Ex Parte Pruitt et alDownload PDFPatent Trial and Appeal BoardMay 24, 201812629913 (P.T.A.B. May. 24, 2018) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 12/629,913 12/03/2009 31781 7590 05/29/2018 ALCON RESEARCH, LTD. PA TENT DEPARTMENT 11460 JOHNS CREEK PARKWAY JOHNS CREEK, GA 30097-1556 FIRST NAMED INVENTOR John Dallas Pruitt 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. PAT053009-US-NP 8758 EXAMINER HUANG, GIGI GEORGIANA ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 05/29/2018 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): patent. docketing@alcon.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JOHN DALLAS PRUITT, LYNN COOK WINTERTON, and JARED NELSON Appeal 2016-007912 Application 12/629,913 Technology Center 1600 Before DEBORAH KATZ, JOHN E. SCHNEIDER, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 submit this appeal under 35 U.S.C. § 134 involving claims to a silicone hydrogel contact lens. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b ). We REVERSE. 1 Appellants identify the real party in interest as Novartis AG. App. Br. 1. Appeal2016-007912 Application 12/629,913 STATEMENT OF THE CASE Appellants' "invention relates to ophthalmic devices, in particular contact lenses, which are capable of gradually releasing one or more hydrophobic comfort agents during wear." Spec. 1 :7-8. Claims 1-3, 8, 9, and 21 are on appeal. Claim 1, the only independent claim, is illustrative: 1. A silicone hydrogel contact lens, comprising: a polymeric matrix and a hydrophobic comfort agent which is not covalently linked to the polymer matrix but distributed therein and which is a building material for the tear film lipid layer of eyes, wherein the polymeric matrix comprises hydrophobic units derived from a silicone-containing monomer or macromer and hydrophilic units derived from a hydrophilic monomer or macromer, wherein the hydrophobic comfort agent is a phospholipid, a monoglyceride, a diglyceride, a triglyceride, a glycolipid, a glyceroglycolipid, a sphingolipid, a sphingoglycolipid, or a mixture thereof, wherein the silicone hydrogel contact lens has an oxygen permeability of at least about 40 barrers, an elastic modulus of from about 0.2 MPa to about 2.0 MPa, and a water content of from about 15% to about 70% by weight when fully hydrated, wherein the silicone hydrogel contact lens is characterized by its capability of gradually releasing the hydrophobic comfort agent from the polymer matrix into the eye of a wearer over at least about 4 hours after the silicone hydrogel contact lens has been stored in a packaging solution for at least about one month and when being worn by the wearer. App. Br. 13 (Claims App.). 2 Appeal2016-007912 Application 12/629,913 The claims stand rejected as follows: I. Claims 1-3, 8, 9, and 21 under 35 U.S.C. § I03(a) over Winterton2 and Gulsen, 3 as evidenced by Dausch4 or Peters5 ("Rejection I"). II. Claims 1-3 and 21 under 35 U.S.C. § I03(a) over Chauhan6 and Jones,7 as evidenced by Dausch or Peters ("Rejection II"). In response to the Examiner's election/restriction requirement, Appellants elected phospholipid as the species of the hydrophobic comfort agent recited in claim 1. Election (May 9, 2012) 1. We limit our analysis of the claims to the patentability of the elected species. See Ex parte Ohs aka, 2 USPQ2d 1460, 1461 (BP AI 1987). Appellants waived attendance at the oral hearing that was scheduled in this appeal for June 13, 2018. 2 Winterton et al., US 2006/0251696 Al, published Nov. 9, 2006. 3 D. Gulsen et al., Dispersion of DMPC liposomes in contact lenses for ophthalmic drug delivery, 30: 12 CURR EYE REs. 1071-80 (2005) ("Gulsen") (Abstract of record). 4 D. Dausch et al., Comparative study of treatment of the dry eye syndrome due to disturbances of the tear film lipid layer with lipid-containing tear substitutes, 223: 12 KLIN MONBL AUGENHELLKD 974--83 (2006) ("Dausch") (English Abstract of record). 5 K. Peters & T. Millar, The role of different phospholipids on tear break-up time using a model eye, 25: 1 CURR EYE REs. 55---60 (2002) ("Peters") (Abstract of record). 6 Chauhan et al., US 2004/0241207 Al, published Dec. 2, 2004. 7 Lyndon Jones & Brian Tighe, Silicone Hydrogel Contact Lens Materials Update-Part 1, HIGH-DK SILICONE HYDROGEL LENSES (2004), http://www.siliconehydrogels.org/editorials/index_july.asp ("Jones"). 3 Appeal2016-007912 Application 12/629,913 REJECTION I The Examiner rejected claims 1-3, 8, 9, and 21 as obvious over Winterton and Gulsen, as evidenced by Dausch or Peters. Final Act. (July 24, 2015) 3-5; Ans. 4--7. Regarding claim 1, the Examiner finds that Winterton teaches, inter alia, "a hydrogel contact lens comprising a guest material that is not covalently linked to the polymer matrix but distributed within the [polymer] matrix." Ans. 5. The Examiner further finds that Winterton teaches the contact lens may comprise a silicone hydrogel. Id. According to the Examiner, Winterton teaches that the guest materials in the hydrogel may include drugs, lubricants, and hydrophilic polymers such as non-crosslinkable PV A for controlled delivery ( e.g., for at least about 6 hours during wear). Id. The Examiner finds that "Winterton does not expressly teach the incorporation of phospholipids" as a comfort agent as in claim 1, so the Examiner turns to Gulsen. Id. at 5---6. According to the Examiner, Gulsen "teaches the encapsulation of drugs in dimyristoyl phosphatidylcholine [(DMPC)] liposomes" and the dispersion of DMPC liposomes in contact lenses for ophthalmic drug delivery. Id. at 6; see also id. (finding that DMPC is a type of phospholipid). The Examiner further cites Dausch as teaching that liposomes improve the tear film layer, and Peters as teaching that phospholipids are tear film stabilizers. Id. The Examiner concludes it would have been obvious to modify Winterton's contact lenses in view of Gulsen's teachings to produce the claimed invention. Id. The Examiner reasons that Gulsen "demonstrates that drug delivery with liposomes such as DMPC in contact lenses is not only known but also provides for sustained and controlled drug release 4 Appeal2016-007912 Application 12/629,913 which is desirable." Id. And, the Examiner reasons, "the characteristics recited such as release capacity in the eye, the water content, permeability, and elastic modulus are intrinsic to the contact lens material" because the structural components of the composition are met. Id. at 7. The Examiner "bears the initial burden ... of presenting a prima facie case ofunpatentability." In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992). On the record here, we are not persuaded the Examiner met the burden to establish that claim 1 would have been obvious. We start with claim construction, which is a prerequisite to comparing the claims to the prior art. Claim 1 requires, among other limitations, "a hydrophobic comfort agent" that is distributed within the hydrogel's polymer matrix. App. Br. 13 (Claims App.). Claim 1 specifies that the contact lens is capable of "gradually releasing the hydrophobic comfort agent from the polymer matrix into the eye of a wearer over at least about 4 hours." Id. Claim 1 also requires that "the hydrophobic comfort agent is a phospholipid." Id. (emphasis added). Notably, this limitation, which previously read "the hydrophobic comfort agent comprises a phospholipid," was amended in prosecution. Amendment (Mar. 29, 2013) 2 ( emphasis added). And, as noted above, the applicant elected phospholipid as the species for examination, and our review is limited to that species on appeal. Ohsaka, 2 USPQ2d at 1461. Although the Specification discloses that "a hydrophobic comfort agent is a compound or a mixture of compounds which can strengthen and/or stabilize the tear film lipid layer," claim 1 is narrower. Spec. 10:8-9. On the record before us, we conclude that the hydrophobic comfort agent of claim 1 must, in fact, be a phospholipid. Accordingly, the comfort agent 5 Appeal2016-007912 Application 12/629,913 limitation is not met by a comfort agent that merely comprises a phospholipid as, for example, one of the agent's structural features. Turning to the rejection on appeal, the Examiner has not shown sufficiently that a drug-filled liposome is a phospholipid as claimed, or that the ordinarily skilled person would interpret such a liposome that way. As Appellants have persuasively argued and shown, a liposome is a colloidal, vesicular structure composed of one or more lipid bilayers surrounding an equal number of aqueous compartments -basically a sphere-like shell that encapsulates a liquid interior in which drugs, proteins, etc. may be contained. App. Br. 5 (citing Shashi8). A phospholipid, on the other hand, is merely a compound having a molecular structure that consists of hydrophilic head and a hydrophobic tail. App. Br. 5; Shashi 10 (Fig. 2). The Examiner asserts that the claims are "written i[ n] open language" and "the instant claims do not preclude the inclusion of drug encapsulated liposomes (e.g. DMPC) and the prior art teaches that the advantage of using them in contact lenses in general." Ans. 10-11. Even assuming the Examiner's characterization was accurate, the Examiner does not show or explain sufficiently how combining the prior art as proposed would result in a conifort agent that is a phospholipid, which phospholipid is distributed in the polymer matrix. The fact that a liposome' s bilayer( s) may be formed with phospholipids is not decisive. Compounds forming a cell membrane are not the same thing as a cell. And a phospholipid is not the same thing as 8 Kant Shashi et al., A COMPLETE REVIEW ON: LIPOSOMES, 3 :7 INTERNATIONAL RESEARCH JOURNAL OF PHARMACY 10-16 (2012) ("Shashi"). 6 Appeal2016-007912 Application 12/629,913 a drug-filled liposome. In short, a building block or structural component of a certain thing is not necessarily synonymous with the thing itself. Moreover, even if liposomes include phospholipids as a structural component, we are not persuaded on this record that the phospholipids that make up the liposome' s bilayer would be released into the wearer's eye over several hours as claimed. App. Br. 6-7; Reply Br. 3. As Appellants point out, Gulsen teaches that the liposome-encapsulated drug is released slowly into the eye. Gulsen. 9 Appellants contend, with supporting evidence, that liposomes are highly stable and would not reasonably be expected to release phospholipids from the polymer matrix. App. Br. 7 (citing Shashi 13). The Examiner provides no persuasive evidence to the contrary. Instead, the Examiner posits that all of the other characteristics recited in the claim, such as release capacity, are "intrinsic" to the composition. Ans. 7. But, as noted above, Gulsen does not describe the liposomes or phospholipids being released from the contact lens matrix material into the eye, and the Examiner has not provided a sufficient evidentiary basis to support the notion that the release capability of phospholipids embedded in silicone hydro gel matrix is "intrinsic" - i.e., inherent. For the above reasons, we conclude that the Examiner did not meet the burden to show by a preponderance of the evidence that claim 1 would have been obvious. We, thus, reverse the rejection of claim 1, as well as the rejection of claims 2, 3, 8, 9, and 21 based on their dependency from claim 9 As Appellants also point out, Gulsen does not teach or suggest that a phospholipid is a drug that is encapsulated by the DMPC liposomes. App. Br. 6 ("Gulsen teaches nothing but the incorporation ( or dispersion) of DMPC liposomes for drugs."). We agree. 7 Appeal2016-007912 Application 12/629,913 I. In re Fritch, 972 F.2d 1260, 1266 (Fed. Cir. 1992) ("[D]ependent claims are nonobvious if the independent claims from which they depend are nonobvious."). REJECTION II According to the Examiner, Chauhan "teaches a [HEMA] contact lens having nanoparticles with a nanoencapsulated drug dispersed within the contact lens wherein the drug can diffuse and migrate through the lens for delivery." Ans. 7. The Examiner finds that Chauhan teaches that the nanoparticles can be drug-containing liposomes, including liposomes formed with a DMPC bilayer. Id. at 8. Because Chauhan does not teach that the contact lens materials include silicone hydrogels, the Examiner cites Jones as teaching that silicone hydrogel contact lenses were known in the art. Id.; see also Jones,passim. The Examiner concludes it would have been obvious "to utilize silicone hydrogel materials as suggested by Jones et al., and produce the instant invention," which, the Examiner reasons, involves a "simple substitution of one hydrogel for another." Id. at 8-9. Like Rejection I, the Examiner further reasons that the claimed characteristics (release capacity, water content, permeability, etc.) would be "intrinsic" to the composition. Id. at 9. Rejection II is deficient for similar reasons to Rejection I. We are not persuaded that Chauhan's DMPC liposomes meet the limitation of claim 1 requiring "the hydrophobic comfort agent is a phospholipid" as explained above (analysis on Rejection I). The Examiner has further not shown that phospholipids that make up a liposome would be released into the eye from a silicone hydro gel matrix; nor has the Examiner provided a sufficient 8 Appeal2016-007912 Application 12/629,913 evidentiary basis to support the conclusion that the release rate would be "intrinsic" (inherent) to the composition. We thus reverse Rejection II. SUMMARY We reverse the rejections for obviousness on appeal. REVERSED 9 Copy with citationCopy as parenthetical citation