GAMBRO LUNDIA AB

Patent Trials and Appeals Board

Oct 19, 2020

2020002571 (P.T.A.B. Oct. 19, 2020)

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.
15/800,719 11/01/2017 Ola CARLSSON 3724361-00248 2645
29178 7590 10/19/2020
K&L Gates LLP - Gambro
P. O. BOX 1135
CHICAGO, IL 60690-1135
EXAMINER
PALLAY, MICHAEL B
ART UNIT PAPER NUMBER
1617
NOTIFICATION DATE DELIVERY MODE
10/19/2020 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):
uspatentmail@klgates.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
__________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
__________

Ex parte OLA CARLSSON, LENNART JONSSON,
TORBJORN LINDEN, and ANDERS WIESLANDER
__________

Appeal 2020-002571
Application 15/800,719
Technology Center 1600
__________

Before DONALD E. ADAMS, JEFFREY N. FREDMAN, and
TAWEN CHANG, Administrative Patent Judges.

FREDMAN, Administrative Patent Judge.

DECISION ON APPEAL
This is an appeal1,2 under 35 U.S.C. § 134(a) involving claims to a
dialysis acid precursor composition product. The Examiner rejected the
claims as obvious. We have jurisdiction under 35 U.S.C. § 6(b). We affirm.

1 We use the word “Appellant” to refer to “applicant” as defined in 37
C.F.R. § 1.42. Appellant identifies the Real Party in Interest as Gambro
Lundia AB (see Appeal Br. 2).
2 We have considered the Specification of Nov. 1, 2017 (“Spec.”); Final
Office Action of Dec. 11, 2018 (“Final Action”); Appeal Brief of Mar. 14,
2019 (“Appeal Br.”); Examiner’s Answer of Dec. 12, 2019 (“Ans.”); and
Reply Brief of Feb. 12, 2020 (“Reply Br.”).
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Statement of the Case
Background
“When a person’s kidney does not function properly uremia is
developed. Dialysis is a well established treatment technique for uremia”
(Spec. ¶ 3). “In hemodialysis, an aqueous solution called dialysis solution is
brought in contact with the opposite membrane surface, the dialysate side, in
a flowing manner. Waste substances (toxins) and solutes are removed/
controlled mainly by diffusion” (id. ¶ 6).
“Dialysis solutions have improved in quality over the years, and the
availability of concentrated precursor compositions for further dilution and
mixing with other components into a ready-for-use dialysis solution have
decreased the costs and improved the environmental issues” (Spec. ¶ 15).
“One way to further limit the costs and improve the environmental issues
would be to provide a dialysis precursor composition in which all
component are dry” (id. ¶ 16). However, “it is difficult to ensure proper
composition and concentration of the different components both within the
granulate and within the prepared ready-for-use dialysis solution” (id. ¶ 23).
The Claims
Claims 1–11 are on appeal. Claim 1 is the sole independent claim, is
representative and reads as follows:
1. A dialysis acid precursor composition product
comprising:
an anhydrous powdered composition including a sodium
containing concentrate, a bicarbonate containing concentrate, a
dry acid and a magnesium salt, and
a sealed moisture-resistant container housing the
anhydrous powdered composition, wherein the container has a
water vapor transmission rate less than 0.3 g/m2/d at 38°C/90%
RH.
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The Rejections
A. The Examiner rejected claims 1–6 under U.S.C. § 103(a) as obvious
over Callan3 (Final Act. 3–4).
B. The Examiner rejected claims 1–11 under U.S.C. § 103(a) as obvious
over Callan and Sugiyama4 (Final Act. 5–6).
Because both rejections rely upon Callan, the same issues relate to
both rejections, and we will therefore consider these rejections together.
The Examiner finds that Callan teaches “a dry, water-free (i.e.,
anhydrous) dialysate precursor composition in powder form” that “is
prepared by mixing together the dry ingredients until a homogenous mixture
results and packaging it in a hermetically-sealed (i.e., airtight, excludes the
passage of gases, moisture-resistant) package” (Final Act. 3). The Examiner
finds the “mixture of dry ingredients contains at a minimum chloride, citrate,
bicarbonate, dextrose (i.e., glucose), and one or more cationic species” (id.).
The Examiner acknowledges that Callan “does not specifically
disclose an example including the specific combination of compounds as
claimed” but finds it would have been obvious “to make such dry water-free
(i.e., anhydrous) dialysate precursor powder composition . . . for
convenience in shipping and preparation in solution form” (Final Act. 4).
The Examiner also finds that “[r]egarding the claimed recitations of the
container having a water vapor transmission rate less than stated amounts,
the package (i.e., container) of Callan et al. as discussed above is
hermetically-sealed . . . which would exclude the passage of water vapor,
and thus have no water vapor transmission” (id.).

3 Callan et al., US 2004/0060865 A1, published Apr. 1, 2004.
4 Sugiyama et al., US 2010/0120702 A1, published May 13, 2010.
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The issue with respect to these rejections is: Does a preponderance of
the evidence of record support the Examiner’s conclusion that Callan and
Callan in view of Sugiyama render the claims obvious?
Findings of Fact
1. Callan teaches “dialysate precursor compositions, which may
be diluted with water and mixed with a base to thereby form a dialysate
composition” (Callan ¶ 14).
2. Callan teaches in one “embodiment the dry acid-concentrate
precursor composition is a powder” (Callan ¶ 21).
3. Callan teaches “dry compositions (e.g., tablets, pellets, powder,
etc.) which upon mixing with water provide a dialysate precursor
composition having the sodium, potassium, calcium, and magnesium
concentrations recited” (Callan ¶ 46).
4. Callan teaches the “dialysate precursor will contain citrate (as
the primary acidic ingredient of the acid concentrate), bicarbonate (as the
primary basic ingredient of the base concentrate) and buffering anion
preferably selected from acetate and/or lactate” (Callan ¶ 56).
5. Callan teaches:
The dry PD composition . . . is described in terms of anionic
species because each anionic species may be introduced into the
composition in any dry form that is physiologically acceptable
and contains the anionic species of interest. Thus, for example,
“citrate” can be introduced into the dry composition in any dry
form that contains citrate. Examples are citric acid (anhydrous)
. . . . Likewise, each of the bicarbonate and chloride may be
introduced simultaneous with cations selected from sodium,
potassium, magnesium and calcium, and may be in anhydrous
or hydrate forms.
(Callan ¶ 108).
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6. Callan teaches “[a]lthough the dry composition will be dry to
the touch, it may contain some water” (Callan ¶ 113).
7. Callan teaches:
The dry PD composition is readily prepared simply by mixing
together weighed quantities of the various dry sterile
ingredients under sterile conditions. Mixing is readily
accomplished by agitating a combination of the ingredients
until a homogeneous mixture results. The pre-weighed dry
mixture may be packaged in hermetically-sealed packages for
convenience in shipping.
(Callan ¶ 115).
8. Sugiyama teaches “solid preparations for dialysis, and more
specifically, to a solid preparation for dialysis wherein decomposition of
glucose contained therein is suppressed, and to methods for producing such
solid preparations for dialysis” (Sugiyama ¶ 1).
9. Sugiyama teaches “[w]hen the moisture percentage of the
binder solution falls below 0.2 percent, particle binding and aggregating
effects become so weak that granulation does not proceed efficiently”
(Sugiyama ¶ 38).
10. Sugiyama teaches “[i]t is preferable to use a container capable
of preventing transmission of water vapor and gases, for example, such as
having water vapor transmission rates of 1.0 g/m2/24 hrs or less (under 40°
C., 90% RH)” (Sugiyama ¶ 53).
Principles of Law
The Examiner has the initial burden of establishing a prima facie case
obviousness under 35 U.S.C. § 103. In re Oetiker, 977 F.2d 1443, 1445
(Fed. Cir. 1992). It is important to provide “a reason that would have
prompted a person of ordinary skill in the relevant field to combine the
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elements in the way the claimed new invention does.” KSR Int’l Co. v.
Teleflex Inc., 550 U.S. 398, 418 (2007).
Analysis
We adopt the Examiner’s findings of fact and conclusion of law (see
Final Act. 3–6, FF 1–10). We agree that Callan or Callan and Sugiyama
render claim 1 obvious to the person of ordinary skill, here reasonably
identified as a chemist or physician with several years experience in dialysis
(see, e.g. Spec. ¶ 9). We address Appellant’s arguments below.
Anhydrous powdered composition
Appellant contends “[t]here is no disclosure in Callan of selecting an
anhydrous powdered composition including a sodium containing
concentrate, a bicarbonate containing concentrate, a dry acid and a
magnesium salt” (Appeal Br. 6). Appellant contends that “not every dry
powder is necessarily anhydrous” (id. at 6–7). Appellant also contends that
“[n]othing in Callan even suggests the problem of caking and lump
formation within powder compositions caused by crystalline water attached
to magnesium chloride hexahydrate” (id. at 7). Appellant contends “[a]s no
benefits for choosing anhydrous compounds are indicated in Callan, the
skilled person would not find any reason to include these more expensive
components” (id. at 8). Appellant contends “the Examiner apparently relies
on hindsight in view of the subject application's disclosure in an attempt to
establish a prima facie case under § 103(a)” (id. at 8).
We find these arguments unpersuasive. Callan teaches, in a single
paragraph, that a dry peritoneal dialysis composition may be composed of a
limited selection of six citrate forms, including anhydrous citric acid, along
with bicarbonate and chloride, and any of four different cations, sodium,
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potassium, magnesium, and calcium in either anhydrous or hydrate form (FF
5). Thus, Callan demonstrates that Appellant’s claim 1 “recites a
combination of elements that were all known in the prior art, and all that was
required to obtain that combination was to substitute one well-known . . .
agent for another.” Wm. Wrigley Jr. Co. v. Cadbury Adams USA LLC, 683
F.3d 1356, 1364 (Fed. Cir. 2012).
Moreover, while Callan may require some minimal selection from the
disclosure to obtain the composition of claim 1, Merck found that prior art
disclosing 1200 “effective combinations does not render any particular
formulation less obvious.” Merck & Co., Inc. v. Biocraft Labs., Inc., 874
F.2d 804, 807 (Fed. Cir. 1989). Appellant never asserts that any of the
obvious compositions of Callan would be ineffective.
We also do not find that the solution to the purported problem of
clumping supports the unobviousness of claim 1. “The discovery of the
cause of a problem . . . does not always result in a patentable invention.” In
re Wiseman, 596 F.2d 1019, 1023 (CCPA 1979). Appellants
are, in effect, arguing that a structure suggested by the prior art,
and, hence, potentially in the possession of the public, is
patentable to them because it also possesses an inherent, but
hitherto unknown, function which they claim to have
discovered. This is not the law. A patent on such a structure
would remove from the public that which is in the public
domain by virtue of its inclusion in, or obviousness from, the
prior art.
Id. In this case, there is no recitation in claim 1 that requires the claimed
composition to result in minimal clumping or formation of brown lumps as
disclosed in paragraph 86 of the Specification. See In re Self, 671 F.2d
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1344, 1348 (CCPA 1982) (“[A]ppellant’s arguments fail from the outset
because . . . they are not based on limitations appearing in the claims.”).
In addition, no comparison between the compositions 1 and 2 of the
Specification and the prior art composition in Example 3 of Callan, the
closest prior art, was performed. See In re Baxter Travenol Labs., 952 F.2d
388, 392 (Fed. Cir. 1991) (“[W]hen unexpected results are used as evidence
of nonobviousness, the results must be shown to be unexpected compared
with the closest prior art.”).
As to the issue of expense of reagents, “a given course of action often
has simultaneous advantages and disadvantages, and this does not
necessarily obviate motivation to combine.” Medichem, S.A. v. Rolabo,
S.L.¸437 F.3d 1157, 1165 (Fed. Cir. 2006). Here, Appellant provides no
evidence that the expense of the reagent components would have impacted
their selection by the ordinary artisan. See In re Pearson, 494 F.2d 1399,
1405 (CCPA 1974) (“Attorney’s argument in a brief cannot take the place of
evidence.”)
We are aware that hindsight bias may plague determinations of
obviousness, Graham v. John Deere Co., 383 U.S. 1, 36 (1966), but 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 this case, Callan teaches that all of the dialysis composition components
are known, are combined by known methods, and yield the predictable result
of a powder. Appellant provides no evidence on this record of unexpected
results.
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Moisture-resistant container
Appellant contends “the anhydrous powdered composition is kept in a
packaging material having a specified feature of having a water vapor
transmission rate less than 0.3 g/m2/d at 38°C/90% R.H.” (Appeal Br. 8).
Appellant contends “[i]t should be noted that improvement of stability is not
only an exchange of a single parameter, like asking for a hermetically sealed
container, but it requires more: careful selection of anhydrous components,
careful selection of the respective concentrations and careful selection of the
container material as well” (id. at 7–8).
We find this argument unpersuasive because the Examiner
specifically finds, and Appellant does not rebut, that Callan teaches the
container “is hermetically-sealed, which means that it is airtight, or excludes
the passage of gases, which would exclude the passage of water vapor, and
thus have no water vapor transmission” (Ans. 4). That is, the Examiner
finds that a hermetically-sealed container has a water vapor transmission rate
of zero, which is a value “less than 0.3 g/m2/d at 38°C/90% RH” required by
claim 1. Appellant provides no rebuttal evidence. See In re Best, 562 F.2d
1252, 1255 (CCPA 1977) (“[T]he PTO can require an applicant to prove that
the prior art products do not necessarily or inherently possess the
characteristics of his claimed product. . . . Whether the rejection is based on
“inherency” under 35 U.S.C. § 102, on “prima facie obviousness” under 35
U.S.C. § 103, jointly or alternatively, the burden of proof is the same, and its
fairness is evidenced by the PTO’s inability to manufacture products or to
obtain and compare prior art products.” (citations and footnote omitted)).
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Sugiyama
Appellant contends
Sugiyama suggests that the solid preparation is enclosed in a
material having a water vapor transmission rate with an upper
limit of 1.0 g/m2/24 hrs, which is more than three times as high
as the wa[t]er vapor transmission rate in present Claim 1.
Notably, Sugiyama does not recognize the water vapor
transmission rate as being a result-effective variable.
(Appeal Br. 10.)
We find this argument unpersuasive because Sugiyama teaches “[i]t is
preferable to use a container capable of preventing transmission of water
vapor and gases, for example, such as having water vapor transmission rates
of 1.0 g/m2/24 hrs or less (under 40° C., 90% RH)” (FF 10). We agree with
the Examiner that Sugiyama’s discussion of preferable water vapor
transmission rates, and recognition that lower values are better, demonstrates
that the transmission rate is a results-effective variable. Indeed, Sugiyama’s
disclosed range of 1.0 g/m2/24 hrs or less overlaps the ranges recited in
Appellant’s claims. See In re Peterson, 315 F.3d at 1329 (“In cases
involving overlapping ranges, we and our predecessor court have
consistently held that even a slight overlap in range establishes a prima facie
case of obviousness.”) Appellant provides no evidence of unexpected
results regarding the water vapor transmission rates that is compared to the
closest prior art of either Sugiyama or Callan.
Conclusion of Law
A preponderance of the evidence of record support the Examiner’s
conclusion that Callan and Callan in view of Sugiyama render the claims
obvious.
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CONCLUSION
In summary:
Claims
Rejected
35 U.S.C. § Reference(s)/Basis Affirmed Reversed
1–6 103 Callan 1–6
1–11 103 Callan, Sugiyama 1–11
Overall
Outcome
1–11

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