Ex Parte KnauerDownload PDFPatent Trial and Appeal BoardOct 30, 201712445113 (P.T.A.B. Oct. 30, 2017) 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. 12/445,113 04/10/2009 Kent A. Knauer CWR-8199US PCT 5088 68705 7590 11/01/2017 TAROLLI, SUNDHEIM, COVELL & TUMMINO, LLP 1300 EAST NINTH STREET SUITE 1700 CLEVELAND, OH 44114 EXAMINER COLEMAN, BRENDA LIBBY ART UNIT PAPER NUMBER 1624 NOTIFICATION DATE DELIVERY MODE 11/01/2017 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): rkline @ tarolli. com docketing@tarolli.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte KENT A KNAUER1 Appeal 2016-005748 Application 12/445,113 Technology Center 1600 Before ULRIKE W. JENKS, RYAN H. FLAX, and DAVID COTTA, Administrative Patent Judges. FLAX, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134(a) involving claims directed to a method for treating mucosal inflammation. Claims 13 and 14 are on appeal as rejected under 35 U.S.C. § 103(a). We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 Appellant identifies the Real Party in Interest as “Case Western Reserve University.” Br. 2. Appeal 2016-005748 Application 12/445,113 STATEMENT OF THE CASE The Specification explains, “the term ‘rhinitis’ refers to inflammation of the nasal mucous membranes resulting from, e.g., a cold, flu, or allergies” and “the term ‘sinusitis’ refers to inflammation of the paranasal sinuses, which can be the result of infection (e.g., bacterial, fungal or viral), allergic or autoimmune causes.” Spec. ^ 19-20. The Specification further states: The present invention generally relates to a pharmaceutical composition and method for treating mucosal inflammation, and more particularly to a non-habituating nasal spray composition and method for intranasally treating rhinitis and/or sinusitis. The present invention is based on the discovery that a nasal spray composition comprising a decongestant and at least one therapeutic agent can effectively reduce or eliminate symptoms associated with inflammation of the nasal mucosa, i.e., rhinitis, sinusitis, or both. Spec. If 11. Claim 13, the sole independent claim, is representative,2 and is reproduced below: 13. A method for treating mucosal inflammation of the paranasal sinus tissue associated with sinusitis in a subject, the method comprising intranasally administering to the subject a therapeutically effective amount of a non-habituating nasal spray composition to treat the mucosal inflammation of the paranasal sinus tissue associated with sinusitis in the subject, the nasal spray composition comprising oxymetazoline hydrochloride and triamcinolone acetonide. Br. 16 (Claims App’x). 2 Appellant argues that claim 14 is patentable only because claim 13, from which it depends, is patentable. Br. 11. 2 Appeal 2016-005748 Application 12/445,113 The following rejection is on appeal: Claims 13 and 14 stand rejected under 35 U.S.C. § 103(a) over Sudsakom3 and Meltzer.4 Final Action 3. FINDINGS OF FACT We agree with and adopt the Examiner’s findings of fact and determinations as to the scope and content of the prior art. We identify the following findings of fact to highlight certain evidence. FF1. Sudsakom discloses, “[tjriamcinolone acetonide (TAA) (Fig. 1) is a glucocorticosteroid that is widely administered topically as a nasal spray for the treatment of allergic rhinitis. Oxymetazoline hydrochloride (OXY) (Fig. 1) is an ai-agonist agent that is also widely used in nasal spray preparations as nasal decongestant.” Sudsakom 1273; see also Final Action 3—4, 6, and Ans. 2, 4-7 (discussing Sudsakom). FF2. Sudsakom further discloses, “a nasal spray formulation that combined both the decongestant property of OXY [oxymetazoline hydrochloride] with the allergic rhinitis properties of TAA [triamcinolone acetonide] was developed with the expectation that the decongestant properties of OXY [oxymetazoline hydrochloride] would enhance the penetration of TAA [triamcinolone acetonide] 3 Sirimas Sudsakom et al., Simultaneous Determination of Triamcinolone Acetonide and Oxymetazoline Hydrochloride in Nasal Spray Formulations by HPLC, 40 J. Pharma. & Biomed. Anal. 1273-80 (2006 (“Sudsakom”). 4 Eli O. Meltzer et al., Allergic Rhinitis, Asthma, and Rhinosinusitis: Diseases of the Integrated Airway, 10 J. Managed Care Pharmacy 310-17 (2004) (“Meltzer”). 3 Appeal 2016-005748 Application 12/445,113 deeper into the nasal sinuses.” Sudsakom 1273; see also Final Action 3—4, 6, and Ans. 2, 4-7 (discussing Sudsakom). FF3. Sudsakom discloses two commercial nasal spray formulations, Tri-Nasal® and Nasacort AQ®, each being a triamcinolone acetonide containing product, to which oxymetazoline hydrochloride was added to provide formulations that were stable when stored under controlled room temperatures (20-25°C). Sudsakom 1274, 1279; see also Final Action 3—4, 6, and Ans. 2, 4-7 (discussing Sudsakom). FF4. Meltzer discloses allergic rhinitis and rhinosinusitis are common conditions and that “recent studies have suggested that allergic rhinitis, rhinosinusitis, and asthma may be manifestations of a common underlying pathology, but there are many unanswered questions.” Meltzer 310, 311; see also Final Action 3-6, and Ans. 2- 7 (discussing Meltzer). FF5. Meltzer discloses “[ajllergic rhinitis, rhinosinusitis, and asthma are frequently comorbid conditions, and this association has been recognized since the early 1900s. Recent studies have strengthened the concept that allergic rhinitis, rhinosinusitis, and asthma are manifestations of an inflammatory process within a continuous airway.” Meltzer 310; see also Final Action 3-6, and Ans. 2-7 (discussing Meltzer). FF6. Meltzer discloses “[ajllergic rhinitis also may be a contributing factor in 25% to 30% of patients with acute maxillary sinusitis and in as many as 60% to 80% of patients with chronic 4 Appeal 2016-005748 Application 12/445,113 sinusitis. At the least, allergic rhinitis is associated with, and probably a predisposing factor in the development of, rhinosinusitis.” Meltzer 311; see also Final Action 3-6, and Ans. 2-7 (discussing Meltzer). FF7. The Specification states that “[rjhinitis, an inflammation of the nasal mucosal membrane, is characterized by sneezing, rhinorrhea, nasal congestion, and increased nasal secretion,” that “[f]ailure to effectively treatment rhinitis may lead to other disorders including infection of the ears, lower respiratory tract, and sinuses,” and “[inflammation of the sinuses, known as rhinosinusitis or sinusitis, is difficult to treat successfully,” but “steroid nasal sprays are commonly used to reduce inflammation.” Spec. 3^1 and 19, 20; see also Final Action 7, and Ans. 3—4, 6 (discussing Specification). FF8. Gawchick confirms that it was well know that “[i]n addition to seasonal and perennial rhinitis, intranasal corticosteroids [e.g., aqueous triamcinolone acetonide at dosages of 110^440 gg once or twice a day] have additional benefits when used to reduce inflammation in the treatment of sinusitis.” Gawchick 309, 310;5 see also Ans. 4, 6 (discussing Gawchick). 5 Sandra M. Gawchick & Consuelo L. Saccar, A Risk-Benefit Assessment of Intranasal Trimcinolone Acetonide in Allergic Rhinitis, 23 Drug Safety 309-22 (2000) (“Gawchick”) (cited by Examiner as evidence supporting, but not the basis for rejection). 5 Appeal 2016-005748 Application 12/445,113 DISCUSSION “[W]hen a patent claims a structure [or method] already known in the prior art that is altered by the mere substitution of one element for another known in the field, the combination must do more than yield a predictable result.” KSRInt’l Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007) (citing U.S. v. Adams, 383 U.S. 39, 50-51 (1966)). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” Id. We find that in view of the findings of fact, under the above precedent, the Examiner has established a prima facie case that claim 13 would have been obvious over Sudsakom and Meltzer, as evidenced by the Specification and Gawchick. FF1-FF8. Appellant has not produced evidence showing, or persuasively argued, that the Examiner’s determinations are incorrect. Only those arguments made by Appellant in the Brief have been considered in this Decision. Arguments not presented in the Brief are waived. See 37 C.F.R. § 41.37(c)(l)(iv). Appellant argues Sudsakom and Meltzer do not teach or suggest treating sinusitis-associated inflammation by administering the claimed formulation of triamcinolone acetonide and oxymetazoline hydrochloride in a nasal spray. Br. 6. Appellant contends that Sudsakom is directed only to treating rhinitis and not sinusitis, or any inflammation outside the nasal cavity. Id. Appellant also contends that, while Sudsakom discloses adding oxymetazoline hydrochloride to triamcinolone acetonide because the former allows the later to penetrate deeper into the nasal sinuses, this does not mean that the reference teaches that such access equates to the composition being 6 Appeal 2016-005748 Application 12/445,113 therapeutically effective in treating sinusitis. Id. at 6-7. Finally, Appellant argues that, even though Meltzer discloses that it is believed that rhinitis and sinusitis are related, comorbid conditions (the integrated airway hypothesis), this does not mean that the reference suggests that treating rhinitis will also treat sinusitis. Id. at 7. These arguments are not persuasive. The evidence shows it was well known that rhinitis and sinusitis are closely related conditions and that the former causes or leads to the later. FF4-FF6, FF8. The evidence also shows it was well known that a primary symptom of each condition is inflammation. FF7. The evidence also shows it was well known that triamcinolone acetonide was useful to treat both rhinitis and sinusitis. FF1, FF8. Therefore, when Sudsakom discloses that oxymetazoline hydrochloride should be added to triamcinolone acetonide to create a formulation where a nasal spray can penetrate to the nasal sinuses, this teaches and suggests treatment of sinusitis using this formulation. See FF2. We conclude there is ample evidence that the claimed method would have been obvious in view of the cited prior art combination. SUMMARY The obviousness rejection is affirmed. 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 7 Copy with citationCopy as parenthetical citation