Ex Parte Drizen et al

Patent Trial and Appeal BoardMay 27, 2014

95001687 (P.T.A.B. May. 27, 2014)

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. 95/001,687 07/13/2011 Alan Drizen 119-1002 4940 27162 7590 05/27/2014 CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO 5 BECKER FARM ROAD ROSELAND, NJ 07068 EXAMINER HUANG, EVELYN MEI ART UNIT PAPER NUMBER 3991 MAIL DATE DELIVERY MODE 05/27/2014 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 ____________ NYCOMED US INC. (Requester) v. GLYCOBIOSCIENCES, INC. (Patent Owner and Appellant) ____________ Appeal 2014-003286 Reexamination Control 95/001,687 US Patent 6,723,345 B2 Technology Center 3900 ____________ Before TONI R. SCHEINER, RICHARD M. LEBOVITZ, and RAE LYNN P. GUEST, Administrative Patent Judges. LEBOVITZ, Administrative Patent Judge. DECISION ON APPEAL This is a decision on the appeal by the Patent Owner from the Examiner’s rejection of claims 1-9 and 16-19 in the above-identified inter partes reexamination of US 6,723,345 B2. The Board’s jurisdiction for this Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 2 appeal is under 35 U.S.C. §§ 6(b), 134, and 315. We affirm-in-part the Examiner’s determination. STATEMENT OF CASE The patent in dispute in this appeal is 6,723,345 B2 (“the ‘345 patent”), which issued April 20, 2004. The claims of the patent are directed to methods of treating dermatologic conditions comprising topically applying a polymer matrix comprising sodium hyaluronate and a nonionic polymer. A request for inter partes reexamination under 35 U.S.C. §§ 311-318 and 37 C.F.R. §§ 1.901-1.997 of claims 1-9 of the ‘345 patent was filed July 13, 2011 by Third Party Requester, Nycomed US, Inc. Request for Inter Partes Reexamination 1. The Patent Owner in this appeal is GlycoBioScience, Inc. Appeal Br. 3. Requester has withdrawn as named Requester and will no longer participatein the reexamination proceeding. Notice of Withdrawal and Non- Participation (Nov. 8, 2012). A Respondent Brief was not filed by the Requester. Patent Owner has notified the US Patent and Trademark Office of litigations involving the ‘345 patent. Patent Owner’s Notice of New Litigation (Dec. 18, 2012); Appeal Br. 3. REJECTIONS The claims stand rejected by the Examiner over numerous combinations of prior art. RAN 50-51. Patent Owner has appealed all of the Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 3 prior art rejections and a rejection of claims 16-19 under 35 U.S.C. § 112. Appeal Br. 5-6. Patent Owner grouped the numerous prior art rejections into six different issues for appeal (issues 1-6), where a different “primary” prior art reference is associated with each different issue. Appeal Br. 5-6. For example, Issue 1 is stated as whether the Examiner improperly rejected claims 1-9 under 35 U.S.C. § 103 as obvious over Finkenaur1 in view of Baldacci,2 Yamamoto,3 Gallina,4 and Pedemonti.5 Appeal Br. 5. The individual rejections based on Finkenaur as a primary reference in this reexamination as set forth by the Examiner are as follows: 1. Claims 1, 2, 3, 5, 7 and 8 as obvious under 35 U.S.C. § 103(a) over Finkenaur in view of Baldacci. RAN 5 (Ground 2). 2. Claims 1, 2, 3, 4, 5, 7, 8 and 9 as obvious under 35 U.S.C. § 103(a) over Finkenaur in view of Yamamoto. RAN 7 (Ground 3). 3. Claims 1, 2, 3, 4, 5, 7, 8 and 9 as obvious under 35 U.S.C. §103(a) over Finkenaur in view of Gallina. RAN 8 (Ground 4). 4. Claims 5-6 as obvious under 35 U.S.C. § 103(a) over Finkenaur in view of Pedemonti. RAN 9 (Ground 5). Prior art Issues 2-6 involve rejections of claims 1-9 and have overlapping issues. Appeal Br. 5-6. Since we affirm the rejections of claims 1 Finkenaur, EP 0 312 208 A1, published April 19, 1989. 2 Baldacci, EP 0 509 120 A1, published October 21, 1992. 3 Yamamotto, WO 91/07974, published June 13, 1991. 4 Gallina, WO 94/15623, published July 21, 1994. 5 Pedemonti, EP 0 480 189 A1, published April 15, 1992. Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 4 1-9 in Issue 1, we do not reach the rejections in Issues 2-6 which reach the same claims. CLAIM Claim 1 is representative and reads as follows: 1. A method for therapeutically treating a dermatologic condition in an animal, which comprises: topically applying to said animal a therapeutically effective dose of a gelled composition for treating said dermatologic condition comprising a polymer matrix which is suspended in a liquid medium; wherein the polymer matrix contains sodium hyaluronate in combination with a non-ionic polymer. FINDINGS OF FACT Finkenaur F1. Finkenaur describes a gel formulation containing peptide growth factors which is useful for topical application to cutaneous wounds. Finkenaur 2:35-40 and Abstract. F2. “The gel forming materials of the present invention may be water soluble polymers capable of forming a viscous aqueous solution or non- water soluble, water swellable polymers (e.g. collagen), which can also form a viscous solution.” Finkenaur 4:14-16. F3. “In the aqueous gel formulations for topical or incisional wound healing, the polymer may be selected from the group consisting of vinyl polymers, polyoxyethylene-polyoxypropylene copolymers, polysaccharides, proteins, poly(ethylene oxide), acrylamide polymers and derivatives or salts thereof. It is understood that poly(ethyleneoxide) includes polyethylene glycol.” 4:23-26 (emphasis added). Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 5 F4. “The polysaccharides useful in the present invention may be selected from the group consisting of cellulose or cellulose derivatives, glycosaminoglycans, agar, pectin, alginic acid, dextran, starch, and chitosan.” Finkenaur 4:35-37 (emphasis added). F5. “The glycosaminoglycans may be selected from the group consisting of hyaluronic acid, chondroitin, chondroitin-4-sulfate, chondroitin-6-sulfate, dermatan sulfate, keratan sulfate, heparin sulfate and heparin.” Finkenaur 4:38-40 (emphasis added). F6. “For example, hyaluronic acid is preferred to be used as sodium hyaluronate to provide suitable water solubility.” Finkenaur 4:21-22. F7. “The glycosaminoglycans may be used to enhance wound healing in combination with any other gel forming polymer.” Finkenaur 4:40-41. F8. “In a further embodiment, the topical or incisional gel may comprise 1 to 20% by weight of a cellulose derivative having a molecular weight of about 50,000 to 700,000. . . . Preferred cellulose derivatives are hydroxypropylmethyl cellulose (HPMC) and methyl cellulose (Me).” Finkenaur 4:55-58. Other preferred cellulose derivatives include methyl cellulose, hydroxyethyl cellulose, carboxymethyl cellulose, hydroxypropylmethyl cellulose, and hydroxypropyl cellulose. Finkenaur 5:47-51. F9. Example 3 is of a HPMC gel formulation. Finkenaur 7. F10. Example 4 is of a hyaluronic gel formulation. Finkenaur 8. Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 6 Baldacci B1. Baldacci teaches a topical composition comprising glycosaminoglycans (GAG), such as hyaluronic acid, for treating vaginal dermatitis. Baldacci 3:53-58; 7: claims 2 and 6. B2. “The GAGs, owing to the fact of possessing always an acidic group per each disaccharide unit, have in solution a behaviour like that of anionic polyelectrolytes.” Baldacci 2:9-10. B3. Claim 2 recites “Topical use of the glycosaminoglycans according to claim 1, characterized in that said glycosaminoglycans are selected among heparan sulfate, dermatan sulfate, chondroitin sulfate A and C, and hyaluronic acid.” Hyaluronic acid is also included in various example formulations. Baldacci 5-6. Yamamoto Y1. “A topical therapeutic preparation which contains an adrenocortical hormone and hyaluronic acid, the amount of said adrenocortical hormone being lower than the usual clinical dose of it, is used for combatting a skin disease.” Yamamoto, Abstract. Y2. A skin disease which can be treated with Yamamoto can be dermatitis and atopic dermatitis. Yamamoto 1:14-16 and 4:10-16. Y3. The topical dermatological composition described in Yamamoto can include “additional conventional excipients for pharmaceutical preparations for topical use according to the established pharmaceutical procedure applicable generally to dermatological preparations for external use.” Yamamoto 4:2-9. Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 7 Y4. “The term 'hyaluronic acid' is used herein to mean not only hyaluronic acid but also any of pharmaceutically acceptable salts, such as sodium salt.” Yamamoto 3:20-22. Gallina G1. “The present invention concerns pharmaceutical compositions which include urea and hyaluronic acid or derivatives of hyaluronic acid.” Gallina 1:4-6. G2. “The derivatives of hyaluronic acid include any pharmaceutically acceptable salt form, for example sodium hyaluronate.” Gallina 1:31-34. G3. The compositions can be used to treat dermatitis, contact dermatitis, and other skin conditions. Gallina 7:26-30 and 28:3-5. G4. The compositions can comprise additional components, including gel bases, suspending vehicles, and other therapeutic agents, such as wound healing agents. Gallina 8:20 to 9:7. Pedemonti P1. Pedemonti describes a pharmaceutical composition comprising hyaluronic acid sodium salt, disinfectants, and excipients for treating sores, burns, and ulcerations. Pedemonti 2:35-40 and 2:55. P2. The excipients include hydroxypropylmethylcellulose. Pedemonti 2:44. P3. Claims 1 and 3 of Pedemonti recite (emphasis added): 1. Pharmaceutical compositions for topical use comprising hyaluronic acid sodium salt and disinfectant substances chosen Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 8 from the group consisting of cresol derivatives, hexetidine, sulfadiazine silver and sulfadiazine zinc salt. 3. Compositions as claimed in claim 1, characterised by comprising as excipients and diluents [,] hydroxypropylmethyl- cellulose, sorbitol, glycerin, polyoxyethylenated glycolyzed glycerides, polyethyleneglycol stearate, stearic acid, oleic acid decyl ester, caprylic and caproic acid esters, ethoxylated glycerides of palmitic and lauric acids, polymerized polyvinyl alcohol, self-emulsifying wax and non-denatured collagen. REJECTIONS BASED ON FINKENAUR Patent Owner grouped all the rejections based on Finkenaur into a single group, first providing arguments against all the rejections, and then separate arguments for each individual rejection. Appeal Br. 8-16. We thus begin with the arguments drawn to the rejections of claims 1-9 based on Finkenaur combined with any of Baldacci, Yamamoto, Gallina and Pedemonti. Appeal Br. 8-13. Patent Owner argues that the claims are drawn to the use of a “two polymer matrix” with or without a drug suspended in it for treatment of a dermatological condition. Appeal Br. 7. Patent Owner cites disclosure in the ‘345 patent of a polymer matrix comprising at last one polymer which “must be sufficiently negatively charged to aid in the dispersion, encapsulation or solubilization of the drug” and which, “[i]n addition to the negatively charged polymers, the transdermal polymer matrix must contain a non-ionic polymer.’” Id. (quoting from the ‘345 patent; emphasis added by Patent Owner). Patent Owner argues that only gel matrix disclosed in Finkenaur is of a single polymer and contends that the passage cited by the Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 9 Examiner relates to acrylamide gel delivery. Id. at 9. Patent Owner further argues that to obtain a two-polymer matrix would require selection from “many classes of polymers.” Id. According to Patent Owner, no importance to the charged state of the GAG is described by Finkenaur in contrast to the claimed subject matter. Id. at 10. Finkenaur teaches a gel formation that contains “water soluble polymers.” F2. While there is a list of polymers to choose from, sodium hyaluronate is specifically disclosed as a water soluble polymer and is used in an example of gel formulation, leading one of ordinary skill to have picked it. F5 and F10. Furthermore, a preponderance of the evidence shows that hyaluronic acid, including sodium hyaluronate, had been used repeatedly in the prior art as topical compositions to treat skin conditions. B1, Y1-Y2, G1-G3, and P1. Contrary to Patent Owner’s arguments, Finkenaur contains express disclosure to make a composition with two gel forming polymers: “The glycosaminoglycans [GAG] may be used to enhance wound healing in combination with any other gel forming polymer.” F7 (emphasis added.) Hyaluronic acid is a preferred GAG. F5, F6, and F10. Thus, there would have been reason to combine hyaluronic acid, or the sodium salt derivative, with any of the gel forming polymers mentioned in Finkenaur, including hydroxyethyl cellulose and hydroxypropyl cellulose (F8), which are nonionic polymers as claimed (‘345 patent, col. 2, ll. 64-67). Finkenaur has an additional statement that “[i]n a further embodiment, the topical or incisional gel may comprise 1 to 20% by weight of a cellulose derivative having a molecular weight of about 50,000 to 700,000. . . . Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 10 Preferred cellulose derivatives are hydroxypropylmethyl cellulose (HPMC).” F8. Thus, this explicit disclosure which would have further led one to combine HPMC, a nonionic polymer, with any of the topical or incisional gels disclosed above it, including hyaluronate. The disclosure of various gel forming polymers in Finkenaur is not so broad that one of ordinary skill in the art would not found the claimed combination of two gel forming polymers obvious. In fact, there are working examples of a hyaluronic acid gel formulation and an HPMC gel formulation (F9-F10), providing evidence that such gel forming polymers are preferred. This disclosure, combined with the disclosure that a GAG (hyaluronic acid is a GAG) may be used “in combination with any other gel forming polymer,” (F8) would have reasonably suggested the subject matter of claim 1. Moreover, the concept of a composition have two gel forming polymers is also described in Pedemonti which teaches a pharmaceutical composition with a hyaluronic acid sodium salt and an excipient, which includes hydroxypropylmethylcellulose, the same combination encompassed by instant claim 1. P1-P3. Patent Owner’s argument about Finkenaur’s failure to attach importance to the charged state of the GAG is not persuasive. GAGs were well known to be anionic, i.e., negatively charged. B2. Finkenaur teaches using GAGs, and in particular hyaluronic acid. “[A]ny need or problem known in the field of endeavor at the time of invention and addressed by the patent can provide a reason for combining the elements in the manner claimed.” KSR Int’l Co. v. Teleflex Inc., 550 U.S. 398, 419-20 (2007). Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 11 Thus, the reason does not have to be same as the inventors. Accordingly, it does not matter that GAGs were not chosen for their charge as the inventors did, as long as there was a reason to have selected them. Pointing to disclosure on page 9, lines 7-10, of Finkenaur, Patent Owner argues that Finkenaur teaches that the nonionic polymers described in the publication, such as cellulose derivatives, should be modified by the addition of ionic groups. Appeal Br. 12. We do not agree. The cited disclosure is generic, and does not specifically teach modifying the cellulose derivative by making them ionic. To the contrary, Finkenaur teaches unmodified HPMC gels. Finkenaur 7:53-58; F9. Patent Owner also points to the disclosure in Finkenaur of acrylamide gels, stating that acrylamide is taught as a substitute for hyaluronate. Appeal Br. 12. Based on this disclosure, Patent Owner states: “If these are substitutes for each other, then one skilled in the art would not be led to combine them but, instead, would replace hyaluronate by an acrylamide.” Id. This argument is not supported by the evidence. Hyaluronate and acrylamide are taught as alternatives, as are cellulose derivative. Finkenaur teaches them in combination or alone. F8. Accordingly, while other combinations of gel forming polymers are reasonably suggested by Finkenaur (Appeal Br. 11), this fact does not negate the teaching in Finkenaur of the combination of hyaluronate and hydroxypropyl cellulose. To the extent unexpected results were relied upon, the Examiner’s reasoning that such results are not commensurate with full scope of claims 1-9 is persuasive. RAN 11. In sum, the Examiner’s determination that a composition comprising both claimed polymers is Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 12 suggested by the cited prior art is supported by a preponderance of the evidence. In reaching this conclusion we recognize that, as argued by Patent Owner, Finkenaur does not expressly teach that a GAG is highly negatively charged or that it be combined with a non-ionic polymer. However, Finkenaur describes a combination of both polymers which meet the claimed limitations. Patent Owner did not provide evidence that the polymers when combined as taught in Finkenaur, or in Pedemonti, would not meet the limitations of a polymer matrix. To find obviousness, the reason for combining the prior art does not have to be same reason as the inventor’s reason for arriving at the claimed invention. KSR, 550 U.S. at 419-20. Furthermore, characterizing hyaluronate as a highly charged molecule and cellulose as a nonionic polymer, respectively, does not change their function. “Mere recognition of latent properties in the prior art does not render nonobvious an otherwise known invention.” In re Baxter Travenol Labs., 952 F.2d 388, 392 (Fed. Cir. 1991). Finkenaur and Baldacci The Examiner found that Finkenaur suggests a composition comprising sodium hyaluronate and the nonionic polymers hydroxypropyl cellulose and hydroxyethyl cellulose for treating dermatological conditions as recited in the claims 1-3. RAN 6. The Examiner acknowledged that Finkenaur does not teach treating dermatitis as recited in claims 3 and 8, but found that treatment of this condition is described in Baldacci, which also describes hyaluronic acid for treating dermatologic conditions, making it Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 13 obvious to use a gel composition as disclosed in Finkenaur for this purpose. Id. at 7. Patent Owner argues that hyaluronic acid “is one of thousands, and mentioning hyaluronic acid for its properties of adhesivity, viscosity, gel formation and moisturizing . . . but conspicuously excluding transdermal effects (because the non-ionic polymer of the claims is not present).” Appeal Br. 13. Hyaluronic acid is expressly disclosed as a suitable GAG, and in claim 3 of Baldacci, is one of four choices. B3. It is also included in Baldacci’s examples, directing one of ordinary skill in the art to have chosen it. To the extent there are differences between the claimed subject matter and Baldacci, the Examiner only relied upon Baldacci for its teaching that hyaluronic acid can be used in compositions to treat dermatitis. Finkenaur and Yamamoto The Examiner found that that Yamamoto discloses a topical composition containing adrenocortical hormone and hyaluronic acid, or a sodium salt of it, for the treatment of diseases such as dermatitis, including contact dermatitis and atopic dermatitis. RAN 7; Y1, Y2, and Y4. The Examiner determined that it would have been obvious for one of ordinary skill in the art to combine the teachings of Finkenaur and Yamamoto to make a gel composition for treating a dermatological condition, as they are both directed to the topical application of a formulation containing hyaluronic acid for treating dermatological conditions. RAN 7-8. Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 14 Patent Owner contends “properties Yamamoto is seeking are completely satisfied without combining hyaluronic acid with any other polymer (Finkenaur or otherwise). This reference doesn't even show the dispersed drug within the matrix (as in claim 5).” Appeal Br. 14. Each of Finkenaur and Yamamoto teaches that formulations containing hyaluronic acid are useful for topical delivery of drugs to treat dermatological conditions. F1 and Y1. It is reasonable, therefore, that one of ordinary skill in the art would have found Finkenaur teachings pertinent to the use described in Yamamoto, particularly in light of Yamamoto’s teaching that a GAG, of which hyaluronic acid is preferred (F5, F6, and F10), can be combined with any other gel forming polymer (F7). It is unnecessary that Yamamoto disclose any shortcomings in its topical therapeutic preparation for the ordinary skilled worker to have found it obvious to have employed an alternative formulation for its adrenocortical hormone since it is obvious to use a prior element for its established function. KSR, 550 U.S. at 416 (“. . . a court must ask whether the improvement is more than the predictable use of prior art elements according to their established functions.”) Furthermore, Yamamoto discloses that excipients may be used in its topical preparations. Y3. Pedemonti teaches that hydroxypropylmethyl cellulose (a nonionic polymer of claim 1) is a conventional excipient (P2), providing further reason to have included it in Yamamoto’s composition. Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 15 Finkenaur and Gallina The Examiner found that Finkenaur does not describe using the gel formulation for treating dermatitis, as recited in instant claims 3 and 8, particularly atopic dermatitis, as recited in instant claims 4 and 9. RAN 8. However, the Examiner found these deficiencies were met by Gallina, which also describes a topical composition comprising hyaluronic acid for treating skin conditions. The Examiner determined it would have been obvious to have formulated Gallina’s composition as a gelled composition in accordance with Finkenaur, motivated by Gallina’s teaching that its compositions can include gel bases (G4). RAN 9. Patent Owner contends the combination of Gallina and Finkenaur “does not produce the two-polymer matrix of the claims because Finkenaur teaches that the hyaluronate can be combined with any gel forming polymer, which, even if initially nonionic, can be modified so as to be ionic if it increases release rate from the gel.” Appeal Br. 15. We have already discussed how Finkenaur reasonably suggests the claimed polymer matrix. We have also addressed the argument that Finkenaur teaches modifying the nonionic polymer HPMC to make it nonionic, pointing out that HPMC is not modified in Finkenaur’s Example 3 (F9). Finkenaur and Pedemonti The Examiner found that Finkenaur does not specify the drug as an amebicide, a broad spectrum or a medium spectrum antibiotic, a fungal medication, a monobactam, an antiviral agent, erythromycin, penicillin, cephalosporin, or a combination thereof as recited in instant claim 6. RAN Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 16 10. However, the Examiner found that Pedemonti describes using such therapeutic agents. Id. The Examiner determined it would have been obvious to have combined the teachings Finkenaur and Pedemonti since both are directed to treating dermatologic conditions with hyaluronic acid. Id.; P1. Furthermore, the Examiner found that Pedemonti describes including HPMC as an excipient (RAN 10; P2-P3). Thus, Pedemonti describes a polymer gel matrix with sodium hyaluronate (P1) and nonionic polymer (P2) as claimed and further incorporating a therapeutic agent as claimed. Patent Owner makes the same unpersuasive arguments already addressed. Appeal Br. 15-16. Summary For the reason discussed above, we affirmed the rejections 2-5 of claims 1-9 based on Finkenaur. To the extent any of the claims were not argued separately, they fall with claim 1. 37 C.F.R. § 41.67(c)(vii ). REJECTION UNDER 112, SECOND PARAGRAPH Claim 16-19 stand rejected under 35 U.S.C. § 112, second paragraph, as failing to comply with the definiteness requirement. RAN 44. The Examiner stated: New independent claims 16 and 18 recite that "the sodium hyaluronate is present in amounts of about 2.1 % to about 2.5% by weight of the polymer matrix, and said cellulose derivative is present in amounts of about 0.1 % to about 1.5% of the polymer matrix." The meaning of which is unclear, as the polymer matrix is understood by one of ordinary skill in the art Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 17 to be made up entirely of polymers (Zatz Decl. ¶ 32). This is especially so as the specification only discloses the amounts of sodium hyaluronate and hydroxyethylcellulose as weight percentages of the gelled composition (Examples 1 and 3). RAN 44-45. Claim 16 is reproduced below (underlining added for emphasis): A method for therapeutically treating a dermatologic condition in an animal, which comprises: topically applying to said animal a therapeutically effective dose of a gelled composition for treating said dermatologic condition comprising a polymer matrix which is suspended in a liquid medium, wherein the polymer matrix contains sodium hyaluronate in combination with a non-ionic polymer that is a cellulose derivative; wherein the sodium hyaluronate is 98% pure from contamination of related mucopolysaccharides, has a sulfated ash content of less than 15%, and a protein content of less than 5%; and wherein the molar ratio of the sodium hyaluronate to the non-ionic polymer is 1:0.5 to 2.0., said sodium hyaluronate is present in amounts of about 2.1 % to about 2.5% by weight of the polymer matrix, and said cellulose derivative is present in amounts of about 0.1 % to about 1.5% of the polymer matrix. The claim refers to “a gelled composition” which comprises “a polymer matrix which is suspended in a liquid medium.” It appears that the recitation that the polymer matrix is suspended in the liquid medium is the basis of the Examiner’s rejection because if the matrix comprises liquid it is redundant to recite that it is also suspended in a liquid medium. However, it is clear from the ‘345 patent that a matrix is not made up of solid polymer, alone, as construed by the Examiner, but requires a liquid. [A] solid matrix formed by the cation-assisted gellation of a liquid filling composition incorporating a vegetable gum together with a pharmaceutically-active compound. Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 18 ‘345 patent, col. 2, ll. 11-14. [I]t has been discovered that the active drug must be suspended or entrapped in a specially designed polymer matrix containing a specific molar ratio of negatively charged polymers and a non-ionic polymer suspended or dissolved in water and solubilizers. ‘345 patent, col. 3, ll. 38-42. One particular criteria of the drug is that they must be solubilized in the polymer matrix solution in order to be topically administered. ‘345 patent, col. 11, ll. 27-29. A polymer matrix would be understood as constituting a gel, or other matrix, comprising water or other solubilizers. Thus, when the phrase “a polymer matrix which is suspended in a liquid medium” is read in the light of the Specification, the ordinary skilled worker would understand that the liquid medium is part of the polymer matrix and that “suspended in a liquid medium” serves to characterize and describe the polymer matrix as comprising water or other liquid solubilizers. For the foregoing reasons, the rejection of claims 16-19 under 35 U.S.C. § 112 is reversed. TIME PERIOD FOR RESPONSE In accordance with 37 C.F.R. § 41.79(a)(1), the “[p]arties to the appeal may file a request for rehearing of the decision within one month of the date of: . . . [t]he original decision of the Board under § 41.77(a).” A request for rehearing must be in compliance with 37 C.F.R. § 41.79(b). Comments in opposition to the request and additional requests for rehearing must be in accordance with 37 C.F.R. § 41.79(c) & (d), respectively. Under 37 C.F.R. § 41.79(e), the times for requesting rehearing under paragraph (a) of this section, for requesting further rehearing under paragraph (d) of this Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 19 section, and for submitting comments under paragraph (c) of this section may not be extended. An appeal to the United States Court of Appeals for the Federal Circuit under 35 U.S.C. §§ 141-144 and 315 and 37 C.F.R. § 1.983 for an inter partes reexamination proceeding “commenced” on or after November 2, 2002 may not be taken “until all parties’ rights to request rehearing have been exhausted, at which time the decision of the Board is final and appealable by any party to the appeal to the Board.” 37 C.F.R. § 41.81. See also MPEP § 2682 (8th ed., Rev. 7, July 2008). In the event neither party files a request for rehearing within the time provided in 37 C.F.R. § 41.79, and this decision becomes final and appealable under 37 C.F.R. § 41.81, a party seeking judicial review must timely serve notice on the Director of the United States Patent and Trademark Office. See 37 C.F.R. §§ 90.1 and 1.983. AFFIRMED-IN-PART Appeal 2014-003286 Reexamination Control No. 95/001,687 US 6,723,345 B2 20 PATENT OWNER: CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & ANGELL 5 Becker Farm Road Roseland, NJ 07068 THIRD PARTY REQUESTER: COVINGTON & BURLING, LLP 1201 Pennsylvania Avenue, NW Washington, DC 20004-2401