Ex Parte Andreoni

Patent Trial and Appeal Board

Dec 14, 2017

12861258 (P.T.A.B. Dec. 14, 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.
12/861,258 08/23/2010 TODD RYAN ANDREONI P-8790 (066810-01317) 1681
47058 7590 12/18/2017
David W. Highet, VP & Chief IP Counsel
Becton, Dickinson and Company
(Dickinson Wright PLLC)
1 Becton Drive, MC 110
Franklin Lakes, NJ 07417-1880
EXAMINER
PATEL, SHEFALI DILIP
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
12/18/2017 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):
lorraine_kow alchuk @ bd .com
ip_docket @bd.com
DWPatents @ dickinson wright. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte TODD RYAN ANDREONI
Appeal 2016-008206
Application 12/861,258
Technology Center 3700
Before JENNIFER D. BAHR, LEE L. STEPINA, and
ANTHONY KNIGHT, Administrative Patent Judges.
BAHR, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
Todd Ryan Andreoni (Appellant)1 appeals under 35 U.S.C. § 134(a)
from the Examiner’s decision, set forth in the Final Action (Aug. 18, 2015)
[hereinafter “Final Act.”] and restated in the Answer (July 1, 2016)
[hereinafter “Ans.”] rejecting claims and 6-19. We have jurisdiction
under 35 U.S.C. § 6(b).
We REVERSE.
1 The Appeal Brief (Feb. 18, 2016) [hereinafter “Appeal Br.”] identifies
Becton, Dickinson and Company as the real party in interest. Appeal Br. 3.
Appeal 2016-008206
Application 12/861,258
THE CLAIMED SUBJECT MATTER
Claim 1, reproduced below, is illustrative of the claimed subject
matter.
1. A skin engagement member for use with a needle assembly
or a medical injector to minimize irritation of a patient’s skin
surrounding an injection site, the needle assembly or the medical
injector including a body member, a needle extending from the
body member and a shield for selectively covering a distal end
of the needle, wherein the shield is movable relative to a distal
end of the body member, said skin engagement member
comprising;
a body;
a surface defined on said body for engaging the patient’s
skin during injection by the needle;
an aperture formed through said body configured to permit
passage therethrough of the needle; and,
rotatable mounting features for rotatably mounting said
body to said shield to permit relative rotation therebetween about
said aperture wherein the body is axially fixed relative to the
shield.
REJECTIONS2
I. Claims 1^1 and 6-19 stand rejected under 35 U.S.C. § 112, first
paragraph, as failing to comply with the written description
requirement.
II. Claims 1—4, 6-8, and 11 stand rejected under 35 U.S.C. § 102(b)
as anticipated by Moos (US 2006/0276747 Al, published Dec. 7,
2006).
2 The Examiner withdrew rejections under 35 U.S.C. § 112, second and
fourth paragraphs, set forth in the Final Action. Advisory Action 2 (Nov.
27, 2015); Ans. 8.
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Application 12/861,258
III. Claims 9, 10, and 12-19 stand rejected under 35 U.S.C. § 103(a) as
unpatentable over Moos and DiBiasi (US 2008/0177235 Al,
published July 24, 2008).
DISCUSSION
Rejection I—Written Description
The Examiner finds that “the Specification does not state or describe
that ‘the body is axially fixed relative to the shield,’” as recited in
independent claims 1 and 11. Ans. 3.
Appellant submits that paragraphs 16 and 17 of the Specification, with
reference to Figure 4, provide support for this limitation. Appeal Br. 9
The fundamental factual inquiry for ascertaining compliance with the
written description requirement is whether the disclosure of the application
relied upon reasonably conveys to those skilled in the art that the inventor
had possession of the claimed subject matter as of the filing date. See Ariad
Pharms., Inc. v. EliLilly & Co., 598 F.3d 1336, 1351 (Fed. Cir. 2010) (en
banc). “This inquiry ... is a question of fact,” and “the level of detail
required to satisfy the written description requirement varies depending on
the nature and scope of the claims and on the complexity and predictability
of the relevant technology.” Id. “The specification must describe an
invention understandable to that skilled artisan and show that the inventor
actually invented the invention claimed.” Id.
Referencing Figure 4, paragraph 16 of Appellant’s Specification
discloses rotatably mounting body 16 to needle assembly 12 or medical
injector 14 by means of snap fingers 40 protruding from body 16 to engage
mounting hole 38 in needle assembly 12 or medical injector 14 “so as to be
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Application 12/861,258
axially fixed relative thereto with relative rotation being permitted.”
Paragraph 17 of the Specification describes providing needle assembly 12 or
medical injector 14 with shield 42. Paragraph 17 of the Specification further
discloses that “body 16 may be rotatably mounted to the shield 42 in the
same manner as described above.” Appellant’s Figure 4 depicts mounting
hole 38 formed in shield 42 and snap fingers 40 depending from body 16
engaged in mounting hole 38. Considering the disclosures of paragraphs 16
and 17 and Figure 4 together, a person having ordinary skill in the art would
understand that, in the embodiment depicted in Figure 4, in which needle
assembly 12 or medical injector 14 is provided with shield 42, the mounting
of body 16 to needle assembly 12 or medical injector 14 is effected by
rotatably mounting body 16 to shield 42 as described in paragraph
16—namely, with snap fingers 40 protruding from body 16 engaging
mounting hole 38 in shield 42, so that body 16 is axially fixed relative to
shield 42 with relative rotation being permitted.
Thus, the present application conveys with reasonable clarity that, as
of the filing date of the present application, Appellant was in possession of
the invention recited in claims 1 and 11—in particular, a skin engagement
member comprising a body and rotatable mounting features for rotatably
mounting the body to the shield of a needle assembly or medical injector to
permit relative rotation therebetween wherein the body is axially fixed
relative to the shield. Accordingly, we do not sustain the rejection of
independent claims 1 and 11 under 35 U.S.C. § 112, first paragraph, as
failing to comply with the written description requirement. We also do not
sustain the like rejection of dependent claims 2—4, 6-10, and 12-19, which is
based solely on their dependence from claim 1 or claim 11. Ans. 3.
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Rejection II Anticipation
Independent claim 1 recites “rotatable mounting features for rotatably
mounting said body to said shield to permit relative rotation therebetween
about said aperture wherein the body is axially fixed relative to the shield.”
Appeal Br. 14 (Claims App.). Independent claim 11 contains the same
limitations. Id. at 15.
In rejecting claims 1 and 11 as anticipated by Moos, the Examiner
reads the claimed body on Moos’s depth stop 52, the claimed shield on
Moos’s threaded member 60, and the claimed rotatable mounting features
on Moos’s threads 76. Ans. 4, 5. The Examiner acknowledges that Moos’s
body (depth stop 52) moves axially along (i.e., relative to) the shield
(threaded member 60) upon rotation of the body, but finds that “the body is
also axially fixed relative to the shield in the state of Figure 2 when the body
is not rotated.” Id. at 10; see Moos ^ 28 (explaining that rotation of depth
stop 52 about the longitudinal axis of threaded member 60 causes depth stop
52 to move axially toward a distal end of threaded member 60).
In the Reply Brief (Sept. 1, 2016) [hereinafter “Reply Br.”], Appellant
submits that “the term ‘fixed’ with respect to the subject application as
would be understood by one skilled in the art is ‘fastened in one position so
that it does not move.’” Reply Br. 5. This proffered definition is consistent
with the description in Appellant’s Specification of rotatable mounting
features comprising snap fingers 40 engaging mounting hole 3 8 so as to
permit relative rotation but cause the engaging components to be axially
fixed relative to one another. Spec. ^ 16; see id. ^ 17 (describing rotatable
mounting of body 16 to shield 42 in this manner). Moreover, the Examiner
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does not proffer a different definition for the term “fixed.” Accordingly, we
apply the definition of “fixed” asserted by Appellant.
The threaded engagement of Moos’s body (depth stop 52) with the
shield (threaded member 60) by means of threads 76, 64 does not fasten the
body in one position so that it does not move relative to the shield. Rather,
as explained in Moos (^ 28), rotation of the body (depth stop 52) about the
longitudinal axis of the shield (threaded member 60) causes the body to
move axially relative to the shield. As Appellant submits, “the lack of
relative motion, at a particular time, between the depth stop 52 and threaded
member 60 does not imply that the two are not movable, and therefore
‘fixed,’ relative to one another.” Reply Br. 5.
Thus, Appellant demonstrates error in the Examiner’s finding that
Moos anticipates the subject matter of independent claims 1 and 11.
Accordingly, we do not sustain the rejection of independent claims 1 and 11
or claims 2—4 and 6-8, which depend from claim 1, under
35 U.S.C. § 102(b) as anticipated by Moos.
Rejection III—Obviousness
The Examiner’s application of DiBiasi in rejecting claims 9, 10, and
12-19, which depend from either claim 1 or claim 11, does not cure the
deficiency in the Examiner’s finding that Moos anticipates the subject matter
of claims 1 and 11. See Ans. 6-8. In particular, the Examiner does not
articulate any findings or reasoning that would explain how adding a drive
element (i.e., spring) to allow for biasing Moos’s shield (threaded member
60) away from the body member (distal handle member 24) and toward the
injection end of the needle, as proposed in the rejection, would cause the
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body (depth stop 52) to be axially fixed relative to the shield (threaded
member 60). See Ans. 4, 5, 6-8.
Accordingly, we do not sustain the rejection of claims 9, 10, and
12-19 under 35 U.S.C. § 103(a) as unpatentable over Moos and DiBiasi
DECISION
The Examiner’s decision rejecting claims and 6-19 under
35 U.S.C. § 112, first paragraph, is REVERSED.
The Examiner’s decision rejecting claims 1—4, 6-8, and 11 under
35 U.S.C. § 102(b) is REVERSED.
The Examiner’s decision rejecting claims 9, 10, and 12-19 under
35 U.S.C. § 103(a) is REVERSED.
REVERSED
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