Kristina KingDownload PDFPatent Trials and Appeals BoardMar 27, 202013721744 - (D) (P.T.A.B. Mar. 27, 2020) 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. 13/721,744 12/20/2012 Kristina KING PLOVIN-0023-D01 4975 23599 7590 03/27/2020 MILLEN, WHITE, ZELANO & BRANIGAN, P.C. 2200 CLARENDON BLVD. SUITE 1400 ARLINGTON, VA 22201 EXAMINER WEBB, WALTER E ART UNIT PAPER NUMBER 1612 NOTIFICATION DATE DELIVERY MODE 03/27/2020 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@mwzb.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KRISTINA KING1 Appeal 2018-008066 Application 13/721,744 Technology Center 1600 Before ERIC B. GRIMES, RICHARD M. LEBOVITZ, and DAVID COTTA, Administrative Patent Judges. GRIMES, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134(a) involving claims to a pharmaceutical composition, which have been rejected for lack of adequate written description, nonenablement, and obviousness-type double patenting. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM-IN-PART. 1 Appellant identifies the real party in interest as Bayer Pharma AG. Appeal Br. 1. We use the word Appellant to refer to “applicant” as defined in 37 C.F.R. § 1.42(a). Appeal 2018-008066 Application 13/721,744 2 STATEMENT OF THE CASE The Specification states that “[a]ccording to a public health service recommendation, all women who can become pregnant should . . . consume 400 μg/day of folic acid to reduce the risk of birth defects.” Spec. 1:15–17. “Folic acid supplementation immediately before discontinuing oral contraceptive use, or immediately after a positive pregnancy test has been obtained, may be insufficient to optimally protect the developing foetus.” Id. at 1:18–20. “Accordingly, folic acid should ideally be added to oral contraceptives.” Id. at 1:29. The “invention relates to solid pharmaceutical compositions, in particular to oral contraceptives, comprising a tetrahydrofolic acid, such as calcium 5-methyl-(6S)-tetrahydrofolate.” Id. at 1:7–9. Claims 92–94, 96–101, and 103 are on appeal. Claim 100, reproduced below, is illustrative: 100. A tablet core comprising a solid pharmaceutical composition comprising particles comprising 3 mg of drospirenone, 0.02 or 0.03 mg of ethinyl estradiol, 10–90 wt%, which is based on tablet core total weight, of microcrystalline cellulose, optionally 20–80 wt%, which is based on tablet core total weight, of lactose monohydrate, and 0.42–0.49 mg of an alkaline earth metal salt of 5-methyl-(6S)- tetrahydrofolic acid, wherein the in vitro dissolutions of drospirenone and the salt of 5-methyl-(6S)-tetrahydrofolic acid individually are such that at least 85% of each is dissolved from the composition within 30 minutes, as determined by the USP XXIX Paddle Method II by water for drospirenone and a 0.03% ascorbic acid aqueous solution, which is adjusted to pH 3.5 with 0.05 M phosphate buffer for the salt of 5-methyl-(6S)- Appeal 2018-008066 Application 13/721,744 3 tetrahydrofolic acid at 37°C as the dissolution media and with 50 rpm as the stirring rate, and wherein the stability of the salt of 5-methyl-(6S)- tetrahydrofolic acid is such that at least 90% of said amount thereof is present in the composition after storage in a closed container for 12 months at 25°C and 60% relative humidity, which tablet has a round shape. Claim 90 is the only other pending independent claim, and is identical to claim 100 except that (a) it does not require a round shape and (b) it requires that at least one of seven specified conditions is satisfied (e.g., “condition 1: the tablet core does not contain lactose monohydrate”). Claim 90 and claims 73, 74, 77, 80, 85–89, 95, and 104, which depend from claim 90, have been allowed. Advisory Action mailed May 22, 2018, at 2. Rejected claims 92–94, 96–99, 101, and 103 depend directly or indirectly from claim 90. Claim 97, for example, is reproduced below: 97. A method for prevention or alleviation of physical changes associated with estrogen deficiency, which is changes in skin condition, comprising administering to a female a composition according to claim 90. The claims stand rejected as follows: Claims 92–94, 96–98, and 103 under 35 U.S.C. § 112, first paragraph, for nonenablement (Final Action2 3–4); Claims 99–101 under 35 U.S.C. § 112, first paragraph, for inadequate written description (Final Action 3); and 2 Office Action mailed Nov. 27, 2017. Appeal 2018-008066 Application 13/721,744 4 Claim 100 for obviousness-type double patenting based on claims 1– 11 of U.S. Patent 8,617,597 and Mueller3 (Final Action 8). OPINION Enablement Claims 92–94, 96–98, and 103 stand rejected under 35 U.S.C. § 112, first paragraph, on the basis that “the specification, while being enabling for preventing pregnancy as an oral contraceptive, does not reasonably provide enablement for prevention . . . of estrogen deficiency symptoms, osteoporosis, anemia, dyspareunia,” as recited in the rejected claims. Final Action 3–4. The Examiner finds that the art is unpredictable, as evidenced by Worst Pills, Best Pills,4 which lists the combination of ethinyl estradiol and drospirenone “as a Do Not Use drug because it can cause increased blood levels of potassium and is no more effective ant [sic, than] other oral contraceptives in preventing pregnancy.” Final Action 5. The Examiner also quotes Biskobing5 as stating that “[o]steoporosis remains a significant clinical problem despite effective therapies.” Id. The Examiner interprets “prevention” as “suggest[ing] that one will not experience the disease when taking the claimed agent; that should one get the disease, it will not worsen; or that following its treatment, it will not recur.” Id. at 6. The Examiner concludes that, “[w]hile such ‘prevention’ might theoretically be possible under strictly controlled laboratory 3 Mueller et al., US 2006/0111334 A1, published May 25, 2006. 4 “Worstpills, Drospirenone and ethinyl estradiol. www.worstpills.org published online December 18, 2004. 4 pages.” PTO-892, Nov. 27, 2017. 5 Biskobing, “Novel therapies for osteoporosis,” Expert. Opin. Investig. Drugs 12(4):611–621 (2003). Appeal 2018-008066 Application 13/721,744 5 conditions, as a practical matter it is nearly impossible to achieve in the ‘real world.’” Id. The Examiner concludes that, “[b]ecause of the known unpredictability of the art, and in the absence of experimental evidence, no one skilled in the art would accept the assertion that the instantly claimed agents could be predictably used as inferred by the claim and contemplated by the specification. Accordingly, the instant claims do not comply with the enablement requirement of §112.” Id. at 6–7. Appellant argues that “the burden lies first with the Patent and Trademark Office to provide evidence or objective reasoning substantiating the allegation that the enabling disclosure is not commensurate in scope with the claims.” Appeal Br. 5 (citing MPEP § 2164.04, In re Marzocchi, 439 F.2d 220, 223 (CCPA 1971)). Appellant argues that “the PTO has not supported its rejection appropriately under the requisite standard.” Id. We agree with Appellant that the Examiner has not carried the initial burden of showing that undue experimentation would be required to practice the rejected claims. When rejecting a claim under the enablement requirement of section 112, the PTO bears an initial burden of setting forth a reasonable explanation as to why it believes that the scope of protection provided by that claim is not adequately enabled by the description of the invention provided in the specification of the application; this includes, of course, providing sufficient reasons for doubting any assertions in the specification as to the scope of enablement. If the PTO meets this burden, the burden then shifts to the applicant to provide suitable proofs indicating that the specification is indeed enabling. In re Wright, 999 F.2d 1557, 1561–62 (Fed. Cir. 1993). Appeal 2018-008066 Application 13/721,744 6 Here, the Specification states that “[t]he compositions and dosage forms described herein provide effective alleviation of all physiological and psychological signs of estrogen deficiency.” Spec. 25:12–14. The Specification states that the disclosed compositions can be used to treat all of the conditions recited in rejected claims 92–94, 96–98, and 103. See id. at 24:1–5 and 25:12 to 26:3. As evidence of nonenablement, the Examiner cites Worst Pills, Best Pills, which states that the combination of drospirenone and ethinyl estradiol “can cause increased blood levels of potassium and is no more effective than other oral contraceptives.” Worst Pills, Best Pills, pp. 1–2. This statement, however, does no more than point out a potential side effect of the claimed composition. It provides no evidence that the claimed composition would not be effective in the claimed methods. Worst Pills, Best Pills therefore does not support the rejection for nonenablement. The Examiner also cites evidence that “[o]steoporosis remains a significant clinical problem despite effective therapies.” Final Action 5 (emphasis added). This statement, however, is evidence that “effective therapies” for osteoporosis exist, rather than showing that the claimed methods are ineffective. The Examiner has pointed to nothing in Biskobing that casts doubt on the claimed method as an effective treatment of osteoporosis, or any of the other recited disorders. In summary, the Examiner has not provided a persuasive basis for doubting the Specification’s presumptively accurate description of the claimed methods as effective treatments. We therefore reverse the rejection Appeal 2018-008066 Application 13/721,744 7 of claims 92–94, 96–98, and 103 under 35 U.S.C. § 112, first paragraph, for nonenablement. Written Description Claims 99–101 stand rejected for lack of adequate written description, on the basis that “[c]laims 99 and 100 recite the phrase ‘has a round shape’ and claim[] 101 . . . recite[s] the phrase ‘a red film-coated tablet’. These phrases are new matter insofar as they were not supported by the disclosure as originally filed.” Final Action 3. With regard to claim 101, which recites “a red film-coated tablet,” Appellant argues that “[f]ilm-coated tablets are explicitly disclosed in the specification” and, with regard to “the film-coating being red,” “the application cites to various comparable prior art products, e.g., at the bottom of page 16, line 8 to page 18, line 36, which are products known to have a variety of colors, thereby conveying that the applicant was in possession of the tablets being red, which is a potential typical color for comparable products.” Appeal Br. 4–5. To show a lack of adequate written description, the Examiner must “sufficiently explain to the applicant what, in the examiner’s view, is missing from the written description. . . . When no such description can be found in the specification, the only thing the PTO can reasonably be expected to do is to point out its nonexistence.” Hyatt v. Dudas, 492 F.3d 1365, 1370 (Fed. Cir. 2007). Here, the Examiner has pointed out that Appellant’s Specification does not describe red film-coated tablets, as recited in claim 101. Appeal 2018-008066 Application 13/721,744 8 “The burden [is] then properly shifted to [Appellant] to cite to the examiner where adequate written description could be found, or to make an amendment to address the deficiency.” Id. at 1371. Appellant, however, cites only a description of film-coated tablets generally, rather than the claimed red film-coated tablets. Appeal Br. 4. A description of film, however, is not a description of red film, “[a]nd while the description requirement does not demand any particular form of disclosure, . . . a description that merely renders the invention obvious does not satisfy the requirement.” Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1352 (Fed. Cir. 2010). Appellant also points to a list of prior art products in the Specification, arguing that they are “known to have a variety of colors.” Appeal Br. 5. The fact that other products were known to have different colors, however, is not evidence that those skilled in the art would have recognized, from the description in the Specification, that the instant inventors were in possession of a product having a specific color. And again, while red might or might not be an obvious color for a film-coated tablet, “a description that merely renders the invention obvious does not satisfy the requirement.” Id. We therefore affirm the rejection of claim 101. With regard to claims 99 and 100, which recite “round” tablets, Appellant argues that, although no literal support for the claim language at issue is present . . . , applicants submit that the claimed concept is present in the original disclosure, and such is how one of ordinary skill in the art would understand the description of the invention. See, for example, the citation to comparable prior art products, e.g., at the bottom of page 3, at lines 37–39, which are round products. Appeal Br. 4. Appeal 2018-008066 Application 13/721,744 9 With regard to claims 99 and 100, we agree with Appellant that those skilled in the art would have recognized that the inventors were in possession of round tablets, as claimed, based on the description of a “tablet” in the Specification. The Specification states that “[i]n those cases where the pharmaceutical formulation is in the form of a solid oral dosage form, in particular a solid unit dosage form (e.g. a tablet, sachet or capsule, in particular a tablet), the dosage form is adapted for oral administration.” Spec. 14:24–26 (emphasis added). Merriam-Webster6 defines a “tablet,” in the context of a pharmaceutical dosage form, as “a small mass of medicated material (as in the shape of a disk)” (emphasis added). Similarly, a “tablet” is defined by MedicineNet7 as follows: “In pharmacy, a medication, usually mixed with a binder powder, molded and formed into the form of a tablet, traditionally circular or disk-shaped, but more recently also oblong or differently shaped” (emphasis added). Although other medical dictionaries define a “tablet” as “vary[ing] in shape,”8 the definitions quoted above demonstrate that the description of a medical dosage form as a “tablet” would be recognized by those skilled in the art to include, and show possession of, a round—i.e., circular or disk- shaped—tablet. We therefore reverse the rejection of claims 99 and 100 for lack of adequate written description. 6 www.merriam-webster.com/dictionary/tablet#medicalDictionary. 7 www.medicinenet.com/script/main/art.asp?articlekey=40499. 8 See, e.g., www.medical-dictionary.thefreedictionary.com/tablet. Appeal 2018-008066 Application 13/721,744 10 Obviousness-type double patenting Claim 100 stands rejected for obviousness-type double patenting based on claims 1–11 of U.S. Patent 8,617,597 and Mueller. The Examiner finds that, “[a]lthough the claims at issue are not identical, they are not patentably distinct from each other because they both claim a tablet core comprising” the same components. Final Action 8. The Examiner acknowledges that “[t]he ’597 patent does not claim a round shape,” but Mueller teaches “a round-shaped tablet core of about 80 mg in weight.” Id. at 9. The Examiner concludes that “[i]t would have been obvious to a person having ordinary skill in the art to employ a round shape for the tablet cores of the ’597 patent.” Id. We agree with the Examiner that a round-shaped tablet is an obvious variant of the “tablet” claimed in the ’597 patent. As discussed above in the context of written description, the ordinary meaning of a “tablet” pharmaceutical dosage form includes a circular or disk-shaped (i.e., round) tablet. Thus, forming the tablet claimed in the ’597 patent into a round shape is an obvious variant of that claimed tablet. Appellant argues that the cited disclosure from the ’597 patent relates to the relationship between tablet shape and hardness, and “this part of the disclosure also does not provide a reason or motivation to make the tablet cores of US ’597 round. This disclosure merely indicates a relationship between hardness ranges and the size and shape of tablets.” Appeal Br. 9. Regardless of whether it would have been obvious to make tablets round in order to optimize their hardness, however, the ordinary definition of a pharmaceutical “tablet” includes a round-shaped tablet, and therefore Appeal 2018-008066 Application 13/721,744 11 tablets having that shape are an obvious species of the generic “tablet” claimed in the ’597 patent. We affirm the rejection of claim 100 for obviousness-type double patenting. DECISION SUMMARY In summary: Claims Rejected 35 U.S.C. § Reference(s)/Basis Affirmed Reversed 92–94, 96– 98, 103 112, first paragraph Enablement 92–94, 96– 98, 103 99–101 112, first paragraph Written description 101 99, 100 100 Obviousness-type double patenting; 8,617,597 B2, Mueller 100 Overall Outcome 100, 101 92–94, 96– 99, 103 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). See 37 C.F.R. § 1.136(a)(1)(iv). AFFIRMED-IN-PART Copy with citationCopy as parenthetical citation