13801268 (P.T.A.B. Oct. 19, 2018)

Ex Parte Mautino et al

Patent Trial and Appeal BoardOct 19, 2018

13801268 (P.T.A.B. Oct. 19, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/801,268 03/13/2013 Mario Mautino 20306 7590 10/19/2018 MCDONNELL BOEHNEN HULBERT & BERGHOFF LLP 300 S. WACKER DRIVE 32NDFLOOR CHICAGO, IL 60606 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 ATTORNEY DOCKET NO. CONFIRMATION NO. 07-793-US-DIV 6490 EXAMINER DECK, JASON A ART UNIT PAPER NUMBER 1627 MAIL DATE DELIVERY MODE 10/19/2018 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 MARIO MAUTINO, FIROZ JAIPUR!, AGNIESZKA MARCINOWICZ-FLICK, TANAY KESHARWANI, and JESSE WALDO Appeal2017-001358 Application 13/801,268 Technology Center 1600 Before MICHAEL J. FITZPATRICK, ULRIKE W. JENKS, and TIMOTHY G. MAJORS, Administrative Patent Judges. MAJORS, Administrative Patent Judge. DECISION ON APPEAL Appellants 1 submit this appeal under 35 U.S.C. Â§ 134 involving claims to a pharmaceutical composition. The Examiner rejected the claims as obvious. We have jurisdiction under 35 U.S.C. Â§ 6(b ). We AFFIRM. 1 Appellants identify the Real Party in Interest as NewLink Genetics Corporation. App. Br. 2. Appeal2017-001358 Application 13/801,268 STATEMENT OF THE CASE Appellants' "disclosure relates to compounds and methods for inhibition of indoleamine 2,3-dioxygenase" and to "treatment of diseases and disorders mediated by indoleamine 2,3-dioxygenase." Spec. ,r 2. Claims 1, 12, and 20 are on appeal. Claim 20 is illustrative and is reproduced below: 20. A pharmaceutical composition comprising a pharmaceutically acceptable excipient, diluent, or carrier and a compound selected from 0-( ( 5-chlorobenzo[b ]thiophen-3-yl)methyl)hydroxylamine, O-(benzo[d]thiazol-2-ylmethyl)hydroxylamine, O-(benzofuran-2-ylmethyl)hydroxylamine, and a pharmaceutically acceptable salt thereof App. Br. 8 (Claims App'x) In response to an election/restriction requirement, Appellants elected: 0-(benzo[ d]thiazol-2-ylmethyl)hydroxylamine ( or its salts) Response to Election/Restriction dated December 5, 2018, 2. We limit our analysis of the claims to the patentability of the elected species. See Ex parte Ohsaka, 2 USPQ2d 1460, 1461 (BPAI 1987). 2 Appeal2017-001358 Application 13/801,268 The claims stand rejected under 35 U.S.C. Â§ 103(a) as obvious over GB '203 2 and Levine. 3 DISCUSSION The issue on appeal is whether a preponderance of the evidence supports the Examiner's conclusion that claims 1, 12, and 20 would have been obvious over the combination of GB '203 and Levine. Appellants do not argue the appealed claims separately. App. Br. 2-5; Reply Br. 2-3. Accordingly, we treat independent claim 20 as representative. 37 C.F.R. Â§ 4I.37(c)(l)(iv). Claim 20 recites a pharmaceutical composition that comprises two ingredients: 0-(benzo[ d]thiazol-2-ylmethyl)hydroxylamine ( or its salt), which is the elected compound, as well as a pharmaceutically acceptable excipient, diluent, or carrier, such as a starch, gelatin, an aqueous or oil suspension, or many other acceptable excipients, etc. 4 The Examiner finds that GB '203 "discloses the compound 2- aminoxymethyl-benzthiazole hydrochloride, (also known as 0- (benzo [ d]thiazol-2-ylmethyl)hydroxylamine hydrochloride; see particularly Example 37, pg. 8)." Ans. 3. According to the Examiner, GB '203 suggests 2 Intezet, GB 1331203, published Sept. 26, 1973 ("GB '203"). 3 Robert J. Levine, Histamine Synthesis in Man: Inhibition by 4-Bromo-3- Hydroxybenzyloxyamine, 154 SCIENCE 1017-19 (1966) ("Levine"). 4 Unlike claim 1, claim 20 does not expressly list the excipients, diluents, or carriers. Thus, the potential excipients, etc. encompassed by claim 20 are broader than those listed in claim 1 and may include, for example, ether. See, e.g., Non-Final Action dated January 8, 2015, 4 (finding that GB '203 discloses the elected compound in an ether suspension). 3 Appeal2017-001358 Application 13/801,268 that the disclosed compounds "have increasing pharmaceutical importance" and that, on this point, the '203 patent cites to and incorporates Levine's teachings. Id. (citing GB '203, 2: 109-114). Because the Examiner finds that "[t]he '203 document does not specific[]ally disclose a composition further comprising gelatin," the Examiner turns to Levine. The Examiner finds that Levine teaches administration of an active methoxyamine (NSD-1055) in a gelatin capsule. Ans. 3; see Levine, 1018. 5 The Examiner concludes it would have been obvious to make a composition comprising the compound of GB '203 's Example 37 (the elected compound) and gelatin. Ans. 4. The Examiner reasons the skilled artisan would have been motivated to make this composition because GB '203 discloses 2-aminoxymethyl-benzthiazole hydrochloride and suggests it is a useful compound with pharmaceutical importance, and Levine teaches that the class of aryl hydroxylamines can be beneficially administered to patients in the form of a gelatin capsule. Id. In combining the teachings of GB '203 and Levine in this way, the Examiner further reasons the skilled artisan would have a reasonable expectation of success in making an improved aryl methoxyamine composition. Id.; see also id. at 7 ("The skilled artisan would have looked to teachings related to compounds of the same type, i.e. biologically active methoxyamines [as in Levine], when making compositions of the compounds disclosed by the '203 patent, 5 The Examiner cites page 1016 of Levine; the described teachings in Levine, however, appear on page 1018. Ans. 3. 4 Appeal2017-001358 Application 13/801,268 and would have utilized information provided by Levine, e.g. the use of gelatin."). Appellants raise multiple arguments. Appellants argue there is "no reason why the ordinary artisan would have selected the particular compound of the '203 patent that the examiner relies on." App. Br. 3. Appellants contend there is "no basis in the cited art from which the ordinary artisan could have predicted that the compound would have therapeutic activity" and, thus, "no reason the ordinary artisan would have combined that compound with a pharmaceutically acceptable excipient, diluent, or carrier." Id. And, Appellants contend, there is "no basis in the cited art from which the ordinary artisan could have reasonably predicted that the resultant composition would have therapeutic utility." Id. The preponderance of the evidence on this record supports the Examiner's conclusion that claim 20 would have been obvious over GB '203 and Levine. We discuss further below. Claim 20 is directed to a composition requiring only two ingredients: the elected compound and an unspecified pharmaceutically acceptable excipient, diluent, or carrier. Catalina Mktg. Int 'l, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed. Cir. 2002) ("[T]he patentability of apparatus or composition claims depends on the claimed structure, not on the use or purpose of that structure."). Claim 20 is not directed to method of using that composition, such as for treating a specific disease or condition. Neither does claim 20 require any particular dosage amount of the elected compound nor does it recite any particular therapeutic efficacy. 5 Appeal2017-001358 Application 13/801,268 The elected compound was known in the prior art as evidenced by GB '203, which exemplifies how it is made. GB '203, 8:30-37 (Example 37); see also id. at 8:93-96 (claiming a "process according to claim 1 ... with reference to any one of the foregoing Examples"). And Levine discloses the formulation of related compounds (substituted aryl methoxyamines) with well-known pharmaceutical excipients, etc., such as gelatin, for more specific therapeutic uses. Levine, 1018. GB '203 further discloses: "The present invention aims at ensuring a new process for the preparation of various types of substituted methoxyamines having increasing pharmaceutical importance," citing Levine in support. GB '203 2: 109-114 ( emphasis added). GB '203 's Example 37 is a substituted methoxyamine and, on this record, we are persuaded the skilled artisan would interpret GB '203 as suggesting that the compound of Example 37 is, at minimum, potentially pharmaceutically important and useful. This provides a sufficient reason on this record to have made a composition that includes the elected compound and a well-known pharmaceutical excipient (e.g., gelatin) - even if that reason were solely to engage in further testing of therapeutic uses for the composition. Even if no specific biological data or activity is disclosed for the elected compound in the cited art, as Appellants contend, that does not demonstrate error in the rejection. App. Br. 4; Reply Br. 2-3. Claim 20 also recites no specific biological or "therapeutic" activity for the composition. Appellants' arguments that a person of ordinary skill in the art would not have predicted or expected a therapeutic benefit are not commensurate in scope with what the claims require, and the skilled person need not have 6 Appeal2017-001358 Application 13/801,268 predicted, a priori, a specific therapeutic activity or efficacy that is unclaimed. In re Self, 671 F.2d 1344, 1348 (CCPA 1982) ("[A]ppellant's arguments fail from the outset because ... they are not based on limitations appearing in the claims."); Intelligent Bio-Systems Inc. v. Illumina Cambridge Ltd., 821 F.3d 1359, 1367 (Fed. Cir. 2016) (holding "[t]he reasonable expectation of success requirement refers to the likelihood of success in combining references to meet the limitations of the claimed invention.") (emphasis added). The evidence on this record does not support the position that the skilled person would have lacked a reasonable expectation of success in making the composition with the ingredients claimed. And, as noted, a sufficient reason exists on this record for the skilled person to have made the composition as broadly as it is recited in claim 20. For the above reasons, we conclude that the preponderance of the evidence supports the Examiner's conclusion that claim 20 would have been obvious over GB '203 and Levine. Claims 1 and 12 have not been argued separately and, thus, fall for the same reasons. 37 C.F.R. Â§ 4I.37(c)(l)(iv). SUMMARY We affirm the rejections for obviousness on appeal. 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. Â§ 1.136(a). AFFIRMED 7