Ex Parte Allgeyer

Patent Trial and Appeal Board

Aug 21, 2018

14859277 (P.T.A.B. Aug. 21, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/859,277
99803 7590
Samuel L. Alberstadt
801 Bermuda Court
Annapolis, MD 21401
09/19/2015
08/22/2018
FIRST NAMED INVENTOR
Dean 0. Allgeyer
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.
DEAN08 9913
EXAMINER
LUCK,SEANM
ART UNIT PAPER NUMBER
2881
MAIL DATE DELIVERY MODE
08/22/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte DEAN 0. ALLGEYER
Appeal2017-010198
Application 14/859,277
Technology Center 2800
Before ROMULO H. DELMENDO, CHRISTOPHER C. KENNEDY, and
MERRELL C. CASHION, JR., Administrative Patent Judges.
DELMENDO, Administrative Patent Judge.
DECISION ON APPEAL
The Applicant (hereinafter "Appellant") 1 appeals under 35 U.S.C.
§ 134(a) from the Primary Examiner's final decision to reject claims 2-7. 2
We have jurisdiction under 35 U.S.C. § 6(b).
We reverse.
1 The Appellant is the Applicant, "Dean 0. Allgeyer, MD, Inc.", which,
according to the Brief, is the real party in interest ( Appeal Brief filed
January 24, 2017 (hereinafter "Br.") 1).
2 Br. 4--13; Final Office Action entered July 25, 2016 (hereinafter "Final
Act.") 9-14; Examiner's Answer entered May 16, 2017 (hereinafter "Ans.")
2-8.
Appeal2017-010198
Application 14/859,277
I. BACKGROUND
The current application claims the benefit of an earlier filing date
under 35 U.S.C. § 120 as a continuation-in-part of Application 13/947,772,
filed July 22, 2013 (Specification filed September 19, 2015 (hereinafter
"Spec.") 1, 11. 4--7). That application is also on appeal (Appeal 2017-
010265) and is being decided concurrently herewith.
The subject matter on appeal relates to a system that includes a
spectroscopic analyzer, which may be used to verify pharmaceuticals as a
means to prevent medication errors (Spec. 1, 11. 8-17). Figure 4, reproduced
below from the Drawings filed September 19, 2015, is illustrative:
FIG. 4
~~ ... -.:-
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-.~:- ·--'.:':.-:.---":_~-~·~
~''Aff~~ti
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Appeal2017-010198
Application 14/859,277
Figure 4 above depicts a spectroscopic analyzer or spectrometer 7 for
reading the fluid contents of test chamber 3, which can be a quartz or plastic
cuvette that is filled to a minimum level 11 from an IV bag 10 and is
designed to provide a light path across which the spectrometer 7 performs its
analysis (id. at 10, 1. 13-12, 1. 17).
Representative claim 6, the sole independent claim on appeal, is
reproduced from the Claims Appendix to the Appeal Brief (Br. 19-20), with
key limitations emphasized, as follows:
6. A system for spectroscopically analyzing a
pharmaceutical fluid, comprising:
a spectrometer;
a test chamber in the spectrometer for rece1vmg the
pharmaceutical fluid, the test chamber also comprising a
translucent material that is transmissive of ultraviolet light; and,
wherein the test chamber and spectrometer are
configured to provide a fixed path for ultraviolet light to be
used in the quantitative application of Beer's law to the
pharmaceutical fluid and wherein the test chamber is
unshielded from ambient light.
II. REJECTIONS ON APPEAL
On appeal, the Examiner maintains two rejections under AIA 35
U.S.C. § 103 as follows:
A. Claims 2, 6, and 7 as unpatentable over Levenson et al. 3
(hereinafter "Levenson") in view of Maiefski et al. 4 (hereinafter
"Maiefski") and Schlaminger; and
B. Claims 3-5 as unpatentable over Levenson in view of Maiefski,
3 US 2010/0324505 Al, published December 23, 2010.
4 US 2004/0027568 Al, published February 12, 2004.
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Application 14/859,277
Schlaminger, and Kim et al. 5 (hereinafter "Kim").
(Ans. 2-8; Final Act. 2-5, 9-14.)6
III. DISCUSSION
The Examiner states that "Levenson teaches ... [a] system for
spectroscopically analyzing a pharmaceutical fluid" but, at the same time,
finds that "Levenson does not adequately teach ... a spectrometer" (Final
Act. 10). To account for this difference, the Examiner principally relies on
Maiefski (id. at 10-11). The Examiner finds further that Schlaminger
"teaches ... wherein the ultraviolet light is to be used in the quantitative
application of Beer[ ']s law to the pharmaceutical fluid" (id. at 11 ). The
Examiner then concludes (id.):
It would have been obvious to one of ordinary skill in art
at the time of the invention to combine the spectroscopic testing
of the fluid as in Maiefski with the apparatus of Levenson for the
benefit of ensuring sample purity. (Maiefski [0006])
It would have been obvious to one of ordinary skill in art
at the time of the invention to combine, if necessary, the use of
Schlaminger's apparatus to test via spectroscopic methods
according to Beer's law to the combination of Levenson and
Maiefski since Beer's law allows for the quantitative detection
of impurities. (Schlaminger [0002])
5 US 2010/0000304 Al, published January 7, 2010.
6 The Examiner states that a rejection under 35 U.S.C. § 112(b) of claim 7
and a provisional obviousness-type double patenting rejection of claims 2-7
as unpatentable over claims 2--4 and 8-13 of Application 13/94 7,772 have
been withdrawn (Ans. 2-3; Final Act. 6-9). Therefore, these rejections are
not before us. In addition, the Appeal Brief includes arguments that an
Amendment after Final Office Action should have been entered (Br. 1 7-18).
Such arguments concerning the entry of amendments relate to a petitionable
matter over which we have no jurisdiction under 35 U.S.C. §§ 6 and I34(a).
M.P.E.P. § 714.13 (Rev. 8.2017, Jan. 2018); 37 C.F.R. § 1.181.
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Appeal2017-010198
Application 14/859,277
The Appellant contends that the Examiner's rejections are flawed
because "Levenson has nothing to do with spectroscopy or any other form of
testing" (Br. 6) and that its combination with Maiefski, which does not
disclose an unshielded test chamber or a fixed, unshielded path for UV light
that can be used in a spectrometer, is based on hindsight (id. at 11-13).
Furthermore, the Appellant argues that "[t]he Examiner's citation to
Schlaminger as a third reference disclosing the use of Beer's law in
spectroscopy does not alter that conclusion" (id. at 11 ).
We agree with the Appellant that the Examiner's rejections are not
well-founded. Our reasons follow.
Levenson describes a device for administering a fluid, wherein the
device includes a ultraviolet light (UV) source positioned to direct UV light
through a window into a fluid chamber at an intensity sufficient to kill or
render non-reproducible at least one species of a microorganism in the fluid
while the fluid is in the chamber (Abst.). Specifically, Levenson's Figure 2
is reproduced as follows:
178
FIG.2
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Appeal2017-010198
Application 14/859,277
Levenson's Figure 2 above depicts a device 140 for administering a fluid
that is decontaminated with UV light into a vein 160, wherein the device 140
includes, inter alia, a fluid reservoir bag 178, a valve 179, a delivery tube
155, an injection cartridge 175, a sterilization cartridge 130 in a housing 120
that also holds a UV light source 125 powered by a power supply 127, and a
catheter 150 with a distal tip 156 (Levenson ,r,r 49--52). Levenson teaches
that one or more surfaces of the cassette 130 comprises a window 234 that
may be made of quartz or another UV-transmissive material (id. ,r 55).
Thus, as the Appellant points out (Br. 6), Levenson is not concerned with
spectroscopy, much less teach a system configured to analyze a
pharmaceutical fluid using spectroscopy.
Maiefski describes an apparatus for spectral analysis using UV and
visible light, wherein the apparatus is a spectrometer assembly for
simultaneously analyzing a plurality of sample flows (Maiefski ,r,r 1, 6; Fig.
1 ). According to Maiefski, the assembly includes a plurality of spectrometer
channels, each connectable to a respective one of the sample flows (Abst.;
Fig. 1 ). Maieski has not been shown to teach a spectrometer system of the
type recited in claim 6, wherein the test chamber is unshielded from ambient
light.
Although the Examiner states that a person having ordinary skill in
the art would have combined Maiefski with Levenson for the benefit of
ensuring sample purity (Final Act. 11 ), that reasoning-based solely on a
conclusory statement-lacks sufficient rational underpinning to support the
obviousness conclusion. Indeed, the articulated reason is found only in the
Appellant's own Specification (Spec. 1, 11. 8-11). Although obviousness
may be predicated upon an analysis that is not limited solely to the prior art
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Application 14/859,277
teachings, the Examiner does not offer any acceptable reasoning other than
impermissible hindsight based on the Inventor's own disclosure. Moreover,
consistent with the Appellant's position (Br. 11-12), the Examiner does not
explain how Levenson's fluid delivery system would be modified in view of
Maiefski to arrive at the Appellant's claimed invention. Therefore, we
cannot sustain the rejections. In re Kahn, 441 F.3d 977, 988 (Fed. Cir.
2006) (cited with approval in KSR Int'! Co. v. Teleflex, Inc., 550 U.S. 398,
418 (2007)).
IV. SUMMARY
Rejections A and Bare not sustained. Therefore, the Examiner's final
decision to reject claims 2-7 is reversed.
REVERSED
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