Ex Parte Jochelson et alDownload PDFPatent Trials and Appeals BoardJan 31, 201713764467 - (D) (P.T.A.B. Jan. 31, 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. 13/764,467 02/11/2013 Philip Jochelson 106229-0703 7057 30542 7590 02/02/2017 FOT FY Rr T ARDNFR T T P EXAMINER 3000 K STREET N.W. KIM, JENNIFER M SUITE 600 WASHINGTON, DC 20007-5109 ART UNIT PAPER NUMBER 1628 NOTIFICATION DATE DELIVERY MODE 02/02/2017 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): ipdocketing @ foley. com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte PHILIP JOCHELSON, ROBERTA L. ROGOWSKI, and NEIL B. KAVEY1 Appeal 2015-008192 Application 13/764,467 Technology Center 1600 Before DEMETRA J. MILLS, RICHARD J. SMITH, and DEVON ZASTROW NEWMAN, 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). 1 Appellants state the real party-in-interest is Pemix Therapeutics Holdings, Inc. Appeal 2015-008192 Application 13/764,467 STATEMENT OF CASE The following claims are representative. 1. A method, comprising: identifying a patient in need of pharmaceutical treatment of a sleep disorder, evaluating the importance to that patient of selecting a pharmaceutical agent to minimize rebound insomnia as a side effect of pharmaceutical treatment of said sleep; and avoiding rebound insomnia in said patient by: selecting doxepin therapy for treating the patient based at least in part on its low incidence of rebound insomnia, and then treating said sleep disorder with doxepin or a pharmaceutically acceptable salt thereof in a daily dosage between about 0.5 milligram and 6 milligrams. 8. A method, comprising: identifying a patient in need of pharmaceutical treatment of a sleep disorder and also evaluating the importance to that patient of avoiding weight gain as a side effect of pharmaceutical treatment of said sleep disorder; selecting a doxepin therapy protocol for the patient to reduce the risk of weight gain as a side effect; and avoiding weight gain as a side effect of pharmaceutical treatment of said sleep disorder in said patient by treating said sleep disorder with doxepin or a pharmaceutically acceptable salt thereof in a daily dosage between about 0.5 milligram and 6 milligrams. Cited References Kavey US 6,211,229 B1 Apr. 3, 2001 Rodenbeck et al., The sleep-improving effects of doxepin are paralleled by a normalized plasma cortisol secretion in primary insomnia, 170 Psychopharmacology 423 428 (2003) (“Rodenbeck”). 2 Appeal 2015-008192 Application 13/764,467 Pinder et al., Doxepin Up-to-Date: A Review of its Pharmacological Properties and Therapeutic Efficacy with Particular Reference to Depression, 13 Drugs 161—218 (1977) (“Pinder”). Grounds of Rejection Claims 1—20 are rejected under 35 U.S.C. § 103(a) as being unpatentable over Kavey2 in view of Rodenbeck and Pinder. FINDINGS OF FACT The Examiner’s findings of fact are set forth in the Final Action at pages 2—8. 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). Rejection 1 Appellants argue the claims in the following groups: Group I, claims 1—7; Group 2, claims 8—20. We select claims 1 and 8 as representative of 2 The Examiner refers to the Kavey reference as Kavey-2 throughout the Final Action and Answer. In this decision we use the terms “Kavey” and “Kavey-2” as both referring to U.S. Patent No. 6,211,229 to Kavey. 3 Appeal 2015-008192 Application 13/764,467 these claim groupings, respectively. 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. With respect to claim 1, the Examiner finds that Kavey-2 teaches a method for treating transient, chronic, and non-chronic forms of insomnia comprising administration of doxepin, or pharmaceutically acceptable forms of doxepin, in an amount ranging from about 0.5 to 20 mg. (Abstract; column 1, lines 51-53). Kavey-2 explicitly teaches treatment comprising administration of doxepin in an amount is about 10 mg or less (column 9, claim 3), 5 mg. or less (column 9, claim 4), and 2 mg. (column 4, line 27). Particularly, Kavey-2 teaches that doxepin is administered for maintenance insomnia (column 2, lines 58-63), and to allow the patient to maintain normal sleep (column 3, lines 51-55). Kavey-2 does not expressly teach the evaluating the importance of minimizing rebound insomnia as well as avoid weight gain as side effects and thereby avoiding rebound insomnia and the weight gain. Final Act. 6. Rodenbeck is relied upon for teaching that, “in some patients rebound insomnia and specific side effects of doxepin must be considered, their finding give a further rationale for the use of sedating antidepressants in the treatment of primary insomnia (abstract, page 426 right-hand column last full paragraph).” Final Act. 6. Pinder teaches that the side-effects of doxepin generally disappear by reduction of dosage (page 205 left-hand column 4 Appeal 2015-008192 Application 13/764,467 under Side-Effects). Pinder teaches that the studies have examined the relationship of dosage to incidence of side- effects. In general, side-effects tended to be dose-related in a study involving males and well as females (page 207 under Dosage and Incidence of Side-Effect). Pinder (page 207, under Less Common Side-Effects) teaches that notable weight gain is one of the less common side effects of doxepin. Final Act. 6—7. The Examiner concludes that It would have been obvious to one of ordinary skill in the art at the time the invention was made to recognize that evaluations such as importance of minimizing rebound insomnia was obviously achieve by Kavey-2 because it is within the routine medical practice in the treatment of insomnia by administration of doxepin that rebound insomnia and specific side effects of doxepin must be considered in some patient populations as taught by Rodenbeck. One of ordinary skill in the art would recognize that Kevey-2 [sic] who is expert in the treatment of insomnia comprising administration of doxepin obviously would have included such evaluations that are must be considered as routine practice as taught by Rodenbeck. With regard to the evaluation regarding avoiding weight gain as side effect, such is obvious because the side effect of weight gain is less common but known adverse effect of doxepin in view of Pinder. Further, such side effect can be avoided by lowering the dose since it is dose related as taught by Pinder. Kevey-2, [sic] who is in expert in the field of treating insomnia comprising administering doxepin would have recognized that the low-dose of doxepin employed by Kevey-2 [sic] would have avoid any side effects including, weight gain and it is well known by Pinder that the side-effect of doxepin is generally disappear by reduction of dosage. Final Act. 7. 5 Appeal 2015-008192 Application 13/764,467 Appellants contend that The claimed method is predicated according to some embodiments, at least in part, on the surprising discovery by the inventors that, unlike many other hypnotic medications, as an effective sleep medication, low dose doxepin caused little or no rebound insomnia, which directs a practitioner to choose about 0.5 mg and 6 mg of doxepin, to patients prone to rebound insomnia. See, e.g., paragraphs [0036] and [0041] of the specification. App. Br. 8. Appellants further contend that The teaching of Rodenbeck that rebound insomnia must be considered is not a teaching or suggestion and does not provide a reasonable expectation that rebound insomnia can be avoided by reducing the dosage. Rather, this indicates that, at 25 mg, doxepin was known to cause rebound insomnia and other side effects in some patients. Thus, based on Rodenbeck, a person skilled in the art when treating a patient having a need to avoid rebound insomnia would avoid using doxepin, rather than administering doxepin to the patient. Therefore, Rodenbeck actually discourages or teaches away from administering doxepin (or at least 25 mg of doxepin) to patients having a need to avoid rebound insomnia. App. Br. 9. Furthermore, Appellants contend that Pinder studied decreasing doxepin dosages from 300 mg to 75 mg. Even the lower dosage of 75 mg is still much higher than the side-effect causing 25 mg dosage described in Rodenbeck (three times of the dosage of Rodenbeck). Rodenbeck showed that rebound insomnia and other side effects were still a problem at dosages much lower than the lowest dosage studied by Pinder, contradictory to Pinder’s general assumption as alleged by the Examiner. In particular, in view that Rodenbeck teaches that rebound insomnia is a side effect of concern caused by 25 mg doxepin, the alleged reduction of totally different side 6 Appeal 2015-008192 Application 13/764,467 effects from 300 mg to 75 mg of doxepin is irrelevant to rebound insomnia and would not provide a motivation to use doxepin when rebound insomnia needs to be avoided. App. Br. 10-11. ANALYSIS We are not convinced by Appellants’ arguments. We agree with the Examiner that while Appellants may take issue with the larger dosages of doxepin described by Pinder and Rodenbeck, Appellants fail to adequately distinguish the disclosure of Kavey, describing a method of administering dosages as low as 0.5 mg of doxepin for the treatment of insomnia. Ans. 3. “It is a general rule that merely discovering and claiming a new benefit of an old process cannot render the process again patentable.” In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990). “Newly discovered results of known processes directed to the same purpose are not patentable because such results are inherent.” Bristol-Myers Squibb v. Ben Venue Laboratories, 246 F.3d 1368, 1376 (Fed. Cir. 2001). In the present case, Kavey essentially discloses the same method, administering the same drug, doxepin, in a similar dosage, to the same patient population, an individual with insomnia, who wants to reduce drug side effects suggested by Rodenbeck, including rebound insomnia and weight gain. In addition, the Examiner finds that Appellants statement that Figure 7 of Pinder “indicates more side effects for patients taking doxepin at the lower dose” is a mischaracterization. Ans. 4; see also App. Br. 9; Pinder, p. 208. In fact, the Examiner concludes from Pinder, Figure 7, that Appellants’ arguments are not persuasive 7 Appeal 2015-008192 Application 13/764,467 because that two of the patients having lower dosages (i.e. between 50mg and lOOmg) of doxepin compared to 300mg had no side effects compared to all of the patients taking 300mg had side-effects. Moreover, the patients started on 75mg per day whose dosage was increased (Fig. 7, indicated as triangles), all five patients had side effects. Accordingly, one of skill in the art would have concluded that lowering dosage as a viable option to reduce any side effects including the rebound insomnia because such option is specifically shown by Pinder on Fig. 7. Thus, Pinder reference would guide one of ordinary skill in the art precisely to the use of doxepin in lower doses to avoid side effect and would work for those patients who has importance of selecting a pharmaceutical agent to minimize any side effect including rebound insomnia. Ans. 4. We agree with the Examiner that Pinder, Fig. 7, supports the Examiner’s position that lower doses of doxepin are associated with reduced side effects. Other arguments made by Appellants have been addressed fully in the Final Action and Answer and we concur with the Examiner’s responses for the reasons of record. With respect to claim 8, Appellants contend that, “even assuming that Pinder suggests the reduction in total side effects and that the total side effects include weight gain, Pinder does not teach or suggest to a person skilled in the art a reduction in weight gain with reduction of dosage.” App. Br. 14. Neither we, nor the Examiner, are persuaded by Appellants’ arguments. We agree with the Examiner that there is a reasonable expectation of successfully treating insomnia with subject population concerned with any side- effect of doxepin including weight gain or rebound insomnia with the low dosages of doxepin taught by Kavey-2 because the side-effect of doxepin in general is dose related and Kavey-2 ’s effective dosages are very low compared with 25mg of Rodenbeck’s amount for treatment of insomnia. 8 Appeal 2015-008192 Application 13/764,467 Ans. 6. Appellants provide no evidence to rebut the Examiner’s contention that there would have been a reasonable expectation of treating insomnia in the subject population concerned with any side-effect of doxepin including weight gain or rebound insomnia with the low dosages of doxepin taught by Kavey. We affirm the rejection of claims 1 and 8 for the reasons of record. Remaining claims 2—7 and 9—20 fall with representative claims 1 and 8. CONCLUSION OF LAW The cited references, and thus a preponderance of the evidence, 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 9 Copy with citationCopy as parenthetical citation