Ex Parte Sidhu et al

Patent Trial and Appeal Board

Apr 5, 2018

13919266 (P.T.A.B. Apr. 5, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/919,266 06/17/2013 Harmeet Sidhu
22428 7590 04/09/2018
Foley & Lardner LLP
3000 K STREET N.W.
SUITE 600
WASHINGTON, DC 20007-5109
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.
101786-0123 4303
EXAMINER
ARIAN!, KADE
ART UNIT PAPER NUMBER
1651
NOTIFICATION DATE DELIVERY MODE
04/09/2018 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):
ipdocketing@foley.com
PTOL-90A (Rev. 04/07)
UNITED ST ATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte HARMEET SIDHU and MIL TON J. ALLISON 1
Appeal2016-006294
Application 13/919,266
Technology Center 1600
Before RICHARD M. LEBOVITZ, RY ANH. FLAX, andDA VID COTT A,
Administrative Patent Judges.
FLAX, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on appeal under 35 U.S.C. § 134(a) involving
claims directed to a method for reducing systemic circulating oxalate in a
subject. Claims 23-27, 29-32, and 34 are on appeal as rejected under the
doctrine of non-statutory obviousness type double patenting. 2 We have
jurisdiction under35 U.S.C. § 6(b).
We reverse.
1 Appellants identify the Real Parties in Interest as "Oxthera, Inc. and The
Milton J. Allison Revocable Trust." Appeal Br. 3.
2 Oral argument was heard in this Appeal on April 3, 2018. A transcript of
the hearing will be made a part of the record in due course.
Appeal2016-006294
Application 13/919,266
STATEMENT OF THE CASE
The appealed claims can be found in the Claims Appendix of the
Appeal Brief. Claim 23 is representative and it reads as follows:
23. A method for reducing systemic circulating oxalate in a
subject in need thereof, comprising orally administering to a
human or animal an effective amount of a composition
comprising viable bacterial cells of Oxalobacter formigenes,
wherein the administering is effected at least once per day for a
period of months or years, and wherein the method is effective
to induce enteric elimination of systemic circulating oxalate.
Appeal Br. 13 (emphasis added).
The following rejection is on appeal:
Claims 23-27, 29-32, and 34 stand rejected on the ground of
nonstatutory obviousness-type double patenting over claims 4--8 and 11 of
Sidhu. 3
FINDINGS OFF ACT
FFI. Sidhu's claim 4 recites:
4. A method for treating a human or animal having increased
oxalate comprising, administering to said a human or animal an
effective amount of freeze-dried viable bacterial cells of
Oxalobacter formigenes or oxalate-reducing enzymes, admixed
with at least one cryopreservative agent, and reducing, in the
gastrointestinal tract, a portion of the oxalate present from
dietary sources or from endogenous sources in the human or
animal, wherein the amount effective in reducing a portion of the
oxalate present from dietary sources or from endogenous sources
is from about 107 to about 1012 colony forming units of
Oxalobacter formigenes or from about 5 to about 5,000 units of
oxalate-reducing enzymes, and wherein the freeze-dried
Oxalobacter formigenes cells or oxalate-reducing enzymes are
3 US 8,486,389 B2 (issued July 16, 2013) ("Sidhu").
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Application 13/919,266
enteric coated for delivery to the small intestine of the human or
animal.
Sidhu 22:16-30 (emphasis added). As noted by the emphasis above,
the Sidhu claims are directed to reducing oxalate in the gastro-
intestinal tract of a human or animal.
FF2. The Specification states:
The present invention comprises methods for
administering compositions containing 0. formigenes to the
gastrointestinal tracts of a human or animal. Subjects are
preferably dosed with enteric capsules containing 2: 106 cfus of
viable O.formigenes cells. Such dosing preferably occurs twice
a day with two major meals. The present invention also
comprises methods for administering oxalate reducing
compositions comprising one or more oxalate reducing
microorganisms, one or more oxalate reducing enzymes or
combinations thereof. A method of the present invention
comprises administering at least one time a day an effective
amount of an oxalate reducing composition wherein the oxalate
reducing composition comprises one or more oxalate reducing
enzymes. Methods also include administering such
compositions more than one time per day, more than two ames
per day, more than three times per day and in a range from 1
to 15 times per day. Such administrations may be continuously,
as in every day for a period of days, weeks, months or years, or
may occur at specific times to treat or prevent oxalate-related
conditions. For example, a person or animal may be
administered oxalate reducing compositions at least once a day
for years to treat or prevent oxalaterelated conditions or a person
or animal may be administered oxalate reducing compositions
at least once a day only at times when oxalate-containing foods
are ingested, or for a restricted time period, such as days or
weeks, following procedures or treatments that interfere with
normal bacterial flora. Such administration can occur throu~
routes known for administration of pharmaceuticals.
Administration through oral or intestinal routes, or in
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Application 13/919,266
combination with food materials are contemplated by the present
invention.
Spec. 22:6-27 (emphasis added). As shown by the emphasis above,
the Specification describes separate embodiments where treatment is
ongoing and administered over an extended period of time and also
where treatment is administered on an as-needed basis.
FF3. The Specification states, "[ s Jome individuals (e.g., patients
with intestinal disease such as Crohn' s disease, inflammatory bowel
disease, or steatorrhea and also patients that have undergone
j ejunoileal bypass surgery) absorb more of the oxalate in their diets
than do others. For these individuals, the incidence of oxalate
urolithiasis increases markedly." Spec. 2:14--17.
FF4. The Specification states,"[ o ]ne embodiment comprises
methods which reduce the risk for developing oxalate-related
disorders by reducing the amount of oxalate in the intestinal tract.
This reduction in the intestinal tract leads to a reduction in systemic
oxalate levels thereby promoting good health," and "[a] reduction of
oxalate in the intestinal tract can also lead to removal of oxalate from
the circulatory system." Spec. 3:28-31, 4:5---6; see also id. at 11 :28-
12:11.
FF5. Further to the preceding fmding of fact, the Specification
states, "the methods of the subject invention for administering oxalate
reducing bacteria or oxalate reducing enzymes can be used to treat or
prevent oxal[ a ]te-related conditions such as primary hyperoxaluria in
addition to treatment of dietary hyperoxaluria." Spec. 12 :6-9. Thus,
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Application 13/919,266
the Specification describes either or both treating existing
hyperoxaluria and/ or preventing occurrence ofhyperoxaluria.
FF6. Appellants' evidence supports that 0. formigenes
colonization in humans and animals is transient in nature, meaning
that, contrary to the understanding of those of ordinary skill in the art
prior to the invention date, to address oxalate reduction in humans or
animals over extended periods of time the bacteria must be
administered over extended periods of time, i.e., to replenish the
bacteria. See Declaration Under 37 C.F.R. § 1.132 dated June 30,
2015, signed by Dr. Harmeet Sidhu ("Sidhu Deel.") (citing Duncan, 4
Daniel 1, 5 and Daniel 2 6).
FF7. Appellants' evidence supports that shorter-term or as-needed
administration of 0. formigenes may be suitable to degrade dietary
oxalate (i.e., in the gastrointestinal tract), but longer-term 0.
formigenes administration is necessary to maintain sufficient bacterial
colonization to reduce systemic oxalate by keeping gastrointestinal
oxalate levels reduced. Sidhu Deel. iii! 11-12.
4 Sylvia H. Duncan et al., Oxalobacter formigenes and Its Potential Role in
Human Health, 68(8) APPL. & ENVIRON. MICROBIO. 3841--47 (2002)
("Duncan").
5 Steven L. Daniel et al., Intestinal Colonization of Laboratory Rats with
Oxalobacter formigenes, 53(8) APPL. & ENVIRON. MICROBIO. 2767-70
( 1987) ("Daniel 1 ").
6 Steven L. Daniel et al., Microbial Degradation of Oxalate in the
Gastrointestinal Tracts of Rats, 53(8) APPL. & ENVIRON. MICROBIO. 1793-
97 (1987) ("Daniel 2").
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Application 13/919,266
DISCUSSION
"[T]he law of obviousness-type double patenting looks to the law of
obviousness generally," such that, "if the later expiring patent is 'merely an
obvious variation of an invention disclosed and claimed in the [reference]
patent,' the later expiring patent is invalid for obviousness-type double
patenting." Abb Vie Inc. v. Mathilda and Terence Kennedy Inst. of
Rheumatology Trust, 764F.3d1366, 1378-79 (Fed. Cir. 2014) (alteration in
original) (citing Amgen Inc. v. F. Hoffman-La Roche Ltd., 580 F.3d 1340
(Fed. Cir. 2009) and Eli Lilly & Co. v. TevaParenteralMeds., Inc., 689 F.3d
1368 (Fed. Cir. 2012), and quotingin re Vogel, 422 F.2d438, 41 (CCPA
1970)).
The Examiner determined:
it would have been obvious to a person of ordinary skill in the art
at the time the invention was made to apply the method(s)
disclosed by claims 1-8 and 11 of US patent No. 8,486,389
[Sidhu] to provide the method as disclosed by claim 23-27, 29-
32 and 34 of instant application, the frequency and duration
(required for a therapeutic effect) of administering the
composition comprising viable cells of Oxalobacter formigenes
would have been optimized by a person of ordinary skill in the
art at the time the invention was made.
Final Action 6.
Appellants argue the Sidhu claims "do not specify or suggest methods
that comprise administering a composition comprising viable bacterial cells
of O.formigenes once per day for a period of months or years," as required
by claim 23. Appeal Br. 8 (emphasis added). Further, Appellants also argue
that Sidhu' s claims "do not specify methods for reducing systemic
circulating oxalate and inducing enteric elimination of systemic circulating
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Application 13/919,266
oxalate," as required by claim 23. Appeal Br. 8 (emphasis added). During
oral argument, Appellants pointed out that the claims of Sidhu are directed
to reducing oxalate in the gastrointestinal tract (FF 1) and argued that,
because this physical location of oxalate reduction was the focus of the
Sidhu claimed invention, there would be no need to administer 0.
formigenes for an extended period of time and, therefore, it would not have
been an obvious variant of the Sidhu-claimed-method to do so.
On the record before us, we are persuaded by Appellants' argument.
We conclude that the Appellants' Specification describes separate
embodiments where O.formigenes bacteria can be administered differently
to either reduce oxalate systemically or to reduce oxalate in the
gastrointestinal tract as needed and that such alternative embodiments are
suitable for either treating existing hyperoxaluric conditions or preventing
them, respectively. FF2-FF7. These two embodiments, one claimed as the
invention in Sidhu and the other claimed as the invention in the appealed
application, involve different therapeutic methodologies, provide different
therapeutic advantages, and are non-obvious in view of one another.
Therefore, we reverse the outstanding double patenting rejection.
SUMMARY
The obviousness-type double patenting rejection over the claims of
Sidhu is reversed
REVERSED
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