Ex Parte Marfurt

Patent Trial and Appeal Board

Nov 2, 2017

13105375 (P.T.A.B. Nov. 2, 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.
13/105,375 05/11/2011 Karen L. Marfurt MSE-2730.1 3127
71331 7590
NIXON PEABODY LLP
70 West Madison, Suite 3500
CHICAGO, IL 60602
11/06/2017 EXAMINER
BARRON, SEAN C
ART UNIT PAPER NUMBER
1653
NOTIFICATION DATE DELIVERY MODE
11/06/2017 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):
docketingchicago @ nixonpeabody.com
ipairlink @ nixonpeabody. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte KAREN L. MARFURT1
Appeal 2016-006319
Application 13/105,375
Technology Center 1600
Before DEMETRA J. MILLS, FRANCISCO C. PRATS, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a
reactive formulation for measuring an analyte in a biological fluid, which
have been rejected as obvious. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
Appellant’s “invention generally relates to size self-limiting reagent
formulations used in optical or electrochemical methods to measure analytes
1 Appellant identifies the Real Party in Interest as Bayer Healthcare LLC,
Diabetes Care Division. (App. Br. 2.)
Appeal 2016-006319
Application 13/105,375
in biological fluids and test strips containing the reagent formulation.”
(Spec. 1|14.)
Claims 1-6, 8-10, 32-36, 38^13, 53-56, and 58 are on appeal.2
Claim 1 is illustrative:
1. A reactive formulation for measuring the amount of an
analyte in a biological fluid comprising:
(a) a water-soluble swellable polymer matrix including
water-insoluble particles having a nominal size of about 0.05 to
20 pm; and
(b) an enzyme system for reacting with said analyte,
wherein the weight ratio of said water-insoluble particles
to said water-soluble swellable polymer matrix is about 1/2 to
2.1/1, wherein the reactive formulation has a thickness of about
6 to 16 pm.
(App. Br. (Claims App. Al).)
Claim 32, the other independent claim, relates to a “test strip for
measuring the glucose content of whole blood samples” and includes, inter
alia, a reactive formulation, like recited in claim 1, in a “reagent layer” of
the test strip. {Id. at A2.)
2 Claims 59 and 60 have been cancelled (App. Br. 3), so the Examiner has
withdrawn the written description and obviousness rejections of those
claims. (Ans. 2; Adv. Act. 2.)
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Appeal 2016-006319
Application 13/105,375
The claims stand rejected as follows:
I. Claims 1-3, 6, 8-10, 32-34, 38^43, 53-56, and 58 under 35
U.S.C. § 103(a) over Doppelfeld,3 Johnson,4 Piejko,5 Ouyang,6
and Lange.7
II. Claims 1 and 2 under 35 U.S.C. § 103(a) over Doppelfeld,
Johnson, Piejko, Ouyang, Lange, and Siddiqi.8
III. Claims 4, 5, 35, and 36 under 35 U.S.C. § 103(a) over
Doppelfeld, Johnson, Piejko, Ouyang, Lange, and Kiser.9
I
The issue on appeal is whether a preponderance of the evidence
supports the Examiner’s conclusion that claims 1-3, 6, 8-10, 32-34, 38^13,
53-56, and 58 would have been obvious over Doppelfeld, Johnson, Piejko,
Ouyang, and Lange.
The Examiner finds that Doppelfeld “teaches a composition
comprising: a water-soluble swellable polymer (Cellulose hydrate or
hydrophilic polyamides), water insoluble particles to act as a distribution
layer, and glucose dehydrogenase,” and, thus, partly satisfies the elements of
independent claims 1 and 32. (Ans. 3.) The Examiner finds that
“Doppelfeld is silent if the cellulose hydrate or hydrophilic polyamide
polymers are water soluble and capable of swelling,” “Doppelfeld does not
3 Doppelfeld et al., US 4,808,529, issued Feb. 28, 1989.
4 Johnson, US 6,555,175 B2, issued Apr. 29, 2003.
5 Piejko, et al., US 4,780,411, issued Oct. 25, 1988.
6 Ouyang, et al., US 6,200,773 Bl, issued Mar. 13, 2001.
7 Lange et al., US 3,802,842, issued Apr. 9, 1974.
8 Siddiqi, US 4,438,067, issued Mar. 20, 1984.
9 Kiser et al., US 5,306,623, issued Apr. 26, 1994.
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Appeal 2016-006319
Application 13/105,375
teach a particle size of 0.05-20 pm,” “Doppelfeld does not teach a polymer
to particle ratio of 1:2 to 2:1,” and “Doppelfeld does not teach a composition
applied as a coating having a thickness of 6-16 pm.” {Id. at 4.) So, the
Examiner turns to Johnson, Piejko, and Lange.10
The Examiner finds that “Johnson teaches hydrophobic polymer
particle size of 10 nm through 1 mm,” and that “polymer particles have
broad application in medical and biological diagnostic assays, including
glucose test strips.” {Id. at 5.) The Examiner finds Piejko relates to test
strips for measuring an analyte, and teaches “a polymer:particle ratio of
1:100 to 2:1.” (Id.) And, the Examiner finds, Lange relates to test strips and
“teaches a composition comprising natural or synthetic polymers, further
structurally and functionally described as a meshwork of fibers, applied as a
coating having a thickness of 5-200 pm.” {Id. at 7.)
The Examiner concludes it would have been obvious to “add the
generic water-soluble and swellable polymers of Piejko to the methods of
making the polymer matrix of Doppelfeld.” {Id.) According to the
Examiner, the skilled person would have been motivated to do so “to
enhance absorption of aqueous solutions comprising analytes to be detected
and so reduce the reaction time because the water-soluble polymer would
draw in the analyte.” {Id.) The Examiner concludes it would have been
obvious to “substitute] the 10 nm-1 mm sized water-insoluble particles of
Johnson for the water-insoluble particles of indeterminate size of Doppelfeld
10 The Examiner’s findings about Ouyang appear to be specific to elements
of claim 32 that go beyond the elements found in both claims 1 and 32.
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Appeal 2016-006319
Application 13/105,375
because Johnson teaches water-insoluble particles that are 10 nm-1 mm in
size have broad application in biological diagnostic assays.” {Id. at 7-8.)
The Examiner further reasons the ordinarily skilled person would
have “a reasonable expectation of success in combining the water-soluble
polymer and water-insoluble particles of Doppelfeld in a ratio of 1:2 to 2:1
in view of the teachings of Piejko” and because the “ratio is an important
results effective variable.” {Id. at 8.) Also, according to the Examiner, the
skilled person would have “a reasonable expectation of success in
substituting the coating thickness of Lange for the thickness of the
composition of Doppelfeld [240 pm] because Lange teaches that a broader
range of thicknesses are suitable for applying a composition ... as a coating
to an article.” {Id. at 10; see also id. at 4.).) The Examiner asserts that
“substitution of the coating thickness of Lange for the thicknesses of
Doppelfeld would yield the predictable result of a coating thickness within
the claimed range of 6-16 [pm] ... of the instant invention, and likely
improve Doppelfeld’s invention as the biological fluid would diffuse faster
through a thinner layer.” {Id. at 10.)
The Examiner “bears the initial burden ... of presenting a prima facie
case of unpatentability.” In re Oetiker, 977 F.2d 1443, 1445 (Fed. Cir.
1992). On the record here, we are not persuaded the Examiner met the
burden to establish that claims 1 and 32 would have been obvious.
First, the Examiner has not provided sufficiently persuasive, evidence-
based reasons to explain why the skilled artisan would have selected
particles with the size claimed (about 0.05 to 20 pm) from the broad
disclosure of Johnson. As pointed out by Appellant, Johnson discloses that
polymers are used for everything from “filters and membranes” to “inkjet
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Appeal 2016-006319
Application 13/105,375
and liquid delivery print heads” to “oil and fuel additives.” (App. Br. 6-7;
see also Johnson 1:55—65.) The portion of Johnson cited by the Examiner
teaches “[pjolymer particles vary in size from about 10 nanometers to about
1,000 micrometers in diameter.” (Id. 10:53-55.) But this is merely a
generic teaching about potential polymer sizes irrespective of any particular
application. The Examiner, in suggesting all such polymers have application
in diagnostic assays (much less glucose strips), overstates Johnson’s
teachings. Examiner responds to Appellant’s argument by pointing to
Johnson’s disclosure related to polymer particles (2 to 200 pm) for liquid
chromatography. Yet Appellant provided persuasive rebuttal argument
distinguishing chromatography from the analyte/test strip art, and even more
specifically from Doppelfeld’s “distribution layer,” in which the Examiner
finds the claimed insoluble polymer particles. (Reply Br. 6; Doppelfeld
1:37—48.) Absent hindsight, we are thus unpersuaded the skilled person
would have predictably modified Doppelfeld’s insoluble particles to make
them in the size recited in claims 1 and 32.
Second, in response to the Examiner’s finding that Piejko teaches a
ratio of between 1:100 to 2:1 of the water-insoluble particles to the water-
soluble swellable polymer matrix, Appellant points out that the Examiner is
relying on a volume ratio, not a weight ratio as claimed. (App. Br. 8—10.)11
11 Appellant’s argument that “Piejko does not disclose, teach, or suggest
water-soluble swellable polymers whatsoever” is unpersuasive. (App. Br.
9.) Piejko teaches that suitable hydrophilic polymers include polyvinyl
alcohol and polyacrylic acid (Piejko 7:3-12), which may be combined with
insoluble polymer particles. (Id. Abstract.) Polyvinyl alcohol and
polyacrylic acid are listed as suitable compounds for forming the polymer
matrix according to the Specification. (Spec. 16, 35, 66.) The
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Application 13/105,375
The Examiner, while acknowledging this deficiency, invokes that it would
have been “routine optimization of a result effective variable” to arrive at the
claimed weight ratio in view of the disclosure of Piejko. (Ans. 18.) We are
not persuaded because the Examiner has not explained how the skilled
person would predictably arrive at the weight ratio claimed from Piejko’s
volume ratios of a hydrophilic phase to the organic phase. (Piejko 8:24—
28.)12
Third, the Examiner has not shown a clear teaching or suggestion in
the art of “the reactive formulation” or “reagent layer” that “has a thickness
of about 6 to 16 pm” as recited in claims 1 and 32 respectively. (App. Br.
(Al-2).) As Appellant persuasively argues, Lange’s indicator or reactive
layer is covered with a fine meshwork. {Id. at 9-10; see also Lange 3:28-37
and Fig. 1 (depicting meshwork (1) covering indicator layer (4).) This
meshwork may have a thickness of 5-200 pm, as the Examiner points out,
but we are unpersuaded Lange teaches or suggests that the indicator/reactive
layer should have a thickness of 6-16 pm like claimed. (Lange 4:19-28;
Ans. 7.) The Examiner is, in effect, mixing and matching sizes of different
structural features in the art without sufficient, evidence-based reasons for
modifying these features in the manner proposed.
Specification discloses these polymer compounds “have high solubility in
aqueous solution” and “rapidly swell when rehydrated in neutral pH
solutions such as whole blood.” {Id. ^ 35.)
12 Piejko does teach “the weight ratio of the at least one hydrophilic polymer
to the at least one hydrophobic polymer is between 10:1 and 1:10.” (Piejko
claim 3.) The Examiner, however, failed to identify this teaching in Piejko,
and it is thus not decisive in our analysis in this appeal.
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Application 13/105,375
The Examiner responds that “a thinner reactive layer as taught by
Lange as compared to Doppelfeld would be predictably advantageous by
improving diffusivity of the analyte and would likely reduce the time needed
in methods of detecting analytes.” (Ans. 18.) We are, however,
unpersuaded. Contrary to the Examiner’s assertion, Lange does not teach a
thinner reactive layer — it teaches a thin, unreactive mesh as already
explained. Also, the art generally teaches use of thicker reagent layers
compared to what is claimed. (See, e.g., Doppelfeld 5:20-55 (total thickness
of 240 pm); Spec. ^ 8 (“In general, relatively thick films of 200-400 pm
were deposited on substrate films in the [prior art] examples.”).) And
finally, the Examiner’s explanation for making a thinner reactive layer is
rooted in hindsight “wherein that which only the invention taught is used
against its teacher.” W.L. Gore & Assocs., Inc. v. Garlock, Inc., 721 F.2d
1540, 1553 (Fed. Cir. 1983). Indeed, it was Appellant, not the prior art, that
observed “[s]uch coatings [from 6 to 16 pm thick] are much thinner than
those commonly used in the art” and that “[i]t was surprising to find that
such thin layers could provide rapid and stable response.” (Spec. ^ 39; see
also id. 44-49 (Examples 1-4); see also Marfurt Decl. ^ 9 (“Rapid and
stable responses were surprisingly achieved using the reactive formulations
of the present invention.”)13.)
For the above reasons, the preponderance of the evidence relied upon
by the Examiner does not support a conclusion that claims 1 or 32 (or the
respective dependent claims) would have been obvious over Doppelfeld,
Johnson, Piejko, Ouyang, and Lange. Rejection I is, thus, reversed.
13 Declaration of Karen L. Marfurt, dated April 22, 2014.
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Appeal 2016-006319
Application 13/105,375
II & III
Rejections II and III rely on the combination of Doppelfeld, Johnson,
Piejko, Ouyang, and Lange. (Ans. 10-12.) The Examiner has not shown the
additional references of Siddiqi (Rejection II) or Kiser (Rejection III) make
up for the deficiencies of the combination of Doppelfeld, Johnson, Piejko,
Ouyang, and Lange described above. Rejections II and III are also reversed.
SUMMARY
We reverse the obviousness rejections on appeal.
REVERSED
9