Ex Parte Goralczyk et al

Patent Trial and Appeal Board

Dec 9, 2016

13505854 (P.T.A.B. Dec. 9, 2016)

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.
13/505,854 05/03/2012 Regina Goralczyk BHD-4662-2197 5907
23117 7590 12/13/2016
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
RAMACHANDRAN, UMAMAHESWARI
ART UNIT PAPER NUMBER
1627
NOTIFICATION DATE DELIVERY MODE
12/13/2016 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):
PTOMAIL@nixonvan.com
pair_nixon @ firsttofile. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte REGINA GORALCZYK,
HASAN MOHAJERI, and ANNIS O. MAYNE-MECHAN
Appeal 2015-004457
Application 13/505,854
Technology Center 1600
Before DONALD E. ADAMS, ULRIKE W. JENKS, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
ADAMS, Administrative Patent Judge.
DECISION ON APPEAL1
This appeal under 35 U.S.C. § 134(a) involves claims 1—3 and 6—8
(Final Act. 1). Examiner entered rejections under 35 U.S.C. § 103(a). We
have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
STATEMENT OF THE CASE
Appellants disclose a “nutraceutical composition or food
compositions comprising lutein and/or zeaxanthin to improve certain
selective memory functions, such as associative learning, associative
1 Appellants identify the real party in interest as “DSM IP Assets B.V.” (Br.
2).
Appeal 2015-004457
Application 13/505,854
memory, learning and memory under stress, and spatial (place) learning”
(Spec. 1: 5—8). Claims 1 and 2 are representative and reproduced below:
1. A method of enhancing an aspect of memory in a healthy
individual, wherein the aspect of memory is selected from the
group consisting of:
associative memory, spatial memory and memory under stress
comprising:
administering a composition consisting of: a) an effective
amount of either lutein
or the combination of lutein and zeaxanthin; and b) an
appropriate carrier; and
observing the enhanced associative memory, spatial memory or
memory under stress.
(Br. 10.)
2. A method of enhancing learning and memory under stress
comprising:
administering a composition consisting of: a) a stress related
learning and
memory enhancing effective amount of either lutein or
the combination of lutein and zeaxanthin; and b) an
appropriate carrier; and
observing the enhanced learning and memory under stress.
The claims stand rejected as follows:
Claims 1—3 and 6 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Romero2 and Snyder.3
2 Romero et al., US 2006/0205826 Al, published Sept. 14, 2006.
3 J. S. Snyder et al., A ROLE FOR ADULT NEUROGENESIS IN SPATIAL
LONG-TERM MEMORY, 130 Neuroscience 843-852 (2005).
2
Appeal 2015-004457
Application 13/505,854
Claims 7 and 8 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Romero, Snyder, and Better
Nutrition.4
ISSUE
Does the preponderance of evidence relied upon by Examiner support
a conclusion of obviousness?
FACTUAL FINDINGS (FF)
FF 1. Appellants define the term “healthy” as “the subject is not suffering
from any conditions which impair his/her mental health, i.e. is not suffering
from conditions characterized by a deterioration in memory such as
dementia, Alzheimer’s disease or the like, depression, or other psychotic
conditions which affect memory and learning such as schizophrenia” (Spec.
5: 20—23; see Ans. 4).
FF 2. Appellants define the term “[tjreatmenf ’ as “encompass[ing]. . .
prevention” and the term “[prevention” as
not limited to the complete absence of symptoms in the future,
but is intended to include: lessening of the risk that an
individual or a population will exhibit a symptom, lessening the
symptoms associated with a particular condition, decreasing the
time of onset of a particular condition, lessening the severity of
a condition, and decreasing the likelihood that an asymptomatic
individual will show a condition in the future.
(Spec. 5: 9-14.)
FF 3. Romero discloses the
[administration of carotenoids[, such as lutein and other
carotenoids,] provide a prophylactic and/or therapeutic effect to
4 Seeing is Believing!, Better Nutrition 27 (Source From Google Books-
Better Nutrition, Nutritional Specialties, Inc., Anaheim, CA) (2004).
3
Appeal 2015-004457
Application 13/505,854
subjects[, including humans,] who are . . . at risk to develop
cognitive decline or other neurological effects, such as diabetic
complications, especially those related to neural tissues like
retinopathy, peripheral neuropathy and central nervous system.
(Romero, Abstract; id. H 1 and 12; see id. at 6: claims 10—12; see Ans. 3;
Ans. 4 (“Romero’s subjects include subjects who are at risk to develop
cognitive decline (e.g. healthy aged adults, diabetic patients)”).
FF 4. Romero discloses that “[djiabetes mellitus correlates with several
brain disturbances, including hypersensitivity to stress, cognitive
impairment, increased risk of stroke and dementia. Within the central
nervous system, the hippocampus is considered a special target for
alterations associated with diabetes” (Romero 1 54).
FF 5. Romero discloses that “[although a proper glycemic control is
desirable to reduce the development of diabetic complications, it is not
sufficient to prevent them completely, the results herein, allow us to propose
lutein as a coad[j]uvant treatment of central nervous system complications in
diabetes” (Romero 158; see also Muriach,5 Abstract (“[although a proper
glycemic control is desirable in preventing the development of diabetic
complications, it is not sufficient to prevent them completely. Lutein could
be an appropriate coadjuvant treatment for the changes observed in this
study”)).
FF 6. Examiner relies on Snyder to disclose “that [] adult hippocampal
neurogenesis has been linked to learning and long-term memory [] and adult
neurogenesis is associated in the formation and/or consolidation of long
5 Maria Muriach et al., Lutein effect on retina and hippocampus of diabetic
mice, 41 Free Radical Biology & Medicine 979-984 (2006).
4
Appeal 2015-004457
Application 13/505,854
term, hippocampus dependent, spatial memories” (Ans. 3, citing Snyder,
Abstract and 851: col. 1, last paragraph, 11. 1—3).
FF 7. Examiner finds that the combination of Romero and Snyder fail to
disclose the administration of lutein “as a capsule or in an amount as
claimed” and relies on Better Nutrition to make up for the foregoing
deficiency in the combination of Romero and Snyder (Ans. 5; id. (Examiner
finds that “Better Nutrition [discloses] lutein as a daily supplement sold as
capsules comprising 10 mg lutein”)).
ANALYSIS
The combination of Romero and Snyder.
Based on the combination of Romero and Snyder, Examiner
concludes that, at the time Appellants’ invention was made, it would have
been prima facie obvious “to have administered a composition comprising
lutein to enhance spatial memory in healthy individuals,” within the scope of
Appellants’ claimed invention, as suggested by the combination of Romero
and Snyder (Ans. 3 4). In this regard, Examiner concludes that “[i]t would
have been obvious to add a pharmaceutical carrier to a drug compound for
easy administration, absorption and to administer the drug by different
routes” (Ans. 4).
We find no error in Examiner’s prima facie case of obviousness.
Romero discloses the
[administration of carotenoids[, such as lutein and other
carotenoids,] provide a prophylactic and/or therapeutic effect to
subjects[, including humans,] who are . . . at risk to develop
cognitive decline or other neurological effects, such as diabetic
5
Appeal 2015-004457
Application 13/505,854
complications, especially those related to neural tissues like
retinopathy, peripheral neuropathy and central nervous system.
(FF 3.) In this regard, Romero discloses that “[djiabetes mellitus correlates
with several brain disturbances, including hypersensitivity to stress,
cognitive impairment, increased risk of stroke and dementia. Within the
central nervous system, the hippocampus is considered a special target for
alterations associated with diabetes” (FF 4). Snyder discloses, inter alia,
that spatial memories are hippocampus dependent (FF 6). Therefore, in
combination, Romero and Snyder suggest the administration of an effective
amount of lutein to produce a prophylactic effect in subjects, which includes
humans, with diabetes mellitus who are at risk of developing cognitive
decline, which correlates with, inter alia, hypersensitivity to stress and
hippocampus alterations affecting, inter alia, spatial memories (FF 3^4 and
6). As Examiner makes clear, Romero’s disclosure of the prophylactic
treatment of diabetic patients who are at risk of developing complications
associated with diabetes, which includes an aspect of memory associated
with memory under stress, reads on Appellants’ definition of a healthy
individual, i.e., an individual with diabetes mellitus who is not suffering
from cognitive decline or any conditions which impair his/her mental health
{see FF 3; c/FF 1).
Claim 1:
As Examiner explains, there is no requirement that a reference, such
as Romero, exemplify all the embodiments that fall within the scope of
reference’s disclosure (see Ans. 7). Therefore, we are not persuaded by
Appellants’ contention that “Romero does not demonstrate any benefits in
6
Appeal 2015-004457
Application 13/505,854
giving lutein to healthy individuals” (Br. 5; cf. FF 3 (wherein Romero
discloses a prophylactic treatment)).
For the foregoing reasons, we are not persuaded by Appellants’
contention that the diabetic mice used in Romero’s studies are not
representative of healthy subjects and associated arguments regarding
Muriach, which Appellants characterize as a “publication [that] appears to
be the journal article containing the same experiments [involving diabetic
mice] as appear in the Romero” (Br. 5—6; see FF 5). In this regard, we
recognize, but are not persuaded by, Appellants’ contention that “Muriach
found that there was no significant difference seen in the water maze test
between any of the test groups” and corresponding extrapolation that “based
on the disclosures in Muriach [], an ordinarily skilled person would not have
any reasonable expectation of success when administering lutein to untreated
healthy mice” (Br. 5—6). Regardless of whether the diabetic mice in
Romero’s exemplification are healthy, as that term is defined in Appellants’
Specification, Appellants’ claimed invention encompasses the prophylactic
treatment of diabetes patients who are not experiencing diabetes associated
complications (see Br. 10; FF 1—2; see FF 4 (wherein Romero discloses the
type of complications that may arise in diabetic patients)). Romero discloses
the administration of lutein for the prophylactic treatment of diabetic
patients (FF 3^4; cf. FF 5 (wherein Romero and Muriach both recognize that
lutein is an appropriate coadjuvant treatment for complications associated
with diabetes)).
Appellants failed to establish an evidentiary basis on this record to
support a conclusion that the prophylactic administration of a composition
comprising lutein, as suggested by the combination of Romero and Muriach,
7
Appeal 2015-004457
Application 13/505,854
to healthy individuals at risk of develop cognitive decline (i.e. individuals
with diabetes mellitus who are not suffering from cognitive decline or any
conditions which impair mental health) will not necessarily result in
enhancing an aspect of memory (such as associative memory, spatial
memory or memory under stress) in those patients. In sum, Appellants’
have, at best, discovered a new benefit of an old process, which cannot
render the old process patentable. See In re Huai-Hung Kao, 639 F.3d 1057,
1071 (Fed. Cir. 2011); In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir.
1990).
Claims 2 and 3:
As discussed above, Romero discloses the administration of lutein for
the prophylactic treatment of diabetic patients who are at risk of developing
cognitive decline, which includes learning and memory under stress and/or
spatial learning and memory deficiencies (FF 3—6; cf FF 2 (wherein
Appellants define treatment as including a prophylactic treatment)).
Therefore, for the reasons discussed above, we are not persuaded by
Appellants’ contentions that the combination of Romero and Snyder fails to
suggest Appellants’ claimed invention.
The combination of Romero, Snyder, and Better Nutrition'.
Based on the combination of Romero, Snyder, and Better Nutrition,
Examiner concludes that, at the time Appellants’ invention was made, it
would have been prima facie obvious “to use lutein, 10 mg capsules[, as
suggested by Better Nutrition,] in” the method suggested by the combination
of Romero and Snyder (see Ans. 5—6). In this regard, Examiner reasons that
8
Appeal 2015-004457
Application 13/505,854
the “[ajdminstration of a 10 mg capsule daily would roughly correspond to a
daily dosage of 0.15 mg/day or two 10 mg lutein capsules would correspond
to 0.28 mg/day,” which “falls within the claimed dosage range of
[Appellants’ claim 8]” (Ans. 6).
Appellants do not address the combination of Romero, Snyder, and
Better Nutrition, therefore, we are compelled to affirm the rejection of
record.
CONCLUSION OF LAW
The preponderance of evidence relied upon by Examiner supports a
conclusion of obviousness.
The rejection of claims 1—3 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Romero and Snyder is affirmed. Claim 6 is not
separately argued and falls with claim 1.
The rejection of claim 7 under 35 U.S.C. § 103(a) as unpatentable
over the combination of Romero, Snyder, and Better Nutrition is affirmed.
Claim 8 is not separately argued and falls with claim 7.
TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
9