Ex Parte Chowdhury

Patent Trial and Appeal BoardMar 6, 2015

12102342 (P.T.A.B. Mar. 6, 2015)

UNITED STATES PATENT AND TRADEMARK OFFICE 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 APPLICATION NO. FILING DATE FIRST NAMED INVENTOR ATTORNEY DOCKET NO. CONFIRMATION NO. 12/102,342 04/14/2008 Dewan Fazlul Hoque Chowdhury 27706/40622 9978 29471 7590 03/06/2015 MCCRACKEN & FRANK LLC P.O. Box 787 Elmhurst, IL 60126 EXAMINER AZPURU, CARLOS A ART UNIT PAPER NUMBER 1617 MAIL DATE DELIVERY MODE 03/06/2015 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte DEWAN FAZLUL HOQUE CHOWDHURY 1 __________ Appeal 2012-008673 Application 12/102,342 Technology Center 1600 __________ Before DONALD E. ADAMS, ERIC B. GRIMES, and CHRISTOPHER G. PAULRAJ, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to amphipathic nanotubes, which have been rejected as anticipated. We have jurisdiction under 35 U.S.C. § 6(b). We reverse. 1 According to Appellant, the Real Party in Interest is Nemaura Pharma Limited (Appeal Br. 2). Appeal 2012-008673 Application 12/102,342 2 STATEMENT OF THE CASE Claims 1–5 are on appeal. 2 Claim 1 is the only independent claim and reads as follows: 1. A nanotube characterized by being amphiphilic, whereby a plurality of the nanotubes are capable of self- assembly into a micelle. DISCUSSION The Examiner has rejected claims 1–5 under 35 U.S.C. § 102(b) as anticipated by Hemolytics. 3 (Ans. 4.) The Examiner finds that “Hemolytics Inc sets out a nanotube composition which is amphipathic.” (Id.) The Examiner concludes that “[t]he ability to self assemble is considered an intended use” (id.), although he also finds that the reference’s “Example 8, page 54, lines 15-55 set out an amphiphilic nanotube structure and discusses self-assembly.” (Id. at 5.) Appellant argues that the Specification “makes it clear that a controlled portion or portions of the exterior of the nanotube is functionalized to form the amphiphilic nanotubes of the invention” (Appeal Br. 4), while in Hemolytics, the “outside, or exterior, of the formed nanotubes are hydrophobic due to the hydrophobic side-chains on the cyclic peptides themselves to assure insertion into the lipid membrane. . . . The inside, or interior, of the formed nanotubes is hydrophilic to allow for the presence of water molecules.” (Id. at 6.) Appellant also argues that the claims require that “a plurality of the same is capable of self-assembly into, or in other words, to form, a micelle” 2 Claim 6 is also pending but is not rejected. (Ans. 3.) 3 Joyce, WO 2005/069750 A2, published Aug. 4, 2005. The Examiner refers to this reference as “Hemolytics” so we do as well. Appeal 2012-008673 Application 12/102,342 3 (id. at 4), while Hemolytics only describes “the formation of a nanotube activation agents from the self-assembly of cyclic peptides, i.e. individual component parts.” (Id. at 5.) Appellant argues that “the nanotube (activation agent) disclosed in Hemolytics is structurally distinct from the amphiphilic nanotubes of the invention, wherein an end (or portion) or a hemicylindrical portion of one side is hydrophobic, and another end (or portion) or a different hemicylindrical portion of the opposite is hydrophilic.” (Id. at 7.) We agree with Appellant that Hemolytics does not disclose a nanotube meeting the limitations of the claims on appeal. Claim 1 is directed to an “amphiphilic” nanotube, where “a plurality of the nanotubes are capable of self-assembly into a micelle.” “[D]uring examination proceedings, claims are given their broadest reasonable interpretation consistent with the specification.” In re Hyatt, 211 F.3d 1367, 1372 (Fed. Cir. 2000). The Specification states that a “micelle is an aggregate of surfactant molecules (typically organic molecules that are amphiphilic, meaning that they have a hydrophobic or lipophobic end and a hydrophilic or lipophilic end) dispersed in a liquid colloid.” (Spec. 1 ¶ 3.) The Specification discloses that, like surfactant molecules, amphiphilic nanotubes can self- assemble to form micelles. (Id. at 2 ¶ 7.) The Specification states that the amphiphilic nanotube may be made by covering a functionisable part of one or more of the nanotubes with a coating that includes a hydrophilic or hydrophobic surfactant. . . . The coating can be applied to an end, to an extending portion which extends away from an end portion towards a distal end of the nanotube, or to a side of the Appeal 2012-008673 Application 12/102,342 4 nanotube such as a hemicylindrical portion of the nanotube surface. The other end or side can be left without a coating, or a coating with opposite hydrophobic or hydrophilic properties can be applied. (Id. at 2 ¶ 9.) The Specification also states that “[i]f the concentration of nanotubes 2 in a liquid colloid is greater than the critical micelle concentration (CMC), then, the nanotubes will spontaneously form a micelle due to the amphiphilic nature of the surfactant coated nanotubes.” (Id. at 7 ¶ 41.) Appellant’s Figure 2 is reproduced below: Figure 2 shows “[a]n example of a spherical micelle where the liquid colloid is water.” (Id. at 7–8 ¶ 41.) “[E]ach nanotube 8 has a hydrophilic end 8a and a hydrophobic end 8b. The hydrophobic ends 8b of the nanotubes 8 cluster together at the centre of the micelle to form a core 10.” (Id. at 8 ¶ 41.) Thus, when the claim language is read in light of the Specification, it requires the claimed nanotube to be amphiphilic and capable of self- assembly to form a micelle. That is, the nanotube has separate hydrophobic and hydrophilic portions that are distributed in such a way that a plurality of Appeal 2012-008673 Application 12/102,342 5 the nanotubes will spontaneously aggregate in a liquid colloid with their hydrophobic portions clustered together and hydrophilic portions contacting the liquid (or vice versa, depending on the liquid colloid). Hemolytics discloses an “activation agent” (Hemolytics 5:1), which can be a nanotube (id. at 6:17), that is “capable of self assembly and integration into [a] vesicle membrane.” (Id. at 5:4–5.) “The activation agent must be able to self assemble in solution. . . . The activation agent may have both a hydrophobic region and a hydrophyllic [sic] region for stable incorporation into a vesicle membrane that is amphipathic.” (Id. at 13:28– 33.) The Examiner points to Example 8 of Hemolytics as disclosing “an amphiphilic nanotube structure and discuss[ing] self-assembly.” (Ans. 5.) That example describes “cyclic peptides [that] are designed to have hydrophobic side chain moieties in order to ensure their insertion and self- assembly within the nonpolar environment of lipid bilayer membranes.” (Hemolytics 54:14–16.) The cyclic peptides form stacks (id. at 54:18) by formation of hydrogen bonds. (Id. at 54:22.) That is, the “cyclic peptides are not only structurally predisposed toward intermolecular interaction, but are also energetically favored to self-assemble, in the lipid bilayer environment, into artificial membrane channels.” (Id. at 55:3–5.) “[T]he hydrophilic interior of the channel structure is expected to be filled with a large number of interacting water molecules.” (Id. at 55:1–2.) Thus, Hemolytics describes nanotubes that are formed by self- assembly of cyclic peptides having hydrophobic groups facing out and hydrophilic groups on their interiors. The cyclic peptides spontaneously stack by forming hydrogen bonds with each other to form a nanotube with a Appeal 2012-008673 Application 12/102,342 6 hydrophobic exterior and hydrophilic channel, and this self-assembly can take place in the lipid bilayer of a vesicle. However, claim 1 requires amphiphilic nanotubes that are amphiphilic—having hydrophobic and hydrophilic regions—in a way that allows “a plurality of the nanotubes [to be] capable of self-assembly into a micelle.” We agree with Appellant (Reply Br. 2) that the claim language requires that a plurality of the claimed nanotubes self-assemble to form a micelle, not merely that each nanotube is capable of being formed by self- assembly within the membrane of a pre-existing micelle (or vesicle). Hemolytics does not describe nanotubes having hydrophobic and hydrophilic regions distributed in such a way that they will self-assemble to form a micelle, and therefore does not anticipate claim 1 or dependent claims 2–5. SUMMARY We reverse the rejection of claims 1–5 as anticipated by Hemolytics. REVERSED bar