Ex Parte AL-MULLA et al

Patent Trial and Appeal Board

Feb 1, 2019

13339347 (P.T.A.B. Feb. 1, 2019)

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
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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).
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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
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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
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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
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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
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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.)
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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
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