Ex Parte Girina et al

Patent Trial and Appeal Board

Jan 10, 2019

14123743 (P.T.A.B. Jan. 10, 2019)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
14/123,743 12/03/2013
7733 7590 01/10/2019
WALKER & JOCKE
231 SOUTH BROADWAY STREET
MEDINA, OH 44256
FIRST NAMED INVENTOR
Marina Borisovna Girina
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.
MINIMAX-1001 US 5636
EXAMINER
PARK, PATRICIA JOO YOUNG
ART UNIT PAPER NUMBER
3793
MAIL DATE DELIVERY MODE
01/10/2019 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 MARINA BORISOVNA GIRINA and
IV AN IV ANOVICH GIRIN
Appeal 2017-011462
Application 14/123,743
Technology Center 3700
Before JEFFREY N. FREDMAN, DEBORAH KATZ, and JOHN G. NEW,
Administrative Patent Judges.
KATZ, Administrative Patent Judge.
DECISION ON APPEAL
Appellants 1 seek our review, under 35 U.S.C. § 134(a), of the
Examiner's decision to reject claims 3-5 and 13-15 (Appeal Brief filed May
26, 2017 ("App. Br."), 2). Claims 6--8, 16, and 17 are withdrawn from
consideration. Id.
1 The inventors of the application are the real parties in interest. (App. Br.
2.)
Appeal 2017-011462
Application 14/123,743
We have jurisdiction under 35 U.S.C. § 6(b). We reverse proforma
the rejections under 35 U.S.C. § 103, and enter new grounds of rejection.
Analysis
Obviousness under 35 U.S.C. § 103
The Examiner rejects Appellants' pending claims under 35 U.S.C.
§ 103 over either Gladshtein (US 2013/0324866 Al, published December 5,
2013), and Grunwald (US 2007/0016072 Al, published January 18, 2007) or
Gladshtein and Grunwald along with other references. 2 (See Final Office
Action mailed November 1, 2016 ("Final Act."), 6-11).
As explained below in the new grounds of rejection for lack of written
description and indefiniteness, substantial confusion exists in the record as to
the proper interpretation and scope of the appealed claims. Presently, the
claims on appeal do not adequately and clearly reflect what the disclosed
invention is. Rather than speculate further about how the present claims
compare to the methods disclosed in the cited prior art, we reverse proforma
the rejections under 35 U.S.C. § 103 at this time. Cf In re Steele, 305 F.2d
859, 863 (CCPA 1962) ("We believe that this confusion arose and has
continued because the claims do not particularly point out and distinctly
claim the invention as required by 35 U.S.C. § 112."). This proforma
2 Specifically, the Examiner rejects claims 3 and 14 over Gladshtein and
Grunwald; claim 4 over Gladshtein, Grunwald, and Chmiel (US 4,327,739,
issued May 4, 1982); claim 5 over Gladshtein, Grunwald, Makin (US
2006/0079868 Al, published April 13, 2006) and Salzman (US
2013/0331704 Al, published December 12, 2013); claim 13 over
Gladshtein, Grunwald, and Kljushnik (US 2007/0275097 Al, published
November 29, 2007); and claim 15 over Gladshtein, Grunwald, Makin,
Salzman, and Keller (US 2008/0260646 Al, October 23, 2008).
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Application 14/123,743
reversal does not limit the citation of the same ( or different) prior art against
the claims in the future, should the rejections under 35 U.S.C. § 112 be
overcome through continued prosecution. 3 As in Steele, "[ o ]ur decision is
not to be construed as meaning that we consider the claims on appeal to be
patentable [over the prior art] as presently drawn." Id.
New Grounds of Rejection
We enter new grounds of rejection. We reject claims 3-5 and 12-15
as failing to meet the written description requirement under 35 U.S.C. § 112,
first paragraph, and for being indefinite under 35 U.S.C. § 112, second
paragraph. We discuss each of these rejections in tum.
Written Description under 3 5 U.S. C § 112, first paragraph
We reject claims 3-5 and 12-15 as failing to meet the written
description requirement under 35 U.S.C. § 112, paragraph. In particular, we
find that the claims on appeal recite new matter that is not supported by the
Specification as filed.
Appellants' Specification provides a method for determining blood
flow characteristics by setting a Doppler ultrasound transducer into the
projection of a single blood vessel or microcirculatory section. (See
Specification ("Spec.") 4: 14--22.) The method may include concurrently
determining quantitative characteristics in the single blood vessel and
3 For example, although the Gladshtein provisional applications (Nos.
61/631,923 and 61/463,049) may not support the claim element of "at the
least one site of catheterization," laser Doppler, and frequency range, these
features may be taught by Grunwald and/or Chmiel.
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Application 14/123,743
microcirculatory section. (Id. at 6:3-10.) The method also may include
displaying the generated data on a screen. (Id. at 7:8-10.) In an application
of the method, the Specification describes using high-frequency ultrasound
Doppler flowmetry for intraoperative monitoring and assessment of blood
flow in the coronary arteries and microvasculature section of the
myocardium. (Id. at 11:9-11.)
Appellants' independent claim 3 recites:
A method of blood flow evaluation comprising:
(a) determining characteristics of blood flow within a
single blood vessel at the at least one site of
catheterization,
(b) determining, concurrently with the determination of
(a), characteristics of blood flow within a
microcirculatory section of a tissue at the at least one
site of catheterization,
wherein determining in (a) and (b) includes
analyzing qualitative and quantitative
characteristics of the blood flow in the single
vessel of (a) and the microcirculatory section of
the tissue of (b ), using at least one ultrasonic
Doppler continuous wave blood flowmeter,
( c) providing visual outputs corresponding to the
qualitative and quantitative characteristics determined
in (a) and (b) through at least one visual display in
operative connection with the at least one flowmeter.
(App. Br. 33, Claims App.) Claim 3 was added to the application in a
preliminary amendment and further amended to add the limitations of
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Application 14/123,743
"analyzing qualitative and quantitative characteristics of blood flow ...
using at least one ultrasonic Doppler continuous wave blood flowmeter" and
"providing visual outputs corresponding to the qualitative and quantitative
characteristics determined in (a) and (b) .... " (See App. Br. 33, Claims
App'x; Spec. 19-21; Amendment filed April 7, 2016.) As explained below,
these limitations lack sufficient support in the Specification as filed.
We begin with the term "qualitative characteristics" of blood
flow, which is recited throughout the claim. Appellants do not direct
us to, and we cannot find, a specific definition of the term
"qualitative" in the Specification. (See App. Br. 2-3, Summary of the
Claimed Subject Matter.) Indeed, the word "qualitative" is absent
from the Specification, including the original claims as filed. (See
Spec.) While the Specification provides numerous examples of
quantitative measurements, such as blood oxygen saturation, there is
no discussion or example of "qualitative characteristics." (See id.)
A description adequate to satisfy 35 U.S.C. § 112, first
paragraph, must 'clearly allow persons of ordinary skill in the
art to recognize that [the inventor] invented what is claimed.'
In other words, the test for sufficiency is whether the disclosure
of the application relied upon reasonably conveys to those
skilled in the art that the inventor had possession of the claimed
subject matter as of the filing date.
Ariad Pharms., Inc. v. Eli Lilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010)
(en bane) (citations omitted). In the absence of identified support for
"qualitative characteristics," and in the absence of any specific examples of
such "qualitative characteristics," we find that Appellants' Specification
does not indicate that the inventors were in possession of a method for
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Application 14/123,743
"analyzing qualitative and quantitative characteristics of blood flow" as
required by claim 3 ( emphasis added).
Appellants' claim 3 also recites "providing visual outputs
corresponding to the qualitative and quantitative characteristics ... through
at least one visual display." As discussed above, we do not find support for
"qualitative characteristics." Moreover, there is no explanation in the
Specification of how qualitative characteristics, in addition to quantitative
characteristics, are displayed. Rather, every discussion of visual outputs in
the Specification refers to displaying data, i.e. quantitative characteristics, on
a connected visualization unit. (See Spec. 5-7.) There is no discussion of
how, or in what format, visual outputs of qualitative characteristics of blood
flow are generated or displayed. In the absence of any such explanation in
the specification, we find that Appellants' Specification does not indicate
that the inventors were in possession of a method for "providing visual
outputs corresponding to the qualitative and quantitative characteristics."
Appellants' claim 3 further recites "using at least one ultrasonic
Doppler continuous wave blood flowmeter." The Specification describes a
prior art device "with an operating frequency of 8 MHz in the CW Doppler
mode," i.e., continuous wave Doppler mode. (Spec. 1-2.) However, the
Specification distinguishes the device, stating that the operating frequency is
"significantly less than 20 MHz, which does not allow for a clear signal
.... ") Id.
Referring to the invention, the Specification describes evaluating the
use of a "high-frequency ultrasound Doppler flowmeter device." (Spec. 11.)
However, as explained in the prior art cited by the Examiner, several types
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Application 14/123,743
of Doppler techniques including continuous wave (CW) and pulsed wave
(PW) were known for measuring blood flow. (See Grunwald ,r 123.) While
it may have been obvious to use a continuous wave blood flowmeter in view
of the prior art, a description that merely renders the invention obvious does
not satisfy the written description requirement. See Ariad, 598 F.3d at 1352.
In the absence of any description of a method of using continuous wave
Doppler ultrasound, we find that Appellants' Specification does not indicate
that the inventors were in possession of a method of "using at least one
ultrasonic Doppler continuous wave blood flowmeter."
Because Appellants' Specification fails to provide written description
support for numerous claim limitations added by amendment, we find that
claims 3-5 and 12-15 do not meet the written description requirement under
35 U.S.C. § 112, first paragraph.
Definiteness under 35 U.S. C. § 112, second paragraph
We enter a new ground of rejection of claims 3-5 and 12-15 as being
indefinite under 35 U.S.C. § 112(b ). In particular, we determine that the
claim term "qualitative" as referenced throughout the claims is ambiguous
and vague. See In re Packard, 751 F.3d 1307, 1312 (Fed. Cir. 2014).
As discussed above, "qualitative" is entirely absent from the
Specification, including the original claims as filed. (See Spec.) Therefore,
there is no specific definition of the term "qualitative" in the Specification.
The common meaning of "qualitative" is relating to the quality of something
rather than its quantity. However, Appellants appeared to disclaim this
meaning during the prosecution of the application. (See App. Br. 18-20.)
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In particular, Appellants argue that neither Gladshtein nor Grunwald
teach determining qualitative blood flow characteristics or providing visual
outputs corresponding to the determined characteristics. (App. Br. 18-20.)
Specifically, Appellants argue that although Gladshtein analyzes signals to
identify a vasoconstriction condition or other parameter of interest, at best
Gladshtein discloses the display of a value corresponding to pressure wave
signals. (Id., see also Reply Br. 12.) Appellants argue that Grunwald
teaches a device used to "determine blood flow direction, nothing more."
(App. Br. 19-20.) Both vasoconstriction and blood flow direction appear to
be qualitative rather than quantitative measurements, however, these are
distinguished by Appellants. (See id.) Appellants' remaining references to
"qualitative characteristics" in the prosecution merely argue that this feature
is missing in the prior art, rather than provide any meaning or explanation of
the term. (See id.)
Given the lack of clarity in the Specification and prosecution history
as to the meaning of "qualitative" recited by the claims, we conclude that
claims 3-5 and 13-15 do not satisfy the definiteness requirement under 35
U.S.C. § 112(b).
Conclusion
The Examiner's rejections of claims 3-5 and 13-15 as obvious under
35 U.S.C. § 103 are proforma reversed.
We have also entered new grounds of rejection for claims 3-5 and 12-
15 pursuant to 37 C.F.R. § 4I.50(b). 37 C.F.R. § 4I.50(b) provides that "[a]
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Application 14/123,743
new ground of rejection ... shall not be considered final for judicial
review."
37 C.F.R. § 4I.50(b) also provides that the Appellants:
WITHIN TWO MONTHS FROM THE DATE OF THE
DECISION, must exercise one of the following two options
with respect to the new ground of rejection to avoid termination
of the appeal as to the rejected claims:
( 1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating
to the claims so rejected, or both, and have the matter
reconsidered by the examiner, in which event the prosecution
will be remanded to the examiner ....
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same record ....
( emphasis added).
REVERSED
37 C.F.R. § 4I.50(b)
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