Ex Parte Menz et alDownload PDFBoard of Patent Appeals and InterferencesNov 30, 200610477069 (B.P.A.I. Nov. 30, 2006) Copy Citation 33The opinion in support of the decision being entered today was not written for publication and is not binding precedent of the Board. UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE BOARD OF PATENT APPEALS AND INTERFERENCES __________ Ex parte DIRK HENNING MENZ, JOACHIM DRESP, and HANS HOERAUF __________ Appeal No. 2006-3179 Application No. 10/477,069 __________ ON BRIEF __________ Before ADAMS, GRIMES, and LEBOVITZ, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This appeal involves claims to methods for passivating the surface of intraocular lens using a fluoroalkyl silane of a defined formula. The Examiner has rejected the claims as obvious. We have jurisdiction under 35 U.S.C. § 134. We affirm. Background Intraocular lens (“IOL”) are used to replace the natural lens of the eye when it does not function properly as a result of mechanical damage or medical conditions, Appeal No. 2006-3179 Page 2 Application No. 10/477,069 such as cataracts. Mänsson,1 column 1, line 11-19. Many of the materials utilized to produce intraocular lens contain reactive groups at their surface which can adversely interact with biological materials upon lens implantation. Specification, page 1. Furthermore, silicone oil can adhere to intraocular lens during silicone oil tamponade, impeding its removal. Id., page 2. To counteract “undesired depositions,” the instant application provides a method of modifying the lens body surface with a fluoroalkyl silane of a defined formula. Id., pages 2 and 4. Discussion Claim construction Claims 1-10, all the pending claims in this application, are on appeal. The claims are rejected under four different grounds of obviousness which are summarized on pages 2-3 of the Brief. Within each grouping, the claims stand or fall together because separate reasons for patentability were not presented. Claim 1 is the only independent claim on appeal. It reads as follows: 1. A method for the passivation of the surface of an intraocular lens, the surface of which comprises Brönsted sites, characterized in that the intraocular lens is dipped into a solution of a fluoroalkyl silane of the general formula RF - (CH2)n - Si - (O-R)3 wherein the residue R is selected from the group of H, CH3, C2H5, C3H7, and the fluoroalkyl residue RF is selected from the series CF3(CF2)m, with m=3 to 11 and n=0 to 4, whereby the Brönsted sites on the surface are deactivated by formation of Si-O-bonds. Passivation is not defined in the specification, but as with any term recited in a claim, we adopt “the broadest reasonable meaning of the words in their ordinary usage 1 Mänsson et al., U.S. Pat. No. 5,429,838, issued Jul. 4, 1995 (of record) Appeal No. 2006-3179 Page 3 Application No. 10/477,069 as they would be understood by one of ordinary skill in the art, taking into account whatever enlightenment by way of definitions or otherwise that may be afforded by the written description contained in the applicant's specification.” In re Morris, 127 F.3d 1048, 1054, 44 USPQ2d 1023, 1027 (Fed. Cir. 1997); In re Crish, 393 F.3d 1253, 1256, 73 USPQ2d 1364, 1367 (Fed. Cir. 2004). According to its dictionary definition,2 “passivate” means “to make inactive or less reactive.” This definition is consistent with the specification which describes the claimed process as inactivating the Brönsted sites located at the lens body surface and also with the body of the claim. Specification, page 4. Brönsted sites are defined in the application to include COOH and OH groups. Id., page 3, ¶¶ 5 and 6; page 5, ¶ 1. Thus, the claimed subject matter is drawn to a method of making the surface of a lens less chemically reactive by exposing it (“dipped into”) to a solution of a fluoroalkyl silane which deactivates the Brönsted sites. Obviousness Gupta in view of Ogawa Claims 1, 3, 5, and 7-9 stand rejected under § 103(a) as obvious over Gupta3 in view Ogawa.4 Gupta teaches the modification of the outermost surface of an acrylic optical lens to produce a surface which is biologically inert and which has “low glare, soil resistance, UV absorbance, and cytotoxic and anti-bacterial properties.” Gupta, page 3, lines 30- 32. Carboxyl groups present on the acrylic polymer chains of the len’s surface are modified in a “surface modifying step” by the addition of “a chemical group selected 2 Webster’s New Collegiate Dictionary 838 (1976) 3 Gupta, EP 348 462 B1, published May 18, 1994 4 Ogawa, U.S. Pat. No. 6,060,123, issued May 9, 2000 Appeal No. 2006-3179 Page 4 Application No. 10/477,069 from a perfluoroalkyl group, an alkyl group (CH2)xCH3 where x=2 to 12, a siloxyl group, cyclohexyl, a UV absorber or a cytotoxic polypeptide, the chemical group being bonded to the surface of the lens body by a sillyl ester.” Id., page 4, lines 24-27. “A typical reagent for the surface modifying step comprises a molecule incorporating a reactive silane group and a group whose presence is desired on the acrylic surface. Hence, the typical reagent may have a formula R1-X-R2, where R1 is a silane group, R2 is a group whose presence is desired on the surface, and X is a joining group, which may or may not be needed.” Id., page 5, lines 31-34. Examples are shown in Table 1, which includes a silane/perfluoroalkyl combination. Ogawa teaches a method of covalently bonding an alkoxysilane surface active agent to a substrate surface to improve its surface properties. Ogawa, column 1, lines 10-18. The process “allows practical reaction rates and does not generate hydrochloric acid.” Id., column 2, lines 6-9. The surface active agents disclosed in the Ogawa patent include silane surface active agents that contain fluoroalkyl groups (the same generic structure described in Gupta). Id., column 5, lines 46-55. Specific examples are described by Gupta which fall within the claimed fluoroalkyl silane general formula. Id., column 9, line 59; column 11, lines 36, 37, and 47-50. The method is described as “applicable for various uses and materials,” including 19 different classes of specifically mentioned articles of manufacture and materials. Id., columns 7-9. The Examiner states that it would have been obvious to the person of ordinary skill in the art to have utilized Ogawa’s silane surface reagent in Gupta’s process to coat intraocular lens for the benefit of achieving a practical reaction rate. Answer, page 6. Appeal No. 2006-3179 Page 5 Application No. 10/477,069 He explains: Ogawa teaches a method analogous to the one taught by Gupta that achieves the surface modification explicitly desired by Gupta (i.e., the formation of a substrate having a siloxane capped with a fluoroalkyl layer, the siloxane bonded to the substrate surface through Si-O bonds). The method of Ogawa comprises dipping the substrate (which has active carboxyl and/or hydroxyl groups thereon) into a solution of the applicant’s specifically claimed fluoroalkyl silane (see Col. 5, lines 46 - 61, Col.11, lines 5 - 60, and Col.12, lines 18 -40). Answer, page 12. Appellants challenge the rejection on several grounds. They argue that there would have been no motivation to have replaced “the type of coating components used in Gupta by a chemically totally different group of compounds” as taught in Ogawa. Brief, page 6, ¶ 4. They contend the differences included the presence of an amide linker in Gupta, which was missing from Ogawa, and a two-component system, rather than the one-component system described by Ogawa. Id., page 5; page 6, ¶¶ 1 and 2. Furthermore, Appellants argue that the references are from different fields of endeavor and therefore not properly combinable. Id., page 5, ¶ 4. “When patentability turns on the question of obviousness, the search for and analysis of the prior art includes evidence relevant to the finding of whether there is a teaching, motivation, or suggestion to select and combine the references relied on as evidence of obviousness.” In re Lee, 277 F.3d 1338, 1343, 61 USPQ2d 1430, 1433 (Fed. Cir. 2002). A suggestion, teaching, or motivation to combine the relevant prior art teachings does not have to be found explicitly in the prior art. “[T]he teaching, motivation, or suggestion may be implicit from the prior art as a whole, rather than expressly stated in the references. The test for an implicit showing is what the combined teachings, knowledge of one of ordinary skill in the art, and the nature of the Appeal No. 2006-3179 Page 6 Application No. 10/477,069 problem to be solved as a whole would have suggested to those of ordinary skill in the art.” In re Kahn, 441 F.3d 977, 987-988, 78 USPQ2d 1329, 1336 (Fed. Cir. 2006). We begin our analysis with the observation that the nature of the problem addressed by Gupta, Ogawa, and the claimed subject matter are the same. Gupta describes his “invention” as the modification of a lens body surface “to possess a desired characteristic.” Gupta, page 3, lines 30-33. Similarly, Ogawa’s patent is directed to processes for modifying substrate surfaces with active agents that confer desirable surface properties. Ogawa, column 5, lines 46-52; column 6, lines 57-60. Claim 1 is also a method of modifying surfaces, particularly by inactivating Bronstëd bases on the surface of an intraocular lens body. In addition to addressing the same general problem, both Gupta and Ogawa are also engaging the same basic technology to solve it, i.e., the application of bifunctional silane/perfluoroalkyl reagents to the substrate surface. The Gupta patent identifies two chemical functionalities present in its surface modifying reagent which are used to achieve the surface properties desired for an artificial optical lens: a reactive silane group and a second functional group that acts to modify the lens’s surface properties. Gupta, page 5. This structure is generically described in Gupta by the formula “R1-X- R2,” where R1 is the silane group, R2 is the second functional group, and X is the joining group. Id., page 5, lines 31-37. In particular, Gupta teaches that the combination of a trialkyamino silane (R1) and perfluoroalkyl (R2) confer biological inertness and low glare to the lens body, depending on the surface thickness. Id., page 6, Table 1. The perfluoroalkyl group derivative is covalently joined to a silane group. The silane group is used to attach the perfluoroalkyl to the lens surface because it is a “versatile” reagent Appeal No. 2006-3179 Page 7 Application No. 10/477,069 that “may be derivatized to incorporate many different R2 groups.” Id., page 5, line 35. The perfluoroalkyl group is used to confer biological inertness, reduced glare, and “soil resistance.” Id., page 7, lines 45-47. Ogawa’s compounds have both functional groups described by Gupta. At column 5, lines 46-55, Ogawa describes a preferred surface active reagent which contains silane and fluoroalkyl (“fluorocarbon”) functionalities. Like Gupta, Ogawa also teaches to use a fluorocarbon group when “dirt repellency” is desired. Ogawa, column 5, line 49. Six of the 24 fluoroalkyl silane compounds disclosed by Ogawa also meet the requirements for the claimed “fluoroalkyl silane” of claim 1. Id., column 11, lines 36, 47-49, and 51-52. There is no express statement to expand Gupta’s coating reagents to the chemically-related structures described by Ogawa, but the fact that Gupta’s surface active reagent is generically described (e.g., page 5, line 33) shows an intent to capture more than just the specific compounds disclosed in his application. In view of the parallels between the two processes, which include structurally-similar compounds being utilized to achieve the same goal of substrate surface modification, the skilled worker would have logically looked to Ogawa to choose surface modifying reagents. Answer, page 12. The skilled worker would have recognized that Ogawa’s compounds have both functional groups required by Gupta’s formula, and therefore would have expected them to be useful in Gupta’s process, providing also the motivation to have used them. Appellants argue that “Ogawa refers to a completely different field of art and seeks to deal with issues that are not seen as problems in Appellants’ claimed field of Appeal No. 2006-3179 Page 8 Application No. 10/477,069 art.” Brief, page 5, ¶ 4. They have defined the problem and field of endeavor too narrowly. As discussed earlier, both Ogawa and Gupta are addressing the same problem – improving substrate surface properties – and are engaging the same technology – surface active agents which include compounds having silane and perfluoroalkyl groups. In In re Dillon, 919 F.2d 688, 693, 16 USPQ2d 1897, 1901 (Fed. Cir. 1990), the court held that prior art references describing hydraulic fluids and fuel combustion, respectively, were “within the field of the inventor’s endeavor” since each utilized structurally-related compounds for similar purposes. Significantly, Ogawa teaches a process for coating surfaces with compounds which fall within Gupta’s scope. Ogawa describes 19 different classes of objects and materials that can be coated in accordance with his method. Id., columns 7-9. Acrylate is also disclosed (column 9, lines 9-10) – the same material that Gupta’s lenses are constructed from – but these materials are described for automobile parts and other commercial, non-medical uses. Ogawa does not include intraocular lens in his list, but the broad disclosure of objects and materials would have reasonably suggested to the person of ordinary skill in the art that Ogawa’s teachings are generally useful for coating surfaces. As indicated in the “Background of the Invention,” Ogawa stated the field of use broadly. “The surface of the substrate such as plastic, metal, ceramics, fiber, woods, concrete, paint or the like have been treated for improved use in a variety of fields.” Id., column 1, lines 22-24. The purpose of surface treatment described by Ogawa is to provide water, oil, and dirt repellency. Id., column 5, lines 49-51. Appellants identify silicone oil adherence during silicone oil tamponade of the eye as a known problem that affects Appeal No. 2006-3179 Page 9 Application No. 10/477,069 intraocular lenses. Specification, page 2, lines 1-3. Thus, the skilled worker, who would have been aware of this problem, would have seen Ogawa’s teaching as a solution to it (i.e., an oil repellant surface), providing the incentive to combine this reference with Gupta. Appellants argue that “there is no mention [in Ogawa] of medical device applications.” Brief, page 5, ¶ 4. We do not agree. Ogawa discloses surgical knives and needles (including acupuncture, syringe, and surgical needles), which are medical devices. Id., column 7, lines 60-64. Culture dishes are also disclosed (column 8, line 7), which would be in contact with biological materials (e.g., cells and tissue culture media), and therefore relevant to the claimed intraocular lens which are also placed in a biological milieu. Appellants in their patent application state that “[t]he protection of intraocular lenses against the sticking of substances originating from biological liquids, as well as medical adjuvants has been a demand in ophthalmology for some time.” Specification, page 1. Having stated the problem in this way, Ogawa’s teaching of surface coated culture dishes would be recognized as addressing the same need identified by Appellants, i.e., to create a surface repellant to biological materials. This also provides adequate motivation to have combined Ogawa with Gupta. In fact, the efficacy of the coating was tested in Appellants’ application by “cell culture experiments” in which the number of cells adhering to coated and uncoated lens was measured. Id., pages 8-9. Appellants contend that “Gupta teaches the use of an at least two-component solution comprising a mixture of an amino functional silane reagent and a perfluoralkyl carboxylic acid (see fig, 4 of Gupta) … Two of … [the] possible reaction products … do Appeal No. 2006-3179 Page 10 Application No. 10/477,069 not lead to capping of the surface with fluoroalkyl groups.” (Underlining removed.) Brief, page 5, ¶ 1. We do not agree with Appellants’ characterization of the solution as a “mixture.” Gupta shows very clearly that silane and perfluoralkyl are chemically reacted to form a single molecule. See Gupta, Fig. 3a showing that the perfluoroalkyl acid and silane (“Z-6020”) are subjected to reflux prior to application by immersion of the device. Id., page 8, lines 3-7. Fig. 4 shows that the resulting “reaction product” contains three possible different molecules, not mixtures. In regard to Appellants’ description of “capping of the surface,” this is apparently a reference to the structure which would be achieved using the claimed reagent to coat the lens surface. However, this structure is not missing from Gupta. Fig. 3b of Gupta contains an illustration of a coated lens body with an inner silane layer and an outermost “fluoroalkyl layer.” The latter tops the lens’ body surface, and thus could be described as “capping” it. Special importance has been placed by Appellants on the amide bond described in certain preferred embodiments disclosed by Gupta. Brief, page 6. Appellants state that Gupta “would instruct one” to use “a reagent mixture which results in amide, siloxane and secondary amine coated surfaces (which are said to all contribute to the biological inertness of the surface, see Gupta page 8, lines 13 - 15)” and thus would not be motivated to replace it with Ogawa’s reagents which lack this linkage. Id., page 6, ¶ 1. Notwithstanding Gupta’s statement about the “contribution” of the amide bond, Fig. 1 attributes the biological inertness to a “thin” layer of fluorocarbon. Its thickness is Appeal No. 2006-3179 Page 11 Application No. 10/477,069 described in Table 1 (page 6) of Gupta to be “50-100 A.”5 Such thicknesses can be achieved using Ogawa’s compounds. See Ogawa, Example 2, line 4, reporting a thickness of 5 nm or 50 angstrom units, and Example 4, line 59, with a thickness of 7 nm or 70 angstrom units. Consequently, we do not find Appellants’ argument to be persuasive. In sum, we conclude that the Examiner has provided adequate evidence to establish a case of prima facie obviousness of claim 1. Claims 3, 5, and 7-9 were not argued separately, and thus fall with claim 1. This rejection is affirmed. Gupta, Ogawa, and Mansson Claim 2 stands rejected under 35 U.S.C. § 103(a) as obvious over Gupta in view of Ogawa, and further in view of Mänsson. Claim 2 reads as follows: 2. The method according to claim 1, characterized in that the intraocular lens is a silicone lens. Claim 2 is drawn to a method of passivating the surface of an intraocular lens that is fabricated from silicone. The Examiner argues that, in view of Mänsson’s teaching that intraocular lenses can be produced from silicone, it would have been obvious to have surface-modified them for the same reasons Gupta teaches for acrylic- based lens. Answer, page 7, § 3. Appellants challenge the rejection, arguing that Mänsson does not describe “the use of passivated lens surfaces to avoid contamination of the lens surface by proteins.” Brief, ¶ spanning pages 8-9. 5 “A” is being used to represent “angstrom unit,” which is equal to 10 nm. Appeal No. 2006-3179 Page 12 Application No. 10/477,069 We agree with the Examiner’s argument. Gupta establishes a general need to improve the surface properties of lens to ensure they are compatible with biological use. Gupta, page 2, lines 5-16. This requirement is dictated by the environment into which the lens is placed, not the material which comprises the lens. Appellants have not established that a silicone lens would not have been reasonably expected to require surface modification. Accordingly, this rejection is affirmed for the reasons set forth by the Examiner. Gupta, Ogawa, Milligan, and Gasmena Claims 4 and 10 stands rejected under 35 U.S.C. § 103(a) as obvious over Gupta in view of Ogawa, and further in view of Milligan6 and Gasmena.7 Claim 4 reads as follows: 4. The method according to claim 1, characterized in that the solution is acidified and comprises between 0.5% by weight and 2% by weight of the fluoroalkyl silane. Claims 4 and 10 require that the coating solution is “acidified” and contains a specific weight percent of the claimed fluoroalkyl silane. The Examiner provides a well- reasoned statement to support the rejection which do not find necessary to repeat here. Answer, page 8. Appellants argue that Milligan is from a “divergent art,” and consequently, motivation is lacking to have combined the references. Brief, page 9. “Two criteria have evolved for determining whether prior art is analogous: (1) whether the art is from the same field of endeavor, regardless of the problem addressed, and (2) if the reference is not within the field of the inventor's endeavor, 6 Milligan, U.S. Pat. No. 5,663,215, issued Sept. 2, 1997 7 Gasmena, U.S. Pat. No. 5,417,744, issued May 23, 1995 Appeal No. 2006-3179 Page 13 Application No. 10/477,069 whether the reference still is reasonably pertinent to the particular problem with which the inventor is involved.” In re Clay, 966 F.2d 656, 658-59, 23 USPQ.2d 1058, 1060 (Fed. Cir. 1992). The Examiner argues that both “Milligan and Gasmena both are directed to the protective coatings art. As such, this is within the field of endevor [sic] [of] the primary reference.” Answer, page 13. We do not find any flaw in this reasoning, and Appellants have not identified a specific deficiency in it. Accordingly, this rejection is affirmed. Gupta, Ogawa, and Bechetoille Claim 6 stands rejected under 35 U.S.C. § 103(a) as obvious over Gupta in view of Ogawa, and further in view of Bechetoille.8 Claim 6 reads as follows: 6. The method according to claim 1, characterized in that the fluorine content in the surface of the intraocular lens after the immersion treatment is between 2% by weight and 15% by weight. The Examiner states that “[i]t would have been obvious to one of ordinary skill in the art to perform the surface-modification process of the combination of Gupta and Ogawa to produce an IOL with a surface fluorine weight percent of 15% because Bechetoille et al. teaches that such a fluorine content is sufficient to impart the properties required by an IOL.” Answer, page 10. Appellants urge that “Bechetoille … refers to a totally different kind of fluorination of the lens surface both chemically and structurally such that the fluorine content values … could not be compared to those cited in claim 6.” Brief, page 10. However, Appellants do not describe the nature of this difference. In this regard, Bechetoille teaches adding F, CF, CF2, and CF3 groups to the lens surface. Bechetoille (English 8 Bechetoille et al. (Bechetoille), EP 487 418 B1 (English translation from French) Appeal No. 2006-3179 Page 14 Application No. 10/477,069 translation), page 7. CF2 and CF3 are also added to the lens surface by the claimed method. Accordingly, we agree with the Examiner that Bechetoille’s teaching about the final fluorine content would have been considered relevant by a person of ordinary skill in the art to the combination of Gupta and Ogawa because the end results are the same, i.e., attachment of fluorine atoms to the surface. Appellants have not identified any deficiency in the Examiner’s argument that it would have been obvious to have used Gupta in view Ogawa to achieve a fluorine content in the recited range. For the foregoing reasons, the rejection of claim 6 is affirmed. Summary The rejections of the claims over prior art are affirmed. Appeal No. 2006-3179 Page 15 Application No. 10/477,069 Time Period for Response No time period for taking any subsequent action in connection with this appeal may be extended under 37 CFR § 1.136(a). AFFIRMED Donald E. Adams ) Administrative Patent Judge ) ) ) ) BOARD OF PATENT Eric Grimes ) Administrative Patent Judge ) APPEALS AND ) ) INTERFERENCES ) Richard M. Lebovitz ) Administrative Patent Judge ) RL/dm Vidas, Arrett & Steinkraus, P.A. 6109 Blue Circle Drive Suite 2000 Minnetonka MN 55343-9185 Copy with citationCopy as parenthetical citation