Ex Parte AL-MULLA et alDownload PDFPatent Trial and Appeal BoardFeb 1, 201913339347 (P.T.A.B. Feb. 1, 2019) Copy Citation UNITED STA TES p A TENT AND TRADEMARK OFFICE APPLICATION NO. FILING DATE FIRST NAMED INVENTOR 13/339,347 12/28/2011 FAHD AL-MULLA 37833 7590 02/05/2019 Richard C. Litman 112 S. West Street Alexandria, VA 22314 UNITED ST A TES OF AMERICA 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. 23588.46 3442 EXAMINER BROWE, DAVID ART UNIT PAPER NUMBER 1617 NOTIFICATION DATE DELIVERY MODE 02/05/2019 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): uspto@4patent.com uspto@nathlaw.com mbashah@nathlaw.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE BEFORE THE PATENT TRIAL AND APPEAL BOARD Ex parte FAHD AL-MULLA and MILAD BIT AR Appeal2017-004369 Application 13/339,347 Technology Center 1600 Before DEBORAH KATZ, RICHARD J. SMITH, and JOHN E. SCHNEIDER, Administrative Patent Judges. KATZ, Administrative Patent Judge. DECISION ON APPEAL Appeal2017-004369 Application 13/339,347 Appellants 1 seek our review, under 35 U.S.C. § 134(a), of the Examiner's decision to reject claim 1, the only claim pending in the application. (App. Br. 1.) We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM. Appellants claim a method of healing wounds in diabetic patients by administering a medicament with 8% lithium. Appellants' claim 1 recites: A method of topically treating impaired wound healing in a diabetic patient, comprising administering to said patient a medicament having an 8% lithium by weight to volume concentration. (App. Br., Claims App'x.) The Examiner rejected claim 1 as being obvious under 35 U.S.C. § 103(a) over Horrobin,2 and Rosenberg3. (Ans. 3-5.) Findings of Fact 1. Horrobin teaches medicaments containing lithium. (See Horrobin, Abstract.) 2. Horrobin teaches that lithium-containing medicaments can be used to treat a variety of conditions, including diabetes. (See Horrobin 4:26- 37.) 1 Appellants do not identify a real party-in-interest in the Appeal Brief, but the application is assigned to Kuwait University. 2 Horrobin, US 5,422,115, issued June 6, 1995. 3 Rosenberg, "Wound healing in the patient with diabetes mellitus," NURS. CLIN. NORTH AM., 25:247-61 (1990). 2 Appeal2017-004369 Application 13/339,347 3. Horrobin claims a method of treating a human or animal condition "wherein the condition is diabetes or a complication associated therewith." (See Horrobin 18:43--45.) 4. Horrobin provides Example 13 with compositions for skin care that include 5% lithium gamma-linolenate and 3% lithium eicosapentaenoate, resulting in 8% lithium. (See Horrobin 13:38--45.) 5. Horrobin provides Example 17, which teaches using lithium as a surface disinfectant at concentrations of 10% ( 10 parts lithium components in 90 parts water). (See Horrobin 14:5-10.) 6. Horrobin teaches using sterile solutions of lithium for wound irrigation during surgery. (See Horrobin 8:8-11.) 7. Horrobin teaches that lithium has been shown to stimulate the production of white blood cells. (See Horrobin 8:2-3.) 8. Robinson teaches that delayed wound healing in diabetes may be due to a delayed response to the injury and impaired functioning of the immune cells necessary for wound healing ( e.g., PMN leukocytes and fibroblasts). (See Robinson, Abstract.) Analysis The Examiner determines that because Horrobin teaches that lithium stimulates the production of white blood cells and Robinson teaches that impaired wound healing in diabetic patients is due to a delayed stimulation of the white blood cells (PMN leukocytes), those of ordinary skill in the art would have considered it obvious to use lithium to treat impaired wound healing in a diabetic patient. (See Ans. 4--5; see also FFs 7 and 8.) In addition, one of ordinary skill in the art would have considered it obvious to use a composition of 8% lithium to treat a wound in a diabetic patient 3 Appeal2017-004369 Application 13/339,347 because Horrobin teaches using lithium to treat the complications of diabetes for skin care (at 8%), for surface disinfection, and for wound irrigation. (See FFs 1-6.) Appellants raise several arguments against the obviousness of the claimed method over Horrobin. Appellants argue that Horrobin fails to teach using lithium to treat "impaired wound healing in diabetes." (See App. Br. 3.) Appellants argue that Horrobin discusses diabetes in a "laundry list of more than twenty disorders," but does not discuss wound healing specifically. (Id.) Appellants argue that even though Horrobin teaches using lithium to irrigate wounds during surgery, the wound healing recited in claim 1 is directed to closing the wound, not to cleaning it during surgery. (See App. Br. 4.) We are not persuaded by any of these arguments because they do not address the Examiner's rejection of claim 1 as being obvious over a combination of prior art references. Instead, Appellants' arguments assert that Horrobin alone does not teach each and every element of the claimed method. "Non-obviousness cannot be established by attacking references individually where the rejection is based upon the teachings of a combination of references." In re Merck & Co., Inc., 800 F.2d 1091, 1097 (Fed. Cir. 1986). Given the teaching in Horrobin that lithium stimulates the production of white blood cells, as well as being useful for treating complications of diabetes, for skin care, and for wound irrigation, and the teaching in Rosenberg that impaired wound healing may be due to delayed response and functioning of specific white blood cells, Appellants' arguments are not persuasive. "[T]he analysis [ of obviousness] need not seek out precise teachings directed to the specific subject matter of the 4 Appeal2017-004369 Application 13/339,347 challenged claim, for a court can take account of the inferences and creative steps that a person of ordinary skill in the art would employ." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,418 (2007). Appellants also argue that the examples of Horrobin do not teach topical administration of lithium to treat impaired wound healing and are different from 8% lithium solutions. (See App. Br. 4; see also App. Br. 5 ("In the 31 examples [of Horrobin], there is no topically-administered composition that can be used in a method of topical application, as currently claimed.").) According to Appellants, the teaching in Example 13 of using lotions, creams, or shampoos for skin care do not read on claim 1 because claim 1 does not require a cream, lotion, or shampoo. (See App. Br. 4.) This argument is not persuasive because claim 1 does not limit the form of the lithium-containing medicament; nor is claim 1 limited to a "solution." Appellants do not direct us to any evidence that claim 1 would exclude the creams, lotions, and shampoos taught in Horrobin Example 13. Appellants argue that Rosenberg "teaches away" from administration of 8% lithium to treat wound healing in diabetic patients because Rosenberg suggests that management of blood glucose levels can have a major impact on the wound complications in diabetes. (See App. Br. 6.) "Under the proper legal standard, a reference will teach away when it suggests that the developments flowing from its disclosures are unlikely to produce the objective of the applicant's invention." Syntex (U.S.A.) LLC v. Apotex, Inc. 407 F.3d 1371, 1380 (Fed. Cir. 2005). Even though Rosenberg may teach other routes of treating wounds in diabetic patients, Appellants do not direct us to any teaching in Rosenberg about lithium. (See App. Br. 7 ("The Rosenberg reference does not teach the use of lithium, much less its use in a 5 Appeal2017-004369 Application 13/339,347 concentration of 8 %.").) Thus, we are not persuaded that Rosenberg specifically warns against or discourages using lithium. We are not persuaded that Rosenberg "teaches away" from the claimed method. Appellants also argue that the Examiner is applying an improper "obvious to try" rationale to support the rejection of claim 1. (See App. Br. 7-8.) Appellants argue that the "[t]he cited prior art provides no indication of which parameters were critical and no direction as to which of many possible choices is likely to be successful." (See App. Br. 8.) We disagree. Appellants fail to address the express teachings in Horrobin to use lithium in methods of treating "diabetes or a complication associated therewith" (Horrobin 18:43--45; FF 3), to use a composition of 8% for skin care (id. 13:38--45; FF 4), to use lithium to stimulate production of white blood cells (id. 8:2-3; FF 7), and the teaching of Rosenberg that wound healing in diabetes patients is due to impaired functioning of the white blood cells, PMN leukocytes (see Rosenberg Abstract; FF 8). With this guidance, we are not persuaded that one of ordinary skill in the art would have had to "try and vary all parameters or try each of numerous possible choices" to arrive at the claimed result, as Appellants argue. (App. Br. 8.) Instead, the teachings ofHorrobin and Rosenberg would have guided one of ordinary skill in the art to use a medicament having 8% lithium to treat complications of diabetes, including impaired wound healing. Appellants argue that their claimed method produces unexpected results as demonstrated in the declarations of inventors Al-Mulla and Bitar. (See App. Br. 9, (citing Affidavit or Declaration Under 37 CPR§ 132 executed by Fahd Al-Mulla ("Al-Mulla Deel.") and Affidavit or Declaration Under 37 CPR§ 132 executed by Milad Bitar ("Bitar Deel."), both filed 6 Appeal2017-004369 Application 13/339,347 October 3, 2014.).) The inventors' declarations provide results of experiments wherein wounds were treated in three groups of animals: (a) "control wounds," which are presumably wounds in animals that are not diabetic and were not treated with lithium; (b) "diabetic wounds," which are presumably wounds that are animals that are diabetic and were not treated with lithium; and (c) "diabetic wounds treated with lithium," which are presumably wounds in diabetic animals that were treated with lithium. (See Al-Mulla Deel. ,r 5 and Bitar Deel. ,r 5.) The inventors testify that As is clearly evident, it was unexpectedly found that the diabetic wounds DPs-Li treatment achieved a greater than 90% wound closure as compared with the control ( diabetic wounds). This result is surprising given that diabetic wounds take much longer and may fail to close at all as shown by the middle picture DPs (b ). (Al-Mulla Deel. ,r 6 and Bitar Deel. ,r 6.) According to Appellants, "[t]he declarations further assert that this result is surprising given that diabetic wounds take much longer and may fail to close at all as shown by the middle picture DPs (b)." (App. Br. 9.) The inventors' declarations do not persuade us that one of ordinary skill in the art would have considered the claimed method to produce unexpected results. Given that Horrobin teaches using lithium to treat complications associated with diabetes and to stimulate white blood cell production, wherein Rosenberg teaches that white blood cell function is a component of diabetic wound healing, it is not clear that the improvement in wound healing demonstrated by the inventors would have been unexpected. The inventors do not address Rosenberg and do not explain why the results would have been unexpected over the combination of Horrobin and Rosenberg. (See Ans. 10-11.) 7 Appeal2017-004369 Application 13/339,347 Appellants fail to persuade us that the Examiner erred in rejecting claim 1 as being obvious over Horrobin and Rosenberg. Conclusion Upon consideration of the record and for the reasons given, the rejection of claim 1 under 35 U.S.C. § 103(a) over Horrobin and Rosenberg is sustained. Therefore, we affirm the decision of the Examiner. No time period for taking any subsequent action in connection with this appeal may be extended under 37 C.F.R. § 1.136. AFFIRMED 8 Copy with citationCopy as parenthetical citation