Ex Parte Walker

Patent Trial and Appeal Board

May 24, 2016

12442972 (P.T.A.B. May. 24, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
12/442,972 0312612009
23347 7590 05/26/2016
GLAXOSMITHKLINE
GLOBAL PATENTS
FIVE MOORE DR., PO BOX 13398
MAIL STOP: 5.5A
FIRST NAMED INVENTOR
Dwight Sherod Walker
RESEARCH TRIANGLE PARK, NC 27709-3398
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.
PR62142USw 5216
EXAMINER
LEE, SHUNK
ART UNIT PAPER NUMBER
2884
NOTIFICATION DATE DELIVERY MODE
05/26/2016 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):
USCIPRTP@GSK.COM
PATRICIA.T.WILSON@GSK.COM
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DWIGHT SHEROD WALKER
Appeal2014-006468
Application 12/442,972
Technology Center 2800
Before BRADLEY R. GARRIS, GEORGE C. BEST, and
BRIAND. RANGE, Administrative Patent Judges.
BEST, Administrative Patent Judge.
DECISION ON APPEAL
The Examiner finally rejected claims 22 and 24 of Application
12/442,972 under 35 U.S.C. § 103(a) as obvious. Final Act. (August 27,
2013). Appellant1 seeks reversal of the rejection pursuant to 35 U.S.C.
§ 134(a). We have jurisdiction under 35 U.S.C. § 6.
For the reasons set forth below, we AFFIRM.
1 Glaxo Group Ltd. d/b/a GlaxoSmithKline is identified as the real party in
interest. Appeal Br. 3.
Appeal2014-006468
Application 12/442,972
BACKGROUND
The '972 Application describes methods for analyzing the properties
of a pharmaceutical composition using a luminescence detection system.
Spec. 1. Claim 22 is representative of the '972 Application's claims and is
reproduced below:
22. A method of in-situ analysis of a pharmaceutical
composition during processing, the pharmaceutical composition
having at least one constituent that emits luminescence in
response to applied radiation, the method consisting essentially
of the steps of:
providing a processing apparatus configured to process
the pharmaceutical composition;
providing a luminescence detection system operatively
associated with said processing apparatus, said detection system
including at least one luminescence sensor having an integral
low current light source having a plurality of light emitting
diodes each of which is adapted to transmit light hainvg [sic] a
wavelength in the range of approximately 300-650 nm, said
sensor being operable with a power input and being adapted
and positioned to direct a plurality of radiation pulses to the
pharmaceutical composition and detect the luminescence solely
emitted from the at least one constituent, said sensor being
further adapted to provide at least one luminescence signal
representing said detected luminescence, and a control module
adapted to control the activation of said power input to said
sensor, and an analyzer adapted to analyze said luminescence
signal;
illuminating the pharmaceutical composition with at least
a respective one of said plurality of radiation pulses;
detecting said luminescence emitted solely from the at
least one constituent; and
determining at least one characteristic of the
pharmaceutical composition from said detected luminescence;
wherein said at least one constituent is selected from the
group consisting of anti-allergies, bronchodilators, beta
2
Appeal2014-006468
Application 12/442,972
agonists, anti-inflammatory steroids, antidiabetic drugs,
antihyperglycemic drugs, anticholinergics and angiotensin-
converting enzyme (ACE) inhibitors.
Appeal Br. 18-19 (Claims App.).
REJECTION
Claims 22 and 24 are rejected under 35 U.S.C. § 103(a) as
unpatentable over the combination of Lakowicz2 and Roscoe. 3 Final Act. 2.
DISCUSSION
Appellant argues that the rejection should be reversed because: (1) the
cited prior art does not describe or suggest each limitation of the claimed
invention, Appeal Br. 12-13; (2) Lakowicz's method requires the addition of
a "likely toxic sensing fluorophore material" to the sample to be tested, id. at
13; (3) the Examiner's rejection "is dependent on claim 22 being considered
completely anticipated by Lakowicz," id. at 14; and (4) the Examiner
impermissibly relied upon hindsight in rejecting claims 22 and 24, id. at 14--
15. We address these arguments seriatim.
First, Appellant argues that the combination of Lakowicz and Roscoe
does not describe or suggest every limitation in claims 22 and 24. Final
Act. 12-13. In particular, Appellant argues:
Lakowicz' method lacks" .. . an explicit description that said at
least one constituent is selected from the group consisting of
anti-allergies, bronchodilators, beta agonists, anti-
injlammatory steroids, antidiabetic drugs, antihyperglycemic
drugs, anticholinergics and angiotensin-converting enzyme
2 US 6,806,089 Bl, issued October 19, 2004.
3 US 2005/0065062 Al, published March 24, 2005.
3
Appeal2014-006468
Application 12/442,972
(ACE) inhibitors" (Office Action, page 5, lines 4-7, emphases
added) and ... at least one constituent comprises salmeterol and
fluticasone propionate (Office Action, page 5, lines 7-8).
Therefore, it is clear the entirety of Applicant's invention is not
disclosed in the cited prior art.
Id. at 12-13.
This argument is not persuasive because it does not address the
Examiner's findings of fact regarding Roscoe. In rejecting claims 22 and
24, the Examiner found that Lakowicz describes every limitation of claim 22
(including determining a characteristic of a pharmaceutical composition)
except for "an explicit description that said at least one constituent is
selected from the group consisting of' several classes of pharmaceutical
compositions. Final Act. 2--4. The Examiner further found that a person
having ordinary skill in the art at the time of the invention would have
interpreted Lakowicz' s failure to describe a specific compound as the
subject of its assay as a suggestion that Lakowicz's methods could be used
to test "any of the known conventional samples that did not require a
detailed description." Id. at 4. The Examiner then turned to Roscoe for a
description of samples comprising any of several broad classes of
pharmaceutical compositions including those specified in claim 22. Id.
Based upon these findings, the Examiner reasoned that a person of ordinary
skill in the art would have used the samples described in Roscoe as the
(unspecified) sample in Lakowicz, and the results of the substitution would
have been predictable. Id. at 4--5.
In other words, Roscoe demonstrates a market pressure to formulate
various pharmaceutical constituents, and a person of ordinary skill would
have had good reason to pursue the known of option of trying to detect those
constituents using the drug detection system of Lakowicz. Based on the
4
Appeal2014-006468
Application 12/442,972
teachings of Lakowicz, the person of skill would have expected success in
using Lakowicz in this known manner. Cf KSR Int 'l Co. v. Teleflex Inc.,
550 U.S. 398, 421 (2007).
Second, Appellant argues that "Lakowicz' method require[s] that a
sample, summarized in the previous sentence, be combined with a likely
toxic sensing fluorophore material, the sensing fluorophore. Toxic materials
cannot become pharmaceuticals, as common sense suggests." Appeal
Br. 13.
This argument is not correct because "the dose makes the poison."
Contrary to Appellant's assertion, toxic materials can become
pharmaceuticals. Indeed, there are many examples of toxic materials that
are the active ingredient in pharmaceutical compositions---e.g., botulinum
toxin (Botox), digitalis (digitalis), and most chemotherapeutic agents.
Appellant has not established that Lakowicz's method requires the use of a
sensing fluorophore in toxic amounts. See also Answer 4.
Third, Appellant argues that the rejection "is dependent on claim 22
being considered completely anticipated by Lakowicz." Appeal Br. 14.
This argument is not persuasive. The Examiner expressly found that
Lakowicz does not anticipate claim 22. Final Act. 4. The Examiner,
however, further explained that a person having ordinary skill in the art at
the time of the invention would have concluded that Lakowicz broadly
describes a method for analyzing a wide range of samples, including
samples comprising drugs. Id. The Examiner then relied upon Roscoe as
describing categories of drugs that could be present in samples tested by
Lakowicz's method. Id.
5
Appeal2014-006468
Application 12/442,972
Fourth, Appellant argues that the Examiner impermissibly relied upon
hindsight in rejecting claims 22 and 24. Appeal Br. 14--15. In particular,
Appellant argues:
Neither Lackowicz [sic] nor Roscoe teach or suggest the
full scope of Applicant's invention. Both references fail to
explicitly describe and include anti-allergies, bronchodilators,
beta agonists, anti-inflammatory steroids, antidiabetic drugs,
antihyperglycemic drugs, anticholinergics, ACE inhibitors,
salmeterol and fluticasone propionate. Let alone do they teach
or suggest to one of skill in the art to take the sensor, in
Lakowicz, used to measure fluorescence intensity in human skin
combine that with the method of making pharmaceutical
compositions, in Roscoe, using model compounds to measure
diffusion across a membrane to build Applicant's invention.
Without question, this is an example of the use of hindsight by
the Office. Such an approach is not appropriate. See e.g., [sic,
See e.g.,] Sensonics Inc. v. Aerosonic Corp., 81 F.3d. [sic] 1566,
1570, 38 USPQ2d 1551, 1554 (Fed. Cir. 1996).
Id. at 15.
This argument is not persuasive. As discussed above, the Examiner
made findings of fact sufficient to conclude that the combination of
Lakowicz and Roscoe rendered claims 22 and 24 prima facie obvious.
Based upon the record before us, Appellant has not demonstrated reversible
error in the Examiner's findings of fact or conclusions of law.
CONCLUSION
For the reasons set forth above, we affirm the rejection of claims 22
and 24 of the '972 Application.
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
6