Ex Parte Horvath et al

Patent Trials and Appeals Board

Aug 9, 2018

13138305 - (D) (P.T.A.B. Aug. 9, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
13/138,305 10/11/2011 Joshua Horvath
47058 7590 08/13/2018
Dickinson Wright - BD
1825 Eye St., NW
Suite 900
WASHINGTON, DC 20006
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.
P-8421 (58433) 7450
EXAMINER
CARPENTER, WILLIAM R
ART UNIT PAPER NUMBER
3763
NOTIFICATION DATE DELIVERY MODE
08/13/2018 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):
DWPatents@dickinsonwright.com
ip.docket@bd.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte JOSHUA HORVATH,
EDWARD ROSEN, and PAUL UPHAM 1
Appeal2017-009710
Application 13/138,305
Technology Center 3700
Before MICHAEL L. HOELTER, PAUL J. KORNICZKY, and
ANTHONY KNIGHT, Administrative Patent Judges.
HOELTER, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
This is a decision on appeal, under 35 U.S.C. § 134(a), from the
Examiner's Final Rejection of claims 1-22. App. Br. 1, 5. We have
jurisdiction under 35 U.S.C. § 6(b). For the reasons explained below, we
AFFIRM the Examiner's rejections.
1 According to Appellants, the real party in interest is Becton, Dickinson and
Company. App. Br. 3.
Appeal2017-009710
Application 13/138,305
THE CLAIMED SUBJECT MATTER
The disclosed subject matter "relates generally to a lubricated needle
for a drug delivery device." Spec. ,r 2. Apparatus claim 1 and method
claims 15 and 22 are independent. Claim 1 is illustrative of the claims on
appeal and is reproduced below.
1. A pen needle, comprising:
a hub having an interior including an open proximal end;
a needle fixedly connected to said hub, said needle
having a patient end, formed for insertion into a patient, and a
proximal end extending into said interior of said hub;
a reusable outer cover for repeatedly receiving said hub
and said needle between multiple injections of the pen needle;
and
a lubricant reservoir disposed in said outer cover such
that at least a portion of said needle is disposed in said lubricant
reservoir whenever said hub and said needle are received by
said outer cover.
REFERENCES RELIED ON BY THE EXAMINER
Kuhlemann et al.
Fischell
Kayerod et al.
Wang et al.
Swenson et al.
Bruun et al.
Walton
us 4,435,177
us 5,545,143
US 2001/0001443 Al
US 6,458,867 B 1
US 6,726,649 B2
US 2006/0196783 Al
WO 93/11814
Mar. 6, 1984
Aug. 13, 1996
May 24, 2001
Oct. 1, 2002
Apr. 27, 2004
Sept. 7, 2006
June 24, 1993
William G. Kohn et al., "Guidelines for Infection Control in Dental
Health-Care Settings - 2003 ," MMWR Recommendations and Reports,
December 19, 2003, 52(RR17), 1---61 (hereinafter "CDC").
J.M. Oli, et al., "Multiple use of ordinary disposable syringes for
insulin injections," British Medical Journal, volume 284, January 23, 1982
(hereinafter "BMJ").
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Application 13/138,305
THE REJECTIONS ON APPEAL 2
Claims 1--4, 7, and 21 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Walton and Fischell.
Claims 5 and 14 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Walton, Fischell, and Wang.
Claim 6 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Walton, Fischell, and Bruun.
Claims 8 and 9 are rejected under 35 U.S.C. § 103(a) as unpatentable
over Walton, Fischell, and Kayerod.
Claims 10, 12, and 13 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Walton, Fischell, and Kuhlemann.
Claim 11 is rejected under 35 U.S.C. § 103(a) as unpatentable over
Walton, Fischell, Kuhlemann, and Bruun.
Claims 15, 16, 17, 20, and 22 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Walton, Fischell, Swenson, CDC, and BMJ. 3
Claims 18 and 19 are rejected under 35 U.S.C. § 103(a) as
unpatentable over Walton, Fischell, Swenson, CDC, BMJ, and Kuhlemann.
2 The Examiner withdrew the initial rejections of claims 15-19 and 22 in
favor of New Grounds of Rejections, which supplements the original
combination of references relied upon for each such rejection with the
additional references of CDC and BMJ. Ans. 3-10. Appellants responded
to the Examiner's further reliance on CDC and BMJ. See Reply Br. 3--4.
3 The Examiner does not initially list claim 20 in the rejection's' summary
statement, but claim 20 is discussed in the body of this rejection. See Ans. 9.
We, thus, consider this omission to be inadvertent error.
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Application 13/138,305
ANALYSIS
The Examiner's rejection of claims 1-4, 7, and 21
as unpatentable over Walton and Fischel!
Appellants argue claims 1, 3, 4, 7, and 21 together. App. Br. 10-12.
Appellants also present a separate argument regarding dependent claim 2.
App. Br. 19. We select claims 1 and 2 for review, with the remaining claims
standing or falling with their respective parent claim. See 3 7 C.F .R.
§ 4I.37(c)(l)(iv).
Claim 1
The Examiner primarily relies on the teachings of Walton, including
the disclosure of a reservoir into which a needle is placed, for disclosure of
claim 1 's limitations, but acknowledges that "Walton does not teach that
said reservoir is a lubricant reservoir." Final Act. 2-3. The Examiner relies
on the teachings of Fischell for disclosing a "lubricant reservoir." Final Act.
3. The Examiner concludes that it would have been obvious "to modify the
reservoir, of the needle of Walton, to be a lubricant reservoir, as taught by
Fischell" because "the lubricant of the lubricant reservoir will lubricate and
coat the exterior surface of the needle as it is inserted through tissue ( column
6, lines 8-10) in order to aid in its insertion through the skin ( column 8, lines
40-42)." Final Act. 3; see also Ans. 13-14 (referencing Fischell 3:33--41).
Appellants contend, "Fischell fails to overcome the deficiencies of
Walton because ... Fischell does not disclose multiple medication
applications ... [and Fischell's injection assembly] is not removed and
reapplied with antibiotic ointment between applications." App. Br. 11.
Appellants state, "based on what is explicitly disclosed in Walton and
Fischell, there is no evidence and there is no motivation for one skilled in the
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Application 13/138,305
art to provide a reusable outer cover for repeatedly receiving a hub and a
needle between multiple injections of a pen needle, as claimed." App. Br.
11.
First, the Examiner relies on Fischell for teaching that Walton's
reservoir can be a "lubricant" reservoir as recited. Final Act. 3. Fischell is
not relied upon for disclosing multiple medication applications, although, in
the Examiner's Answer, the "Examiner submits that there is nothing
physically preventing the needle of Fischell from performing a plurality of
penetrations." Ans. 13. Regarding Appellants' contention as to what is
"explicitly disclosed in Walton and Fischell," we have been instructed that a
"person of ordinary skill is also a person of ordinary creativity, not an
automaton." KSR Int'! Co. v. Teleflex Inc., 550 U.S. 398,421 (2007). We
have further been instructed, "[t]he use of patents as references is not limited
to what the patentees describe as their own inventions or to the problems
with which they are concerned. They are part of the literature of the art,
relevant for all they contain." In re Heck, 699 F.2d 1331, 1333 (Fed. Cir.
1983). These instructions become important when one skilled in the art
considers Walton's teaching of the danger of contracting a virus "if a needle,
once used, is reused in an unsterilized form." Walton 1.4 From this, one
skilled in the art would comprehend that Walton discloses needle re-use and
that the danger of needle re-use recedes if the needle is sterilized between
uses.
More particularly, the Examiner, when addressing Appellants'
contention regarding "repeatedly receiving a hub and a needle between
4 Walton does not provide line or paragraph numbering. Hence, reference to
Walton will be by page number only.
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Application 13/138,305
multiple injections of a pen needle, as claimed" (App. Br. 11 ), finds such
multiple injection language to be "functional language directed toward the
intended use of the claimed pen needle." Ans. 11. The Examiner explains
that "the invention need only be capable of performing the specified
function" and "submits that there is no structural reason why the invention
of Walton could not be used to provide multiple medication applications,
particularly in a serialized fashion to a single patient over a plurality of
injection sites." Ans. 11; see also Ans. 12. Appellants' argument that
Walton pertains to a "single use" assembly (App. Br. 11; see also Reply Br.
3 addressing both Walton and Fischell) does not address or identify any
structural distinction that would preclude the device of Walton ( or Fischell,
see above) from being employed multiple times.
We are instructed, "apparatus claims cover what a device is, not what
a device does." Hewlett-Packard Co. v. Bausch & Lomb Inc., 909 F.2d
1464, 1468 (Fed. Cir. 1990). We are further instructed that merely asserting
that Walton is capable of performing the recited function is not sufficient;
the Examiner need also provide a motivation to do so. See KSR, 550 U.S. at
418; see also In re Giannelli, 739 F.3d 1375, 1380 (Fed. Cir. 2014). Here,
Appellants do not address or dispute the Examiner's above-stated rationale
regarding re-use, i.e., "to provide multiple medication applications,
particularly in a serialized fashion to a single patient over a plurality of
injection sites." Ans. 11. Finally, it is also noted that Appellants themselves
acknowledge, "[m]any existing pen needles are used for multiple injections."
Spec. ,r 11.
Appellants also assert the Examiner relied on "hindsight." App. Br.
15-18. However, in rejecting claim 1, the Examiner specifically relied on
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the teachings expressed in Fischell as a basis for combining Walton and
Fischell together. See Final Act. 3 (referencing Fischell 6:8-10; 8:40-42);
Ans. 13-14 (referencing Fischell 3:33--41). Appellants further contend that
"Walton teaches away from the obviousness analysis" (App. Br. 18-19) but
does not disclose where Walton criticizes, discredits or otherwise
discourages investigation into the claimed solution. See In re Fulton, 391
F.3d 1195, 1201 (Fed. Cir. 2004); see also Polaris Indus., Inc. v. Arctic Cat,
Inc., 882 F.3d 1056, 1069-70 (Fed. Cir. 2018) (holding that even in the
absence of a teaching away, general preferences as stated in the prior art are
still relevant to determining whether a skilled artisan would be motivated to
combine the prior art in the manner claimed). Here, Walton can be said to
specifically suggest re-sterilization of the needle after each use so as to avoid
the risk of contracting viruses. See Walton 1. Appellants additionally
contend that Walton and Fischell are "unrelated" and, thus, it would not
have been obvious to combine them. App. Br. 11, 17. However, we agree
with the Examiner's assessment that "Walton and Fischell are both directed
toward medical, drug delivery devices which utilize a needle." Ans. 13.
Accordingly, and based on the record presented, we are not persuaded
by Appellants of Examiner error. We sustain the Examiner's rejection of
claims 1, 4, 7, and 21 as unpatentable over Walton and Fischell.
Claim 2
Claim 2 depends from claim 1 and further recites "wherein a seal is
removably connected to said outer cover." The Examiner references
Walton's cap 12 that is "removably connected to said outer cover (Figure
2A)" as disclosing this limitation. Final Act. 3. Appellants contend,
Walton's cap 12 "is not removably connected to the housing 11." App. Br.
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Application 13/138,305
19. However, Walton specifically teaches that "cap 12 may be folded closed
and snap engaged about the finger guide 16." Walton 3. Walton also
teaches, "[a]ltematively the cap may be formed as a separate component."
Walton 2. Consequently, Appellants' contention is not persuasive that the
Examiner erred in relying on Walton's cap 12 as disclosing this limitation.
Final Act. 3; see also Ans. 12.
Accordingly, and based on the record presented, we are not persuaded
by Appellants of Examiner error. We sustain the Examiner's rejection of
claim 2 (and its dependent claim 3) as unpatentable over Walton and
Fischell.
The rejection of claims 15, 16, 17, 20, and 22
as unpatentable over Walton, Fischel!, Swenson, CDC, and BMJ
Appellants argue claims 15 and 22 together (Reply Br. 3--4) and do
not present separate arguments regarding claims 16, 17, and 20. See Reply
Br. 5; App. Br. 19--20. We select claim 15 for review, with the remaining
claims standing or falling therewith.
Consistent with arguments previously presented with respect to claim
1, Appellants also contend that the Examiner "is ignoring the basic operation
of the devices of' the cited references. Reply Br. 3. For example,
Appellants contend, "Walton explicitly teaches away from the proposed
modification" regarding re-use of the needle and that "the Examiner's
Answer is inconsistent with the explicit configuration and operation of the
device disclosed in Walton." Reply Br. 3--4. However, as above, a review
of Walton would at least suggest a need to re-sterilize a needle before it is
re-used to avoid contracting viruses. See Walton 1. Hence, Appellants do
not explain how Walton "teaches away" from using a needle multiple times
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Application 13/138,305
(provided proper safeguards are taken). Appellants also contend, "none of
the applied references discloses repeated lubrication of the needle between
injections." Reply Br. 4. However, the Examiner states, "the general
concept of the reapplication of a fluid material via introduction of the
implement into a reservoir containing said material is notoriously well
known." Ans. 8. As support, the Examiner provides such examples as "re-
inking the nib of a fountain pen or rewetting the bristles of a paint brush."
Ans. 8. Thus, according to the Examiner, "an ordinary artisan would
reasonably recognize and appreciate that the act of reinserting the needle of
Walton back into the modified outer cover would result in the reapplication
of the lubricating antibiotic ointment." Ans. 8. Appellants do not dispute
this assertion by the Examiner, or indicate how it might be in error.
Appellants again acknowledge that "multiple injection needles are
commonly known" (see, e.g., Spec. ,r 11) but that this does not mean that
one skilled in the art would "modify a single-use pen needle device to arrive
at the Appellants' claimed device." Reply Br. 4. However, the matter of
"single-use," and how Walton is capable of multiple uses, has previously
been discussed, with Appellants' contentions found wanting.
In view of the above, Appellants do not indicate how the Examiner
erred in concluding that claims 15, 16, 17, 20, and 22 are unpatentable over
Walton, Fischell, Swenson, CDC, and BMJ.
The Examiner's rejections of claims 5, 6, 8-14, 18, and 19
Appellants do not separately argue the further rejections of these
claims based on the Examiner's additional reliance on the teachings of
Wang, Bruun, Kayerod, and Kuhlemann. See App. Br. 19-20, Reply Br. 5.
We sustain their rejection.
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Application 13/138,305
DECISION
The Examiner's rejections of claims 1-22 are affirmed.
No time period for taking any subsequent action in connection with
this appeal (see 37 C.F.R. § 1.136(a)(l)) may be extended (see 37 C.F.R.
§ 1.136(a)(l )(iv)).
AFFIRMED
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