Ex Parte Perez et al

Patent Trial and Appeal Board

Sep 29, 2016

12797854 (P.T.A.B. Sep. 29, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121797,854 06/10/2010
41577 7590 10/03/2016
Woodard, Emhardt, Moriarty, McNett & Henry LLP
Roche Diagnostics Operations, Inc. (PD)
111 Monument Circle, Suite 3700
Indianapolis, IN 46204-5137
Edward Perez
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.
007404-001090 21373 US6 5724
EXAMINER
TOWA,RENET
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
10/03/2016 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):
DocketDept@uspatent.com
pair_roche@firsttofile.com
meg.ward@contractors.roche.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte EDWARD PEREZ, CHARLES C. RANEY, and PAUL PATEL
Appeal2013-005185
Application 12/797,854
Technology Center 3700
Before KEN B. BARRETT, BRANDON J. WARNER, and
LEE L. STEPINA, Administrative Patent Judges.
WARNER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Edward Perez et al. ("Appellants") 1 appeal under 35 U.S.C. § 134(a)
from the Examiner's decision rejecting claims 1-18, which are all the
pending claims. Appeal Br. 6. We have jurisdiction over the appeal under
35 U.S.C. § 6(b).
We REVERSE.
According to Appellants, the real party in interest is Roche
Diagnostics Operations, Inc. Appeal Br. 4.
Appeal2013-005185
Application 12/797,854
CLAIMED SUBJECT MATTER
Appellants' disclosed invention "relates to the sampling of a bodily
fluid obtained from an incision in the skin, and more particularly to
acquiring the fluid by capillary action." Spec. 1.2 Claims 1, 5, and 11 are
independent. Claims 1 and 11, reproduced below with emphasis added, are
illustrative of the subject matter on appeal.
1. A method for expressing and testing bodily fluid
obtained from an incision in the skin, the method comprising:
attaching a first disposable test strip to a lancing device
with a lancet, the first disposable test strip including a test strip
integrally formed with a first constricting member, a first fluid
passageway, and a first test area;
bulging the skin toward an opening to the first fluid
passageway and expressing bodily fluid from the incision by
pressing skin-engaging surfaces of the first constricting member
against the skin and moving the skin-engaging surfaces toward
one another, wherein the opening to the first fluid passageway
is located on the surface of the first test strip adjacent the first
constricting member;
lancing the bulged skin with the lancet to create an
mc1s10n;
drawing the bodily fluid by capillary action from the skin
through the opening and along the first fluid passageway to the
first test area, the first test area being in fluid communication
with the first fluid passageway;
testing the bodily fluid in the first test area;
removing the first test strip from the lancing device and
disposing of the first test strip; and
2 We note that Appellants' Specification does not provide line or
paragraph numbering; accordingly, reference herein is made only to page
numbers.
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Appeal2013-005185
Application 12/797,854
attaching a second disposable test strip to the lancing
device, the second disposable test strip including a second
constricting member, a second fluid passageway, and a second
test area.
11. An apparatus for expressing and testing bodily fluid
obtained from an incision in the skin, the apparatus comprising:
a lancing device for forming an incision in the skin; and
an integrated test strip with a bottom surface; said test
strip attached to said lancing device during sampling with said
test strip bottom surface facing the skin, said integrated test
strip including:
a constricting member for constricting the skin,
said constricting member integrally formed with said test
strip and extending from said test strip bottom surface to
at least two skin-engaging surfaces,
a fluid passageway for collecting bodily fluid, said
fluid passageway integrally formed with said test strip
and including an opening on the surface of said test strip
adjacent said constricting member; wherein said skin-
engaging surfaces move closer together and draw the
skin inward toward said opening as said at least two skin-
engaging surfaces contact and are pressed against the
skin,
a test area including a test reagent for testing
bodily fluid, said test area integrally formed with said test
strip and in fluid communication with said fluid
passageway; and
wherein said integrated test strip, said constricting
member, said fluid passageway and said test area are
removable from said lancing device as a single unit and are
disposable as a single unit.
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Appeal2013-005185
Application 12/797,854
EVIDENCE
The Examiner relied on the following evidence in rejecting the claims
on appeal:
Douglas us 5,951,493 Sept. 14, 1999
Cunningham US 6,306, 104 B 1 Oct. 23, 2001
Nishikawa US 6,315,738 Bl Nov. 13, 2001
Prausnitz US 6,743,211 Bl June 1, 2004
REJECTIONS
The following rejections are before us for review:
I. Claims 1, 2, 4, 5, 8-12, 17, and 18 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Nishikawa and
Douglas. Final Act. 2-7.
II. Claims 3, 6, 7, and 13-15 stand rejected under 35 U.S.C.
§ 103(a) as being unpatentable over Nishikawa, Douglas, and
Prausnitz. Id. at 7-8.
III. Claim 16 stands rejected under 35 U.S.C. § 103(a) as being
unpatentable over Nishikawa, Douglas, Prausnitz, and
Cunningham. Id. at 8-9.
IV. Claims 1-14 and 16-18 stand rejected under 35 U.S.C. § 103(a)
as being unpatentable over Nishikawa and Cunningham. Id. at
9-15.
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Appeal2013-005185
Application 12/797,854
ANALYSIS
All the claims recite, in relevant part, a disposable "test strip" that is
integrally formed with a constricting member, a fluid passageway, and a test
area. See Appeal Br., Claims App. Appellants argue that Nishikawa, as
relied on by the Examiner, does not disclose such a "test strip," as recited in
the claims, when this term is interpreted as one of ordinary skill in the art
would understand it. See Appeal Br. 18-22; Reply Br. 5-11. For the
reasons that Appellants advance, we agree that the Examiner's broad
interpretation of "test strip," and thus the corresponding reliance on
Nishikawa, is unreasonable.
In rejecting the claims, the Examiner relied on Nishikawa's second
housing 3 as disclosing the recited "test strip." Final Act. 2---6 (citing
Nishikawa, col. 7, 11. 11-13, 27-30; col. 10, 11. 20-25; col. 12, 11. 47-59;
col. 14, 11. 66----67; col. 15, 11. 1--40; Figs. 4, 6, 13-23). The Examiner makes
it clear in the Answer that "the entire component 3 of Nishikawa is
[considered to be] a 'test strip' based on the customary meaning obtained
from the instant specification, drawings[,] and the prior art." Ans. 20
(emphasis added); see id. at 16-21. The Examiner specifically states that the
rejection relied on the entire "component 3 of Nishikawa, including the
opening 31, passageway 33, the body fluid detection means 32, and the
housing 32a," as "constitut[ing] a 'test strip"' as claimed.3 Id. at 19.
3 We note that Nishikawa itself expressly identifies a "test strip"
differently than the Examiner, disclosing that, in the embodiment relied on
by the Examiner, "a test strip is used in the body detection means," both of
which are identified interchangeably with reference number 32, with the test
strip being secured in "test strip holder" 36, which is formed as a recess in
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Appeal2013-005185
Application 12/797,854
We understand the Examiner's point to be that a "test strip," as
claimed, may be formed as an assembly of multiple elements. See id. at
17-21 (including reproductions of figures and accompanying glossaries of
terms for asserted "test strips" of the present invention, Douglas '713,4 and
Nishikawa). This general point is well taken; in fact, the recited "test strip"
includes multiple "integrally formed" or "integrated" components. See
Appeal Br., Claims App.; see also Spec. 20-22; Figs. 11-14. Be that as it
may, such an assembly of multiple elements must still take the form of a
"test strip," as that term would be understood by one of ordinary skill in the
art, in order to fall within the scope of the present claims.
During patent examination, claims are to be given their broadest
reasonable interpretation consistent with the specification, with claim
language being read in light of the specification as it would be interpreted by
one of ordinary skill in the art. See In re Am. Acad. of Sci. Tech Ctr., 367
F.3d 1359, 1364 (Fed. Cir. 2004); see also In re Cortright, 165 F.3d 1353,
1358 (Fed. Cir. 1999) (although an examiner must give claims their broadest
reasonable interpretation, this interpretation must be consistent with the one
that one of ordinary skill in the art would reach). Thus, in the absence of
any special definition in the specification, claim terms are to be given their
plain meaning-that is the ordinary and customary meaning for a person of
ordinary skill in the art-unless the plain meaning would be inconsistent
with the specification. See In re Zletz, 893, F.2d 319, 321 (Fed. Cir. 1989);
"test strip housing" 32a. Nishikawa, col. 9, 11. 49-52 (emphasis added);
Figs. 3, 4; see id. col. 9, 1. 49- col. 10, 1. 26; Figs. 18-21.
4 We note that this reference (US 5,872,713, issued Feb. 16, 1999) is of
record in the present case, but is not relied on for any rejection before us for
review as part of the present appeal.
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Application 12/797,854
see also MPEP § 2111.01. Here, a plain meaning of "strip" is "a long
narrow piece of a material," which is consistent with the use of this term
within Appellants' Specification. See Merriam-Webster's Collegiate
Dictionary (I Ith ed. 2003); see also Spec. 20-22; Figs. 11-14.
Accordingly, a "test strip," in the context of the claim language, would be
such a long narrow piece of a material that is used for biological testing.
The entire component 3 of Nishikawa (described as being a second
housing), 5 as relied on in the rejections, is not a long narrow piece of
material. 6 See, e.g., Nishikawa, Figs. 1--4, 18-21. This is contrary to the
structure of claimed test strip 26, which is a long narrow piece of material.
See, e.g., Figs. 11-14. Consequently, the Examiner's reliance on the entire
component 3 of Nishikawa as meeting the recited disposable "test strip" that
is integrally formed with a constricting member, a fluid passageway, and a
test area, as claimed, is not supported by a preponderance of the evidence.
We note that each of Douglas, Prausnitz, and Cunningham is relied on for
teaching additional claimed elements, but not to cure the deficiency of
Nishikawa identified above. See Final Act. 7-15.
In brief, Appellants persuasively assert that the Examiner has
misconstrued the scope of the claims and, in doing so, has failed to establish
a supported finding that Nishikawa discloses a "test strip" that is integrally
5 In particular, Nishikawa describes and depicts second housing 3 as
a resin-formed container with a relatively substantial height that must be
"capable of holding the first housing 2 [which itself contains sleeve 21 and
lancet 4] in its interior." Nishikawa, col. 7, 11. 33-37 (boldface omitted); see
id. col. 9, 1. 31-col. 10, 1. 26; col. 8, 1. 66-col. 9, 1. 7; col. 9, 11. 60-61;
Figs. 1--4, 18-21.
6 As may be expected, however, Nishikawa's test strip 32 is a long
narrow piece of material. See supra note 3.
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Appeal2013-005185
Application 12/797,854
formed with a constricting member, a fluid passageway, and a test area, as
recited in the claims. Accordingly, because Rejections I-IV are premised on
a claim interpretation that is unreasonably broad, as discussed supra, we do
not sustain these rejections.
DECISION
We REVERSE the Examiner's rejections of claims 1-18.
REVERSED
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