Ex Parte Macfarlane et al

Patent Trial and Appeal Board

Apr 20, 2016

12777671 (P.T.A.B. Apr. 20, 2016)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
121777,671 05/11/2010 K. Angela Macfarlane
4372 7590 04/22/2016
ARENT FOX LLP
1717 K Street, NW
WASHINGTON, DC 20006-5344
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
ATTORNEY DOCKET NO. CONFIRMATION NO.
032001.00267 4832
EXAMINER
CHAO, ELMER M
ART UNIT PAPER NUMBER
3777
NOTIFICATION DATE DELIVERY MODE
04/22/2016 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
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PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte K. ANGELA MACFARLANE and SASCHA ZARINS
Appeal2014-001992 1
Application 12/777,671 2
Technology Center 3700
Before MICHAEL C. ASTORINO, BRUCE T. WIEDER, and
AMEE A. SHAH, Administrative Patent Judges.
SHAH, Administrative Patent Judge.
DECISION ON APPEAL
The Appellants appeal under 35 U.S.C. § 134(a) from the Examiner's
decision finally rejecting claims 28-34, 36-42, and 44--51. We have
jurisdiction under 35 U.S.C. § 6(b).
We affirm-in-part.
1 Throughout this opinion, we refer to the Appeal Brief ("Appeal Br.," filed
June 4, 2013), the Examiner's Answer ("Ans.," mailed Sept. 17, 2013), the
Reply Brief ("Reply Br.," filed Nov. 18, 2013), the Final Office Action
("Final Act.," mailed Jan. 4, 2013), and the Specification ("Spec.," filed
May 11, 2010).
2 According to the Appellants, the real party in interest is Devicor Medical
Products, Inc. Appeal Br. 1.
Appeal2014-001992
Application 12/777,671
STATEMENT OF THE CASE
The Appellants' invention is directed to a "subcutaneous biopsy
cavity marking device that permanently remains within the biopsy cavity
after deployment, and which has one or more marker elements that allows
identification of the biopsy cavity center, orientation, or margin, using
various imaging modalities." Spec. i-f 15.
Claims 28 and 36 are the independent claims on appeal. Claim 28,
which we reproduce below, is illustrative of the subject matter on appeal:
28. A breast biopsy marker comprising:
a first marker element;
a second marker element having an outer surface;
the first marker element formed from a nonabsorbable
metallic material detectable by an imaging means other than
ultrasound;
the second marker element formed from a nonabsorbable
polymer detectable by ultrasound; and
the first marker element is disposed around and contacts a
portion of the outer surface of the second marker element.
Appeal Br. 21 (Claims App.).
REJECTIONS ON APPEAL
Claims 28, 29, and 31-34 stand rejected on the grounds of
nonstatutory obviousness-type double patenting as unpatentable over claims
1, 4, 15, 16, 19, and 20 of Macfarlane (US 7,783,336 B2, iss. Aug. 24,
2010). Ans. 2; Final Act. 3.
2
Appeal2014-001992
Application 12/777,671
Claims 28-32, 34, 36-40, 42, 44--48, and 503 stand rejected under
35 U.S.C. § 103(a) as being unpatentable over Sirimanne et al.
(US 6,371,904 Bl, iss. Apr. 16, 2002) (hereafter referred to as "Sirimanne
'904") and Sirimanne et al. (US 2002/0035324 Al, pub. Mar. 21, 2002)
(hereafter referred to as "Sirimanne '324"). Ans. 2; see also Final Act. 7.4
Claims 33, 41, 49, and 51 stand rejected under 35 U.S.C. § 103(a) as
being unpatentable over Sirimanne '904, Sirimanne '324, and Cutrer
(US 6,440,058 B 1, iss. Aug. 27, 2002). 5 Ans. 4; Final Act. 8.
3 We note that claims 29, 30, 32, 37, 38, and 40 are not included in the
heading of the rejection (Ans. 2), but are included in the body of the
rejection following the heading (Ans. 4). Thus, we include these claims in
this rejection.
4 We note that the heading for the rejection of the claims as obvious over
Sirimanne '904 and Sirimanne '324 changed from "Claims 28, 36, and 44--
47" in the Final 1A..ction, page 7, to "Claims 28, 31, 34, 36, 39, 42, 44--48,
and 50" in the Answer, page 2. In the Final Action, claims 30, 31, 34, 39,
42, and 48 were rejected under 36 U.S.C. § 102 as anticipated by Sirimanne
'904 (Final Act. 4) that has been withdrawn (Ans. 8). To the extent the
Examiner included a new ground of rejection of claims 30, 31, 34, 39, 42,
and 48 under 35 U.S.C. § 103 as obvious over Sirimanne '904 and
Sirimanne '324 in the Answer (37 C.F.R. § 41.39(a)(2)), the Appellants have
chosen to maintain the appeal and have addressed the new ground. See
Reply Br. 2; 37 C.F.R. § 41.39(b).
5 We note the heading for the rejection of claims 33, 41, 49, and 51 cites
only Sirimanne '904 and Cutter. However, since the claims are dependent
from claims 28 and 3 6 and § 102(b) rejection of claims 28 and 3 6 has been
withdrawn, the dependent claims are now rejected over Sirimanne '904 and
Sirimanne '324, and further Cutter. To the extent the Examiner included
this as a new ground of rejection in the Answer (37 C.F.R. § 41.39(a)(2)),
the Appellants have chosen to maintain the appeal and have addressed the
new ground. See Reply Br. 2; 37 C.F.R. § 41.39(b).
3
Appeal2014-001992
Application 12/777,671
Claims 28, 29, 31-33, 36, 37, 39--41, 44, 45, and 48-51 stand rejected
under 35 U.S.C. § 103(a) as being unpatentable over Sirimanne '324 and
Sirimanne '904. Ans. 5; Final Act. 9. 6
Claims 28 and 36 stand rejected under 35 U.S.C § 103(a) as being
unpatentable over Noppe (US 5,206,122, iss. Apr. 27, 1993) and Sirimanne
'324. Ans. 7; Final Act. 12.
ANALYSIS
Double Patenting Rejection
The Appellants provide no argument against this rejection in the
Appeal Brief as the Appellants "do not believe this rejection needs to be
addressed on appeal."7 Appeal Br. 9. Thus, we summarily affirm the
double-patenting rejection.
6 The Examiner has withdrawn the rejection of claims 28-32, 34, 36--40, 42,
45, 48, and 50 under 35 U.S.C. § 102(b) an anticipated by Sirimanne '904
(Ans. 8), the rejection of claims 28 and 36 under 35 U.S.C. § 102(b) as
anticipated by a pushpin (Ans. 10), and the alternate rejection of claims 28-
45 and 48-51under35 U.S.C. § 103(a) as unpatentable over Sirimanne '904
and Sirimanne '324 (id.)
7 The Appellants' argument in the Reply Brief, pages 2 and 3, is not
considered because an argument regarding the double patenting rejection
was not raised in the Appeal Brief, the Examiner did not raise an argument
in the Answer to which the Reply Brief is responsive, and no good cause is
shown why the new argument should be considered. 37 C.F.R.
§ 41.41 (b )(2).
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Appeal2014-001992
Application 12/777,671
Rejection of claims 28, 31, 34, 36, 39, 42, 44-48, and 50 as obvious over
Sirimanne '904 and Sirimanne '324
Each of independent claims 28 and 3 6 recites limitations of a "first
marker element formed from a nonabsorbable metallic material" and a
"second marker element formed from a nonabsorbable polymer." Appeal
Br. 21, 22 (Claims App.).
The Examiner finds that Sirimanne '904 teaches a breast biopsy
marker comprising a first marker element formed from nonabsorbable
metallic material as claimed, and a second marker formed from a polymer.
See Ans. 2-3; see also Final Act. 5. The Examiner finds that Sirimanne '904
does not "explicitly teach the second marker being non-bioabsorbable," i.e.,
that Sirimanne '904 does not explicitly teach a nonabsorbable polymer
marker. Ans. 3, Final Act. 7. The Examiner finds that Sirimanne '324 at
paragraph 55 teaches that "preferably markers should last [a] long time in
the body, even permanently" and concludes "it would have been obvious to
a person of ordinary skill in the art at the time of the invention to modify the
invention to include a non-bioabsorbable second marker." Ans. 3; Final
Act. 7.
Sirimanne '324 at paragraph 55 discloses that
marker (150) in the device shown in FIG. lF may be
permanently radiopaque or echogenic, or it also may be
bioabsorbable and optionally coated with a radiopaque and/or
echogenic coating that similarly degrades over a predetermined
period of time. It is more important from a clinical standpoint
that the marker remain detectable either permanently or, if the
patient is uncomfortable with such a scenario, for at least a period
of about one to five years so that the physician may follow up
with the patient to ensure the health of the tissue in the vicinity
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Appeal2014-001992
Application 12/777,671
of the biopsy cavity. Especially preferable is a marker whose
radiopacity or echogenicity lasts from between about one and
three years.
Thus, Sirimanne '324 at paragraph 55 discloses that markers can be
permanently radiopaque (metallic) or in the alternate, bioabsorbable
(polymer). See also id. i-fi-160, 61, Reply Br. 5. The Examiner does not make
any findings that the permanent, metallic marker of Sirimanne '324 can be
polymer nor that the bioabsorbable, polymer marker can be
permanent/nonabsorbable. Moreover, although Sirimanne '324 discloses
that it is "preferable" to have a marker whose radiopacity lasts between one
and three years (Sirimanne '324, i155), it is not clear that the "preference" is
for permanent/nonabsorbable markers. Thus, we agree with the Appellants'
argument that "making marker 150 permanent does not address that which is
claimed" of a second nonabsorbable polymer marker (Appeal Br. 14). The
Examiner does not provide a prima facie case of obviousness because the
Examiner fails to provide sufficient rational underpinning to support a legal
conclusion of obviousness. See KSR Int 'l Co. v. Teleflex Inc., 550 U.S. 398,
418 (2007).
Therefore, we are persuaded that the Examiner erred in the rejection
of independent claims 28 and 36 over Sirimanne '904 and Sirimanne '324,
and do not sustain the rejection of independent claims 28 and 36. For the
same reason, we also do not sustain the Examiner's rejection of dependent
claims 31, 34, 39, 42, 44--48, and 50 over Sirimanne '904 and
Sirimanne '324.
6
Appeal2014-001992
Application 12/777,671
Rejections of claims 33, 35, 41, 43, 49, and 51 as obvious over
Sirimanne '904, Sirimanne '324, and Cutrer or Burbank
Because we do not sustain the rejection of claims 28 and 36 over
Sirimanne '904 and Sirimanne '324, we also do not sustain the rejections of
claims 33, 35, 41, 43, 49, and 51, each of which ultimately depends from
one of independent claims 28 and 36. Cf In re Fritch, 972 F.2d. 1260, 1266
(Fed. Cir. 1992) ("dependent claims are nonobvious if the independent
claims from which they depend are nonobvious").
Alternate rejections of claims 28, 29, 31-33, 36, 37, 39--41, 44, 45, and
48-51 as obvious over Sirimanne '324 and Sirimanne '904 and of claims 28
and 36 as obvious over Noppe and Sirimanne '324
The Examiner's alternate rejections of claims 28, 29, 31-33, 36, 37,
39--41, 44, 45, and 48-51 and of claims 28 and 36 rely on the same
inadequately-supported conclusion discussed above with respect to claims
28 and 36 (see Ans. 6, 8; Final Act. 10, 12), and thus, we do not sustain
these alternate rejections for the same reason we do not sustain the rejection
of claims 28 and 36 as obvious over Sirimanne '904 and Sirimanne '324.
DECISION
The Examiner's rejection of claims 28, 29, and 31-34 on the grounds
of nonstatutory obviousness-type double patenting is summarily
AFFIRMED.
The Examiner's rejections of claims 28-34, 36--42, and 44--51 under
35 U.S.C. § 103(a) are REVERSED.
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Appeal2014-001992
Application 12/777,671
No time period of taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a). See 37 C.F.R.
§ 1.136(a)(l )(iv).
AFFIRMED-IN-PART
8