Ex Parte ZeigersonDownload PDFPatent Trial and Appeal BoardDec 6, 201814541328 (P.T.A.B. Dec. 6, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 14/541,328 11/14/2014 109357 7590 12/10/2018 Evonik Corporation Intellectual Property Management 299 Jefferson Road Parsippany, NJ 07054-0677 FIRST NAMED INVENTOR Ehud Zeigerson UNITED STATES DEPARTMENT OF COMMERCE United States Patent and Trademark Office Address: COMMISSIONER FOR PATENTS P.O. Box 1450 Alexandria, Virginia 22313-1450 www .uspto.gov ATTORNEY DOCKET NO. CONFIRMATION NO. 2003Pl2001 WOUS02 8925 EXAMINER GREENE, NAN A ART UNIT PAPER NUMBER 1619 NOTIFICATION DATE DELIVERY MODE 12/10/2018 ELECTRONIC Please find below and/or attached an Office communication concerning this application or proceeding. The time period for reply, if any, is set in the attached communication. Notice of the Office communication was sent electronically on above-indicated "Notification Date" to the following e-mail address(es): ipm-na@evonik.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte EHUD ZEIGERSON (APPLICANT: EVONIK CORPORATION) Appeal2017-008749 Application 14/541,328 1 Technology Center 1600 Before DONALD E. ADAMS, ERIC B. GRIMES, and RICHARD M. LEBOVITZ, Administrative Patent Judges. ADAMS, Administrative Patent Judge. DECISION ON APPEAL This Appeal under 35 U.S.C. § 134(a) involves claims 1, 3, 5-16, 19- 31, 42, and 43 (Non-Final Act. 2 2). Examiner entered rejections under the judicially-created doctrine of improper Markush grouping and 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1 Appellant identifies "Evonik Corporation" as the real party in interest (Br. 1 ). 2 Examiner's March 3, 2016 Non-Final Office Action. Appeal2017-008749 Application 14/541,328 STATEMENT OF THE CASE Appellant's disclosure relates to "the production of emulsion-based microparticles and a method for producing emulsion-based microparticles containing biological or chemical agents" (Spec. 1: 10-11 ). Claims 1, 14, and 43 are representative and reproduced below: 1. A method of preparing microparticles, comprising: (a) preparing a first phase, said first phase comprising a solvent, active agent and a polymer; (b) preparing a second phase comprising a solvent; ( c) passing said first phase and said second phase through a packed bed apparatus under laminar flow conditions, wherein the packed bed apparatus contains a packing material selected from the group consisting of metal, ceramic, plastic and glass, and wherein the packing material is spherical beads ranging in size from 20 to 1000 µm, and wherein said method results in the formation of microparticles; and ( d) collecting said microparticles containing said active agent. (Br. 13 (emphasis added).) 14. The method of claim 1, wherein said active agent is selected from the group consisting of antioxidants, porosity enhancers, solvents, salts, cosmetics, food additives, textile- chemicals, agro-chemicals, plasticizers, stabilizers, pigments, opacifiers, adhesives, pesticides, fragrances, antifoulants, dyes, salts, oils, inks, cosmetics, catalysts, detergents, curing agents, flavors, foods, fuels, herbicides, metals, paints, photographic agents, biocides, pigments, plasticizers, propellants, solvents, stabilizers, polymer additives,[]an organic molecule, an inorganic molecule, antiinfectives, cytotoxics, antihypertensives, antifungal agents, antipsychotics, antibodies, proteins, peptides, antidiabetic agents, immune stimulants, immune suppressants, antibiotics, antivirals, anticonvulsants, antihistamines, cardiovascular agents, anticoagulants, hormones, antimalarials, analgesics, anesthetics, nucleic acids, steroids, aptamers, hormones, steroids, blood clotting factors, hemopoietic factors, cytokines, interleukins, colony stimulating 2 Appeal2017-008749 Application 14/541,328 factors, growth factors, growth factor analogs and fragments thereof. (Id. at 14) 43. A method of preparing microparticles, comprising: (a) preparing a first phase, said first phase comprising a solvent, active agent and a polymer; (b) preparing a second phase comprising a solvent; ( c) passing said first phase and said second phase through a packed bed apparatus under laminar flow conditions, wherein the packed bed apparatus contains a packing material selected from the group consisting of metal, ceramic, plastic and glass, and wherein the packing material is spherical beads ranging in size from 20 to 1000 µm, and wherein said method results in the formation of microparticles; and ( d) collecting said microparticles containing said active agent, wherein said microparticles are from about 1 µm to about 200 µmin diameter. (Id. at 17.) Grounds of rejection before this Panel for review: 3 Claims 14 and 29 stand rejected under the judicially created doctrine of improper Markush grouping. Claims 1, 3, 5-10, 12-16, 19-25, 27-31, 42, and 43 stand rejected under 35 U.S.C. § 103(a) as unpatentable over the combination ofLi, 4 Wright, 5 Hovenkamp, 6 Huber, 7 and Edwards. 8 3 Examiner withdrew the nonstatutory double patenting rejection on this record (see Ans. 11 ). 4 Li et al., US 4,183,681, issued Jan. 15, 1980. 5 Wright et al., US 6,379,704 B2, issued Apr. 30, 2002. 6 Tobias Benedikt Hovekamp Experimental and Numerical Investigation of Porous Media Flow with regard to the Emulsion Process, Laboratory of Food Process Engineering (ETH Zurich) (2002). 7 Huber, US 4,165,219, issued Aug. 21, 1979. 8 Edwards, US 4,501,501, issued Feb. 26, 1985. 3 Appeal2017-008749 Application 14/541,328 Claims 11 and 26 stand rejected under 35 U.S.C. § I03(a) as unpatentable over the combination of Li, Wright, Hovenkamp, Huber, Edwards, Y ani, 9 and Donovan. 10 Improper Markush Grouping: ISSUE Does the evidence of record support Examiner's conclusion that Appellant's claims 14 and 29 contain improper Markush groupings? ANALYSIS Appellant discloses a method for producing "emulsion-based microparticles containing ... [active] agents" (Spec. 1:10-11). Appellant's independent claims 1, 16, and 43 are each directed to a method of preparing microparticles comprising, inter alia, active agents (see App. Br. 13, 15, and 17). Appellant's claims 14 and 29 depend directly from Appellant's independent claims 1 and 16, respectively (see App. Br. 16). Appellant's Specification defines the term "active agent" as "any biological or chemical agent" and provides examples of such agents (Spec. 15 :26-27; see also id. at 5:21-35 (providing examples of biological agents); 14:1-8 (providing examples of chemical agents); 21: 17-19 ("it will be apparent that certain agents that are both chemically and/or physiologically related may be substituted for the agents described herein while the same or similar results would be achieved")). Thus, all species of Appellant's claimed invention are useful in preparing microparticles comprising, inter alia, active agents and, therefore, 9 Yanai et al., US 5,846,562, issued Dec. 8, 1998. 10 Donovan, US 2002/0028216 Al, published Mar. 7, 2002. 4 Appeal2017-008749 Application 14/541,328 share a common use in the preparation of structurally similar microparticles comprising an active agent (see generally Br. 12). Therefore, we are not persuaded by Examiner's conclusion that Appellant's claims contain an improper Markush grouping (see Non-Final Act. 2-3; Ans. 2--4). CONCLUSION The preponderance of evidence of record fails to support Examiner's conclusion that Appellant's claims 14 and 29 contain improper Markush groupings. The rejection of claims 14 and 29 under the judicially created doctrine of improper Markush grouping is reversed. Obviousness: ISSUE Does the preponderance of evidence relied upon by Examiner support a conclusion of obviousness? FACTUAL FINDINGS (FF) FF 1. Li discloses the preparation of emulsions utilizing an emulsification device comprising an enclosure having orifices thereby permitting flow of a fluid through the enclosure along one of its axis, of any cross-section profile perpendicular to its axis for fluid flow, which enclosure is packed with a material which causes the flow of fluids to be broken down into many fine streams which fine streams, being in intimate contact one with the other, remix rapidly and repeatedly, resulting in the formation of the desired emulsion. The fluids which are mixed in the packed enclosure are fed to the enclosure by fluid feeding means such as pumps or by gravity feed tanks and conduits communicatively attached to the packed enclosure. The fluids fed into the packed enclosure are introduced into the enclosure in close proximity one to 5 Appeal2017-008749 Application 14/541,328 another so as to insure maximum intermixing of the different fluids. (Li, Abstract; see Non-Final Act. 7.) FF 2. Li's Figure 1 is reproduced below: FIGURE! PACKED TUBE EMULSIFIER ORGAN!C - INORaANIC PHASE i>t,ASE s1L _____ EMllLSIOII Li's Figure 1: [I]s a schematic showing a typical packed tube emulsifier which can be used in the method of the instant invention wherein the arrow pointing into an opening indicates the entrance ( 1) into which the immiscible fluids are simultaneously introduced for passage through the enclosure (3) to the exit (2), indicated by the arrow pointing away from the enclosure (3), fluid flow being through the enclosure in the direction resulting from the indicated mode of fluid introduction. The cross hatching ( 4) in the enclosure (3) represents the packing filling the enclosure which may be any of the packings described in greater detail below and recited as operable in the method. (Li 1 :58 - 2:2 ( emphasis omitted); see Non-Final Act. 6-7.) FF 3. Li discloses: Suitable packing material is selected from the group consisting of steel metal sponge ... , metal shavings, ceramic chips, Berl Saddle ... , animal hair or plastic brush, metal tubes shorter than the internal diameter of the enclosure and mixtures of the 6 Appeal2017-008749 Application 14/541,328 above, [preferably] metal shavings, metal sponge ( such as Kurly Kate) and 'Cannon' packing. (Li 3:12-19; see Non-Final Act. 7; cf Li 3:19-24 ("The proper choice of packing material is critical since it has been discovered that numerous seemingly attractive materials will not function to give emulsions. Some that will not work are perforated glass beads, metal Fenske rings, Raschig rings (glass), steel wool, [and] wooden straw").) FF 4. Li discloses that a "packed tube, like Kenics mixer, is a type of static or motionless mixer, it is much more effective in making high ratio emulsions than Kenics because of the structure difference between the two devices," wherein a "packed tube is much more densely packed in a random manner as compared to Kenics" (Li 5:3--4; see Non-Final Act. 8). FF 5. Li discloses: [T]he length of the enclosure from entrance orifices to exit orifices, the amount of packing, the density of the packing, and the type of material packed is left to the discretion of the practitioner, depending on the type of emulsion desired, the density of the fluids used and the final ratio of internal to external phase desired. (Li 3:35--40; Non-Final Act. 7.) FF 6. Examiner finds, inter alia, that Li "does not expressly teach forming microparticles using their packed tube emulsifier under laminar flow conditions[] [or that] the packing material is spherical beads ranging in size from 20 to 1000 µm" (Non-Final Act. 9) FF 7. Wright "relates to a method and an apparatus for preparing microparticles having a selected polymer molecular weight" (Wright 1: 14-- 17; see Non-Final Act. 9-10 (Wright discloses, inter alia, "a method for 7 Appeal2017-008749 Application 14/541,328 preparing microparticles ... using a Kenics static mixer" ( emphasis omitted) (citing Wright 5:52-57))). FF 8. Examiner relies upon Hovenkamp to disclose a method of preparing emulsions, wherein the method "includes a packed bed (static) mixer wherein the packing media is in the form of sphere packings of glass or steel spheres, ranging from 70 µm to 40 mm (i.e. 4000 µm) in diameter with random or regular packing" (Non-Final Act. 10 (emphasis omitted) (citing Hovenkamp, Abstract and § 1.2). FF 9. Huber "relates to a process for the analysis of aqueous or non- aqueous solutions, in which the sample is introduced into a stream of reagent and the reaction product formed is measured in a suitable detector" (Huber 1:5-9). FF 10. Huber discloses a process, wherein the reaction is carried out "in a chromatographic column which is filled with an inert, finely divided material, e[. Jg. glass beads of from 50 to 200 µm diameter" (Huber 1 :41--44; see also Non-Final Act. 10 (Examiner relies upon Huber to disclose "a packed column ... filled with an inert, finely divided material, such as glass beads having a diameter from 50 µm to 200 µm ... which has a mixing function")). FF 11. Edwards: [P]rovides a process for the dispersion of particulate solids in liquid media comprising pumping a liquid premix containing an admixture of said solids and said liquid media through a plurality of orifices at a laminar flow velocity, there being sufficient pressure drop across said plurality of orifices to provide shear energy to cause said dispersion, the orifices being the network of tortuous paths formed from substantially nondeformable spherical particles arranged in a series of beds, each bed consisting of spherical particles of a substantially 8 Appeal2017-008749 Application 14/541,328 uniform size and comprising at least one coarse bed of particles having a diameter of at least about 0.5 mm, at least one intermediate bed of particles having a diameter of about from 0.5 to 0.15 mm, and at least one fine bed of particles having a diameter of about from 0.15 to 0.05 mm, and wherein the flow rate of the liquid medium is adjusted to provide a shear rate of about from 1500 to 6300 sec-1 in each coarse bed, a shear rate of about from 3300 to 15,000 sec-1 in each intermediate bed, and a shear rate of about from 10,000 to 3,000 sec-1 in each fine bed. (Edwards 1 :56-2:8; see Non-Final Act. 11 (Edwards discloses the use of "spherical particles of uniform size" "[t]o achieve [packed] beds of uniform and predictable flow characteristics" (Non-Final Act. 11 ). ) FF 12. Examiner finds that the combination of Li, Wright, Hovenkamp, Huber, and Edwards fails to suggest the use of "the protein, albumin, as an emulsion stabilizer" and relies upon Yanai and Donovan to make up for this deficiency (Non-Final Action 13-14). FF 13. Zeigerson declares: Laminar flow and turbulent flow are two different flow regiments. Laminar flow occurs when a fluid flows in parallel layers with no disruption between the layers. At low velocities, there is no lateral mixing of the fluid layers. The conditions that influence whether a given fluid flow is laminar or turbulent are the fluid kinematic viscosity, inertial forces ( e.g. fluid velocity), and dimensional parameters ( e.g. the size of flow path). Lower fluid viscosity, larger inertial forces and larger dimensional parameters promote turbulent flow, while laminar flow is promoted by higher fluid viscosity, smaller inertial forces and smaller dimensional parameters. (Zeigerson Dec. 11 ,r 11.) 11 Declaration of Ehud Zeigerson, signed May 1, 2013. 9 Appeal2017-008749 Application 14/541,328 FF 14. Zeigerson declares that "[ e ]mulsions will not form in an emulsifier that is designed to produce emulsions under turbulent flow conditions if operated under laminar flow conditions created by a lower fluid velocity because in the absence of turbulence no mixing of the phases can occur" (id. ,r 13; see also id. ,r 16 ("[a] high-void fraction packing cannot produce emulsion under laminar flow conditions because the mixing elements will not generate turbulence, and as a result the two immiscible fluids will not mix)). FF 15. Zeigerson declares that "Li's packed column is an emulsifier that is designed to promote emulsions under turbulent flow conditions; it is a sub- type of a turbulent static mixer" (Zeigerson Dec. ,r 13; see also id. ,r 16 (Due to "the tube packing materials used by Li ... 90% or more of Li's column volume is void, and 10% or less of the column volume is packing material," which "is typical for static mixers that use mixing elements for producing turbulence. . . . Therefore, the method described by Li is not capable of producing emulsion under laminar flow conditions")). ANALYSIS The rejection over the combination of Li, Wright, Hovenkamp, Huber, and Edwards: Each of Appellant's independent claims requires, inter alia, the use of "a packed bed apparatus under laminar flow conditions" (see App. Br. 13, 15, and 17). Based on the combination of Li, Wright, Hovenkamp, Huber, and Edwards, Examiner concludes that, at the time Appellant's invention was made, it would have been prima facie obvious "to use the packed bed static mixer of LI as a means for forming the emulsion microparticles of WRIGHT because LI suggests that the packed bed static mixer is much more effective 10 Appeal2017-008749 Application 14/541,328 in making high ratio emulsions ... than the Kenics static mixer used by WRIGHT" (Non-Final Act. 11). In this regard, Examiner reasons: [O]ne of ordinary skill in the art would have been motivated to use the spherical beads of HOVENKAMP, HUBER, or EDWARDS in the packed bed static mixer of LI because[] ... , of their availability, low cost, and the ability to construct uniform beds with predictable flow characteristics, in addition to easy clean-up[, as suggested by Edwards]. (Id.) We are not persuaded. Although Examiner recognizes that Li does not disclose the production of microparticles under laminar flow conditions, Examiner asserts that because "LI directly suggest[ s] gravity feed tanks as an alternative to pumps, suggesting a lower flow rate, and criticizes current emulsification machines as being too powerful[;] ... the emulsion mixing process described by LI would have reasonably been under laminar flow conditions" (Non-Final Act. at 8; see Br. 5). Appellant contends, however, that "even if Li ... lowers the power of its apparatus, laminar flow conditions would still not be achieved" (Br. 5 ( emphasis omitted) ( citing Zeigerson Dec. ,r 11); see FF 13). In this regard, Appellant contends that "[fJluid velocity is just one of the elements in creating laminar flow, and one cannot reasonably determine that Li ... is operating under laminar flow conditions based solely on observing fluid velocity alone" (Br. 5 ( emphasis omitted)). As Appellant explains, Li's apparatus "is not capable of producing emulsion under laminar flow conditions because the void ratio of Li's apparatus would make it a sub-type of a turbulent static mixer" and "[ e ]mulsions will not form in an apparatus that is designed to produce emulsions under turbulent flow conditions if operated under laminar flow 11 Appeal2017-008749 Application 14/541,328 conditions created by lower fluid velocity because in the absence of turbulence no mixing of the phases occur" in Li's apparatus (Br. 7 ( citing Zeigerson Dec. ,r 13); FF 13-15). In this regard, Appellant contends that in contrast to Appellant's declaratory evidence, "Examiner has not provided any scientific reasoning or evidence that Li et al.' s method uses laminar flow rather than a turbulent flow" (Br. 5---6; see FF 13-15). We find that the preponderance of evidence on this record falls in favor of Appellant. The Specification expressly distinguishes "laminar flow" conditions from "turbulent flow" (Spec. 4:11-14; see id. at 6:36 ("a non-turbulent, or laminar flow"); id. at 7:7-8). On this record, Examiner failed to establish an evidentiary basis to support a conclusion that Li discloses a process of preparing microparticles under laminar flow conditions (see FF 6 (Li "does not expressly teach forming microparticles using their packed tube emulsifier under laminar flow conditions"); cf Non- Final Act. 8 ("the emulsion mixing process described by LI would have reasonably been under laminar flow conditions")). We recognize Examiner's reliance on Wright to disclose the preparation of microparticles using a Kenics static mixer, which, like Li's packed tube, "is a type of static or motionless mixer" (FF 4 and 7). Examiner, however, failed to establish an evidentiary basis on this record to support a conclusion that Wright discloses a process of preparing microparticles under laminar flow conditions, namely, Examiner did establish that a static mixer employs non-turbulent, laminar flow conditions. Indeed, as argued by Appellants, the Specification teaches that static mixers are "turbulent mixing devices" (Spec. 2:5-11 ). Thus, Examiner failed to 12 Appeal2017-008749 Application 14/541,328 establish that the combination of Li and Wright suggests a process for preparing microparticles under laminar flow conditions. Examiner relies on the combination of Hovenkamp, Huber, and Edwards, to suggest packing materials that fall within the scope of Appellant's claimed invention (FF 8-12). Examiner, however, failed to establish an evidentiary basis on this record to support a conclusion that a person of ordinary skill in this art would have found it prima facie obvious to use the packing materials suggested by the combination of Hovenkamp, Huber, and Edwards in the device suggested by the combination of Li and Wright in order to produce microparticles under laminar flow conditions (see App. Br. 8-9 ("[a] skilled artisan would not have turned to [Hovenkamp] or Huber if their goal was to make microparticles using laminar flow conditions") ( emphasis omitted); id. at 9 ("Edwards [] does not teach making emulsions or microparticles") ). The rejection over the combination of Li, Wright, Hovenkamp, Huber, Edwards, Yanai, and Donovan: 12 Appellant's claim 11 depends ultimately from and further limits the second phase of Appellant's claim 1 to further comprise an emulsion stabilizer that is albumin. Based on the combination of Li, Wright, Hovenkamp, Huber, Edwards, Yanai, and Donovan, Examiner concludes that, at the time Appellants' invention was made, it would have been prima facie obvious "to 12 We recognize that Appellant provides separate arguments for Appellant's claims 11 and 26 (see Br. 10-11). Appellant's arguments, however, are the same for each claim. Therefore, we have considered Appellant's claims 11 and 26 as a single group, wherein claim 11 is representative. 13 Appeal2017-008749 Application 14/541,328 use albumin as the emulsion stabilizer," as disclosed by the combination of Yanai and Donovan, in the process of preparing microparticles suggested by the combination of Li, Wright, Hovenkamp, Huber, and Edwards (Non-Final Act. 14). As Appellant explains, however, Yanai and Donovan fail to make up for the deficiencies in the combination of Li, Wright, Hovenkamp, Huber, and Edwards discussed above (see App. Br. 10-11). CONCLUSION The preponderance of evidence relied upon by Examiner fails to support a conclusion of obviousness. The rejection of claims 1, 3, 5-10, 12-16, 19-25, 27-31, 42, and 43 under 35 U.S.C. § 103(a) as unpatentable over the combination of Li, Wright, Hovenkamp, Huber, and Edwards is reversed. The rejection of claims 11 and 26 under 35 U.S.C. § 103(a) as unpatentable over the combination of Li, Wright, Hovenkamp, Huber, Edwards, Y ani, and Donovan is reversed. REVERSED 14 Copy with citationCopy as parenthetical citation