Ex Parte HuntDownload PDFPatent Trial and Appeal BoardJan 16, 201813933723 (P.T.A.B. Jan. 16, 2018) 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. 13/933,723 07/02/2013 Terrence J. Hunt 17319CP3CNlDVlDVlCON(BOT) 9565 51957 7590 01/18/2018 ALLERGAN, INC. 2525 DUPONT DRIVE, T2-7H IRVINE, CA 92612-1599 EXAMINER MINNIFIELD, NITA M ART UNIT PAPER NUMBER 1645 NOTIFICATION DATE DELIVERY MODE 01/18/2018 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): patents_ip @ allergan. com pair_allergan @ firsttofile.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte TERRENCE J. HUNT1 (Applicant: Allergan, Inc.) Appeal 2017-004867 Application 13/933,723 Technology Center 1600 Before ERIC B. GRIMES, RICHARD J. SMITH, and DAVID COTTA, Administrative Patent Judges. SMITH, Administrative Patent Judge. DECISION ON APPEAL This is an appeal under 35 U.S.C. § 134 involving claims to a device or system related to a botulinum toxin. We have jurisdiction under 35 U.S.C. § 6(b). We affirm. 1 According to Appellant, the real party in interest is Allergan, Inc. (Br. 3.) Appeal 2017-004867 Application 13/933,723 STATEMENT OF THE CASE Claims on Appeal Claims 1—4 and 6—10 are on appeal.2 (Claims Appendix, Br. 16—17.) Claims 1 and 6 are illustrative and read as follows: 1. A device comprising at least two chambers, wherein a first chamber comprises an acidic solution of Botulinum toxin, and a second chamber comprises a buffering solution, wherein the buffering solution is present in an amount sufficient to raise the pH of the acidic botulinum toxin solution to at or near physiological pH after mixing. (Id. at 16.) 6. A system for preparing a pharmaceutical composition comprising: a first component comprising a botulinum toxin; and a second component comprising a reconstitution vehicle, wherein the reconstitution vehicles comprises at least one stabilizer and a buffering solution; wherein the second component is mixed with the first component prior to administration to a patient; and wherein the buffering solution in the reconstitution vehicle brings the pH of the pharmaceutical composition to at or near physiological pH after mixing. (Id. at 16-17.) Examiner’s Rejections 1. Claims 1—4 and 6—10 stand rejected under 35 U.S.C. § 101 as directed to non-statutory subject matter (i.e., a natural phenomenon). (Final Act. 2-6.) 2. Claims 6—9 stand provisionally rejected on the ground of nonstatutory double patenting over claims 6—8 of copending Application No. 14/215,482.3 (Id. at 17-18.) 2 Claim 5 is withdrawn from consideration as drawn to a nonelected invention. (Office Action dated Sept. 10, 2015 (“Final Act.”).) 3 This rejection is moot because Application No. 14/215,482 is abandoned. 2 Appeal 2017-004867 Application 13/933,723 FINDINGS OF FACT FF 1. The Examiner finds that Johnson et al. (US 5,512,547, issued April 30, 1996) (“Johnson”) “discloses pharmaceutical compositions comprising botulinum toxin and human serum albumin [], both components hav[e] their natural structure and therefore are natural products.” (Final Act. 4, citing Johnson cols. 1—2.) FF 2. The Examiner finds that Goodnough et al. (Stabilization of Botulinum Toxin Type A during Lyophilization, Applied and Environmental Microbiology 58 (10), 3426—28 (1992)) (“Goodnough”) teaches that “full recovery of type A botulinum toxin can be obtained after lyophilization, therefore indicating that the structure is the same as the natural product as well as function. . . . [t]he structure and function is not markedly different from what exists in nature.” (Final Act. 4, citing Goodnough Abstract and 3426.) FF 3. The Examiner finds that “[bjased on the state of the art, the instant product claim recites something that appears to be a natural product that is not markedly different in structure and function from naturally occurring products. There is no structural difference because each of the components of the claimed invention is not markedly different.” (Final Act. 4.) FF 4. The Examiner finds that the claimed two component system only recites natural products. These natural products have their same structure and their functions have not changed. Even when combined they still have the same structure and function; there is nothing recited in the claim, nor in the specification, that indicates that the botulinum toxin is markedly different. (Advisory Action dated Jan. 29, 2016, at 2.) 3 Appeal 2017-004867 Application 13/933,723 FF 5. The Specification states that a multiple (i.e. two or more) component system for the making of a final formulation can provide the benefit of allowing incorporation of ingredients which are not sufficiently compatible for long-term shelf storage with the first component of the two component system or which for other reasons it is not desirable to include with the first component of the pharmaceutical composition. (Spec. 69,11. 5-10.) FF 6. The Specification states that “‘[bjotulinum toxin’ means a neurotoxin produced by Clostridium botulinum, as well as a botulinum toxin (or the light chain or the heavy chain thereof) made recombinantly by a non-Clostridial species.” (Id. at 30,11. 26—28.) DISCUSSION Rejection No. 1 Issue Whether a preponderance of evidence of record supports the Examiner’s rejection of claims 1—4 and 6—10 under 35 U.S.C. § 101. Principles of Law On issues of patent eligibility, we “first determine whether the claims at issue are directed to a patent-ineligible concept,” such as laws of nature, natural phenomena, and abstract ideas. Alice Corp. Pty Ltd. v. CLS Bank Int'l, 134 S.Ct. 2347, 2355 (2014) (“Alice”). If this threshold is met, we move to the second step of the inquiry and “consider the elements of each claim both individually and ‘as an ordered combination’ to determine whether the additional elements ‘transform the nature of the claim’ into a 4 Appeal 2017-004867 Application 13/933,723 patent-eligible application.” Id. (quoting Mayo Collaborative Services v. Prometheus Laboratories, Inc., 132 S.Ct. 1289, 1297—98 (2012) (‘Mayo”)). Analysis We adopt the Examiner’s findings and conclusion that the claims are directed to non-statutory subject matter. (Final Act. 2—6; Adv. Act. 2; Ans. 3—8.) We discern no error in the rejection of claims 1—4 and 6—10 under Section 101. We limit our consideration to claims 1 and 6 because the claims were not argued separately. Claim Construction Claims under examination are given their broadest reasonable interpretation consistent with the specification, as interpreted by one of ordinary skill in the art. In re Am. Academy of Sci. Tech Center, 367 F.3d 1359, 1364 (Fed. Cir. 2004). Here, we agree with the Examiner that “device” claim 1 and “system” claim 6 “seem[] to be a box with [two] vials in it.” (Final Act. 3.) Moreover, according to the Examiner, “the components of the invention are specifically claimed as being separate (i.e. ‘two chambers’).” (Ans. 5.) This construction of separate components is consistent with the Specification’s description of a multi-component system. (FF 5.) Moreover, the “wherein” clauses at the end of claims 1 and 6 indicate that the components are separate, and that the purpose of the separate components is to be mixed. (Br. 16—17.) Accordingly, those “wherein” clauses do not change the scope of the claims from two separate components to a composition of the components, but merely state the context in which the 5 Appeal 2017-004867 Application 13/933,723 two separate components may be used. See Boehringer Ingelheim Vetmedica v. Schering-Plough Corp., 320 F.3d 1339, 1345 (Fed. Cir. 2003) (“An intended use or purpose usually will not limit the scope of the claim because such statements usually do no more than define a context in which the invention operates.”). Alice Inquiry — Step 1 The Examiner finds that claims 1 and 6 are “directed to a judicial exception (i.e., a law of nature, a natural phenomenon, or an abstract idea) without significantly more.” (Final Act. 2.) In particular, the Examiner finds that claims 1 and 6 “are directed to a natural phenomenon, device or system comprising botulinum neurotoxin and a buffering solution and stabilizer. . . . [claims 1 and 6] do not include additional elements that are sufficient to amount to significantly more than the judicial exception.” (Id.) Appellant contends that claims 1 and 6 quality as eligible subject matter, relying on the USPTO Interim Eligibility Guidance (December 2014) (“Interim Guidance”) and Nature-Based Product Examples (December 2014) (“Examples”).4 (Br. 10—14.) Appellant specifically points to a hypothetical claim to a fountain-style firework in which the claim is identified as patent eligible because [although the claim recites two nature-based products (calcium chloride and gunpowder), analysis of the claim as a whole indicates that the claim is focused on the assembly of components that together form the firework, and not the nature- based products. Thus, it is not necessary to apply the markedly 4 Links to both the Interim Guidance and Examples may be found at https://www.uspto.gov/patent/laws-and-regulations/examination- policy/subject-matter-eligibility. 6 Appeal 2017-004867 Application 13/933,723 different characteristics analysis in order to conclude that the claim is not directed to an exception. (Br. 11, citing Examples at 1 (claim 2).) Based on the foregoing, Appellant argues that although claims 1 and 6 recite nature-based products, analysis of the claims as a whole indicates that the claims are focused on the assembly of components that together form the claimed device or the claimed system and not the nature-based products. Thus, it is not necessary to apply the markedly different characteristics analysis in order to conclude that the claims are not directed to an exception. The claims therefore qualify as eligible subject matter. (Br. 11.) Appellant also argues that the Examiner’s position that the two nature- based products ‘“are specifically claimed as being separate’ appears to be irrelevant in this analysis; since, as set forth above, the markedly different characteristics analysis is not needed in this case.” (Br. 13—14.) We are not persuaded. The firework claim argued by Appellant also recites a cardboard body having different compartments for the calcium chloride and gunpowder, as well as other elements, such as a plastic ignition fuse extending out of the cardboard body. (Br. 11, Examples at 1.) Here, unlike the firework claim, claims 1 and 6 merely recite two natural components in separate vials or other chambers (e.g., in the form of a “kit”) that are “intended to be combined when used.” (Ans. 4—5.) As the Examiner explains, “these two chambers are not connected and therefore they are not comparable to the Gunpowder and Fireworks Example.” {Id. at 5.) Moreover, we agree with the Examiner that “the markedly different characteristics analysis should be applied,” and we also agree that claims 1 7 Appeal 2017-004867 Application 13/933,723 and 6 “do not recite any markedly different characteristics or properties” from the individual nature-based components. {Id. at 5—6; FF 3, 4.) Alice Inquiry — Step 2 Appellant does not specifically argue the second step of the Alice framework.5 However, Appellant does contest the Examiner’s reliance on Johnson, Goodnough, and Fleer6 * 8as showing that the claimed device is “well-understood, routine and conventional in the field.” (Br. 12, citing Final Act. 3—4.) According to Appellant, reliance on prior art for such purpose “seems inconsistent with the guidelines provided by the Eligibility Guidance and the Analysis Examples.” (Br. 12.) We discern no error in the Examiner’s reliance on the cited art. A “well-understood, routine, and conventional” analysis, as in the present case, may establish that the claim limitations, as a whole, do not add significantly more so as to transform a judicial exception (i.e. natural phenomena) into a patent-eligible invention under the second step of the Alice framework. See Mayo, 132 S.Ct. at 1294. Moreover, we agree with the Examiner’s analysis that claims 1 and 6 as a whole do not amount to “significantly more than the judicial exception.” (Final Act. 6; Ans. 6.) Thus, for example, even if the Appellant’s separate components are part of a kit, that would be insufficient to provide the inventive concept necessary to render the claims patent eligible, or otherwise transform the nature of the claims into a patent-eligible application. See Mayo, 132 S.Ct. at 1297; see also Genetic Technologies Ltd. 5 The firework example argued by Appellant states that the hypothetical claim “qualifies as eligible subject matter” {Alice Step 1). {See Examples at 1.) Furthermore, Appellant concludes the Brief by stating that “claims 1 and 6 quality as eligible subject matter.” (Br. 14.) 6 Fleer et al., EPO 0361991 A2, pub. April 4, 1990 (“Fleer”). 8 Appeal 2017-004867 Application 13/933,723 v. Merial L.L.C., 818 F.3d 1369, 1375—77 (Fed. Cir. 2016). Accordingly, for the reasons of record and as set forth above, we affirm the rejection of claims 1 and 6 under 35 U.S.C. § 101. Conclusion A preponderance of evidence of record supports the Examiner’s rejection of claims 1 and 6 under 35 U.S.C. § 101. Claims 2-4 and 7—10 were not argued separately and fall with claims 1 and 6. SUMMARY We affirm the rejection of claims 1^4 and 6—10 under 35 U.S.C. §101. 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 9 Copy with citationCopy as parenthetical citation