Ex Parte Passlick-Deetjen et al

Patent Trial and Appeal Board

Aug 31, 2018

11596181 (P.T.A.B. Aug. 31, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE
11/596,181 11/13/2006
86723 7590 08/31/2018
Kilyk & Bowersox, P.L.L.C.
400 holiday Court, Suite 102
Warrenton, VA 20186
FIRST NAMED INVENTOR
Jutta Passlick-Deetjen
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.
P7 l 551USO (3192-066) 7236
EXAMINER
CHOI, FRANK I
ART UNIT PAPER NUMBER
1616
MAIL DATE DELIVERY MODE
08/31/2018 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 JUTTA P ASSLICK-DEETJEN, THOMAS P. SCHAUB, and
GEORG TOPP 1
Appeal2017-000440
Application 11/596, 181
Technology Center 1600
Before DEMETRA J. MILLS, ERIC B. GRIMES, and
JEFFREY N. FREDMAN, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35 U.S.C. § 134(a) involving claims to a set
for use in peritoneal dialysis, which have been rejected as obvious. We have
jurisdiction under 35 U.S.C. § 6(b ).
We affirm-in-part.
STATEMENT OF THE CASE
The Specification states that, "[ d]uring the dialysis treatment, there is
a transfer of numerous blood components, inter alia of sodium ions, from the
1 Appellants identify the Real Party in Interest as Fresenius Medical Care
Deutschland GmbH. Appeal Br. 3.
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Application 11/596, 181
blood of the patient to the dialysate via the peritoneum." Spec. 1. The
Specification discloses that known peritoneal dialysis solutions having
sodium concentrations of 120 mmol/I2 or 134 mmol/1 have disadvantages.
Id. at 2-3. The Specification discloses "a solution for peritoneal dialysis
which has a blood pressure-lowering effect and in which the side effects
known by the use of peritoneal dialysis solutions with a low sodium content
do not occur." Id. at 3.
Claims 1, 3, 6-8, 14, 15, and 17 are on appeal. Claim I is illustrative
and reads as follows:
1. A set for use in peritoneal dialysis, the set comprising
two separate solutions, a first separate solution and second
separate solution, wherein the first separate solution includes an
osmotic agent and a physiolocially [ sic, physiologically]
compatible acid,
wherein when the two separate solutions are mixed to
form a mixed solution, the mixed solution contains sodium ions
in a concentration in the range from 124 to 126 mmol/1 and
chloride ions in a concentration in the range from 91-94
mmo 1/1.
DISCUSSION
The Examiner has rejected all of the claims on appeal under 35 U.S.C.
§ 103 (a) as obvious based on Duponchelle, 3 Elisabettini, 4 and Shockley5
(Non-Final Action6 3). The Examiner finds that Duponchelle discloses "a
2 The terms "mmol/1 " "mmol/L " and "mM" are equivalent and are used
' ' interchangeably in this opinion.
3 US 6,309,673 Bl; Oct. 30, 2001.
4 US 2003/0138501 Al; July 24, 2003.
5 US 5,589,197; Dec. 31, 1996.
6 Office Action mailed June 9, 2015.
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Application 11/596, 181
two part peritoneal dialysis solution which is contained in a two-chambered
container where ... one chamber can contain dextrose, calcium chloride,
magnesium chloride and an acid and the other chamber can contain sodium
chloride, lactate and bicarbonate." Id. The Examiner finds that Duponchelle
also discloses that the solution obtained by mixing the contents of the two
chambers contains 100-150 mM sodium and 70-120 mM chloride, among
other things. Id.
The Examiner finds that Elisabettini similarly discloses a two-part
dialysis solution, where the mixed solution contains 100-600 mmol/L
sodium and 70-130 mmol/L chloride. Id. at 3--4. The Examiner finds that
Shockley discloses "discloses a low sodium peritoneal dialysis solution"
containing, among other things, about 125 meq/L 7 sodium and 0-100 meq/L
chloride. Id. at 4. The Examiner concludes that the set of claim 1 would
have been obvious based on the teachings of the cited references. Id. at 3-5.
We agree with the Examiner that the cited references support a prima
facie case of obviousness with respect to claim 1. Duponchelle discloses
"peritoneal dialysis solutions ... formulated and stored in at least two
parts-an alkaline bicarbonate concentrate and an acidic concentrate."
Duponchelle 4: 17-22. Duponchelle discloses that the solutions can be
stored in a container having a first chamber and a second chamber. Id. at
4:33--44.
[I]n an embodiment, the first chamber 12 contains a dextrose
concentrate, whereas the second chamber contains a
7 Appellants acknowledge that "1 mEq of Na+ is equal to 1 mmol thereof.
Similarly, 1 mEq of c1- is equal to 1 mmol thereof." Appeal Br. 15,
footnote 4. Thus, Shockley's units of mEq/L are equivalent to claim 1 's
units of mmol/1.
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Application 11/596, 181
bicarbonate concentrate. In a preferred embodiment, the first
chamber 12 further includes calcium chloride, magnesium
chloride and a physiologically tolerable acid to adjust the pH of
the acidic concentrate. The second chamber 14 can further
include sodium chloride and lactate.
Id. at 6:60-66. Dextrose is an osmotic agent, as recited in claim 1. See
Spec. 5 ("osmotic agent (for example glucose)"; dextrose (as disclosed in
Duponchelle) is simply the D-isomer of glucose; see Elisabettini ,r 29 ("In an
embodiment, the bicarbonate-based solution includes ... anhydrous glucose
or dextrose, hydrous glucose or dextrose.").
Thus, Duponchelle discloses a set for peritoneal dialysis comprising a
first separate solution that includes an osmotic agent and a physiologically
compatible acid. Duponchelle also discloses that, when the two solutions in
its set "are mixed together to form a ready-to-use solution for peritoneal
dialysis ... the subsequent dialysis solution contains the following
ingredients in the identified amount: ... sodium ( 100 to 150 mM); ...
chloride (70 to 120 mM)." Id. at 7:53---63. Duponchelle therefore discloses
a set for peritoneal dialysis having solutions that include the same
components as recited in claim 1 on appeal, and combine to form a dialysis
solution having amounts of sodium and chloride that encompass those
recited in claim 1.
Elisabettini similarly discloses a solution that "includes at least two
separate components including a bicarbonate concentrate and an electrolyte
concentrate which can be readily and sterilely mixed to form a ready-to-use
formulation for patient administration" for "dialysis therapy." Elisabettini
,r 26. Elisabettini discloses that an embodiment of its solution contains
about 100-160 mmol/L sodium and about 70-130 mmol/L chloride, among
other things. Id. ,r 30.
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Shockley discloses "an improved peritoneal dialysis solution."
Shockley 2: 15-16. Shockley discloses "specific examples of peritoneal
solutions of [its] invention" that include sodium concentrations of 125
mEq/L and chloride concentrations of 88 mEq/L. Id. at Table 1, solutions 4,
9, 13, and 1 7. As noted above, Appellants agree that, for sodium and
chloride, units of mEq/L are equivalent to the mmol/1 units recited in the
claims.
The cited references disclose sets comprising two separate solutions
comprising the components recited in claim 1, and disclose that the mixed
solutions contain a range of sodium and chloride ions that encompasses the
range recited in claim 1. The set recited in claim 1 thus would have been
obvious in view of the cited references. See In re Peterson, 315 F.3d 1325,
1330 (Fed. Cir. 2003) ("[T]he existence of overlapping or encompassing
ranges shifts the burden to the applicant to show that his invention would not
have been obvious.").
Appellants argue that "[ n ]either the Duponchelle nor Elisabettini
reference teaches or suggests either one of narrow range of 124-126 mmol/1
for sodium and the narrow range of 91-94 mmol/1 for chloride ions in a PD
[peritoneal dialysis] solution, nor their combination to which the claims on
appeal are limited." Appeal Br. 15.
This argument is unpersuasive.
[W]here there is a range disclosed in the prior art, and the
claimed invention falls within that range, there is a presumption
of obviousness. But the presumption will be rebutted if it can
be shown: ( 1) That the prior art taught away from the claimed
invention, In re Geisler, 116 F.3d 1465, 1471 (Fed. Cir. 1997);
or (2) that there are new and unexpected results relative to the
prior art, In re Woodruff, 919 F.2d 1575, 1578 (Fed. Cir. 1990).
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Iron Grip Barbell Co. v. USA Sports, Inc., 392 F.3d 1317, 1322 (Fed. Cir.
2004 ). Here, there are ranges of sodium and chloride concentrations
disclosed in the prior art, for a peritoneal dialysis solution, that encompass
the ranges recited in claim 1. The burden therefore falls on Appellants to
show that the prior art taught away from the claimed invention or that the
claimed invention achieved unexpected results.
To that end, Appellants argue that "the objective evidence of
nonobviousness in the present application and the Passlick-Deetjen
Declaration[ 8] are adequate to rebut any ... primafacie obviousness."
Appeal Br. 20. Appellants argue that "[ w ]ith regard to the objective
evidence in the present application, a comparison is made between the Phase
II Study table in the present application and Shockley Figure 4." Id.
Appellants argue that
[t]he comparison of the results in Fig. 4 Shockley with
the results for the dialysis patients treated with a PD solution of
the present invention in the Phase II Study shows that the
ultrafiltration volume achieved in accordance with the presently
claimed invention is remarkably higher than that obtained
according to Shockley.
Id. at 22.
Appellants also argue that "Dr. Passlick-Deetjen details a clinical
study comparing the safety and efficacy of a peritoneal dialysis solution
('PD solution') according to the present invention with a similar PD solution
according to the alleged prior art with a higher sodium content" and that
"Dr. Passlick-Deetjen concludes that the presently claimed PD solution
8 Declaration under 37 C.F.R. § 1.132 of Jutta Passlick-Deetjen, filed Sept.
12, 2013.
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Application 11/596, 181
markedly improved the patients' blood pressure, while providing adequate
dialysis." Id. at 23. Appellants contend that "the unexpected advantage
achieved by the presently claimed invention, demonstrated by the clinical
study described in the Passlick-Deetjen Declaration, is not specifically the
lowering of blood pressure, but instead is the constant tolerability and
efficiency of PD therapy in addition to the lower blood pressure." Id. at 24.
We are not persuaded that Appellants' evidence of unexpected results
is sufficient to overcome the prima facie case of obviousness. The
Specification presents evidence that a peritoneal dialysis solution having 125
mmol/1 produced better results than a similar one having 120 mmol/1
sodium. Spec. 8. The Passlick-Deetjen Declaration presents a comparison
of a peritoneal dialysis solution having 125 mmol/L sodium with one having
134 mmol/L sodium. Appeal Br. 45 (Passlick-Deetjen Deel., Exh. A). Dr.
Passlick-Deetjen states that, "[i]n respect to sodium removal and blood
pressure control a major improvement could be seen with the PD solution of
the invention." Passlick-Deetjen Deel. ,r 11.
However, "[t]o be particularly probative, evidence of unexpected
results must establish that there is a difference between the results obtained
and those of the closest prior art, and that the difference would not have
been expected by one of ordinary skill in the art at the time of the
invention." Bristol-Myers Squibb Co. v. Teva Pharms. USA, Inc., 752 F.3d
967, 977 (Fed. Cir. 2014) (emphasis added). Here, the closest prior art
embodiment is disclosed by Shockley, which provides "Examples of
Specific Compositions" that include ones having 125 mEq/L (mmol/L) of
sodium and 88 mEq/L (mmol/L) of chloride. Shockley Table 1. These prior
art compositions thus differ from those of claim 1 only in the amount of
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Application 11/596, 181
chloride included, and are closer prior art embodiments than those compared
to the claimed composition in the Specification and in the Passlick-Deetjen
Declaration. Appellants' evidence of unexpected results are therefore not
persuasive of nonobviousness.
Appellants argue, however, that "Shockley[] is not directed to
multiple part solutions for PD, nor PD solutions that contain a physiolocially
[sic] compatible acid in one of the separated solution parts." Appeal Br. 25.
This argument is unpersuasive, because both the Specification and the
Passlick-Deetjen Declaration describe only the results of administering a
single, mixed solution to patients. See Spec. 8; Passlick-Deetjen Declaration
,r,r 4, 6, 11. The Specification states that a two-part solution "produces the
advantage that, on the one hand, the degradation of glucose is prevented
during the heat sterilization and that, on the other hand, no special demands
have to be made on the pouch material with respect to the CO2 barrier
properties due to the low CO2 partial pressure." Spec. 4. Appellants,
however, have not pointed to evidence of record that shows that a two-part
solution provides different results, after mixing, compared to a similar one-
part solution.
We therefore affirm the rejection of claim 1 under 35 U.S.C. § 103 as
obvious based on Duponchelle, Elisabettini, and Shockley. Claims 3, 6, 7,
and 17 fall with claim 1 because they were not argued separately.
Appellants rely on the same arguments with respect to claim 15. Appeal Br.
31-3 2. We therefore affirm the rejection of claim 15 for the reasons
discussed above.
With regard to claim 8, Appellants argue that the claim specifies that
the first separate solution includes specific components in specific mmol/1
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Application 11/596, 181
ranges, and that the cited references do not suggest the recited composition.
Appeal Br. 28-29.
We agree with Appellants that the Examiner has not shown that the
cited references support a prima facie case of obviousness with respect to
claim 8, which requires that the first separate solution comprises, in addition
to an osmotic agent and a physiologically compatible acid, 172-200 mmol/1
sodium. Duponchelle discloses that its first separate solution, containing
dextrose and an acid, does not contain sodium. Duponchelle 8:50-63. The
Examiner has not identified any specific disclosure in the cited references
that would make obvious an embodiment in which a separate solution
includes an osmotic agent, a physiologically compatible acid, and 172-200
mmol/1 sodium. See Ans. 8-9. The Examiner reasons that "one of ordinary
skill in the art would expect that one chamber can contain sodium, calcium,
magnesium, H+ access [sic, excess?], chloride, glucose at various
concentrations, including the claimed concentrations, so long that when
combined, the use solution contains physiologically acceptable
concentrations of the constituents." Ans. 9. However, the Examiner has not
pointed to evidence of record to support the position that it would have been
obvious to provide sodium in the solution comprising an osmotic agent and a
physiologically compatible acid that is disclosed by Duponchelle. We
therefore reverse the rejection of claim 8.
Regarding claim 14, Appellants argue:
In the cited part, Duponchelle does not describe the structure
and function of the "peel seal" mentioned at column 6, lines 53-
55 in any detail. The patent cited at column 6, lines 49-52 by
Duponchelle as providing an example of the multi-chambered
container does not appear to describe the peel seal. As
indicated, claim 14 on appeal specifies a separation of the first
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and second chambers "by weld seam dimensioned such that the
welded seam opens on pressure on one of the chambers filled
with liquid so that the content of the two chambers can be
mixed with one another."
Appeal Br. 30-31.
This argument is not persuasive. Duponchelle states that "[a] variety
of containers can be used to house the two parts of the bicarbonate-
containing solution, such as separate containers (i.e. flasks or bags) that are
connected by a suitable fluid communication means." Duponchelle 6:31-34.
Duponchelle exemplifies a container having two chambers connected by a
frangible connector (id. at 6:37--42) but also states that "[a]ltematively, both
containers can be separated by a peel seal, which is broken before use by the
patient" (id. at 53-55). Based on these disclosures, we agree with the
Examiner that the "weld seam" recited in claim 14 would have been obvious
to a person of ordinary skill in the art.
SUMMARY
We affirm the rejection of claims 1, 3, 6, 7, 14, 15, and 17 under 35
U.S.C. § 103(a) based on Duponchelle, Elisabettini, and Shockley.
We reverse the rejection under 35 U.S.C. § 103(a) based on
Duponchelle, Elisabettini, and Shockley as applied to claim 8.
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-IN-PART
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