Cristianne Johanna Ferdinand. Rijcken et al.Download PDFPatent Trials and Appeals BoardOct 9, 201914129529 - (D) (P.T.A.B. Oct. 9, 2019) 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. 14/129,529 02/12/2014 Cristianne Johanna Ferdinand Rijcken 31363-20168.00 4872 25225 7590 10/09/2019 MORRISON & FOERSTER LLP 12531 HIGH BLUFF DRIVE SUITE 100 SAN DIEGO, CA 92130-2040 EXAMINER VU, JAKE MINH ART UNIT PAPER NUMBER 1618 NOTIFICATION DATE DELIVERY MODE 10/09/2019 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): EOfficeSD@mofo.com PatentDocket@mofo.com pair_mofo@firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________ Ex parte CRISTIANNE JOHANNA FERDINAND RIJCKEN, MARTIN STIGTER, and JOSEPHUS JOHANNES MARIA HOLTHUIS ____________ Appeal 2018-007684 Application 14/129,5291 Technology Center 1600 ____________ Before FRANCISCO C. PRATS, TAWEN CHANG, and DAVID COTTA, Administrative Patent Judges. COTTA, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a method for providing the bloodstream of a vertebrate subject with an intact nanoparticulate control release system comprising at least one active ingredient for systemic treatment of a disease. The Examiner rejected the claims on appeal as obvious under 35 U.S.C. § 103(a). We reverse. 1 We use the word “Appellant” to refer to “applicant” as defined in 37 C.F.R. § 1.42. According to Appellant, the real party in interest is Cristal Delivery B.V. App. Br. 1. Appeal 2018-007684 Application 14/129,529 2 STATEMENT OF THE CASE The Specification discloses that “[n]anoparticulate carriers and controlled release systems are often administered intravenously, however it would be desirable to have other administration routes available.” Spec. 1. The Specification teaches that “[u]pon subcutaneous administration, nanocarriers do not have direct access to bloodstream. They either enter lymphatic capillaries draining the injection site or remain at the site of injection.” Id. at 2. “For those particles remaining at the injection site, destabilization and degradation take place with time, thereby possibly releasing the therapeutic agents” which “may have toxic effect and may harm the injection site, causing inflammation and discomfort to the patient.” Id. According to the Specification, “[t]here is thus a need for [a] control release system such as nanoparticles and micelles that may [be] administered other than intravenously.” Id. at 3. The Specification discloses that “the present invention is directed to use of [a] control release system to administer an active ingredient to an organism, wherein the administration is not intravenous.” Id. at 4. The Specification discloses that controlled release by non-intravenous administration is accomplished by “a control release system wherein active ingredients such as drug molecules are first non-covalently entrapped in polymer phases, and especially in polymer-rich phases, in an aqueous environment, and subsequently are conjugated to a 3D-polymer network.” Id. at 5. The Specification states that “[s]urprisingly it has been found that [this] control release system . . . has good properties when administered in routes other than intravenously.” Id. at 4. Appeal 2018-007684 Application 14/129,529 3 Claims 1, 10–20, 22, 23, and 27–33 are on appeal. Claim 1 is representative and reads as follows: 1. Method to provide the bloodstream of a vertebrate subject with an intact nanoparticulate control release system comprising at least one active ingredient for systemic treatment of a disease which method comprises administering the nanoparticulate control release system via a subcutaneous or intraperitoneal route, and wherein the control release system is obtained by (i) mixing active ingredient comprising a first reactive moiety with an aqueous solution or dispersion comprising polymer chains, said polymer chains comprising at least one second reactive moiety capable of reacting with said first reactive moiety of said at least one active ingredient, the polymer chains further being capable of cross-linking intra- or intermolecularly; and (ii) subjecting this mixture to cross-linking forming a 3D-matrix under such conditions that simultaneously with the formation of the 3D- matrix, said at least one active ingredient is entrapped, wherein the polymer chains comprise polymers of hydrophobically modified esters of N-hydroxyalkyl- (meth)acrylamide and N-(meth)acryloyl amino acids; and wherein said at least one active ingredient is covalently coupled to the 3D matrix. App. Br. 7. Appeal 2018-007684 Application 14/129,529 4 The claims were rejected as follows: Claims 1, 10–18, 22, 23, and 27–33 were rejected under 35 U.S.C. § 103(a) as being obvious over the combination of Rijcken 1,2 and Palliative Care Tips.3 Claims 1, 10–20, 22, 23, and 27–33 were rejected under 35 U.S.C. § 103(a) as being obvious over the combination of Rijcken 1, Palliative Care Tips, Rijcken 2,4 and Lavasanifar.5 ANALYSIS The same issue is dispositive with respect to both rejections. Accordingly, we address both rejections together. Rijcken 1 discloses a method in which “active ingredients such as drug molecules are first noncovalently entrapped in polymer phases and especially in polymer-rich phases, in an aqueous environment, and subsequently are conjugated to a 3D-polymer network.” Rijcken 1, 4. In finding the pending claims obvious over the cited art, the Examiner found that Rijcken 1 disclosed most of the elements of claim 1. The Examiner acknowledged, however, that Rijcken 1 did not disclose “administering the 2 Rijcken et al., WO 2010/033022 A1, published Mar. 25, 2010 (“Rijcken 1”). 3 Royal Alexandria Hospital, Palliative Care Tips, Issue 14: Subcutaneous Administration of Opioids and Anti-Emetics (May 2006) (“Palliative Care Tips”). 4 Rijcken et al., WO 2012/039602, published Mar. 29, 2012 (“Rijcken 2”). 5 Lavasanifar et al., US Patent Publication No. 2010/0137206 A1, published June 3, 2010 (“Lavasanifar”). Appeal 2018-007684 Application 14/129,529 5 nanoparticulate control release system via a subcutaneous or intraperitoneal route,” as required by all of the pending claims. Final Act.6 5. The Examiner concluded that it would have been obvious to administer the composition disclosed in Rijcken subcutaneously because “the prior art had routinely administered dexamethasone and chemo drugs via subcutaneous injection.” Id. As evidence, the Examiner relies upon Palliative Care Tips as teaching “that subcutaneous route is preferred whenever possible, wherein dexamethasone are commonly given by the subcutaneous route.” Id. The Examiner also asserted that subcutaneous administration was obvious because “RIJCKEN1 teaches injecting nanoparticles into the blood stream or direct injection into the tumor or organ (see RIJCKEN1 at pg. 14, line 5-10), wherein skin (cutaneous) and other tissues (subcutaneous) are considered to be an organ.” Ans. 8. Appellant “do[es] not disagree with the assertion that the structural features of the nanoparticulate control release system are disclosed in the art”; Appellant argues, however, that it is “unable to discern how the disclosure of Palliative Care Tips would lead one skilled in the art to administer these structures subcutaneously.” Reply Br. 2. As stated in In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir. 1992): “[T]he examiner bears the initial burden . . . of presenting a prima facie case of unpatentability.” Appellant has persuaded us that the Examiner has not carried the burden of establishing that the claimed invention would have been obvious over the cited art. Palliative Care Tips discloses that “60%-70% of palliative patients will become unable to take oral medications during the course of their 6 Office Action mailed September 27, 2017 (“Final Act.”). Appeal 2018-007684 Application 14/129,529 6 illness, and will require medications through either the rectal or the parenteral route (intravenous, subcutaneous or intramuscular).” Palliative Care Tips, 1. It then discusses intravenous, intramuscular, and subcutaneous administration, concluding that “the subcutaneous route is preferred whenever possible.” Id. As Appellant points out, however, all of the drugs listed in Palliative Care Tips are small molecule drugs. Reply Br. 2. Accordingly, we agree with Appellant that this teaching does not provide a reasonable expectation that subcutaneous administration would have been successful with respect to the claimed nanoparticulate control release system, particularly given the knowledge in the art that nanocarriers injected subcutaneously either degrade or are taken up by the lymphatic system. Spec. 2. We also disagree with the Examiner that Rijcken 1 teaches subcutaneous injection. Rijcken 1 discloses “controlled release of (drug) molecules entrapped in the cross-linked micelles upon administration in vivo. e.g. by oral application, injection in the blood stream, or by direct injection in an organ or tumour.” Rijcken 1, 14. The Examiner asserts that this disclosure teaches subcutaneous administration because “skin (cutaneous) and other tissues (subcutaneous) are considered to be an organ.” Ans. 8. We are not persuaded because we do not consider subcutaneous injection to be injection into an organ. To the contrary, subcutaneous administration requires administration under the skin. Spec. 22. Subcutaneous administration is distinct from intradermal (administration into the skin) and intramuscular (into a muscle) administration. Id. While the skin and muscles are organs, we do not identify in the Specification or in Appeal 2018-007684 Application 14/129,529 7 the art of record sufficient support for the Examiner’s position that a composition administered subcutaneously is injected into an organ. Accordingly, we reverse the Examiner’s rejections of claims 1, 10–20, 22, 23, and 27–33. SUMMARY In summary: Claims Rejected Basis Affirmed Reversed 1, 10–18, 22, 23, and 27–33 § 103(a), Rijcken 1, and Palliative Care Tips. 1, 10–18, 22, 23, and 27–33 1, 10–20, 22, 23, and 27–33 § 103(a), Rijcken 1, Palliative Care Tips, Rijcken 2, and Lavasanifar 1, 10–20, 22, 23, and 27–33 Overall Outcome 1, 10–20, 22, 23, and 27–33 REVERSED Copy with citationCopy as parenthetical citation