Ex Parte Nishikawa et al

Patent Trial and Appeal Board

Dec 11, 2012

10520180 (P.T.A.B. Dec. 11, 2012)

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.
10/520,180 01/05/2005 Hisao Nishikawa 029650-162 7679
7590 12/11/2012
Burns Doane
Swecker & Mathis
PO Box 1404
Alexandria, VA 22313-1404
EXAMINER
BOUCHELLE, LAURA A
ART UNIT PAPER NUMBER
3763
MAIL DATE DELIVERY MODE
12/11/2012 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 HISAO NISHIKAWA, TETSUYA OOYAUCHI and
TERUYUKI YATABE
________________

Appeal 2010-000901
Application 10/520,180
Technology Center 3700
________________

Before STEVEN D.A. McCARTHY, JOHN W. MORRISON and
NEIL T. POWELL, Administrative Patent Judges.

McCARTHY, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE 1
The Appellants appeal under 35 U.S.C. § 134 from the Examiner’s 2
final decision rejecting claims 1, 3-5 and 7-18. The Examiner rejects under 3
35 U.S.C. § 103(a) claims 1 and 3-5 as being unpatentable over Gross (US 4
4,781,691, issued Nov. 1, 1988); claims 7 and 13 as being unpatentable over 5
Gross and Hardt (US 5,575,778, issued Nov. 19, 1996); 6

 The Appellants identify the real party in interest as Terumo KK.
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claims 8-11 and 14-17 as being unpatentable over Gross and Peery (US 1
7,063,681 B1, issued Jun. 20, 2006); and claims 12 and 18 as being 2
unpatentable over Gross and Kaneko (US 6,517,523 B1, issued Feb. 11, 3
2003). Claims 2, 6 and 19-22 are cancelled. We have jurisdiction under 35 4
U.S.C. § 6(b). 5
We AFFIRM. 6
Claims 1 and 4 are independent. Independent claim 1 recites: 7
1. An injection needle comprising a puncture 8
section having a needle point capable of piercing a 9
living body, a proximal end section having outside and 10
inside diameters greater than said puncture section, and 11
a tapered section interconnecting said puncture section 12
and said proximal end section, wherein 13
said proximal end section possesses an outside 14
diameter ranging from 0.35 mm to 1 mm, 15
said puncture section possesses an outside 16
diameter ranging from 0.1 mm to 0.5 mm, 17
the length from said puncture section to said 18
tapered section ranges from 0.2 mm to 15 mm, 19
the length of said tapered section ranges from 1.5 20
mm to 10 mm, 21
the total length of said puncture section, said 22
proximal end section and said tapered section to be 23
inserted in the living body ranges from 5 mm to 40 mm, 24
said tapered section possesses an outer profile 25
forming an angle ranging from 0.5 degree to 1 degree 26
and 20 minutes with respect to a line parallel to a 27
central axis of the injection needle, 28
said tapered section provides puncture resistance 29
smaller than said puncture section, and 30
a puncture resistance at the puncture section is 7 31
gf or less. 32

 The abbreviation “gf” is understood to mean gram-force or the force
exerted by the earth’s gravity on one gram of material at sea level. The
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ISSUES 1
The Appellants present substantive arguments addressing only the 2
rejection of claim 1 under § 103(a) as being unpatentable over Gross. (See 3
Br. 7-22). In particular, the section of the Appeal Brief addressing the 4
rejection of independent claim 4 merely incorporates by reference the 5
arguments directed against the rejection of claim 1. (See Br. 23). Therefore, 6
the Appellants argue the rejection of claims 1 and 3-5 as a group. Claim 1 is 7
representative. 8
As to the remaining grounds of rejection entered by the Examiner, the 9
Appellants merely argue that none of the secondary references remedies 10
perceived deficiencies in the teachings of Gross as discussed in connection 11
with the rejections of claims 1 and 4. (See Br. 23). Since the Appellants 12
have not identified any such deficiency, the Appellants’ argument 13
addressing these grounds of rejection raises no separate issues. 14
Only issues and findings of fact contested by the Appellants have 15
been considered. See Ex parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 16
2010). Two issues are dispositive of this appeal: 17
First, would one of ordinary skill in the art familiar with 18
the teachings of Gross have had reason to construct an injection 19
needle having a tapered section possessing a length ranging 20
from 1.5 mm to 10 mm and an outer profile forming an angle 21
ranging from 0.5 degree to 1 degree and 20 minutes with 22
respect to a line parallel to a central axis of the injection needle? 23
(See Br. 8-17). 24

Specification indicates that 1 gf equals approximately 9.8 × 10-3 N. (See
Spec. 27, l. 23, Spec. 28 ll. 1-3).
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Second, would one of ordinary skill in the art familiar 1
with the teachings of Gross have had reason to construct an 2
injection needle having a puncture section possessing a 3
puncture resistance of 7 gf or less; and a tapered section which 4
provides puncture resistance smaller than the puncture section 5
of the injection needle? (See Br. 18-21). 6
7
FINDINGS OF FACT 8
The record supports the following findings of fact (“FF”) by a 9
preponderance of the evidence. 10
1. Gross describes a stepped injection needle 10 for performing a 11
spinal anesthesia procedure. (Gross, col. 2, ll. 54-56 and col. 3, ll. 49-51). 12
2. The stepped injection needle 10 described by Gross includes a 13
first elongated tubular portion 14 of uniform diameter and a second 14
elongated tubular portion 16 of uniform diameter. The uniform diameter of 15
the first elongated tubular portion 14 is larger than the uniform diameter of 16
the second elongated tubular portion 16. (Gross, col. 3, ll. 51-57 and figs. 2 17
and 3). The distal end of the second elongated tubular portion 16 has a 18
beveled tip 20 to facilitate passage of the needle 10 through body tissue. 19
(Gross, col. 3, ll. 60-62). 20
3. The stepped injection needle 10 described by Gross also 21
includes an intermediate portion 18 which extends from the distal end of the 22
first elongated tubular portion 14 to the proximal end of the second 23
elongated tubular portion 16. (Gross, col. 3, ll. 57-60 and figs. 2 and 3). 24
Figures 2 and 3 of Gross depict the first elongated tubular portion 14, the 25
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second elongated tubular portion 16 and the intermediate portion 18 as 1
forming a unitary structure. 2
4. The intermediate portion 18 described by Gross tapers inwardly 3
from the diameter of the first elongated tubular portion 14 to the diameter of 4
the second elongated tubular portion 16 as one travels distally from the distal 5
end of the first elongated tubular portion 14 to the proximal end of the 6
second elongated tubular portion 16. (Gross, col. 3, ll. 57-60 and figs. 2 and 7
3). 8
5. Gross describes the first elongated tubular portion 14 as 9
possessing a uniform outer diameter in the range of approximately 0.025 10
inch (0.64 mm) to 0.050 inch (1.3 mm). (Gross, col. 4, ll. 1-5). This range 11
substantially overlaps the range from 0.35 mm to 1 mm recited in claim 1. 12
6. Gross describes the second elongated tubular portion 16 as 13
possessing a uniform outer diameter in the range of approximately 0.018 14
inch (0.46 mm) to 0.025 inch (0.64 mm). (Gross, col. 3, ll. 63-66). This 15
range substantially overlaps the range from 0.1 mm to 0.5 mm recited in 16
claim 1. 17
7. Gross describes the minimum length of the second elongated 18
tubular portion 16 as being in the range of approximately ¼ inch (6.4 mm) to 19
¾ inch (19 mm). (Gross, col. 3, l. 66 – col. 4, l. 1). This range substantially 20
overlaps the range from 0.2 mm to 15 mm recited in claim 1. 21
8. Gross describes the first elongated tubular portion 14, the 22
second elongated tubular portion 16 and the intermediate portion 18 as 23
having a combined length of approximately 3½ inches (89 mm). (Gross, 24
col. 4, ll. 5-8). Therefore, the injection needle 10 is susceptible of being 25
inserted in a living body to a length ranging from 5 mm to 40 mm. 26
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9. Gross does not appear to state the length of the intermediate 1
portion 18. While Figures 2 and 3 of Gross depict the intermediate portion 2
18 as possessing an outer profile forming an angle with respect to a line 3
parallel to a central axis of the injection needle 10, Gross does not appear to 4
quantify the angle. (See Ans. 6, ll. 16-17). 5
10. The intermediate portion 18 as depicted in Figures 2 and 3 of 6
Gross possesses an outer profile forming an angle with respect to a line 7
parallel to a central axis of the injection needle 10. 8
11. Gross teaches that relatively thin prior art needles were 9
relatively weak and might bend when inserted into a patient’s body. (Gross, 10
col. 2, ll. 47-51). Thus, Gross also teaches providing the injection needle 10 11
with a first elongated tubular portion 14 providing additional strength to the 12
injection needle 10 as the needle 10 passes through the patient’s body. 13
(Gross, col. 4, ll. 29-33). 14
12. Gross teaches that the tapered intermediate portion 18 facilitates 15
passage of the injection needle 10 through body tissue. (Id.) 16
13. Gross additionally teaches minimizing the outer diameter of the 17
second elongated tubular portion 16 in order to minimize the opening 18
created by puncturing the dura mater surrounding the spine while 19
performing a spinal anesthesia procedure. (Gross, col. 4, ll. 56-60). 20
14. Therefore, we adopt and incorporate by reference the 21
Examiner’s findings on page 8, lines 1-9 of the Answer. In particular, the 22
teachings of Gross support the Examiner’s finding that one of ordinary skill 23
in the art familiar with the teachings of Gross would have recognized the 24
length of the intermediate portion 18 of the injection needle 10 described by 25
Gross to have been a result effective variable. That is, one of ordinary skill 26
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in the art would have recognized that an increase in the length of the 1
intermediate portion 18 given a second elongated tubular section 16 of fixed 2
uniform diameter would have been effective to decrease resistance to 3
passage of the intermediate portion 18 through body tissue. One of ordinary 4
skill in the art would have recognized a constraint on this result effective 5
variable in that an increase in the length of the intermediate portion 18 given 6
a second elongated tubular section 16 of fixed uniform diameter would have 7
reduced the capacity of the first elongated tubular portion 14 to strengthen 8
the injection needle 10 against bending. 9
15. The Examiner correctly took Official Notice of the following 10
fact as a matter of common sense (that is, an elementary application of 11
trigonometry): Once one of ordinary skill in the art selected the outer 12
diameter of the first elongated tubular portion 14; the outer diameter of the 13
second elongated tubular portion 16; and the length of the intermediate 14
portion 18, the angle formed by the outer profile of the intermediate portion 15
18 with respect to a line parallel to the central axis of the injection needle 10 16
would have been fixed. (See Ans. 4, ll. 14-16). 17
16. One of ordinary skill in the art familiar with the teachings of 18
Gross would have recognized the length of the intermediate portion 18 of the 19
injection needle 10 to have been a result effective variable. (FF 14). This 20
length, together with the outer diameters of the first and second elongated 21
tubular portions, would have fixed the angle formed by the outer profile of 22
the intermediate portion 18 with respect to a line parallel to the central axis 23
of the injection needle 10. (FF 15). Therefore, the range of angles formed 24
by the outer profile of the intermediate portion 18 with respect to a line 25
parallel to the central axis of the injection needle 10 would have flowed 26
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naturally from optimizing the length of the intermediate portion 18 of the 1
injection needle 10. 2
17. During prosecution, the Examiner had reason to believe that the 3
injection needle of Gross, as optimized, would have had a second elongated 4
tubular portion 16 with a tip portion 20 possessing a puncture resistance of 5
7 gf or less; and an intermediate portion 18 providing puncture resistance 6
smaller than the tip portion 20. (See Final Office Action mailed August 6, 7
2008 (“Final Rejection”) at 2). The Appellants have not submitted 8
persuasive evidence to rebut the Examiner’s reasons for believing that the 9
injection needle of Gross, as optimized, meets these functional limitations. 10
18. Therefore, we adopt the findings that the injection needle of 11
Gross, as optimized, would have had a second elongated tubular portion 16 12
with a tip portion 20 possessing a puncture resistance of 7 gf or less; and an 13
intermediate portion 18 providing puncture resistance smaller than the tip 14
portion 20. 15
16
ANALYSIS 17
First Issue 18
The Examiner concludes that one of ordinary skill in the art would 19
have had reason to optimize the length of the intermediate portion 18 in 20
order to balance needle strength against resistance to the passage of the 21
needle through body tissue. (Ans. 4, ll. 3-7). The Examiner also concludes 22
that this optimization would have yielded a length within the range from 1.5 23
mm to 10 mm recited in claim 1. (See Ans. 8, ll. 1-3). The Appellants 24
disagree. (See Br. 8-17). 25
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The Examiner correctly concludes that one of ordinary skill in the art 1
would have recognized the length of the intermediate portion 18 to have 2
been a result effective variable for purposes of optimizing the balance 3
between needle strength and resistance to passage of the needle through 4
body tissue. (FF 16). The Appellants concede that: 5
The injection needle that is the subject of the 6
invention here seeks to balance a number of 7
competing concerns – avoiding an excessively 8
thick or large injection needle that inflicts pain on 9
the patient during usage and creates patient 10
anxiety, while at the same time avoiding an 11
excessively thin injection needle that possesses 12
reduced mechanical strength and exhibits 13
relatively large flow passage resistance. 14
(Br. 11; see also Br. 14-15). Gross teaches design factors including 15
minimizing the resistance of the tapered intermediate portion 18 to passage 16
through body tissue (FF 12) while avoiding an excessively thick outer 17
diameter for the second elongated tubular portion (FF 13) and avoiding an 18
excessively thin outer diameter for the first elongated tubular portion that 19
might reduce mechanical strength (FF 11). The design factors taught by 20
Gross are sufficiently similar to those which the Appellants seek to balance 21
that one would have anticipated optimization according to the factors taught 22
by Gross to have yielded an intermediate portion length within the range 23
recited in claim 1. 24
Therefore, the Examiner correctly concludes that it would have been 25
obvious to optimize the injection needle 10 in such a manner as to yield a 26
needle having an intermediate portion 18 ranging from 1.5 mm to 10 mm. 27
The same optimization would have yielded an intermediate portion 18 28
possessing an outer profile forming an angle ranging from 0.5 degree to 1 29
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degree and 20 minutes with respect to a line parallel to a central axis of the 1
injection needle. The latter property would have flowed naturally from the 2
former. (See FF 16). Even were this not true, the length of the intermediate 3
portion 18 and the angle formed by the outer profile of the intermediate 4
portion 18 are closely related. It would have been obvious to simultaneously 5
optimize both the length of the intermediate portion 18 and the angle formed 6
by the outer profile of the intermediate portion 18 in terms of the same 7
design factors. 8
9
Second Issue 10
The Appellants argue that one of ordinary skill in the art familiar with 11
the teachings of Gross would not have had reason to construct an injection 12
needle having a puncture section possessing a puncture resistance of 7 gf or 13
less; or a tapered section which provides puncture resistance smaller than the 14
puncture section of the injection needle. (See Br. 18-21). These limitations 15
are functional in the sense that one of ordinary skill in the art could 16
determine if the limitations are satisfied only by reference to the action of 17
the claimed injection needle on body tissue, which is not an element of the 18
claimed injection needle. Functional limitations in a structural claim are 19
satisfied by structure capable of performing the functions. See In re 20
Schreiber, 128 F.3d 1473, 1478-79 (Fed. Cir. 1997). 21
Where claimed and prior art products are identical or substantially 22
identical, 23
the [Patent and Trademark Office] can require an 24
applicant to prove that the prior art products do not 25
necessarily or inherently possess the characteristics 26
of [the] claimed product. Whether the rejection is 27
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based on ‘inherency’ under 35 U.S.C. § 102, on 1
‘prima facie obviousness’ under 35 U.S.C. § 103, 2
jointly or alternatively, the burden of proof is the 3
same, and its fairness is evidenced by the PTO’s 4
inability to manufacture products or to obtain and 5
compare prior art products. 6
In re Best, 562 F.2d 1252, 1255 (CCPA 1977) (citations omitted). Here, the 7
Examiner correctly concludes that it would have been obvious to optimize 8
the injection needle described by Gross in such a manner as to meet each 9
structural limitation recited in claim 1. (See also FF 2-7). Therefore, the 10
Examiner has reason to believe that the injection needle of Gross as 11
optimized would have the same characteristics as the injection needle 12
claimed in claim 1 Such characteristics include the capacity to meet the 13
same functional limitations. 14
As stated in Re Swinehart, 439 F.2d 210, 213 (CCPA 1971): 15
where the Patent Office has reason to believe that a functional 16
limitation asserted to be critical for establishing novelty in the 17
claimed subject matter may, in fact, be an inherent 18
characteristic of the prior art, it possesses the authority to 19
require the applicant to prove that the subject matter shown to 20
be in the prior art does not possess the characteristic relied on. 21
Here, the Examiner’s conclusion that it would have been obvious to 22
optimize the injection needle described by Gross in such a manner as to meet 23
each structural limitation recited in claim 1 provides the Examiner reason to 24
believe that the injection needle of Gross, as optimized, would have been 25
capable of performing the functional limitations recited at the end of claim 1. 26
During prosecution, the Examiner found that the “puncture 27
resistance [of the injection needle of Gross as optimized] is inherently 7gf or 28
less since the device has the same size and shape as applicants[’].” (Final 29
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Office Action mailed August 6, 2008 (“Final Rej’n”) at 2). The substantial 1
structural identity between the injection needle claimed in claim 1 and the 2
injection needle of Gross as optimized provided the Examiner reason to 3
believe that this functional limitation is met. The Examiner also found that 4
“Gross discloses that the tapered section 18 facilitates passage of the needle 5
through the body tissue (Col. 4, lines 30-33).” (Final Rej’n at 2). In view of 6
this finding and the substantial structural identity between the injection 7
needle claimed in claim 1 and the injection needle of Gross as optimized, the 8
Examiner had reason to believe that the intermediate portion 18 of the 9
injection needle of Gross as optimized necessarily provides a puncture 10
resistance smaller than that of the second elongated tubular portion 16. 11
These findings shifted to the Appellants the burden of producing 12
evidence to rebut the Examiner’s reasons for believing these findings to be 13
true. The Appellants produced no persuasive evidence to rebut the 14
Examiner’s reasons. Therefore, the Examiner correctly found that that the 15
injection needle of Gross as optimized would have had a second elongated 16
tubular portion 16 with a tip portion 20 possessing a puncture resistance of 7 17
gf or less; and an intermediate portion 18 providing puncture resistance 18
smaller than the tip portion 20. These findings imply that satisfaction of the 19
functional limitations wherein “said tapered section provides puncture 20
resistance smaller than said puncture section,” and wherein the injection 21
needle possessed “a puncture resistance at the puncture section is 7 gf or 22
less” flowed naturally from the optimization of the injection needle 23
described by Gross. See Ex parte Obiaya, 227 USPQ 58, 60 (BPAI 24
1985)(“The fact that appellant has recognized another advantage which 25
would flow naturally from following the suggestions of the prior art cannot 26
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be the basis for patentability when the differences would otherwise be 1
obvious.”). 2
Therefore, we sustain the rejection of claims 1 and 3-5 under § 103(a) 3
as being unpatentable over Gross. Since the Appellants have not identified 4
any deficiency in the teachings of Gross as applied to the rejection of claim 5
1, we also sustain the rejection of claims 7 and 13 under § 103(a) as being 6
unpatentable over Gross and Hardt; claims 8-11 and 14-17 under 7
§ 103(a) as being unpatentable over Gross and Peery; and claims 12 and 18 8
under § 103(a) as being unpatentable over Gross and Kaneko. 9
10
DECISION 11
We AFFIRM the Examiner’s decision rejecting claims 1, 3-5 and 7-12
18. 13
No time period for taking any subsequent action in connection with 14
this appeal may be extended under 37 C.F.R. § 1.136(a)(1)(iv). 15
16
AFFIRMED 17
18
19
Klh 20