Ex Parte Grispo

Patent Trial and Appeal Board

Nov 5, 2013

10780269 (P.T.A.B. Nov. 5, 2013)

UNITED STATES PATENT AND TRADEMARK OFFICE
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BEFORE THE PATENT TRIAL AND APPEAL BOARD
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Ex parte KEITH M. GRISPO
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Appeal 2011-012184
Application 10/780,269
Technology Center 3700
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Before ERIC GRIMES, LORA M. GREEN, and ZHENYU YANG,
Administrative Patent Judges.

YANG, Administrative Patent Judge.

DECISION ON APPEAL
This is a decision on appeal1 under 35 U.S.C. § 134 involving claims
to methods for purging air from dual head injectors. The Examiner rejected
claims 57, 58, and 68-80 as obvious. We have jurisdiction under 35 U.S.C.
§ 6(b).
We affirm.

1 Appellant identifies Mallinckrodt Inc. as the Real Party in Interest. (App.
Br. 1.)
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Application 10/780,269

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STATEMENT OF THE CASE
Claims 57, 58, and 68-80 are rejected and on appeal. They are
directed to methods of using dual head injectors, and specifically, of purging
air from such injectors. The Examiner rejected the claims under 35 U.S.C.
§ 103(a) as obvious over the combination of Emig2 and Stellant.3
Claims 57 and 71 are independent claims. Claim 57 is representative
of the subject matter on appeal. It reads:
57. A method of using a dual head injector, the method comprising:
mounting a first syringe to the injector;
mounting a second syringe to the injector;
coupling a first section of Y-tubing to the first syringe;
coupling a second section of the Y-tubing to the second
syringe . . . ;
initiating a purging operation . . . wherein the first
syringe comprises contrast media prior to the initiation of the
purging operation, wherein the second syringe comprises saline
prior to the initiation of the purging operation, and wherein the
purging operation comprises:
advancing a first plunger drive ram of the injector
to move a plunger of the first syringe to a first predetermined
stop point where the plunger of the first syringe stops, wherein
the advancing of the first plunger drive ram purges air from the
first syringe and the first section of Y-tubing and fills the first
section of the Y-tubing with contrast media from the first
syringe . . . ; and
advancing a second plunger drive ram of the
injector to move a plunger of the second syringe to a second
predetermined stop point where the plunger of the second
syringe stops, wherein the advancing of the second plunger

2 Emig et al., U.S. Patent No. 6,471,674 B1, issued on Oct. 29, 2002.
3 Medrad, Inc., STELLANT CT INJECTION SYSTEM, Operation Manual Catalog
#SOM 700 EN (2003).
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drive ram purges air from the second syringe, the second
section of the Y-tubing, the intersection of the first, second, and
third sections of the Y-tubing, and the third section of the Y-
tubing, wherein the advancing of the first plunger drive ram
occurs before the advancing of the second plunger drive ram,
and wherein the advancing of the second plunger drive ram
comprises filling each of the second and third sections of the Y-
tubing with saline from the second syringe; and
initiating an injection procedure . . . .
(Emphasis added.)

DISCUSSION
The only issue Appellant raises on appeal is whether the combination
of Emig and Stellant would render the claimed invention obvious, even
though neither reference explicitly discloses the sequence of the steps of
advancing the two plunger drive rams as recited in the claims.
In rejecting claim 57, the Examiner found that Emig and Stellant
disclose all the limitations except the sequence of advancing the two plunger
drive rams. (Final Rej. 4, Ans. 6.) Citing column 6, lines 6-19 of Emig, the
Examiner acknowledged that “it is not clear if Emig et al in view of Stellant
explicitly disclose wherein the advancing of the first plunger drive ram
occurs before the advancing of the second plunger drive ram.” (Final Rej. 4;
Ans. 6.) Nevertheless, according to the Examiner,
It would have been obvious to one having ordinary skill in the
art at the time the invention was made to modify the purge
protocol as taught by Emig et al with [the advancing of] the
first plunger drive ram occurring before the advancing of the
second plunger drive ram since changes in sequence are prima
facie obvious in the absence of new or unexpected results (See
MPEP 2144.04(IV)(C)). Having the first plunger drive ram
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advancing before the second plunger drive ram does not
provide a new or unexpected result in this case.
(Final Rej. 4-5; Ans. 6-7.)
Appellant argues that the Examiner erred in relying upon the
presumption that “there are only two options for undertaking a purging
operation: 1) a saline push followed by a contrast push; or 2) a contrast push
followed by a saline push.” (App. Br. 11.) According to Appellant, “[a]
purging operation could be configured in any appropriate manner, for
instance one or more saline pushes, one or more contrast pushes, and in any
combination (e.g., a saline push, followed by a contrast push, followed by
another saline push).” (Id.) Appellant asserts that “[b]ased upon the vast
option set for configuring a purging operation (which plunger drive ram to
move at what time, and for how long), one skilled in the art simply would
not be motivated to modify the teachings of Emig and/or Stellant OMC in
any manner that would [yield] Appellant’s invention of claim 57.”4 (Id. at
12.)
A preponderance of the evidence supports the Examiner’s position
that the claimed two-step purging operation, i.e., “push the contrast first
followed by a saline push,” would have been obvious. (Ans. 10.) This is so
even if, as Appellant would like us to find, there are more than two purging

4 At one point, Appellant argues that “Emig could be interpreted to define a
purging operation that uses a saline prime, followed by a contrast prime.
This is the exact opposite of the purging sequence set forth in claim 57 . . . .”
(App. Br. 9.) Upon reviewing Emig, we find no merit in this assertion.
Indeed, a few pages later, in the same brief, Appellant concedes that “Emig
does not explicitly disclose any sequence at all for the saline prime and
contrast prime addressed therein.” (Id. at 13.)
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sequences because as the Examiner correctly pointed out, “changes in
sequence are prima facie obvious in the absence of new or unexpected
results.” (Final Rej. 5; Ans. 7.)
Appellant faults the Examiner for relying on MPEP § 2144.04(IV)(C)
to support the obviousness rejection. (App. Br. 12-13.) Appellant first
argues that because he has demonstrated the criticality of the sequence in the
purging operation, “reliance by the Examiner on the rationale of MPEP
§ 2144.04(IV)(C) is inappropriate.” (Id. at 12.) According to Appellant:
[T]he order of the advancement of the first and second syringe
plunger drivers for a purging operation in accordance with
claim 57 has been the focus of prosecution. Moreover, such a
specific order reduces the waste of relatively expensive
contrast, purges air prior to injection, and does so in what is in
effect a simple two-step process (i.e., two syringe plunger drive
ram movements).
(Id.)
Appellant has not pointed to any disclosure in the Specification, and
we find none, that support this argument of criticality. (See Ans. 10-11
(stating that Appellant “does not mention ‘waste,’ ‘expense,’ or ‘simple’ in
the specification as originally filed. Simply put, the Appellant lacks support
for the purported criticality in the originally filed specification”)). The
Examiner is also correct in the observation that Emig “discloses the exact
reasoning and criticality” for the air purging steps. (Id. at 11.) Indeed, Emig
teaches “priming” of the fluid delivery path “to remove air from the fluid
path and minimize wastage of contrast medium.” (Emig, col. 6, ll. 9-11.)
Appellant has not provided any persuasive reasoning or credible evidence
that the claimed invention achieves any advantage over, or even any result
different from, Emig. See In re Hampel, 162 F.2d 483, 485 (CCPA 1947)
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(upholding affirmance of obviousness rejection because “[t]here is nothing
in the instant record which indicates that the particular order of steps
produces results differing in any way from those which would be brought
about if another order of steps were followed”).
Noting that the heading of the MPEP section is “Changes in Sequence
of Adding Ingredients,” Appellant also contends that the legal precedent
cited therein “on its face is inapplicable to claim 57.” (App. Br. 13.) We
find Appellant’s argument unpersuasive. As the Examiner correctly pointed
out, “the cases cited in 2144.04(IV)(c) are directed to processes and the
obviousness of ordering of the known steps within that process.” (Ans. 11.)
For example, in Ex parte Rubin, the claims were directed to a method of
forming a laminated sheet requiring first impregnating the sheet with a
thermosetting material and then coating it with a metallic film. 128 USPQ
440, 441 (BPAI 1959). The examiner decided that the prior art reference
disclosing a process of making a laminated sheet with the two steps reversed
rendered the claims prima facie obvious. Id. Because “no unexpected result
is obtained by reversing the order of steps,” the Board of Patent Appeals and
Interferences affirmed the obviousness rejection. Id. at 442. See also In re
Burhans, 154 F.2d 690, 692 (CCPA 1946) (affirming obviousness rejection
“in the absence of any proof in the record that the order of performing the
steps produces any new and unexpected results”).
Similarly in this case, Appellant points to no evidence in the record
showing that the claimed order of steps produces results differing in any way
from those which would be brought about if another order of steps were
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followed. Absent such new and unexpected results, we affirm the
Examiner’s rejection of claim 57.5 Claims 58 and 68-70 fall with claim 57.
Appellant argues that the deficiency of Emig in view of Stellant is
also applicable to claim 71. (App. Br. 16.) This argument is not persuasive
as we found no deficiency in the combination of Emig and Stellant. Thus,
we affirm the Examiner’s rejection of claim 71 for the same reason
discussed above. Claims 72-80 fall with claim 71.

SUMMARY
We affirm the rejections on appeal.

TIME PERIOD FOR RESPONSE
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

cdc

5 Appellant also contends that the Examiner’s other rationales supporting the
obviousness rejection are flawed. (See App. Br. 13-15.) We do not address
those arguments as we affirm based on the Examiner’s first rationale.