Ex Parte Kuroda et al

Patent Trial and Appeal Board

Sep 5, 2017

10579449 (P.T.A.B. Sep. 5, 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.
10/579,449 08/16/2006 Mariko Kuroda P29911 8465
7055 7590 09/07/2017
GREENBLUM & BERNSTEIN, P.L.C.
1950 ROLAND CLARKE PLACE
RESTON, VA 20191
EXAMINER
ANDERSON, DENISE R
ART UNIT PAPER NUMBER
1779
NOTIFICATION DATE DELIVERY MODE
09/07/2017 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):
gbpatent@gbpatent.com
greenblum.bernsteinplc@gmail.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte1 MARIKO KURODA, MASAYA FUKE, and MASAKI KATOU
Appeal 2016-002959
Application 10/579,449
Technology Center 1700
Before CHUNG K. PAK, CHRISTOPHER C. KENNEDY, and
MICHAEL G. MCMANUS, Administrative Patent Judges.
PAK, Administrative Patent Judge.
DECISION ON APPEAL
This is a decision on an appeal under 35 U.S.C. § 134(a) from the
Examiner’s decision2 rejecting claims 1, 2, 6-9, and 21-27, which are all of
the claims pending in the above-identified application. We have
jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
STATEMENT OF THE CASE
The subject matter of the claims on appeal relates to “a hollow fiber
membrane for blood purification and a blood purification apparatus
1 Appellants identify the real party in interest as “ASAHI KASEI MEDICAL
CO., LTD of Tokyo, Japan[.]” Appeal Brief filed April 23, 2015 (“Appeal
Br.”) 2.
2 Final Action entered August 21, 2014 (“Final Act.”) 2-16; and the
Examiner’s Answer entered November 20, 2015 (“Ans.”) 2-19.
Appeal 2016-002959
Application 10/579,449
including the same.” Spec.311. The hollow fiber membrane is made of a
hydrophobic polymer and a hydrophilic polymer and has an integrally
continuous structure from the inner surface to the outer surface. Spec. Tflf 9
and 13. This hollow fiber membrane exhibits “a zeta potential on the inner
surface thereof greater than -3.0 mV but less than 0 mV at pH 7.5, when
measured using a sample with an embedded resin on the outer side for
allowing the electrolyte solution to flow through only the inside of the
hollow fiber, and using a 0.001 mol/1 potassium chloride aqueous solution as
an electrolyte solution[.]” Spec. 19.
In order to express the zeta potential on the inner surface in the hollow
fiber membrane, controlling the content of the hydrophilic polymer is
important. Spec. 120. “[I]t is [also] important to control the membrane
forming conditions in the process[,] from membrane-forming, extrusion of
the raw spinning solution to be coagulated from a spinneret, to the
coagulating bath.” Spec. 128. “In particular, control of the running time
and relative humidity of the air gap in the dry-and-wet spinning, and control
of subsequent coagulation conditions are important.” Id. Tables 1 and 2
show the effects of the membrane forming conditions and the hydrophilic
polymer content (polyvinyl pyrrolidone (PVP)) on the zeta potential
expressed on the inner surface of the hollow fiber membrane. Spec. H 61
and 62.
3 Appellants’ Specification filed May 16, 2006 (“Spec.”).
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Application 10/579,449
Details of the appealed subject matter are recited in representative
claim l,4 which is reproduced below from the Claims Appendix of the
Appeal Brief (with disputed limitations italicized):
1. A hollow fiber membrane for blood purification
having an integrally continuous structure from the inner
membrane surface to the outer membrane surface and
comprising a hydrophobic polymer and a hydrophilic polymer,
and
the hollow fiber membrane comprising a polyvinyl
pyrrolidone as the hydrophilic polymer in the range of 3.0 to
5.0 wt% based on the hollow fiber membrane,
exhibiting a zeta potential on the inner surface thereof of
greater than -3.0 mV but less than 0 mV at pH 7.5, when
measured using a sample with an embedded resin on the outer
side for allowing the electrolyte solution to flow through only
the inside of the hollow fiber, and using a 0.001 mol/l
potassium chloride aqueous solution as an electrolyte solution.
Appeal Br. 15, Claims Appendix.
The Examiner maintains, and Appellants seek review of, the
following grounds5 of rejection:
1. Claims 1, 2, 6, 21, and 27 under 35 U.S.C. § 102(b) as anticipated
by Kozawa (US 6,355,730 B1 issued Mar. 12, 2002);
4 Claim 1 is the broadest claim on appeal.
5 At page 3 of the Final Action, the Examiner states that the § 112, second
paragraph, rejection of claims 1, 2, 6-9, and 21-26 set forth in the Non-Final
Action entered November 14, 2013 is withdrawn. At page 14 of the
Answer, the Examiner states that the § 102(b) rejection of claims 1, 2, 6, 21,
and 27 as anticipated by Kim is no longer maintained.
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Application 10/579,449
2. Claims 1, 2, 6, 21, and 27 under 35 U.S.C. § 102(b) as anticipated
by Heilmann (US 4,906,375 issued Mar. 6, 1990);
3. Claims 7, 22, and 23 under 35 U.S.C. § 103(a) as unpatentable
over the combined teachings of Kozawa and Kim (US 2004/0167237 A1
published Aug. 26, 2004);
4. Claims 8, 9, 24, and 25 under 35 U.S.C. § 103(a) as unpatentable
over the combined teachings of Kozawa and Carlsen (US Re. 36,914 issued
Oct. 17, 2000);
5. Claim 26 under 35 U.S.C. § 103(a) as unpatentable over the
combined teachings of Kozawa, Kim, and Carlson;
6. Claims 7, 22, and 23 under 35 U.S.C. § 103(a) as unpatentable
over the combined teachings of Heilmann and Kim;
7. Claims 8, 9, 24, and 25 under 35 U.S.C. § 103(a) as unpatentable
over the combined teachings of Heilmann and Carlsen; and
8. Claim 26 under 35 U.S.C. § 103(a) as unpatentable over the
combined teachings of Heilmann, Kim, and Carlsen. Final Act. 2-16; Ans.
2-19; Appeal Br. 7; Reply Brief filed January 20, 2016 (“Reply Br.”) 1-5.
DISCUSSION
Upon consideration of the evidence relied upon by the Examiner and
Appellants in light of each of Appellants’ contentions, we find reversible
error in the Examiner’s decision rejecting claims 1, 2, 6-9, and 21-27 under
35 U.S.C. §§ 102(b) and 103(a). Accordingly, we reverse the Examiner’s
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Application 10/579,449
§§ 102(b) and 103(a) rejections of the above claims substantially for the
reasons set forth in the Appeal Brief. We add the following primarily for
emphasis and completeness.
All of the §§ 102(b) and 103(a) rejections are based on the Examiner’s
finding that the hollow fiber membrane disclosed by either Kozawa or
Heilmann inherently exhibits
a zeta potential on the inner surface thereof greater than -3.0
mV but less than 0 mV at pH 7.5, when measured using a
sample with an embedded resin on the outer side for allowing
the electrolyte solution to flow through only the inside of the
hollow fiber, and using a 0.001 mol/1 potassium chloride
aqueous solution as an electrolyte solution
as recited in claim 1. Final Act. 2-16; Ans. 2-19.
Thus, the dispositive question raised here is whether the Examiner has
supplied sufficient facts and/or technical reasoning to demonstrate that the
hollow fiber membrane disclosed by either Kozawa or Heilmann necessarily
or inherently has the zeta potential property recited in claim 1 ? On this
record, we answer this question in the negative.6
To demonstrate inherency, the Examiner must supply “a basis in fact
and/or technical reasoning to reasonably support the determination that the
allegedly inherent characteristic necessarily flows from the teachings of the
6 Upon return of this application to the Examiner’s jurisdiction, the
Examiner is advised to consider Non-patent document 1 (“The high
performance membrane for hemodialysis stuff,” Tokyo Igakusha Co., Ltd.,
pages 130-131 (1990)) discussed in the “BACKGROUND ART” section of
the Specification, together with the disclosure of Kozawa or Heilmann, to
determine whether the collective teachings of either Kozawa and Non-patent
document 1 or Heilmann and Non-patent document 1 would have rendered
the claimed subject matter obvious within the meaning of 35 U.S.C.
§ 103(a).
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applied prior art.” Ex parte Levy, 17USPQ2d 1461, 1464 (BPAI 1990).
Where the result or property in question is a necessary or inevitable
consequence of what was deliberately intended, it is of no import that the
reference did not appreciate the result or property. See, e.g., MEEIL/Biophile
Int'l Corp. v. Milgraum, 192 F.3d 1362, 1366 (Fed. Cir. 1999); In re Oelrich,
666 F.2d 578, 581 (CCPA 1981). Inherency, however, may not be
established by probabilities or possibilities. In re Robertson, 169 F.3d 743,
745 (Fed. Cir. 1999); see also Oelrich, 666 F.2d at 581 (“Inherency...may
not be established by probabilities or possibilities. The mere fact that a
certain thing may result from a given set of circumstances is not sufficient.”)
Here, as indicated supra, the zeta potential recited in claim 1 is
dependent on both the membrane forming conditions and the hydrophilic
polymer content of the composition used for making a hollow fiber
membrane. See also Spec. Tflf 20, 28, 61 and 62. Nevertheless, the Examiner
does not demonstrate that both the membrane forming conditions and the
hydrophilic polymer content taught by either Kozawa or Heilmann are
identical or substantially identical to those used by Appellants to show that
the hollow fiber membrane taught by either Kozawa or Heilmann inherently
or necessarily exhibits the recited zeta potential. Final Act. 2-16; Ans. 2-
19. Nor does the Examiner supply any technical reasoning to support that
the membrane forming conditions and the hydrophilic polymer content
taught by either Kozawa or Heilmann are sufficient to demonstrate that the
hollow fiber membrane taught by either Kozawa or Heilmann inherently or
necessarily exhibits the recited zeta potential.7 Final Act. 2-16; Ans. 2-19.
7 Although we need not discuss Comparative Example 3 in the Specification,
we note that it employs a homogeneous raw spinning solution consisting of
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For example, the Examiner does not identify a disclosure in either Kozawa
or Heilmann concerning relative humidity, which, as explained above,
appears to be relevant to the zeta potential of the produced hollow fiber
membrane.
Accordingly, on this record, we concur with Appellants that the
Examiner fails to carry the burden of establishing a prima facie case of
unpatentability regarding the subject matter recited in claims 1, 2, 6-9, and
21-27 within the meaning of 35 U.S.C. §§ 102(b) and 103(a). In re Oetiker,
977 F.2d 1443, 1445 (Fed. Cir. 1992) (“[T]he examiner bears the initial
burden, on review of the prior art or on any other ground, of presenting a
prima facie case of unpatentability.”)
ORDER
Upon consideration of the record, and for the reasons given, it is
18 parts by weight of a polysulfone-based resin (PSf), 4.8 parts by weight of
a polyvinyl pyrrolidone (PVP manufactured by BASF as “K-90”), and 77.2
parts by weight of dimethylacetamide, which appears to be closer to the
claimed composition than the spinning solution used in Comparative
Example 2 of Kozawa relied upon by the Examiner or the spinning solution
used in Example 1 of Heilmann. Compare Spec.^1 56, 61, and 62, with
Kozawa, col. 11,11. 10-37 and Heilmann, col. 10,1. 1-col. 11,1.10. Yet,
Comparative Example 3 in the Specification does not produce a hollow fiber
membrane having the recited zeta potential, when different hollow fiber
forming conditions than those used for forming the claimed hollow fiber
membrane are employed. Spec.^Hf 61 and 62.
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Application 10/579,449
ORDERED that the decision of the Examiner to reject claims 1,2, 6—
9, and 21-27 under 35 U.S.C. §§ 102(b) and 103(a) is REVERSED.
REVERSED
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