Ex Parte Solazzo

Patent Trial and Appeal Board

Oct 11, 2018

14578759 (P.T.A.B. Oct. 11, 2018)

UNITED STA TES p A TENT AND TRADEMARK OFFICE
APPLICATION NO. FILING DATE FIRST NAMED INVENTOR
14/578,759 12/22/2014 Anthony Solazzo
27162 7590 10/11/2018
CARELLA, BYRNE, CECCHI, OLSTEIN, BRODY & AGNELLO
5 BECKER FARM ROAD
ROSELAND, NJ 07068
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.
259555.1 4301
EXAMINER
MARCETICH, ADAM M
ART UNIT PAPER NUMBER
3781
MAIL DATE DELIVERY MODE
10/11/2018 PAPER
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.
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte ANTHONY SOLAZZ0 1
Appeal2018-002999
Application 14/578,759
Technology Center 3700
Before DANIELS. SONG, GEORGE R. HOSKINS, and
NATHAN A. ENGELS, Administrative Patent Judges.
SONG, Administrative Patent Judge.
DECISION ON APPEAL
STATEMENT OF THE CASE
The Appellant appeals under 35 U.S.C. § 134(a) from the Examiner's
Final Office Action (hereinafter "Final Act.") rejecting claims 1-17 in the
present application (App. Br. 1). We have jurisdiction under 35 U.S.C.
§§ 6(b) and 134(a).
We AFFIRM.
The claimed invention is directed to an adapter for fixation of a
ureteral catheter and a clip (Abstract). Representative independent claims 1
and 5 read as follows (App. Br. 22, 23, Claims App'x, emphasis added):
1 The Appellant identifies the real party in interest as GU-TEK, INC.
(Appeal Brief (hereinafter "App. Br.") 1 ).
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1. A one-piece adapter comprising
a main body portion defining a main flow path for
conducting a flow of fluid from a Foley catheter connected to an
inlet end of said flow path to a drainage bag connected to an
outlet end of said flow path; and
a shoulder portion at an inlet end of said main body
portion having a pair of orifices therein and a pair of collars
thereon, each said orifice being in communication with said main
flow path and each said collar being disposed at an inlet end of a
respective orifice of said pair of orifices for receiving a ureteral
catheter therein for delivery of a flow of fluid therethrough to
said main path.
5. A clip for engagement with a Foley catheter and at least
one ureteral catheter, said clip comprising
a pair of arcuate sections disposed in hinged relation to
pivot between an open position relative to each other and a closed
position relative to each other, each said arcuate section having a
curvilinear portion defining a first transverse passage with the
other of said arcuate sections for receiving a Foley catheter
therein and a recess defining a second transverse passage for
receiving a ureteral catheter therein.
Independent claims 9 and 14 are directed to a kit or a system having
an adapter and a clip (App. Br. 23-25).
REJECTIONS
1. The Examiner rejects claim 1 under 35 U.S.C. § I02(a)(l) as
anticipated by Womack (US 4,425,124, iss. Jan. 10, 1984) (Final Act. 2).
The Examiner also rejects various claims under 35 U.S.C. § 103 as
follows:
2. Claims 2 and 3 as obvious over Womack in view of Smith (US
2008/0228163 Al, pub. Sept. 18, 2008) (Final Act. 4).
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3. Claim 4 as obvious over Womack in view of Shirley (US
2008/0140055 Al, pub. June 12, 2008) (Final Act. 5).
4. Claims 5-8 as obvious over Raulerson (US 2005/0038453 Al,
pub. Feb. 17, 2005) in view of Secord (US 4,637,097, iss. Jan. 20, 1987)
(Final Act. 6).
5. Claims 9, 10, and 14 as obvious over Womack in view of
Raulerson and Secord (Final Act. 10).
6. Claims 11 and 12 as obvious over Womack in view of
Raulerson, Secord, and Smith (Final Act. 12).
7. Claim 13 as obvious over Womack in view of Raulerson,
Secord, and Shirley (Final Act. 14 ).
8. Claims 15 and 16 as obvious over Womack in view of Prichard
(US 5,988,700, iss. Nov. 23, 1999) (Final Act. 14).
9. Claim 17 as obvious over Raulerson in view of Secord and
Bush (US 3,757,387, iss. Sept. 11, 1973) (Final Act. 16).
ANALYSIS
Only those arguments actually made by the Appellant have been
considered in this Decision. Arguments that the Appellant could have made
but chose not to make have not been considered and are deemed to be
waived. See 37 C.F.R. § 4I.37(c)(l)(iv); In re Jung, 637 F.3d 1356, 1365-
66 (Fed. Cir. 2011); Ex parte Frye, 94 USPQ2d 1072, 1075-76 (BPAI 2010
(precedential) ).
Rejection 1
The Examiner rejects claim 1 as anticipated by Womack, finding that
Womack discloses a "one-piece adapter" including a shoulder portion and
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collars (Final Act. 2-3 and citations therein). The Appellant disagrees for
the reasons we discuss below.
One-piece Adapter
The Appellant argues "Womack does not disclose a one-piece
adapter. Instead, Womack discloses a multi-piece assembly comprised of a
combining chamber 34, 'O' rings 52 and threaded collars 52 [sic, 50]."
(App. Br. 7). According to the Appellant, because claim 1 is directed to a
one-piece adapter, this requires "all components of the adapter, i.e. main
body portion and a shoulder portion, to be integrally connected." (Reply Br.
3).
However, the Examiner responds that "Womack discloses that at least
a central or main body component consists of one piece, which is integrally
connected. In Fig. 5, Womack shows that all segments of chamber 34 are
integrally connected or molded." (Ans. 17). The Examiner further clarifies
that "rings 52 and threaded collars 50 are not cited as part of the claimed
one-piece adapter. Instead, only combining chamber 34, tubular extensions
36 and 38 and coupling threads 44 are cited." (Ans. 18).
We agree with the Examiner's assessment that the combining
chamber of Womack satisfies the recitation of a one-piece adapter. The
cross-sectional view shown in Figure 5 of Womack clearly discloses that
secondary tubular extensions are integrally formed as part of the combining
chamber 34 (Womack, Fig. 5). The other components of Womack noted by
the Appellant function to "effect a seal between one end of one of the
tubular extensions and a catheter tube" by compressing the 0-ring or ferrule
52 (Womack, col. 2, 11. 52-59) and do not impact the function of the
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combining chamber 34 in providing the main flow path and a pair of orifices
that are in communication with the main flow path as recited by claim 1.
Shoulder
The Appellant argues that Womack does not disclose a one-piece
adapter having a "shoulder portion at an inlet end of said main body portion"
in the manner regarded by the Appellant "as illustrated in Figs. 5 to 7,"
because Womack's tubular extensions "extend away from the chamber 34
forming a pair of 'arms'." (App. Br. 9). The Appellant also argues that "the
Examiner provides no evidence that one skilled in the art would read the
tubular extensions 36 and 38 of Womack to be a shoulder portion as set
forth in claim 1." (App. Br. 10). According to the Appellant, Womack lacks
a shoulder portion because its secondary tubular extensions 36 and 38 are
"displaced from the basic central axis of chamber 34 by angle A of
approximately 20°." (App. Br. 8, citing Womack, col. 2, 11. 38--43; see also
Reply Br. 3). The Appellant also argues that in Womack, "the inlet end of
the one piece combining chamber 34 receives only a tubular member 22.
Clearly, the inlet end of the combining chamber 34 does not receive the
extensions 36 and 38." (Reply Br. 4).
We do not find the Appellant's arguments persuasive. Firstly, while
the Appellant references the specific embodiment shown in Figures 5-7 of
the Appellant's drawings, the Examiner is correct that "it is important not to
import into a claim limitations that are not part of the claim." (Ans. 18). In
that regard, the Examiner is also correct that the claim "recites only 'a
shoulder portion ... having a pair of orifices therein' and does not recite
further structures that distinguish it from extensions 36 and 38 of Womack."
(Ans. 18). The Examiner is also correct that "the specification provides no
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evidence that the claimed shoulder portion must resemble an anatomical
structure." 2 (Ans. 19).
Secondly, we observe that the secondary tubular extensions of
Womack are provided at the inlet end of its combining chamber (Womack,
Fig. 5). Thirdly, in the Appellant's disclosed invention, the passages for the
ureteral catheter tubes are also angled (id.). Fourthly, the inlet end of
Womack receives not only tubular member 22, but its tubular extensions 3 6
and 38 receive ureteral catheter tubes 46, 48 (Womack, Figs. 3, 5).
Collars
The Appellant argues that
the threads 44 on the ends 40 of the tubular extensions 36, 38 of
Womack do not constitute "a pair of collars" as the applicant
regards "collars". Note that the collars of claim 1 receive ureteral
catheters whereas the threads 44 of Womack do not receive the
ureteral catheters 46, 48 but receive collars 50 on the outside
thereof.
(App. Br. 9; see also Reply Br. 7). The Appellant also argues that "one
skilled in the art would [not] read the threads 44 on the ends 40 of the
tubular extensions 36, 38 of Womack as a pair of collars as set forth claim
1." (App. Br. 10).
The Appellant appears to not fully appreciate the Examiner's rejection
and Womack. As the Appellant notes with respect to Womack, "the ends of
the tubular extensions 36 and 38 receive catheter tubes 46 and 48,
respectively .... That is to say, the threaded ends are the ends of the
extensions 36 and 38." (Reply Br. 6, emphasis added). This is correct and
2 To any extent that the Appellant's physiological analogy/argument has
merit, we observe that arms are connected to shoulders.
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consistent with the Examiner's citation to Womack, which states that
"ureteral catheter tube ( 46 or 48) ... is inserted into an end 40 of tubular
extensions 36 and 38." (Womack, col. 2, 11. 48-51; see also Fig. 5).
Accordingly, the Examiner is finding that the portion at the end of the
tubular extensions ( with the threads 44 and its orifice) correspond to the
claimed collars that receive the catheter tubes, not that the jagged surfaces of
the threads 44 themselves correspond to the recited collar. In that respect,
we observe that the collars of the Appellant's adapter have a cylindrical
outer surface, which does not receive a catheter either, but instead, it is the
entire structure of the adapter at the collars with their corresponding bores
21 that receives the ureteral catheter tube.
Accordingly, for the reasons discussed above, we do not find the
Appellant's assertion of error persuasive, and affirm Rejection 1.
Rejection 2
Claims 2 and 3 stand rejected as obvious over Womack in view of
Smith (Final Act. 4). The Examiner finds that Womack's device includes a
cap, but "does not connect the cap to said shoulder portion, and also lacks a
tear-away notch." (Final Act. 4). The Examiner relies on Smith for
disclosing such a cap connection, concluding that it would have been
obvious to one of ordinary skill in the art to have modified Womack "with
the connected cap and tear-away notch of Smith in order to manufacture the
adapter more efficiently and indicate tampering." (Final Act. 5).
The Appellant argues that "[ t ]he Examiner provides no evidence that
one of ordinary skill in the art would consider 'tampering' to be a concern in
the construction of the assembly and cap 66 of Womack. Hence, there is no
reason why one of ordinary skill in the art would look to Smith for a
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teaching to modify Womack." (App. Br. 12). The Appellant also argues
that Smith is "directed to a needle venting device for a sealed container for
use with the reconstitution of toxic drugs. As such, Smith is non-analogous
to Womack." (App. Br. 13).
We are not persuaded by the Appellant's arguments. Firstly, the
Appellant does not dispute the Examiner's finding that providing such a
connection for the cap would have been obvious "in order to manufacture
the adapter more efficiently." (Final Act. 5). Secondly, Smith discloses that
the tether with a thin wall section is provided for showing evidence of
tampering (Smith ,r 99). We are persuaded by the Examiner's response that
"any invasive device or conduit intended to be placed in the body needs to
be sterile for safety, to prevent infection," and that such features "will
discourage reusing the adapter from non-malicious action such as distraction
or carelessness." (Ans. 20).
As to the Appellant's non-analogous argument, we agree with the
Examiner that Smith is analogous because "both Womack and Smith
describe plastic fluid couplings or equipment for fluid handling, in the
context of medical devices" (Ans. 20), and thus, Smith is reasonably
pertinent to the manner in which a cap of an adapter may be implemented
and manufactured. The Appellant relies on dependency on claim 2 for
patentability of claim 3 (App. Br. 13), and thus, claim 3 falls with claim 2.
Therefore, in view of the above considerations, we affirm Rejection 2.
Rejection 3
Claim 4 stands rejected as obvious over Womack in view of Shirley
(Final Act. 5). The Appellant relies on dependency on claim 1 for
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patentability of claim 4 (App. Br. 13). Accordingly, claim 4 falls with claim
1, and Rejection 3 is affirmed.
Rejection 4
Claims 5-8 stand rejected as obvious over Raulerson in view of
Secord (Final Act. 6). We generally agree with the Examiner's rejection and
address the Appellant's numerous arguments infra.
The Appellant argues that "[ n ]either Raulerson nor Secord describes
a clip for engagement with a Foley catheter and at least one ureteral
catheter." (App. Br. 14). Our understanding is that "Foley catheter" refers
to a catheter that is used to drain the bladder of urine (see Spec. 1 ).
However, the Appellant does not provide objective evidence and explanation
as to how a Foley catheter differs from other catheters with respect to their
ability to be retained by a clip.
The Appellant also argues that "Raulerson has a pair of arcuate
sections 110, 120 (Fig. 3) that, when closed, do not define a passage for
receiving a Foley catheter," but instead, the pair of arcuate sections define a
passageway 130 sized for a conduit (App. Br. 15). However, the Appellant
overlooks the fact that Raulerson explicitly discloses that "[t]he conduit may
be a single catheter or a plurality of catheters." (Raulerson ,r 15, emphasis
added).
In addition, the Appellant argues that "Secord describes a clip to
bundle multiple cables within a single passageway." (App. Br. 14).
However, to the extent that the Appellant's invention defines two
passageways, we observe that the passageways are connected with each
other (Figs. 8, 10). Secord is similar in that it discloses three passageways
that are connected with each other (Secord, Figs. 2, 3).
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The Appellant further argues that "[t]here is no disclosure in Secord
that the cables are of different sizes" (App. Br. 14), and "a ureteral catheter
needs to fit into a ureter of a diameter of 3--4 mm. It is self-evident that an
automotive cable is not of the approximate dimensions of a ureteral catheter
and that a urologist would not wish to implant an automotive cable in the
ureter of a patient." (App. Br. 16).
However, the Examiner explains that "[b ]oth Raulerson and Secord
are fully capable of restraining these types of catheters" (Ans. 21 ), and that
"Secord is not necessarily cited as teaching dimensions or a size of a
catheter. Instead, Secord is cited as teaching the concept of a transverse
passage that accommodates one or more conduits." (Ans. 22). In that
regard, sizing of articles is not ordinarily a patentable feature. In re Rose,
220 F .2d 459, 463 (CCP A 1955) ("size of the article under consideration []
is not ordinarily a matter of invention"); see also Gardner v. TEC Systems,
Inc., 725 F.2d 1338, 1346 (Fed. Cir. 1984); In re Kirke, 40 F.2d 765, 767
(CCPA 1930). In view of Raulerson's disclosure of securing multiple
catheters, and Secord's disclosure of providing multiple passageways, we do
not find the Appellant's arguments based on sizing of the clip persuasive to
establish patentability.
The Appellant further argues that in Secord, the first transverse
passage 86 is formed on a rib rather than on an arcuate section as required by
claim 5 (App. Br. 17). However, this argument is unpersuasive because
"Raulerson surrounds conduit 140 with the pair of arcuate sections 110, 120
by sliding conduit 140 sideways into the opened passageway 130." (Ans.
21 ). In that regard, non-obviousness cannot be established by attacking
references individually where the rejection is based upon the teachings of a
combination of references. In re Merck, 800 F.2d 1091, 1097 (Fed. Cir.
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1986); In re Keller, 642 F.2d 413,425 (CCPA 1981). Moreover, ribs 54 of
Secord referenced by the Appellant are integral features of clip halves 30, 32
that are semi-circular, i.e., arcuate sections (see Secord, Figs. 4, 5). Thus,
the Appellant's argument is also unpersuasive because the ribs of Secord are
not a separate piece as the Appellant's argument appears to imply, but
instead, are part of Secord' s arcuate sections. Furthermore, the claims at
issue does not foreclose having ribs.
Accordingly, in view of the above, we affirm Rejection 4.
Rejection 5
Claims 9, 10, and 14, which are generally directed to a kit or a system
having an adapter and a clip, stand rejected as obvious over Womack in
view of Raulerson and Secord (Final Act. 10). The Examiner relies on
Womack for disclosing substantially the invention claimed, except for the
recited clip having arcuate sections (Final Act. 10-11 ). The Examiner relies
on the clip disclosed in Raulerson, finding that its clip "prevents a catheter
from snagging or accidental dislodging." (Final Act. 11, citing Raulerson ,r,r
4, 6). Thus, the Examiner concludes that:
One would [have been] motivated to modify Womack with the
clip of Raulerson to prevent the catheter from snagging while it
extends through a patient's urinary system. Therefore, it would
have been obvious to one of ordinary skill in the art at the time
the invention was made to modify Womack with the clip of
Raulerson in order to protect an invasive catheter against tugging
or dislodging.
(Final Act. 11 ).
The Appellant relies on unpersuasive arguments submitted with
respect to claims 1 and 5 discussed above for patentability of claims 10 and
14 (App. Br. 19). The Appellant also argues that "the Examiner has not
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carried the burden of providing evidence that the Foley catheter 10 of
Womack extending from a bladder of a patient runs a risk of snagging" or
dislodging (App. Br. 18). According to the Appellant, "since the housing 14
of the Foley catheter 10 [of] Womack containing the drainage tube 19
extends from the person of the patient to the combining chamber 34 over a
short distance, there does not appear to be any risk of the housing 14
snagging." (App. Br. 18).
The Appellant's argument is unpersuasive in that while the distance
between the patient and the combining chamber may be short, Figure 1 of
Womack depicts the ureteral catheters 46, 48 bowing outwardly away from
the Foley catheter 10, suggesting a risk of snagging if left unsecured. Thus,
we agree with the Examiner (Ans. 23) that shortening the size and length of
this gap by using clips will reduce the risk of snagging.
The Appellant also argues that "Womack has a balloon 18 expanded
within a bladder to hold the catheter in place" so there is no risk of
dislodging (App. Br. 18). However, we also agree with the Examiner that
"[a] skilled artisan would have sought to avoid pulling or tugging on this
catheter and its balloon, to avoid damaging the urethra or bladder neck."
(Ans. 23). The Appellant further argues that "the Examiner has not
explained how a Raulerson clip could possibly hold the three catheters 10,
46 and 48 or do so without kinking of the ureteral catheters 36, 38." (App.
Br. 19). However, the basis of this argument appears to pertain to sizing,
which is unpersuasive for the reasons already discussed above.
Therefore, in view of the above considerations, we affirm Rejection 5.
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Rejection 6
Claims 11 and 12 stand rejected as obvious over Womack in view of
Raulerson, Secord, and Smith (Final Act. 12). The Appellant states that
claim 11 stands or falls with claim 2, and relies on dependency of claim 12
for patentability (App. Br. 20). Accordingly, having found that claim 2 is
not patentable, we affirm Rejection 6.
Rejection 7
Claim 13 stands rejected as obvious over Womack in view of
Raulerson, Secord, and Shirley (Final Act. 14). The Appellant states that
claim 13 stands or falls with claim 9 (App. Br. 20). Accordingly, having
found that claim 9 is not patentable, we affirm Rejection 7.
Rejection 8
Claims 15 and 16 stand rejected as obvious over Womack in view of
Prichard (Final Act. 14). The Appellant states that claim 15 stands or falls
with claim 1 (App. Br. 20). The Appellant also argues that Prichard does not
recite the term "tapered" as asserted by the Examiner (App. Br. 20).
However, the portion of Prichard cited by the Examiner references Figure 1
which clearly shows a tapered channel (see Prichard, Fig. 1 ). The Examiner
also correctly points out that "Fig. 5 of Prichard clearly shows a tapered
channel." (Ans. 25). Accordingly, having found that claim 1 is not
patentable, and the proffered argument unpersuasive, we affirm Rejection 8.
Rejection 9
Claim 17 stands rejected as obvious over Raulerson in view of Secord
and Bush (Final Act. 16). The Appellant states that claim 17 stands or falls
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with claim 1 (App. Br. 20). Accordingly, having found that claim 1 is not
patentable, we affirm Rejection 9.
CONCLUSION
The Examiner's rejection of claims 1-17 is AFFIRMED.
No time period for 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
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