Ex Parte Field

Patent Trial and Appeal Board

Mar 29, 2017

13064382 (P.T.A.B. Mar. 29, 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.
13/064,382 03/22/2011 Stephen James Field 44313-0002002 1169
26161 7590 03/31/2017
FISH & RICHARDSON P.C. (BO)
P.O. BOX 1022
MINNEAPOLIS, MN 55440-1022
EXAMINER
MENDOZA, MICHAEL G
ART UNIT PAPER NUMBER
3731
NOTIFICATION DATE DELIVERY MODE
03/31/2017 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):
PATDOCTC@fr.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte STEPHEN JAMES FIELD1
Appeal 2015-007566
Application 13/064,382
Technology Center 3700
Before DONALD E. ADAMS, ERIC B. GRIMES, and
RICHARD M. LEBOVITZ, Administrative Patent Judges.
GRIMES, Administrative Patent Judge.
DECISION ON APPEAL
This is an appeal under 35U.S.C. § 134 involving claims to a medical
device, which have been rejected as anticipated or obvious. We have
jurisdiction under 35 U.S.C. § 6(b).
We reverse and enter a new ground of rejection.
STATEMENT OF THE CASE
Claims 19-30 and 32^42 are on appeal. Claims 19, 33, 34, 36, and 37
are the only independent claims and read as follows (emphasis added):
1 Appellant identifies the Real Party in Interest as Smiths Group PLC.
(Appeal Br. 3.)
Appeal 2015-007566
Application 13/064,382
19. A medico-surgical device having a shaft consisting of a plastics
material including gas bubbles in said plastics material through the major
part of the thickness of the shaft in at least a part of the shaft, wherein said
gas bubbles are selected to increase the visibility of the device under
ultrasound imaging, and wherein the visibility of the device under ultrasound
imaging is increased solely by the presence of said gas bubbles in said shaft.
33. A medico-surgical device having a tubular shaft with an outer surface
and a bore defined by an inner surface of the shaft, said shaft consisting of a
plastics material including gas bubbles in said plastics material extending
through the major part of the thickness of the shaft from said outer surface to
said inner surface in at least a part of the shaft, wherein said gas bubbles are
selected to increase the visibility of the device under ultrasound imaging
substantially solely by reflection of ultrasound energy at the interface with
the gas in the bubbles.
34. An embryo replacement catheter comprising a hub and a shaft,
wherein said shaft consists of a wall extruded of a transparent plastics
material incorporating gas bubbles within its thickness, said shaft having a
bore extending therethrough, wherein the density and size of said bubbles is
selected to increase visibility of the catheter under ultrasound imaging whilst
enabling an embryo within the catheter to be viewed by the eye.
36. A method of making a medico-surgical device having a shaft
consisting of a wall of a plastics material containing a chemical foaming
agent such as to form gas bubbles through a major part of the thickness of
the wall sufficient to increase the visibility of said device under ultrasound
observation.
37. A medico-surgical device visible under ultrasound imaging in the
shape of an elongate hollow shaft consisting of an extruded transparent
plastics material having only gas bubbles incorporated therein, the density
and size of the bubbles selected to enhance the visibility of the device under
the ultrasound imaging.
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Appeal 2015-007566
Application 13/064,382
The claims stand rejected as follows:
Claims 19-28 and 33 under 35 U.S.C. § 102(b) as anticipated by
Bosley2 (Final Act.3 4);
Claims 29 and 30 under 35 U.S.C. § 102(b) as anticipated by, or
alternatively under 35 U.S.C. § 103(a) as obvious based on, Bosley (Final
Act. 5);
Claims 32, 34, 35, and 37^42 under 35 U.S.C. § 103 as obvious based
on Bosley and Sheridan4 (Final Act. 6); and
Claim 36 under 35 U.S.C. § 103(a) as obvious based on Bosley and
Kobayashi5 (Final Act. 6).
I
All of the claims on appeal are directed to a device having a shaft
“consisting of’ or that “consists of’ a wall of a plastics material and gas
bubbles. “[Cjlosed transition phrases such as ‘consisting of are understood
to exclude any elements, steps, or ingredients not specified in the claim.”
AFGIndus., Inc. v. CardinalIG Co., 239 F.3d 1239, 1245 (Fed. Cir. 2001).
Thus, the claimed devices are limited to those that contain only a plastics
material and gas bubbles in the wall of their shaft.
The Examiner has rejected claims 1—28 and 33 as anticipated by
Bosley. The Examiner finds that Bosley discloses all of the limitations of
the claimed device, including “a shaft consisting of plastics material. . .
2 Bosley, US 5,289,831, issued March 1, 1994
3 Office Action mailed Sept. 15, 2014.
4 Sheridan et al., US 3,605,750, issued Sept. 20, 1971.
5 Kobayashi et al., US 5,646,194, issued July 8, 1997.
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Appeal 2015-007566
Application 13/064,382
including gas bubbles (Bosley discloses hollow microspheres, because the
microspheres 127 are hollow they fit within the definition of a ‘bubble’.
Bosley further states that gas alone can be used as an alternative to the
microspheres in col. 8, lines 23-32).” (Final Act. 4.) The Examiner also
finds that the gas bubbles “increase the visibility of the shaft under
ultrasound imaging, and wherein the visibility of the shaft under ultrasound
imaging is increased solely b[y] the presence of sai[d] gas bubbles in the
shaft (col. 7, lines 46-52).” {Id. at 4—5.)
Appellant argues that “the interpretation by the examiner that a hollow
microsphere is the same as a gas bubble is misplaced insofar as a hollow
microsphere must have a wall that is made of a hard material, which in turn
makes the glass microsphere a thing that is made of a hard material.”
(Appeal Br. 15.)
We agree with Appellant that Bosley’s disclosure does not support the
Examiner’s finding that its device has a wall that consists of a plastics
material and gas bubbles. Bosley discloses a medical device (e.g., a
catheter) that is visible under ultrasound imaging and has a shaft “with
discrete sound reflective particles 127 embedded in the matrix material.
Preferably, matrix material 125 is a plastic.” (Bosley 7:39-52.) “Particles
127 are preferably made of a hard material” and “glass microspheres are
very suitable.” {Id. at 7:61—65.) “[A] partially spherical surface may be
provided on the outside and/or the inside of particles 127, as for example a
particle with a hollow spherical space therein.” {Id. at 8:5—8.)
Bosley states that “[additionally, liquids, gases, gels, micro-
encapsulants, and/or coacervates suspended in the matrix may alternatively
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Appeal 2015-007566
Application 13/064,382
be used either alone or in combination, so long as they form a composite
with ultrasonically reflective particles in the matrix.” {Id. at 8:23—27.)
Thus, Bosley discloses that including solid or hollow particles in the
wall of its device increases its visibility under ultrasound observation, and
that gases can be included in the matrix “so long as they form a composite
with ultrasonically reflective particles in the matrix.” {Id. at 8:26—27.)
Bosley does not disclose including gas bubbles, by themselves, in the plastic
wall of its device. As Appellant argues (Appeal Br. 15), hollow particles are
not gas bubbles; they are particles with gas inside them. Thus, Bosley does
not disclose the limitation of the independent claims requiring a shaft
“consisting of’ or that “consists of’ a wall of a plastics material and gas
bubbles. Bosley therefore does not anticipate the rejected claims.
II
The Examiner has rejected dependent claims 29 and 30 as anticipated
by, or alternatively as obvious based on, Bosley. The Examiner has also
rejected claims 32, 34, 35, and 36-42 as obvious based on Bosley and either
Sheridan or Kobayashi.
Each of these rejections, however, is based on the Examiner’s finding
that Bosley discloses a device or method meeting all of the limitations of the
independent claims. {See Final Act. 6—7.) For the reasons discussed above,
the evidence does not support that finding. The Examiner has not pointed to
evidence or provided sound reasoning to support a conclusion that the
disputed limitation would have been obvious based on any of the cited
references. We therefore reverse the remaining rejections.
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Application 13/064,382
III
Under the provisions of 37 C.F.R. § 41.50(b), we enter the following
new ground of rejection: Claim 36 is rejected under 35 U.S.C. § 112,
second paragraph, as indefinite.
Claim 36 is directed to a “method of making a medico-surgical
device,” but does not recite any active steps. See Kaneka Corp. v. Xiamen
Kingdomway Group Co., 790 F.3d 1298, 1305 (Fed. Cir. 2015) (“A process
is defined as ‘an act, or a series of acts.’ Gottschalk v. Benson, 409 U.S. 63,
70, 93 S. Ct. 253, 34 L.Ed.2d 273 (1972); In re Kollar, 286 F.3d 1326, 1332
(Fed. Cir. 2002) (‘[A] process . . . consists of a series of acts or steps. ... I
consists of doing something, and therefore has to be carried out or
performed.’).”).
Because claim 36 is directed to a process but does not set out what
step(s) that process includes, it “fail[s] to inform, with reasonable certainty,
those skilled in the art about the scope of the invention.” Nautilus, Inc. v.
Biosig Instruments, Inc., 134 S. Ct. 2120, 2124 (2014). See also Ex parte
Erlich, 3 USPQ2d 1011, 1017 (BPAI 1987) (“[A] method claim should at
least recite a positive, active step(s) so that the claim will ‘set out and
circumscribe a particular area with a reasonable degree of precision and
particularity,’ In re Moore, and make it clear what subject matter these
claims encompass, In re Hammack, as well as making clear the subject
matter from which others would be excluded, In re Hammack, supra.
Without reciting any active, positive steps, claims 6 and 7 fail to achieve
these purposes.”).
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Application 13/064,382
SUMMARY
We reverse all of the rejections on appeal. We enter a new ground of
rejection of claim 36.
TIME PERIOD FOR RESPONSE
This decision contains a new ground of rejection pursuant to 37
C.F.R. § 41.50(b). Section 41.50(b) provides “[a] new ground of rejection
pursuant to this paragraph shall not be considered final for judicial review.”
Section 41.50(b) also provides:
When the Board enters such a non-final decision, the appellant,
within two months from the date of the decision, must exercise
one of the following two options with respect to the new ground
of rejection to avoid termination of the appeal as to the rejected
claims:
(1) Reopen prosecution. Submit an appropriate
amendment of the claims so rejected or new Evidence relating to
the claims so rejected, or both, and have the matter reconsidered
by the examiner, in which event the prosecution will be
remanded to the examiner. The new ground of rejection is
binding upon the examiner unless an amendment or new
Evidence not previously of Record is made which, in the opinion
of the examiner, overcomes the new ground of rejection
designated in the decision. Should the examiner reject the claims,
appellant may again appeal to the Board pursuant to this subpart.
(2) Request rehearing. Request that the proceeding be
reheard under § 41.52 by the Board upon the same Record. The
request for rehearing must address any new ground of rejection
and state with particularity the points believed to have been
misapprehended or overlooked in entering the new ground of
rejection and also state all other grounds upon which rehearing
is sought.
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Application 13/064,382
Further guidance on responding to a new ground of rejection can be
found in the Manual of Patent Examining Procedure § 1214.01.
REVERSED; 37 C.F.R, $ 41.50(b)
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