Francis Derk et al.

Patent Trials and Appeals Board

Mar 31, 2021

2020005136 (P.T.A.B. Mar. 31, 2021)

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.
15/414,715 01/25/2017 Francis F. Derk ALO-10002 2943
131270 7590 03/31/2021
BELZER PC
ATTN: John G. Posa
2905 Bull St.
Savannah, GA 31405
EXAMINER
BYRD, BRIGID K
ART UNIT PAPER NUMBER
3771
NOTIFICATION DATE DELIVERY MODE
03/31/2021 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):
231patents@gmail.com
johnposa@gmail.com
jposa@belzerlaw.com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
____________________

BEFORE THE PATENT TRIAL AND APPEAL BOARD
____________________

Ex parte FRANCIS F. DERK and DEREK T. DENTON
____________

Appeal 2020-005136
Application 15/414,715
Technology Center 3700
____________

Before SUSAN L. C. MITCHELL, BRANDON J. WARNER, and
LISA M. GUIJT, Administrative Patent Judges.

GUIJT, Administrative Patent Judge.

DECISION ON APPEAL

STATEMENT OF THE CASE
Appellant1 seeks our review under 35 U.S.C. § 134(a) of the rejection
of claims 1 and 3–9. We have jurisdiction under 35 U.S.C. § 6(b).
We REVERSE.
THE INVENTION
Appellant’s invention relates to “debridement and, in particular, to an
inexpensive, disposable yet effective tool for removal of dead, damaged, or
infected tissue.” Spec. ¶ 2. The sole independent claim on appeal, claim 1,
reproduced below, is illustrative of the subject matter on appeal.

1 We use the word “Appellant” to refer to “applicant” as defined in
37 C.F.R. § 1.42. Appellant identifies Francis F. Derk et al. as the real party
in interest. Appeal Br. 1.
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1. A wound debridement implement, comprising:
an elongated, integrally molded hand-held member having
a proximal handle with a gripping portion, a distal head portion,
and a flex portion between the handle and head portions;
the head portion defining a bottom surface with a plurality
of fluted structures, each fluted structure defining a partial,
truncated cone with a curving or semi-circular sharp edge
oriented toward the handle of the implement such that a user
pulls the implement toward them during debridement;
the handle portion being angled relative to the bottom
surface of the head portion; and
wherein the implement is packaged in sterilized form and
disposable after use.
THE REJECTIONS2
The Examiner relies upon the following as evidence in support of the
rejections:
NAME REFERENCE DATE
Barraclough US 2007/0208354 A1 Sept. 6, 2007
Grace US 2008/0091216 A1 Apr. 17, 2008
Keller US 2010/0145359 A1 June 10, 2010
Mercado US 2010/0228267 A1 Sept. 9, 2010
Hall US 2011/0282337 A1 Nov. 17, 2011
Luzon US 2013/0138119 A1 May 30, 2013
The following rejections are before us for review:
I. Claims 1, 3, 5, 6, 8, and 9 stand rejected under 35 U.S.C.
§ 103 as being unpatentable over Grace, Barraclough,
Keller, and Hall.

2 The Examiner’s objection to claim 1 and rejection of claim 9 under
35 U.S.C. § 112(b) have been withdrawn. Adv. Act. 1.
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II. Claim 4 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Grace, Barraclough, Keller, Hall, and
Luzon.
III. Claim 7 stands rejected under 35 U.S.C. § 103 as being
unpatentable over Grace, Barraclough, Keller, Hall, and
Mercado.

OPINION
Rejection I
Regarding independent claim 1, the Examiner finds that Grace
discloses a wound debridement implement comprising an elongated,
integrally molded hand-held member (i.e., carrier 60) having a proximal
handle with a gripping portion (i.e., handle section 64) and a distal head
portion (i.e., head section 62), as claimed. Final Act. 4 (citing Grace,
Abstract, ¶¶ 48–54, Figs. 4–11). The Examiner also finds that Grace’s head
portion (or head section 62) defines a bottom surface (i.e., the bottom
surface of blade body 71) with a plurality of fluted structures (i.e., teeth 73),
as claimed. Id.; see, e.g., Grace, Figs. 5, 6. The Examiner construes the
term “integral,” as in the claim language “integrally molded,” to mean
“‘formed as a unit with another part,’” and the Examiner finds that Grace’s
hand-held member (including carrier member 60, head section 62, and
handle section 64) is integrally molded. Ans. 3–4 (citing Grace ¶¶ 40, 48,
Fig. 4). The Examiner relies on Barraclough for disclosing a flex portion
(i.e., zone of flexure 52), on Hall for disclosing fluted structures, each
defining a partial, truncated cone with a curving or semi-circular sharp edge
(i.e., cutting features 616a), and on Keller for teaching a rasp packaged in
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sterilized form, as further required by claim 1. Final Act. 5–7 (citations
omitted).
Appellant argues that the “claimed integrally molded hand-held
member includes everything—a proximal handle and a distal head portion
defining a bottom surface with a plurality of fluted structures,” as compared
to Grace’s member, which “integrates a physically separate, metallic blade
body [made] by etching a flat blank of material to form . . . the teeth.”
Appeal Br. 3. Appellant submits that Grace’s device, as relied on by the
Examiner, “is not integrally molded,” but rather, “is intentionally
constructed to receive a removable/replaceable blade body 71.” Id. at 2–3
(citing Grace, Figs. 6, 7). Appellant explains that, whereas all of the recited
components comprising the claimed hand-held member are integrally
molded, “Grace’s member integrates a physically separate, metallic blade
body.” Id. at 3 (emphasis added) (also citing Grace ¶ 45). Appellant
submits that “[o]ne of skill in the art would appreciate that Appellant’s
implement is integrally molded, which dictates the same material for
everything” (emphasis added), and concludes that “Grace’s member
incorporates a physically separate, metallic blade body, precluding integral
molding.” Reply Br. 1–2.
During examination of a patent application, pending claims are given
their broadest reasonable construction consistent with the specification. In
re Am. Acad. of Sci. Tech Ctr., 367 F.3d 1359, 1364 (Fed. Cir. 2004). Under
the broadest reasonable interpretation standard, claim terms are given their
ordinary and customary meaning as would be understood by one of ordinary
skill in the art in the context of the entire disclosure. In re Translogic Tech.,
Inc., 504 F.3d 1249, 1257 (Fed. Cir. 2007). With respect to product-by-
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process claims, process steps are relevant to the extent they change a
structure or characteristic of the product which distinguishes it from
products made by other processes. See In re Garnero, 412 F.2d 276, 279
(CCPA 1979).
We agree with Appellant that the Examiner’s construction of the term
“integral” does not correspond to, or address correctly, the claim limitation
“integrally molded.” Appellant, however, does not give an express
definition of the claim language “integrally molded” or provide sufficient
support for concluding that “integrally molded” necessarily dictates that the
handle, head portion, and flex portion of the claimed member must all be
made from the same material. However, Appellant’s argument implies that
the claim language “integrally molded” is a process-by-product limitation
that results in a product having a distinctive structural characteristic, namely,
a unitary or one-piece construction, and for the reasons below, we agree.
Appellant’s Specification discloses that “[t]he preferred embodiment
comprises an elongated, integrally molded hand-held member having a
proximal handle with a gripping portion, a distal head portion, and a flex
portion between the handle and head portions.” Spec. ¶ 7 (emphasis added).
The Specification further discloses the meaning of “integrally molded” in
the context of the invention, stating that “[t]he implement is preferably
constructed as a unitary object, fabricated through injection molding,”
wherein “[a]ny number of plastics may be used for construction, including
PCV, polyethylene, and vinyl.” Id. ¶ 13 (emphasis added). Thus, on the
record before us, we find that the claim language “integrally molded” is a
product-by-process limitation that imparts a distinct structural characteristic
to the claimed member, namely, that the member is a unitary or one-piece
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object. We also find that claim 1 applies this structural limitation to the
bottom surface of the head portion, as well as to the fluted structures on the
head portion’s bottom surface. In other words, we construe the product-by-
process limitation of claim 1 (i.e., “integrally molded”) as requiring that the
handle with gripping portion, flex portion, and all of the head portion
defining a bottom surface with a plurality of fluted structures, together, are a
unitary, one-piece member.
Further, we are persuaded by Appellant’s argument that neither
Grace’s palm-held device with plastic carrier 22 encapsulating blade body
24 (see, e.g., Grace ¶¶ 26–28, 37–47, Figs. 1–3) nor Grace’s carrier 60
formed with head and handle sections 62, 64, wherein “head section 62 is
oval in configuration and adapted to receive a blade body, e.g., blade body
24 [formed from a blank]” (id. ¶ 48, Figs. 4, 5), are disclosed as unitary,
one-piece members. Rather, with respect to either carrier construction,
Grace discloses blade bodies 24, 71 as being formed from a blank, and
further, as being integrated into the carrier, such that blade bodies 24, 71 are
not unitary or a one-piece member with the carriers. See, e.g., id. ¶¶ 45, 49.
Although Grace discloses a “highly efficient manufacturing process,”
wherein the blade body and carrier “may be formed into a fully integrated
unit,” an integrated unit is not necessarily unitary. Id. ¶ 44 (emphasis
added). Thus, the Examiner errs by relying on Grace for disclosing an
integrally molded member having a handle and a head portion, wherein the
head portion defines a bottom surface with fluted structures.
Regarding the Examiner’s reliance on Hall, we also agree with
Appellant’s argument that Hall is not analogous art, for the reasons
discussed below. See, e.g., Appeal Br. 4 (submitting that Hall is in the field
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of endeavor of “invasive surgical procedures” and also “not reasonably
pertinent to any problems faced by Appellant”).
A reference qualifies as prior art for an obviousness determination
when it is analogous to the claimed invention. Innovention Toys, LLC. v.
MGA Entm’t., Inc., 637 F.3d 1314, 1321 (Fed. Cir. 2011).
Two separate tests define the scope of analogous prior art: (1)
whether the art is from the same field of endeavor, regardless of
the problem addressed, and (2) if the reference is not within the
field of the inventor’s endeavor, whether the reference still is
reasonably pertinent to the particular problem with which the
inventor is involved.
In re Bigio, 381 F.3d 1320, 1325 (Fed. Cir. 2004). The “field of endeavor”
test asks if the structure and function of the prior art is such that it would be
considered by a person of ordinary skill in the art because of similarity to the
structure and function of the claimed invention as disclosed in the
application. Id. at 1325–26. “A reference is reasonably pertinent if . . . it is
one which, because of the matter with which it deals, logically would have
commended itself to an inventor’s attention in considering his problem.” In
re Clay, 966 F.2d 656, 659 (Fed. Cir. 1992). “If a reference disclosure has
the same purpose as the claimed invention, the reference relates to the same
problem, and that fact supports use of that reference in an obviousness
rejection.” Id.
Here, we find that Hall, titled, “Instrument for Debriding Fistula and
Applying Therapeutic Cells,” is from the field of endeavor of “devices that
are operable to harvest tissue, mince or morcellate tissue, mix tissue particles
with other medical fluid components, and/or dispense a medical fluid at a
target site in a patient” (Hall ¶ 34), which is in a field of endeavor distinct
from the claimed wound debridement implement in the field of endeavor of
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hand-held devices for the debridement or removal of dead, damaged, or
infected surface tissue (see, e.g., Spec. ¶¶ 2, 4).
Regarding the second prong of the analogous art test, we also find that
Hall is not reasonably pertinent to particular problems with which Appellant
is involved with respect to the claimed invention; for example, Appellant’s
claimed invention addresses the need for an economical yet effective
alternative to somewhat complicated and expensive powered and non-
powered hand-held debridement tools. See id. ¶¶ 4–6. In particular,
Appellant’s problems are on a different structural scale than Hall’s teachings
regarding “[p]romoting and improving tissue healing around the fistula
opening and in a fistula tract” (Hall ¶ 2) or “harvest[ing] desired components
from a . . . tissue specimen” (id. ¶ 3).
Regarding Hall’s fluted structure (or cutting features 616a), as relied
on by the Examiner in the rejection of claim 1, Hall discloses that “the
cutting features (616a) may debride epithelial cells from the wall of a
fistula” (or an abnormal or surgically made passage between a hollow or
tubular organ and the body surface, or between two hollow or tubular
organs), and we do not view problems associated with debridement of
epithelial cells from the wall of a fistula to involve problems reasonably
pertinent to Appellant’s hand-held debridement device that removes dead,
damaged, or infected tissue from on exposed surface of a wound. Thus, Hall
is not analogous art to the claimed invention, and the Examiner improperly
relies on Hall in the obviousness rejection of claim 1.
Accordingly, for the reasons set forth above, we do not sustain the
Examiner’s rejection of independent claim 1 and dependent claims 3, 5, 6, 8,
and 9.
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Rejections II and III
The Examiner’s reliance on Luzon for teaching a ribbed or accordion-
shaped flex portion, and on Mercado for teaching a gripping portion with a
ruler or graduating markings, does not cure the deficiencies in the
Examiner’s findings with respect to Grace or improper reliance on Hall. See
Final Act. 9–10.
Accordingly, we do not sustain the Examiner’s rejections of claims 4
and 7.

CONCLUSION
In summary:
Claim(s)
Rejected
35
U.S.C.
§
Reference(s)/Basis Affirmed Reversed
1, 3, 5, 6,
8, 9
103 Grace, Barraclough, Hall 1, 3, 5, 6,
8, 9
4 103 Grace, Barraclough, Hall,
Luzon
4
7 103 Grace, Barraclough, Hall,
Mercado
7
Overall
Outcome
1, 3–9
REVERSED