Opinion ID: 706793
Heading Depth: 4
Heading Rank: 1

Heading: an outer layer which is impermeable to the passage of nicotine,

Text: 10 (b) an inner layer adapted to be placed on the surface of a user's skin, said inner layer being sufficiently porous to enable the passage of nicotine therethrough for transdermal application to the bloodstream of a user, 11 (c) means associated with said patch to enable said patch to be temporarily and releasably attached to the skin of a user, and 12 (d) said outer layer and said inner layer forming a nicotine receiving area for receiving nicotine to allow the nicotine to pass through the inner layer. 13 Col. 17, 1.61-col. 18, 1.8. Claim 2 is a dependent claim. It claims [t]he patch of claim 1 further characterized in that said patch is provided with a membrane in the nicotine receiving area to receive and enable a release of the nicotine. Col. 18, 11.9-12. 14 Ciba argues that, as far as claims 1 and 2 are concerned, material issues of fact exist as to (1) whether the Fox letter is too speculative to be a complete disclosure of the inventions of those claims, and (2) whether the district court erred in expanding the Fox letter by 'reading into' it extrinsic information not necessarily inherent in the Fox letter. We address these contentions in reverse order. 15 [E]xtrinsic evidence may be considered when it is used to explain, but not expand, the meaning of a reference. In re Baxter Travenol Labs., 952 F.2d 388, 390, 21 USPQ2d 1281, 1284 (Fed.Cir.1991) (citing Scripps Clinic & Research Found. v. Genentech, Inc., 927 F.2d 1565, 1566-67, 18 USPQ2d 1001, 1010 (Fed.Cir.1991)). Thus, although references cannot be combined for purposes of anticipation, additional references may be used to interpret the allegedly anticipating reference and shed light on what it would have meant to those skilled in the art at the time of the invention. Studiengesellschaft Kohle, m.b.H. v. Dart Indus., Inc., 726 F.2d 724, 726-27, 220 USPQ 841, 842 (Fed.Cir.1984). However, such evidence must make clear that the missing descriptive matter is necessarily present in the thing described in the reference, and that it would be so recognized by persons of ordinary skill. Continental Can Co. USA Inc. v. Monsanto Co., 948 F.2d 1264, 1268, 20 USPQ2d 1746, 1749 (Fed.Cir.1991). 16 Ciba argues that the district court improperly used extrinsic evidence, in the form of three known nitroglycerine patches, one known scopolamine patch, and associated product literature, to supplement the disclosure of the Fox reference. According to Ciba, the Fox reference did not necessarily describe the particular nitroglycerin or scopolamine patch to be used in constructing a transdermal nicotine delivery patch. Ciba argues that because there were two other nitroglycerin patches and one other scopolamine patch that Dr. Barry could have chosen for his experiments, the particular nitroglycerin patch chosen by Dr. Barry was not the one necessarily described by the Fox reference. Ergo, it was improper for the court to rely on the extrinsic evidence used by Dr. Barry in making a nicotine patch according to the Fox reference. 17 We reject Ciba's argument. We have carefully reviewed the Barry declaration and are satisfied that it does not go beyond explaining what the Fox reference would have meant to those skilled in the art in 1984. 2 Nor has Ciba established any disputed issues of material fact on this point. 18 Ciba's second argument is that there are disputed issues of material fact with respect to whether the Fox reference represents mere speculation and conjecture regarding transdermal nicotine patches. We disagree. First, the Fox reference recommends the development of [a]lternative routes of [nicotine] administration more cosmetic than chewing tobacco or snuffs. The express suggestion in the reference to substitute nicotine for the drug in an existing nitroglycerine or scopolamine patch, when made to one of ordinary skill in the art of transdermal drug delivery, is both definite and specific. 19 Second, as noted above, Alza supported its motion for summary judgment with the Barry declaration. In addition to what he said in his declaration, at his deposition Dr. Barry testified as follows with respect to the Fox reference: 20 All the elements of the patent are there. The Fox article refers to absorption of nicotine through the buckle [sic] membrane of the mouth, through chewing gum. It suggests that an alternative way of delivering nicotine would be by a transdermal means, and it specifically taught to put the nicotine into a commercial patch, such as nitroglycerine and scopolomine [sic ]. I said that from what I could see you could put the nicotine into the Transderm-Nitro patch and you would achieve blood levels of nicotine appropriate for smoking cessation therapy. 21 Dr. Barry then went on to describe his experiment with the Transderm-Nitro patch. 22 In opposition to Alza's motion for summary judgment, Ciba presented the declarations of Drs. Enscore, Jed Rose, and Martin Jarvis. We agree with the district court, however, that neither the Enscore nor the Rose declaration raises a genuine issue of material fact. Ciba, 864 F.Supp. at 433-34, 33 USPQ2d at 1021. Turning to the third item, in his declaration Dr. Jarvis expressed the opinion that the Fox reference is a speculative disclosure which merely mentions administering nicotine transdermally as one of three possibilities for administering nicotine that are 'more cosmetic' then chewing tobacco or snuff. According to Dr. Jarvis, Fox also does not state whether any of the possibilities would deliver the correct dosage of nicotine to satisfy a smoker's demand for nicotine, or whether any of these possibilities would deliver nicotine with sufficient rapidity to satisfy a smoker. Dr. Jarvis did not take issue, though, with either the Fox reference's or Dr. Barry's statements with respect to the transdermal application of nicotine through patches. Neither did Dr. Jarvis take issue with Dr. Barry's statement concerning what the Fox reference would have meant to one skilled in the art in 1984. Dr. Jarvis's statement quoted above to the effect that the Fox reference does not address the efficacy of the transdermal delivery of nicotine through patches is not pertinent to claims 1 and 2. These claims do not require any particular level of nicotine delivery. They merely recite, in clause (b) of claim 1, a patch with an inner layer being sufficiently porous to enable the passage of nicotine therethough for transdermal application to the bloodstream of a user, and, in claim 2, a patch with a membrane in the nicotine receiving area to receive and enable a release of the nicotine. 23 Finally, Ciba claims that the Fox reference would not have enabled one of ordinary skill in the art to make the claimed invention because, in addition to the nitroglycerin patch selected by Dr. Barry for his experiment, at least three other types of nitroglycerin/scopolamine patches existed that arguably would not have resulted in the claimed invention. Stated differently, according to Ciba, it would have required undue experimentation for one of ordinary skill in the art to have made the claimed invention based on the Fox reference, and thus the Fox reference is not an enabling reference. 3 24 The key to analyzing an undue experimentation attack on the enablement of a patent, and therefore of an anticipatory reference, is in determining what is undue, because some trial and error is permissible. See W.L. Gore & Assocs. v. Garlock, Inc., 721 F.2d 1540, 1557, 220 USPQ 303, 316 (Fed.Cir.1983) (Assuming some experimentation were needed, a patent is not invalid because of a need for experimentation. A patent is invalid only when those skilled in the art are required to engage in undue experimentation to practice the invention. (cite omitted) (emphasis in original)), cert. denied, 469 U.S. 851 (1984). Ciba implicitly contends that choosing between four available nitroglycerin/scopolamine patches represents undue experimentation for someone of skill in the art, or at least that fact issues surround a determination as to whether or not that is true. 25 Dr. Barry testified at his deposition that replacing scopolamine with nicotine practically would be a bit difficult because the patch is so small to clean out, put material in and reseal. This is evidence not that undue experimentation is required, but rather that one of ordinary skill in the art would pursue more promising options (known nitroglycerin patches) rather than less promising ones (the known scopolamine patch). Similarly, Ciba contends that the experiments Dr. Barry sets out as being relatively straightforward for Transderm-Nitro [the patch actually tested by Dr. Barry] probably would be far more difficult, if not impossible, for the other available nitroglycerin and scopolamine patch constructions. Ciba's proposition does not help it, though, for it supports the conclusion that experimentation with the other patches would be difficult, if not impossible, and therefore not readily undertaken by one of ordinary skill in the art. 26 For the foregoing reasons, as far as claims 1 and 2 are concerned, we hold that Ciba has failed to demonstrate the existence of any genuine issues of material fact as to whether the Fox reference properly serves as an anticipatory reference. Accordingly, we affirm the district court's grant of summary judgment of invalidity with respect to those claims.