IBS Centers for Advanced Food Allerge Testing, LLC

Patent Trials and Appeals BoardJan 15, 2021

2020000862 (P.T.A.B. Jan. 15, 2021)

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. 15/448,543 03/02/2017 Michael Stierstorfer 0083-0001US2 6013 56719 7590 01/15/2021 MEDLER FERRO WOODHOUSE & MILLS PLLC 8201 Greensboro Drive, Suite 1060 McLean, VA 22102 EXAMINER NGUYEN, HUONG Q ART UNIT PAPER NUMBER 3791 NOTIFICATION DATE DELIVERY MODE 01/15/2021 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): aferro@medlerferro.com docketing@medlerferro.com tmedler@medlerferro.com PTOL-90A (Rev. 04/07) UNITED STATES PATENT AND TRADEMARK OFFICE ____________________ BEFORE THE PATENT TRIAL AND APPEAL BOARD ____________________ Ex parte MICHAEL STIERSTORFER ____________________ Appeal 2020-000862 Application 15/448,543 Technology Center 3700 ____________________ Before MICHAEL C. ASTORINO, PHILIP J. HOFFMANN, and CYNTHIA L. MURPHY, Administrative Patent Judges. HOFFMANN, Administrative Patent Judge. DECISION ON APPEAL STATEMENT OF THE CASE Pursuant to 35 U.S.C. § 134(a), Appellant1 appeals from the Examiner’s rejection of claims 15–18 and 20–33. We have jurisdiction under 35 U.S.C. § 6(b). Appellant participated in an oral hearing with the Board on October 15, 2020. 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 “IBS CENTERS FOR ADVANCED FOOD ALLERGY TESTING, LLC.” Appeal Br. 3. Appeal 2020-000862 Application 15/448,543 2 According to Appellant, the invention “relates to methods and items for irritable bowel syndrome (IBS) related testing and treatment, and more particularly to IBS related patch testing.” Spec. ¶ 2. Claims 15 and 25 are the independent claims on appeal. Below, we reproduce independent claim 15 as illustrative of the appealed claims. 15. A method of identifying allergens that cause irritable bowel syndrome (IBS) in a patient using a relation between Type 4 allergic contact dermatitis and IBS, comprising: selecting a patient having one of: (1) a history of IBS and (2) symptoms of IBS; applying, to skin of the patient, a patch comprising one or more test materials selected from the group consisting of food and food based additive substances that are known to cause Type 4 allergic contact dermatitis, wherein the patch is configured to be attached to skin such that the one or more test materials is brought into contact with skin to which the patch is attached; determining whether a positive Type 4 allergic contact dermatitis reaction has occurred on the skin of the patient; and limiting the intake by the patient of at least one material that gives the positive Type 4 allergic contact dermatitis reaction to determine whether the one or more test materials cause IBS in the patient. Appeal 2020-000862 Application 15/448,543 3 REJECTION AND PRIOR ART The Examiner rejects claims 15–18 and 20–33 under 35 U.S.C. § 103 as unpatentable over Breneman2 and Cousins.3 ANALYSIS As discussed in detail below, we review the record to determine whether it would have been obvious to combine Breneman and Cousins to provide the recitations recited in Appellant’s claims 15–18 and 20–33. Based on our review, we do not sustain the Examiner’s obviousness rejection. The Examiner bases the rejection on two findings of fact, the first of which is a finding that Breneman discloses using a patch test to identify Types 1, 2, 3, and 4 allergies. See, e.g., Answer 3. The Examiner also finds that Cousins discloses a relationship between Types 1, 2, and 3 allergies and irritable bowel syndrome (IBS). Id. Thus, according to the Examiner, “from the teaching of Cousins, it would [have] be[en] obvious to a skilled artisan to use a test for IBS using Type 1, 2, and 3 food allergies.” Id. (citation to Cousins omitted). The Examiner continues: Upon a further and next logical reasoning step, since Breneman also discloses testing for food allergies/contact dermatitis using Type 4 immune response, with the knowledge of Cousins, a skilled artisan would also reasonably envision testing for IBS using another alternative food allergy testing method, i.e.[,] Type 4 contact dermatitis, since that mode of testing for food allergies is well-known as taught by Breneman. 2 US 4,543,964, issued Oct. 1, 1985. 3 US 2007/0122840 A1, published May 31, 2007. Appeal 2020-000862 Application 15/448,543 4 Thus, the relationship between Type 4 food allergies/contact dermatitis and IBS is made obvious with the prior art. Id. at 4. The reason we do not sustain the rejection is because Appellant submits evidence sufficient to call into the question the correctness of both of the above findings of fact. The Examiner’s above-discussed finding that Breneman uses a patch test to identify Types 1, 2, 3, and 4 allergies is based on the disclosure of Breneman itself. See, e.g., Answer 3. For example, Breneman’s Abstract states that the invention is [a] device for the detecting of an individual’s Gell-Coombs Types I, II, III and IV immune response reactions to edible substances includes a mixture of an edible substance and a solution of nontoxic aprotic solvent, such as DMSO and water. The solvent acts as a carrier transporting the food beneath the skin. The device holds the mixture against the skin and prevents evaporation of the solution. Breneman, Abstract. Nonetheless, Appellant submits evidence persuading us that [w]hile Breneman . . . [states] that Type 1, 2 and 3 allergic reactions can be determined using a skin patch test . . . , this is incorrect. As discussed in detail in Appellant’s [Appeal] brief, Appellant has specifically shown in the declaration of Michael S. Smith . . . that only Type 4 allergic dermatitis reactions can be determined using a skin patch test. Reply Br. 2 (citations omitted). The Declaration of Michael S. Smith, M.D., M.B.A. (hereinafter “Smith Declaration”) indicates that Dr. Smith is “Senior Faculty at the Icahn School of Medicine at Mount Sinai and Chief of Gastroenterology and Hepatology at Mount Sinai West and Mount Sinai St. Appeal 2020-000862 Application 15/448,543 5 Luke’s Hospitals in New York; NY.” Smith Declaration ¶ 1. At least paragraphs 5 and 12 of Dr. Smith’s Declaration provide evidence sufficient to persuade us that Type 4 allergic reactions, and not Types 1, 2, and 3 allergic reactions, may be determined using a skin patch test. Id. ¶ 5, 12. Importantly, nothing in Breneman demonstrates to us that Breneman purports to discover that Types 1, 2, and 3 allergic reactions may be determined using a skin patch test—instead Breneman appears to discuss what was believed to be known. Similarly, the Examiner bases the above-discussed finding that Cousins shows a relationship between Types 1, 2, and 3 allergies and IBS on Cousins’s disclosure. Specifically, Cousins states that “[a] number of chronic pathological conditions are thought to be caused or provoked by allergic reactions to allergens present in food,” and then identifies “irritable bowel syndrome” as well as seventeen other conditions “considered in some cases to be provoked or caused by intolerance to allergens present in food.” Cousins ¶ 3. Although this may appear to be a passing reference to a relationship between IBS and allergies, two paragraphs later Cousins further discusses IBS and diet in some depth. To wit, Cousins states that [i]rritable bowel syndrome (IBS) is a chronic bowel disorder resulting from abnormal contractions of the large intestine. . . . Research into the causes of IBS have not discovered any anatomical or biochemical abnormalities in the bowel of sufferers of IBS nor are there any specific tests to determine whether a person, or animal, is susceptible to IBS. . . . It is thought that diet has an influence on the severity of IBS and that stress can also contribute. Id. ¶ 5. Nonetheless, Appellant’s evidence is sufficient to persuade us “that a positive correlation between any food allergy and IBS was not recognized Appeal 2020-000862 Application 15/448,543 6 as scientifically accurate” at the time Cousins was filed. Reply Br. 4. Before discussing why this is the case, we note that nothing in Cousins demonstrates to us that Cousins purports to discover such a relationship, but instead Cousins appears to indicate that such a relationship is already known. Dr. Smith’s statements provide evidence that “those working in the field did not consider there to be a link between any food allergies, whether they be Type 1, Type 2, Type 3 or Type 4, and IBS.” Reply Br. 4. Specifically, Dr. Smith declares that “IBS was not thought,” “in the scientific community,” “to be caused by allergic reactions.” Smith Declaration ¶ 9. Dr. Smith continues, stating that “[t]his incorrect statement was in direct contradiction with the prevailing view of experts working in the field as depicted in [certain] references . . . even years after (2010 and 2012) Cousins’[s] filing in 2003.” Id. (citations omitted). The references cited by Dr. Smith include a report by an expert panel regarding guidelines for diagnosis and management of food allergies, a Harvard Medical School report, and a textbook on clinical gastroenterology. Id. None of these references discloses that IBS is thought to be caused by allergic reactions. Thus, based on our review of the record, as we state above, Appellant submits evidence sufficient to call into the question the correctness of both of the above findings of fact. Consequently, we cannot sustain the Examiner’s obviousness rejection of the claims. CONCLUSION We REVERSE the Examiner’s obviousness rejection of claims 15–18 and 20–33. Appeal 2020-000862 Application 15/448,543 7 In summary: REVERSED Claims Rejected 35 U.S.C. § Basis/Reference(s) Affirmed Reversed 15–18, 20–33 103 Breneman, Cousins 15–18, 20–33