as lecithin and 60% (w/w) - 99% (w/w) of a different surfactant, such as hydrogenated castor oil or a derivative or precursor thereof (see paragraphs 0029-0030). In a further example, the dispersing agent comprises two or more surfactants selected from the group consisting of hydrogenated castor oil, lecithin, macrogolglycerol hydroxystearate, oat oil, polar lipids, phosphatidylcholine, poloxamers, polyoxyl 35 castor oil, polyoxyl 40 castor oil, polysorbate 20, polysorbate 60, polysorbate 80, polyglycerol polyricinoleate, D-alpha- tocopherol polyethylene glycol 1000 succinate (TPGS), glyceryl monooleate and polyglycerol esters of fatty acids, wherein each of the surfactants are present at a concentration of 0.5% (w/w) - 70% (w/w) (see paragraph 0031). The combination of polysorbate 20 and polysorbate 80 is clearly taught by KOKKINIS et al. For KOKKINIS et al. to be a proper reference used for rejection under 35 USC 103, KOKKINIS et al. do not have to teach the claimed invention in anticipation manner or in a single embodiment. A reference may be relied upon for all that it would have reasonably suggested to one having ordinary skill in the art, including nonpreferred embodiments. Merck & Co. v. Biocraft Labs., Inc. 874 F.2d 804, 10 USPQ2d 1843 (Fed. Cir. 1989), cert. denied, 493 U.S. 975 (1989). See also Upsher-Smith Labs. v. Pamlab, LLC, 412 F.3d 1319, 1323, 75 USPQ2d 1213, 1215 (Fed. Cir. 2005) (reference disclosing optional inclusion of a particular component teaches compositions that both do and do not contain that component); Celeritas Technologies Ltd. v. Rockwell International Corp., 150 F.3d 1354, 1361, 47 USPQ2d 1516, 1522-23 (Fed. Cir. 1998) (The court held that the prior art anticipated the claims even though it taught away from the claimed invention. "The fact that a modem with a single carrier data signal is shown to be less than optimal does not vitiate the fact that it is disclosed."). Disclosed examples and preferred embodiments do not constitute a teaching away from a broader disclosure or nonpreferred embodiments. In re Susi, 440 F.2d 442, 169 USPQ 423 (CCPA 1971). "A known or obvious composition does not become patentable simply because it has been described as somewhat inferior to some other product for the same use." In re Gurley, 27 F.3d 551, 554, 31 USPQ2d 1130, 1132 (Fed. Cir. 1994) (The invention was directed to an epoxy impregnated fiber-reinforced printed circuit material. The applied prior art reference taught a printed circuit material similar to that of the claims but impregnated with polyester-imide resin instead of epoxy. The reference, however, disclosed that epoxy was known for this use, but that epoxy impregnated circuit boards have "relatively acceptable dimensional stability" and "some degree of flexibility," but are inferior to circuit boards impregnated with polyester-imide resins. The court upheld the rejection concluding that applicant’s argument that the reference teaches away from using epoxy was insufficient to overcome the rejection since "Gurley asserted no discovery beyond what was known in the art." Id. at 554, 31 USPQ2d at 1132.). Furthermore, "[t]he prior art’s mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed…." In re Fulton, 391 F.3d 1195, 1201, 73 USPQ2d 1141, 1146 (Fed. Cir. 2004). The selection of a known material such as the mixture of polysorbate 20 and polysorbate 80 from the teachings of KOKKINIS et al. based on its suitability (being dispersing agent) for its intended use supported a prima facie obviousness determination in Sinclair & Carroll Co. v. Interchemical Corp., 325 U.S. 327, 65 USPQ 297 (1945) (Claims to a printing ink comprising a solvent having the vapor pressure characteristics of butyl carbitol so that the ink would not dry at room temperature but would dry quickly upon heating were held invalid over a reference teaching a printing ink made with a different solvent that was nonvolatile at room temperature but highly volatile when heated in view of an article which taught the desired boiling point and vapor pressure characteristics of a solvent for printing inks and a catalog teaching the boiling point and vapor pressure characteristics of butyl carbitol.) The examiner also brings applicant’s attention that the concept of picking any of the dispersing agent from the Markush list of KOKKINIS et al. is prima facie obvious and is within the purview of one of ordinary skill in the art as the specific combination of features claimed are taught by KOKKINIS et al. If applicants resort to argue the reference does not provide any motivation to select this specific dispersing agents, 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. One of ordinary skill in the art would have had a reasonable expectation of success in producing the instant invention by following the teachings of the teachings of KOKKINIS et al. because KOKKINIS et al. a substantially identical or similar composition.
Conclusion
No claims are 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.
Any inquiry concerning this communication or earlier communications from the examiner should be directed to TIGABU KASSA whose telephone number is (571)270-5867. The examiner can normally be reached on 8 AM-5 PM.
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/TIGABU KASSA/Primary Examiner, Art Unit 1619
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