Kevin P. EatonDownload PDFPatent Trials and Appeals BoardNov 7, 201915078167 - (D) (P.T.A.B. Nov. 7, 2019) 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. 15/078,167 03/23/2016 Kevin P. Eaton 173.00003 8971 130655 7590 11/07/2019 Harper Bates & Champion LLP 1717 Main Street, Suite 3550 Dallas, TX 75201 EXAMINER SCHLIENTZ, NATHAN W ART UNIT PAPER NUMBER 1616 NOTIFICATION DATE DELIVERY MODE 11/07/2019 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): docketing@harperbates.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte DAN DEVLIN and KEVIN P. EATON1 Appeal 2018–006185 Application 15/078,167 Technology Center 1600 Before ULRIKE W. JENKS, ROBERT A. POLLOCK, and JOHN E. SCHNEIDER, Administrative Patent Judges. POLLOCK, Administrative Patent Judge. DECISION ON APPEAL Appellant appeals under 35 U.S.C. § 134(a) from the final rejection of claims 1–4. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. STATEMENT OF THE CASE The ’716 application, entitled “Treatment of Dermatological Conditions,” relates to a method of treating dermatological conditions such as psoriasis, dermatitis, or dandruff using a multiple vitamin supplement 1 Appellant identifies Kevin P. Eaton and Daniel Joseph Devlin, IV as real parties in interest. App. Br. 2. Appeal 2018–006185 Application 15/078,167 2 compositions comprising folic acid, vitamin B12, and vitamin B6. See, e.g., Spec. Title, Abstract, ¶¶ 9–10. In particular, independent claim 1 recites: 1. A method of treating psoriasis by administering to a person a vitamin supplement composition comprising at least about 25 micrograms to about 2,200 micrograms of folic acid, at least about 25 micrograms to about 2,500 micrograms of vitamin B 12, and at least about 0.5 milligrams to about 20 milligrams of vitamin B6, wherein said composition is essentially free of anti-oxidants.[2] Appeal Br. 13 (Appendix A)(italics added). With respect to the last element of claim 1, the Specification states: By “essentially free” it is meant that the vitamin composition should not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement. The presence of lower amounts of antioxidants would not render the vitamin composition of the present invention ineffective or of reduced effectiveness. Spec. ¶ 7. The identical claims currently under appeal were the subject of a prior appeal to the United States Court of Appeals for the Federal Circuit. In re Eaton, 545 F. App’x 994 (Fed. Cir. 2013). In reversing the Board’s prior determination that claims 1–4 were unpatentable over prior art not presently before us, the Federal Circuit confirmed that “‘essentially free’ of antioxidants means a composition that ‘should not contain an amount of 2 Depending from claim 1, claim 3 specifies that the “composition comprises 800 micrograms of folic acid, 115 micrograms of vitamin B12, and 10 milligrams of vitamin B6.” Dependent claims 2 and 4 specify that the “composition is in the form of a tablet.” Appeal 2018–006185 Application 15/078,167 3 antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement.’” Id. at 997. The court emphasized that the proper construction “does not require ‘no’ added [antioxidants such as] vitamin C, vitamin E, or the like. Rather, the correct construction requires that “lower amounts” of antioxidants may be present, but the effectiveness of the composition must not be reduced. Id. at 997. Noting that the compositions disclosed in the cited references included antioxidants (id. at 995–996), the Court determined that the Examiner and the Board erred in not analyzing those compositions for reduced effectiveness resulting from the antioxidant component (id. at 997–998). The instant rejections involve the following five references: • EP 0 595 005 A1, published May 4, 1994 (“Serfontein”); • US 5,932,624, issued Aug. 3, 1999 (“Herbert”); • US 2002/0132800 Al, published Sept. 19, 2002 (“Popp”); • US 7,115,286 B2, issued Oct. 3, 2006 (“Meredith”);3 and • US 5,563,126, issued Oct. 8, 1996 (“Allen”). In the appeal before us, the Examiner maintains three rejections under pre-AIA 35 U.S.C § 103(a): claims 1–4 in view of Serfontein; claims 1–4 in view of Herbert, Serfontein, Popp, and Meredith; and claims 1 and 2 in view of Allen, Serfontein, Popp, and Meredith. Answer 3. The Examiner also provisionally rejects claims 1–4 for obviousness-type double patenting over 3 Although initially arguing that the Examiner had not shown that Meredith is prior art (App. Br. 10), Appellant has not rebutted the Examiner’s reasoned assertion that Meredith qualifies as prior art because it is entitled to the filing date of Provisional Application No. 60/485,421 (Ans. 6). On this record we agree with the Examiner that Meredith qualifies as prior art. Appeal 2018–006185 Application 15/078,167 4 claims 25–47 of copending Application No. 11/145,716. Id.; Final Rej. 24– 26.4 All other rejections have been withdrawn. Id. at 4. FACTUAL FINDINGS We have reviewed Appellant’s contentions that the Examiner erred in rejecting claims 1–4 as unpatentable over the cited art. We disagree with Appellant’s contentions and adopt the findings concerning the scope and content of the prior art set forth in the Examiner’s Answer and Final Rejection (to the extent directed to the references discussed below). For emphasis, we highlight and address the following: FF1. Serfontein is a European Patent Application entitled “Pharmaceutical preparations for lowering homocysteine levels, containing vitamin B6, folic acid and vitamin B12.” Serfontein claims: 1. The use in the manufacture of a pharmaceutical preparation for lowering levels of homocysteine or for the prophylaxis or treatment of elevated levels of homocysteine or of clinical conditions associated therewith in a patient of a combination comprising a) vitamin B6; b) folate or a suitable active metabolite of folate or a substance which release folate in vivo; c) vitamin B12, with or without intrinsic factor. 4 Appellant does not address the obviousness-type double patenting rejection in this appeal. But see Final Rej. 26 (noting that “Applicant states that they will submit a Terminal Disclaimer in compliance with 37 C.F.R. § 1.321(c) or 1.321(d) once the application is allowed”). Because the rejection is provisional, we do not address it here. See Ex. Parte Moncla, Appeal 2009- 006448 (PTAB June 22, 2010) (Precedential). Appeal 2018–006185 Application 15/078,167 5 Serfontein, 18:51–56; see also, id. at 4:37–42. According to Serfontein, the disclosed preparations are “applicable to the lowering of total homocysteine blood levels if elevated by any known causes, including . . . psoriasis.” Id. at 4:42–48. FF2. Further, and as described by the Examiner, Serfontein teaches that the dosage form may be a tablet (pg. 5, In. 58; and pg. 6, In. 44–45). Serfontein also teaches that the preferred dosage is 5 mg vitamin B6, 1,000 μg folic acid and 500 μg vitamin B12 (pg. 8, Table). Serfontein also teaches tablets comprising 2.5 mg pyridoxal + 2.5 mg pyridoxine (5 mg vitamin B6), 0.5 mg folic acid and 0.25 mg cyanocobalamin (vitamin B12) (Example 4); and tablets comprising 2 mg pyridoxal + 8 mg pyridoxine (10 mg vitamin B6), 0.65 mg folate and 0.4 mg cyanocobalamin (vitamin B12) (Example 8). Final Rej. 4. FF3. Serfontein further teaches that the disclosed compositions may “optionally” include antioxidants, such as betaine and/or its precursor, choline. Id. at Abstract, 7:22–27. The reference also states that “the invention preferably provides for the co-administration . . . of an antioxidant,” such as vitamin C, vitamin E, selenium, and/or coenzyme Q10 “preferably incorporated into the same pharmaceutical preparation.” Id. at 6:58–7:5; see also id. at 21 (claim 23 reciting the addition of one or more antioxidants to the invention of claims 1–22). FF4. Herbert teaches vitamin supplement compositions comprising folic acid, vitamin B12, and vitamin B6 that are “essentially free of antioxidants,” where that term means that the vitamin composition of the present invention must not contain an amount of antioxidants which would tend to damage and inactivate some of the vitamin B12 and/or folic acid of the vitamin supplement. The presence lower amounts of Appeal 2018–006185 Application 15/078,167 6 antioxidants would not render the vitamin composition of the present invention ineffective or of reduced effectiveness. Herbert, Abstract, 1:64–2:24, 3:53–59, claim 1. FF5. Herbert teaches the administration of supplement compositions comprising folic acid, vitamin B12, and vitamin B6 to “lowering high serum homocysteine levels to protect against the incidence of heart attack and other blood vessel related disorders.” 2:1–5. “Preferably, the supplement is administered orally,” e.g., as tablets. Id. at 3:30–36. Preferred unit dosages effective to reduce elevated serum homocysteine levels to normal “generally range from 300 to about 2,000 micrograms of folic acid, 25 to about 1,000 micrograms of vitamin B12, and 5 to about 20 milligrams of vitamin B6, with 500 micrograms of folic acid, 25 micrograms of vitamin B12 and 10 milligrams of vitamin B6.” Id. at 3:62–4:19; see claims 12–15. FF6. Allen teaches oral administration of compositions comprising folic acid, vitamin B6 and vitamin B12 to prevent and treat elevated levels of serum metabolites, including homocysteine. Allen, Abstract; 1:16–48, 5:62–6:2, claim 1. In one embodiment the composition comprises 0.3–10 mg of vitamin B12, 0.1-0.4 mg folic acid and 5-75 mg vitamin B6. Id. at 6:3–18, 7:15–22, claim 2. The Examiner reasonably infers that Allen teaches that such compositions may be formulated as tablets. See Final Rej. 8 (citing Allen 8:11). FF7. Popp is directed to dietary supplement compositions for improving and maintaining healthy skin. See e.g., Popp, Title, Abstract, ¶ 3. According to Popp, “[p]soriasis patients are known to be deficient in folic acid. Supplementation with folic acid may benefit psoriasis and seborrheic dermatitis patients.” Id. ¶ 31. Appeal 2018–006185 Application 15/078,167 7 FF8. Meredith is generally directed to oral compositions “to inhibit insects from biting a subject” and/or “reduce swelling, itching, redness and/or inflammation of the local area of an insect bite.” Meredith, Abstract. Meredith discloses that such compositions may include vitamins. See e.g., id. Consistent with this disclosure, Meredith “provides general background information on vitamins” (id. at 14:8–21:31) noting for example that, “[s]ufferers of psoriasis my consider taking extra folic acid,” (id. at 16:22–23), vitamin B6 may “assist[] in the prevention of dandruff, eczema, and psoriasis” (id. at 18:36–39), and a deficiency of vitamin B12 “may . . . result in the raising of the level of homocysteine in the blood” (id. at 20:10–13). ANALYSIS As an initial matter, Appellant appears to argue that we should allow claims 1–4 on appeal because the Examiner previously allowed the same claim language over Serfontein, Meredith, and Popp. See App. Br. 3–7, 11; Reply, 2 (citing MPEP §§ 1308.01, 706,04). While we appreciate Appellant’s frustration with the course of prosecution, Appellant points to no authority for the requested remedy and we find no error in the Examiner’s reconsideration of the record in light of the Federal Circuit’s guidance in Eaton, discussed above. We, therefore, proceed to a brief overview of the Examiner’s rejections. In rejecting claims 1–4 as obvious in view of Serfontein, the Examiner finds that “Serfontein teaches that compositions comprising folic acid, vitamin B6 and vitamin B12 are applicable to the lowering of total homocysteine blood levels if elevated by any known cause, including psoriasis.” Final Rej. 5 (citing Serfontein, 4:43–46). According to the Appeal 2018–006185 Application 15/078,167 8 Examiner, it would have been obvious to use such compositions to treat a psoriatic patient “because Serfontein teaches that the pharmaceutical preparations can be used to lower total homocysteine levels caused by psoriasis.” Id. With respect to claim 1’s requirement that the composition is essentially free of anti-oxidants, the Examiner reasons that because Serfontein teaches this limitation because it discloses that inclusion of antioxidants is optional and “Examples 4 and 8 and Claim 1 of Serfontein do not contain an antioxidant.” Id. With respect to the rejection of claims 1–4 in view of Herbert, Serfontein, Popp, and Meredith, the Examiner relies on Herbert as teaching vitamin supplement compositions comprising folic acid, vitamin B12, and vitamin B6 that are expressly described as “essentially free of antioxidants.” Id. at 7. The Examiner reasons that one of ordinary skill in the art would have found it obvious to use Herbert’s compositions for the treatment of psoriasis because Serfontein teaches that compositions comprising folic acid, vitamin B12, and vitamin B6 can be used to lower homocysteine levels caused by psoriasis, whereas Meredith and Popp, respectively, teach the benefits of vitamin B6 and folic acid supplementation in the prevention or treatment of psoriasis. See id. at 7–8. With respect to the rejection of claims 1 and 2 in view of Allen, Serfontein, Popp, and Meredith, the Examiner states: Allen et al. teach compositions comprising folic acid, vitamin B6 and vitamin B12 for preventing and treating elevated serum homocysteine levels. Serfontein teaches that psoriasis can cause elevated homocysteine levels, and Meredith and Popp et al. teach that vitamin B6 and folic acid, respectively, may be beneficial in the treatment of psoriasis. Therefore, it would have been prima facie obvious for a person having ordinary skill in Appeal 2018–006185 Application 15/078,167 9 the art to treat psoriasis with a composition according to Allen et al. comprising vitamin B6, folic acid and vitamin B12. Id. at 14–15; see id. at 12–13. Appellant argues that, “[t]he Examiner has not shown that Meredith, Serfontein, or Popp et al. disclose the essentially free of antioxidants limitation, and all of them teach away from it anyway.” App. Br. 8. We do not find Appellant’s arguments persuasive. Teaching away requires a reference to actually criticize, discredit, or otherwise discourage the claimed solution. See In re Fulton, 391 F.3d 1195, 1201 (Fed. Cir. 2004). Accordingly, “a teaching that a composition may be optimal or standard does not criticize, discredit, or otherwise discourage investigation into other compositions.” Galderma Labs., LP v. Tolmar, Inc. 737 F.3d 731, 738–39 (Fed. Cir. 2013). With respect to Meredith, Appellant points to the passage at column 16, lines 34–36 of the reference stating: “Folic acid is more effective when taken with the B group vitamins–especially vitamin B12 and vitamin B6. Vitamin C is also recommended.” Id. at 9 (emphasis added). While we do not dispute that vitamin C has antioxidant properties, the Examiner relies on Meredith’s “general background information on vitamins,” and in particular, Meredith’s teaching that vitamin B6 may be beneficial in the treatment of psoriasis. See, e.g., Ans. 5 (“Meredith teaches that sufferers of psoriasis may consider taking extra folic acid; pyridoxine may be of benefit for assisting in the prevention of psoriasis; and a deficiency in vitamin B12 may result in the raising of the level of homocysteine in the blood.”); FF8. At best, the passage quoted by Appellant merely suggests that, in some embodiments, vitamin B6 may be administered in conjunction with vitamin C. This is insufficient to show teaching away from administering Appeal 2018–006185 Application 15/078,167 10 vitamin B6 in the absence of vitamin C or any other antioxidant because “mere disclosure of more than one alternative does not constitute a teaching away from any of these alternatives because such disclosure does not criticize, discredit, or otherwise discourage the solution claimed.” In re Fulton, 391 F.3d at 1201. The Examiner similarly relies on Popp as teaching that “psoriasis patients are known to be deficient in folic acid, and supplementation with folic acid may benefit psoriasis patients.” Ans. 5–6; see Popp ¶ 31. Although Appellant appears to argue that Popp’s disclosure of a dietary supplement comprising, inter alia, lycopene carotenoids as an essential ingredient (App. Br. 8–9), comprises a teaching away, the information relied on by the Examiner appears as part of a general description of the biological uses of various vitamins and minerals. See Popp ¶¶ 20–35. In determining obviousness, “[a] reference must be considered for everything that it teaches, not simply the described invention or a preferred embodiment.” In re Applied Materials, 692 F.3d 1289, 1298 (Fed. Cir. 2012). Here, the reference, particularly as relied on by the Examiner, does not teach away from the use of folic acid in the absence of lycopene carotenoids or antioxidants generally. Appellant further focuses on Serfontein’s statement that “the invention preferably provides for the co-administration with the aforesaid substances . . . of an antioxidant, more particularly [] vitamin C . . . .” App. Br. 9 (quoting Serfontein 6:58–7:1). The case law is clear, however, that even an expressed preference for certain embodiments does not constitute a teaching away from a broader disclosure or non-preferred embodiments. In re Susi, 440 F.2d 442 (CCPA 1971). Here, as the Examiner points out, Appeal 2018–006185 Application 15/078,167 11 Serfontein discloses that inclusion of antioxidants is optional, whereas “Examples 4 and 8 and Claim 1 of Serfontein do not contain an antioxidant.” See Final Rej. 4–5; Ans. 6–7; FF1–3. As such, we agree with the Examiner that rather than teach away from any claim element, Serfontein expressly discloses the antioxidant-free compositions set forth in the appealed claims. Appellant further argues that the Examiner’s rejections fail because neither Serfontein nor Meredith are analogous art. App. Br. 9–10. We do not find Appellant’s arguments persuasive. “Prior art is analogous if it is from the same field of endeavor or if it is reasonably pertinent to the particular problem the inventor is trying to solve.” Circuit Check Inc. v. QXQ Inc., 795 F.3d 1331, 1335 (Fed. Cir. 2015). Serfontein, discloses “pharmaceutical preparation[s] for lowering levels of homocysteine or for the prophylaxis or treatment of elevated levels of homocysteine or of clinical conditions associated therewith in a patient.” Serfontein, claim 1. Given Serfontein’s explanation that such preparations are “applicable to the lowering of total homocysteine blood levels if elevated by any known causes, including . . . psoriasis” (id. at 4:42–48), the reference is both within the same field of endeavor, and reasonably pertinent to applicant’s invention. Appellant argues that Meredith is not analogous art because it is “an insect repellant reference.” App. Br. 9. We do not entirely agree with Appellant’s characterization. Meredith is generally directed to oral compositions “to inhibit insects from biting a subject” and/or “reduce swelling, itching, redness and/or inflammation of the local area of an insect bite.” Meredith, Abstract (emphasis added). Accordingly, Meredith teaches vitamin-containing compositions for the amelioration of skin conditions (i.e., Appeal 2018–006185 Application 15/078,167 12 swelling, itching, redness and/or inflammation in the local area of an insect bite), which, broadly speaking, is in the same field of endeavor as the treatment of the specific skin conditions set for in the Specification. See Spec. ¶ 2 (“The present invention relates generally to the treatment of dermatological conditions, including but not limited to psoriasis, dermatitis, and dandruff.”). Moreover, given that Meredith’s “general background information on vitamins” explains that that, “[s]ufferers of psoriasis my consider taking extra folic acid,” (id. at 16:22–23), and vitamin B6 “may assist in the prevention of dandruff, eczema, and psoriasis” (id. at 18:36–39), the reference is at least reasonably pertinent to the treatment of the dermatological conditions highlighted in Appellant’s Specification. See e.g., Spec. ¶¶ 9–10. (disclosing multiple vitamin supplement compositions for the “[t]herapeutic treatment of dermatological conditions such as psoriasis, dermatitis, or dandruff”). In view of the above, we conclude that the Examiner has established a prima facie case of unpatentability, which Appellant has not rebutted. SUMMARY We affirm the rejection of claims 1–4 under 35 U.S.C. § 103(a) as unpatentable over the cited art as set forth in the table below. Appeal 2018–006185 Application 15/078,167 13 DECISION SUMMARY Claims Rejected 35 U.S.C. § Basis Affirmed Reversed 1–4 103(a) Serfontein 1–4 1–4 103(a) Herbert, Serfontein, Popp, and Meredith 1–4 1, 2 103(a) Allen, Serfontein, Popp, and Meredith 1, 2 TIME PERIOD FOR RESPONSE 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 Copy with citationCopy as parenthetical citation