Ex Parte Hughes et alDownload PDFPatent Trials and Appeals BoardApr 25, 201911742350 - (D) (P.T.A.B. Apr. 25, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 11/742,350 04/30/2007 51957 7590 04/29/2019 ALLERGAN, INC. 2525 DUPONT DRIVE, T2-7H IRVINE, CA 92612-1599 FIRST NAMED INVENTOR Patrick M. Hughes 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. 18197 (OCU) 4711 EXAMINER DILLAHUNT, SANDRA E ART UNIT PAPER NUMBER 1646 NOTIFICATION DATE DELIVERY MODE 04/29/2019 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): patents_ip@allergan.com pair_allergan@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PA TRICK M. HUGHES, GERALD W. DEVRIES, ROBERT T. LYONS, JOHN T. TROGDEN, and SCOTT M. WHITCUP 1 Appeal 2018-003513 Application 11/742,350 Technology Center 1600 Before JOHN G. NEW, JAMES A. WORTH, and ELIZABETH A. LA VIER, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants identify Allergan, Inc., as the real party-in-interest. App. Br. 3. Appeal 2018-003513 Application 11/742,350 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner's Final Rejection of claims 1, 5, 15, and 20-32 as unpatentable under 35 U.S.C. § 112, first paragraph, as lacking written descriptive support. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to anti-angiogenesis compositions, and methods of using such compositions, useful for injection into the vitreous of human eyes. Abstract. REPRESENTATIVE CLAIM Claim 1 is representative of the claims on appeal and recites: 1. A method for treating a posterior ocular condition, the method comprising: administering into the vitreous of an eye of a mammal suffering from an ocular condition a composition consisting of: a therapeutically effective amount of a macromolecular anti-angiogenic component (MAAC), wherein the MAAC is a protein, a viscosity inducing component in an amount effective to increase the viscosity of the composition to a viscosity at about 25°C of at least 10 cps at a shear rate of about 0.1/second, wherein said viscosity inducing component is injectable into the vitreous of a mammalian eye without permanently diminishing visual acuity, 2 Appeal 2018-003513 Application 11/742,350 sodium chloride, dibasic sodium phosphate heptahydrate, monobasic sodium phosphate monohydrate, and water; wherein the posterior ocular condition is glaucoma; and wherein the administering is by subconjunctival, suprachoroidal, intravitreal or combination thereof. App. Br. 24. ISSUES AND ANALYSES We adopt the Examiner's findings, reasoning, and conclusion that the claims lack written descriptive support. We address the arguments raised by Appellants below. Issue 1 Appellants argue that the Examiner erred in concluding that the limitation of claim 1 reciting: "a macromolecular anti-angiogenic component (MAAC), wherein the MAAC is a protein" lacks written descriptive support in Appellants' Specification. App. Br. 10. Analysis The Examiner finds that Appellants' Specification discloses that a characteristic of the claimed macromolecular anti-angiogenic components ("MAACs") is the ability of the component to reduce the extent of angiogenesis, particularly vascular endothelial growth factor ("VEGF")- 3 Appeal 2018-003513 Application 11/742,350 associated angiogenesis. Final Act. 4 ( citing Spec. 40). The Examiner finds that the Specification discloses that MAACs include proteins, polyclonal or monoclonal antibodies, antibody fragments, such as a monovalent fraction antigen-binding papain fragment ("Fab") or a bivalent fraction antigen binding pepsin fragment ("F'ab2"). Id. ( citing Spec. 19). The Examiner finds that the Specification teaches that the MAACs may comprise one or more therapeutic agents selected from the group consisting of anti- angiogenesis compounds, ocular hemorrhage treatment compounds, macromolecular non-steroidal anti-inflammatory agents, growth factor inhibitors (e.g., VEGF inhibitors), growth factors, cytokines, and antibodies. Id. ( citing Spec. 55). The Examiner further finds that the Appellants' Specification discloses that anti-angiogenic proteins include endostatin, angiostatin, tumstatin, pigment epithelium-derived factor, and VEGF trap. Final Act. 4 ( citing Spec. 67). The Examiner also determines that the Specification discloses two compositions, comprising the protein angiogenesis inhibitors ranibizumab and bevacizumab. Id. ( citing Spec. Ex. 1 ). The Examiner therefore finds that the claims encompass a broad, even "vast," genus of "MAAC" proteins that are defined by their common function of inhibiting angiogenesis and treating glaucoma. Final Act. 5. However, the Examiner finds, Appellants' Specification only provides guidance regarding two proteins (ranibizumab and bevacizumab) that are capable of the required function. Id. The Examiner finds that the Specification broadly defines the term "MAAC" as any agent that reduces angiogenesis and teaches that MAACs include agents such as proteins, 4 Appeal 2018-003513 Application 11/742,350 antibodies, antibody mimetics, angiogenesis inhibitors, and receptor inhibitors. Id. The Examiner further finds that the Specification defines no express relationship between the function of the claimed MAACs in reducing angiogenesis and the structure of the MAACs. Final Act. 5. The Examiner finds that, with the exception of ranibizumab and bevacizumab, Appellants' Specification provides no guidance regarding which agents have the function of treating glaucoma. Id. The Examiner concludes that Appellants' Specification provides insufficient written description to support the genus of proteins encompassed by the claims. Id. Appellants dispute the Examiner's finding that ranibizumab and bevacizumab are the only anti-angiogenic proteins that are described in their Specification. App. Br. 11. Appellants point to page 67 of the Specification which discloses: In another embodiment of the present viscous MAAC-containing formulations, the therapeutic component comprises an anti- angiogenic protein selected from the group consisting of endostatin (e.g., NCBI Accession Number AAK50626), angiostatin (e.g., NCBI Accession Number P00747), tumstatin (NCBI Accession Number AAF72632), pigment epithelium derived factor (e.g., NCBI Accession Number AAA84914), and VEGF TRAP (Regeneron Pharmaceuticals, New York). VEGF Trap is a fusion protein that contains portions of the extracellular domains of two different VEGF receptors connected to the Fe region (C-terminus) of a human antibody. Id. at 12. Appellants assert that a person of ordinary skill would know by their NCBI Accession numbers that these are all commercially known and available anti-angiogenic proteins. Id. 5 Appeal 2018-003513 Application 11/742,350 Appellants further argue that their Specification discloses: (1) detailed methods in how to make anti-VEGF monoclonal antibodies; (2) where anti-VEGF monoclonal antibodies, such as IMC-l 8FL, can be obtained from IMCLONE and IMC-1121 Fab; (3) three additional VEGFR inhibitory antibody mimics, such as the VEGFR-2 inhibitors CT322, C7Sl00 and C7Cl00 made by Control Therapeutics, Inc.; (4) urokinase inhibitors; (5) the amino acid sequence ofurokinase inhibitor A6; (6) another MAAC protein which is combined with cisplatin; (7) variations of A6, with 80-90 % homology to A6 by amino acid substitutions; (8) rapamycin, alone and in combination with other drugs such as triamcinolone acetonide; (9) and cyclophilins, CCI-779 (Wyeth), AP2384 l (Ariad), and ABT- (Abbott Laboratories). App. Br. 12 (citing Spec. 69-72). Appellants also assert that their Specification discloses salts of MAACs. Id. ( citing Spec. 73). Appellants further point to Example 17 of the Specification, which describes use of the: (10) antibody mimic ADNECTIN®, an engineered antibody, including CT-322, C7Sl00, and C7Cl00; and (11) the amino acid sequence of antibody muMAb VEGF A.4.6.1. App. Br. 12-13 (citing Spec. 56, Fig. 1 ). Appellants argue that all of these compounds are MAACs as defined by the Specification. Id. at 13. Appellants also point to the Specification's incorporation by reference the following prior art: (1) US Ser. No. 11/370,301 (the '"301 application"); (2) US Ser. No. 11/364,687 (the '"687 application"); (3) US Ser. No. 60/721,600 (the '"600 application"); (4) US Ser. No. 11/116,698 (the '"698 application"); (5) US 2005/0074865 Al (the '"865 application"); (6) US 6 Appeal 2018-003513 Application 11/742,350 2004/0259155 Al (the '"155 application"); and (7) US 6,329,386 (the '"386 patent"). App. Br. 13-17. According to Appellants, the '301 application discloses: "anti- angiogenic macromolecule, any ocular hemorrhage treatment macromolecule, any non-steroidal anti-inflammatory macromolecule, any VEGF inhibitory macromolecule, [and] any peptide," including anti-VEGF or anti-VEGFR monoclonal antibodies including IMC-18Fl, or an antibody under the name ofIMC-1121 Fab, and VEGFR inhibitory antibody mimics, such as the VEGFR-2 inhibitors CT322, C7Sl00 and C7Cl00. App. Br. 13- 14. Appellants argue that the '687 application discloses anti-VEGF antibody IMC-18Fl, IMC-1121, F-506 binding proteins everolimus and pimecrolimus, CCl-779 (Wyeth), AP23841 (Ariad), ABT-578 (Abbot), and monoclonal antibody fragment F-200 Fab. App. Br. 14-15 ( citing '687 application, pg. 23, 11. 17-19, Example 9 on pg. 62, 1. 15). Appellants assert that the '600 application discloses antibodies A.4.6.1, F(ab)l2, and hum III, all of which, Appellants argue, inhibit human VEGF activity and are MAACs. App. Br. 15. Appellants also point to Tables 1 and 2 of the '600 application, which disclose: "multiple proteins for delivery for anti-VEGF therapy," and to Examples 8-18, which disclose FAB-IMC -1121, F200 Fab, endostatin, and "[other] antiangiogenic proteins." Id. With respect to the '698 application, Appellants assert that the reference discloses ranibizumab, pegatanib, Macugen, endostatin, angiostatin, tumstatin, pigment epithelium-derived factor, and VEGF Trap, anti-VEGF antibodies, anti-VEGF receptor antibodies, anti-integrin 7 Appeal 2018-003513 Application 11/742,350 antibodies, and effective fragments thereof. App. Br. 15. Appellants also argue that the '698 application discloses antibodies IMC- l 8Fl and IMC- 112 lFab, urokinase inhibitor A6, the FK506-binding proteins, Everolimus and pimecrolimus, CCl-779 (Wyeth), AP23841 (Ariad), and ABT-578 (Abbott Laboratories), all of which, Appellant contend, are MAACs, as defined by their Specification. Id. The Appellants also point to the '698 applications' teaching of the delivery of a number of these compositions to the eye. Id. at 15-16. Appellants contend that the '865 application teaches adzymes, which are defined as: "chimeric protein constructs that join one or more catalytic domains with one or more targeting moieties," and which may target VEGF. App. Br. 16. The '155 application, Appellants argue, discloses two tyrosine receptor kinases Flt-1 and Flk-1 which bind VEGF with high affinity, and also A VASTIN®, which the application discloses is an investigational recombinant humanized antibody to VEGF. App. Br. 1 7. Finally, Appellants argue that the '386 patent teaches rapamycin and its analogs, which is described as an "antibiotic, an immunosuppressive agent, and an anti-angiogenic agent." App. Br. 17. Appellants therefore assert that the claim term "MAAC" is well supported by a representative number of MAAC species in the Specification. App. Br. 17. Indeed, Appellants assert that: "Any protein that has anti- angiogenic properties will function in treating glaucoma." Id. at 18-19 ( emphasis added). Appellants disagree with the Examiner's finding that there is no written description of the claimed invention because the: "[S]pecification 8 Appeal 2018-003513 Application 11/742,350 does not provide any evidence that the claimed 'anti-angiogenic' function correlates with any structural characteristic of the biomolecules encompassed by the term MAAC." App. Br. 19 (quoting Final Act. 13). Rather, Appellants argue, the Specification plainly discloses a representative number of species of MAAC proteins that fall within the scope of the claims. Id. That alone, Appellants contends, suffices to end the inquiry under 35 U.S.C. § 112, first paragraph. Id. (citingAriad Pharms. Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1350 (Fed. Cir. 2010) (en bane)). Appellants argue that all of the proteins listed in the Specification are of either known amino acid sequences, because they are commercially available, or the amino acid sequence is described. Id. at 19-20. According to Appellants, it is not always the case that species within a genus have common structural characteristics nor is it required. Id. at 20. Appellants assert that there is no requirement in patent law that the structure of the claimed MAACs be the same or similar or have a correlation between structure and function. Id. Appellants next point to the Examiner's finding that: [W]hen a claim covers a genus of inventions, the specification must provide written description support for the entire scope of the genus. In cases such as this one, where the genus is identified by reference to a function, the functional identification must be coupled with a known or disclosed correlation between function and structure. App. Br. 20 ( quoting Final Act. 14 ( citing MPEP § 2163). Appellants quote MPEP § 2163 as stating: A "representative number of species" means that the species which are adequately described are representative of the entire genus. Thus, when there is substantial variation within the genus, one must describe a sufficient variety of species to reflect the variation within the genus. Satisfactory disclosure of a 9 Appeal 2018-003513 Application 11/742,350 "representative number" depends on whether one of skill in the art would recognize that the applicant was in possession of the necessary common attributes or features possessed by the members of the genus in view of the species disclosed. For inventions in an unpredictable art, adequate written description of a genus which embraces widely variant species cannot be achieved by disclosing only one species within the genus. Instead, the disclosure must adequately reflect the structural diversity of the claimed genus, either through the disclosure of sufficient species that are "representative of the full variety or scope of the genus," or by the establishment of "a reasonable structure-function correlation." Such correlations may be established "by the inventor as described in the specification," or they may be "known in the art at the time of the filing date. App. Br. 20 (internal citations omitted). Appellants argue that, having allegedly disclosed hundreds of species of disclosed MAAC proteins capable of [ the inhibition of] angiogenesis in their Specification, the Specification has provided more than a representative number to support the generic term MAAC as defined in the claims. Id. at 21. We are not persuaded by Appellants' arguments. Claim 1 recites, in relevant part: "a therapeutically effective amount of a macromolecular anti- angiogenic component (MAAC), wherein the MAAC is a protein .... " Appellants' Specification defines MAACs thusly: In particular, the MAACs of the present invention are inhibitors of angiogenesis, particularly ocular angiogenesis, such as choroidal neovascularization (CNV) accompanying a condition such as macular degeneration, in particular, though not exclusively, exudative macular degeneration, diabetic retinopathy, retinal ischemia and macular edema. Spec. 17. Appellants' claims and Specification, therefore, define MAACs both structurally (i.e., it is a protein), and functionally, i.e., as an inhibitor of 10 Appeal 2018-003513 Application 11/742,350 angiogenesis. The structural categorization, "a protein," is far too broad to provide a meaningful limitation to the claim other than requiring a common level of structure, i.e., polypeptide(s) with tertiary/quaternary structure. There are, of course, protein species without number performing a vast variety of structural and physiological functions, quite apart from those capable of inhibiting angiogenesis. The more meaningful limitation within the scope of the claim 1 is that the protein in question must be "anti- angiogenic," i.e., an inhibitor of angiogenesis. Consequently, the more meaningful limitation of claim 1, in that it limits the scope of the claims, and the one that speaks directly to defining Appellants' claimed invention, is a functional limitation, viz., that the protein in question must be capable of inhibiting angiogenesis. Our reviewing court has held that: A definition by function, as we have previously indicated, does not suffice to define the genus because it is only an indication of what the [ material] does, rather than what it is. It is only a definition of a useful result rather than a definition of what achieves that result. ... The description requirement of the patent statute requires a description of an invention, not an indication of a result that one might achieve if one made that invention. Accordingly, naming a type of material generally known to exist, in the absence of knowledge as to what that material consists of, is not a description of that material. Regents of the Univ. of California v. Eli Lilly & Co., 119 F.3d 1559, 1568 (Fed. Cir. 1997) (internal citations omitted); see also In re Wilder, 736 F.2d 1516, 1521 (Fed. Cir. 1984) (affirming rejection because the specification does "little more than outlin[ e] goals appellants hope the claimed invention achieves and the problems the invention will hopefully ameliorate"). 11 Appeal 2018-003513 Application 11/742,350 Consequently, the Federal Circuit has explained, with respect to the written description requirement of the first paragraph of Section 112: [A] sufficient description of a genus instead requires the disclosure of either a representative number of species falling within the scope of the genus or structural features common to the members of the genus so that one of skill in the art can "visualize or recognize" the members of the genus. We explained that an adequate written description requires a precise definition, such as by structure, formula, chemical name, physical properties, or other properties, of species falling within the genus sufficient to distinguish the genus from other materials. We have also held that functional claim language can meet the written description requirement when the art has established a correlation between structure and function. Ariad, 598 F.3d at 1350 (internal citations omitted). Appellants' Specification does not meet any of these requirements. Appellants argue that their Specification has fulfilled the written description requirement of Section 112 because it discloses, either directly or by incorporation, a representative number of species of MAACs. However, Appellants' argument begs the fundamental question of what is meant, precisely, by inhibition of angiogenesis. As the Examiner observes, angiogenesis is a complex physiological signaling cascade that results in generation of new blood vessels. See Ans. 15; see also Spec. 6 ("A novel treatment for macular degeneration is to use a MAAC, such as a VEGF inhibiting aptamer, or other VEGF-inhibiting compound, such as a [sic] to stop the main signaling cascade for angiogenesis, thereby preventing these symptoms"). Consequently, the scope of Appellants' claimed genus of MAACs ( and therefore of claim 1) would be capable of inhibiting angiogenesis at any stage of the cascade. However, Appellants' 12 Appeal 2018-003513 Application 11/742,350 Specification discloses no evidence that the anti-angiogenic species disclosed in their Specification are representative of the scope of possible inhibitors of angiogenesis, as claimed. In other words, although Appellants' Specification defines MAACs as being capable of inhibiting angiogenesis, the Specification fails to identify every possible means of inhibiting the angiogenic process and disclosing a species of MAAC that would inhibit that process. As such, the disclosures of Appellants' Specification fail to identify the genus MAAC in such a way that a person of ordinary skill in the art could visualize or recognize the all of the members of the genus. See Ariad, 598 F.3d at 1350. The Specification therefore fails to provide adequate written descriptive support for the claim term MAACs. When there is substantial variation within the genus, as there must be in this instance, Appellants are obliged to describe a sufficient variety of species to reflect the variation within the genus. See AbbVie Deutschland GmbH & Co., KG v. Janssen Biotech, Inc., 759 F.3d 1285, 1300 (Fed. Cir. 2014) (holding that a patentee of a biotechnological invention cannot necessarily claim a genus after only describing a limited number of species because there maybe unpredictability in the results obtained from species other than those specifically enumerated). Furthermore, viewed as a primarily functional limitation, Appellants' Specification fails to disclose the requisite correlation between structure and function; indeed, Appellants do not attempt to argue that it does. Ariad, 598 F.3d at 1350. Finally, Appellants' Specification fails to disclose "structural features common to the members of the genus." Id. Because we therefore conclude that the limitation of claim 1 reciting: "a therapeutically effective amount of a macromolecular anti-angiogenic 13 Appeal 2018-003513 Application 11/742,350 component (MAAC), wherein the MAAC is a protein" fails to meet the written description requirement of 35 U.S.C. § 112, first paragraph, we uphold the Examiner's conclusion in this respect. Issue 2 Appellants argue the Examiner erred in finding that the Specification fails to provide adequate written descriptive support of the limitation of claims 24-30 reciting "at least" a given viscosity. App. Br. 21. Analysis Claim 30 is representative of these claims and recites: "The method of claim 1 wherein said viscosity[ -]inducing component has a viscosity of at least 300,000 cps at a shear rate of 0.1/second at 25°C." App. Br. 26. Appellants dispute the Examiner's finding that: The phrase "at least" has no upper limit and thus the claims encompass embodiments beyond the range of range of 10 cps to 300,000. The two compositions comprising sodium hyaluronate to yield a particular viscosity is not deemed to be representative of the genus of compositions encompassed by the claims. Therefore, the [S]pecification does not provide written description for the full scope of the claims. App. Br. 21 ( quoting Final Act. 11 ). Appellants argue that their Specification discloses that: Advantageously, the present compositions have viscosities of at least about 10 cps or at least about 100 cps or at least 10 about 1000 cps, more preferably at least about 10,000 cps and still more preferably at least about 70,000 cps or more, for example up to about 200,000 cps or about 250,000 cps. 14 Appeal 2018-003513 Application 11/742,350 Id. at 21-22 ( quoting Spec. 42). Appellants contend that the Specification thus discloses written support for viscosity of greater than 300,000 cps. Id. at 22. Appellants contend that this is not a genus/species situation, because viscosity ranges are not generic terms. Id. The Examiner responds that the claims in question describe the genus of agents by the function of increasing the viscosity of the composition to a viscosity of at about 25°C of at least 10 cps, at least 1,000 cps; at least 20,000 cps; at least 70,000 cps; at least 200,000 cps; at least 150,000 cps; and at least 300,000, respectively. Ans. 27. The Examiner finds that Appellants' Specification discloses that the viscosity-inducing components include, but are not limited to, hyaluronic acid (such as a polymeric hyaluronic acid), carbomers, polyacrylic acid, cellulosic derivatives, polycarbophil, polyvinylpyrrolidone, gelatin, dextrin, polysaccharides, polyacrylamide, polyvinyl alcohol, polyvinyl acetate, derivatives thereof, and mixtures and copolymers thereof. Id. The Examiner therefore finds that the claims encompass any number of agents, however, the Specification only discloses a single viscosity inducing-component, sodium hyaluronate, having viscosities of 170,000 cps and 200,000 cps, and provides no guidance regarding the structure of the viscosity-inducing component that will yield the desired viscosities of the compositions recited in the various claims. Ans. 27. The Examiner finds that the claims identify the viscosity-inducing component solely by function without providing a corresponding structure common to the members of the genus that yields the function. Id. The Examiner therefore concludes that the Specification fails to provide written description for the genus of agents encompassed by the term "viscosity[-]inducing component." Id. 15 Appeal 2018-003513 Application 11/742,350 We are not persuaded by the Examiner's reasoning. Appellants' claim 1, from which the claims at issue depend, recites, in relevant part: [A] viscosity inducing component in an amount effective to increase the viscosity of the composition to a viscosity at about 25°C of at least 10 cps at a shear rate of about 0.1/second, wherein said viscosity inducing component is injectable into the vitreous of a mammalian eye without permanently diminishing visual acuity. Appellants' Specification discloses that: "The viscosity-inducing component of the present compositions is present in an amount effective to increase the viscosity of the composition, which is usually an aqueous composition, preferably in fluid or gel form" and that: "Viscosity inducing components have been proposed, known, and/or used in ophthalmic compositions for treatment of the eye. Advantageously, the viscosity inducing component is present in an amount in a range of about 0.5% to about 20% (w/v) of the composition." Spec. 27. Appellants' Specification further discloses that: In one embodiment, the present compositions have a viscosity of at least about 10 cps or at least about 100 cps, preferably at least about 1,000 cps, more preferably at least about 10,000 cps and still more preferably at least about 70,000 cps, for example, up to about 250,000 cps, or about 300,000 cps, at a shear rate of 0.1/second at about 25°C. Id. at 28. As examples, the Specification discloses: Examples of useful viscosity inducing components include, but are not limited to, hyaluronic acid (such as a polymeric hyaluronic acid), carbomers, polyacrylic acid, cellulosic derivatives, polycarbophil, polyvinylpyrrolidone, gelatin, dextrin, polysaccharides, polyacrylamide, polyvinyl alcohol, polyvinyl acetate, derivatives thereof and mixtures and copolymers thereof. In a particularly preferred embodiment the 16 Appeal 2018-003513 Application 11/742,350 composition comprises a hyaluronic acid component, such as a polymeric hyaluronic acid component, including a cross-linked polymeric hyaluronic acid. Id. at 43-44. More specifically, the Specification discloses: A more detailed embodiment within the scope of our invention is a pharmaceutical composition for treating a posterior ocular condition, the pharmaceutical composition consisting essentially of a MAAC, polymeric hyaluronate, in which polymeric hyaluronate the MAAC is soluble, sodium chloride, sodium phosphate, and water. The pharmaceutical composition can have a viscosity at a shear rate 0.1/second of between about 128,000 cps and about 225,000 cps. Id. at 33. Appellants Tables 1 and 4 disclose various embodiments of the claimed composition, with sodium hyaluronate, 0.05% w/v, having viscosities ranging between 20 and 500 cps. Spec. 82-83. Appellants' Table 3 discloses embodiments containing 2.3% and 2.5% (w/v) sodium hyaluronate, with viscosities of about 170,000 and 200,000 cps, respectively. Id. at 86. Finally, Appellants' Table 5 discloses other embodiments of Appellants' composition containing sodium hyaluronate at 2.0%, 2.5%, and 3.0% (w/v) with viscosities of 100,000, 180,000, and 300,000 cps, respectively. Id. at 84. Appellants' claims at issue recite a viscosity inducing agent functionally, i.e., by the magnitude of the viscosity they induce in the resultant composition. Appellants' Specification thus discloses numerous embodiments using various concentrations of sodium hyaluronate as a representative viscosity-inducing agent, with resultant viscosities ranging between 20 and 300,000 cps, as recited in the claims. We consequently 17 Appeal 2018-003513 Application 11/742,350 agree with Appellants that the claims have sufficient written descriptive support in the Specification. However, this conclusion does not disturb our conclusion supra, that claim 1 and its dependents lack written support for the limitation reciting: "a therapeutically effective amount of a macromolecular anti-angiogenic component (MAAC), wherein the MAAC is a protein." We consequently affirm the Examiner's rejection of the claims. DECISION The Examiner's rejection of claims 1, 5, 15, and 20-32 as unpatentable under 35 U.S.C. § 112, first paragraph is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv). AFFIRMED 18 Copy with citationCopy as parenthetical citation