Ex Parte Schraa et al

Patent Trial and Appeal Board

Jun 6, 2017

12669895 (P.T.A.B. Jun. 6, 2017)

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.
12/669,895 08/31/2010 Olaf Schraa ECC-6801 7945
30452 7590 06/07/2017
EDWARDS T TFFSr’TFNr’FS TORPOR ATTON
EXAMINER
LEGAL DEPARTMENT AGAHI, PUYA
ONE EDWARDS WAY
IRVINE, CA 92614 ART UNIT PAPER NUMBER
3735
MAIL DATE DELIVERY MODE
06/07/2017 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 OLAF SCHRAA, BOB SCHRAA, and
JOS J.G.M. SETTELS
Appeal 2016-001080
Application 12/669,8951
Technology Center 3700
Before ULRIKE W. JENKS, JOHN G. NEW, and
DEVON ZASTROW NEWMAN, Administrative Patent Judges.
NEWMAN, Administrative Patent Judge.
DECISION ON APPEAL
This appeal under 35 U.S.C. § 134 involves claims to a cuff for
determining a physiological parameter. The Examiner entered final
rejections that the claims are indefinite and obvious.
We have jurisdiction under 35 U.S.C. § 6(b). We AFFIRM.
1 Appellants identify the Real Party in Interest as BMEYE B.V. App. Br. 2.
Appeal 2016-001080
Application 12/669,895
STATEMENT OF THE CASE
Background
The Specification discloses that a disadvantage of prior art cuffs is
that:
both the back-layer and the top-layer of the inflatable bladder
deform to some extent due to applied cuff pressure. This may
result in inaccurate reading of physiological parameters such as
blood pressure of the cuff due to a changing angle of reflection
for a reflective set-up, or a displacement between, for example,
the emitter and detector for a transmissive set-up.
Spec. 1: 24—2:2.
The Specification discloses:
a photoplethysmograph arranged with
an emitter for emitting a radiation in a direction of a tissue
to be investigated;
a detector for detecting the radiation from the tissue; and
an inflatable bladder for transferring pressure to the tissue,
said inflatable bladder comprising a back-layer and a top-layer,
wherein the top-layer is conceived to be brought in contact with
the tissue, the top-layer being substantially more flexible than the
back-layer.
Spec 2:10-18.
The Claims
Claims 1, 3—7, 9, 14—19, 21, and 22 are pending and on appeal. App.
Br. 3. Sole independent claim 1 is illustrative and reads as follows, with the
relevant claim language emphasized:
1. A cuff for determining a physiological parameter, comprising:
a photoplethysmograph including an emitter configured to
emit radiation in a direction of a tissue to be investigated;
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Application 12/669,895
a detector configured to detect the radiation from the
tissue; and
an inflatable bladder configured to transfer pressure to the
tissue, said inflatable bladder comprising a back-layer and a top-
layer,
wherein the top-layer is configured to be brought into
contact with the tissue,
wherein the back-layer comprises a flexible substantially
non-elastic material which does not undergo deformation under
application of a suitable internal cuff pressure and the top layer
comprises a flexible substantially elastic material which does
undergo deformation under application of the suitable internal
cuff pressure, and
wherein the back-layer and the top layer have
substantially the same thickness.
App. Br. 16 (Claims App.).
The Issues
The following rejections are before us to review:
Claims 1, 3—7, 9, 14—19, 21, and 22 are rejected under pre-AIA 35
U.S.C. § 112 (second paragraph), as indefinite. Non-Final Act.2 2.
Claims 1, 3—7, 9, 14, and 17—19 are rejected under 35 U.S.C. § 103(a)
as obvious over Boehmer3 and Voith.4 Non-Final Act. 4.
Claim 15 is rejected under 35 U.S.C. § 103(a) as obvious over
Boehmer and Voith in view of Chin.5 Non-Final Act. 6.
2 Examiner’s Non-Final Action, mailed April 21, 2014 (“Non-Final Act.”).
3 US 4,726,382, issued Feb. 23, 1988 (“Boehmer”).
4 US 5,840,036, issued Nov. 24, 1998 (“Voith”).
5 US 2002/0038082 Al, published Mar. 28, 2002 (“Chin”).
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Claim 16 is rejected under 35 U.S.C. § 103(a) as obvious over
Boehmer and Voith in view of Banet.6 Non-Final Act. 7.
Claims 21 and 22 are rejected under 35 U.S.C. § 103(a) as being
unpatentable over Boehmer, Voith, and Chesney.7 Non-Final Act. 8.
INDEFINITENESS
The Examiner finds that:
Claim 1, and all dependent claims thereof, recites “a flexible
substantially nonelastic material”, “a flexible substantially
elastic material”, and “substantially the same thickness” which
renders the claim indefinite. The term “substantially” in claim 1
is a relative term which renders the claim indefinite. The term
“substantially” is not defined by the claim, the specification does
not provide a standard for ascertaining the requisite degree, and
one of ordinary skill in the art would not be reasonably apprised
of the scope of the invention.
Non-Final Act. 2.
Issue
The issue before us is: Did the Examiner err in concluding that the
claim language “a flexible substantially nonelastic material”, “a flexible
substantially elastic material”, and “substantially the same thickness”
renders claim 1 indefinite?
Analysis
Appellants argue that “substantially” is a commonly used term in
patent parlance that is approved by our reviewing Court for use in the
manner employed by Appellants. App. Br. 5—7. We agree that “terms in the
6 US 2007/0276262 Al, published Nov. 29, 2007 (“Banet”).
7 US 6,048,318, issued April 11, 2000 (“Chesney”).
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claims such as ‘approach each other,’ ‘close to,’ ‘substantially equal,’ and
‘closely approximate’ ... are ubiquitous in patent claims. Such usages,
when serving reasonably to describe the claimed subject matter to those of
skill in the field of the invention, and to distinguish the claimed subject
matter from the prior art, have been accepted in patent examination and
upheld by the courts.” Andrew Corp. v. Gabriel Electronics, Inc., 847 F.2d.
819, 821 (Fed. Cir. 1988). Our reviewing court has held that prior to
issuance, the test for indefiniteness under 35 U.S.C. § 112, second paragraph
is a “lack of clarity (in its several forms) based on the perspective of one of
ordinary skill in the art in view of the entire written description and
developing prosecution history.” In re Packard, 751 F.3d 1307, 1312 (Fed.
Cir. 2014).
The issue then becomes: did Appellants’ use of “substantially” in each
case sufficiently describe the claimed subject matter to the skilled artisan
and distinguish the claimed subject matter from the prior art?
Appellants argue that the first two uses of “substantially” in claim 1
describe the relative performance of materials under stress, e.g.,: “In this
patent application, a non-elastic material does not deform appreciably under
stresses below the material’s fairly high yield strength. An elastic material,
in contrast, deforms readily under even rather moderate stress levels.” App.
Br. at 6. Appellants note that the Specification contains specific definitions
of “elastic material” (“comprises at least any material having a tensile stress
at 50% strain of less than 5 MPa”) and “non-elastic material” (“comprises at
least any material having a yield strength of more than 50 MPa”). Id.
Appellants further argue that “‘non-elastic’ and ‘elastic’ materials are purely
theoretical; no such perfect materials exist anywhere in nature . . . modifying
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those terms with ‘substantially’ in fact provides a somewhat truer
representation of the actual physical reality than would use of either term
unmodified and alone.” Id. at 7—8.
Similarly, Appellants argue that the third use of “substantially” in the
claim language “the back-layer and the top layer have substantially the same
thickness . . . reflects the true physical reality of the world somewhat better
than would the bare unmodified ‘the same[]’ [because] the thicknesses of
two different physical items will always be different.” Id. at 9. According
to Appellants, this use of “substantially” “conveys the ordinary, everyday
sense that the two thicknesses are fundamentally the same, reasonably the
same, nearly the same, that the difference between the two layers’
thicknesses are merely minor and thus insubstantial, etc..'’’ Id. at 9—10.
The Examiner has the better position. As the Examiner found,
Appellants’ Specification does not define “substantially” or provide
examples indicating what would or would not constitute “substantially
elastic,” “substantially non-elastic,” or “substantially the same thickness.”
Thus, the Specification does not satisfy Appellants’ obligation to define their
claims with particularity.
We acknowledge Appellants’ argument that the Specification informs
the skilled artisan that an inelastic material suitable for use with the claimed
invention should have a yield strength of close to > 50 MPa, and that the top
layer should use elastic material having a tensile stress that is close to 50%
strain of less than 5 MPa. App. Br. 6. However, the skilled artisan is
without guidance as to how “close” these measurements must be to fall
within the claim term “substantially”. In addition, no guidance is provided
for how “substantially the same thickness” should be interpreted.
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Appellants have not met the burden set forth in Packard of either
modifying the word substantially, providing a separate definition of the word
substantially, or providing a persuasive explanation as to why the word
substantially is not unclear in the context of claim 1. Appellants focus on
the limited information provided in the Specification regarding single
measurement points of tensile stress and yield strength does not address the
core question at hand: what does the word “substantially” mean as it is
recited in claim 1?
Appellants do not answer this question and does not provide any
evidence as to how a person of skill would understand “substantially” aside
from an implied understanding by one of skill in the art. App. Br. 6—10. We
find that the claims, read in light of the Specification, fail to inform the
skilled artisan with reasonable certainty as to the metes and bounds of
“substantially” in any of the three uses in claim 1 such that the skilled artisan
could distinguish their subject matter from the prior art. Accordingly, we
affirm the Examiner’s rejection of claims 1, 3—7, 9, 14—19, 21, and 22 as
indefinite under 35U.S.C. § 112.
OBVIOUSNESS
Appellants address the four obviousness rejections together on appeal.
See App. Br. 10-14. We agree that the same issues are relevant to all
rejections and consider the rejections together.8 In addition, because
8 As we discussed above, we find the limitations of “substantially elastic,”
“substantially non-elastic,” and “substantially the same thickness” to be
indefinite in the appealed claims. While Steele counsels that a prior art
rejection cannot be sustained if the hypothetical person of ordinary skill in
the art would have to make speculative assumptions concerning the meaning
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Appellants argue only the patentability of claim 1 (App. Br. 15), and do not
separately argue the rejections of claims 3—7, 9, 14, and 17—19 under
35 U.S.C. § 103(a) as obvious over Boehmer and Voith, the rejection of
claim 15 under 35 U.S.C. § 103(a) as obvious over Boehmer and Voith in
view of Chin, or the rejection of claim 16 under 35 U.S.C. 103(a) as obvious
over Boehmer and Voith in view of Banet, we focus our analysis on claim 1.
Claims 2—5, 10, 13, 25, and 31—61 will stand or fall with claim 1. 37 C.F.R.
§41.37 (c)(l)(iv).
The Examiner finds that Boehmer teaches:
a cuff for determining a physiological parameter . . . ,
comprising: a photoplethysmograph including an emitter
configured to emit a radiation in a direction of a tissue to be
investigated . . . ; a detector configured to detect the radiation
from the tissue . . . ; an inflatable bladder configured to transfer
pressure to the tissue . . . , said inflatable bladder comprising a
back-layer and a top-layer, wherein the top-layer is conceived to
be brought into contact with the tissue . . . , wherein the back-
layer comprises a flexible substantially non-elastic material . . .
which does not undergo deformation a suitable internal cuff
pressure and the top layer comprises a flexible substantially
elastic material which undergoes deformation under application
of the suitable internal cuff pressure.
Non-Final Act. 4.
In short, the Examiner concludes Boehmer discloses all elements of
claim 1 except that “Boehmer does not explicitly show the thickness of the
coated mylar strip 56 (i.e. back layer), in particular the thickness of the
of claim language, see In re Steele, 305 F.2d 859, 862 (CCPA 1962), we
address the obviousness rejections with respect to these claims in the
interests of compact prosecution.
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mylar strip having substantially the same thickness as the inner urethane film
with thickness of about 1-2 mils (i.e. top layer).” Id. at 4—5. The Examiner
finds “Voith teaches [a] blood pressure measuring apparatus (title) including
a protective layer 34 of film, such as Mylar, and [a thickness of] about 1-2
mils”. Id. at 5.
The Examiner concludes that the skilled artisan would have found it
obvious “to modify Boehmer’s mylar strip to match the same thickness of
Voith’s mylar layer because doing so would provide protection to
surrounding layers in a cuff configuration and using 1-2 mils thickness for a
mylar strip is known in the art.” Id.
We agree with the Examiner that Boehmer and Voith establisha prima
facie case of obviousness. Boehmer discloses a “cuff. . . comprised of an
inflatable bladder that contacts the patient[’s] finger.” Boehmer, Abstract.
Boehmer discloses a light source and light detector connected to the inner
surface of a flexible circuit {id. at 3:41—43) with the component wires of the
circuit connected “to the electronic circuitry used with the blood pressure
monitoring equipment.” Id. at 3:64-4:2. The circuit is adhered to the
inflatable bladder with a double-sided adhesive mylar strip, and “which
covers entirely the metalized layer 14 of inflatable bladder 12, thus
providing an adhesive as well as electrical insulation.” Id. at 4:5—8. Voith
also discloses an “inflatable bladder 12 [that] comprises two pieces of
material such as urethane film of the same general dimensions and which are
heat sealed together about their periphery forming there between an
inflatable chamber.” Id. at 2:65—3:1. The inner urethane film that faces the
patient[’s] finger “preferably . . . has a thickness of about 1—2 mils.” Id. at
3:4—5.
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Voith discloses a blood pressure monitoring system comprising a cuff
placed around the arm. Voith, Abstract. Voith discloses that the cuff
includes a transducer for measuring blood pressure (a physiological
parameter). Id. at 4:14—19. Voith discloses that “[a] protective layer 34 of
film, such as Mylar, and about 1-2 mils, thick is laminated to the film 30
above the electrodes”. Id. at 4:34—36.
Issue
The issue with respect to this rejection is whether a preponderance of
the evidence supports the Examiner’s conclusion that Boehmer and Voith
suggest the subject matter of claim 1.
Analysis
We adopt and incorporate by reference the Examiner’s findings and
conclusions with respect to these references as presented in the Non-Final
Action and Answer. Non-Final Act. 4—9; Ans. 5—7. The findings of fact
included in the analysis below are provided only to highlight certain
evidence of record relevant to our analysis.
We agree with the Examiner that the cuff of claim 1 would have been
obvious based on Boehmer and Voith. Boehmer suggests a cuff that meets
all of the limitations of claim 1 except that it does not expressly disclose that
the film above the electrodes (the “back-layer” of claim 1) is “substantially
the same thickness” as that of the “front-layer”. However, Voith describes a
cuff for measuring a physiological parameter (blood pressure) that employs
a mylar film of the exact dimensions used by Boehmer, 1—2 mils. Thus, we
agree with the Examiner that it would have been obvious to the skilled
artisan to use a back-layer of the same dimension as the front-layer, as
taught by Voith.
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Appellants concede that Boehmer and Voith are analogous art (App.
Br. 12) but argue that because the cuffs are used on different body parts
(fingers in Boehmer and arms in Voith) the teachings are not combinable.
Specifically,
the locations and flows of blood through the vessels in these body
parts differ substantially [,] [tjhere is thus no reason to assume
that a configuration - and in particular a detailed parts dimension
- useful or optimal in one type of device will necessarily be
optimal or even applicable in the other.
App. Br. 11-12.
Appellants’ argument on this point is not persuasive. The cuffs of
Boehmer and Voith are both used on cylindrical body parts to measure a
physiological parameter. Appellants do not provide evidence that the
configuration in Voith, specifically the use of a mylar film of 1—2 mils as a
back-layer, would not work in Boehmer, particularly as Boehmer discloses
use of urethane film of precisely the same dimension. Appellants’
arguments without more do not meet this requirement. See In re Geisler,
116 F.3d 1465, 1470 (Fed. Cir. 1997) (“[Attorney argument [is] not the
kind of factual evidence that is required to rebut a prima facie case of
obviousness”). See also Leapfrog Enters., Inc. v. Fisher-Price, Inc., 485
F.3d 1157, 1162 (Fed. Cir. 2007) (citing KSR Int 7 Co. v. Teleflex Inc., 550
U.S. 398, 416 (2007) (finding appealed claims unpatentable because
Appellant provided no evidence that the claimed difference in size was
“uniquely challenging or difficult for one of ordinary skill in the art” as it
pertained to modifying the prior art as suggested the Examiner).
Appellants also argue:
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the operations of the inflatable bladders in the two types of
device [s] are substantially different [because i]n Boehmer’s
device — and in the device described in the current application -
pressure is applied via the inflatable bladder and varied
continuously, so that a dynamic trace can be taken of the
patient’s blood pressure as it varies over the complete cardiac
cycle.
App. Br. 12. Appellants argue this differs from Voith’s cuff, “in which a
relatively high pressure is applied at the start to occlude blood flow through
the vessel [and] is then released slowly while characteristic sounds are
listened for, until the pressure drops to a point where blood flow can resume
in the vessel.” Id. at 12—13. According to Appellants, because the pressure
in Voith’s cuff is “driven, controlled, and applied much less dynamically and
continuously than in cuffs of the type described in Boehmer or the present
application”, one cannot assume the materials and parts of Voith could be
compatible. Id. at 13.
Appellants’ argument on this point is not persuasive. Appellants do
not provide evidence to show or persuasively explain why different
mechanisms of operating of the bladder would prevent the skilled artisan
from using a back-layer of the same dimension as the front layer. The
claimed bladder must only be “configured to transfer pressure to the tissue,”
which both bladders disclosed in Boehmer and Voith accomplish. We
conclude that one of ordinary skill in the art would have had a reasonable
expectation of success in using a back-layer of the same thickness as the
front layer based on the combined disclosures of Boehmer and Voith.
“Obviousness does not require absolute predictability of success. ... For
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obviousness under § 103, all that is required is a reasonable expectation of
success.” In re O’Farrell, 853 F.2d 894, 903-04 (Fed. Cir. 1988).
Appellants further argue that Boehmer’s cuff already has a mylar
layer, thus “there is no reason to believe that making the thickness 1—2 mils
as it is in Voith would provide any improvement to Boehmer.” App. Br. 13.
Appellants further speculate that the existing layer could already be thicker
or need to be thinner than 1—2 mils, and that modifying it could be
detrimental to operation of the cuff. Id. As Boehmer is silent about the
thickness of the mylar layer on the back of the cuff and states no thickness
requirement tied to bladder performance (notably, claim 1 also lacks this
element), we are not persuaded that this a reason the skilled artisan would
find the absence of Boehmer’s disclosure to be a reason to avoid using a
layer of the thickness taught in Voith.
Finally, Appellants argue that “nowhere in the art cited thus far is it
taught that those [the thicknesses of Boehmer and Voith] should correspond.
Nowhere, that is, outside of the current applicants’ own specification and
claims” and assert that the Examiner’s rejection is based on impermissible
hindsight. App. Br. 14.
We are not persuaded. While we are fully aware that hindsight bias
may plague determinations of obviousness, Graham v. John Deere Co., 383
U.S. 1,36 (1966), we are also mindful that the Supreme Court has clearly
stated that the “combination of familiar elements according to known
methods is likely to be obvious when it does no more than yield predictable
results.” KSR, 550 U.S. at 416. In the instant case, Appellants point to no
evidence that any of the Examiner’s findings were beyond the level of
ordinary skill at the time of the invention or could have been taken only
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from Appellants’ Specification. See In re McLaughlin, 443 F.2d 1392, 1395
(CCPA 1971). Accordingly, we affirm the rejection of claim 1 as obvious.
Having not been argued separately, we likewise affirm the rejection of
claims 3—7, 9, 14—19, 21, and 22.
As discussed above, Appellants have waived arguments directed to
Chin, Banet, and Chesney. We therefore also affirm the rejection of claims
15, 16, 21, and 22 over the combination of those references with Boehmer
and Voith. See Hyatt v. Dudas, 551 F.3d 1307, 1314 (Fed. Cir. 2008) (“In
the event of such a waiver, the PTO may affirm the rejection of the group of
claims that the examiner rejected on that ground without considering the
merits of those rejections.”).
SUMMARY
We affirm the rejection of claims 1, 3—7, 9, 14—19, 21, and 22 as
indefinite under 35U.S.C. § 112.
We affirm the rejection of claims 1, 3—7, 9, 14, and 17—19 under 35
U.S.C. § 103(a) as obvious over Boehmer and Voith.
We affirm the rejection of claim 15 under 35 U.S.C. § 103(a) as
obvious over Boehmer and Voith in view of Chin.
We affirm the rejection of claim 16 under 35 U.S.C. § 103(a) as
obvious over Boehmer and Voith in view of Banet.
We affirm the rejection of claims 21 and 22 under 35 U.S.C. § 103(a)
as obvious over Boehmer, Voith, and Chesney.
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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
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