Ex Parte Barker et al

Patent Trial and Appeal Board

Jan 25, 2018

14497802 (P.T.A.B. Jan. 25, 2018)

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.
14/497,802 09/26/2014 Felix BARKER SW-4662-2923 1081
23117 7590 01/29/2018
NIXON & VANDERHYE, PC
901 NORTH GLEBE ROAD, 11TH FLOOR
ARLINGTON, VA 22203
EXAMINER
HUANG, GIGI GEORGIANA
ART UNIT PAPER NUMBER
1621
NOTIFICATION DATE DELIVERY MODE
01/29/2018 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):
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 FELIX BARKER, REGINA GORALCZYK,
and WOLFGANG SCHALCH1
Appeal 2016-008383
Application 14/497,802
Technology Center 1600
Before TAWEN CHANG, RACHEL H. TOWNSEND, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
TOWNSEND, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
method of promoting recovery from the physiological effects of glare, which
have been rejected as anticipated and obvious. We have jurisdiction under
35 U.S.C. § 6(b).
We affirm.
1 Appellant is the Applicant, DSM IP ASSETS B.V., which according to the
Brief, is the real party in interest. (Br. 3.)
Appeal 2016-008383
Application 14/497,802
STATEMENT OF THE CASE
Administration of lutein and zeaxanthin has been found to
lower the risk for developing age-related macular disease (AMD). (Spec. 1.)
The present invention is directed at the use of such carotenoids to improve
visual performance also in the absence of AMD. {Id. at 1-2.)
Claims 28^41 are on appeal. Claim 28 is representative and reads as
follows:
28. A method of promoting recovery from the physiological
effects of glare which comprises administering to a healthy
person in need of such treatment an effective amount of a
carotenoid in a daily dosage within the range of from about 0.1
mg per kg body weight to 1.0 mg per kg body weight, based on
the total weight of the carotenoid devoid of any ester group,
wherein the carotenoid is selected from the group
consisting of: lutein, zeaxanthin, mesozeaxanthin, astaxanthin
or esters thereof, or mixtures thereof; and
wherein the esters thereof are selected from the group
consisting of esters of acetic acid, propionic acid, palmitic acid,
stearic acid, succinic acid, oleic acid, linoleic acid,
docosahexaenoic acid, and arachidonic acid.
(Br. 23.)
2
Appeal 2016-008383
Application 14/497,802
The following grounds of rejection by the Examiner are before us on
review:2
Claims 28, 29, 31, 35, 36, and 38 under 35 U.S.C. § 102(b) as
anticipated over Olmedilla.3
Claims 28, 33, 35, and 40 under 35 U.S.C. § 103 as unpatentable over
Olmedilla and “The Dark Side of Nighttime Driving.”4
Claims 28, 34, 35, and 41 under 35 U.S.C. § 103 as unpatentable over
Olmedilla and Richter5 or Gorsek.6
Claims 28-32 and 35-39 under 35 U.S.C. § 103 as unpatentable over
Gorenbein.7
2 We note that the Examiner objected to the Specification because it does not
recite treating a healthy person, nor does it delineate how that patient
population is different from a person in need of treatment from the
physiological effects of glare. (Final Action 2-3.) While that objection has
not been withdrawn by the Examiner, we note that such objection is not
appealable, 37 C.F.R. § 1.113(a), and, thus, we do not address the
Examiner’s objection.
3 Olmedilla et al., Lutein in patients with cataracts and age-related macular
degeneration: a long-term supplementation study, 81 J. Sci. Food Agric.
904-9 (2001)
4 The Dark Side of Nighttime Driving, reproduced by TransSafety, Inc. in
Road Injury Prevention & Litigation Journal, (1999), available at
http ://www.usroads.com/ioumals/rili/9910/ri991003 .htm.
5 Richter et al., Double-masked, placebo-controlled, randomized trial of
lutein and antioxidant supplementation in the intervention of atrophic
age-related macular degeneration: the Veterans LAST study
(Lutein Antioxidant Supplementation Trial), 75(4) Optometry, 216-30,
(2004). The Examiner relies only on the abstract available at
http://www.ncbi.nlm.nih.gov/pubmed, as do we.
6 Gorsek, US 6,103,756, issued Aug. 15, 2000.
7 Gorenbein et al., US 5,955,102, issued Sept. 21, 1999.
3
Appeal 2016-008383
Application 14/497,802
Claims 28, 33, 35, and 40 under 35 U.S.C. § 103 as unpatentable over
Gorenbein and “The Dark Side of Nighttime Driving.”
Claims 28, 34, 35, and 41 under 35 U.S.C. § 103 as unpatentable over
Gorenbein and Gorsek.
DISCUSSION
Claim Interpretation
The Examiner contends that the term “healthy person” as used in the
claims is interpreted to be “a person who can have a disease/condition but is
not suffering from a terminal condition.” (Final Action 4.) The Examiner
explains that the Specification does not define the term “healthy person.”
{Id. at 3.) Furthermore, the Examiner notes that the claim is for treating a
person who is affected by the physiological effects of glare, and, thus, is
considered to have a “health condition.” {Id. at 2, 4.) In light of this
definition, the Examiner notes that healthy person in need of treatment as
required by Appellant’s claim encompasses people who have age-related
macular degeneration (“AMD”). {Id. at 3.)
Appellant does not address the Examiner’s interpretation head-on, but
rather, argues that a person without AMD is a healthy person. (Br. at 10.)
While we do not disagree with Appellant that a person without AMD may be
considered a healthy person in that she/he does not have macular
degeneration, that fact alone does not establish the person is “healthy.”
Moreover, that fact also does not serve to define the scope of the population
of “healthy person[s]” to which the claims are directed.
We agree with the Examiner that “healthy person” is not defined or
used in the Specification. However, if a person has a “disease,” whether or
not it is a “terminal condition,” i.e., one that is reasonably expected to result
4
Appeal 2016-008383
Application 14/497,802
in the death of a person, the fact that the person has a disease is sufficient to
define that person as not healthy because “healthy” is generally understood
to be, inter alia, free of disease or ailment. See, e.g., “health”,
MedicineNet.com, available at
https://www.medicinenet.com/script/main/art.asp?articlekey=3663, last
visited January 12, 2018 (“As officially defined by the World Health
Organization, a state of complete physical, mental, and social well-being,
not merely the absence of disease or infirmity.”).
Thus, we disagree with the Examiner’s conclusion that a “healthy
person” can have a disease/condition so long as that condition is not
terminal. Rather, we find the term to mean, a person that is at least free of
any disease or medical infirmity.
No Anticipation
The Examiner finds that Olmedilla teaches supplementation with
lutein (in a mixed ester form from marigold flowers) for patients having
cataracts and AMD, which supplementation resulted in improvement in
glare sensitivity. (Final Action 4-5.) The amount of lutein provided was
about 7 mg/day. (Id. at 5.)
We disagree with the Examiner that Olmedilla anticipates the claims.
The patient population who were supplemented with lutein were not healthy
as we have construed the term above because they had cataracts and AMD,
which are both diseases.
Consequently, we reverse the Examiner’s rejection of claims 28, 29,
31, 35, 36, and 38 under 35 U.S.C. § 102(b) as anticipated over Olmedilla.
5
Appeal 2016-008383
Application 14/497,802
Non-Obviousness of the claims over Olmedilla and additional references
The Examiner’s rejections of claims 28, 33, 35, and 40 under 35
U.S.C. § 103 as unpatentable over Olmedilla and “The Dark Side of
Nighttime Driving,” and claims 28, 34, 35, and 41 under 35 U.S.C. § 103 as
unpatentable over Olmedilla and Richter or Gorsek, rely on the Examiner’s
position that Olmedilla teaches administering lutein to healthy persons.
(See, e.g., Final Action 7-9.) For the reasons set forth above, we disagree
with the Examiner’s position. Consequently, we reverse these rejections as
well.
Obviousness of the claims over Gorenbein
The Examiner finds that Gorenbein teaches supplementation with a
composition that includes lutein to improve vision, including night vision
acuity and adaptation to light, both of which encompass the physiological
effects of glare. (Final Action 11.) The Examiner further points out that
Gorenbein teaches the amount of lutein to be administered is in the range of
1 to 6 mg/day, which the Examiner concludes overlaps with the claimed
range because a standard man is 70 kg and, thus, claim 28 requires about 7
to 70 mg of lutein. (Id.) The Examiner further contends that “as the patient
is treated for the physiological effects of glare (i.e. night vision acuity and
adaptation to light), the effects of glare are intrinsically addressed regardless
of when the circumstances occur to the patient (e.g. driving at night).” (Id.
at 12.)
We agree with the Examiner’s findings and conclusion of obviousness
set forth above. Gorenbein teaches that the nutritional supplement that
6
Appeal 2016-008383
Application 14/497,802
includes lutein is “useful for improving night vision acuity.” (Gorenbein
Abs.; 1:34-38, 58-63; claim 7.) We also agree with the Examiner that the
amount of lutein disclosed for use in the supplementation, about 1-6
mg/day, overlaps with the claimed amount of about 0.1 to 1.0 mg/kg, which
as the Examiner explained reasonably may be interpreted to be about 7 to 70
mg of lutein for an average adult male, Merck & Co. v. Teva Pharms. USA,
Inc., 395 F.3d 1364, 1369-70 (Fed. Cir. 2005) (holding that the ordinary
meaning of the term “about” is “approximately”), and/or is close enough
such that one skilled in the art would have expected the disclosed dosage to
achieve the same effect, In re Peterson, 315 F.3d 1325, 1330 (Fed. Cir.
2003) (“the existence of overlapping or encompassing ranges shifts the
burden to the applicant to show that his invention would not have been
obvious”).
“[WJhere the general conditions of a claim are disclosed in the prior
art, it is not inventive to discover the optimum or workable ranges by routine
experimentation.” In re Aller, 220 F.2d 454, 456 (CCPA 1955); In re
Boesch, 617 F.2d 272, 276 (CCPA 1980) (“[DJiscovery of an optimum value
of a result effective variable in a known process is ordinarily within the skill
of the art.”) The motivation to optimize comes from the natural desire of
those skilled in the art to experiment with, and improve upon, known
conditions taught in the prior art. In re Peterson, 315 F.3d 1325, 1330 (Fed.
Cir. 2003). Appellant has not provided evidence that optimization of the
dosage resulted in a property or benefit that a person of ordinary skill in the
relevant art would have found to be unexpected. See In re Antonie, 559 F.2d
618, 620 (CCPA 1977). The Specification does not indicate the lower limit
of the range is critical for achieving the claimed result. Indeed the
7
Appeal 2016-008383
Application 14/497,802
Specification indicates that a “[preferred solid pharmaceutical preparations
comprise, per dosage unit, about 6 mg to about 12 mg of lutein . . . (Spec.
4:10-11 ; see also Ex. 3.)
Appellant’s argument that claim 28 is directed to treating a healthy
person such as a person without AMD and that Gorenbein “does not teach
this limitation of the claim” (Br. 16-17), is not persuasive. Gorenbein
broadly teaches providing a nutritional supplement and is not directed to
providing it to non-healthy persons. Rather, Gorenbein simply notes that
“[djespite the recognition of the beneficial properties of. . . antioxidants
such as lutein” (Gorenbein 1:58-59), which includes being one of the “major
constituents of the macula lutea region of the retina, which is responsible for
sharp, detailed viewing” {id. at 1:34-37), the American diet “contains few
foods which supply” this nutrient {id. at 1:60-61). For that reason, lutein is
included in a supplement to be taken by persons to improve vision, including
night vision. {Id. at 1:62-2:6.)
In light of the foregoing, Appellant does not persuade us that the
Examiner erred in rejecting claim 28 for obviousness over Gorenbein.
While Appellant argues claim 35 separately (Br. 17-18), the argument
above is the only argument asserted for why the Examiner’s rejection is in
error. For the reasons just discussed, this argument is not persuasive. Thus,
Appellant does not persuade us that the Examiner erred in rejecting
independent claim 35 for obviousness over Gorenbein.
Claims 29-32 and 36-39 have not been argued separately and
therefore fall with claims 28 and 35, respectively. 37 C.F.R.
§ 41.37(c)(l)(iv).
8
Appeal 2016-008383
Application 14/497,802
Obviousness of the claims over Gorenbein and additional references
Appellant argues that the Examiner’s rejection of the claims over
Gorenbein and additional references is in error because Gorenbein does not
treat a healthy person. (See, e.g., Br. 18-22.) For the reasons just discussed,
this argument is not persuasive. Thus, Appellant does not persuade us that
the Examiner erred in rejecting claims 28, 33, 35, and 40 under 35 U.S.C.
§ 103 as unpatentable over Gorenbein and “The Dark Side of Nighttime
Driving” or claims 28, 34, 35, and 41 under 35 U.S.C. § 103 as unpatentable
over Gorenbein and Gorsek
SUMMARY
We reverse the rejection claims 28, 29, 31, 35, 36, and 38 under 35
U.S.C. § 102(b) as anticipated over Olmedilla.
We reverse the rejection of claims 28, 33, 35, and 40 under 35 U.S.C.
§ 103 as unpatentable over Olmedilla and “The Dark Side of Nighttime
Driving.”
We reverse the rejection of claims 28, 34, 35, and 41 under 35 U.S.C.
§ 103 as unpatentable over Olmedilla and Richter or Gorsek.
We affirm the rejection of claims 28-32 and 35-39 under 35 U.S.C.
§ 103 as unpatentable over Gorenbein.
We affirm the rejection of claims 28, 33, 35, and 40 under 35 U.S.C.
§ 103 as unpatentable over Gorenbein and “The Dark Side of Nighttime
Driving.”
We affirm the rejection of claims 28, 34, 35, and 41 under 35 U.S.C.
§ 103 as unpatentable over Gorenbein and Gorsek
9
Appeal 2016-008383
Application 14/497,802
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
10