Ex Parte Hanlon et al

Patent Trial and Appeal Board

Jan 8, 2018

13663771 (P.T.A.B. Jan. 8, 2018)

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.
13/663,771 10/30/2012 Matthew A. Hanlon 060210.00649 2187
27305 7590 01/10/2018
HOWARD & HOWARD ATTORNEYS PLLC
450 West Fourth Street
Royal Oak, MI 48067
EXAMINER
DELLA, JAYMI E
ART UNIT PAPER NUMBER
3739
NOTIFICATION DATE DELIVERY MODE
01/10/2018 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):
IPDocket@HowardandHoward.com
dtrost @ HowardandHoward. com
tmorris @ Howardandhoward. com
PTOL-90A (Rev. 04/07)
UNITED STATES PATENT AND TRADEMARK OFFICE
BEFORE THE PATENT TRIAL AND APPEAL BOARD
Ex parte MATTHEW A. HANLON, JAMES C. EASLEY,
and ROBERT F. SPETZLER
Appeal 2017-000455
Application 13/663,771
Technology Center 3700
Before DEBORAH KATZ, RICHARD J. SMITH, and
TIMOTHY G. MAJORS, Administrative Patent Judges.
MAJORS, Administrative Patent Judge.
DECISION ON APPEAL
Appellants1 submit this appeal under 35 U.S.C. § 134(a) involving
claims to disposable forceps, which have been rejected as obvious and for
nonstatutory double patenting. We have jurisdiction under 35 U.S.C. § 6(b).
We AFFIRM.
1 Appellants identify the Real Party in Interest as Synergetics, Inc. Br. 2.
By Power of Attorney submitted June 1, 2016, however, applicants identify
Stryker Corporation as assignee of the present application.
Appeal 2016-000455
Application 13/663,771
STATEMENT OF THE CASE
Appellants’ “invention pertains to disposable, bipolar electrosurgical
forceps that are designed to prevent the sticking of body tissue to the tips of
the forceps.” Spec. 11.
In describing known bipolar electrosurgical forceps, the Specification
states that the tips of the forceps (the portions contacting body tissue) are
typically constructed with a biocompatible material. Id. 12. According to
the Specification, “the biocompatible material commonly used on the tips of
the forceps is an expensive metal such as stainless steel, titanium, tungsten
and gold or silver.” Id. The Specification explains that “current passing
through the forceps tips and the body tissue . . . causes the tissue to be joined
or coagulated,” but “the heat produced in the forceps tips can also result in
pieces of the body tissue sticking to the tips.” Id. Tflf 3^4. “[Sterilization of
the forceps following the surgical procedure requires scrubbing or scraping
of the forceps tips to remove the body tissue,” which “can also result in a
portion of the expensive biocompatible metal being removed from the tips.”
Id. 14. Over time, the Specification explains, repeated sterilization (e.g.,
scrubbing) may remove a sufficient amount of the biocompatible metal so
that the expensive instrument is no longer useful and must be discarded. Id.
To address the stated disadvantages with known forceps designs, the
Specification discloses that “what is needed is a novel construction of
bipolar forceps that provides biocompatible metal at the forceps distal ends,
but is constructed in a manner that reduces manufacturing costs and enables
disposal of the forceps after one use.” Id. 17.
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Claims 10, 12—14, and 16—20 are on appeal.2 Claim 10 is illustrative
10. Disposable, tissue sticking resistant forceps comprising:
first and second elongate pincers consisting of copper,
each first and second elongate pincer having an intermediate
body portion that is shaped and dimensioned to be held in a single
hand, and each first and second elongate pincer having a
proximal end portion and a distal end portion at opposite ends of
the intermediate body portion, the first and second elongate
pincer proximal end portions being secured together;
first and second electrically conductive cords permanently
secured to the proximal end portions of the respective first and
second elongate pincers, the first and second electrically
conductive cords each having flexible lengths that extend from
the first and second pincers to first and second electrical
connectors on the respective first and second electrically
conductive cords; and,
first and second tips on the distal end portions of the
respective first and second elongate pincers, each of the first and
second tips consisting of a layer of a biocompatible metal on the
copper at only the first and second tips of the first and second
elongate pincers, where the layer of biocompatible metal has a
thickness that is not more than 0.010 inches.
Br. 15 (Claims App.).
The claims stand rejected as follows:
I. Claims 10, 12—14, 17, and 18 under 35 U.S.C. § 103(a) over
Bagley,3 Eggers,4 and Asahara.5 Final Act.6 9-14.
2 Claims 1—9 were canceled by an after-final amendment. See Adv. Act. 1
(Sept. 4, 2015).
3 Bagley, US 4,100,489, issued Aug. 13, 1963.
4 Eggers et al., US 5,484,436, issued Jan. 16, 1996.
5 Asahara et al., EP 1 709 923 A2, published Oct. 11, 2006.
6 Final Rejection mailed Feb. 2, 2015 (hereinafter “Final Act.”).
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Application 13/663,771
II. Claims 16, 19, and 20 under 35 U.S.C. § 103(a) over Bagley,
Eggers, Asahara, and Kirwan.7 Id. at 14—15; see also id. at 6.
III. Claims 10, 12—14, and 16—20 for nonstatutory double patenting
over claims 1—17 ofU.S. Patent No. 8,361,070 B2. Id. at 15—
16.
I & II
Issue
Appellants did not provide separate argument related to Rejection II,
which rejection relates to certain dependent claims and relies on Rejection I
— the combination of Bagley, Eggers, and Asahara as demonstrating the
obviousness of, inter alia, independent claims 10 and 18. We, thus, address
Rejections I and II together.
We also note that Appellants argue the patentability of the rejected
claims as a group. Accordingly, we select independent claim 10 as
representative. 37 C.F.R. § 41.37(c)(l)(iv).
The issue is: has the Examiner established by a preponderance of the
evidence that claim 10 would have been obvious over Bagley, Eggers, and
Asahara?
Findings of Fact (FF)
The Examiner’s findings of fact and statement of the rejection are
provided at pages 9-15 of the Final Rejection dated Feb. 2, 2015. See also
1 Kirwan, JR. et al., US 2004/0034349 Al, published Feb. 19, 2004
(“Kirwan”).
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Application 13/663,771
Final Act. 16—18; Ans. 2—5. The following findings are provided for
emphasis and convenient reference.
FF 1. The Specification defines “disposable” as being “specifically
designed for one use in an electrosurgical procedure and for disposal after
that one use.” Spec. 1 8.
FF 2. Bagley teaches a cautery instrument, and more specifically
electro-coagulation forceps and circuits for use with such forceps. Bagley
Figs. 1—4; see also id. 1:52—65.
FF 3. Fig. 3 of Bagley, reproduced below, is a cross-sectional view of
electro-surgical forceps.
Id. Fig. 3. Fig. 3 shows, among other things, metal forceps body (27),
including forceps tips (30 and 31). Id. at 2:31—70. Fig. 3 further shows
conductor wires (25 and 26), which are respectively electrically connected to
the metal forceps body at connector member (33) and pin (34). Id. at 2:28—
31 and 2:49-62. Conductor wires are further in electrical contact with
switch contacts (28 and 29) on the opposing arms of the forceps. Id. at
2:28-40. Bagley teaches “switch contacts 28 and 29 are disposed on the
inside surfaces of the arms of the forceps so as to touch one another when
the forceps arms are closed under pressure from the surgeon’s fingers to
bring the tips 30 and 31 together.” Id. at 2:41—45. Bagley further teaches
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the forceps may be partially coated with an insulating material (e.g., rubber)
(36). Id. at 2:63—71.
FF 4. Eggers relates to “[bjipolar electrosurgical instruments having
simplified structures which are manufactured using improved manufacturing
techniques.” Eggers 1:58—62; see also id. Abstract (“Bipolar surgical
instruments for simultaneously cutting and coagulating tissue,” having
“increased manufacturability and durability, reduced component cost and
reduced assembly requirements.”). Instruments exemplified in Eggers
include bipolar electrosurgical scissors for cutting and cauterizing tissue. Id.
Fig. 1,2:51-55.
FF 5. Eggers teaches “materials of high electrical and thermal
conductivity, and structurally strong enough for shearing tissue, such as
copper or copper alloys, may be used” to make the bipolar surgical
instruments. Id. at 3:14—18.
FF 6. Asahara teaches “bipolar forceps that are used for coagulation,
dissection or similar surgical manipulation by the application of high-
frequency current in a surgical operation, which suppresses attachment and
sticking of burned protein to arm tip portions.” Asahara, Abstract.
FF 7. Asahara teaches a forceps design wherein
each opposed surface la of each [forceps] tip end portion 1 is
plated, by bright dipping, with a noble-metal plated film 2
excellent in thermal and electrical conductivity and having as
much flattened or smoothed surface as possible to provide
microscopic current density on the tip end portion 1 of each arm
to thereby prevent temperature variations.
Id. 1 5; see also id. Fig. 2. Asahara teaches noble-metals “excellent in
electrical and thermal conductivity and excellent in biocompatibility”
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include “gold, platinum, silver, palladium, nickel, chromium, copper, and
tin.” Id. 125.
FF. 8. According to Asahara, the bright-dipping method is “effective
to some extent” and “is an easy method to improve the corrosiveness and
conductivity of the arms.” Id. 1 5. Asahara teaches, however, that the
bright-dipping method “is not effective enough to suppress the deposition of
protein on the tip end portion,” so another method involving coating the
forceps tips with a composite/laminate film is also described. Id.', see also
id. 24—32, Fig. 1 (composite film (3) formed of a noble metal (3a), non-
conductive fine particles (3b) and a dispersing agent (not shown), and
laminate film (4) comprising a noble-metal material); see also id. 1136-46
(comparative testing). Asahara teaches the thickness of the composite film
is “in the range of 3 pm or more to 50 pm.” Id. 128. Asahara teaches the
laminate film thickness is “in the range of 0.2 pm to 10 pm.” Id. 131.
Analysis
Claim 10
The Examiner finds Bagley teaches the forceps of claim 10 with a few
exceptions. Final Act. 9—11. First, the Examiner finds, “Bagley fails to
disclose the pincers being constructed entirely of copper.” Id. at 10.
Second, the Examiner finds, Bagley does not disclose “a layer of a
biocompatible metal... at only the first and second tips of the pincers”
having the layer thickness (“not more than 0.010 inches” (256 microns))
required by claim 10. Id. at 10. So, the Examiner turns to Eggers and
Asahara. Id. at 10-11.
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According to the Examiner, Eggers teaches “electrosurgical forceps
(10) comprising pincers (11, 12), the pincers being made of copper,” and
Asahara teaches plating the tips of the forceps with a biocompatible noble
metal. Id. The Examiner concludes it would have been obvious to modify
Bagley’s device so the pincers are made of copper “to provide the benefit of
a material of high electrical and thermal conductivity as taught by Eggers,”
and to coat the tips of Bagley’s forceps with a noble metal “to provide the
benefit of improving the corrosiveness and conductivity of the arms” as
taught by Asahara. Id. The Examiner notes that Asahara does not expressly
disclose the thickness of the noble-metal coating according to the bright-
dipping method, but the Examiner cites the thickness of the composite film
coating in Asahara’s alternative embodiment (e.g., 13—60 micrometers). Id.
at 11. From that teaching and based on routine experimentation, the
Examiner reasons the skilled person would have found obvious a noble-
metal coating on the tips of less than 256 microns/0.010 inches as recited in
claim 10. Id.
Unless otherwise indicated, we agree with and adopt the Examiner’s
findings of fact and conclusion that claim 10 would have been obvious over
Bagley, Eggers, and Asahara. The Examiner provided sufficient articulated
reasoning with rational underpinning for modifying Bagley’s forceps to
make the pincers out of copper. Eggers suggests copper is a durable,
relatively inexpensive, and highly conductive material, which would provide
advantages for the electrosurgical forceps like described in Bagley. FF 4—5.
Although Eggers exemplifies electrosurgical scissors, we are unpersuaded
the skilled artisan would read its teachings so narrowly. Quite the opposite,
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Eggers generally describes “[h]emostatic bipolar electrosurgical instruments
which both manipulate, or sever, and coagulate tissue.”8 Eggers, 1:17—18.
Whether the instrument is holding and cauterizing/coagulating tissues (as
with forceps) or cutting and cauterizing/coagulating tissues (as with the
scissors exemplified in Eggers), the basic electrosurgical principles used in
these devices significantly overlap.
As for coating the tips of the forceps with a biocompatible metal,
Asahara provides a reason for that modification. Asahara teaches coating
the tips with a noble metal (e.g., gold) provides improved conductivity and
protection against corrosion. FF 6—7. Moreover, Asahara teaches that bright
dipping with gold reduced protein adhesion and deposition compared to
titanium or stainless-steel tipped forceps. FF 8; see also Asahara 139 (Table
1 (Comparative Example 3 (gold-plated) vs. Comparative Examples 1
(stainless steel) and 2 (titanium)). Although Asahara’s composite films
(e.g., gold mixed with PTFE fine particles) provided even better resistance
against protein deposition than the gold bright-dipped forceps {id.),
obviousness does not require the combination be the best or “most desirable
combination available.” In re Fulton, 391 F.3d 1195, 1200 (Fed. Cir. 2004).
Below we further address Appellants’ arguments.
Appellants argue claim 10 is directed to “disposable” forceps, and that
neither Bagley nor the other cited references disclose forceps designed for
8 We observe that Eggers further identifies additional patents and
incorporates their contents in the entirety. At least one of those patents (US
5,330,471, issued Jul. 19, 1994, col. 3:8—15) expressly describes bipolar
electrosurgical forceps.
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disposal after a single use. Br. 6. We agree with Appellants that
“disposable” is defined in the Specification. Id. It means “the forceps are
specifically designed for one use in an electrosurgical procedure and for
disposal after than one use.” FF 1; Spec. 1 8.
Notwithstanding the above, the claim term “disposable” fails to
structurally distinguish over the prior art in the Examiner’s combination.
Claim 10 is directed to an apparatus (forceps), not a method of using that
apparatus. “[T]he patentability of apparatus or composition claims depends
on the claimed structure, not on the use or purpose of that structure.”
Catalina Mktg. Inti, Inc. v. Coolsavings.com, Inc., 289 F.3d 801, 809 (Fed.
Cir. 2002). And the term “disposable” appears only in the preamble and
reflects an intended use of the forceps. “‘[PJreamble language that merely
states the purpose or intended use of an invention is generally not treated as
limiting the scope of the claim.’” Marrin v. Griffin, 599 F.3d 1290, 1294
(Fed. Cir. 2010) (quoting Bicon, Inc. v. Straumann Co., 441 F.3d 945, 952
(Fed. Cir. 2006)). So too, the definition of “disposable” does not add
structure, but merely informs how the claimed forceps are to be used — for
one surgical procedure and then discarded. Hence, the recitation of
“disposable” in the claim is not limiting, and the absence of express mention
of “disposable” forceps in the cited prior art does not demonstrate error in
the rejection.
Even if the term “disposable” was limiting, it is at best functional
language. As such, the Examiner need only establish that the prior art is
capable of being discarded after a single use. See In re Swinehart, 439 F.2d
210, 213 (CCPA 1971). Although some of the prior art forceps designs
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might be more costly to make, as the Examiner notes, “the forceps are still
capable of being disposed of/thrown away after being used.” Ans. 2—3.
Appellants, in identifying additional components (e.g., switch contacts, a
conducting pin, etc.) that are in Bagley’s design, fail to provide persuasive
evidence that Bagley’s forceps are not capable of being disposed of after a
single use. Br. 7—8. Again, Appellants identify no material structural
difference between claim 10 and the prior art as modified by the Examiner.
Appellants argue Eggers does not teach use of copper for the pincers
of electrosurgical forceps, but rather for scissors. Br. 8—9. According to
Appellants, Eggers is non-analogous art. Id. at 9.
Appellants’ argument is unpersuasive. Eggers relates more generally
to electrosurgical coagulating instruments and thus is in the same field of
endeavor as the inventors here. Ans. 3. Appellants assert a distinction
between cutting tissue with scissors and joining tissue with forceps. Br. 9.
As explained above, we are not persuaded the field should be parsed so
narrowly. True, scissors cut and forceps hold. But both handheld devices
apply electricity and heat along opposing metallic arms to a targeted area to
coagulate tissues at the surgical site.
Even if the inventors’ field of endeavor and that described in Eggers
were different, Eggers is reasonably pertinent to the problem the inventors
were trying to solve. As the Examiner points out, Eggers teaches copper is
an excellent material for an electrosurgical electrode having high thermal
and electrical conductivity. Ans. 3. The claimed electrosurgical forceps
operate on this same principle, and require conductive electrode pincers or
arms like Eggers’s scissors. Spec. Tflf 1,3. Also, the pertinence of Eggers to
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the invention is all the more evident in view of Eggers’s teaching that its
electro surgical-instrument design is simplified and lower cost — problems
that expressly motivated the inventors’ forceps design here. FF 4—5; see
Spec. 119 (“the construction of the forceps is simplified and comprises a
minimum number of parts to reduce the manufacturing costs”).
Appellants argue Asahara discloses reusable, not “disposable,”
forceps, and that the Examiner is using impermissible hindsight to find any
teaching in the art of disposable forceps. Br. 10—11. This argument is
unpersuasive for reasons already explained. “Disposable” as recited does
not structurally limit the claim, and whether Asahara’s forceps are “intended
to be reused” or cleaned is irrelevant absent identification of structural
differences between apparatus claim 10 and the prior art. Id. at 11.
Appellants argue Asahara’s teaching of noble-metal coatings on the
pincer tips “is not a complete solution to the problem” of protein deposition,
and thus Asahara “teaches away” from the limitations of claim 10. Br. 11—
12. We disagree. In re Fulton, 391 F.3d at 1201 (“The prior art’s mere
disclosure of more than one alternative does not constitute a teaching away
from . . . alternatives because such disclosure does not criticize, discredit, or
otherwise discourage the solution claimed.”). An “obvious composition
does not become patentable simply because it has been described as
somewhat inferior to some other product for the same use.” In re Gurley, 27
F.3d 551, 553 (Fed. Cir. 1994); see also In reMouttet, 686 F.3d 1322, 1334
(Fed. Cir. 2012) (“[J]ust because better alternatives exist in the prior art does
not mean that an inferior combination is inapt for obviousness purposes.”).
The existence of better alternatives (e.g., gold composite film) in Asahara is,
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thus, not a teaching away from less effective alternatives (e.g., gold bright-
dipped coating). FF 7—8. On the record here, a skilled person would still
have a reason to use noble-metal tipped pincers and would reasonably expect
that design would provide some improvement against protein deposition,
while also providing improved conductivity and resistance to corrosion for
the reasons explained above. FF 6—7.
Finally, Appellants argue the composite film cited by the Examiner as
meeting the thickness limitation of claim 10 includes “three elements” and
does not satisfy the claim, which recites “pincers consisting of a layer of
biocompatible metal... at only the first and second tips.” Br. 13 (emphasis
added). According to Appellants, one of the three elements of the composite
film is a noble metal, but the film also includes non-conductive fine particles
and a dispersing agent. Id.
We remain unpersuaded. Although Asahara does not expressly
disclose the thickness of the bright-dipped (noble-metal only) coating, the
Examiner’s citation to the thickness of Asahara’s alternative embodiment
(composite-film coating) as providing a suggestion to the skilled person was
reasonable. Ans. 4—5. Indeed, absent evidence to the contrary, we are
persuaded the skilled person would use the range (e.g., 13—60 pm) of the
alternative embodiment as a guide and experiment accordingly with the
coatings consisting of the noble metal alone. The drawings, while not
dispositive, suggest a comparable thickness of the composite film and the
bright-dipped coating. Asahara Figs. 1—2. And we find nothing in Asahara
to indicate the noble-metal coating should be orders of magnitude thicker
than the composite film, such that the coating would fall outside the broad
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thickness range of claim 10 — essentially anything between 0 and 256
microns. As the range recited in claim 10 wholly encompasses the
thicknesses exemplified in Asahara, the Examiner has made a prima facie
showing on this record that the art teaches or suggests a layer of
biocompatible metal on the pincer tips with the relevant thickness.
Conclusion of Law
The preponderance of the evidence supports the Examiner’s
conclusion that claim 10 would have been obvious over Bagley, Eggers, and
Asahara. Claims 12—14, 17, and 18 have not been argued separately and
therefore fall with claim 10. As pointed out above, Appellants did not argue
Rejection II separately, and we thus affirm the rejection of claims 16, 19,
and 20 as obvious over Bagley, Eggers, Asahara, and Kirwan as well.
Ill
Appellants did not argue the rejection of the claims for double
patenting. The rejection is summarily affirmed. Hyatt v. Dudas, 551 F.3d
1307, 1314 (Fed. Cir. 2008).
SUMMARY
We affirm the rejection of claims 10, 12—14, and 16—20 as obvious.
We further affirm the rejection of claims 10, 12—14, and 16—20 for
nonstatutory double patenting.
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TIME PERIOD FOR RESPONSE
No time period for taking any subsequent action in connection with
this appeal may be extended under 37 C.F.R. § 1.136(a).
AFFIRMED
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