Ex Parte Brooks-Korn

Patent Trial and Appeal BoardSep 17, 2012

10367386 (P.T.A.B. Sep. 17, 2012)

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. 10/367,386 02/14/2003 Howard Brooks-Korn 01172.0002.NPUS01 2961 7590 09/17/2012 David A. Lowin Chemin de la Viane 37 Le Mont-sur Lausanne, CH1052 SWITZERLAND EXAMINER CHONG, YONG SOO ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 09/17/2012 PAPER 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. PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE __________ BEFORE THE PATENT TRIAL AND APPEAL BOARD __________ Ex parte HOWARD BROOKS-KORN __________ Appeal 2011-005869 Application 10/367,386 Technology Center 1600 __________ Before LORA M. GREEN, MELANIE L. McCOLLUM, and STEPHEN WALSH, Administrative Patent Judges. GREEN, Administrative Patent Judge. DECISION ON APPEAL This is a decision on appeal under 35 U.S.C. § 134 from the Examiner‟s rejection of claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 38-41. 1 We have jurisdiction under 35 U.S.C. § 6(b). 1 Claims 11, 12, 15, 16, 28, and 29 are also pending, but stand withdrawn from consideration (App. Br. 6). Appeal 2011-005869 Application 10/367,386 2 STATEMENT OF THE CASE Claims 1 and 39 are the independent claims on appeal, and read as follows: 1. A method for treating paresis/paralysis resulting from a neurologic or neurogenic disorder comprising administering to a subject in need thereof an effective amount of an opioid compound. 39. A method for treating paresis/paralysis resulting from a neurogenic disorder comprising administering to a subject in need thereof an effective amount of an opioid compound. The claims have also been subject to an election of species, and have only been examined to the extent they read on the use of oxycodone for treating laryngeal paresis/paralysis (App. Br. 8). The following grounds of rejection are before us for review: I. Claims 1, 3, 13, 14, 23, 26, 27, 30-32, 34, and 39-41 stand provisionally rejected under the judicially created doctrine of obviousness-type double patenting as being unpatentable over claims 1-5, 7-14, and 19 of USSN 11/395,200 (Ans. 3). II. Claim 38 stands rejected under 35 U.S.C. § 112, first paragraph, as containing new matter (Ans. 4). III. Claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39-41 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by Borsodi, 2 Johnson, 3 and Longer 4 (Ans. 5). 2 Borsodi et al., US 5,317,022, issued May 31, 1994. 3 Johnson et al., US 5,393,545, issued Feb. 28, 1995. Appeal 2011-005869 Application 10/367,386 3 IV. Claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39-41 stand rejected under 35 U.S.C. § 103(a) as being rendered obvious by Lalley, 5 Johnson, and Longer (Ans. 7). We affirm-in-part. ANALYSIS Rejection I As Appellant does not argue the merits of the obviousness-type double patenting rejection, we summarily affirm it. Rejection II The Examiner rejects claim 38 under 35 U.S.C. § 112, first paragraph, as containing new matter (Ans. 4). According to the Examiner, “claim 38 recites the negative limitation „neurologic disorder is other than morphine toxicity,‟” finding that “[t]here is no clear support in the specification for this negative limitation” (id.). Appellant argues that the rejection is inconsistent with the case law, as it is “essentially premised upon the position that one skilled in the art would read Applicant‟s disclosure as teaching that morphine toxicity-induced respiratory depression should be treated by administering more morphine” (App. Br. 13). We agree with Appellant, and thus reverse the rejection. 4 Mark A. Longer, PhD and Joseph R. Robinson, PhD, in REMINGTON‟S PHARMACEUTICAL SCIENCES 18 th Ed., pgs. 1676-1682 (1990). 5 Lalley, US 6,706,704 B2, issued Mar. 16, 2004. Appeal 2011-005869 Application 10/367,386 4 Rejection III The Examiner rejects claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39- 41 as being rendered obvious by Borsodi, Johnson, and Longer (Ans. 5). The Examiner finds that Borsodi teaches a preparation for treating respiratory depression (Ans. 5). Specifically, the Examiner finds that Borsodi teaches “that oxycodone and dihydrocodeinone derivatives of general formula I can inhibit the respiratory depression in rats caused by morphine, which in turn is attributed to respiratory paralysis (col. 3, lines 17- 47)” (id.). Thus, according to the Examiner, Borsodi discloses “the compound oxycodone as recited in col. 3, line 18 of the Borsodi patent” (id. at 9). The Examiner relies on Johnson for teaching “that nervous disorders lead to larynx paralysis, which can lead to respiratory paralysis,” and Longer for teaching “advantages of administering a drug using sustained release drug therapy” (id. at 6). Appellant argues: Borsodi discloses that certain derivatives of oxycodone and dihydrocodeinone can be used as analgesics without the appearance of lethal respiratory depression. Borsodi discloses analgesics; not a biologically active preparation for human or veterinary use for treating respiratory depression. Borsodi teaches that oxycodone potentiates the toxicity of morphine; not that oxycodone can inhibit the respiratory depression in rats caused by morphine. (App. Br. 12.) Specifically, Appellant asserts that oxycodone is not a compound taught as having utility in the method of Borsodi, but it is compounds of Appeal 2011-005869 Application 10/367,386 5 Formula I of Borsodi that have utility, which are different from oxycodone (id. at 15-17). According to Appellant, the Examiner has misinterpreted the teachings of Borsodi at col. 3, ll. 17-47 of the patent (id. at 17-18). Appellant asserts that in fact, Borsodi teaches that oxycodone potentiates morphine toxicity-induced respiratory depression (id. at 21 (citing Borsodi, col. 3, l. 66-col. 4, l. 3 and col. 9, ll. 13-15). We agree with Appellant that the combination of Borsodi, Johnson, and Longer does not render the claimed method as it reads on the use of oxycodone for treating laryngeal paresis/paralysis obvious. Borsodi teaches that “[i]t is known that the morphine-like analgetics (opiates) act as respiratory-depressants” (Borsodi, col. 1, ll. 18-19). According to Borsodi: We have found surprisingly that oxycodone and dihydrocodeinone derivatives of general formula (I) are irreversible inhibitors or a dose-dependent manner of specific binding of ( 3 H)naloxone at isotope concentrations of 1 nM and they have a lower affinity to the ( 3 H)naloxone binding sites as compared with the corresponding morphine derivatives. (Id. at col. 3, ll. 18-24.) The Examiner reads that to mean that Borsodi teaches that oxycodone, as well as dihydrocodeinone derivatives of general formula (I) are irreversible inhibitors or a dose-dependent manner of specific binding of ( 3 H)naloxone. We agree with Appellant, that in the context of the reference as a whole, a better reading is oxycodone derivatives of general formula (I) as well as dihydrocodeinone derivatives of general formula (I). For example, Borsodi teaches that the invention is drawn to “a biologically active composition for selective blocking of the opiate binding Appeal 2011-005869 Application 10/367,386 6 sites of the bra[i]n which are responsible for respiratory depression, which contains codeinone derivatives of the general formula (I) or its salts in a biologically active quantity” (id. at col. 1, ll. 4-9). Borsodi then refers to dihydrocodeinone and oxycodone as “„mother compounds.‟” Specifically, Borsodi teaches: It has to be mentioned that amongst the referred “mother compounds” dihydrocodeinone and oxycodone cause respiratory depression in 50-2500 μg/kg and 10-2500 μ/kg s.c. doses. Both compounds unambiguously potentiate the respiratory depression effect of morphine. (Id. at col. 3, l. 66-col. 4, l. 3.) Thus, the ordinary artisan would understand that oxycodone is not useful for inhibiting respiratory depression caused by morphine, but in fact potentiates the respiratory depression effect of morphine. Therefore, contrary to the findings of the Examiner, Borsodi does not teach the use of oxycodone for inhibiting respiratory depression. As neither Johnson nor Longer make up that deficiency of Borsodi, we reverse Rejection III. Rejection IV The Examiner rejects claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39- 41 as being rendered obvious by Lalley, Johnson, and Longer (Ans. 7). The Examiner finds that Lalley teaches that a “pharmaceutical composition comprising oxycodone can inhibit respiratory depression (col. 2, lines 17-30) in mammals including humans, cats, and dogs (col. 7, lines 42-67)” (id.). The Examiner relies on Johnson and Longer as set forth above. Appeal 2011-005869 Application 10/367,386 7 Appellant argues: Lalley discloses two-component pharmaceutical compositions comprising an opiate or opioid and a D1-dopamine receptor agonist that is effective to inhibit the respiratory depression of the opiate or opioid; not that a “pharmaceutical composition comprising oxycodone can inhibit respiratory depression.” (App. Br. 12.) Appellant argues that Lalley in fact teaches that oxycodone causes respiratory depression (id. at 30 (citing Lalley, col. 2, ll. 17-30)). We again agree with Appellant that the combination of Lalley, Johnson, and Longer does not render the claimed method as it reads on the use of oxycodone for treating laryngeal paresis/paralysis obvious. Lalley is drawn to a “method of inducing opioid analgesia and anesthesia in mammals, including humans, without suppressing respiration” (Lalley, col. 1, ll. 1-12). Specifically, Lalley teaches [A] pharmaceutical composition for inducing analgesia or anasthesia in a mammalian subject, while simultaneously eliminating or inhibiting respiratory depression in the subject. The pharmaceutical composition comprises, in combination, an opiate or opioid analgesic or anesthetic, a D1-dopamine receptor agonist, and a pharmaceutically-suitable carrier therefor. More specifically, in the preferred composition, the opiate or opioid is selected from the group consisting of … oxycodone, …; and the D1-dopamine receptor agonist is selected from the group consisting of …. (Id. at col. 2, ll. 17-44 (emphasis added).) Thus, in the method of using the composition, Lalley teaches that the opiates or opioids induce respiratory depression, which is inhibited through the use of a D1-dopamine receptor agonist (id. at col. 2, ll. 45-55). Appeal 2011-005869 Application 10/367,386 8 Thus, the ordinary artisan would understand that oxycodone is not useful for inhibiting respiratory depression, but in fact induces respiratory depression when used to induce analgesia or anesthesia in a mammal. Therefore, contrary to the findings of the Examiner, Lalley does not teach the use of oxycodone for inhibiting respiratory depression. As neither Johnson nor Longer make up that deficiency of Lalley, we reverse Rejection IV. SUMMARY We affirm the provisional rejection of claims 1, 3, 13, 14, 23, 26, 27, 30-32, 34, and 39-41 under the judicially created doctrine of obviousness- type double patenting as being unpatentable over claims 1-5, 7-14, and 19 of USSN 11/395,200. We reverse the rejection of claim 38 under 35 U.S.C. § 112, first paragraph, as containing new matter; the rejection of claims 1-3, 13, 14, 17- 23, 26, 27, 30-34, and 39-41 under 35 U.S.C. § 103(a) as being rendered obvious by Borsodi, Johnson, and Longer; and the rejection of claims 1-3, 13, 14, 17-23, 26, 27, 30-34, and 39-41 under 35 U.S.C. § 103(a) as being rendered obvious by Lalley, Johnson, and Longer. 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-IN-PART Appeal 2011-005869 Application 10/367,386 9 cdc