Ex Parte Gupta

Board of Patent Appeals and Interferences

Feb 15, 2011

11028114 (B.P.A.I. Feb. 15, 2011)

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.
11/028,114 12/30/2004 Ajay Gupta ROC004 P-307 8804
277 7590 02/16/2011
PRICE HENEVELD COOPER DEWITT & LITTON, LLP
695 KENMOOR, S.E.
P O BOX 2567
GRAND RAPIDS, MI 49501
EXAMINER
MENON, KRISHNAN S
ART UNIT PAPER NUMBER
1777
MAIL DATE DELIVERY MODE
02/16/2011 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 BOARD OF PATENT APPEALS
AND INTERFERENCES
____________

Ex parte AJAY GUPTA
____________

Appeal 2010-002544
Application 11/028,114
Technology Center 1700
____________

Before CHUNG K. PAK, BEVERLY A. FRANKLIN, and
MICHAEL P. COLAIANNI, Administrative Patent Judges.

PAK, Administrative Patent Judge.

DECISION ON APPEAL1
Appellant appeals under 35 U.S.C. § 134(a) from the Examiner’s final
rejection of claims 1 through 3, 6 through 9, 11, and 27, all of the claims

1 The two-month time period for filing an appeal or commencing a civil
action, as recited in 37 C.F.R. § 1.304, or for filing a request for rehearing,
as recited in 37 C.F.R. § 41.52, begins to run from the “MAIL DATE”
(paper delivery mode) or the “NOTIFICATION DATE” (electronic delivery
mode) shown on the PTOL-90A cover letter attached to this decision.
Appeal 2010-002544
Application 11/028,114

pending in the above-identified application.2 An oral hearing was held on
January 20, 2011. We have jurisdiction under 35 U.S.C. § 6.
STATEMENT OF THE CASE
The subject matter on appeal is directed to “[a] method for the
replenishment of plasma phosphate in a subject in need thereof.” (See claim
1 and Spec. 1, ll. 14-15). According to page 1, line 17 to page 2, line 17, of
the Specification:
Phosphate depletion is commonly seen in certain patient
populations including alcoholics, malnourished, acutely ill
patients, patients receiving parenteral nutrition, patients being
referred after prolonged fasting, or dialysis patients. . . . This
invention provides a method and pharmaceutical composition
for administering pyrophosphate for the prevention or treatment
of phosphate or pyrophosphate depletion.
Specifically, in patients with kidney failure, excess
removal of phosphate and pyrophosphate anions can occur
during hemodialysis or peritoneal dialysis. Depletion of these
anions from tissues and plasma leads to disorders of bone and
mineral metabolism including osteomalacia and calcification of
soft tissues and bone disease.
…
In dialysis patients, hyperphosphatemia is controlled by
removal of phosphate during hemodialysis or peritoneal
dialysis.

Details of the appealed subject matter are recited in representative claim 1
reproduced from the Claims Appendix to the Appeal Brief as shown below:
1. A method for the replenishment of plasma phosphate in a
subject in need thereof, said method comprising parenterally administering

2 See generally the Appeal Brief filed June 2, 2009 (“App. Br.), the
Examiner’s Answer dated July 20, 2009 (“Ans.”), and the Reply Brief filed
September 21, 2009 (“Reply Br.”).

2
Appeal 2010-002544
Application 11/028,114

to the subject in need of replenishment of plasma phosphate a composition
comprising a compound selected from the group consisting of
pyrophosphoric acid, an organic pyrophosphate, calcium pyrophosphate,
magnesium pyrophosphate, sodium pyrophosphate, and potassium
pyrophosphate in an amount that is therapeutically effective for the
replenishment of plasma phosphate, said compound being in the
composition at a concentration equivalent to an inorganic phosphorus
concentration of at least 0.5 mg per deciliter.

As evidence of unpatentability of the claimed subject matter, the
Examiner relies on the following references at page 3 of the Answer:
Gupta ‘434 WO 98/29434 Jul. 9, 1998
Gupta ‘275 US 6,689,275 B1 Feb. 10, 2004
Gupta ‘468 US 6,779,468 B1 Aug. 24, 2004
O’Neill US 2007/0148258 A1 Jun. 28, 2007

As evidence of patentability of the claimed subject matter, Appellant
relies on the following evidence:
Ajay Gupta et al., Dialysate iron therapy: Infusion of soluble ferric
pyrophosphate via the dialysate during hemodialysis, in 55 Kidney
International 1891-1898 (1999) (hereinafter referred to as “Exhibit 1”).

ASN Kidney News 1-28 (January 2009) (hereinafter referred to as
“Exhibit 2”).

Cecilia M. Giachelli et al., Regulation of Vascular Calcification:
Rolese of Phosphate and Osteopontin, in 96 Circulation Research, American
Heart Association 717-722 (2005) (hereinafter referred to as “Exhibit 3).

Afshin Farzaneh-Far et al., Biology of Vascular Calcification in Renal
Disease, in 101 Nephron Experimental Nephrology e134-e138 (2005)
(hereinafter referred to as “Exhibit 4”).
3
Appeal 2010-002544
Application 11/028,114

Appellant seeks review of the following grounds of rejection set forth
in the Answer (App. Br. 3)3:
1) Claims 1 through 3, 6 through 9, 11, and 27 on the ground of
nonstatutory obviousness-type double patenting as unpatentable over claims
1 through 4 of Gupta ‘468 and ‘275 in view of Gupta ‘434 and O’Neill; and
2) Claims 1 through 3, 6, 7, 9, 11, and 27 under 35 U.S.C.
§ 103(a) as unpatentable over the disclosure of O’Neill.
RELEVENT FACTS, PRINCIPLES OF LAW, ISSUE, ANALYSIS, AND
CONCLUSIONS
I. OBVIOUSNESS-TYPE DOUBLE PATENTING
Appellant contends that one of ordinary skill in the art would not have
been led to employ the claimed concentration of the claimed non-iron
containing pyrophosphate in the method recited in Gupta ‘468 and ‘275
(App. Br. 5 and Reply Br. 1-4). The Examiner appears to take the position
that iron pyrophosphate and the claimed non-iron containing pyrophosphates
taught by O’Neill are equivalent (Ans. 9).
Thus, the dispositive question is: Has the Examiner erred in
concluding that one of ordinary skill in the art would have been led to
employ the claimed concentration of any of the claimed non-iron containing
pyrophosphates in the method recited in the claims of Gupta ‘468 and ‘275
relied upon by the Examiner? On this record, we answer this question in the
affirmative

3 The Examiner has inadvertently extended the rejections of record to
cancelled claims 12 through 14. (Compare Ans. 5 and 7 with App. Br. 2 and
3.)
4
Appeal 2010-002544
Application 11/028,114

As correctly stated by Appellant at page 5 of the Appeal Brief, the
claims of Gupta ‘468 and ‘275 are directed to a method of delivering iron to
a patient with iron deficiency via administering an effective amount of iron
pyrophosphate to the patient. The Examiner has not shown that Gupta ‘434
and/or O’Neill teach that any of the claimed non-iron containing
pyrophosphate compounds would be useful for treating patients with iron
deficiency. Nor has the Examiner proffered any evidence that the claimed
pyrophosphate compounds taught by O’Neill and iron pyrophosphate recited
or disclosed in Gupta ‘468, ‘275 and ‘434 are equivalent for the purpose of
delivering iron to a patient with iron deficiency and that a patient with iron
deficiency is encompassed by the phrase “the subject in need of
replenishment of plasma phosphate” recited in claim 1.
It follows that the Examiner has erred in concluding that one of
ordinary skill in the art would have been led to employ the claimed
concentration of the claimed non-iron containing pyrophosphate in the
method claimed and disclosed in Gupta ‘468 and ‘275.
Accordingly, we reverse the Examiner’s decision rejecting claims 1
through 3, 6 through 9, 11, and 27 on the ground of nonstatutory
obviousness-type double patenting as unpatentable over claims 1 through 4
of Gupta ‘468 and‘275 in view of Gupta ‘434 and O’Neill.
II. OBVIOUSNESS
Appellant does not dispute the Examiner’s finding that O’Neill
teaches parenterally administering the claimed pyrophosphate to a patient
suffering from vascular calcification (Compare Ans. 7-8 with App. Br. 6).
Rather, Appellant contends that O’Neill does not teach or suggest
administering the pyrophosphate to “the subject in need of replenishment of
5
Appeal 2010-002544
Application 11/028,114

plasma phosphate” recited in claim 1 (See, e.g., App. Br. 14 and Reply Br. 4-
10).
Thus, the first critical question is: Given the broadest reasonable
interpretation4 of the phrase “the subject in need of replenishment of plasma
phosphate” recited in claim 1 consistent with the Specification, does such
phrase encompass the patient suffering from vascular calcification taught by
O’Neill? On this record, we answer this question in the affirmative.
As is apparent from page 1, line 17 to page 2, line 17 of the
Specification discussed supra, the claimed “the subject in need of
replenishment of plasma phosphate” is described as including, among others,
patients who are alcoholics, malnourished, acutely ill patients, patients
receiving parenteral nutrition, patients being referred after prolonged fasting,
or dialysis patients, and patients suffering from vascular calcification.
Nowhere does the Specification limit, much less precisely define, the
claimed “the subject in need of replenishment of plasma phosphate” to
exclude the patients suffering from vascular calcification taught by O’Neill.
In re Morris, 127 F.3d 1048, 1056 (Fed. Cir. 1997) (“It is the applicants’
burden to precisely define the invention, not the PTO’s.”).
Appellant relies on extrinsic evidence, namely Exhibits 2 through 4, to
show that the claimed “subject in need of replenishment of plasma
phosphate” does not include the patients suffering from vascular
calcification taught by O’Neill (App. Br. 14-15). However, such extrinsic
evidence is not controlling in claim interpretation, especially since it is

4 It is well settled that during examination proceedings, all words in a claim
are normally given their broadest reasonable construction consistent with the
Specification. In re Icon Health and Fitness, Inc., 496 F.3d 1374, 1379
(Fed. Cir. 2007).
6
Appeal 2010-002544
Application 11/028,114

clearly at odds with the claim construction mandated by the written
description in the Specification. Phillips v. AWH Corp., 415 F.3d 1303,
1318 (Fed. Cir. 2005)(en banc), quoting Key Pharms. V. Hercon Labs.
Corp., 161 F.3d 709, 716 (Fed. Cir. 1998) (“[A] court should discount any
expert testimony [and/or other extrinsic evidence] ‘that is clearly at odds
with the claim construction mandated by the claims themselves, the written
description, and the prosecution history, in other words, with the written
record of the patent.’”). As stated by our reviewing court in Phillips, 415
F.3d at 1315(quoting Vitronics Corp. v. Conceptronic, Inc., 90 F.3d 1576,
1582 (1996):
“The specification is always highly relevant to the claim
construction analysis. Usually, it is dispositive; it is the single
best guide to the meaning of a disputed term.”

Appellant also contends that O’Neill does not teach or suggest using
the claimed concentration of a pyrophosphate in the claimed composition
(App. Br. 16-17 and Reply Br. 8-10). Claim 1 on appeal requires that the
pyrophosphate in the composition be “at a concentration equivalent to an
inorganic phosphorus concentration of at least 0.5 mg per deciliter,” without
identifying the composition as a dialysis solution and without excluding the
subsequent use of such composition in a dialysis solution. In re Baxter, 656
F.2d 679, 686-87 (CCPA 1981) (When a claim employs the transitional term
"comprising," it is interpreted as not precluding the presence of additional
materials and/or steps, which are not recited.). Claims 9 and 10, which are
dependent on claim 1, further indicate the use of such pyrophosphate-
containing compositions in a solution to form a dialysis solution containing
about 2 µmole to about 12 mmol of pyrophosphate per liter or form a
7
Appeal 2010-002544
Application 11/028,114

dialysis solution for delivering about 0.05 µmol to about 100 mmole of the
pyrophosphate per day, respectively to the claimed subject.
Thus, the second critical question is: Does O’Neill teach or suggest a
composition having the claimed pyrophosphate concentration useful for its
dialysis solution within the meaning of 35 U.S.C. § 103(a)? On this record,
we also answer this question in the affirmative.
As correctly found by the Examiner at page 18 of the Answer, O’Neill
teaches using a composition (concentrate) having a pyrophosphate
concentration of about 90 µmol to about 225 µmol (p. 9, para. 0089).
Consistent with this broad teaching, O’Neill also exemplifies compositions
containing, inter alia, 125 µmol of the claimed pyrophosphate being used
with a dialysis solution (pp. 9-10, paras. 0092 and 000093, Exs. 1 and 2).
Appellant’s own calculation at page 14 of the Appeal Brief indicates that
such pyrophosphate concentrations taught by O’Neill overlap with the
claimed concentration of a pyrophosphate in the claimed composition.
Indeed, Appellant does not dispute the Examiner’s finding that such
pyrophosphate concentrations taught by O’Neill overlap with the claimed
concentration of a pyrophosphate in the claimed composition. (Compare
Ans. 8 with App. Br. 14-18 and Reply Br. 1-10). Thus, we concur with the
Examiner that it would have been prima facie obvious to employ a
composition containing the claimed pyrophosphate concentration in
O’Neill’s method of parenterally administering the claimed pyrophosphate
to a patient suffering from vascular calcification. As our reviewing court
stated in In re Peterson, 315 F.3d 1325, 1329 (Fed. Cir. 2003):
In cases involving overlapping ranges, we and our
predecessor court have consistently held that even
a slight overlap in range establishes a prima facie
8
Appeal 2010-002544
Application 11/028,114

case of obviousness. . . . We have also held that a
prima facie case of obviousness exists when the
claimed range and the prior art range do not
overlap but are close enough such that one skilled
in the art would have expected them to have the
same properties. Titanium Metals Corp. v.
Banner, 778 F.2d 775, 783, 227 USPQ 773, 779
(Fed. Cir. 1985).

Appellant argues that O’Neill does not teach the claimed
pyrophosphate concentration in a composition since the final dialysis
solution taught at paragraphs 0089 and 0090 of O’Neill has a pyrophosphate
concentration of about 1 to about 10 µmol, preferably about 3 to about 5
µmol (App. Br. 14). However, this argument is not persuasive to show
reversible error on the part of the Examiner because it is based on limitations
that do not appear in the claims. In re Self, 671 F.2d 1344, 1348 (CCPA
1982) (“[A]ppellant's arguments fail from the outset because . . . they are not
based on limitations appearing in the claims.”). In this regard, we note that
claim 1 does not require a dialysis solution itself to have the claimed
pyrophosphate concentration. Claim 1 only requires a composition,
inclusive of the concentrate containing at least two ingredients taught by
O’Neill, to have the claimed pyrophosphate concentration. Indeed, further
limiting dependent claims 9 and 10 indicate the use of a solution, inclusive
of a dialysis solution, having the same pyrophosphate concentration as that
in O’Neill’s final dialysis solution.
Accordingly, we affirm the Examiner’s decision rejecting claims 1
through 3, 6, 7, 9, 11, and 27 under 35 U.S.C. § 103(a) as unpatentable over
the disclosure of O’Neill.

9
Appeal 2010-002544
Application 11/028,114

ORDER
Upon consideration of the record, and for the reasons given, it is
ORDERED that the decision of the Examiner to reject claims 1
through 3, 6 through 9, 11, and 27 on the ground of nonstatutory
obviousness-type double patenting as unpatentable over claims 1 through 4
of Gupta ‘468 and‘275 in view of Gupta ‘434 and O’Neill is REVERSED;
FURTHER ORDERED that the decision of the Examiner to reject
claims 1 through 3, 6, 7, 9, 11, and 27 under 35 U.S.C. § 103(a) as
unpatentable over the disclosure of O’Neill is AFFIRMED; and,
FURTHER ORDERED that no time period for taking any subsequent
action in connection with this appeal may be extended under 37 C.F.R.
§ 1.136(a)(1)(iv).
AFFIRMED

Ssl

PRICE HENEVELD COOPER DEWITT & LITTON, LLP
695 KENMOOR, S.E.
P O BOX 2567
GRAND RAPIDS, MI 49501
10