Ex Parte Ollmar et al

Patent Trial and Appeal Board

Oct 27, 2016

11302498 (P.T.A.B. Oct. 27, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
111302,498 12/14/2005
127226 7590 10/31/2016
Birch, Stewart, Kolasch & Birch, LLP
P.O. Box 747
Falls Church, VA 22040-0747
FIRST NAMED INVENTOR
Stig Ollmar
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.
5808-0105PUS 1 1227
EXAMINER
NGUYEN, HUONG Q
ART UNIT PAPER NUMBER
3736
NOTIFICATION DATE DELIVERY MODE
10/31/2016 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):
mailroom@bskb.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STIG OLLMAR, ULRIK BIRGERSSON,
PETER ABERG, INGRID NICANDER,
and THIERRY CORMAN
Appeal2014-006128
Application 11/302,498
Technology Center 3700
Before JOHN C. KERINS, ANNETTE R. REIMERS, and
JAMES J. MAYBERRY, Administrative Patent Judges.
MAYBERRY, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Stig Olhnar et al. (Appellants) seek our review under 35 U.S.C. § 134
of the Examiner's Final rejection of claims 1, 6-20, 25-28, and 33--43. We
have jurisdiction under 35 U.S.C. § 6(b ).
We AFFIRM.
Appeal2014-006128
Application 11/302,498
CLAIMED SUBJECT MATTER
The claims are directed to a medical apparatus and method for
determining biological conditions using impedance measurements. Spec. 1,
11. 5-10. Claims 1, 20, and 28, are independent. Claim 1, reproduced below,
is illustrative of the claimed subject matter:
1. A medical apparatus for the diagnosing of a diseased
condition of the skin of a subject, comprising:
an electrically conducting probe including a plurality of
electrodes, each electrode comprising a base substrate and a
plurality of micro-needles, wherein said probe is adapted to be
placed against a surface of the subject such that said micro-
needles penetrate the stratum comeum, wherein said medical
apparatus is adapted to initiate an impedance measurement
session including passing an electrical current through the
electrodes to obtain values of skin impedance, and use reference
data to determine whether the obtained impedance values
indicate the diseased condition,
said micro-needles being integrally formed with said
substrate and arranged in a laterally spaced relationship apart
from each other and having a length being sufficient to
penetrate the stratum comeum, said micro-needles having a
substantially triangular cross-section parallel to the base
substrate along an entire length thereof, and said micro-needles
being arranged with at least one oblique surface extending from
a tip thereof to the base substrate such that the cross-section
parallel to the base substrate tapers continuously along the
entire length thereof from the base substrate to the tip, and
the substantially triangular cross-section at the bottom of
said micro-needles having two equal sides with a length of s 1
and a third side with a length of b 1, wherein s 1 is between 20
µm and 200 µm, and b 1 is between 20 µm and 200 µm.
Br. A-1, Claims App.
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Application 11/302,498
REFERENCES
The prior art relied upon by the Examiner in rejecting the claims on
appeal is:
Park
Allen
Kenan
Brenneman
Yuzhakov
Ollmar
US 2002/0082543 Al
US 2002/0138049 Al
US 2003/0078482 Al
US 2003/0236543 Al
US 2005/0209565 Al
EP 1 600 104 Al
REJECTIONS
June 27, 2002
Sept. 26, 2002
Apr. 24, 2003
Dec. 25, 2003
Sept. 22, 2005
Nov. 30, 2005
I. Claims 1, 6-20, 25-28, and 33--42 stand rejected under 35 U.S.C.
§ 112, second paragraph, as being indefinite.
II. Claims 1, 6-18, 20, 25-28, 33-39, and 43 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Ollmar, Brenneman, Park,
Allen, and Yuzhakov.
III. Claims 19 and 40--42 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Ollmar, Brenneman, Park, Yuzhakov, Allen, and
Kenan.
ANALYSIS
Rejection I
Independent claims 1, 20, and 28 each require an electrode of an
electrically conducting probe to comprise micro-needles, with the "micro-
needles having a substantially triangular cross-section parallel to the base
substrate" of the electrode. See Br. A-l-A-6, Claims App. (emphasis
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Application 11/302,498
added). The Examiner determines that the term "substantially" is a relative
term that renders the claims indefinite. Final Act. 2. The Examiner finds
that "the [S]pecification does not provide a standard for ascertaining the
requisite degree [attributable to the term 'substantially'], and one of ordinary
skill in the art would not be reasonably apprised of the scope of the
invention thus rendering the metes and bounds of the invention unclear." Id.
Appellants contend that the Manual of Patent Examining Procedure
(MPEP) expressly permits the use of the term "substantially." Br. 13
(referencing MPEP § 2173.0S(b )). Appellants argue that the Examiner's
rejection ignores the Patent Office's policy, as reflected in the MPEP, that
the term "substantially" is not indefinite. Id.
Appellants further contend that "the term 'substantially' is disclosed
in the [S]pecification." Br. 13 (referencing Spec. 6, 11. 32-33, which reads:
"each of the micro-needles is arranged with a substantially triangular cross-
section"). Appellants also identify the disclosure at page 11, lines 17-19 of
the Specification, which describes Figures 1 a, 1 b, 2a, and 2b and states
"[t]he dimensions bl and sl of the micro-needle will be substantially constant
along the height hl and will taper continuously in a direction from the
surface of the base substrate 12 along the height h2-hl." Id. Appellants
argue that "[i]n describing the relationship between the sides of the cross-
section which include the term 'substantially,' the [S]pecification makes
reference to the drawings where one can see the relationship between the
sides of the cross-section." Id.
Appellants finally argue that the Examiner's position seems to require
Appellants to provide a precise definition of the term "substantially," which
is not required by the case law. Br. 14.
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Application 11/302,498
Appellants' arguments do not inform us of Examiner error. As
Appellants recognize, "the term 'substantially' is a descriptive term
commonly used in patent claims to 'avoid a strict numerical boundary to the
specified parameter."' Ecolab, Inc. v. Envirochem, Inc., 264 F.3d 1358,
1367 (Fed. Cir. 2001). Although we agree with Appellants that the term
"substantially" is not per se indefinite, "[ w ]hen a 'word of degree' is used
[in a claim], [we] must determine whether the patent provides 'some
standard for measuring that degree."' Biosig Instruments, Inc. v. Nautilus,
Inc., 783 F.3d 1374, 1378 (Fed.Cir.2015). 1 "Claim language employing
terms of degree has long been found definite where it provided enough
certainty to one of skill in the art when read in the context of the invention."
Id. In addition, "[t]he degree of precision necessary for adequate claims is a
function of the nature of the subject matter." Id. at 1382
We agree with the Examiner that Appellants' Specification fails to
provide a standard for measuring the degree associated with the term
"substantially triangular." Appellants' reliance on the disclosure in the
Specification at page 6, lines 32-33 is unavailing. This disclosure merely
mimics the claim language-stating that each micro-needle has a
substantially triangular cross-section-and provides no further measure of
what constitutes "substantially triangular."
1 This statement of the law is consistent with the MPEP. See MPEP
§ 2173.05(b). Contrary to Appellants' characterization, the MPEP does not
provide a policy that the term "substantially" in a claim is definite. Instead,
it provides that "[t]erms of degree are not necessarily indefinite." Id. As the
MPEP makes clear, "when a term of degree is used in the claim, the
examiner should determine whether the specification provides some
standard for measuring that degree." Id.
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Application 11/302,498
Appellants' reliance on the disclosure at page 11, lines 17-19 of the
Specification is equally unavailing. This disclosure provides that the side
lengths of the triangle forming the triangular cross-section of the micro-
needle remain substantially constant from the base substrate of the micro-
needle to a height "hl" above the base substrate. See Spec. 11, 17-19; Fig.
1 a. As provided in this disclosure, the length of the two sides s 1 and third
side b 1 do not necessarily remain absolutely constant from the base substrate
of the micro-needle to a height "h 1" above the base substrate. However,
even if one or more of the lengths change, the shape of the cross sectional
area of the microneedle would remain a triangle. Tellingly, Figures 1 band
2b, the only illustrations of the cross-section of a micro-needle, depict needle
cross-sections that are exactly triangular in shape. See id., Figs. 1 b, 2b.
Appellants fail to identify any disclosure in the Specification that
indicates what is meant by a cross-section that is "substantially" triangular.
For example, would a cross section depicted in Figures 1 b and 2b, but with
comers that are rounded at the intersection of the sides instead of pointed, be
"substantially" triangular? Would a cross section with one or more of the
comers removed and replaced with a short line segment, thus forming a
four-, five-, or six-sided polygon be "substantially" triangular? We find that
the Specification does not disclose a standard to answer these questions.
Similarly, Appellants do not offer any evidence to support a finding
that, although the Specification does not provide a standard for measuring
the degree associated with the term "substantially," a person having ordinary
skill in the art would understand what the term "substantially" means in the
context of the claims. Cf Enzo Biochem, Inc. v. Applera Corp., 599 F.3d
1325, 1335 (Fed. Cir. 2010) (noting that, during prosecution of the claim at
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issue, the patentee relied on a declaration to overcome an indefiniteness
rejection concerning the term "substantially"). We agree with the Examiner
that an artisan of ordinary skill would not understand the scope of the
invention of claims 1, 20, and 28 without a standard for measuring the
degree associated with the term "substantially" in the Specification. See
Answer 2. The nature of the subject matter-a polygon-shaped cross-
section of a micro-needle---does not lend itself to an understanding of the
term "substantially."
The Examiner also rejects claims 11, 12, 15-17, 26, 27, 38, and 43 for
using the term "about." Final Act. 2. As with the term "substantially," the
Examiner determines that the term "about" is not defined in the claims. Id.
The Examiner finds that the Specification does not disclose a standard for
measuring the degree associated with the term "about" and that a person
having ordinary skill in the art would not understand the scope of the claims
without such a standard. Id. Appellants provide the same arguments with
respect to the term "about" as they made with respect to the term
"substantially." See Br. 13-14.
We determine that Appellants have the better argument for this issue.
"The use of the word 'about' avoids a strict numerical boundary to the
specified parameter. Its range must be interpreted in its technologic and
stylistic context." Pall Corp. v. Micron Separations, Inc., 66 F.3d 1211,
1217 (Fed. Cir. 1995). In each of the rejected claims, the term "about" is
used to modify a numerical value. Although we agree with the Examiner
that the Specification does not provide a standard for measuring the degree
associated with the term "about," we find that, in the stylistic context that the
term is used (modifying a numerical value), an artisan of ordinary skill
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would understand that the term "about" means within a small variation of
the modified value, such as to allow for manufacturing tolerances.
Accordingly, for the reasons above, we sustain the Examiner's
rejection of independent claims 1, 20, and 28 under 35 U.S.C. § 112, second
paragraph, as being indefinite for using the term "substantially." We also
sustain the Examiner's rejection of claims 6-19, 25-27, and 33--42, which
depend, directly or indirectly, from one of claims 1, 20, and 28. We do not
sustain the Examiner's further rejection of claims 11, 12, 15-17, 26, 27, 38,
and 43 under 35 U.S.C. § 112, second paragraph, as being indefinite for
using the term "about."
Rejection II
Independent claims 1, 20, and 28 each recite, in relevant part, "the
substantially triangular cross-section at the bottom of said micro-needles
having two equal sides with a length of s 1 and a third side with a length of
bl." See Br. A-1-A-6, Claims App. The Examiner relies on Yuzhakov for
teaching the above quoted subject matter, finding that Yuzhakov "teach[ es]
that it is [] well known in the art for analogous microneedles with triangular
cross sections to have specifically isosceles triangle configurations (at least
two equal sides)." Final Act. 5 (referencing Yuzhakov i-f 24).
Appellants contend that the micro-needle discussed in paragraph 24 of
Yuzhakov has a star-shaped cross-section, not a cross-section of an isosceles
triangle, that is, a triangle with at least two equal sides. Br. 16. As
Appellants explain, although each blade ofYuzhakov's micro-needle 900
has a cross-section of an isosceles triangle, the entire micro-needle has a
star-shaped cross-section. Id. Appellants argue that the Examiner fails to
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explain why a person of ordinary skill in the art would take the limited
teaching of the shape of part of a micro-needle to modify Ollmar's micro-
needle. Id. at 16-17. That is, if an artisan of ordinary skill did modify
Ollmar's micro-needle based on the teachings of Yuzhakov's micro-needle
900, then Yuzhakov's teachings would yield a micro-needle with a star-
shaped cross-section, not a triangular cross-section. Id.
The Examiner responds that Yuzhakov is used for the limited teaching
of a triangular cross section with two equal sides, as Brenneman, Park, and
Allen are relied on for the triangular cross-section of the micro-needle.
Answer 3.
We determine that Appellants have the better argument. "Rejections
on obviousness grounds cannot be sustained by mere conclusory statements;
instead, there must be some articulated reasoning with some rational
underpinning to support the legal conclusion of obviousness." KSR Int'! Co.
v. Teleflex Inc., 550 U.S. 398, 418 (2007) (quoting In re Kahn, 441 F.3d
977, 988 (Fed. Cir. 2006)). Here, the Examiner fails to articulate a
persuasive reason, supported by a rational underpinning, why a person
having ordinary skill in the art would modify Ollmar's micro-needle to form
a micro-needle with a cross-section of an isosceles triangle, based on
Yuzhakov's teaching of a micro-needle with a star-shaped cross-section,
with each blade of the star having a cross-section of an isosceles triangle.
The Examiner recognizes that Yuzhakov's micro-needle has a star-shaped
cross-section, yet fails to persuasively explain why an artisan of ordinary
skill would look to the shape of a single blade of Yuzhakov to modify the
triangular cross-sectioned micro-needle of the combined teachings of
Ollmar, Brenneman, Park, and Allen. See Answer 3.
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For the reason above, we do not sustain the Examiner's rejection of
claims 1, 6-18, 20, 25-28, 33-39, and 43 under 35 U.S.C. § 103(a) as being
unpatentable over Ollmar, Brenneman, Park, Allen, and Yuzhakov.
Re} ection III
In rejecting dependent claims 19 and 40-42, the Examiner relies on
Yuzhakov for disclosing the subject matter requiring "the substantially
triangular cross-section at the bottom of said micro-needles having two
equal sides with a length of s 1 and a third side with a length of b 1" of
independent claims 1 and 20, from which claims 19 and 40-42 ultimately
depend. See Final Act. 7. Accordingly, for the reason discussed above in
connection with our analysis of Rejection II, we do not sustain the
Examiner's rejection of claims 19 and 40-42 under 35 U.S.C. § 103(a) as
being unpatentable over Ollmar, Brenneman, Park, Yuzhakov, Allen, and
Kenan.
DECISION
We affirm the Examiner's rejection of claims 1, 6-20, 25-28, and 33-
42 under 35 U.S.C. § 112, second paragraph, as being indefinite.
We reverse the Examiner's rejection of claims 1, 6-18, 20, 25-28,
33-39, and 43 under 35 U.S.C. § 103(a) as being unpatentable over Ollmar,
Brenneman, Park, Allen, and Yuzhakov.
We reverse the Examiner's rejection of claims 19 and 40-4 2 under 3 5
U.S.C. § 103(a) as being unpatentable over Ollmar, Brenneman, Park,
Yuzhakov, Allen, and Kenan.
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No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a)(l )(iv).
AFFIRMED
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