Ex Parte Montenegro et alDownload PDFPatent Trials and Appeals BoardMay 2, 201913392673 - (D) (P.T.A.B. May. 2, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE 13/392,673 05/07/2012 15204 7590 05/02/2019 Harris Beach/Syracuse 333 West Washington Street Suite 200 Syracuse, NY 13202 FIRST NAMED INVENTOR Rivelino Montenegro 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. 3021_002US 1279 EXAMINER LAU, JONATHAN S ART UNIT PAPER NUMBER 1623 MAIL DATE DELIVERY MODE 05/02/2019 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 RIVELINO MONTENEGRO, THOMAS FREIER, and KARSTEN HENC01 Appeal 2018-003710 Application 13/392,673 Technology Center 1600 Before JOHN G. NEW, ELIZABETH A. LA VIER, and RYAN H. FLAX, Administrative Patent Judges. NEW, Administrative Patent Judge. DECISION ON APPEAL 1 Appellants identify MEDOVENT GMBH, as the real party-in-interest. App. Br. 3. Appeal 2018-003710 Application 13/392,673 SUMMARY Appellants file this appeal under 35 U.S.C. § 134(a) from the Examiner's Final Rejection of claim 39 as unpatentable under 35 U.S.C. § 102(a) or (e) as being anticipated by Beaulieu et al. (US 2009/0117213 Al, 7 May 2009) ("Beaulieu"). Claims 1-9, 16-18, 38, and 40 have been cancelled. Claims 10-15 and 19-37 have been withdrawn. We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. NATURE OF THE CLAIMED INVENTION Appellants' invention is directed to a pharmaceutical composition comprising a chitosan for use in an antimicrobial treatment of a patient's tissue. Abstract. REPRESENTATIVE CLAIM Claim 39 is representative of the claims on appeal and recites: 39. A method for treating a microbial infection, reducing the risk of a microbial infection, reducing the microbial load of an existing microbial infection, or reducing the spread of a microbial infection, wherein the microbial infection is selected from the group consisting of methicillin-resistant Staphylococcus aureus (MRSA) infection, oxacillin-resistant Staphylococcus aureus (ORSA) infection, multidrug-resistant Clostridium difficile infection, penicillin-resistant Streptococcus pneumonia infection, multidrug-resistant Pseudomonas aeruginosa infection, multidrug-resistant Acinetobacter baumannii infection, vancomycin-resistant Enterococcus infection, and combinations thereof, the method comprising: 2 Appeal 2018-003710 Application 13/392,673 administering to a patient an effective amount of a native chitosan, wherein the native chitosan has a degree of acetylation of less than 2.5%. App. Br. 14. ISSUES AND ANALYSES We adopt the Examiner's findings, reasoning, and conclusion that the claims are anticipated by the prior art. We address the arguments raised by Appellants below. Issue 1 Appellants argue that the Examiner erred because the cited prior art does not disclose that chitosan, with a degree of acetylation of 2.5% or less, has activity against multiply resistant hospital germs. App. Br. 8. Analysis Appellants argue that paragraph [0079] of Beaulieu, upon which the Examiner relies, discloses only that chitosan has generally antibacterial effects, and "increases the anti-viral, antibacterial and hemostatic effects of the material." App. Br. 8, 9. Appellants assert that this cannot be understood to imply an activity specifically against the germs recited in claim 39, because "antibacterial" merely means that a substance is active against some strain of bacteria, but not necessarily one of those recited in claim 39. Id. at 9. Appellants argue further that in paragraph [0079] of Beaulieu there is no disclosure that this antibacterial activity stems from the mixture's chitosan content. Appellants contend that, whenever Beaulieu discloses 3 Appeal 2018-003710 Application 13/392,673 antibacterial activity, including, at some instances an activity against methicillin-resistant Staphylococcus aureus (MRSA, the only multiply resistant hospital germ mentioned in Beaulieu), it refers only to a mixture of an alcohol and chitosan. App. Br. 9. Finally, Appellants argue that Beaulieu' s disclosure of "highly deacetylated" and a degree of deacetylation of "greater or equal to 95%" do not constitute disclosure of a degree of acetylation (DA) of less than 2.5%, as claimed. App. Br. 10. We find none of these arguments persuasive. We begin by considering whether the preamble of claim 39 is limiting. Appellants' claim 39 recites, in relevant part: A method for treating a microbial infection, [etc.] ... wherein the microbial infection is selected from the group consisting of [ various bacterial species], the method comprising: .... " As such, this language of the claim is its preamble because it does not directly recite the steps or processes of the claimed method. "[A] claim preamble has the import that the claim as a whole suggests for it." Bell Commc 'ns Research, Inc. v. Vitalink Commc 'ns Corp., 55 F .3d 615, 620 (Fed. Cir. 1995). In instances where a patentee uses the claim preamble to recite structural limitations of the claimed invention, the PTO and courts give effect to that usage. Rowe v. Dror, 112 F.3d 473, 478 (Fed. Cir. 1997) (citing Corning Glass Works v. Sumitomo Elec. U.S.A., Inc., 868 F.2d 1251, 1257 (Fed. Cir. 1989)). Conversely, where a patentee defines a structurally complete invention in the claim body and uses the preamble only to state a purpose or intended use for the invention, the preamble is not a claim limitation. Id. ( citing Bell Commc 'ns, 55 F .3d at 620; Kropa v. Robie, 187 F.2d 150 (1951)). 4 Appeal 2018-003710 Application 13/392,673 In claim 39, the preambular language recites the various drug-resistant bacterial species to be treated by Appellants' method of: "administering to a patient an effective amount of a native chitosan, wherein the native chitosan has a degree of acetylation of less than 2.5%," and is recited only an intended purpose of Appellants' method, i.e., the treatment of bacterial infection. The body of Appellants' claim, recited in its entirety in the previous sentence is a structurally complete claim: it requires the administration an effective amount of chitosan in which less than 2.5% of the chitosan is acetylated. The preambular language, in contrast, speaks only to the intended purpose of this method. A preamble may also limit an invention when it is employed to distinguish a new use of a prior art apparatus or process. Bristol-Myers Squibb Co. v. Ben Venue Labs., Inc., 246 F.3d 1368, 1375 (Fed. Cir. 2001). Beaulieu expressly discloses: Chitosan materials used in the solutions preferably have relatively low molecular weights and relatively high levels of deacetylation, which, when combined with alcohol, provides an antiviral, antibacterial and hemostatic solution that has an extended efficient shelf life that has multiple and various uses, such uses against infection on humans and on inanimate objects, hemostatic treatment of cuts, abrasion, and the likes on skin, inhibition of biofilm accumulation and killing of bacteria in pre- accumulated biofilms, such as biofilms that may occur in water treatment systems, and other various uses. Beaulieu ,i 69. Beaulieu thus discloses that chitosan-alcohol solutions can be used, inter alia, in the treatment of bacterial infections in human. We therefore find that Appellants' claim is not directed to a new use of a process, but only recites the use of its method against a subset of bacterial species. 5 Appeal 2018-003710 Application 13/392,673 We consequently conclude that because: (1) the preambular language recites only the intended purpose of the claimed method; and (2) the claimed method is not directed to a new or different use than that disclosed by Beaulieu, the preambular language is not limiting upon claim 39. Moreover, even were we to conclude, arguendo, that the language of the preamble limits the scope of claim 39, we would still not find Appellants' arguments persuasive. Paragraph [O 101] of Beaulieu teaches: "Application by swabbing, dabbing or spraying can be used to treat infections such as Staphylococcus vulgaris (acne), methicillin resistant Staphylococcus aureus (MRSA), Acinetobacter baumannii and other bacterial infections." Beaulieu thus expressly teaches that its chitosan-based solutions can be used in the treatment of MRSA, which is one of the species named in claim 39' s preamble. Beaulieu also, in that passage, similarly discloses generally the treatment of Acinetobacter baumannii, which includes multi-drug resistant strains of that species of bacteria. Furthermore, paragraph [0069] of Beaulieu, quoted supra, discloses that chitosan-alcohol solutions have antibacterial activity. The species recited in the preamble of claim 39 are all, undeniably, bacteria. Consequently, Beaulieu's disclosure of the antibacterial activity of chitosan- alcohols solutions ( e.g., against MRSA) anticipates the activity of Appellants' claimed method against the bacterial species recited in the preamble to claim 39. Furthermore, Appellants contend that there is no disclosure of Beaulieu that the antibacterial activity stems from the mixture's chitosan content. See App. Br. 9. We find that this argument is not persuasive for two related reasons. First, there is no requirement in the claim that chitosan 6 Appeal 2018-003710 Application 13/392,673 has specific antibacterial activity; the claims require merely treating a patient with chitosan. Second, claim 39 recites: "the method comprising." Use of the transition "comprising" in the language of a claim creates a presumption that the claim does not exclude additional, unrecited elements. Crystal Semiconductor Corp. v. TriTech Microelectronics Int'!, Inc., 246 F.3d 1336, 1348 (Fed. Cir. 2001). Therefore, the language of claim 39 does not preclude the inclusion of other compounds, including the alcohol of Beaulieu, or other antibacterial agents. Finally, Appellants argue that Beaulieu' s disclosure of a degree of deacetylation of greater or equal to 95% does not constitute disclosure of a degree of acetylation (DA) of less than 2.5%. App. Br. 10. We disagree. Beaulieu discloses that: "The chitosan material 18 also has a high degree of deacetylation, preferably greater than or equal to 75% deacetylated, more preferably greater than or equal to 85% deacetylated, and most preferably greater than or equal to 95% deacetylated." (Emphasis added). Beaulieu thus teaches that, in its most preferred embodiment, the chitosan is (by simple subtraction) equal to or less than 5% acetylated (i.e., 0%-5% acetylated). The latter concentrations include within their scope the claimed concentrations of less than 2.5%. Moreover, this is supported by Beaulieu's disclosure of an embodiment with 99% deacetylated (1 % acetylated) chitosan. See Beaulieu ,-J 178. We therefore find that Beaulieu discloses this limitation of claim 39. 7 Appeal 2018-003710 Application 13/392,673 Issue 2 Appellants argue that the Examiner erred because Beaulieu discloses activity of a mixture of alcohol and chitosan against MRSA that is outside the range recited in claim 39. App. Br. 10. Analysis Appellants argue that Beaulieu discloses activity of a mixture of alcohol and chitosan against methicillin-resistant Staph. aureus that is outside of the range recited in claim 39. App. Br. 10. Appellants argue that the exemplary embodiments employing the solutions of Table 1 of Beaulieu have a degree of deacetylation of 95%, which corresponds to a degree of acetylation (DA) of 5%, which is outside the less than 2.5% range recited in claim 39. Id. at 10-11 (citing Beaulieu ,-J,-J 101-135). We agree with Appellants that the exemplary embodiments of Beaulieu teach chitosan with 95% deacetylation. However, Beaulieu also teaches the use of chitosan having: "a high degree of deacetylation ... most preferably greater than or equal to 95% deacetylated" and "99% deascetylated chitosan." As we have explained supra, this includes the claimed degree of acetylation (DA) of less than 2.5%. Consequently, we do not find this argument persuasive. Appellants also argue that the exemplary embodiment of Beaulieu disclosing a 1 % degree of acetylation is irrelevant to Appellants' claims, because that particular embodiment relates to blood coagulation experiments and not to antibacterial activity. App. Br. 11-12. However, for the same reasons we have explained supra, we find this argument no more persuasive than Appellants' other arguments with respect to the exemplary 8 Appeal 2018-003710 Application 13/392,673 embodiments of Beaulieu. We consequently affirm the Examiner's rejection of claim 3 9. DECISION The Examiner's rejection of claim 39 under 35 U.S.C. § 102(a) or (e) is affirmed. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § l .136(a)(l )(iv). AFFIRMED 9 Copy with citationCopy as parenthetical citation