IBS Centers for Advanced Food Allerge Testing, LLC

Patent Trials and Appeals Board

Jan 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.

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Application 15/448,543

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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.
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Application 15/448,543

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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.
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Application 15/448,543

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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
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Application 15/448,543

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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.
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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