Ex Parte Chang et alDownload PDFPatent Trial and Appeal BoardJul 23, 201412072578 (P.T.A.B. Jul. 23, 2014) Copy Citation 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. 12/072,578 02/27/2008 Yunik Chang 767.0131 5237 29085 7590 07/24/2014 HOWARD EISENBERG, ESQ. 1220 LIMBERLOST LANE GLADWYNE, PA 19035 EXAMINER MAIER, LEIGH C ART UNIT PAPER NUMBER 1673 MAIL DATE DELIVERY MODE 07/24/2014 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 __________ Ex parte YUNIK CHANG and GORDON J. DOW __________ Appeal 2012-003874 Application 12/072,578 Technology Center 1600 __________ Before DEMETRA J. MILLS, ERIC B. GRIMES, and ULRIKE W. JENKS, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134. The Examiner has rejected the claims for lack of written descriptive support and anticipation. We have jurisdiction under 35 U.S.C. § 6(b). Appeal 2012-003874 Application 12/072,578 2 STATEMENT OF CASE The following claims are representative. 1. A method for increasing the dissolved concentration of betacyclodextrin in an aqueous fluid composition comprising combining in the aqueous fluid composition betacyclodextrin and niacin or niacinamide in amounts that are sufficient to provide a dissolved concentration of betacyclodextrin in the aqueous fluid between 0.5% and 1.5% w/w at 5° C. 7. An aqueous solution composition comprising betacyclodextrin and niacin or niacinamide, wherein the concentration of betacyclodextrin that is dissolved in the aqueous fluid is between 0.5% and 1.5% w/w and, wherein, when the temperature of the aqueous solution composition is brought to 5° C. the betacyclodextrin does not precipitate. 13. A method for increasing the solubility capacity of betacyclodextrin in an aqueous solution at 5° C comprising combining in the aqueous solution optionally a gelling agent, the betacyclodextrin in an amount sufficient to provide a dissolved concentration in the aqueous gel between 0.5% and 1.5% w/w, and an amount of niacin or niacinamide that is sufficient to maintain the dissolved concentration of betacyclodextrin in the aqueous solution at a concentration of between 0.5% and 1.5% w/w for one week at a temperature of 5° C . 24. A method for increasing the dissolved concentration of betacyclodextrin in an aqueous fluid composition comprising combining in the aqueous fluid composition betacyclodextrin and niacin or niacinamide in an amount that is sufficient to provide a dissolved concentration of betacyclodextrin in the aqueous fluid that is higher than the saturated dissolved concentration of betacyclodextrin in the aqueous fluid in the absence of the niacin or niacinamide. Appeal 2012-003874 Application 12/072,578 3 Cited References Chang et al., US 6,881,726 B2, patented Apr. 19, 2005. Pedersen, Effect of hydrotropic substances on the complexation of clotrimazole with β-cyclodextrin, 19 DRUG DEV. INDUS. PHARM. 439-448 (1993). Grounds of Rejection 1. Claims 1, 3, 7, 9, 13, and 21-23 are rejected under 35 U.S.C. § 112, first paragraph, as failing to comply with the written description requirement. 2. Claims 1, 3, 7, 9, 13, and 18-25 are rejected under 35 U.S.C. § 102(b) as being anticipated by Chang. 3. Claims 1, 3, 7, 9, 13, 18-20, 24, and 25 are rejected under 35 U.S.C. § 102(b) as being anticipated by Pedersen. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Answer at pages 4- 6. The following facts are highlighted. 1. On page 9, lines 3-8, the Specification discloses the following: In accordance with the invention, the concentration of cyclodextrin in aqueous solution may be between 0.1% and 20%, or higher. Preferably, the concentration of cyclodextrin in the solution is no more than about 5% w/w. In the case of beta- cyclodextrin [BCD] the concentration in aqueous solution is limited by its solubility in water. An aqueous solution, such as a gel, of beta-cyclodextrin is saturated at a concentration of about 0.5% at 5°C (refrigerator temperature). Appeal 2012-003874 Application 12/072,578 4 2. On page 9, lines 9-12, the Specification discloses the following: The solutions, especially in gel formulation, are non- tacky, fast-drying, and cosmetically elegant. The solutions, including the gel formulations, are physically stable at 5°C (refrigerator temperature) or room temperature conditions for at least 7 days. No crystal formation or precipitation is observed after one week at 5°C. 3. On page 10, lines 1-9, the Specification discloses the following: For example, if a stable 1% MTZ [metronidazole] aqueous solution is desired, 0.1% to 1.0% BCD may be used and an amount of niacinamide or niacin may be combined in the solution to bring the solubility of MTZ to 1%. The amount of niacinamide to be combined in the solution is less than that which, without the presence of BCD in the solution, can enhance the solubility of MTZ sufficiently to obtain a 1% solution of MTZ, or whatever level of MTZ is desired. In accordance with this embodiment of the invention for a 1% aqueous solution of MTZ, the concentration of BCD % w/w in the solution is preferably at a level of 1.0% or less and the concentration of niacinamide or niacin equal to or more than that of BCD. 4. Table 1 of the Specification is reproduced below. Appeal 2012-003874 Application 12/072,578 5 Table 1 shows a generic formula gel used in subsequent formulary examples in the Specification. Amounts of BCD and niacin or niacinamide in the generic gel are imported into the table from subsequent Tables in the Specification. (Spec. 12, ll. 7-15.) 5. Table 2 of the Specification is reproduced below. Table 2 shows the stability of various BCD concentrations at 5°C. Some of these concentrations were tested in the gels of Table 1 in subsequent Examples in the Specification. Table 2 does not show the presence of niacin, and thus no niacin is present in the gel of Table 1 when Table 2 is imported into Table 1. Table 2 show that at a concentration of BCD at 1.5% w/w formed crystals at one week. (Spec. 13, ll. 1-9.) Written Description Rejection Discussion ISSUE The Examiner contends that Appeal 2012-003874 Application 12/072,578 6 The concentration range of beta-cyclodextrin (BCD) in solution has been broadened from 0.5% to 1.0% w/w to 0.5% to 1.5% w/w [in the pending claims]. Although the original claims for this continuing application support the compositions and methods, this is the only support for the new method, and this concentration was not recited in the original claims. In support of this amendment, Applicant cites Table 2, which discloses concentration of BCD as high as 1.5% w/w. Table 2 is a demonstration of the solubility of BCD at various concentrations. (Ans. 4-5.) Appellants argue that The application expressly discloses that the solutions described were observed at a temperature of 5° C (refrigerator temperature) and that they were stable when observed after one week. The application expressly discloses that the concentration of cyclodextrin is between 0.1 and 20% and that, in the case of beta-cyclodextrin (BCD), it is saturated at a concentration of 0.5% at 5° C. The application further states that 0.1 % to 1.0% BCD concentration may be used (which is above the saturated concentration of BCD in aqueous fluid) and that an amount of niacinamide or niacin is combined with the BCD to bring the solubility of metronidazole (MTZ) to 1%. Further, the specification states that the solution of BCD and niacinamide or niacin is prepared, and then the metronidazole is added. (App. Br. 14-15.) The issue is: Does the Specification as originally filed support the pending claim scope. Appeal 2012-003874 Application 12/072,578 7 PRINCIPLES OF LAW The purpose of the written description requirement is to “ensure that the scope of the right to exclude, as set forth in the claims does not overreach the scope of the inventor’s contribution to the field of art as described in the patent specification.†Reiffin v. Microsoft Corp., 214 F.3d 1342, 1345 (Fed. Cir. 2000). To that end, to satisfy the written description requirement, the inventor “must also convey with reasonable clarity to those skilled in the art that, as of the filing date sought, he or she was in possession of the invention.†Vas-Cath Inc. v. Mahurkar, 935 F.2d 1555, 1563-64 (Fed. Cir. 1991). “One shows that one is ‘in possession’ of the invention by describing the invention, with all its claimed limitations†(emphasis in original). Lockwood v. American Airlines, 107 F.3d 1565, 1572 (Fed. Cir. 1997). It is not necessary for the specification to describe the claimed invention ipsissimis verbis; all that is required is that it reasonably convey to those skilled in the art that, as of the filing date sought, the inventor was in possession of the claimed invention. Union Oil Co. of California v. Atlantic Richfield Co., 208 F.3d 989, 997 (Fed. Cir. 2000); Vas-Cath Inc. v. Mahurkar, 935 F.2d at 1563-64; In re Gosteli, 872 F.2d 1008, 1012 (Fed. Cir. 1989); In re Edwards, 568 F.2d 1349, 1351-52 (CCPA 1978). When an Applicant claims a class, the Applicant “must describe that class in order to meet the description requirement of the statute.†In re Lukach, 442 F.2d 967, 968 (CCPA 1971). “[W]hile the description requirement does not demand any particular form of disclosure …, or that the specification recite the claimed invention in haec verba, a description that merely renders the invention obvious does not satisfy the requirement.†Ariad Pharms, Inc. v. Eli Lilly and Co., 598 F.3d 1336, 1352 (Fed. Cir. Appeal 2012-003874 Application 12/072,578 8 2010) (citations omitted). “[T]he specification must demonstrate that the applicant has made a generic invention that achieves the claimed result and do so by showing that the applicant has invented species sufficient to support a claim to the functionally-defined genus.†Id. at 1349. “[A]n adequate written description of a claimed genus requires more than a generic statement of an invention's boundaries.†Id. ANALYSIS We are persuaded by the Examiner’s argument that there is no descriptive support in the application as originally filed for the claimed BCD concentration range of between 0.5% and 1.5% w/w at 5° C. Appellants submit that “the disclosure at page 9, lines 4-8 [FF1], support a concentration of BCD greater than 1.0%, including the 0.5% to 1.5% as called for in claim 1.†(App. Br. 13.) Appellants argue that As called for in present independent claim 7, an aqueous solution composition comprises betacyclodextrin and niacin or niacinamide (page 5, lines 4-6), wherein the betacyclodextrin that is dissolved in the aqueous fluid is between 0.5% and 1.5% w/w (support is found in the specification on page 13, Table 2, which discloses a BCD concentration of 1.5% and on page 12, Table 1, which discloses that BCD concentration and niacinamide or niacin concentration are as shown in Table 2 to 6, and on page 9, lines 4-5), wherein, when the temperature of the aqueous composition is brought to 5° C, the BCD does not precipitate (page 9, lines 9-12). Claim 9 depends from claim 7 and calls for physically stable for one week at 5° C (page 9, line 11). (App. Br. 8-9, emphasis added.) In our view, one of ordinary skill in the art would find that the Specification does not reasonably convey to those skilled in the art that, as Appeal 2012-003874 Application 12/072,578 9 of the filing date sought, the inventor was in possession of the claimed BCD concentration range of between 0.5% and 1.5% w/w at 5° C. The generic disclosure of cyclodextrin in aqueous solution of between 0.1% and 20%, or higher at page 9, lines 4-8 (FF1), alone, is not sufficient to support the specific pending claim scope. Put another way, when an Applicant claims a class, such as the broad genus of BCD in aqueous solution of between 0.1% and 1.5%, the Applicant “must describe that class in order to meet the description requirement of the statute.†In re Lukach, 442 F.2d at 968. Merely drawing a fence around the outer limits of a purported genus of up to 20% concentration cyclodextrin is not an adequate substitute for a description showing that one has invented—that is, has possession of—a genus including a 1.5% concentration of BCD and not just the species of Table 4 of the Specification. See Lockwood, 107 F.3d at 1572. The Specification, page 9, lines 7-8, states that, “[a]n aqueous solution, such as a gel, of betacyclodextrin is saturated at a concentration of about 0.5% at 5°C (refrigerator temperature).†The Specification Table 4 (page 14) exemplifies BCD concentrations in an aqueous solution consistent with claim 1 of no higher than 1% w/w. As such, the Specification does not support aqueous solutions as claimed with BCD concentrations of up to 1.5%. Appellants point to no specific example in the Specification of solubilized concentrations of BCD in the aqueous solutions within the claim scope. It remains unclear from Table 2 of the Specification, what amount of niacin or niacinamide is required to obtain a stable concentration of 1.5% BCD in an aqueous fluid. Appeal 2012-003874 Application 12/072,578 10 Thus, the amended claimed range including a dissolved concentration of beta-cyclodextrin in the aqueous fluid between 0.5% and 1.5% w/w at 5° C is not supported by the original application as filed. The written description rejection is affirmed. Anticipation rejections Anticipation by Chang ISSUE The Examiner finds that The instant application is filed as a continuation of 11/037,430, filed 1/18/05, which is a continuation of 10/033,835, filed 12/24/01. However, the parent, ‘430, does not support the methods recited in instant claims 1, 3 and 13 or the product recited in instant claims 7 and 9. … The examiner does not find that the specification, as originally filed in the grandparent application, S. N. 10/033,835, provides written description for the instant claims. It is noted that the title and abstract filed in the instant application are not present in ‘835. The specification describes both β-cyclodextrin and niacin (amide) as being solubilizing agents. However, the specification concentrates on how they both are used in combination with metronidazole to solubilize that agent. Claim 1 has been amended so that the composition is a “fluid†rather than a “gel.†The concentration range has been broadened from 0.5% to l.0% w/w to 0.5% to l.5% w/w. The specification describes combining the niacin or niacinamide with BCD before the addition of the MTZ suggesting a transitory mixture of BCD and niacin or niacinamide. See page 10, lines 15-17. However, the specification further describes the preparation of the solution including MTZ at elevated temperature before cooling, so clearly this does not support a Appeal 2012-003874 Application 12/072,578 11 solution with niacin or niacinamide with BCD but without MTZ at 5° C, much less one that is physically stable for a week at that temperature. There is no discussion regarding the stability of any solution not containing MTZ at this temperature. (Final Rej. 2-3.) The Examiner finds that The [Chang] reference discloses an aqueous gel composition comprising niacin or niacinamide and BCD that is stable for a week at 5° C. See Tables 4 and 6. The preparation of this composition anticipates [ ] the instant composition. In preparing the compositions, the reference also accomplishes the step of each method, thereby anticipating the method claims. This finding of anticipation is not inconsistent with the finding that applications 11/037,430 and 10/033,835 do not fully support the instant claims. A narrow disclosure that anticipates a broader claim does not necessarily provide full written description for said broader claim. Neither does a disclosure of a mixture of components necessarily describe a particular action of one component upon another component. (Ans. 5.) Appellants contend that the Chang patent is not prior art to the present application. In particular, Appellants argue that The present application was filed on February 27, 2008 as a continuation of application 11/037,430, which was a continuation of application 10/033,885, which eventually issued as the cited Chang patent. The present application contains the identical disclosure as that of the Chang patent. As discussed above … dealing with the rejection of the present claims, under 35 U.S.C. §112, first paragraph, for lack of compliance with the written description requirement, each of the pending claims is fully supported in the present specification. Accordingly, because the present specification is identical to that of the Chang patent and is a direct continuation Appeal 2012-003874 Application 12/072,578 12 of the Chang patent, the present claims are entitled to claim priority from the Chang patent. (App. Br. 20.) The issue is: Is Chang prior art to the present claims? ANALYSIS Appellants argue that the anticipation rejection is improper because Chang is not prior art to the present application and that the present application a “continuation of application 11/037,430, which was a continuation of application 10/033,885, which eventually issued as the cited Chang patent. The present application contains the identical disclosure as that of the Chang patent.†(App. Br. 20.) We find that Chang is prior art to the pending claims of the present application. We have found above, that the pending claims do not find support in the original Specification, as filed. Therefore, the added pending claims including the 1.5% BCD concentration are not entitled to the priority date of the 10/033,835 application filed Dec. 24, 2001, and therefore U.S. Patent 6,881,726 to Chang issuing April 19, 2005 from the ’835 application is prior art to the present application which was filed February 27, 2008. In view of the fact that the written description rejection has been affirmed, we agree with the Examiner that Chang is prior art to the present application and the anticipation rejection is affirmed. Anticipation by Pedersen The Examiner argues that Appeal 2012-003874 Application 12/072,578 13 Pedersen discloses aqueous solutions comprising nicotinamide (niacinamide) in combination with BCD at concentrations within the recited range. See page 442, 1st full paragraph. The reference is silent regarding stability at 5° C. However, the Office does not have the facilities for preparing the claimed materials and comparing them with prior art inventions, the burden is on Applicant to show a novel or unobvious difference between the claimed product and the product of the prior art. See In re Best, 562 F.2d 1252, 195 USPQ 430 (CCPA 1977) and In re Fitzgerald, 619 F.2d 67, 205 USPQ 594 (CCPA 1980). (Ans. 5-6.) Appellants contend that Pedersen discloses on page 442, first paragraph following the heading “β-CD solubility in nicotinamide solution," that up to 180 mg of BCD were added to 10 ml samples of ammonium phosphate buffer containing 0.5 M nicotinamide and that these samples were stored at a temperature of 23 +/- 2°C. This corresponds to a concentration of BCD of 1.8%. Funk, J. Incl. Phenom. Molec. Recog. Chem. 16:299-314 (1993), a reference previously cited by the Examiner and presented to the Examiner in the Amendment filed on July 11, 2011 in response to this basis of rejection, discloses that the solubility of BCD in water at room temperature is 1.8%. Thus, the concentration of BCD dissolved in the aqueous formulation of Pedersen in the presence of nicotinamide, is no higher than the saturated concentration of BCD in the absence of nicotinamide. Pedersen did not disclose any studies regarding the solubilization of higher concentrations of BCD. Further, there is no suggestion in Petersen [sic] that the solubility of BCD in an aqueous composition, in the presence of nicotinamide can be increased above its saturated solubility in an aqueous composition that lacks nicotinamide. (App. Br. 21.) Appeal 2012-003874 Application 12/072,578 14 The issue is: Does the Examiner’s cited prior art, Pedersen, support a prima facie case of anticipation of the pending claims. PRINCIPLES OF LAW In making our determination, we apply the preponderance of the evidence standard. See, e.g., Ethicon, Inc. v. Quigg, 849 F.2d 1422, 1427 (Fed. Cir. 1988) (explaining the general evidentiary standard for proceedings before the Office). In order for a prior art reference to serve as an anticipatory reference, it must disclose every limitation of the claimed invention, either explicitly or inherently. See In re Schreiber, 128 F.3d 1473, 1477 (Fed. Cir. 1997). To anticipate, every element and limitation of the claimed invention must be found in a single prior art reference, arranged as in the claim. Karsten Mfg. Corp. v. Cleveland Golf Co., 242 F.3d 1376, 1383 (Fed. Cir. 2001). “[T]he examiner must provide some evidence or scientific reasoning to establish the reasonableness of the examiner’s belief that the functional limitation is an inherent characteristic of the prior art†before the burden is shifted to Applicants to disprove the inherency. Ex parte Skinner, 2 USPQ2d 1788, 1789 (BPAI 1986). “Inherency, however, may not be established by probabilities or possibilities. The mere fact that a certain thing may result from a given set of circumstances is not sufficient.†MEHL/Biophile Int’l Corp. v. Milgraum, 192 F.3d 1362, 1365 (Fed. Cir. 1999). ANALYSIS We do not find that the Examiner has set forth a prima facie case of anticipation of the pending claims over Pedersen. Appeal 2012-003874 Application 12/072,578 15 The Examiner argues that, “Pedersen discloses aqueous solutions comprising nicotinamide (niacinamide) in combination with BCD at concentrations within the recited range. See page 442, 1st full paragraph. The reference is silent regarding stability at 5° C.†(Ans. 5.) Thus, the Examiner argues that the reference disclosure is sufficient to shift the burden of proof to Appellants to show that the claimed method and that of Pedersen are not the same. (Ans. 5-6.) We are not persuaded by the Examiner’s argument and do not find that the Examiner has provided sufficient evidence to shift the burden of proof to Appellants. The portion of Pedersen, page 442, that the Examiner relies upon reads: Various amounts of β-CD (0, 20, 40, 60, 80, 100, 120, 140, 160 and 180 mg) were added to 10 ml samples of ammonium phosphate buffer containing 0.5 M nicotinamide. The samples were heated gently to dissolve the β-CD, afterwards they were stored for 72 hours at 23±2°C. The samples were examined for precipitate. Appellants calculate that the BCD in Pedersen’s 180 mg sample corresponds to a concentration of 1.8% BCD (App. Br. 21). Since that is the highest-concentration sample disclosed by Pedersen, it is reasonable to conclude that some of the lower-concentration samples are within the 0.5% to 1.5% range recited in the claim. However, the claims on appeal also require that amounts of BCD and niacin (or niacinamide) be sufficient to provide a dissolved BCD concentration in the range of 0.5 to 1.5% at 5° C (see claim 1, emphasis added). Although Pedersen discloses that its samples were stored at room temperature (23 ± 2° C), not at refrigerator temperature (5° C), the Examiner Appeal 2012-003874 Application 12/072,578 16 has not pointed to evidence supporting a finding that Pedersen’s samples would inherently have maintained solubility of BCD at a concentration within the claimed range at 5° C, as required by the claims on appeal, and therefore has not made a showing sufficient to shift the burden of proof to Appellants. We do not find that the Examiner has met the burden of proof in the first instance to support a prima facie case of anticipation and the anticipation rejection in view of Pedersen is reversed. CONCLUSION OF LAW The written description rejection is affirmed. The anticipation rejection in view of Chang is affirmed. The anticipation rejection in view of Pedersen is reversed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a). AFFIRMED cdc Copy with citationCopy as parenthetical citation