Ex parte Samsel

Board of Patent Appeals and Interferences

Apr 29, 1999

08325847 (B.P.A.I. Apr. 29, 1999)

Application for patent filed October 19, 1994.1
1
THIS OPINION WAS NOT WRITTEN FOR PUBLICATION
The opinion in support of the decision being entered today (1) was not written for publication in a law
journal and (2) is not binding precedent of the Board.
Paper No. 19
UNITED STATES PATENT AND TRADEMARK OFFICE
_____________
BEFORE THE BOARD OF PATENT APPEALS
AND INTERFERENCES
_____________
Ex parte W. SCOTT SAMSEL
_____________
Appeal No. 97-1871
Application 08/325,8471
______________
ON BRIEF
_______________
Before CALVERT, STAAB and NASE, Administrative Patent Judges.
CALVERT, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal from the final rejection of claims 1 to 18 and 20 to 32, all the claims remaining
in the application.
The appealed claims are reproduced in Appendix I of appellant's brief.
The subject matter in issue is exemplified by claim 1:
Appeal No. 97-1871
Application 08/325,847
The McIntosh patent is of record in the application; a copy of Stametz is enclosed herewith.2
2
1. A method for producing blunt tip surgical needles, comprising:
a) providing a curved surgical needle with a sharp pointed tip;
b) forming a substantially hemispherical radius on the tip of said surgical needle by a first
tumbling operation in a tumbler with a first medium for a first duration of tumbling time, wherein the ratio
of the radius after tumbling to the diameter of the needle ranges from about 0.15 to about 0.29.
The references applied in the final rejection are:
Schulte 1,678,359 July 24, 1928
Balz et al. (Balz) 2,318,580 May 11, 1943
Baylin 2,435,488 Feb. 3, 1948
Gillette et al. (Gillette) 2,683,343 July 13, 1954
Gleszer 2,978,850 Apr. 11, 1961
Bishop 3,239,970 Mar. 15, 1966
Kittredge et al. (Kittredge) 3,613,317 Oct. 19, 1971
Samsel et al. (Samsel) 5,447,465 Sept. 5, 1995
(filed Aug. 19, 1993)
Smith et al. (Smith) 5,477,604 Dec. 26, 1995
(filed Nov. 1, 1993)
Additional references applied herein in rejections pursuant to 37 CFR §1.196(b) are: 2
McIntosh 5,123,910 June 23, 1992
Stametz et al. (Stametz) 5,601,475 Feb. 11, 1997
(effective filing date July 27, 1994)
The appealed claims stand finally rejected as follows:
(I.) Claims 1 to 18, 20, 21 and 30 to 32, unpatentable as being based on a specification which fails to
Appeal No. 97-1871
Application 08/325,847
A rejection of claims 1 to 18 and 20 to 32 as unpatentable over Samsel in view of Smith3
under 35 U.S.C. § 103 was not repeated in the answer and therefore is presumed to have been
withdrawn. Ex parte Emm, 118 USPQ 180 (Bd. Apps. 1957).
These Sections are not in the current (July 1998) edition of the MPEP, but are quoted in part4
(continued...)
3
comply with 35 U.S.C. § 112, first paragraph.
(II.) Unpatentable under 35 U.S.C. § 103 over the following combinations of references:
(a) Claims 1 to 3, 8, 9, 20 to 22, 31 and 32, Baylin in view of Bishop and Smith;
(b) Claims 10 and 11, Baylin in view of Bishop, Smith and Kittredge;
(c) Claim 12, Baylin in view of Bishop, Smith and Gleszer;
(d) Claims 16 and 17, Baylin in view of Bishop, Smith and Schulte;
(e) Claim 18, Baylin in view of Bishop, Smith and Gillette;
(f) Claims 4 to 7, 13 to 15, 23 to 25 and 27 to 30, Baylin in view of Bishop, Smith and Balz;
(g) Claim 26, Baylin in view of Bishop, Balz and Gleszer.
(III.) Claims 1 to 18 and 20 to 32, unpatentable over claims 1 to 15 of Samsel on the ground of
obviousness-type double patenting. 3
Rejection (I)
On page 3 of the answer, the examiner states that the basis of this rejection is that "the
disclosure is enabling only for claims limited to those not claiming the ratio range which is treated as new
matter as noted below. See M.P.E.P. §§ 706.03(n) and 706.03(z)."4
Appeal No. 97-1871
Application 08/325,847
(...continued)4
in footnotes 19 and 20 of In re Vaeck, 947 F.2d 488, 492, 20 USPQ2d 1438, 1442 (Fed. Cir. 1991).
They apparently have been replaced by MPEP § 2164.08.
4
The examiner does not specify what "the ratio range" is, but it appears from the final rejection and the
arguments in appellant's brief and the examiner's answer that this expression is understood by appellant
and the examiner to apply to three claimed ratio ranges, i.e.:
(1) the range of the ratio of the radius after tumbling to the diameter of the needle recited in claim 1, and
((2) the ranges of the ratio of the particle diameter of the second (burnishing) medium to the diameter
of the surgical needle recited in claims 4 and 30.
With regard to the question of lack of enablement, on which the rejection is ostensibly based,
the scope of the claims must bear a reasonable correlation to the scope of enablement provided by the
specification. In re Vaeck, 947 F.2d at 495, 20 USPQ2d at 1444-45. In other words, there must be
sufficient disclosure to teach those of ordinary skill how to make and use the invention as broadly as it is
claimed. Id.
Whether the disclosure of species within a range is sufficient to enable one of ordinary skill to
make and use subject matter within the scope of the range is dependent on the predictability of the
effect of changes in the subject matter. Thus, as stated in In re Fisher, 427 F.2d 833, 839, 166 USPQ
18, 24 (CCPA 1970):
In cases involving predictable factors, such as mechanical or electrical elements, a single
embodiment provides broad enablement in the sense that, once imagined, other
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Application 08/325,847
5
embodiments can be made without difficulty and their performance characteristics
predicted by resort to known scientific laws. In cases involving unpredictable factors,
such as most chemical reactions and physiological activity,
the scope of enablement obviously varies inversely with the degree of unpredictability of
the factors involved.
In the present case, Examples 2 and 3 on pages 5 to 6 of the specification disclose how to
make needles having a particular tip radius and body diameter. The ratios recited in claim 1 (range (1),
supra) as the end points of the claimed range are ratios calculated from the tip radius and needle
diameter of the needles resulting from Examples 2 and 3, respectively. This is a case involving
mechanical elements, and it appears to us that, given the disclosure in the present application, and
particularly Examples 2 and 3, it would be evident to one of ordinary skill, using only routine
experimentation, how to produce needles having ratios falling between the end points of the claimed
range. For similar reasons, we reach the same conclusion with respect to the ranges ( (2), supra)
recited in claims 4 and 30. Appellant's disclosure therefore satisfies the enablement requirement of §
112, first paragraph. See National Recovery Technologies Inc., v. Magnetic Separation Systems Inc.,
F.3d , 49 USPQ2d 1671, 1676 (Fed. Cir. 1999) ("In order to satisfy the enablement requirement
of § 112, paragraph 1, the specification must enable one of ordinary skill in the art to practice the
claimed invention without undue experimentation").
However, this does not end the inquiry under the first paragraph of § 112, because although the
examiner states the basis of the rejection as lack of enablement, both he and the appellant have argued
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the rejection as though the basis were a lack of written description, which is a separate statutory
requirement. Thus, on pages 7 to 9 and 18 of the brief, appellant argues the rejection in terms of new
matter or lack of support, both of which concern the written description requirement of § 112, first
paragraph, see In re Higbee, 527 F.2d 1405, 1406 , 188 USPQ 488, 489 (CCPA 1976), and cites
cases relating thereto (e.g., In re Herschler, 591 F.2d 693, 701, 200 USPQ 711, 717 (CCPA 1979),
cited on page 8 of the brief). Likewise, the examiner's arguments on pages 8 and 9 of the answer
concern the question of lack of support. We will therefore treat the rejection under § 112, first
paragraph, as having included the ground of non-compliance with the written description requirement.
In order to comply with the written description requirement, appellant's application, as filed,
"must contain sufficient disclosure, expressly or inherently, to make it clear to persons skilled in the art
that appellant possessed the subject matter claimed." In re Mott, 539 F.2d 1291, 1297, 190 USPQ
536, 541 (CCPA 1976). This requirement is separate and distinct from that of enablement. Vas-Cath
Inc. v. Mahurkar, 935 F.2d 1555, 1563, 19 USPQ2d 1111, 1117 (Fed. Cir. 1991); In re Barker,
559 F.2d 588, 593, 194 USPQ 470, 474 (Fed. Cir. 1977), cert. denied, 434 U.S. 1064 (1978).
Considering first the range recited in claim 1, the end points of that range, about 0.15 to about 0.29, are
inherently described in the application as filed, since they are calculable from the values given in
Examples 2 and 3, respectively. However, we do not consider that this disclosure would convey to
one of ordinary skill that appellant had invented a method in which the ratio range would be within the
Appeal No. 97-1871
Application 08/325,847
7
range recited in claim 1, i.e., that one skilled in the art could derive the claimed range from appellant's
disclosure. Vas-Cath Inc., 935 F.2d at 1565, 19 USPQ2d at 1119. The end points of the range are
simply two values calculated from two examples, and we find no disclosure in the application as filed
that the ratio of the tip radius to the needle diameter should fall between those points, or even that the
radius of the tip has or should have any relationship whatsoever to the diameter of the needle. There is,
therefore, nothing in the disclosure which describes the claimed range limitations "so clearly that persons
of ordinary skill in the art will recognize from the disclosure that appellants invented processes including
those limitations." In re Wertheim, 541 F.2d 257, 262, 191 USPQ 90, 96 (CCPA 1976).
We reach the same conclusion with regard to the ranges of the ratio of the particle diameter of
the second medium to the diameter of the surgical needle recited in claims 4 and 30. Here again, while
the end points of these ranges can be calculated by picking and choosing various particle diameters and
needle diameters disclosed in the specification (as demonstrated on page 18 of the brief), the
application as filed does not convey that appellant was in possession of the claimed ranges as of the
filing date of his application.
Rejection (I) will accordingly be sustained.
Rejections (II)(a) to (g)
On page 3 of the brief, appellant groups the claims on appeal into five groups, of which Group
1 consists of claims 1, 3, 8 to 12, 16 to 18, 20, 21, 31 and 32. Accordingly, we select claim 1 from
Appeal No. 97-1871
Application 08/325,847
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this group and shall decide the appeal as to the § 103 rejections of the claims of this group based
thereon.
In rejecting claim 1 et al under 35 U.S.C. § 103 (rejection (II)(a)), the examiner applied Baylin
in view of Bishop and Smith, citing Bishop for its disclosure of various tumbling media, and Smith for its
disclosure of curved needles. It is however unnecessary to consider either Bishop or Smith with regard
to claim 1, because claim 1 does not recite any particular medium, nor does it recite curved needles.
Appellant's only argument concerning Baylin, as applied to the Group 1 claims, is (brief, page
10):
Baylin discloses the tumbling of knitting needles in order to polish them, but neither
discloses nor suggests the steps of providing a needle with a sharp pointed tip and then
forming a radius on the tip of the needle by tumbling. Baylin's needles are stacked in
aligned parallel relationship so that the rotating and to-and-fro motion of the container
causes them to rub along their sides. If, as the Office Action suggests, Baylin starts out
with pointed needles, this fact does not militate against appellant's argument. The Baylin
needles would be expected to keep their points for their original purpose of knitting.
The tips of the Baylin needles are not disclosed as being blunted or radiused by this
operation.
We do not agree with this argument. Baylin discloses tumbling the container 16 containing
knitting needles and a "suitable abradant" (col. 2, lines 29 and 32). The needles to be tumbled would
have sharp pointed tips, as claimed, the term "sharp" being but a relative term and applicable to the tip
of a knitting needle. The examiner takes the position that the tips of Baylin's needles would inherently
have radii formed on them when tumbled with an abradant; as he states on page 9 of the answer:
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Application 08/325,847
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A skilled artisan would realize that it is inherent that needles will be deburred or blunted
or radiused when tumbled in a container with an abradant. The abradant does not
discriminate between parts of the object being tumbled and any sharp edges on the
needles will be blunted or "radiused".
We consider the examiner's position to be reasonable, for even if the needles are stacked in aligned
relationship, as appellant asserts, the abradant would still contact their tips. Moreover, such radiusing
would not prevent their use for knitting as appellant implies. Appellant has not met his burden of
showing that a radius would not inherently be formed on the tips of Baylin's needles. See In re
Schreiber, 128 F.3d 1473, 1478, 44 USPQ2d 1429, 1432 (Fed. Cir. 1997).
We will therefore sustain the rejection under § 103 of claim 1, and of claims 3, 8 to 12, 16 to
18, 20, 21, 31 and 32 grouped therewith.
Appellant's Group 2 contains only claim 2, which depends on claim 1 and recites that the
needle is curved. We will not sustain this rejection, because even though Smith discloses a curved
surgical needle, we find nothing in Smith which would suggest curving the knitting needles disclosed by
Baylin, which are used for an entirely different purpose. We likewise will not sustain the rejections of
claims 22 to 30 (appellant's Groups 4 and 5), all of which call for curved needles.
Finally, the claims in appellant's Group 3, Claims 4 to 7 and 13 to 15, all are dependent on
claim 4 and therefore include the recitations of claim 4 that "the second medium comprises particles
having a hardness greater than that of the needles [sic: needle] and having no surface feature with a
radius less than the diameter of the needle." We find no disclosure in any of the applied references,
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Application 08/325,847
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particularly Balz, which would teach or suggest these limitations, and will not sustain the rejection of
claims 4 to 7 and 13 to 15 under § 103.
Rejection (III)
The examiner states in the answer as to this rejection (pages 7 and 8):
The patented and the pending claims set forth the same invention of substantially the
same scope except the invention of patented claims 1-15 contain needle size and
particle size limitations. However, it is well known in the art that the size of the tumbling
media and the size of the articles being tumbled can be varied and are strictly choices of
the operator.
It would have been obvious to one of ordinary skill in the art to have utilized the
process of claims 1-5 without specific limitations on the tumbling media or the articles
being tumbled.
The only argument we find in appellant's brief concerning this rejection is on page 15 (original
emphasis):
Reversal of this rejection is respectfully requested. Samsel et al. claims a process
for deburring reducing the sharp edges of needle blanks. There is no suggestion in the
Samsel et al. claims to radius the tip of an already sharply pointed needle to provide a
blunt tip having the recited radius. Accordingly, it is respectfully submitted that the
claims in the present application are not obvious over the claims in the Samsel et al.
'465 patent.
The examiner responds at page 11 of the answer:
Appellant correctly states that the Samsel et al. reference claims a method for
deburring and reducing sharp edges of needle blanks. However, it is offered that
"deburring and reducing sharp edges" is essentially the same thing as forming a
substantially hemispherical radius tip because the tip before Appellant's method is a
sharp edge and it is reduced. Further, it is offered that the treatment of needle blanks
and the treatment of needles are substantially the same scope. The Samsel et al. claims
Appeal No. 97-1871
Application 08/325,847
11
suggest that sharp edges along the entire needle are subject to "radiusing" or reduction.
We consider the examiner's position to be correct. There would appear to be little practical
difference between the "needles" recited in appellant's claims and the "needle blanks" recited in the
claims of the Samsel patent, and in particular, the "polished needle blanks" recited in claims 5 to 15 of
the patent. Moreover, claims 22 to 30 only claim the treatment of "partially finished" needles. For the
reasons stated by the examiner, supra, this rejection will be sustained.
Rejections Pursuant to 37 CFR § 1.196(b)
Pursuant to 37 CFR § 1.196(b), we enter the following new grounds of rejection.
(a) Claims 1 to 3, 8 to 11, 16, 20, 21, 31 and 32 are rejected under 35 U.S.C. § 103 as
unpatentable over Stametz in view of McIntosh. Stametz discloses a method of producing blunt tip
surgical needles (including curved needles) by tumbling sharp, tapered tip needles 10 with an abrasive
40. The abrasive may include a liquid (col. 2, line 48), the abrasive medium may be porcelain, etc.,
spheres (col. 5, lines 11 to 21), and the needles may be 420 stainless steel (col. 5, line 37). As for the
ratio range recited in claim 1, McIntosh teaches that blunt surgical needles should have a percentage of
bluntness (diameter of curvature) of 25 to 62% of the diameter of the needle (col. 9, lines 12 to 19).
This is the same as a ratio of tip radius to needle diameter of 0.125 to 0.31, which embraces the range
recited in claim 1. Also, McIntosh teaches the use of needle diameters of 0.026 to 0.050 inches and tip
Appeal No. 97-1871
Application 08/325,847
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radii of 0.003 to 0.0155 inches (0.006 to 0.031 inches in diameter) (col. 9, lines 23 to 26). In view of
this disclosure, it would have been obvious to one of ordinary skill in the art to use the Stametz process
to produce needles having the ratios, tip radii (diameters) and shaft diameters taught by McIntosh as
being desirable for blunt surgical needles.
(b) Claim 22 is rejected under 35 U.S.C. § 102(e) as being anticipated by Stametz. Note
Stametz' disclosure that the needles being tumbled may be "semi-finished" and have tapered tips (col.
4, lines 7 to 10).
We note that since appellant is claiming the same invention as at least claim 1 of the Stametz
patent, it cannot be overcome via an affidavit or declaration under 37 CFR § 1.131.
See MPEP § 715.05.
Remand to the Examiner
This application is remanded to the examiner to determine whether claims 4 to 7, 12 to 15, 17,
18 and 23 to 30 should be rejected under § 103 as unpatentable over Stametz in view of other prior
art.
Conclusion
The examiner's decision to reject claims 1 to 18, 20, 21 and 30 to 32 under 35 U.S.C.
§ 112, first paragraph, and to reject claims 1 to 18 and 20 to 32 on the ground of obviousness-type
double patenting, is affirmed. The examiner's decision to reject claims 1 to 18 and 20 to 32 under 35
Appeal No. 97-1871
Application 08/325,847
13
U.S.C. § 103 is affirmed as to claims 1, 3, 8 to 12, 16 to 18, 20, 21, 31 and 32, and is reversed as to
claims 2, 4 to 7, 13 to 15 and 22 to 30. Claims 1 to 3, 8 to 11, 16, 20 to 22, 31 and 32 are rejected
pursuant to 37 CFR § 1.196(b), and the application is remanded to the examiner.
In addition to affirming the examiner’s rejections of one or more claims, this decision contains
new grounds of rejection pursuant to 37 CFR § 1.196(b)(amended effective Dec. 1, 1997, by final rule
notice, 62 Fed. Reg. 53,131, 53,197 (Oct. 10, 1997), 1203 Off. Gaz. Pat. & Trademark Office 63,
122 (Oct. 21, 1997)). 37 CFR § 1.196(b) provides, “A new ground of rejection shall not be
considered final for purposes of judicial review.”
Regarding any affirmed rejection, 37 CFR § 1.197(b) provides:
(b) Appellant may file a single request for rehearing within two months from the date of
the original decision . . . .
37 CFR § 1.196(b) also provides that the appellant, WITHIN TWO MONTHS FROM THE
DATE OF THE DECISION, must exercise one of the following two options with respect to the new
grounds of rejection to avoid termination of proceedings (37 CFR § 1.197(c)) as to the rejected claims:
(1) Submit an appropriate amendment of the claims so rejected or a showing of
facts relating to the claims so rejected, or both, and have the matter reconsidered by the
examiner, in which event the application will be remanded to the examiner. . . .
(2) Request that the application be reheard under § 1.197(b) by the Board of
Patent Appeals and Interferences upon the same record. . . .
Appeal No. 97-1871
Application 08/325,847
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Should the appellant elect to prosecute further before the Primary Examiner pursuant to 37
CFR § 1.196(b)(1), in order to preserve the right to seek review under 35 U.S.C. §§ 141 or
145 with respect to the affirmed rejections, the effective date of the affirmance is deferred until
conclusion of the prosecution before the examiner unless, as a mere incident to the limited prosecution,
the affirmed rejections are overcome.
If the appellant elects prosecution before the examiner and this does not result in allowance of
the application, abandonment or a second appeal, this case should be returned to the Board of Patent
Appeals and Interferences for final action on the affirmed rejections, including any timely request for
rehearing thereof.
No time period for taking any subsequent action in connection with this appeal may be
extended under 37 CFR § 1.136(a).
AFFIRMED; 37 CFR § 1.196(b);
REMANDED
IAN A. CALVERT )
Administrative Patent Judge )
)
)
) BOARD OF PATENT
Appeal No. 97-1871
Application 08/325,847
15
LAWRENCE J. STAAB )
Administrative Patent Judge ) APPEALS AND
)
) INTERFERENCES
)
JEFFREY V. NASE )
Administrative Patent Judge )
IAC/dal
Appeal No. 97-1871
Application 08/325,847
16
JOHN C. ANDRES
UNITED STATES SURGICAL CORP.
150 GLOVER AVENUE
NORWALK, CT 06856