Ex Parte RayDownload PDFPatent Trial and Appeal BoardNov 28, 201714566313 (P.T.A.B. Nov. 28, 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. 14/566,313 12/10/2014 Jay Richard Ray II 8138-66 (0293122) 4994 30448 7590 11/30/2017 AKERMAN LLP P.O. BOX 3188 WEST PALM BEACH, FL 33402-3188 EXAMINER SONG, JIANFENG ART UNIT PAPER NUMBER 1613 NOTIFICATION DATE DELIVERY MODE 11/30/2017 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): ip @ akerman.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte JAY RICHARD RAY, II Appeal 2017-003249 Application 14/566,313 Technology Center 1600 Before DEMETRA J. MILLS, RICHARD J. SMITH, and RYAN H. FLAX, Administrative Patent Judges. MILLS, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35U.S.C. § 134. The Examiner has rejected the claims for obviousness. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. Appeal 2017-003249 Application 14/566,313 STATEMENT OF CASE The following claim is representative. 19. A method of treating a patient for an upper or lower respiratory tract infection, the method comprising: preparing a dry powder formulation for nebulization, wherein the dry powder formulation comprises (i) tobramycin or a pharmaceutically acceptable salt thereof, (ii) an excipient base, and (iii) either acetylcysteine or a pharmaceutically acceptable salt thereof, or levofloxacin or a pharmaceutically acceptable salt thereof; adding the dry powder formulation to a sodium chloride solution to produce a solution dosage form; nebulizing the solution dosage form to form particles wherein a majority of the particles are greater than 10 microns; and intranasally administering to a patient the nebulized solution dosage form to treat an infection of the upper or lower respiratory tract. Cited References Osbakken et al. US 2002/0061281 Al May 23, 2002 Speirs et al. US 2003/0143162 Al July 31,2003 O’Neil et al. US 2012/0328671 Al Dec. 27, 2012 Hoffman W 0 2006/060027 A2 June 8, 2006 PCCA LoxaSperse, Powder Excipient Base for Use in Nebulization and Irrigation Compounds PCCA # 30-4701, www.pccrarx.com (2013). NasoNeb, Sinus Solutions by Medlnvent, LLC https://web.archive.org/web/20131115060216/http:l/nasoneb.com/index.php? page=nebulizer (last viewed Dec. 14, 2015 10:35:40 PM). 2 Appeal 2017-003249 Application 14/566,313 Grounds of Rejection Claims 1, 2, 4—6, 19, 21, 22, 24, 26—28, and 32-42 are rejected under 35 U.S.C. § 103 as being unpatentable over PCCA, O’Neil et al., Osbakken et al., Hoffman et al., Speirs et al., and Medlnvent. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Final Action at pages 3—19. We agree with and adopt these facts. 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). “The combination of familiar elements according to known methods is likely to be obvious when it does no more than yield predictable results.” KSRInt! Co. v. Teleflex Inc., 550 U.S. 398, 416 (2007). Obviousness Rejection The Examiner finds that the difference between the instant application and PCCA is that PCCA do not expressly teach the combination of N-acetylcysteine and Tobramycin, combination of Tobramycin and levofloxacin, preparing a dry powder formulation comprising Nacetylcysteine and Tobramycin which is encapsulated into a capsule, preparing a dry powder formulation comprising N-acetylcysteine and levofloxacin which is encapsulated into a capsule; sodium chloride solution for neubulization; particle size lOum to 25um. This deficiency in PCCA is cured by the teachings of O’Neil et al., Osbakken et al., and Hoffman et al., Speirs et al. and Medlnvent[.] 3 Appeal 2017-003249 Application 14/566,313 Final Act. 9—10. The Examiner concludes that One of ordinary skill in the art would have been motivated to have particle size from 10[p]m to 25[p]m because Medlnvent teaches it is [an] advantage to have particle size more than 10[g]m, for example 23.3 [p]m, with NasoNeb Nasal Nebulizer, for delivery of drug to the nasal and paranasal sinus cavities. Therefore, it is obvious for one of ordinary skill in the art to have particle size from 10[p]m to 25[p]m and produce the instant claimed invention with reasonable expectation of success. Final Act. 12—13. Appellants contend that PCCA and O’Neil are silent with respect to suitable particle sizes that may be formed by nebulizing a solution dosage form that includes any of the active agents recited in claim 19 to treat an infection of the upper or lower respiratory tract. And while Hoffman, Osbakken, and Speirs describe nebulization of compositions that include certain active agents recited in claim 19, all three of these references teach particle sizes between 1 pm and 5 pm or no more than 20% above 5 pm. Therefore, the alleged combination of PCCA, O'Neil, Hoffman, Osbakken, and Speirs fails to disclose, teach, or suggest “nebulizing the solution dosage form to form particles wherein a majority of the particles are greater than 10 microns ” as recited in claim 19. App. Br. 14. Appellant further argues that (1) Medlnvent fails to teach or suggest any actives or combinations of actives, much less actives recited in claim 19, that may be advantageously nebulized in large particles of 23.3 pm for deposition in the nasal and paranasal sinus cavities and (2) PCCA and O’Neil are both silent with respect to particle size, and Hoffman, Osbakken, and Speirs teach that compositions that include certain actives recited in claim 19 are to be administered in particle sizes between 1 pm and 5 pm or no more than 20% above 5 pm. Also absent is any teaching or suggestion to nebulize the 4 Appeal 2017-003249 Application 14/566,313 alleged combination of PCCA, O’Neil, Hoffman, Osbakken, and Speirs to form large particles (23.3 pm) for deposition in the nasal and paranasal sinus cavities according to Medlnvent. App. Br. 15. ANALYSIS We agree with the Examiner’s fact finding, statement of the rejection and responses to Appellants’ arguments as set forth in the Answer. We find that the Examiner has provided evidence to support a prima facie case of obviousness. We provide the following additional comment to the Examiner’s argument set forth in the Final Rejection and Answer. Appellant’s arguments focus primarily on the particle sizes of the prepared dry powder formulations for nebulization delivered in the claimed method. App. Br. 11-12. We are not persuaded by Appellants’ arguments. Appellant errs in attacking the references individually, as the rejection is based on a combination of references. See In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). The references cannot be read in isolation, but must be considered for what they teach in combination with the prior art as a whole. See, id. Medlnvent discloses nasal delivery, nebulizer formulations with a particle size of 23.3 pm for delivery to the nasal and paranasal sinus cavities. P. 1. The Examiner finds that a sinus infection is considered an upper respiratory tract infection (Final Act. 4), thus delivery to the nasal cavity is delivery to the upper respiratory tract. The Examiner further finds that, “Medlnvent clearly suggest [the] advantage of larger particle size (10[p]m to 25[p]m) for the treatment of nasal infection to have large percentage of drugs in the nose instead of lung.” Ans. 18—19. 5 Appeal 2017-003249 Application 14/566,313 Appellant has failed to provide sufficient argument or evidence rebutting the Examiner’s determination that the Medlnvent reference taught and suggested nebulizer particle sizes for drug delivery to the upper respiratory tract. The remaining references, in combination, disclose dry powder, nasal nebulization formulations, including tobramycin, n- acetylcysteine and/or levofloxacin. Final Act. 5-9. Arguments not made are waived. The obviousness rejection is affirmed for the reasons of record. CONCLUSION OF LAW The cited references support the Examiner’s obviousness rejections, which are affirmed for the reasons of record. All pending, rejected claims fall. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136(a)(l)(iv). AFFIRMED 6 Copy with citationCopy as parenthetical citation